Table 4.

Treatment-related adverse events

Adverse event	Any grade	Grade 3–4
Overall	79 (66%)	19 (16%)
Fatigue	36 (30%)	4 (3%)
Diarrhoea	14 (12%)	2 (2%)
Pruritus	13 (11%)	1 (1%)
Decreased appetite	11 (9%)	1 (1%)
Hypothyroidism	8 (7%)	0
Anaemia	6 (5%)	1 (1%)
Chills	6 (5%)	0
Nausea	6 (5%)	0
Pyrexia	6 (5%)	0
Rash	6 (5%)	1 (1%)
Vomiting	6 (5%)	0
Rash, maculopapular	5 (4%)	0
Alanine aminotransferase increased	5 (4%)	4 (3%)
Arthralgia	5 (4%)	0
Aspartate aminotransferase increased	4 (3%)	3 (3%)
Blood alkaline phosphatase increased	4 (3%)	1 (1%)
Blood bilirubin increased	4 (3%)	2 (2%)
Dyspnoea	4 (3%)	0
Infusion-related reaction	4 (3%)	0
Lymphocyte count decreased	4 (3%)	0
Asthenia	3 (3%)	0
Back pain	3 (3%)	0
Dermatitis acneiform	3 (3%)	0
Dry mouth	3 (3%)	0
Headache	3 (3%)	0
Hypophosphataemia	3 (3%)	2 (2%)
Hypotension	3 (3%)	1 (1%)
Influenza-like illness	3 (3%)	0
Muscle spasms	3 (3%)	0
Thrombocytopenia	3 (3%)	0
Renal failure	2 (2%)	2 (2%)
Autoimmune colitis	1 (1%)	1 (1%)
Liver disorder	1 (1%)	1 (1%)
Hypersensitivity	1 (1%)	1 (1%)
Multiple organ dysfunction syndrome	1 (1%)	1 (1%)
Portal vein thrombosis	1 (1%)	1 (1%)

Events considered to be related to treatment by the investigator reported in ≥3 patients (any grade) or in ≥1 patient (grade 3 or 4). Multiple occurrences of the same event are counted once at maximum severity. Treatment-emergent adverse events include events occurring on or after the first dose of study drug until either 30 days after the last administration of study drug, initiation of subsequent non-protocol anti-cancer therapy or clinical cutoff date, whichever came first. Data cutoff: July 4, 2016.