Table 3.
Adverse events summary
| n (%) |
Pembrolizumab + Epacadostat n = 34 |
Pembrolizumab Monotherapy n = 19 |
EXTREME n = 34 |
|---|---|---|---|
| Any-grade all-cause AE | 34 (100) | 17 (89) | 34 (100) |
| Grade 3–4 | 16 (47) | 13 (68) | 29 (85) |
| Led to discontinuation | 3 (98) | 2 (11) | 7 (21) |
| Serious | 12 (35) | 8 (42) | 12 (35) |
| Serious, led to discontinuation | 2 (6) | 1 (5) | 1 (3) |
| Treatment-related AEa | 28 (82) | 12 (63) | 34 (100) |
| Grade 3–4 | 8 (24) | 3 (16) | 28 (82) |
| Led to discontinuation | 2 (6) | 2 (11) | 6 (18) |
| Serious | 4 (12) | 2 (11) | 3 (9) |
| Serious, led to discontinuation | 1 (3) | 1 (5) | 0 |
| Died | 0 | 0 | 0 |
AE Adverse event
aDetermined by the investigator to be related to study treatment