Table 3.
Summary of treatment-related adverse events (TRAEs)
| Event, n (%) | Nivolumab (n=18)* |
Nivolumab plus ipilimumab (n=21)* |
Nivolumab plus ipilimumab plus cobimetinib (n=30)* | |||
| Any grade | Grade 3/4 | Any grade | Grade 3/4 | Any grade | Grade 3/4 | |
| Any TRAE | 12 (67) | 2 (11) | 18 (86) | 8 (38) | 28 (93) | 11 (37) |
| Serious TRAE | 3 (17) | 1 (6) | 6 (29) | 6 (29) | 5 (17) | 3 (10) |
| TRAEs leading to discontinuation | 1 (6) | 1 (6) | 4 (19) | 4 (19) | 5 (17) | 2 (7) |
| TRAEs of any grade in ≥20% of patients in any treatment arm | ||||||
| Diarrhea | 5 (28) | 0 | 10 (48) | 1 (5) | 16 (53) | 1 (3) |
| Pyrexia | 4 (22) | 0 | 5 (24) | 1 (5) | 5 (17) | 1 (3) |
| Fatigue | 3 (17) | 0 | 6 (29) | 2 (10) | 12 (40) | 3 (10) |
| Pruritus | 1 (6) | 0 | 5 (24) | 0 | 9 (30) | 1 (3) |
| Nausea | 1 (6) | 0 | 5 (24) | 0 | 4 (13) | 0 |
| Dermatitis acneiform | 1 (6) | 0 | 0 | 0 | 6 (20) | 0 |
| Rash | 0 | 0 | 3 (14) | 0 | 11 (37) | 0 |
*Patients who received at least one dose of any study medication. Adverse events were assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events, V.4.0, and Medical Dictionary for Regulatory Activities V.21.0.