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. Author manuscript; available in PMC: 2024 Jan 17.
Published in final edited form as: Lancet Gastroenterol Hepatol. 2023 Mar 16;8(6):511–522. doi: 10.1016/S2468-1253(23)00068-7

Table 2.

Adverse events

Empty Cell Empty Cell Semaglutide 2·4 mg group (n=47) Placebo group (n=24)
On-treatment observation period, weeks 51·1 (9·9) 53·5 (5·9)
All patients with adverse events 42 (89%) 19 (79%)
Gastrointestinal disorders 36 (77%) 8 (33%)
Nausea 21 (45%) 4 (17%)
Diarrhoea 9 (19%) 2 (8%)
Vomiting 8 (17%) 0 (0%)
Abdominal pain 6 (13%) 1 (4%)
Decreased appetite 6 (13%) 1 (4%)
Eructation 6 (13%) 0 (0%)
Abdominal pain upper 5 (11%) 2 (8%)
Dyspepsia 5 (11%) 0 (0%)
Patients with other adverse events (≥10% in either treatment group)
Urinary tract infection 3 (6%) 4 (17%)
Back pain 0 3 (13%)
Patients with serious adverse events
On-treatment 6 (13%) 2 (8%)
In-trial 6 (13%) 2 (8%)
Serious adverse events
Gastrointestinal disorders 3 (6%) 2 (8%)
Eye disorders 1 (2%) 0
Hepatobiliary disorders 1 (2%) 0
Injury, poisoning, and procedural complications 1 (2%) 0
Metabolism and nutrition disorders 1 (2%) 0
Nervous system disorders 1 (2%) 0
Renal and urinary disorders 1 (2%) 0
Respiratory, thoracic, and mediastinal disorders 1 (2%) 0
Musculoskeletal and connective tissues disorders 0 1 (4%)
Psychiatric disorders 0 1 (4%)
Fatal events 0 0
Severity*
Mild 37 (79%) 17 (71%)
Moderate 26 (55%) 10 (42%)
Severe 8 (17%) 1 (4%)
Relationship to trial product*
Probable 22 (47%) 4 (17%)
Possible 23 (49%) 9 (38%)
Unlikely 31 (66%) 18 (75%)
Leading to withdrawal of trial product 3 (6%) 0
Leading to withdrawal from trial 0 0

Data are n (%) unless otherwise stated. Data are from all exposed patients on treatment (safety analysis set). %=proportion of patients with at least one adverse event. Numbers are patients with at least one adverse event.

*

Patients could have more than one adverse event.