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. Author manuscript; available in PMC: 2017 Jun 18.
Published in final edited form as: Lancet Oncol. 2016 Jun 4;17(7):943–955. doi: 10.1016/S1470-2045(16)30126-7

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.