Table 3.
Most common TRAEs (≥15% in any arm) and select TRAEs among all treated patients.
| Patients, n (%) | Nivolumab (n = 236) | IC (n = 111) | ||
|---|---|---|---|---|
| Any grade | Grade 3–4 | Any grade | Grade 3–4 | |
| Any TRAE | 146 (61.9) | 36 (15.3) | 88 (79.3) | 41 (36.9) |
| TRAEs in ≥15% of patients | 37 (15.7) | 5 (2.1) | 20 (18.0) | 3 (2.7) |
| Fatigue | 37 (15.7) | 5 (2.1) | 20 (18.0) | 3 (2.7) |
| Nausea | 22 (9.3) | 0 | 23 (20.7) | 1 (0.9) |
| Anemia | 12 (5.1) | 3 (1.3) | 19 (17.1) | 6 (5.4) |
| Asthenia | 10 (4.2) | 1 (0.4) | 17 (15.3) | 2 (1.8) |
| Select TRAEs | ||||
| Skin | 41 (17.4) | 0 | 14 (12.6) | 2 (1.8) |
| Endocrine | 22 (9.3) | 1 (0.4) | 1 (0.9) | 0 |
| Gastrointestinal | 20 (8.5) | 1 (0.4) | 16 (14.4) | 2 (1.8) |
| Hepatic | 7 (3.0) | 2 (0.8) | 5 (4.5) | 1 (0.9) |
| Pulmonary | 7 (3.0) | 2 (0.8) | 1 (0.9) | 0 |
| Hypersensitivity/infusion reactions | 3 (1.3) | 0 | 2 (1.8) | 1 (0.9) |
| Renal | 3 (1.3) | 0 | 2 (1.8) | 1 (0.9) |
IC, investigator’s choice; TRAEs, treatment-related adverse events.