Table 2.
Nivolumab monotherapy and combination with ipilimumab side effect profile
| Adverse event category | Nivolumab
|
Ipilimumab
|
Nivolumab + ipilimumab
|
|||
|---|---|---|---|---|---|---|
| Any, n (%) | Grades 3–4, n (%) | Any, n (%) | Grades 3–4, n (%) | Any, n (%) | Grades 3–4, n (%) | |
| Endocrine | ||||||
| Hypothyroidism | 27 (8.6) | 0 | 13 (4.2) | 1 (0.3) | 47 (15) | 1 (0.3) |
| Hyperthyroidism | 13 (4.2) | 0 | 3 (1) | 0 | 31 (9.9) | 3 (1) |
| Hypophysitis | 2 (0.6) | 1 (0.3) | 12 (3.9) | 6 (1.9) | 24 (7.7) | 5 (1.6) |
| Pyrexia | 18 (5.8) | 0 | 21 (6.8) | 1 (0.3) | 58 (6.8) | 1 (0.3) |
| Gastrointestinal | ||||||
| Elevated ALT/AST | 24 (7.7) | 7 (2.2) | 23 (7.3) | 7 (2.2) | 103 (33) | 45 (14.4) |
| Diarrhea | 60 (19.2) | 7 (2.2) | 103 (33.1) | 19 (6.1) | 138 (44.1) | 29 (9.3) |
| Colitis | 4 (1.3) | 2 (0.6) | 36 (11.6) | 27 (8.7) | 37 (11.8) | 24 (7.7) |
| Nausea | 41 (13.1) | 0 | 50 (16.1) | 2 (0.6) | 81 (25.9) | 7 (2.2) |
| Vomiting | 20 (6.4) | 1 (0.3) | 23 (7.4) | 1 (0.3) | 48 (15.3) | 8 (2.6) |
| Decreased appetite | 34 (10.9) | 0 | 39 (12.5) | 1 (0.3) | 56 (17.9) | 4 (1.3) |
| Musculoskeletal | ||||||
| Arthralgia | 24 (7.7) | 0 | 19 (6.1) | 0 | 33 (10.5) | 1 (0.3) |
| Neuropsychiatric | ||||||
| Fatigue | 107 (34.2) | 4 (1.3) | 87 (28) | 3 (1) | 110 (35.1) | 13 (4.2) |
| Headache | 23 (7.3) | 0 | 24 (7.7) | 1 (0.3) | 32 (10.2) | 1 (0.3) |
| Pulmonary | ||||||
| Pneumonitis | 4 (1.3) | 1 (0.3) | 5 (1.6) | 1 (0.3) | 20 (6.4) | 3 (1) |
| Dyspnea | 14 (4.5) | 1 (0.3) | 13 (4.2) | 0 | 32 (10.2) | 2 (0.6) |
| Skin | ||||||
| Rash | 81 (25.9) | 2 (0.6) | 102 (32.8) | 6 (1.9) | 126 (40.3) | 15 (4.8) |
| Vitiligo | 23 (7.3) | 1 (0.3) | 12 (3.9) | 0 | 21 (6.7) | 0 |
| Pruritus | 59 (18.8) | 0 | 110 (35.4) | 1 (0.3) | 104 (33.2) | 6 (1.9) |
| Discontinuation due to treatment-related AE | 24 (7.7) | 16 (5.1) | 46 (14.8) | 41 (13.2) | 114 (36.4) | 92 (29.4) |
Note: Data from Robert C, Long GV, Brady B, et al. Nivolumab in previously untreated melanoma without BRAF mutation. N Engl J Med. 2015;372(4):320–330.42
Abbreviations: AE, adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase.