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) |
ir immune related, GI gastrointestinal, ALT alanine aminotransferases, AST aspartate aminotransferases, MUP melanoma of unknown primary
aPatients may have had more than one adverse event
bOther gastrointestinal disorders were abdominal pain (n = 6 grade 1/2; n = 3 grade 3/4), constipation (n = 1 grade 1/2) and elevated lipase (n = 1 grade 3/4)