Table 2 Safety summary
Participantsa, n (%) | Nivolumab plus ipilimumab (n = 282) | Nivolumab (n = 318) | Durvalumab (n = 317) |
|---|---|---|---|
AEs | |||
Any grade | 279 (99) | 315 (99) | 312 (98) |
Grade 3–4 | 191 (68) | 210 (66) | 183 (58) |
AEs leading to discontinuation | |||
Any grade | 71 (25) | 62 (20) | 58 (18) |
Grade 3–4 | 44 (16) | 37 (12) | 37 (12) |
SAEs | |||
Any grade | 155 (55) | 156 (49) | 136 (43) |
Grade 3–4 | 103 (36) | 112 (35) | 90 (28) |
TRAEs | |||
Any grade | 269 (95) | 307 (96) | 305 (96) |
Grade 3–4 | 161 (57) | 172 (54) | 154 (49) |
Radiotherapy-related AEs | |||
Any grade | 226 (80) | 257 (81) | 248 (78) |
Grade 3–4 | 85 (30) | 81 (26) | 80 (25) |
TRAEs leading to discontinuation | |||
Any grade | 61 (22) | 50 (16) | 40 (13) |
Grade 3–4 | 40 (14) | 30 (9) | 24 (8) |
Treatment-related SAEs | |||
Any grade | 94 (33) | 86 (27) | 72 (23) |
Grade 3–4 | 63 (22) | 63 (20) | 53 (17) |