Immune-mediated adverse events* occurring in at least one patient in either treatment arm (all-subjects-as-treated population)
| Event, n (%) | Pembrolizumab + dabrafenib + trametinib n=60 | Placebo +dabrafenib + trametinib n=60 |
| At least one immune-mediated adverse event | 31 (51.7) | 9 (15.0) |
| Pneumonitis | 10 (16.7) | 2 (3.3) |
| Hypothyroidism | 5 (8.3) | 1 (1.7) |
| Severe skin reactions | 5 (8.3) | 1 (1.7) |
| Hepatitis† | 4 (6.7) | 2 (3.3) |
| Hyperthyroidism | 3 (5.0) | 0 (0.0) |
| Uveitis | 3 (5.0) | 2 (3.3) |
| Colitis | 2 (3.3) | 1 (1.7) |
| Hypophysitis | 2 (3.3) | 0 (0.0) |
| Nephritis | 2 (3.3) | 0 (0.0) |
| Infusion reactions | 1 (1.7) | 1 (1.7) |
| Myositis | 0 (0.0) | 1 (1.7) |
*Immune-mediated adverse events were selected from a prespecified list and defined as events of unknown cause associated with drug exposure and consistent with an immune event.
†Includes autoimmune hepatitis, drug-induced liver injury, and hepatitis.