Table 2.
Summary of all-cause AEs.
| 31-trial pooled safety dataset | Label safety dataset | |
|---|---|---|
| N = 8937 | N = 2799 | |
| AEs of any cause | 8630 (96.6) | 2727 (97.4) |
| Grade 3–5 AEs | 4525 (50.6) | 1273 (45.5) |
| Serious AEs | 3513 (39.3) | 1042 (37.2) |
| Led to discontinuation | 1135 (12.7) | 334 (11.9) |
| Led to death | 527 (5.9) | 110 (3.9) |
| Any AE in ≥ 10% of patients in either dataset | ||
| Fatigue | 2654 (29.7) | 1044 (37.3) |
| Nausea | 1827 (20.4) | 685 (24.5) |
| Decreased appetite | 1812 (20.3) | 630 (22.5) |
| Diarrhea | 1773 (19.8) | 625 (22.3) |
| Constipation | 1585 (17.7) | 498 (17.8) |
| Cough | 1570 (17.6) | 615 (22.0) |
| Pruritus | 1522 (17.0) | 580 (20.7) |
| Arthralgia | 1480 (16.6) | 636 (22.7) |
| Anemia | 1458 (16.3) | 347 (12.4) |
| Dyspnea | 1332 (14.9) | 534 (19.1) |
| Rash | 1212 (13.6) | 508 (18.1) |
| Vomiting | 1198 (13.4) | 387 (13.8) |
| Pyrexia | 1182 (13.2) | 357 (12.8) |
| Asthenia | 1059 (11.8) | 362 (12.9) |
| Back pain | 1019 (11.4) | 344 (12.3) |
| Hypothyroidism | 935 (10.5) | 236 (8.4) |
| Abdominal pain | 923 (10.3) | 274 (9.8) |
| Headache | 885 (9.9) | 400 (14.3) |
Data are n (%).
AE, adverse event.