TABLE I.
Adverse events
| Event or management | Ipilimumab (311 patients) | Nivolumab (313 patients) | Nivolumab–ipilimumab (313 patients) |
|---|---|---|---|
| Grade 3 or 4 [n (%)] | |||
| Any | 173 (55.6) | 136 (43.5) | 215 (68.7) |
| Treatment-related | 85 (27.3) | 51 (16.3) | 172 (55) |
| Diarrhea | 19 (6.1) | 7 (2.2) | 29 (9.3) |
| Fatigue | 3 (1.0) | 4 (1.3) | 13 (4.2) |
| Pruritus | 1 (0.3) | 0 | 6 (1.9) |
| Colitis | 27 (8.7) | 2 (0.6) | 24 (7.7) |
| Hepatic | 5 (1.6) | 8 (2.6) | 59 (18.8) |
|
| |||
| Treatment-related leading to discontinuation | 41 (13.2) | 16 (5.1) | 92 (29.4) |
|
| |||
| Management of events (%) | |||
| With immune modulatory agents, including topical agents | 55.9 | 47 | 83.4 |
| With secondary immunosuppressive agentsa | 5.1 | 0.6 | 6.1 |
a
For example, infliximab.