Trial Outcomes & Findings for Semaglutide Effects on Heart Disease and Stroke in Patients With Overweight or Obesity (NCT NCT03574597)
NCT ID: NCT03574597
Last Updated: 2024-08-30
Results Overview
Number of participants with first occurrence of composite outcome measure consisted of CV death (undetermined cause of death presumed CV death), non-fatal MI, or non-fatal stroke are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
COMPLETED
PHASE3
17604 participants
From randomisation (week 0) up to 240 weeks
2024-08-30
Participant Flow
The participants were screened at 811 sites in 41 countries. Out of 811 sites, participants were randomised at 804 sites.
Participants were randomized in a 1:1 ratio to receive treatment with either semaglutide or placebo as an adjunct to standard-of-care.
Participant milestones
| Measure |
Semaglutide
Participants received semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 16 (0.25 milligrams \[mg\], 0.5 mg, 1.0 mg and 1.7 mg) followed by maintenance dose of 2.4 mg once weekly up to the end of treatment period.
|
Placebo
Participants received placebo (matched to semaglutide) subcutaneously once weekly up to the end of treatment period.
|
|---|---|---|
|
Overall Study
STARTED
|
8803
|
8801
|
|
Overall Study
Full Analysis Set (FAS)
|
8803
|
8801
|
|
Overall Study
COMPLETED
|
8544
|
8517
|
|
Overall Study
NOT COMPLETED
|
259
|
284
|
Reasons for withdrawal
| Measure |
Semaglutide
Participants received semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 16 (0.25 milligrams \[mg\], 0.5 mg, 1.0 mg and 1.7 mg) followed by maintenance dose of 2.4 mg once weekly up to the end of treatment period.
|
Placebo
Participants received placebo (matched to semaglutide) subcutaneously once weekly up to the end of treatment period.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
67
|
96
|
|
Overall Study
Lost to Follow-up
|
192
|
188
|
Baseline Characteristics
Semaglutide Effects on Heart Disease and Stroke in Patients With Overweight or Obesity
Baseline characteristics by cohort
| Measure |
Semaglutide
n=8803 Participants
Participants received semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 16 (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) followed by maintenance dose of 2.4 mg once weekly up to the end of treatment period.
|
Placebo
n=8801 Participants
Participants received placebo (matched to semaglutide) subcutaneously once weekly up to the end of treatment period.
|
Total
n=17604 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.6 Years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
61.6 Years
STANDARD_DEVIATION 8.8 • n=7 Participants
|
61.6 Years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2448 Participants
n=5 Participants
|
2424 Participants
n=7 Participants
|
4872 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6355 Participants
n=5 Participants
|
6377 Participants
n=7 Participants
|
12732 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
914 Participants
n=5 Participants
|
908 Participants
n=7 Participants
|
1822 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7794 Participants
n=5 Participants
|
7817 Participants
n=7 Participants
|
15611 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
95 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
171 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
23 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
720 Participants
n=5 Participants
|
727 Participants
n=7 Participants
|
1447 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
348 Participants
n=5 Participants
|
323 Participants
n=7 Participants
|
671 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
7387 Participants
n=5 Participants
|
7404 Participants
n=7 Participants
|
14791 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
227 Participants
n=5 Participants
|
247 Participants
n=7 Participants
|
474 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
95 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
169 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From randomisation (week 0) up to 240 weeksPopulation: FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation.
Number of participants with first occurrence of composite outcome measure consisted of CV death (undetermined cause of death presumed CV death), non-fatal MI, or non-fatal stroke are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Outcome measures
| Measure |
Semaglutide
n=8803 Participants
Participants received semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 16 (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) followed by maintenance dose of 2.4 mg once weekly up to the end of treatment period.
|
Placebo
n=8801 Participants
Participants received placebo (matched to semaglutide) subcutaneously once weekly up to the end of treatment period.
|
|---|---|---|
|
Participants From Time of Randomization to First Occurrence of a Composite Outcome Measure Consisting of: Cardiovascular (CV) Death, Non-fatal Myocardial Infarction (MI), or Non-fatal Stroke
|
569 Participants
|
701 Participants
|
SECONDARY outcome
Timeframe: From randomisation (week 0) up to 240 weeksPopulation: FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation.
Number of participants with CV death are presented. The outcome measure was evalulated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Outcome measures
| Measure |
Semaglutide
n=8803 Participants
Participants received semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 16 (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) followed by maintenance dose of 2.4 mg once weekly up to the end of treatment period.
|
Placebo
n=8801 Participants
Participants received placebo (matched to semaglutide) subcutaneously once weekly up to the end of treatment period.
|
|---|---|---|
|
Participants From Time of Randomisation to CV Death
|
223 Participants
|
262 Participants
|
SECONDARY outcome
Timeframe: From randomisation (week 0) up to 240 weeksPopulation: FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation.
Number of participants with first occurrence of a composite HF outcome measure consisted of HF hospitalisation, urgent HF visit or CV death are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Outcome measures
| Measure |
Semaglutide
n=8803 Participants
Participants received semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 16 (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) followed by maintenance dose of 2.4 mg once weekly up to the end of treatment period.
|
Placebo
n=8801 Participants
Participants received placebo (matched to semaglutide) subcutaneously once weekly up to the end of treatment period.
|
|---|---|---|
|
Participants From Time of Randomisation to First Occurrence of a Composite Heart Failure (HF) Outcome Measure Consisting of: HF Hospitalisation, Urgent HF Visit or CV Death
|
300 Participants
|
361 Participants
|
SECONDARY outcome
Timeframe: From randomisation (week 0) up to 240 weeksPopulation: FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation.
Number of participants with all-cause death are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Outcome measures
| Measure |
Semaglutide
n=8803 Participants
Participants received semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 16 (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) followed by maintenance dose of 2.4 mg once weekly up to the end of treatment period.
|
Placebo
n=8801 Participants
Participants received placebo (matched to semaglutide) subcutaneously once weekly up to the end of treatment period.
|
|---|---|---|
|
Participants From Time of Randomisation to All-cause Death
|
375 Participants
|
458 Participants
|
SECONDARY outcome
Timeframe: From randomisation (week 0) up to 240 weeksPopulation: FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation.
Number of participants with first occurrence of an expanded composite CV outcome measure consisted of CV death, non-fatal MI, non-fatal stroke, coronary revascularisation or UAP requiring hospitalisation are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Outcome measures
| Measure |
Semaglutide
n=8803 Participants
Participants received semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 16 (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) followed by maintenance dose of 2.4 mg once weekly up to the end of treatment period.
|
Placebo
n=8801 Participants
Participants received placebo (matched to semaglutide) subcutaneously once weekly up to the end of treatment period.
|
|---|---|---|
|
Participants From Time of Randomisation to First Occurrence of an Expanded Composite CV Outcome Measure Consisting of: CV Death, Non-fatal MI, Non-fatal Stroke, Coronary Revascularisation or Unstable Angina Pectoris (UAP) Requiring Hospitalisation
|
873 Participants
|
1074 Participants
|
SECONDARY outcome
Timeframe: From randomisation (week 0) up to 240 weeksPopulation: FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation.
Number of participants with first occurrence of a composite outcome measure consisted of all-cause death, non-fatal MI, or non-fatal stroke are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Outcome measures
| Measure |
Semaglutide
n=8803 Participants
Participants received semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 16 (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) followed by maintenance dose of 2.4 mg once weekly up to the end of treatment period.
|
Placebo
n=8801 Participants
Participants received placebo (matched to semaglutide) subcutaneously once weekly up to the end of treatment period.
|
|---|---|---|
|
Participants From Time of Randomisation to First Occurrence of a Composite Outcome Measure Consisting of: All-cause Death, Non-fatal MI, or Non-fatal Stroke
|
710 Participants
|
877 Participants
|
SECONDARY outcome
Timeframe: From randomisation (week 0) up to 240 weeksPopulation: FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation.
Number of participants with first occurrence of non-fatal MI are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Outcome measures
| Measure |
Semaglutide
n=8803 Participants
Participants received semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 16 (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) followed by maintenance dose of 2.4 mg once weekly up to the end of treatment period.
|
Placebo
n=8801 Participants
Participants received placebo (matched to semaglutide) subcutaneously once weekly up to the end of treatment period.
|
|---|---|---|
|
Participants From Time of Randomisation to First Occurrence of Non-fatal MI
|
234 Participants
|
322 Participants
|
SECONDARY outcome
Timeframe: From randomisation (week 0) up to 240 weeksPopulation: FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation.
Number of participants with first occurrence of non-fatal stroke are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Outcome measures
| Measure |
Semaglutide
n=8803 Participants
Participants received semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 16 (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) followed by maintenance dose of 2.4 mg once weekly up to the end of treatment period.
|
Placebo
n=8801 Participants
Participants received placebo (matched to semaglutide) subcutaneously once weekly up to the end of treatment period.
|
|---|---|---|
|
Participants From Time of Randomisation to First Occurrence of Non-fatal Stroke
|
154 Participants
|
165 Participants
|
SECONDARY outcome
Timeframe: From randomisation (week 0) up to 240 weeksPopulation: FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation.
Number of participants with first occurrence of coronary revascularisation are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Outcome measures
| Measure |
Semaglutide
n=8803 Participants
Participants received semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 16 (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) followed by maintenance dose of 2.4 mg once weekly up to the end of treatment period.
|
Placebo
n=8801 Participants
Participants received placebo (matched to semaglutide) subcutaneously once weekly up to the end of treatment period.
|
|---|---|---|
|
Participants From Time of Randomisation to First Occurrence of Coronary Revascularisation
|
473 Participants
|
608 Participants
|
SECONDARY outcome
Timeframe: From randomisation (week 0) up to 240 weeksPopulation: FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation.
Number of participants with first occurrence of UAP requiring hospitalisation are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Outcome measures
| Measure |
Semaglutide
n=8803 Participants
Participants received semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 16 (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) followed by maintenance dose of 2.4 mg once weekly up to the end of treatment period.
|
Placebo
n=8801 Participants
Participants received placebo (matched to semaglutide) subcutaneously once weekly up to the end of treatment period.
|
|---|---|---|
|
Participants From Time of Randomisation to First Occurrence of UAP Requiring Hospitalisation
|
109 Participants
|
124 Participants
|
SECONDARY outcome
Timeframe: From randomisation (week 0) up to 240 weeksPopulation: FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation.
Number of participants with first occurrence of HF requiring hospitalisation or urgent HF visit are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Outcome measures
| Measure |
Semaglutide
n=8803 Participants
Participants received semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 16 (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) followed by maintenance dose of 2.4 mg once weekly up to the end of treatment period.
|
Placebo
n=8801 Participants
Participants received placebo (matched to semaglutide) subcutaneously once weekly up to the end of treatment period.
|
|---|---|---|
|
Participants From Time of Randomisation to First Occurrence of HF Requiring Hospitalisation or Urgent HF Visit
|
97 Participants
|
122 Participants
|
SECONDARY outcome
Timeframe: From randomisation (week 0) up to 240 weeksPopulation: FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation. Here, overall number of participants analyzed = number of participants with HbA1c less than (\<) 48 mmol/mol (6.5%) at screening. Participants with ≥ 48 mmol/mol (6.5%) at screening were excluded from this analysis.
Number of participants with first occurrence of HbA1c ≥ 48 mmol/mol (6.5%) are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Outcome measures
| Measure |
Semaglutide
n=8800 Participants
Participants received semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 16 (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) followed by maintenance dose of 2.4 mg once weekly up to the end of treatment period.
|
Placebo
n=8797 Participants
Participants received placebo (matched to semaglutide) subcutaneously once weekly up to the end of treatment period.
|
|---|---|---|
|
Participants From Time of Randomisation to First Occurrence of Glycosylated Haemoglobin (HbA1c) Greater Than Equals to (≥) 48 Millimole Per Mole (mmol/Mol) (6.5 Percentage [%])
|
306 Participants
|
1059 Participants
|
SECONDARY outcome
Timeframe: From randomisation (week 0) up to 240 weeksPopulation: FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation.
Number of participants with first occurrence of a 5-component composite nephropathy outcome measure consisted of onset of persistent macroalbuminuria (UACR \> 300 milligram per gram \[mg/g\]), persistent 50% reduction in estimated glomerular filtration rate (eGFR) compared with baseline (randomisation), onset of persistent eGFR \< 15 ml/min/1.73m\^2, initiation of chronic renal replacement therapy (dialysis or transplantation) or renal death. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Outcome measures
| Measure |
Semaglutide
n=8803 Participants
Participants received semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 16 (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) followed by maintenance dose of 2.4 mg once weekly up to the end of treatment period.
|
Placebo
n=8801 Participants
Participants received placebo (matched to semaglutide) subcutaneously once weekly up to the end of treatment period.
|
|---|---|---|
|
Participants From Time of Randomisation to First Occurrence of a 5-component Composite Nephropathy Outcome Measure
|
155 Participants
|
198 Participants
|
SECONDARY outcome
Timeframe: From randomisation (week 0) up to 240 weeksPopulation: FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation. Here, overall number of participants analyzed = number of participants with HbA1c \<39 mmol/mol (5.7%) at screening.
Number of participants with HbA1c ≥ 39 mmol/mol (5.7%) are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Outcome measures
| Measure |
Semaglutide
n=2925 Participants
Participants received semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 16 (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) followed by maintenance dose of 2.4 mg once weekly up to the end of treatment period.
|
Placebo
n=2980 Participants
Participants received placebo (matched to semaglutide) subcutaneously once weekly up to the end of treatment period.
|
|---|---|---|
|
Participants From Time of Randomisation to HbA1c ≥ 39 mmol/Mol (5.7%) (for Participants With a Screening HbA1c <39 mmol/Mol [5.7%])
|
623 Participants
|
1501 Participants
|
SECONDARY outcome
Timeframe: At week 52, week 104Population: FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation. Here, overall number of participants analyzed = number of participants with HbA1c ≥ 39 mmol/mol (5.7%) at screening. And, number analyzed = number of participants who contributed to the analysis at that particular timepoint.
Number of participants with HbA1c \< 39 mmol/mol (5.7%) are presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Outcome measures
| Measure |
Semaglutide
n=5877 Participants
Participants received semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 16 (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) followed by maintenance dose of 2.4 mg once weekly up to the end of treatment period.
|
Placebo
n=5819 Participants
Participants received placebo (matched to semaglutide) subcutaneously once weekly up to the end of treatment period.
|
|---|---|---|
|
Participants With HbA1c < 39 mmol/Mol (5.7%) (for Participants With a Screening HbA1c ≥ 39 mmol/Mol [5.7%])
Week 52
|
3363 Participants
|
955 Participants
|
|
Participants With HbA1c < 39 mmol/Mol (5.7%) (for Participants With a Screening HbA1c ≥ 39 mmol/Mol [5.7%])
Week 104
|
3271 Participants
|
978 Participants
|
SECONDARY outcome
Timeframe: Week 0, week 104Population: FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation. Here, overall number of participants analyzed = number of participants who contributed to the analysis.
Change in SBP from randomisation (week 0) to week 104 is presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Outcome measures
| Measure |
Semaglutide
n=7475 Participants
Participants received semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 16 (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) followed by maintenance dose of 2.4 mg once weekly up to the end of treatment period.
|
Placebo
n=7385 Participants
Participants received placebo (matched to semaglutide) subcutaneously once weekly up to the end of treatment period.
|
|---|---|---|
|
Change in Systolic Blood Pressure (SBP)
|
-3.8 Millimetre of mercury (mmHg)
Standard Deviation 16.4
|
-0.6 Millimetre of mercury (mmHg)
Standard Deviation 16.0
|
SECONDARY outcome
Timeframe: Week 0, week 104Population: FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation. Here, overall number of participants analyzed = number of participants who contributed to the analysis.
Change in DBP from randomisation (week 0) to week 104 is presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Outcome measures
| Measure |
Semaglutide
n=7475 Participants
Participants received semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 16 (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) followed by maintenance dose of 2.4 mg once weekly up to the end of treatment period.
|
Placebo
n=7384 Participants
Participants received placebo (matched to semaglutide) subcutaneously once weekly up to the end of treatment period.
|
|---|---|---|
|
Change in Diastolic Blood Pressure (DBP)
|
-1.1 mmHg
Standard Deviation 10.4
|
-0.4 mmHg
Standard Deviation 10.4
|
SECONDARY outcome
Timeframe: Week 0, week 104Population: FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation. Here, overall number of participants analyzed = number of participants who contributed to the analysis.
Change in pulse from randomisation (week 0) to week 104 is presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Outcome measures
| Measure |
Semaglutide
n=7473 Participants
Participants received semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 16 (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) followed by maintenance dose of 2.4 mg once weekly up to the end of treatment period.
|
Placebo
n=7385 Participants
Participants received placebo (matched to semaglutide) subcutaneously once weekly up to the end of treatment period.
|
|---|---|---|
|
Change in Pulse
|
3.8 beats per mintue (bpm)
Standard Deviation 11.0
|
0.9 beats per mintue (bpm)
Standard Deviation 10.7
|
SECONDARY outcome
Timeframe: Week 0, week 104Population: FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation. Here, overall number of participants analyzed = number of participants who contributed to the analysis.
Change in hsCRP (milligram per liter \[mg/L\]) from randomisation (week 0) to week 104 presented as ratio to baseline (week 0). The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Outcome measures
| Measure |
Semaglutide
n=7472 Participants
Participants received semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 16 (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) followed by maintenance dose of 2.4 mg once weekly up to the end of treatment period.
|
Placebo
n=7400 Participants
Participants received placebo (matched to semaglutide) subcutaneously once weekly up to the end of treatment period.
|
|---|---|---|
|
Change in High Sensitivity C-Reactive Protein (hsCRP) - Ratio to Baseline
|
0.61 ratio of hsCRP
Geometric Coefficient of Variation 149.53
|
1.00 ratio of hsCRP
Geometric Coefficient of Variation 133.25
|
SECONDARY outcome
Timeframe: Week 0, week 104Population: FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation. Here, overall number of participants analyzed = number of participants who contributed to the analysis.
Change in total cholesterol (milligram per deciliter \[mg/dL\]) from randomisation (week 0) to week 104 is presented as ratio to baseline (week 0). The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Outcome measures
| Measure |
Semaglutide
n=7461 Participants
Participants received semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 16 (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) followed by maintenance dose of 2.4 mg once weekly up to the end of treatment period.
|
Placebo
n=7394 Participants
Participants received placebo (matched to semaglutide) subcutaneously once weekly up to the end of treatment period.
|
|---|---|---|
|
Change in Total Cholesterol - Ratio to Baseline
|
0.95 ratio of total cholesterol
Geometric Coefficient of Variation 21.54
|
0.98 ratio of total cholesterol
Geometric Coefficient of Variation 21.24
|
SECONDARY outcome
Timeframe: Week 0, week 104Population: FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation. Here, overall number of participants analyzed = number of participants who contributed to the analysis.
Change in HDL (mg/dL) from randomisation (week 0) to week 104 is presented as ratio to baseline (week 0). The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Outcome measures
| Measure |
Semaglutide
n=7137 Participants
Participants received semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 16 (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) followed by maintenance dose of 2.4 mg once weekly up to the end of treatment period.
|
Placebo
n=7091 Participants
Participants received placebo (matched to semaglutide) subcutaneously once weekly up to the end of treatment period.
|
|---|---|---|
|
Change in High Density Lipoprotein (HDL) Cholesterol - Ratio to Baseline
|
1.05 ratio of HDL
Geometric Coefficient of Variation 17.39
|
1.01 ratio of HDL
Geometric Coefficient of Variation 16.69
|
SECONDARY outcome
Timeframe: Week 0, week 104Population: FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation. Here, overall number of participants analyzed = number of participants who contributed to the analysis.
Change in LDL (mg/dL) from randomisation (week 0) to week 104 is presented as ratio to baseline (week 0). The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Outcome measures
| Measure |
Semaglutide
n=7138 Participants
Participants received semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 16 (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) followed by maintenance dose of 2.4 mg once weekly up to the end of treatment period.
|
Placebo
n=7088 Participants
Participants received placebo (matched to semaglutide) subcutaneously once weekly up to the end of treatment period.
|
|---|---|---|
|
Change in Low Density Lipoprotein (LDL) Cholesterol - Ratio to Baseline
|
0.95 ratio of LDL
Geometric Coefficient of Variation 37.43
|
0.97 ratio of LDL
Geometric Coefficient of Variation 37.83
|
SECONDARY outcome
Timeframe: Week 0, week 104Population: FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation. Here, overall number of participants analyzed = number of participants who contributed to the analysis.
Change in triglycerides (mg/dL) from randomisation (week 0) to week 104 is presented as ratio to baseline (week 0). The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Outcome measures
| Measure |
Semaglutide
n=7432 Participants
Participants received semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 16 (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) followed by maintenance dose of 2.4 mg once weekly up to the end of treatment period.
|
Placebo
n=7364 Participants
Participants received placebo (matched to semaglutide) subcutaneously once weekly up to the end of treatment period.
|
|---|---|---|
|
Change in Triglycerides - Ratio to Baseline
|
0.82 ratio of triglycerides
Geometric Coefficient of Variation 46.33
|
0.97 ratio of triglycerides
Geometric Coefficient of Variation 44.31
|
SECONDARY outcome
Timeframe: Week 0, week 104Population: FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation. Here, overall number of participants analyzed = number of participants who contributed to the analysis.
Percentage change in body weight from randomisation (week 0) to week 104 is presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Outcome measures
| Measure |
Semaglutide
n=7474 Participants
Participants received semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 16 (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) followed by maintenance dose of 2.4 mg once weekly up to the end of treatment period.
|
Placebo
n=7378 Participants
Participants received placebo (matched to semaglutide) subcutaneously once weekly up to the end of treatment period.
|
|---|---|---|
|
Change in Body Weight
|
-9.39 percentage change in body weight
Standard Deviation 8.62
|
-0.87 percentage change in body weight
Standard Deviation 6.08
|
SECONDARY outcome
Timeframe: Week 0, week 104Population: FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation. Here, overall number of participants analyzed = number of participants who contributed to the analysis.
Change is waist circumference from randomisation (week 0) to week 104 is presented. The outcome measure was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Outcome measures
| Measure |
Semaglutide
n=7373 Participants
Participants received semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 16 (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) followed by maintenance dose of 2.4 mg once weekly up to the end of treatment period.
|
Placebo
n=7273 Participants
Participants received placebo (matched to semaglutide) subcutaneously once weekly up to the end of treatment period.
|
|---|---|---|
|
Change in Waist Circumference
|
-7.5 centimeter (cm)
Standard Deviation 9.4
|
-1.0 centimeter (cm)
Standard Deviation 7.3
|
SECONDARY outcome
Timeframe: Week 0, week 104Population: FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation. Here, overall number of participants analyzed = number of participants who contributed to the analysis.
EQ-5D-5L is a PRO tool used to estimate impact on participant's health-related quality of life and provides a description of their problems by dimensions (descriptive system). EQ-5D has 5 dimensions: mobility, self-care, usual activities, pain, anxiety/depression, and each dimension has 5 levels: not at all, mild, moderate, severe, extreme. Participant marks most appropriate statement in each dimension, resulting in 1-digit number and digits from 5 dimensions can be combined in 5-digit number describing participant's health state. Index score records an average health status according to dimensions using an algorithm, ranges 0-1 with higher score indicates better health status. Outcome measure was evaluated based on data from in-trial observation period (defined as date of randomisation to one of the dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant \[who were lost to follow-up\], date of death).
Outcome measures
| Measure |
Semaglutide
n=6761 Participants
Participants received semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 16 (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) followed by maintenance dose of 2.4 mg once weekly up to the end of treatment period.
|
Placebo
n=6665 Participants
Participants received placebo (matched to semaglutide) subcutaneously once weekly up to the end of treatment period.
|
|---|---|---|
|
Change From Randomisation (Week 0) in Participant Reported Outcome (PRO): EuroQol Five Dimensions Five Level Questionnaire (EQ-5D-5L) Index Score to Week 104
|
0.01 score on a scale
Standard Deviation 0.14
|
-0.01 score on a scale
Standard Deviation 0.14
|
SECONDARY outcome
Timeframe: Week 0, week 104Population: FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation. Here, overall number of participants analyzed = number of participants who contributed to the analysis.
EQ-5D-5L is a PRO tool used to estimate impact on participant's health-related quality of life and provides a description of their problems by dimensions (descriptive system). EQ-5D has 5 dimensions: mobility, self-care, usual activities, pain, anxiety/depression, and each dimension has 5 levels: not at all, mild, moderate, severe, extreme. Participant marks most appropriate statement in each dimension, resulting in 1-digit number and digits from 5 dimensions can be combined in 5-digit number describing participant's health state. VAS component records a participant's overall self-rated health on a range of 0-100 with higher score indicates better self-reported health status. Outcome measure was evaluated based on data from in-trial observation period (defined as date of randomisation to one of the dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant \[who were lost to follow-up\], date of death).
Outcome measures
| Measure |
Semaglutide
n=6761 Participants
Participants received semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 16 (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) followed by maintenance dose of 2.4 mg once weekly up to the end of treatment period.
|
Placebo
n=6665 Participants
Participants received placebo (matched to semaglutide) subcutaneously once weekly up to the end of treatment period.
|
|---|---|---|
|
Change From Randomisation (Week 0) in PRO: EuroQol Five Dimensions Visual Analogue Scale (EQ-5D-VAS) to Week 104
|
2.38 score on a scale
Standard Deviation 15.38
|
0.77 score on a scale
Standard Deviation 15.79
|
SECONDARY outcome
Timeframe: Week 0, week 104Population: FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation. Here, overall number of participants analyzed = number of participants who contributed to the analysis.
Change in HbA1c (percentage) from randomisation (week 0) to week 104 is presented. The outcome measure was evaulated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Outcome measures
| Measure |
Semaglutide
n=7439 Participants
Participants received semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 16 (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) followed by maintenance dose of 2.4 mg once weekly up to the end of treatment period.
|
Placebo
n=7351 Participants
Participants received placebo (matched to semaglutide) subcutaneously once weekly up to the end of treatment period.
|
|---|---|---|
|
Change in HbA1c - Percentage
|
-0.31 Percentage of HbA1c
Standard Deviation 0.37
|
0.01 Percentage of HbA1c
Standard Deviation 0.36
|
SECONDARY outcome
Timeframe: Week 0, week 104Population: FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation. Here, overall number of participants analyzed = number of participants who contributed to the analysis.
Change in HbA1c (mmol/mol) from randomisation (week 0) to week 104 is presented. The outcome measure was evaulated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when participant withdrew consent, date of last contact with participant for participants who were lost to follow-up (participant did not complete the trial and did not withdraw consent), date of death.
Outcome measures
| Measure |
Semaglutide
n=7439 Participants
Participants received semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 16 (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) followed by maintenance dose of 2.4 mg once weekly up to the end of treatment period.
|
Placebo
n=7351 Participants
Participants received placebo (matched to semaglutide) subcutaneously once weekly up to the end of treatment period.
|
|---|---|---|
|
Change in HbA1c - mmol/Mol
|
-3.38 mmol/mol
Standard Deviation 4.06
|
0.10 mmol/mol
Standard Deviation 3.94
|
Adverse Events
Semaglutide
Placebo
Serious adverse events
| Measure |
Semaglutide
n=8803 participants at risk
Participants received semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 16 (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) followed by maintenance dose of 2.4 mg once weekly up to the end of treatment period.
|
Placebo
n=8801 participants at risk
Participants received placebo (matched to semaglutide) subcutaneously once weekly up to the end of treatment period.
|
|---|---|---|
|
Nervous system disorders
Brain injury
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Brain oedema
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Brain stem infarction
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.06%
5/8801 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer recurrent
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage II
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage IV
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Reproductive system and breast disorders
Breast fibrosis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Reproductive system and breast disorders
Breast oedema
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Breath odour
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Bronchiolitis
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Bronchitis
|
0.10%
9/8803 • Number of events 9 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.17%
15/8801 • Number of events 15 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Bronchitis mycoplasmal
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Bronchitis viral
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Bundle branch block left
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Bundle branch block right
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Burn infection
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Investigations
C-reactive protein increased
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Congenital, familial and genetic disorders
CADASIL
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
COVID-19
|
1.4%
124/8803 • Number of events 126 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
1.6%
137/8801 • Number of events 137 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
COVID-19 pneumonia
|
1.4%
119/8803 • Number of events 119 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
1.7%
148/8801 • Number of events 148 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Renal and urinary disorders
Calculus bladder
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Renal and urinary disorders
Calculus urethral
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Renal and urinary disorders
Calculus urinary
|
0.08%
7/8803 • Number of events 7 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.05%
4/8801 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Campylobacter infection
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Carbuncle
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour pulmonary
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Cardiac aneurysm
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Cardiac arrest
|
0.30%
26/8803 • Number of events 26 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.37%
33/8801 • Number of events 33 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
General disorders
Cardiac death
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Cardiac failure
|
1.00%
88/8803 • Number of events 114 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
1.3%
113/8801 • Number of events 127 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Cardiac failure acute
|
0.36%
32/8803 • Number of events 46 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.50%
44/8801 • Number of events 50 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Cardiac failure chronic
|
0.26%
23/8803 • Number of events 24 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.32%
28/8801 • Number of events 29 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Cardiac failure congestive
|
0.35%
31/8803 • Number of events 37 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.41%
36/8801 • Number of events 51 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Cardiac perforation
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Cardiac perfusion defect
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Cardiac procedure complication
|
0.01%
1/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Investigations
Cardiac stress test abnormal
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Cardiac tamponade
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Cardiac valve disease
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Cardiac ventricular thrombosis
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.12%
11/8803 • Number of events 11 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.12%
11/8801 • Number of events 11 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Cardiogenic shock
|
0.07%
6/8803 • Number of events 6 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.11%
10/8801 • Number of events 10 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.06%
5/8801 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Carotid arterial embolus
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Carotid arteriosclerosis
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Carotid artery aneurysm
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Carotid artery disease
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Carotid artery occlusion
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.06%
5/8801 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Carotid artery stenosis
|
0.25%
22/8803 • Number of events 23 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.27%
24/8801 • Number of events 26 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Carotid artery thrombosis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Carotid sinus syndrome
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.08%
7/8803 • Number of events 8 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal neoplasm
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Abdominal distension
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.06%
5/8803 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.07%
6/8801 • Number of events 6 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Blood and lymphatic system disorders
Abdominal lymphadenopathy
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.10%
9/8803 • Number of events 10 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.20%
18/8801 • Number of events 19 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.12%
11/8803 • Number of events 12 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.14%
12/8801 • Number of events 12 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Abdominal strangulated hernia
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Abdominal symptom
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Psychiatric disorders
Abnormal behaviour
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Reproductive system and breast disorders
Abnormal uterine bleeding
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Abscess limb
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Abscess neck
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Accelerated hypertension
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Accident
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Accident at home
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Accident at work
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
General disorders
Accidental death
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Acinetobacter bacteraemia
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acoustic neuroma
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.01%
1/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Acute abdomen
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Acute coronary syndrome
|
0.25%
22/8803 • Number of events 23 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.20%
18/8801 • Number of events 18 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Renal and urinary disorders
Acute kidney injury
|
0.90%
79/8803 • Number of events 87 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
1.2%
105/8801 • Number of events 116 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Acute left ventricular failure
|
0.07%
6/8803 • Number of events 6 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.08%
7/8801 • Number of events 8 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Acute myocardial infarction
|
2.4%
209/8803 • Number of events 220 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
3.3%
293/8801 • Number of events 324 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.06%
5/8803 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.08%
7/8801 • Number of events 7 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.32%
28/8803 • Number of events 30 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.52%
46/8801 • Number of events 51 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.07%
6/8803 • Number of events 6 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.06%
5/8801 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma metastatic
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.17%
15/8803 • Number of events 16 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.17%
15/8801 • Number of events 15 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of salivary gland
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Psychiatric disorders
Adjustment disorder with depressed mood
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Reproductive system and breast disorders
Adnexa uteri cyst
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal adenoma
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Endocrine disorders
Adrenal mass
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenocortical carcinoma
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Blood and lymphatic system disorders
Agranulocytosis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Investigations
Alanine aminotransferase increased
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.05%
4/8801 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Psychiatric disorders
Alcohol use disorder
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Hepatobiliary disorders
Alcoholic liver disease
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Psychiatric disorders
Alcoholism
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Immune system disorders
Allergy to arthropod bite
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Immune system disorders
Allergy to arthropod sting
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Alpha haemolytic streptococcal infection
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Eye disorders
Amaurosis fugax
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Amnesia
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.06%
5/8801 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Investigations
Amylase increased
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Immune system disorders
Amyloidosis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Amyotrophic lateral sclerosis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.41%
36/8803 • Number of events 40 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.34%
30/8801 • Number of events 38 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Anal abscess
|
0.06%
5/8803 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Anal fissure
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Anal fistula
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.07%
6/8801 • Number of events 6 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Anal polyp
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Anal prolapse
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Immune system disorders
Anaphylactic reaction
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.05%
4/8801 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Anastomotic ulcer haemorrhage
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Aneurysm ruptured
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Aneurysm thrombosis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Angina pectoris
|
1.3%
116/8803 • Number of events 126 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
1.7%
150/8801 • Number of events 176 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Angina unstable
|
2.1%
182/8803 • Number of events 205 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
2.4%
209/8801 • Number of events 242 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Anginal equivalent
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Surgical and medical procedures
Angioplasty
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.06%
5/8803 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.14%
12/8801 • Number of events 12 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Ankylosing spondylitis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Anorectal varices haemorrhage
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Anterior cord syndrome
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Renal and urinary disorders
Anticoagulant-related nephropathy
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Investigations
Anticoagulation drug level above therapeutic
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Blood and lymphatic system disorders
Antiphospholipid syndrome
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Psychiatric disorders
Anxiety
|
0.07%
6/8803 • Number of events 8 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Psychiatric disorders
Anxiety disorder
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Aortic aneurysm
|
0.20%
18/8803 • Number of events 18 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.19%
17/8801 • Number of events 17 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Aortic arteriosclerosis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Aortic dissection
|
0.05%
4/8803 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.05%
4/8801 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Aortic occlusion
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Aortic pseudoaneurysm
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Aortic stenosis
|
0.07%
6/8803 • Number of events 6 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.22%
19/8801 • Number of events 19 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Aortic valve incompetence
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.05%
4/8801 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Aortic valve stenosis
|
0.08%
7/8803 • Number of events 8 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.07%
6/8801 • Number of events 6 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Aorto-atrial fistula
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Aphasia
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Appendiceal abscess
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Appendicitis
|
0.20%
18/8803 • Number of events 18 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.18%
16/8801 • Number of events 17 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Appendicitis perforated
|
0.07%
6/8803 • Number of events 6 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.06%
5/8801 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Appendix disorder
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Arrhythmia
|
0.08%
7/8803 • Number of events 7 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.08%
7/8801 • Number of events 7 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Arrhythmic storm
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Arterial disorder
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Arterial injury
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Arterial restenosis
|
0.01%
1/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Surgical and medical procedures
Arterial stent insertion
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Arteriosclerosis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.08%
7/8803 • Number of events 7 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.07%
6/8801 • Number of events 6 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Arteriovenous fistula
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.22%
19/8803 • Number of events 19 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.12%
11/8801 • Number of events 11 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.08%
7/8803 • Number of events 8 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.11%
10/8801 • Number of events 10 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Arthritis bacterial
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.05%
4/8801 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Arthritis infective
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Arthrofibrosis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Ascites
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Investigations
Aspartate aminotransferase increased
|
0.05%
4/8803 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.05%
4/8801 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
General disorders
Asthenia
|
0.11%
10/8803 • Number of events 11 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.06%
5/8801 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.06%
5/8803 • Number of events 7 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.15%
13/8801 • Number of events 18 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Ataxia
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Atrial fibrillation
|
1.4%
127/8803 • Number of events 139 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
1.7%
152/8801 • Number of events 181 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Atrial flutter
|
0.26%
23/8803 • Number of events 24 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.25%
22/8801 • Number of events 25 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Surgical and medical procedures
Atrial septal defect repair
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Atrial tachycardia
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.07%
6/8801 • Number of events 7 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Atrial thrombosis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Atrioventricular block
|
0.05%
4/8803 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Atrioventricular block complete
|
0.08%
7/8803 • Number of events 7 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.09%
8/8801 • Number of events 9 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.05%
4/8803 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.08%
7/8801 • Number of events 7 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Atypical pneumonia
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell small lymphocytic lymphoma
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Back disorder
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Back injury
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.16%
14/8803 • Number of events 14 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.30%
26/8801 • Number of events 28 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Bacterial colitis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Barrett's oesophagus
|
0.02%
2/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.20%
18/8803 • Number of events 21 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.31%
27/8801 • Number of events 36 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Basal ganglia stroke
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Basilar artery aneurysm
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Basilar artery occlusion
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Behcet's syndrome
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Bell's palsy
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign duodenal neoplasm
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign gastrointestinal neoplasm
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign lung neoplasm
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign mediastinal neoplasm
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of bladder
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of cervix uteri
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of skin
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of thyroid gland
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.39%
34/8803 • Number of events 35 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.24%
21/8801 • Number of events 21 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign salivary gland neoplasm
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Congenital, familial and genetic disorders
Bicuspid aortic valve
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Hepatobiliary disorders
Bile duct stone
|
0.18%
16/8803 • Number of events 16 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.11%
10/8801 • Number of events 10 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Psychiatric disorders
Bipolar disorder
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder adenocarcinoma stage unspecified
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.09%
8/8801 • Number of events 8 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder papilloma
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Renal and urinary disorders
Bladder stenosis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.11%
10/8803 • Number of events 10 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.19%
17/8801 • Number of events 18 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Bleeding varicose vein
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Eye disorders
Blindness transient
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Eye disorders
Blindness unilateral
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Investigations
Blood alkaline phosphatase increased
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Investigations
Blood bilirubin increased
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Investigations
Blood calcitonin increased
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Investigations
Blood creatinine increased
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.11%
10/8803 • Number of events 10 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.10%
9/8801 • Number of events 9 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Investigations
Blood osmolarity decreased
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Investigations
Blood potassium decreased
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Investigations
Blood potassium increased
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Blood pressure fluctuation
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Investigations
Blood pressure increased
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Investigations
Blood urine present
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Investigations
Body temperature decreased
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Investigations
Body temperature increased
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Bone deformity
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Bone fistula
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.07%
6/8803 • Number of events 17 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.07%
6/8801 • Number of events 6 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Bradycardia
|
0.10%
9/8803 • Number of events 9 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.10%
9/8801 • Number of events 9 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
IIIrd nerve paresis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic interstitial pneumonia
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Ileus
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Iliac artery disease
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Iliac artery occlusion
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Iliac artery stenosis
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.07%
6/8801 • Number of events 6 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Immune-mediated lung disease
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Immunisation reaction
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.05%
4/8803 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
General disorders
Impaired healing
|
0.07%
6/8803 • Number of events 6 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.06%
5/8801 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Implant site infection
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Surgical and medical procedures
Implantable defibrillator insertion
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
General disorders
Incarcerated hernia
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Incarcerated incisional hernia
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Incarcerated inguinal hernia
|
0.05%
4/8803 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Incarcerated umbilical hernia
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Incision site haemorrhage
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.07%
6/8803 • Number of events 6 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.07%
6/8801 • Number of events 6 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Incisional hernia, obstructive
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Infected bite
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Infected cyst
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Infected lymphocele
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Infected skin ulcer
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Infection
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Infectious pleural effusion
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.06%
5/8801 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Inferior vena cava stenosis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Influenza
|
0.10%
9/8803 • Number of events 9 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.09%
8/8801 • Number of events 8 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
General disorders
Influenza like illness
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.44%
39/8803 • Number of events 41 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.27%
24/8801 • Number of events 24 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Injection site cellulitis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
General disorders
Injection site haematoma
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Intensive care unit acquired weakness
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Intercostal neuralgia
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Intermittent claudication
|
0.07%
6/8803 • Number of events 6 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.09%
8/8801 • Number of events 8 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Investigations
International normalised ratio increased
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc displacement
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.18%
16/8803 • Number of events 17 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.17%
15/8801 • Number of events 15 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intestinal adenocarcinoma
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Intestinal gangrene
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Intestinal haematoma
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.01%
1/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.12%
11/8803 • Number of events 11 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.09%
8/8801 • Number of events 10 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Intestinal polyp
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Intra-abdominal haematoma
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Surgical and medical procedures
Intra-cerebral aneurysm operation
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Intracardiac thrombus
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Intracranial aneurysm
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.06%
5/8801 • Number of events 6 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Intracranial haematoma
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Intracranial hypotension
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Intracranial mass
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic fracture
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Intraventricular haemorrhage
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.09%
8/8803 • Number of events 8 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.07%
6/8801 • Number of events 6 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive lobular breast carcinoma
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive papillary breast carcinoma
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.09%
8/8803 • Number of events 8 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.08%
7/8801 • Number of events 7 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.10%
9/8803 • Number of events 9 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Hepatobiliary disorders
Ischaemic hepatitis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Ischaemic stroke
|
0.90%
79/8803 • Number of events 87 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.91%
80/8801 • Number of events 84 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Joint abscess
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Joint ankylosis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.07%
6/8803 • Number of events 6 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.08%
7/8801 • Number of events 8 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.08%
7/8803 • Number of events 7 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Joint instability
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Lacunar infarction
|
0.07%
6/8803 • Number of events 6 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Keratoacanthoma
|
0.02%
2/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Renal and urinary disorders
Kidney fibrosis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Kidney infection
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Immune system disorders
Kidney transplant rejection
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Klebsiella urinary tract infection
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Lacunar stroke
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large cell lung cancer metastatic
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.07%
6/8801 • Number of events 6 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large intestine benign neoplasm
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Large intestine infection
|
0.05%
4/8803 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.12%
11/8803 • Number of events 11 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.10%
9/8801 • Number of events 10 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal squamous cell carcinoma
|
0.05%
4/8803 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Laryngitis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Left ventricular failure
|
0.05%
4/8803 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.07%
6/8801 • Number of events 6 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Product Issues
Lead dislodgement
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lentigo maligna
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Leptospirosis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Leriche syndrome
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Leukoplakia oral
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Limb crushing injury
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.06%
5/8803 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.06%
5/8801 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Limb traumatic amputation
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip and/or oral cavity cancer
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Investigations
Lipase increased
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.06%
5/8801 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Liposarcoma recurrent
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Surgical and medical procedures
Liposuction
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Lisfranc fracture
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Hepatobiliary disorders
Liver disorder
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Investigations
Liver function test increased
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Hepatobiliary disorders
Liver injury
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Localised infection
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Loss of consciousness
|
0.06%
5/8803 • Number of events 6 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.05%
4/8801 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.08%
7/8801 • Number of events 7 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Lower respiratory tract infection
|
0.06%
5/8803 • Number of events 6 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.06%
5/8801 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Renal and urinary disorders
Lower urinary tract symptoms
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.06%
5/8803 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.05%
4/8801 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.22%
19/8803 • Number of events 20 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.17%
15/8801 • Number of events 15 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.06%
5/8801 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Lumbosacral plexus injury
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Lumbosacral radiculopathy
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.11%
10/8803 • Number of events 10 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.09%
8/8801 • Number of events 8 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma recurrent
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma stage I
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma stage III
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.05%
4/8801 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified stage II
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Otitis externa candida
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Otitis media
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified stage IV
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Lung consolidation
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Otitis media chronic
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.06%
5/8803 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma metastatic
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Lyme disease
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Blood and lymphatic system disorders
Lymphadenopathy mediastinal
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Lymphangitis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Lymphoedema
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Blood and lymphatic system disorders
Lymphoid tissue hyperplasia
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Hemiparaesthesia
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Macroangiopathy
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Eye disorders
Macular degeneration
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Eye disorders
Macular hole
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Eye disorders
Macular oedema
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Eye disorders
Macular rupture
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Eye disorders
Maculopathy
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Maisonneuve fracture
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Psychiatric disorders
Major depression
|
0.02%
2/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.06%
5/8801 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Malabsorption
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
General disorders
Malaise
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.11%
10/8803 • Number of events 10 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.10%
9/8801 • Number of events 9 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.06%
5/8803 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of ampulla of Vater
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of renal pelvis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of unknown primary site
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of uterine adnexa
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.07%
6/8803 • Number of events 6 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Psychiatric disorders
Mania
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mantle cell lymphoma stage III
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Mastitis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Medical device site infection
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
General disorders
Medical device site ulcer
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Medullary thyroid cancer
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Melaena
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanoma recurrent
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Memory impairment
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Ear and labyrinth disorders
Meniere's disease
|
0.02%
2/8803 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma benign
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Meningitis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Meningitis bacterial
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Meningitis tuberculous
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Meningoradiculitis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Meniscopathy
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.09%
8/8803 • Number of events 8 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.05%
4/8801 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Psychiatric disorders
Mental disorder
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Psychiatric disorders
Mental status changes
|
0.05%
4/8803 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.06%
5/8801 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Mental status changes postoperative
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Mesenteric abscess
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Mesenteric artery embolism
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Mesenteric vein thrombosis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mesothelioma
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.06%
5/8803 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Metapneumovirus infection
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Metapneumovirus pneumonia
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.03%
3/8803 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.05%
4/8803 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to soft tissue
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic gastric cancer
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic salivary gland cancer
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Metabolism and nutrition disorders
Diabetic ketosis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic uterine cancer
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Cervical cord compression
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Blood and lymphatic system disorders
Methaemoglobinaemia
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Renal and urinary disorders
Microalbuminuria
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Microvascular coronary artery disease
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Renal and urinary disorders
Micturition urgency
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Migraine
|
0.07%
6/8803 • Number of events 6 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Reproductive system and breast disorders
Cervical polyp
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Migraine with aura
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Mitral valve incompetence
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.08%
7/8801 • Number of events 7 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Mitral valve stenosis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Psychiatric disorders
Mixed anxiety and depressive disorder
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.05%
4/8801 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.11%
10/8801 • Number of events 10 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Multiple sclerosis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Muscle necrosis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.05%
4/8801 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.15%
13/8803 • Number of events 14 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.15%
13/8801 • Number of events 14 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.05%
4/8803 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Myalgia intercostal
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Myasthenia gravis
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Mycetoma mycotic
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelofibrosis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Myelomalacia
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Myelopathy
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Myocardial fibrosis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Myocardial infarction
|
0.40%
35/8803 • Number of events 36 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.35%
31/8801 • Number of events 32 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Myocardial injury
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Myocardial ischaemia
|
0.24%
21/8803 • Number of events 21 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.35%
31/8801 • Number of events 31 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Myopericarditis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Narcotic bowel syndrome
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nasopharyngeal cancer
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngeal polyp
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Nausea
|
0.14%
12/8803 • Number of events 12 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.09%
8/8801 • Number of events 8 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Neck deformity
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.05%
4/8801 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm prostate
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Eye disorders
Neovascular age-related macular degeneration
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.28%
25/8803 • Number of events 27 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.27%
24/8801 • Number of events 30 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Renal and urinary disorders
Nephropathy
|
0.01%
1/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Renal and urinary disorders
Nephropathy toxic
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Renal and urinary disorders
Nephrosclerosis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Nerve compression
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Nerve injury
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Neuralgic amyotrophy
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Neuritis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine breast tumour
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma metastatic
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma of prostate
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma of the skin
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine tumour of the lung
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine tumour of the lung metastatic
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Neuropathy peripheral
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Neutropenic sepsis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Hepatobiliary disorders
Non-alcoholic steatohepatitis
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
General disorders
Non-cardiac chest pain
|
1.00%
88/8803 • Number of events 96 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
1.2%
103/8801 • Number of events 112 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.05%
4/8803 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer stage IV
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Blood and lymphatic system disorders
Normocytic anaemia
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Nosocomial infection
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.05%
4/8801 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.05%
4/8803 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.08%
7/8801 • Number of events 7 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive sleep apnoea syndrome
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Occipital neuralgia
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Investigations
Occult blood positive
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Eye disorders
Ocular hypertension
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Congenital, familial and genetic disorders
Odontogenic cyst
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
General disorders
Oedema
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Oedema mouth
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
General disorders
Oedema peripheral
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.07%
6/8801 • Number of events 6 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Oedematous pancreatitis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.05%
4/8803 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma recurrent
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma stage IV
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Oesophageal disorder
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Oesophageal polyp
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal squamous cell carcinoma
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.05%
4/8801 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian adenoma
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Oesophagitis
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Oesophagitis ulcerative
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Open globe injury
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Ophthalmic herpes zoster
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Eye disorders
Optic ischaemic neuropathy
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oral papilloma
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Orchitis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oropharyngeal cancer
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oropharyngeal squamous cell carcinoma
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Orthostatic hypotension
|
0.17%
15/8803 • Number of events 15 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.11%
10/8801 • Number of events 11 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.95%
84/8803 • Number of events 93 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.90%
79/8801 • Number of events 86 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Osteoma
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Osteomyelitis
|
0.05%
4/8803 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.05%
4/8801 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Osteomyelitis chronic
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.05%
4/8801 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Eye disorders
Cataract
|
0.14%
12/8803 • Number of events 14 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.20%
18/8801 • Number of events 22 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Surgical and medical procedures
Cataract operation
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
General disorders
Catheter site haemorrhage
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Investigations
Catheterisation cardiac
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Cellulitis
|
0.33%
29/8803 • Number of events 31 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.47%
41/8801 • Number of events 43 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Cellulitis staphylococcal
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Central nervous system inflammation
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Central nervous system vasculitis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Central pain syndrome
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Cerebellar haemorrhage
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Cerebellar infarction
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.05%
4/8801 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Cerebellar ischaemia
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.05%
4/8801 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Cerebellar stroke
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Cerebral artery embolism
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Cerebral circulatory failure
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Cerebral haematoma
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.08%
7/8803 • Number of events 7 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.09%
8/8801 • Number of events 8 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Cerebral infarction
|
0.19%
17/8803 • Number of events 18 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.26%
23/8801 • Number of events 25 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Device related infection
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Cerebral ischaemia
|
0.09%
8/8803 • Number of events 8 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.07%
6/8801 • Number of events 6 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Cerebral small vessel ischaemic disease
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Cerebrovascular accident
|
0.40%
35/8803 • Number of events 36 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.55%
48/8801 • Number of events 50 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Cerebrovascular insufficiency
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Cervical radiculopathy
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.05%
4/8801 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.06%
5/8803 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.10%
9/8801 • Number of events 9 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Cervicitis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma stage II
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
General disorders
Chest discomfort
|
0.05%
4/8803 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.08%
7/8801 • Number of events 9 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
General disorders
Chest pain
|
0.50%
44/8803 • Number of events 45 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.53%
47/8801 • Number of events 48 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Chest wall abscess
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.02%
2/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Hepatobiliary disorders
Cholangitis
|
0.07%
6/8803 • Number of events 6 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.05%
4/8801 • Number of events 7 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Cholangitis infective
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Hepatobiliary disorders
Cholecystitis
|
0.15%
13/8803 • Number of events 13 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.17%
15/8801 • Number of events 15 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.31%
27/8803 • Number of events 27 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.34%
30/8801 • Number of events 31 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.11%
10/8803 • Number of events 10 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.05%
4/8801 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Cholecystitis infective
|
0.05%
4/8803 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.05%
4/8801 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.50%
44/8803 • Number of events 46 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.35%
31/8801 • Number of events 33 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Hepatobiliary disorders
Cholelithiasis migration
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Hepatobiliary disorders
Cholelithiasis obstructive
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Choroid melanoma
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Chronic coronary syndrome
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.06%
5/8801 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.05%
4/8803 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.08%
7/8803 • Number of events 7 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.08%
7/8801 • Number of events 7 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia stage 1
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.36%
32/8803 • Number of events 43 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.57%
50/8801 • Number of events 63 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Chronic sinusitis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Circulatory collapse
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.09%
8/8801 • Number of events 8 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
0.07%
6/8803 • Number of events 6 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.05%
4/8801 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Clostridial sepsis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Clostridium difficile colitis
|
0.05%
4/8803 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Investigations
Coagulation time shortened
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Device related sepsis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Colitis
|
0.16%
14/8803 • Number of events 15 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.11%
10/8801 • Number of events 11 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.10%
9/8803 • Number of events 9 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.10%
9/8803 • Number of events 9 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.06%
5/8801 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer stage III
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
General disorders
Device related thrombosis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Colon dysplasia
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Colonic abscess
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal adenocarcinoma
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal adenoma
|
0.12%
11/8803 • Number of events 12 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.05%
4/8801 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer metastatic
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Coma
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Psychiatric disorders
Completed suicide
|
0.06%
5/8803 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Complicated appendicitis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.05%
4/8801 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
General disorders
Complication associated with device
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Concussion
|
0.05%
4/8803 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.05%
4/8801 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Psychiatric disorders
Confusional state
|
0.05%
4/8803 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.06%
5/8801 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Conjunctivitis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Constipation
|
0.09%
8/8803 • Number of events 8 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.07%
6/8801 • Number of events 6 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Immune system disorders
Contrast media allergy
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Contusion
|
0.05%
4/8803 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.07%
6/8801 • Number of events 6 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Conus medullaris syndrome
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Psychiatric disorders
Conversion disorder
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Coordination abnormal
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Cor pulmonale
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Eye disorders
Corneal degeneration
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Congenital, familial and genetic disorders
Corneal dystrophy
|
0.01%
1/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Eye disorders
Corneal erosion
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Surgical and medical procedures
Coronary angioplasty
|
0.55%
48/8803 • Number of events 51 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.73%
64/8801 • Number of events 68 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Surgical and medical procedures
Coronary arterial stent insertion
|
2.8%
245/8803 • Number of events 270 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
3.2%
279/8801 • Number of events 343 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Surgical and medical procedures
Coronary artery bypass
|
0.78%
69/8803 • Number of events 69 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.90%
79/8801 • Number of events 79 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Coronary artery disease
|
0.90%
79/8803 • Number of events 80 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
1.2%
106/8801 • Number of events 113 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Coronary artery dissection
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.05%
4/8801 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Coronary artery insufficiency
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Coronary artery occlusion
|
0.12%
11/8803 • Number of events 11 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.14%
12/8801 • Number of events 12 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Coronary artery reocclusion
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Coronary artery restenosis
|
0.05%
4/8803 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.05%
4/8801 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Coronary artery stenosis
|
0.50%
44/8803 • Number of events 49 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.60%
53/8801 • Number of events 58 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Coronary artery thrombosis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Coronary bypass stenosis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Coronary ostial stenosis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Surgical and medical procedures
Coronary revascularisation
|
0.26%
23/8803 • Number of events 27 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.42%
37/8801 • Number of events 38 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Coronary vascular graft occlusion
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Coronary vascular graft stenosis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Coronavirus infection
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Corticobasal degeneration
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.06%
5/8801 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Cranial nerve disorder
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.07%
6/8803 • Number of events 6 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.06%
5/8801 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Crohn's disease
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Crush injury
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Investigations
Culture positive
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Endocrine disorders
Cushing's syndrome
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Cystitis
|
0.06%
5/8803 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Cystitis bacterial
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Cystitis radiation
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Reproductive system and breast disorders
Cystocele
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Eye disorders
Dacryostenosis acquired
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
General disorders
Death
|
0.62%
55/8803 • Number of events 55 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.65%
57/8801 • Number of events 57 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Deep vein thrombosis
|
0.15%
13/8803 • Number of events 14 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.15%
13/8801 • Number of events 13 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Deep vein thrombosis postoperative
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.22%
19/8803 • Number of events 21 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.16%
14/8801 • Number of events 14 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Psychiatric disorders
Delirium
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Dementia
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Dementia with Lewy bodies
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Demyelinating polyneuropathy
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Dengue fever
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Dengue haemorrhagic fever
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Dental alveolar anomaly
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Psychiatric disorders
Depression
|
0.15%
13/8803 • Number of events 14 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.11%
10/8801 • Number of events 10 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Psychiatric disorders
Depression suicidal
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Product Issues
Device breakage
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Product Issues
Device dislocation
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.08%
7/8801 • Number of events 7 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Product Issues
Device failure
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Product Issues
Device loosening
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Product Issues
Device malfunction
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.05%
4/8801 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Product Issues
Device occlusion
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Device related bacteraemia
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.26%
23/8803 • Number of events 23 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.18%
16/8801 • Number of events 17 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Diastasis recti abdominis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Diastolic dysfunction
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Dieulafoy's vascular malformation
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma stage I
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma stage III
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Dilated cardiomyopathy
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Diplegia
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Eye disorders
Diplopia
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
General disorders
Discomfort
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Psychiatric disorders
Dissociative amnesia
|
0.01%
1/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Psychiatric disorders
Dissociative identity disorder
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Diverticulitis
|
0.16%
14/8803 • Number of events 17 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.26%
23/8801 • Number of events 26 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Diverticulitis intestinal haemorrhagic
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Diverticulitis intestinal perforated
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Diverticulum
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.06%
5/8801 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.08%
7/8803 • Number of events 7 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.06%
5/8801 • Number of events 6 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Dizziness
|
0.11%
10/8803 • Number of events 10 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.16%
14/8801 • Number of events 14 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Dizziness postural
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Psychiatric disorders
Drug abuse
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Immune system disorders
Drug hypersensitivity
|
0.05%
4/8803 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
General disorders
Drug intolerance
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Skin and subcutaneous tissue disorders
Drug reaction with eosinophilia and systemic symptoms
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Dry gangrene
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ductal adenocarcinoma of pancreas
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.05%
4/8803 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.08%
7/8801 • Number of events 7 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Duodenal ulcer perforation
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Duodenitis
|
0.05%
4/8803 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's contracture
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Dural arteriovenous fistula
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Dysarthria
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.06%
5/8803 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Dysphagia
|
0.06%
5/8803 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.22%
19/8803 • Number of events 20 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.40%
35/8801 • Number of events 36 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea at rest
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.09%
8/8801 • Number of events 8 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Renal and urinary disorders
Dysuria
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Skin and subcutaneous tissue disorders
Eczema nummular
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Investigations
Ejection fraction decreased
|
0.05%
4/8803 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Investigations
Electrocardiogram ST segment abnormal
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
General disorders
Electrocution
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Embolic cerebral infarction
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Embolic stroke
|
0.07%
6/8803 • Number of events 6 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Embolism arterial
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.05%
4/8801 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Encephalitis autoimmune
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Encephalopathy
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.06%
5/8801 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Renal and urinary disorders
End stage renal disease
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Endocarditis
|
0.05%
4/8803 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Endocarditis bacterial
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Eye disorders
Endocrine ophthalmopathy
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.07%
6/8801 • Number of events 6 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Endophthalmitis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Enlarged uvula
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Enteritis
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Hypertensive emergency
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Enterobacter sepsis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Enterocolitis
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Enterocolitis viral
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Reproductive system and breast disorders
Epididymal disorder
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Epididymitis
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Epiglottic cyst
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Epilepsy
|
0.05%
4/8803 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.10%
9/8801 • Number of events 9 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Epiploic appendagitis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Eye disorders
Epiretinal membrane
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.10%
9/8803 • Number of events 10 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.07%
6/8801 • Number of events 6 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Epithelioid mesothelioma
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Erosive duodenitis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Eructation
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Erysipelas
|
0.11%
10/8803 • Number of events 11 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.15%
13/8801 • Number of events 13 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Escherichia pyelonephritis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Escherichia sepsis
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Essential thrombocythaemia
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Skin and subcutaneous tissue disorders
Excessive skin
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Investigations
Exercise electrocardiogram abnormal
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Extradural haematoma
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Extranodal marginal zone B-cell lymphoma (MALT type)
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Extraskeletal ossification
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Extremity necrosis
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Eyelid seborrhoeic keratosis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.05%
4/8801 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Facial nerve disorder
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Facial paralysis
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Facial paresis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Congenital, familial and genetic disorders
Factor II mutation
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Fall
|
0.58%
51/8803 • Number of events 55 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.40%
35/8801 • Number of events 39 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Investigations
False positive investigation result
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
General disorders
Fat necrosis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
General disorders
Fatigue
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.05%
4/8803 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
General disorders
Feeling cold
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Femoral artery aneurysm
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Femoral artery embolism
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Femoral hernia
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.12%
11/8803 • Number of events 11 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.10%
9/8801 • Number of events 9 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.15%
13/8803 • Number of events 13 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.12%
11/8801 • Number of events 11 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Investigations
Fibrin D dimer increased
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroadenoma of breast
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Flatulence
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Focal peritonitis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Renal and urinary disorders
Focal segmental glomerulosclerosis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Follicular lymphoma
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Follicular thyroid cancer
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Immune system disorders
Food allergy
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Metabolism and nutrition disorders
Food intolerance
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Food poisoning
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.06%
5/8803 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.07%
6/8801 • Number of events 6 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Foreign body in gastrointestinal tract
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Foreign body in respiratory tract
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Frontotemporal dementia
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Functional gastrointestinal disorder
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
General disorders
Gait disturbance
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder adenocarcinoma
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder cancer
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Hepatobiliary disorders
Gallbladder cholesterolosis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Hepatobiliary disorders
Gallbladder disorder
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Hepatobiliary disorders
Gallbladder necrosis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Hepatobiliary disorders
Gallbladder polyp
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Hepatobiliary disorders
Gallbladder rupture
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Gangrene
|
0.05%
4/8803 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.05%
4/8801 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer stage I
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Investigations
Gastric pH decreased
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Gastric perforation
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Gastric polyps
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.06%
5/8803 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.10%
9/8801 • Number of events 9 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.06%
5/8801 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Gastric volvulus
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Gastritis
|
0.16%
14/8803 • Number of events 14 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.15%
13/8801 • Number of events 13 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Gastroduodenal ulcer
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Gastroenteritis
|
0.17%
15/8803 • Number of events 16 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.12%
11/8801 • Number of events 12 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal adenocarcinoma
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Gastrointestinal angiodysplasia
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Congenital, familial and genetic disorders
Gastrointestinal arteriovenous malformation
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Gastrointestinal bacterial overgrowth
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal cancer metastatic
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.25%
22/8803 • Number of events 22 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.17%
15/8801 • Number of events 17 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Gastrointestinal infection
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Gastrointestinal oedema
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Gastrointestinal organ contusion
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Gastrointestinal polyp
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Gastrointestinal procedural complication
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Psychiatric disorders
Gastrointestinal somatic symptom disorder
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Gastrointestinal stoma complication
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal stromal tumour
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal tract adenoma
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Gastrointestinal vascular malformation haemorrhagic
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Gastrointestinal wall thickening
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.14%
12/8803 • Number of events 13 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.15%
13/8801 • Number of events 13 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Gastroparesis postoperative
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
General disorders
General physical health deterioration
|
0.05%
4/8803 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
General disorders
Generalised oedema
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Giant cell arteritis
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Giardiasis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Eye disorders
Glaucoma
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Investigations
Glycosylated haemoglobin increased
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Endocrine disorders
Goitre
|
0.08%
7/8803 • Number of events 7 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.05%
4/8801 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Metabolism and nutrition disorders
Gout
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Graft infection
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
General disorders
Granuloma
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Endocrine disorders
Graves' disease
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Greater trochanteric pain syndrome
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
H1N1 influenza
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of bone
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Haematemesis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Haematochezia
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Haematoma
|
0.05%
4/8803 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.05%
4/8801 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Haematoma infection
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Renal and urinary disorders
Haematuria
|
0.18%
16/8803 • Number of events 17 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.12%
11/8801 • Number of events 11 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Blood and lymphatic system disorders
Haemolysis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Haemorrhage
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.08%
7/8803 • Number of events 7 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.14%
12/8801 • Number of events 12 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Haemorrhagic transformation stroke
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.05%
4/8803 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.05%
4/8801 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.06%
5/8801 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
General disorders
Hanging
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Head and neck cancer metastatic
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Head injury
|
0.09%
8/8803 • Number of events 8 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.11%
10/8801 • Number of events 10 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Headache
|
0.08%
7/8803 • Number of events 8 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.12%
11/8801 • Number of events 11 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Investigations
Heart rate irregular
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Immune system disorders
Heart transplant rejection
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Heat exhaustion
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Heat illness
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Helicobacter gastritis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Helicobacter infection
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Hemianopia
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Hemiparesis
|
0.05%
4/8803 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Hemiplegia
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Hemiplegic migraine
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.05%
4/8801 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Investigations
Hepatic enzyme abnormal
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Hepatobiliary disorders
Hepatic fibrosis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Hepatobiliary disorders
Hepatitis alcoholic
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.10%
9/8803 • Number of events 10 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.06%
5/8801 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Hepatobiliary disorders
Hepatorenal syndrome
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
General disorders
Hernia
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Herpes ophthalmic
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Herpes zoster
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.05%
4/8801 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.05%
4/8803 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.07%
6/8801 • Number of events 6 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.12%
11/8803 • Number of events 11 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hormone receptor positive HER2 negative breast cancer
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hormone receptor positive breast cancer
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Surgical and medical procedures
Hospitalisation
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.08%
7/8803 • Number of events 8 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.12%
11/8801 • Number of events 11 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Hydrocephalus
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Reproductive system and breast disorders
Hydrometra
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Renal and urinary disorders
Hydronephrosis
|
0.07%
6/8803 • Number of events 6 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Endocrine disorders
Hyperaldosteronism
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.01%
1/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.08%
7/8801 • Number of events 8 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Endocrine disorders
Hyperparathyroidism
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Endocrine disorders
Hyperparathyroidism primary
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Hepatobiliary disorders
Hyperplastic cholecystopathy
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Hypersensitivity pneumonitis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Hypertension
|
0.31%
27/8803 • Number of events 30 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.27%
24/8801 • Number of events 24 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Hypertensive crisis
|
0.05%
4/8803 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.15%
13/8801 • Number of events 15 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Hypertensive encephalopathy
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Hypertensive heart disease
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Shock
|
0.08%
7/8803 • Number of events 7 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Hypertensive urgency
|
0.06%
5/8803 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.15%
13/8801 • Number of events 16 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
General disorders
Hyperthermia
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Endocrine disorders
Hyperthyroidism
|
0.05%
4/8803 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Congenital, familial and genetic disorders
Hypertrophic cardiomyopathy
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.05%
4/8801 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Hypoaesthesia
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.08%
7/8801 • Number of events 7 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Blood and lymphatic system disorders
Hypochromic anaemia
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.22%
19/8803 • Number of events 25 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.20%
18/8801 • Number of events 18 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Hypokinesia
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.06%
5/8803 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.08%
7/8801 • Number of events 7 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Endocrine disorders
Hypoparathyroidism secondary
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hypopharyngeal cancer
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Hypotension
|
0.26%
23/8803 • Number of events 24 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.28%
25/8801 • Number of events 30 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
General disorders
Hypothermia
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Endocrine disorders
Hypothyroidism
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Hypovolaemic shock
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Scrotal cellulitis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Reproductive system and breast disorders
Scrotal cyst
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Scrotal infection
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sebaceous carcinoma
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Immune system disorders
Secondary immunodeficiency
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Seizure
|
0.16%
14/8803 • Number of events 14 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.07%
6/8801 • Number of events 6 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Seizure like phenomena
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seminoma
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
General disorders
Sensation of foreign body
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Sensory disturbance
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Sensory loss
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Sepsis
|
0.41%
36/8803 • Number of events 36 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.40%
35/8801 • Number of events 35 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Septic shock
|
0.12%
11/8803 • Number of events 12 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.17%
15/8801 • Number of events 15 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Surgical and medical procedures
Sequestrectomy
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Seroma
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Serratia bacteraemia
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Shoulder fracture
|
0.05%
4/8803 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Silent myocardial infarction
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Sinoatrial block
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sinonasal papilloma
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Sinus bradycardia
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.05%
4/8801 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Sinus node dysfunction
|
0.08%
7/8803 • Number of events 7 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.17%
15/8801 • Number of events 15 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Sinusitis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.11%
10/8803 • Number of events 10 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Skin and subcutaneous tissue disorders
Skin oedema
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Surgical and medical procedures
Sleeve gastrectomy
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin squamous cell carcinoma recurrent
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Skull fractured base
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.11%
10/8801 • Number of events 10 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Psychiatric disorders
Sleep disorder
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.07%
6/8803 • Number of events 6 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer metastatic
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer recurrent
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.11%
10/8803 • Number of events 10 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.11%
10/8801 • Number of events 12 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small intestine carcinoma metastatic
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Snoring
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Soft tissue sarcoma
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Speech disorder
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Reproductive system and breast disorders
Spermatic cord disorder
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Hepatobiliary disorders
Sphincter of Oddi dysfunction
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Spinal claudication
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.09%
8/8803 • Number of events 9 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.06%
5/8801 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Spinal cord abscess
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Spinal cord infarction
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Spinal cord injury cervical
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Spinal cord neoplasm
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Spinal epidural haematoma
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.06%
5/8803 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.08%
7/8801 • Number of events 7 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.08%
7/8803 • Number of events 7 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.08%
7/8801 • Number of events 7 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Spinal synovial cyst
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Blood and lymphatic system disorders
Splenic haemorrhage
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Spondylitis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.06%
5/8803 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.06%
5/8801 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamoproliferative lesion
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.06%
5/8803 • Number of events 8 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of head and neck
|
0.01%
1/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.06%
5/8803 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.06%
5/8801 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.12%
11/8803 • Number of events 13 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.10%
9/8801 • Number of events 10 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the oral cavity
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the tongue
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Staphylococcal infection
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Skin and subcutaneous tissue disorders
Stasis dermatitis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Status epilepticus
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Status migrainosus
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Surgical and medical procedures
Stent placement
|
0.11%
10/8803 • Number of events 10 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.14%
12/8801 • Number of events 13 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
General disorders
Stent-graft endoleak
|
0.02%
2/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Stoma obstruction
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Stoma site haemorrhage
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Stomal hernia
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Strangulated umbilical hernia
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Streptococcal sepsis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.07%
6/8803 • Number of events 6 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.14%
12/8801 • Number of events 12 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Renal and urinary disorders
Subcapsular renal haematoma
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Subclavian artery occlusion
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Subclavian artery stenosis
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.18%
16/8803 • Number of events 16 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.07%
6/8801 • Number of events 6 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.05%
4/8801 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Subperiosteal abscess
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Psychiatric disorders
Substance-induced psychotic disorder
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
General disorders
Sudden cardiac death
|
0.09%
8/8803 • Number of events 8 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.14%
12/8801 • Number of events 12 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
General disorders
Sudden death
|
0.06%
5/8803 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.18%
16/8801 • Number of events 16 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Psychiatric disorders
Suicidal ideation
|
0.05%
4/8803 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.05%
4/8801 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Psychiatric disorders
Suicide attempt
|
0.01%
1/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Superficial vein thrombosis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.20%
18/8803 • Number of events 19 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.08%
7/8801 • Number of events 7 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Hepatobiliary disorders
Suspected drug-induced liver injury
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Syncope
|
0.74%
65/8803 • Number of events 71 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.62%
55/8801 • Number of events 63 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.05%
4/8803 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Synovial rupture
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
General disorders
Systemic inflammatory response syndrome
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Systemic sclerosis pulmonary
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
T-cell lymphoma
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Tachyarrhythmia
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Tachycardia
|
0.05%
4/8803 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.06%
5/8801 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Takayasu's arteritis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Tendon disorder
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.06%
5/8803 • Number of events 6 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.07%
6/8801 • Number of events 8 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis stenosans
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Tension headache
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Terminal ileitis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Testicular cancer metastatic
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Thalamic infarction
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Thalamus haemorrhage
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.05%
4/8801 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.06%
5/8803 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.05%
4/8801 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.07%
6/8803 • Number of events 6 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Thrombotic cerebral infarction
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Thrombotic stroke
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid adenoma
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Endocrine disorders
Thyroid mass
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Endocrine disorders
Thyroiditis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Endocrine disorders
Thyroiditis acute
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.10%
9/8801 • Number of events 9 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
General disorders
Tissue infiltration
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Tonsillitis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Tonsillitis bacterial
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Tooth abscess
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Tooth infection
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Toxic encephalopathy
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Endocrine disorders
Toxic goitre
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.01%
1/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.05%
4/8801 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tracheal cancer
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal compression
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal stenosis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Tracheomalacia
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Investigations
Transaminases increased
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Transient aphasia
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Transient global amnesia
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Transient ischaemic attack
|
0.44%
39/8803 • Number of events 42 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.67%
59/8801 • Number of events 63 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell cancer of renal pelvis and ureter metastatic
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell cancer of the renal pelvis and ureter
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell cancer of the renal pelvis and ureter localised
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.11%
10/8803 • Number of events 10 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma metastatic
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma recurrent
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Surgical and medical procedures
Transurethral prostatectomy
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Traumatic arthritis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Traumatic arthrosis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Traumatic haemothorax
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Traumatic heart injury
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haematoma
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Traumatic pancreatitis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
General disorders
Treatment noncompliance
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Tremor
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Investigations
Troponin abnormal
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Investigations
Troponin increased
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Tuberculosis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.17%
15/8801 • Number of events 15 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Congenital, familial and genetic disorders
Type IIa hyperlipidaemia
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Typical aura without headache
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
General disorders
Ulcer haemorrhage
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Ulnar nerve injury
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.10%
9/8803 • Number of events 9 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.05%
4/8801 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Undifferentiated spondyloarthritis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.14%
12/8803 • Number of events 13 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.16%
14/8801 • Number of events 14 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.05%
4/8801 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Renal and urinary disorders
Urate nephropathy
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.23%
20/8803 • Number of events 21 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.11%
10/8801 • Number of events 10 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Renal and urinary disorders
Urethral meatus stenosis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Renal and urinary disorders
Urethral obstruction
|
0.01%
1/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Renal and urinary disorders
Urethral stenosis
|
0.05%
4/8803 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Renal and urinary disorders
Urge incontinence
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.06%
5/8801 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Renal and urinary disorders
Urinary retention
|
0.12%
11/8803 • Number of events 11 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.08%
7/8801 • Number of events 7 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Urinary retention postoperative
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Urinary tract candidiasis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Urinary tract infection
|
0.36%
32/8803 • Number of events 40 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.49%
43/8801 • Number of events 46 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Urinary tract infection pseudomonal
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Investigations
Urine analysis abnormal
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Urosepsis
|
0.16%
14/8803 • Number of events 15 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.16%
14/8801 • Number of events 15 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Reproductive system and breast disorders
Uterovaginal prolapse
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Vagus nerve paralysis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Varicose ulceration
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Varicose vein
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Vascular access site pseudoaneurysm
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Vascular dementia
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Vascular device infection
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
General disorders
Vascular device occlusion
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Vascular encephalopathy
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Vascular graft infection
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
0.08%
7/8803 • Number of events 11 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.09%
8/8801 • Number of events 9 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Vascular graft restenosis
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Vascular graft stenosis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Vascular graft thrombosis
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Vascular injury
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Vascular occlusion
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Vascular procedure complication
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.05%
4/8803 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.05%
4/8801 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Vascular stenosis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
General disorders
Vascular stent occlusion
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.09%
8/8801 • Number of events 9 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
General disorders
Vascular stent stenosis
|
0.25%
22/8803 • Number of events 22 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.24%
21/8801 • Number of events 25 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
General disorders
Vascular stent thrombosis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Venous thrombosis limb
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.05%
4/8803 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.05%
4/8801 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.14%
12/8803 • Number of events 12 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.10%
9/8801 • Number of events 10 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Ventricular fibrillation
|
0.08%
7/8803 • Number of events 7 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.12%
11/8801 • Number of events 12 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Congenital, familial and genetic disorders
Ventricular septal defect
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Ventricular tachyarrhythmia
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Ventricular tachycardia
|
0.41%
36/8803 • Number of events 36 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.43%
38/8801 • Number of events 49 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Vertebral artery stenosis
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Vertebral foraminal stenosis
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Vertebral osteophyte
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Vertebrobasilar artery dissection
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Vertebrobasilar stroke
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Ear and labyrinth disorders
Vertigo
|
0.20%
18/8803 • Number of events 18 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.08%
7/8801 • Number of events 8 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Vertigo CNS origin
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.08%
7/8801 • Number of events 7 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Vestibular neuronitis
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Viral diarrhoea
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Viral infection
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Eye disorders
Visual impairment
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.05%
4/8801 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Eye disorders
Vitreoretinal traction syndrome
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Eye disorders
Vitreous detachment
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Eye disorders
Vitreous haemorrhage
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord thickening
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Volvulus
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Vomiting
|
0.20%
18/8803 • Number of events 18 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.14%
12/8801 • Number of events 12 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Waldenstrom's macroglobulinaemia
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Investigations
Weight decreased
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Investigations
Weight increased
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Wound
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Wound infection
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Wound infection bacterial
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Wound infection pseudomonas
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Wound infection staphylococcal
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Wound necrosis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Wound sepsis
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.05%
4/8801 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Abdominal abscess
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Abdominal hernia obstructive
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Abdominal sepsis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Metabolism and nutrition disorders
Acidosis hyperchloraemic
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Acquired oesophageal web
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acrochordon
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Acute disseminated encephalomyelitis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Ear and labyrinth disorders
Acute vestibular syndrome
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Metabolism and nutrition disorders
Adult failure to thrive
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Psychiatric disorders
Alcohol abuse
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Alcohol induced persisting dementia
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Altered state of consciousness
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Eye disorders
Amaurosis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Blood and lymphatic system disorders
Anaemia of chronic disease
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal squamous cell carcinoma
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Anastomotic ulcer
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Immune system disorders
Anti-neutrophil cytoplasmic antibody positive vasculitis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Investigations
Anti-thyroid antibody positive
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Aortic valve disease mixed
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Arterial occlusive disease
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Bacterial pyelonephritis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of prostate
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of thymus
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Bifascicular block
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Psychiatric disorders
Bipolar I disorder
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Investigations
Body mass index increased
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone cancer metastatic
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Bone contusion
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Surgical and medical procedures
Breast reconstruction
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour of the gastrointestinal tract
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Surgical and medical procedures
Cardiac pacemaker replacement
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Cardiomegaly
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Cardiorenal syndrome
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Eye disorders
Cataract cortical
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Psychiatric disorders
Catatonia
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Cellulitis orbital
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Central nervous system infection
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Reproductive system and breast disorders
Cervix disorder
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Chordae tendinae rupture
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Chronic inflammatory demyelinating polyradiculoneuropathy
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer stage II
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conjunctival neoplasm
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Hepatobiliary disorders
Cryptogenic cirrhosis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Eye disorders
Dermatochalasis
|
0.01%
1/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Diaphragmatic hernia
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Diffuse idiopathic skeletal hyperostosis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Encephalitis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Erosive oesophagitis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Essential hypertension
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
General disorders
Exercise tolerance decreased
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Eye haemangioma
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Eye disorders
Eyelid ptosis
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Facet joint syndrome
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Focal dyscognitive seizures
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Gastric ulcer helicobacter
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Gastroenteritis bacterial
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Gastrointestinal ulcer haemorrhage
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Congenital, familial and genetic disorders
Gilbert's syndrome
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Granulomatosis with polyangiitis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Psychiatric disorders
Hallucination, visual
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Hashimoto's encephalopathy
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Hepatobiliary procedural complication
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Herpes simplex meningitis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Infective spondylitis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Internal haemorrhage
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Intervertebral discitis
|
0.02%
2/8803 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Intestinal pseudo-obstruction
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Intracranial pressure increased
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive breast carcinoma
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Ischaemic mitral regurgitation
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Klebsiella sepsis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Large intestinal ulcer
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Laryngospasm
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Eye disorders
Lenticular opacities
|
0.01%
1/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Skin and subcutaneous tissue disorders
Lichenoid keratosis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Liver abscess
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
General disorders
Localised oedema
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified stage III
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Renal and urinary disorders
Lupus nephritis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Lymphatic fistula
|
0.01%
1/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Monoparesis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Motor neurone disease
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Moyamoya disease
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Multiple sclerosis relapse
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Investigations
Myocardial necrosis marker increased
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Eye disorders
Myopia
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Nasal abscess
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Necrotising fasciitis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Psychiatric disorders
Neurosis
|
0.01%
1/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Normal pressure hydrocephalus
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Blood and lymphatic system disorders
Normochromic anaemia
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Norovirus infection
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal cancer metastatic
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma recurrent
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Oesophageal spasm
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oncologic complication
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Ophthalmic herpes simplex
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Optic neuritis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Orthostatic tremor
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Pancreatitis relapsing
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary serous endometrial carcinoma
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Psychiatric disorders
Paranoia
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Paraspinal abscess
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Parotid abscess
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Pelvic floor dysfunction
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Skin and subcutaneous tissue disorders
Pemphigoid
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Peripheral paralysis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Peroneal nerve palsy
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Psychiatric disorders
Personality change
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Pharyngeal abscess
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pleural mesothelioma
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Pneumonia influenzal
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Polyneuropathy alcoholic
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Post procedural fistula
|
0.01%
1/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary granuloma
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Pulseless electrical activity
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Reactive gastropathy
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Renal and urinary disorders
Renal haematoma
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Renal and urinary disorders
Renal pseudoaneurysm
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Immune system disorders
Sarcoidosis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Scrotal haematoma
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Reproductive system and breast disorders
Scrotal pain
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Septic encephalopathy
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Sinus arrest
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small intestine neuroendocrine tumour
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Spinal cord compression
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Spinal retrolisthesis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Spindle cell sarcoma
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Spondylitic myelopathy
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Stoma complication
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Stoma site infection
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Subdiaphragmatic abscess
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Superficial spreading melanoma stage I
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Skin and subcutaneous tissue disorders
Systemic lupus erythematosus rash
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Tachycardia induced cardiomyopathy
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Thalamic stroke
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil cancer
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Ulcerative gastritis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ureteric cancer
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Renal and urinary disorders
Urinary bladder haemorrhage
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
VIth nerve paralysis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Vascular access site haematoma
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Ventricular dysfunction
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Ear and labyrinth disorders
Vestibular ataxia
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Eye disorders
Visual field defect
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Congenital, familial and genetic disorders
Vitello-intestinal duct remnant
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Vocal cord paralysis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Psychiatric disorders
Withdrawal catatonia
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Reproductive system and breast disorders
Ovarian cyst ruptured
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian epithelial cancer
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian granulosa cell tumour
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Overdose
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
General disorders
Pain
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.06%
5/8803 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.05%
4/8801 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Painful respiration
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Palpitations
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.10%
9/8801 • Number of events 9 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.06%
5/8801 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Pancreatic cyst
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Investigations
Pancreatic enzymes increased
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neoplasm
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neuroendocrine tumour
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Pancreatitis
|
0.06%
5/8803 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.10%
9/8803 • Number of events 12 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.16%
14/8801 • Number of events 15 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Psychiatric disorders
Panic attack
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary cystadenoma lymphomatosum
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Pneumonia pseudomonal
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary renal cell carcinoma
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.05%
4/8803 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Paraparesis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.05%
4/8801 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Parkinsonian rest tremor
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Parkinsonism
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Paronychia
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Parotitis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Partial seizures
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Congenital, familial and genetic disorders
Patent ductus arteriosus
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Renal and urinary disorders
Pelvi-ureteric obstruction
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.09%
8/8803 • Number of events 8 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.06%
5/8801 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Reproductive system and breast disorders
Pelvic organ prolapse
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Penetrating aortic ulcer
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Penile squamous cell carcinoma
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Peptic ulcer haemorrhage
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Surgical and medical procedures
Percutaneous coronary intervention
|
0.80%
70/8803 • Number of events 81 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
1.3%
114/8801 • Number of events 124 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Perianal streptococcal infection
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Pericardial effusion
|
0.06%
5/8803 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.05%
4/8801 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Pericardial haemorrhage
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Pericarditis
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.05%
4/8801 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Perineal abscess
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.42%
37/8803 • Number of events 41 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.51%
45/8801 • Number of events 58 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Peripheral arterial reocclusion
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.10%
9/8803 • Number of events 10 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.05%
4/8801 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Peripheral artery occlusion
|
0.07%
6/8803 • Number of events 7 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.10%
9/8801 • Number of events 15 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Peripheral artery restenosis
|
0.02%
2/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.06%
5/8801 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Peripheral artery stenosis
|
0.09%
8/8803 • Number of events 8 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.11%
10/8801 • Number of events 13 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.05%
4/8803 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Peripheral embolism
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Peripheral ischaemia
|
0.05%
4/8803 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.06%
5/8801 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Peripheral nerve lesion
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
General disorders
Peripheral swelling
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Peripheral vascular disorder
|
0.05%
4/8803 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.08%
7/8801 • Number of events 7 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Peripheral venous disease
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Periprosthetic fracture
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Peritoneal abscess
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Peritonitis
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.06%
5/8801 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Peritonitis bacterial
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Peritonsillar abscess
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Psychiatric disorders
Persistent depressive disorder
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Pharyngitis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Pharyngo-oesophageal diverticulum
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Philadelphia positive chronic myeloid leukaemia
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Phyllodes tumour
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.06%
5/8803 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.06%
5/8801 • Number of events 6 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasmacytoma
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.14%
12/8803 • Number of events 13 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.18%
16/8801 • Number of events 16 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Pneumonia
|
1.0%
89/8803 • Number of events 102 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
1.5%
132/8801 • Number of events 146 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Pneumonia aspiration
|
0.05%
4/8803 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.10%
9/8801 • Number of events 9 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Pneumonia bacterial
|
0.06%
5/8803 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.07%
6/8801 • Number of events 6 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Pneumonia chlamydial
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Pneumonia klebsiella
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Pneumonia legionella
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Pneumonia necrotising
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Pneumonia streptococcal
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Pneumonia viral
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.05%
4/8801 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis aspiration
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.07%
6/8803 • Number of events 6 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.07%
6/8801 • Number of events 6 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Poisoning
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Blood and lymphatic system disorders
Polycythaemia
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Polycythaemia vera
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Polyneuropathy
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
General disorders
Polyp
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Renal and urinary disorders
Polyuria
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Vascular disorders
Popliteal artery entrapment syndrome
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Hepatobiliary disorders
Portal hypertensive biliopathy
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Portal hypertensive gastropathy
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Hepatobiliary disorders
Portosplenomesenteric venous thrombosis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Hepatobiliary disorders
Post cholecystectomy syndrome
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Post procedural cellulitis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Post procedural fever
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Post procedural haematuria
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.14%
12/8803 • Number of events 12 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.08%
7/8801 • Number of events 8 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Post procedural infection
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.07%
6/8801 • Number of events 6 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Post procedural inflammation
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Post procedural myocardial infarction
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Post procedural pulmonary embolism
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Post procedural sepsis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.05%
4/8801 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Post procedural stroke
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Post stroke epilepsy
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Post stroke seizure
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Post-acute COVID-19 syndrome
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Post-traumatic headache
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.05%
4/8801 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Postoperative abscess
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Postoperative renal failure
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Postoperative respiratory distress
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Postoperative thrombosis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Postoperative wound infection
|
0.09%
8/8803 • Number of events 8 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.09%
8/8801 • Number of events 8 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Postpericardiotomy syndrome
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Renal and urinary disorders
Prerenal failure
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Presyncope
|
0.16%
14/8803 • Number of events 14 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.17%
15/8801 • Number of events 15 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Primary myelofibrosis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Primary progressive multiple sclerosis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Prinzmetal angina
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
General disorders
Procedural failure
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Procedural pneumothorax
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.68%
60/8803 • Number of events 60 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.61%
54/8801 • Number of events 54 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.06%
5/8803 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.09%
8/8801 • Number of events 8 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer recurrent
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer stage I
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer stage II
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.05%
4/8801 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer stage III
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer stage IV
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Prostate infection
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Prostatic abscess
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
0.05%
4/8803 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Reproductive system and breast disorders
Prostatic obstruction
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Reproductive system and breast disorders
Prostatitis
|
0.05%
4/8803 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.06%
5/8803 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Product Issues
Prosthetic cardiac valve malfunction
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
General disorders
Prosthetic cardiac valve stenosis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Prosthetic valve endocarditis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Renal and urinary disorders
Proteinuria
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Pseudoaneurysm infection
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Pseudomembranous colitis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Pseudomonal bacteraemia
|
0.01%
1/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Pseudoradicular syndrome
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Pseudostroke
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Psychiatric disorders
Psychotic disorder
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Pulmonary contusion
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.43%
38/8803 • Number of events 39 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.49%
43/8801 • Number of events 44 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haematoma
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary infarction
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.05%
4/8803 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary microemboli
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.09%
8/8803 • Number of events 8 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.14%
12/8801 • Number of events 12 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Pulmonary sepsis
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Skin and subcutaneous tissue disorders
Purpura fulminans
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Pyelonephritis
|
0.12%
11/8803 • Number of events 11 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.08%
7/8801 • Number of events 7 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Pyelonephritis acute
|
0.05%
4/8803 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
General disorders
Pyrexia
|
0.06%
5/8803 • Number of events 6 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.05%
4/8801 • Number of events 6 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Radiculopathy
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.05%
4/8803 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.07%
6/8801 • Number of events 6 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.05%
4/8803 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer metastatic
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.06%
5/8801 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal neoplasm
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Rectal polyp
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Reproductive system and breast disorders
Rectocele
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectosigmoid cancer
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Reflux gastritis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Relapsing-remitting multiple sclerosis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Renal abscess
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer metastatic
|
0.05%
4/8803 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.05%
4/8803 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.06%
5/8801 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Renal and urinary disorders
Renal colic
|
0.06%
5/8803 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Renal and urinary disorders
Renal cortical necrosis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Renal and urinary disorders
Renal failure
|
0.05%
4/8803 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.05%
4/8801 • Number of events 4 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Renal and urinary disorders
Renal impairment
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.07%
6/8801 • Number of events 6 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Renal and urinary disorders
Renal infarct
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Renal and urinary disorders
Renal mass
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Renal and urinary disorders
Renal tubular dysfunction
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.03%
3/8803 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Renal and urinary disorders
Renal vein thrombosis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.11%
10/8803 • Number of events 10 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.18%
16/8801 • Number of events 16 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Respiratory tract infection
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.06%
5/8801 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Respiratory tract infection viral
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Eye disorders
Retinal artery embolism
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Eye disorders
Retinal artery occlusion
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Eye disorders
Retinal artery thrombosis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Eye disorders
Retinal detachment
|
0.06%
5/8803 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Eye disorders
Retinal tear
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Eye disorders
Retinal vascular occlusion
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Eye disorders
Retinal vein occlusion
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Eye disorders
Retinopathy hypertensive
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Reversible cerebral vasoconstriction syndrome
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.08%
7/8801 • Number of events 7 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Eye disorders
Rhegmatogenous retinal detachment
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.17%
15/8803 • Number of events 16 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.24%
21/8801 • Number of events 21 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Cardiac disorders
Right ventricular failure
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.12%
11/8803 • Number of events 11 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.19%
17/8801 • Number of events 17 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.15%
13/8803 • Number of events 15 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.06%
5/8801 • Number of events 5 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Ruptured cerebral aneurysm
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
SARS-CoV-2 sepsis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.03%
3/8801 • Number of events 3 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Sacral pain
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Sacroiliitis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland cancer
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland cancer stage IV
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Salmonella sepsis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Salmonellosis
|
0.02%
2/8803 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.02%
2/8801 • Number of events 2 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Psychiatric disorders
Schizophrenia
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.00%
0/8801 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Injury, poisoning and procedural complications
Sciatic nerve injury
|
0.00%
0/8803 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Nervous system disorders
Sciatica
|
0.08%
7/8803 • Number of events 7 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.09%
8/8801 • Number of events 9 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Infections and infestations
Scrotal abscess
|
0.01%
1/8803 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.01%
1/8801 • Number of events 1 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
Other adverse events
| Measure |
Semaglutide
n=8803 participants at risk
Participants received semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 16 (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) followed by maintenance dose of 2.4 mg once weekly up to the end of treatment period.
|
Placebo
n=8801 participants at risk
Participants received placebo (matched to semaglutide) subcutaneously once weekly up to the end of treatment period.
|
|---|---|---|
|
Infections and infestations
COVID-19
|
20.3%
1787/8803 • Number of events 1933 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
20.3%
1785/8801 • Number of events 1935 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Constipation
|
8.1%
715/8803 • Number of events 855 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
2.6%
231/8801 • Number of events 256 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.6%
585/8803 • Number of events 655 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
1.3%
112/8801 • Number of events 123 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Diarrhoea
|
10.6%
933/8803 • Number of events 1417 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
4.0%
353/8801 • Number of events 429 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Dyspepsia
|
5.3%
468/8803 • Number of events 629 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
1.1%
94/8801 • Number of events 102 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Nausea
|
18.1%
1592/8803 • Number of events 2260 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
3.8%
337/8801 • Number of events 414 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
|
Gastrointestinal disorders
Vomiting
|
6.5%
576/8803 • Number of events 752 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
0.99%
87/8801 • Number of events 106 • From randomisation (week 0) up to 240 weeks
AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically and more details on the approach followed for collecting the AEs is mentioned in the section 9.2 of protocol. AEs were not separately collected for each dose level. Hence, AEs are presented in randomized arm (semaglutide vs placebo).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
- Publication restrictions are in place
Restriction type: OTHER