Safety profile of nivolumab by dose level and tumor type

Dose (mg/kg Q2W)
Patients with treatment-related AEs, % (n)0.10.31310Total
(N = 17)(N = 18)(N = 86)(N = 54)(N = 131)(N = 306)
Any grade77 (13)78 (14)81 (70)74 (40)71 (93)75 (230)
Grade 3/429 (5)17 (3)14 (12)20 (11)16 (21)17 (52)
Serious grade 3/46 (1)05 (4)9 (5)11 (14)8 (24)
Leading to DC18 (3)011 (9)7 (4)12 (16)11 (32)
Deaths2 (2)4 (2)1 (1)2 (5)
Tumor type
Patients with treatment-related AEs, % (n)NSCLCMELRCCCRCmCRPCTotal
(N = 129)(N = 107)(N = 34)(N = 19)(N = 17)(N = 306)
Dose levels (mg/kg)1–100.1–101, 101010
Any grade71 (91)84 (90)85 (29)58 (11)53 (9)75 (230)
Grade 3/414 (18)22 (24)18 (6)16 (3)6 (1)17 (52)
Serious grade 3/46 (8)9 (10)9 (3)11 (2)6 (1)8 (24)
Leading to DC12 (16)9 (10)9 (3)16 (3)011 (32)
Deaths3 (4)5 (1)2 (5)

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