Table 4 Reported adverse events in overall study population (n = 103 patients totally)
Adverse events (AE)a | Cutaneous melanoma | Mucosal melanoma | MUP | Total | ||||
|---|---|---|---|---|---|---|---|---|
No. patients (%) | 83 (100) | 7 (100) | 13 (100) | 103 (100) | ||||
All grades | Grade 3/4 | All grades | Grade 3/4 | All grades | Grade 3/4 | All grades | Grade 3/4 | |
Patients with at least one AE | 79 (95) | 36 (43) | 6 (86) | 4 (57) | 13 (100) | 7 (54) | 98 (95) | 47 (46) |
Patients with treatment-related AE | 57 (69) | 14 (17) | 3 (43) | 2 (29) | 11 (85) | 4 (31) | 71 (69) | 20 (19) |
Patients with any irAE | 40 (48) | 12 (15) | 2 (29) | 1 (14) | 10 (77) | 4 (31) | 52 (51) | 17 (17) |
irDermatitis | 21 (25) | – | 1 (14) | – | 3 (23) | – | 25 (24) | – |
Pruritus | 8 (10) | – | 1 (14) | – | 2 (15) | – | 11 (11) | – |
Rash | 8 (10) | – | – | – | 1 (8) | – | 9 (9) | – |
Erythema multiforme | 4 (5) | – | – | – | – | – | 4 (4) | – |
Hand-foot-syndrome | 1 (1) | – | – | – | – | – | 1 (1) | – |
irGastrointestinal disorders | 39 (47) | 15 (18) | 2 (28) | 1 (14) | 8 (62) | 4 (31) | 49 (48) | 20 (20) |
Colitis | 6 (7) | 4 (5) | – | – | 1 (8) | 1 (8) | 7 (7) | 5 (5) |
Diarrhea | 25 (30) | 8 (10) | 1 (14) | 1 (14) | 4 (31) | 1 (8) | 30 (29) | 10 (10) |
GI-perforation | 1 (1) | 1 (1) | – | – | – | – | 1 (1) | 1 (1) |
Otherb | 7 (9) | 2 (2) | 1 (14) | – | 3 (23) | 2 (15) | 11 (11) | 4 (4) |
irEndocrine disorders | 5 (6) | 1 (1) | – | – | – | – | 5 (5) | 1 (1) |
Hypophysitis | 4 (5) | 1 (1) | – | – | – | – | 4 (4) | – |
Hypothyroidism | 1 (1) | – | – | – | – | – | 1 (1) | – |
irHepatic disorders | 4 (5) | 1 (1) | – | – | – | – | 4 (4) | 1 (1) |
Increased ALT | 1 (1) | – | – | – | – | – | 1 (1) | – |
Increased AST | 1 (1) | – | – | – | – | – | 1 (1) | – |
Other | 2 (2) | 1 (1) | – | – | – | – | 2 (2) | 1 (1) |