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Table 1 Safety profile of nivolumab by dose level and tumor type

From: Nivolumab dose selection: challenges, opportunities, and lessons learned for cancer immunotherapy

  Dose (mg/kg Q2W)  
Patients with treatment-related AEs, % (n) 0.1 0.3 1 3 10 Total
(N = 17) (N = 18) (N = 86) (N = 54) (N = 131) (N = 306)
Any grade 77 (13) 78 (14) 81 (70) 74 (40) 71 (93) 75 (230)
Grade 3/4 29 (5) 17 (3) 14 (12) 20 (11) 16 (21) 17 (52)
Serious grade 3/4 6 (1) 0 5 (4) 9 (5) 11 (14) 8 (24)
Leading to DC 18 (3) 0 11 (9) 7 (4) 12 (16) 11 (32)
Deaths 2 (2) 4 (2) 1 (1) 2 (5)
  Tumor type  
Patients with treatment-related AEs, % (n) NSCLC MEL RCC CRC mCRPC Total
(N = 129) (N = 107) (N = 34) (N = 19) (N = 17) (N = 306)
Dose levels (mg/kg) 1–10 0.1–10 1, 10 10 10  
Any grade 71 (91) 84 (90) 85 (29) 58 (11) 53 (9) 75 (230)
Grade 3/4 14 (18) 22 (24) 18 (6) 16 (3) 6 (1) 17 (52)
Serious grade 3/4 6 (8) 9 (10) 9 (3) 11 (2) 6 (1) 8 (24)
Leading to DC 12 (16) 9 (10) 9 (3) 16 (3) 0 11 (32)
Deaths 3 (4) 5 (1) 2 (5)
  1. AE adverse event, CRC colorectal cancer, DC discontinuation, mCRPC metastatic castration-resistant prostate cancer, MEL melanoma, NSCLC non-small cell lung cancer, Q2W every 2 weeks