Table 3. Treatment-related adverse events during the second induction period.
Nivolumab followed by ipilimumab (n=58) | Ipilimumab followed by nivolumab (n=53) | |||||
---|---|---|---|---|---|---|
Grade 1–2 | Grade 3 | Grade 4 | Grade 1–2 | Grade 3 | Grade 4 | |
Increased ALT | 8 (14%) | 6 (10%) | 1 (2%) | 12 (23%) | 1 (2%) | 0 |
Increased AST | 8 (14%) | 5 (9%) | 0 | 12 (23%) | 1 (2%) | 0 |
Increased lipase | 6 (10%) | 1 (2%) | 0 | 9 (17%) | 4 (8%) | 1 (2%) |
Increased amylase | 5 (9%) | 0 | 0 | 7 (13%) | 2 (4%) | 0 |
Increased blood alkaline phosphatase | 4 (7%) | 2 (3%) | 0 | 2 (4%) | 0 | 0 |
Decreased lymphocyte count | 1 (2%) | 1 (2%) | 0 | 1 (2%) | 0 | 0 |
Increased blood creatinine | 0 | 1 (2%) | 0 | 0 | 0 | 0 |
Increased hepatic enzyme | 0 | 0 | 1 (2%) | 0 | 0 | 0 |
Pruritus | 16 (28%) | 1 (2%) | 0 | 5 (9%) | 0 | 0 |
Rash | 14 (24%) | 2 (3%) | 0 | 5 (9%) | 1 (2%) | 0 |
Rash (maculopapular) | 6 (10%) | 1 (2%) | 0 | 4 (8%) | 1 (2%) | 0 |
Dermatitis (exfoliative) | 0 | 1 (2%) | 0 | 0 | 0 | 0 |
Diarrhoea | 17 (29%) | 7 (12%) | 0 | 9 (17%) | 1 (2%) | 0 |
Nausea | 13 (22%) | 2 (3%) | 0 | 2 (4%) | 0 | 0 |
Colitis | 1 (2%) | 9 (16%) | 0 | 0 | 5 (10%) | 0 |
Vomiting | 4 (7%) | 2 (3%) | 0 | 4 (8%) | 0 | 0 |
Abdominal pain | 4 (7%) | 1 (2%) | 0 | 3 (6%) | 0 | 0 |
Crohn's disease | 0 | 1 (2%) | 0 | 0 | 0 | 0 |
Enterocolitis | 0 | 0 | 0 | 0 | 1 (2%) | 0 |
Fatigue | 20 (34%) | 1 (2%) | 0 | 11 (21%) | 3 (6%) | 0 |
Pyrexia | 10 (17%) | 0 | 0 | 1 (2%) | 0 | 0 |
Headache | 8 (14%) | 2 (3%) | 0 | 4 (8%) | 1 (2%) | 0 |
Hypothyroidism | 7 (12%) | 0 | 0 | 5 (9%) | 0 | 0 |
Hypophysitis | 4 (7%) | 0 | 0 | 1 (2%) | 2 (4%) | 0 |
Adrenal insufficiency | 1 (2%) | 1 (2%) | 0 | 1 (2%) | 0 | 0 |
Decreased appetite | 7 (12%) | 0 | 0 | 4 (8%) | 1 (2%) | 0 |
Dehydration | 2 (3%) | 1 (2%) | 0 | 1 (2%) | 1 (2%) | 0 |
Polydipsia | 0 | 0 | 0 | 0 | 1 (2%) | 0 |
Muscular weakness | 2 (3%) | 1 (2%) | 0 | 1 (2%) | 0 | 0 |
Respiratory failure | 0 | 0 | 1 (2%) | 0 | 0 | 0 |
Hepatitis | 0 | 3 (5%) | 0 | 0 | 0 | 0 |
Hepatotoxicity | 0 | 0 | 1 (2%) | 0 | 0 | 0 |
Autoimmune disorder | 0 | 1 (2%) | 0 | 0 | 0 | 0 |
Acute kidney injury | 0 | 1 (2%) | 0 | 0 | 0 | 0 |
Renal failure | 0 | 0 | 1 (2%) | 0 | 0 | 0 |
Hypotension | 0 | 1 (2%) | 0 | 0 | 0 | 0 |
Data are n (%). ALT=alanine aminotransferase. AST=aspartate aminotransferase. No treatment-related deaths were recorded.