Table 3.
Selected TRAEs
| Event | Ipilimumab (N=9) | Ipilimumab plus nivolumab (N=10) | Total (N=19) | |||
| Any grade | Grade 3 or 4 | Any grade | Grade 3 or 4 | Any grade | Grade 3 or 4 | |
| Any TRAE | 9 (100) | 5 (56) | 9 (90) | 4 (40) | 18 (95) | 9 (47) |
| Pruritus | 5 (56) | 0 | 5 (50) | 0 | 10 (53) | 0 |
| Maculopapular rash | 3 (33) | 0 | 4 (40) | 0 | 7 (37) | 0 |
| Diarrhea | 3 (33) | 1 (11) | 6 (60) | 2 (20) | 9 (47) | 3 (16) |
| Colitis | 2 (22) | 2 (22) | 1 (10) | 0 | 3 (16) | 2 (11) |
| Alanine aminotransferase increased | 2 (22) | 0 | 5 (50) | 1 (10) | 7 (37) | 1 (5) |
| Aspartate aminotransferase increased | 1 (11) | 0 | 4 (40) | 1 (10) | 5 (26) | 1 (5) |
| Hyponatremia | 2 (22) | 1 (11) | 2 (20) | 0 | 4 (21) | 1 (5) |
| Hypokalemia | 2 (22) | 1 (11) | 1 (10) | 1 (10) | 3 (16) | 2 (11) |
| Arthralgia | 2 (22) | 0 | 1 (10) | 0 | 3 (16) | 0 |
| Hypophysitis | 1 (11) | 0 | 3 (30) | 0 | 4 (21) | 0 |
| Adrenal insufficiency | 1 (11) | 1 (11) | 0 | 0 | 1 (5) | 1 (5) |
| White blood cell count decreased | 2 (22) | 1 (11) | 1 (10) | 0 | 3 (16) | 1 (5) |
| Neutrophil count decreased | 1 (11) | 1 (11) | 1 (10) | 0 | 2 (11) | 1 (5) |
| Urinary tract infection | 1 (11) | 1 (11) | 0 | 0 | 1 (5) | 1 (5) |
| Hypotension | 0 | 0 | 2 (20) | 1 (10) | 2 (11) | 1 (5) |
| TRAE leading to discontinuation | 1 (11) | 1 (11) | 4 (40) | 0 | 5 (26) | 1 (5) |
TRAE, treatment-related adverse event.