Table 3.
Treatment-Related Adverse Events.*
| Event | Nivolumab (N = 267) | Chemotherapy (N = 263) | ||
|---|---|---|---|---|
| Any Grade | Grade 3 or 4 | Any Grade | Grade 3 or 4 | |
| number of patients with event (percent) | ||||
| Any event | 190 (71) | 47 (18) | 243 (92) | 133 (51) |
| Any serious event | 46 (17) | 35 (13) | 48 (18) | 41 (16) |
| Any event leading to discontinuation of therapy | 26 (10) | 21 (8) | 35 (13) | 17 (6) |
| Fatigue | 56 (21) | 3 (1) | 93 (35) | 14 (5) |
| Diarrhea | 37 (14) | 3 (1) | 34 (13) | 5 (2) |
| Decreased appetite | 32 (12) | 1 (<1) | 73 (28) | 4 (2) |
| Nausea | 31 (12) | 1 (<1) | 127 (48) | 5 (2) |
| Rash | 26 (10) | 2 (1) | 15 (6) | 1 (<1) |
| Vomiting | 15 (6) | 0 | 60 (23) | 5 (2) |
| Constipation | 9 (3) | 0 | 29 (11) | 0 |
| Anemia | 9 (3) | 1 (<1) | 113 (43) | 46 (17) |
| Asthenia | 8 (3) | 0 | 28 (11) | 4 (2) |
| Thrombocytopenia | 2 (1) | 1 (<1) | 38 (14) | 22 (8) |
| Platelet count decreased | 2 (1) | 0 | 33 (13) | 9 (3) |
| Neutrophil count decreased | 1 (<1) | 1 (<1) | 36 (14) | 20 (8) |
| Neutropenia | 0 | 0 | 48 (18) | 29 (11) |
*
Data are based on an August 2, 2016, database lock. Safety analyses included all the patients who had received at least one dose of nivolumab or chemotherapy. Included are events that were reported in at least 10% of the patients in either trial group from the time of the first dose of nivolumab or chemotherapy to 30 days after the receipt of the last dose or to the time of the first dose of nivolumab crossover, whichever came first. The relatedness of adverse events to treatment was adjudicated by the investigators.