Most frequent (≥5%) GI disorders on treatment by preferred term (predefined MedDRA search)
| Semaglutide 0.05 mg, n = 64 | Semaglutide 0.1 mg, n = 63 | Semaglutide 0.2 mg, n = 65 | Semaglutide 0.3 mg, n = 63 | Semaglutide flexible dose, n = 64 | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| N | % | E | R | N | % | E | R | N | % | E | R | N | % | E | R | N | % | E | R | |
| GI AEs | 21 | 32.8 | 61 | 162 | 28 | 44.4 | 90 | 236 | 30 | 46.2 | 106 | 283 | 34 | 54.0 | 101 | 268 | 36 | 56.3 | 128 | 322 |
| Nausea | 11 | 17.2 | 16 | 42 | 12 | 19.0 | 20 | 52 | 14 | 21.5 | 22 | 59 | 16 | 25.4 | 22 | 58 | 25 | 39.1 | 34 | 85 |
| Diarrhea | 7 | 10.9 | 10 | 26 | 10 | 15.9 | 13 | 34 | 10 | 15.4 | 15 | 40 | 16 | 25.4 | 29 | 77 | 11 | 17.2 | 22 | 55 |
| Vomiting | 6 | 9.4 | 10 | 26 | 4 | 6.3 | 13 | 34 | 6 | 9.2 | 9 | 24 | 6 | 9.5 | 8 | 21 | 6 | 9.4 | 8 | 20 |
| Constipation | 2 | 3.1 | 2 | 5 | 4 | 6.3 | 4 | 10 | 6 | 9.2 | 11 | 29 | 5 | 7.9 | 7 | 19 | 4 | 6.3 | 6 | 15 |
| Dyspepsia | 1 | 1.6 | 6 | 16 | 5 | 7.9 | 7 | 18 | 5 | 7.7 | 8 | 21 | 6 | 9.5 | 6 | 16 | 4 | 6.3 | 4 | 10 |
| Abdominal discomfort | 2 | 3.1 | 2 | 5 | 3 | 4.8 | 4 | 10 | 1 | 1.5 | 1 | 3 | 2 | 3.2 | 3 | 8 | 4 | 6.3 | 4 | 10 |
| Abdominal pain | 2 | 3.1 | 4 | 11 | 2 | 3.2 | 4 | 10 | 3 | 4.6 | 7 | 19 | 5 | 7.9 | 6 | 16 | 4 | 6.3 | 7 | 18 |
| Flatulence | 2 | 3.1 | 2 | 5 | 1 | 1.6 | 5 | 13 | 4 | 6.2 | 6 | 16 | 1 | 1.6 | 1 | 3 | 6 | 9.4 | 9 | 23 |
| Abdominal pain, upper | 0 | — | — | — | 1 | 1.6 | 1 | 3 | 4 | 6.2 | 5 | 13 | 4 | 6.3 | 4 | 11 | 6 | 9.4 | 8 | 20 |
| Gastroesophageal reflux disease | 0 | — | — | — | 4 | 6.3 | 8 | 21 | 3 | 4.6 | 3 | 8 | 3 | 4.8 | 3 | 8 | 4 | 6.3 | 5 | 13 |
| Liraglutide 0.3 mg, n = 64 | Liraglutide 0.6 mg, n = 64 | Liraglutide 1.2 mg, n = 64 | Liraglutide 1.8 mg, n = 65 | Pooled placebo, n = 129 | ||||||||||||||||
| N | % | E | R | N | % | E | R | N | % | E | R | N | % | E | R | N | % | E | R | |
| GI AEs | 14 | 21.9 | 25 | 65 | 19 | 29.7 | 62 | 161 | 20 | 31.3 | 40 | 106 | 27 | 41.5 | 81 | 207 | 29 | 22.5 | 54 | 73 |
| Nausea | 6 | 9.4 | 7 | 18 | 7 | 10.9 | 11 | 29 | 7 | 10.9 | 11 | 29 | 13 | 20.0 | 18 | 46 | 6 | 4.7 | 7 | 9 |
| Diarrhea | 5 | 7.8 | 5 | 13 | 5 | 7.8 | 9 | 23 | 5 | 7.8 | 8 | 21 | 7 | 10.8 | 15 | 38 | 14 | 10.9 | 18 | 24 |
| Vomiting | 1 | 1.6 | 1 | 3 | 7 | 10.9 | 10 | 26 | 1 | 1.6 | 1 | 3 | 5 | 7.7 | 8 | 20 | 3 | 2.3 | 3 | 4 |
| Constipation | 0 | — | — | — | 3 | 4.7 | 3 | 8 | 1 | 1.6 | 2 | 5 | 7 | 10.8 | 7 | 18 | 4 | 3.1 | 4 | 5 |
| Dyspepsia | 2 | 3.1 | 2 | 5 | 3 | 4.7 | 3 | 8 | 1 | 1.6 | 1 | 3 | 3 | 4.6 | 3 | 8 | 1 | 0.8 | 1 | 1 |
| Abdominal discomfort | 1 | 1.6 | 1 | 3 | 3 | 4.7 | 5 | 13 | 2 | 3.1 | 2 | 5 | 4 | 6.2 | 13 | 33 | 3 | 2.3 | 4 | 5 |
| Abdominal pain | 3 | 4.7 | 3 | 8 | 0 | — | — | — | 4 | 6.3 | 4 | 11 | 0 | — | — | — | 0 | — | — | — |
E, number of events; MedDRA, Medical Dictionary for Regulatory Activities; N, number of patients experiencing at least one event; R, event rate per 100 years of exposure; %, percentage of patients experiencing at least one event. GI AEs were defined as any of the AEs listed in the table. All AEs, either observed by the investigator or subject, were reported by the investigator and evaluated. The “on treatment” overview includes treatment-emergent AEs with onset at or after the date of the first trial product dose and before or at the date of the last trial product dose plus 7 weeks plus the 7 days’ visit window for the end-of-treatment follow-up visit (56 days). The observation time is the duration of this period.