Table 2.

Treatment-related adverse events

	Nivolumab and ipilimumab (n=94)				Ipilimumab (n=46)
	Grade 1–2	Grade 3	Grade 4	Grade 5	Grade 1–2	Grade 3	Grade 4	Grade 5
Overall
Any event	34 (35)	41 (44)	10 (11)	1 (1)*	34 (74)	8 (17)	1 (2)	0
Adverse events reported in 10% or more of patients
Rash	36 (38)	4 (4)	0	0	14 (30)	0	0	0
Pruritus	37 (39)	1 (1)	0	0	15 (33)	0	0	0
Rash maculo-papular	12 (13)	3 (3)	0	0	6 (13)	0	0	0
Diarrhoea	33 (35)	8 (9)	1 (1)	0	11 (24)	4 (9)	1 (2)	0
Nausea	19 (20)	8 (9)	1 (1)	0	8 (17)	1 (2)	0	0
Colitis	5 (5)	11 (12)	1 (1)	0	2 (4)	1 (2)	0	0
Abdominal pain	12 (13)	0	0	0	4 (9)	1 (2)	0	0
Vomiting	11 (12)	1 (1)	0	0	3 (6)	0	0	0
Fatigue	29 (31)	4 (4)	1 (1)	0	22 (48)	0	0	0
Pyrexia	14 (15)	2 (2)	1 (1)	0	6 (13)	0	0	0
Chills	11 (12)	0	0	0	5 (11)	0	0	0
Increased aspartate aminotransferase	19 (20)	7 (7)	0	0	4 (9)	0	0	0
Increased alanine aminotransferase	14 (15)	8 (9)	2 (2)	0	4 (9)	0	0	0
Increased lipase	8 (9)	5 (5)	4 (4)	0	2 (4)	0	0	0
Increased amylase	9 (10)	1 (1)	1 (1)	0	0	0	0	0
Headache	11 (12)	2 (2)	0	0	4 (9)	0	0	0
Hypothyroidism	16 (17)	0	0	0	6 (13)	0	0	0
Hypophysitis	10 (11)	2 (2)	0	0	1 (2)	2 (4)	0	0
Cough	10 (11)	0	0	0	4 (9)	0	0	0
Decreased appetite	11 (12)	0	0	0	4 (9)	0	0	0
Myalgia	9 (10)	0	0	0	5 (11)	0	0	0
Adverse events leading to discontinuation
Any event	6 (6)	23 (25)	5 (5)	1 (1)	0	3 (7)	1 (2)	0

Data are n (%).

^*Death due to ventricular arrhythmia occurred within the safety reporting period per protocol, ie, up to 30 days after the last dose of study drug. Two other deaths occurred outside of the safety window reporting period: one in a patient who was clinically improving from pneumonitis and had an iatrogenic pneumothorax (69 days after the last treatment) and one in a patient with panhypopituitarism with cortisol deficiency and adrenal crisis (87 days after the last treatment).