Table 3.

AEs

Nivolumab N = 34 Any gradeGrade 3–4
Any AEs32 (94)16 (47)
Most common AEs by preferred term (≥5% of patients)
 Viral upper respiratory tract infection10 (29)0 (0)
 Weight decreased7 (21)0 (0)
 Diarrhea6 (18)2 (6)
 Rash6 (18)1 (3)
 Pyrexia6 (18)0 (0)
 Lipase increased5 (15)4 (12)
 Stomatitis5 (15)1 (3)
 Nausea5 (15)0 (0)
 Amylase increased4 (12)2 (6)
 Decreased appetite4 (12)2 (6)
 Arthralgia4 (12)0 (0)
 Vomiting3 (9)0 (0)
 Fatigue3 (9)0 (0)
 Malaise3 (9)0 (0)
 Upper respiratory tract infection3 (9)0 (0)
 Gamma-glutamyltransferase increased2 (6)2 (6)
 Pneumonitis2 (6)2 (6)
 Anemia2 (6)1 (3)
 Hypophosphatemia2 (6)1 (3)
 Interstitial lung disease2 (6)1 (3)
 Hypothyroidism2 (6)0 (0)
 Constipation2 (6)0 (0)
 Dental caries2 (6)0 (0)
 Mucosal inflammation2 (6)0 (0)
 Edema peripheral2 (6)0 (0)
 Lymphocyte count decreased2 (6)0 (0)
 Hyperkalemia2 (6)0 (0)
 Hypoalbuminemia2 (6)0 (0)
 Myalgia2 (6)0 (0)
 Dyspnea2 (6)0 (0)
 Pneumothorax2 (6)0 (0)
 Rash maculo-papular2 (6)0 (0)
AEs leading to discontinuation of study treatment4 (12)3 (9)
AEs leading to interruption of study treatment15 (44)10 (29)
  • NOTE: Data are presented as n (%).