Table 2. Treatment-related adverse events during the first induction period.
Nivolumab followed by ipilimumab (n=68) | Ipilimumab followed by nivolumab (n=70) | |||||
---|---|---|---|---|---|---|
Grade 1–2 | Grade 3 | Grade 4 | Grade 1–2 | Grade 3 | Grade 4 | |
Pruritus | 9 (13%) | 0 | 0 | 23 (33%) | 0 | 0 |
Rash | 11 (16%) | 0 | 0 | 15 (21%) | 1 (1%) | 0 |
Rash (maculopapular) | 5 (7%) | 0 | 0 | 9 (13%) | 0 | 0 |
Fatigue | 26 (38%) | 0 | 0 | 24 (34%) | 1 (1%) | 0 |
Chills | 3 (4%) | 0 | 0 | 9 (13%) | 0 | 0 |
Diarrhoea | 8 (12%) | 0 | 0 | 23 (33%) | 1 (1%) | 0 |
Nausea | 7 (10%) | 0 | 0 | 11 (16%) | 2 (3%) | 0 |
Colitis | 0 | 0 | 0 | 3 (4%) | 9 (13%) | 0 |
Autoimmune colitis | 0 | 0 | 0 | 0 | 1 (1%) | 0 |
Diarrhoea (haemorrhagic) | 0 | 0 | 0 | 0 | 1 (1%) | 0 |
Increased ALT | 4 (6%) | 0 | 0 | 7 (10%) | 1 (1%) | 0 |
Increased AST | 4 (6%) | 0 | 0 | 7 (10%) | 0 | 0 |
Increased lipase | 1 (1%) | 1 (1%) | 0 | 7 (10%) | 1 (1%) | 0 |
Decreased neutrophil count | 1 (1%) | 0 | 0 | 0 | 0 | 1 (1%) |
Decreased white blood cell count | 1 (1%) | 0 | 0 | 0 | 1 (1%) | 0 |
Muscular weakness | 2 (3%) | 0 | 0 | 1 (1%) | 1 (1%) | 0 |
Headache | 3 (4%) | 1 (2%) | 0 | 3 (4%) | 0 | 0 |
Demyelinating polyneuropathy | 0 | 0 | 1 (2%) | 0 | 0 | 0 |
Myasthenia gravis | 0 | 0 | 1 (2%) | 0 | 0 | 0 |
Dyspnoea | 4 (6%) | 1 (1%) | 0 | 1 (1%) | 0 | 0 |
Pneumonitis | 1 (1%) | 1 (1%) | 0 | 0 | 0 | 0 |
Macular oedema | 2 (3%) | 0 | 0 | 0 | 1 (1%) | 0 |
Mental status changes | 0 | 0 | 0 | 0 | 1 (1%) | 0 |
Renal failure | 0 | 0 | 0 | 0 | 1 (1%) | 0 |
Data are n (%). ALT=alanine aminotransferase. AST=aspartate aminotransferase. No treatment-related deaths were recorded.