Table 3. Treatment-Related Adverse Events Reported in at Least 5% of Patients*.
| Event | Nivolumab (N = 131) | Docetaxel (N = 129) | ||
|---|---|---|---|---|
| Any Grade | Grade 3 or 4 | Any Grade | Grade 3 or 4 | |
| number of patients with an event (percent) | ||||
| Any event | 76 (58) | 9 (7) | 111 (86) | 71 (55) |
| Fatigue | 21 (16) | 1 (1) | 42 (33) | 10 (8) |
| Decreased appetite | 14 (11) | 1 (1) | 25 (19) | 1 (1) |
| Asthenia | 13 (10) | 0 | 18 (14) | 5 (4) |
| Nausea | 12 (9) | 0 | 30 (23) | 2 (2) |
| Diarrhea | 10 (8) | 0 | 26 (20) | 3 (2) |
| Arthralgia | 7 (5) | 0 | 9 (7) | 0 |
| Pyrexia | 6 (5) | 0 | 10 (8) | 1 (1) |
| Pneumonitis | 6 (5) | 0 | 0 | 0 |
| Rash | 5 (4) | 0 | 8 (6) | 2 (2) |
| Mucosal inflammation | 3 (2) | 0 | 12 (9) | 0 |
| Myalgia | 2 (2) | 0 | 13 (10) | 0 |
| Anemia | 2 (2) | 0 | 28 (22) | 4 (3) |
| Peripheral neuropathy | 1 (1) | 0 | 15 (12) | 3 (2) |
| Leukopenia | 1 (1) | 1 (1) | 8 (6) | 5 (4) |
| Neutropenia | 1 (1) | 0 | 42 (33) | 38 (30) |
| Febrile neutropenia | 0 | 0 | 14 (11) | 13 (10) |
| Alopecia | 0 | 0 | 29 (22) | 1 (1) |
*
Safety analyses included all the patients who received at least one dose of study drug. No treatment-related deaths occurred in patients treated with nivolumab. Treatment-related deaths were reported in three patients treated with docetaxel (one death each from interstitial lung disease, pulmonary hemorrhage, and sepsis).