Table 2.
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.