Table 3.
Treatment-related adverse events (TRAEs) in ≥10% of patients. Abbreviation: IC = investigator’s choice.
| < 65 Years | ≥65 Years | |||||||
|---|---|---|---|---|---|---|---|---|
| Nivolumab (n = 168) | IC (n = 71) | Nivolumab (n = 68) | IC (n = 40) | |||||
| Any Grade | Grade 3–4 | Any Grade | Grade 3–4 | Any Grade | Grade 3–4 | Any Grade | Grade 3–4 | |
| Any TRAE, n (%) | 107 (63.7) | 27 (16.1) | 55 (77.5) | 22 (31.0) | 39 (57.4) | 9 (13.2) | 33 (82.5) | 19 (47.5) |
| Fatigue | 24 (14.3) | 3 (1.8) | 14 (19.7) | 1 (1.4) | 13 (19.1) | 2 (2.9) | 6 (15.0) | 2 (5.0) |
| Nausea | 17 (10.1) | 0 | 16 (22.5) | 1 (1.4) | 5 (7.4) | 0 | 7 (17.5) | 0 |
| Rash | 14 (8.3) | 0 | 1 (1.4) | 0 | 5 (7.4) | 0 | 4 (10.0) | 1 (2.5) |
| Diarrhea | 13 (7.7) | 1 (0.6) | 7 (9.9) | 1 (1.4) | 7 (10.3) | 0 | 9 (22.5) | 1 (2.5) |
| Decreased appetite | 11 (6.5) | 0 | 6 (8.5) | 0 | 8 (11.8) | 0 | 2 (5.0) | 0 |
| Anemia | 8 (4.8) | 2 (1.2) | 13 (18.3) | 3 (4.2) | 4 (5.9) | 1 (1.5) | 6 (15.0) | 3 (7.5) |
| Asthenia | 8 (4.8) | 0 | 12 (16.9) | 2 (2.8) | 2 (2.9) | 1 (1.5) | 5 (12.5) | 0 |
| Vomiting | 6 (3.6) | 0 | 4 (5.6) | 0 | 2 (2.9) | 0 | 4 (10.0) | 0 |
| Mucosal inflammation | 4 (2.4) | 0 | 9 (12.7) | 1 (1.4) | 0 | 0 | 6 (15.0) | 1 (2.5) |
| Stomatitis | 2 (1.2) | 1 (0.6) | 8 (11.3) | 2 (2.8) | 4 (5.9) | 0 | 4 (10.0) | 1 (2.5) |
| Alopecia | 0 | 0 | 10 (14.1) | 0 | 0 | 0 | 4 (10.0) | 0 |