Table 2.
Treatment-related adverse events (TRAEs)
| Adverse event | All | ≥Grade 3 |
| n (%) | n (%) | |
| Any event | 24 (92) | 11 (42) |
| Anemia | 8 (31) | 1 (4) |
| Amylase increased | 7 (27) | 3 (12) |
| Cortisol increased | 7 (27) | 0 (0) |
| AST increased | 6 (23) | 0 (0) |
| Diarrhea | 6 (23) | 2 (8) |
| Fatigue | 6 (23) | 0 (0) |
| Lipase increased | 6 (23) | 4 (15) |
| ALT increased | 5 (19) | 0 (0) |
| Anorexia | 5 (19) | 1 (4) |
| Cough | 4 (15) | 0 (0) |
| Hyperglycemia | 4 (15) | 1 (4) |
| Cortisol decreased | 4 (15) | 0 (0) |
| ESR increased | 4 (15) | 0 (0) |
| Creatinine increased | 3 (12) | 0 (0) |
| Hypoalbuminemia | 3 (12) | 0 (0) |
| Dry skin | 3 (12) | 0 (0) |
| Nausea | 3(12) | 1 (4) |
| Dyspnea | 2 (8) | 0 (0) |
| Myalgia | 2 (8) | 0 (0) |
| Hypernatremia | 2 (8) | 0 (0) |
| Generalized muscle weakness | 2 (8) | 0 (0) |
| White blood cell decreased | 2 (8) | 0 (0) |
| GGT increased | 2 (8) | 0 (0) |
| ACTH decreased | 2 (8) | 0 (0) |
| ACTH increased | 2 (8) | 0 (0) |
| Dry mouth | 2 (8) | 0 (0) |
| Any immune event | 20 (77) | 4 (15) |
| Rash | 10 (38) | 0 (0) |
| Hypothyroidism | 5 (19) | 0 (0) |
| Colitis/diarrhea | 4 (15) | 2 (8) |
| Pneumonitis | 3 (12) | 0 (0) |
| Hypophysitis | 2 (8) | 0 (0) |
| Hyperthyroidism | 2 (8) | 0 (0) |
| Arthralgia | 2 (8) | 0 (0) |
| Pruritus | 2 (8) | 0 (0) |
| Type 1 diabetes mellitus | 1 (4) | 1 (4) |
| Pancreatitis | 1 (4) | 0 (0) |
| Myositis | 1 (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.