Rates of drug-related adverse events reported in the CheckMate 025 trial and in the Italian Early Access Program of nivolumab in mRCC
| CheckMate025 | Italian EAP | |||||
|---|---|---|---|---|---|---|
| Everolimus N = 397 | Nivolumab N = 406 | Nivolumab N = 389 | ||||
| Any grade | Grade ≥ 3 | Any grade | Grade ≥ 3 | Any grade | Grade ≥ 3 | |
| Treatment-related AEs, % | 88 | 37 | 79 | 19 | 32 | 7 |
| Fatigue | 34 | 3 | 33 | 2 | 13 | 2 |
| Pyrexia | NR | NR | NR | NR | 3 | 0 |
| Nausea | 17 | 1 | 14 | < 1 | 0 | 0 |
| Pruritus | 10 | 0 | 14 | 0 | 0 | 0 |
| Diarrhea | 21 | 1 | 12 | 1 | 5 | 1 |
| Decreased appetite | 21 | 1 | 12 | < 1 | 1 | < 1 |
| Rash | 20 | 1 | 10 | < 1 | 9 | < 1 |
| Hypothyroidism | NR | NR | NR | NR | 2 | 0 |
| Hyperthyroidism | NR | NR | NR | NR | 2 | 0 |
| Hypophisitis | NR | NR | NR | NR | < 1 | < 1 |
| Hypertransaminasemia | NR | NR | NR | NR | 1 | 0 |
| Cough | 19 | 0 | 9 | 0 | 0 | 0 |
| Anemia | 24 | 8 | 8 | 2 | 2 | < 1 |
| Dyspnea | 13 | < 1 | 7 | 1 | 3 | 1 |
| Edema peripheral | 14 | < 1 | 4 | 0 | 0 | 0 |
| Pneumonitis | 15 | 3 | 4 | 1 | 2 | < 1 |
| Mucosal inflammation | 19 | 3 | 3 | 0 | 0 | 0 |
| Dysgeusia | 13 | 0 | 3 | 0 | 0 | 0 |
| Hyperglycemia | 12 | 3 | 2 | 1 | < 1 | < 1 |
| Stomatitis | 29 | 4 | 2 | 0 | 0 | 0 |
| Hypertriglyceridemia | 16 | 4 | 1 | 0 | 0 | 0 |
| Epistaxis | 10 | 0 | 1 | 0 | 0 | 0 |
Abbreviations: NR not reported, N number, AEs adverse events, EAP Early Access Program