Table 2

Treatment-related adverse events (TRAEs)

Adverse eventAll≥Grade 3
n (%)n (%)
Any event24 (92)11 (42)
 Anemia8 (31)1 (4)
 Amylase increased7 (27)3 (12)
 Cortisol increased7 (27)0 (0)
 AST increased6 (23)0 (0)
 Diarrhea6 (23)2 (8)
 Fatigue6 (23)0 (0)
 Lipase increased6 (23)4 (15)
 ALT increased5 (19)0 (0)
 Anorexia5 (19)1 (4)
 Cough4 (15)0 (0)
 Hyperglycemia4 (15)1 (4)
 Cortisol decreased4 (15)0 (0)
 ESR increased4 (15)0 (0)
 Creatinine increased3 (12)0 (0)
 Hypoalbuminemia3 (12)0 (0)
 Dry skin3 (12)0 (0)
 Nausea3(12)1 (4)
 Dyspnea2 (8)0 (0)
 Myalgia2 (8)0 (0)
 Hypernatremia2 (8)0 (0)
 Generalized muscle weakness2 (8)0 (0)
 White blood cell decreased2 (8)0 (0)
 GGT increased2 (8)0 (0)
 ACTH decreased2 (8)0 (0)
 ACTH increased2 (8)0 (0)
 Dry mouth2 (8)0 (0)
Any immune event20 (77)4 (15)
 Rash10 (38)0 (0)
 Hypothyroidism5 (19)0 (0)
 Colitis/diarrhea4 (15)2 (8)
 Pneumonitis3 (12)0 (0)
 Hypophysitis2 (8)0 (0)
 Hyperthyroidism2 (8)0 (0)
 Arthralgia2 (8)0 (0)
 Pruritus2 (8)0 (0)
 Type 1 diabetes mellitus1 (4)1 (4)
 Pancreatitis1 (4)0 (0)
 Myositis1 (4)1 (4)
  • Adverse events (AEs) were graded by NCI CTCAE V.4.03. AEs that were related to treatment that occurred in at least two patients or were immune-related or occurred at least once at Grade 3 or higher are included. No Grade 5 events occurred.

  • ACTH, adrenocorticotropic hormone; ALT, alanine aminotransferase; AST, aspartate aminotransferase; ESR, erythrocyte sedimentation rate; GGT, gamma-glutamyltransferase.