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.