Table 2.
Adverse events by baseline BMI (pooled data from SUSTAIN 1 to 5 trials)
| Semaglutide 0.5 mg | Semaglutide 1.0 mg | Comparator | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Number of subjects | N | (%) | E | R | Number of subjects | N | (%) | E | R | Number of subjects | N | (%) | E | R | |
| Adverse events (any grade) | |||||||||||||||
| <25 kg/m2 | 99 | 71 | (71.0) | 341 | 438.2 | 116 | 84 | (71.7) | 383 | 414.8 | 119 | 74 | (63.4) | 215 | 241.3 |
| 25 to <30 kg/m2 | 285 | 202 | (71.0) | 847 | 384.8 | 406 | 284 | (69.8) | 1348 | 391.2 | 385 | 258 | (67.2) | 914 | 273.4 |
| 30 to <35 kg/m2 | 311 | 224 | (72.0) | 932 | 367.6 | 440 | 309 | (70.4) | 1236 | 327.1 | 471 | 329 | (69.6) | 1291 | 306.8 |
| ≥35 kg/m2 | 335 | 234 | (69.8) | 1009 | 370.5 | 470 | 337 | (71.8) | 1598 | 388.0 | 457 | 319 | (69.7) | 1333 | 328.5 |
| Serious adverse events | |||||||||||||||
| <25 kg/m2 | 99 | 4 | (3.9) | 10 | 11.9 | 116 | 2 | (1.8) | 3 | 3.6 | 119 | 3 | (2.7) | 3 | 3.6 |
| 25 to <30 kg/m2 | 285 | 16 | (5.6) | 20 | 9.1 | 406 | 26 | (6.5) | 34 | 9.9 | 385 | 21 | (5.6) | 28 | 8.5 |
| 30 to <35 kg/m2 | 311 | 25 | (8.0) | 36 | 14.1 | 440 | 31 | (7.1) | 48 | 12.7 | 471 | 28 | (5.9) | 33 | 7.9 |
| ≥35 kg/m2 | 335 | 22 | (6.5) | 40 | 14.6 | 470 | 45 | (9.6) | 52 | 12.6 | 457 | 33 | (7.2) | 40 | 9.9 |
| Gastrointestinal disorders | |||||||||||||||
| <25 kg/m2 | 99 | 45 | (45.2) | 135 | 173.3 | 116 | 55 | (48.0) | 169 | 181.9 | 119 | 17 | (15.5) | 47 | 56.3 |
| 25 to <30 kg/m2 | 285 | 121 | (42.5) | 298 | 135.9 | 406 | 176 | (43.3) | 624 | 181.5 | 385 | 84 | (22.0) | 167 | 50.1 |
| 30 to <35 kg/m2 | 311 | 116 | (37.1) | 293 | 115.4 | 440 | 168 | (38.3) | 444 | 117.6 | 471 | 123 | (26.0) | 256 | 60.9 |
| ≥35 kg/m2 | 335 | 129 | (38.7) | 276 | 102.2 | 470 | 183 | (38.9) | 578 | 140.8 | 457 | 101 | (22.1) | 216 | 53.8 |
| Adverse events leading to premature treatment discontinuation | |||||||||||||||
| <25 kg/m2 | 99 | 11 | (11.7) | 16 | 22.1 | 116 | 19 | (16.5) | 22 | 25.8 | 119 | 7 | (6.5) | 16 | 20.1 |
| 25 to <30 kg/m2 | 285 | 31 | (10.9) | 53 | 24.2 | 406 | 36 | (8.9) | 67 | 19.3 | 385 | 13 | (3.4) | 22 | 6.7 |
| 30 to <35 kg/m2 | 311 | 14 | (4.5) | 22 | 8.7 | 440 | 34 | (7.8) | 50 | 13.2 | 471 | 17 | (3.5) | 23 | 5.4 |
| ≥35 kg/m2 | 335 | 11 | (3.3) | 19 | 7.1 | 470 | 30 | (6.4) | 47 | 11.3 | 457 | 12 | (2.6) | 18 | 4.5 |
| Nausea and/or vomiting adverse events | 1031 | 217 | (21.0) | ‐ | ‐ | 1434 | 346 | (24.1) | ‐ | ‐ | 1434 | 131 | (9.1) | ‐ | ‐ |
Abbreviations: BMI, body mass index; E, number of events; N, number of subjects in the safety analysis set experiencing at least one event; R, event rate per 100 patient years. %, percentage of subjects experiencing at least one event. The % and R are the Cochran–Mantel–Haenszel adjusted percentage and event rate.