Table 2.
Treatment-Related Adverse Events Reported in >10% of Patients (All Treated Patients).*
| Event | Nivolumab N=406 |
Everolimus N=397 |
||
|---|---|---|---|---|
| Any Grade | Grade 3 or 4 | Any Grade | Grade 3 or 4 | |
| All treatment-related adverse events, n (%) | 319 (79) | 76 (19) | 349 (88) | 145 (37) |
| Fatigue | 134 (33) | 10 (3) | 134 (34) | 11 (3) |
| Nausea | 57 (14) | 1 (0) | 66 (17) | 3 (1) |
| Pruritus | 57 (14) | 0 | 39 (10) | 0 |
| Diarrhea | 50 (12) | 5 (1) | 84 (21) | 5 (1) |
| Decreased appetite | 48 (12) | 2 (1) | 82 (21) | 4 (1) |
| Rash | 41 (10) | 2 (1) | 79 (20) | 3 (1) |
| Cough | 36 (9) | 0 | 77 (19) | 0 |
| Anemia | 32 (8) | 7 (2) | 94 (24) | 31 (8) |
| Dyspnea | 30 (7) | 3 (1) | 51 (13) | 2 (1) |
| Edema peripheral | 17 (4) | 0 | 56 (14) | 2 (1) |
| Pneumonitis | 16 (4) | 6 (2) | 58 (15) | 11 (3) |
| Mucosal inflammation | 11 (3) | 0 | 75 (19) | 12 (3) |
| Dysgeusia | 11 (3) | 0 | 51 (13) | 0 |
| Hyperglycemia | 9 (2) | 5 (1) | 46 (12) | 15 (4) |
| Stomatitis | 8 (2) | 0 | 117 (30) | 17 (4) |
| Hypertriglyceridemia | 5 (1) | 0 | 64 (16) | 20 (5) |
| Epistaxis | 3 (1) | 0 | 41 (10) | 0 |