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Table 2 Rates of drug-related adverse events reported in the CheckMate 025 trial and in the Italian Early Access Program of nivolumab in mRCC

From: Real-world efficacy and safety of nivolumab in previously-treated metastatic renal cell carcinoma, and association between immune-related adverse events and survival: the Italian expanded access program

  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
  1. Abbreviations: NR not reported, N number, AEs adverse events, EAP Early Access Program