Table 3.

Adverse Events (Safety Population).^*

Event	Nivolumab alone (N=313)		Nivolumab plus Ipilimumab (N=313)		Ipilimumab alone (N=311)
	Total	Grade 3 or 4	Total	Grade 3 or 4	Total	Grade 3 or 4
	no. of patients with event (%)
Any adverse event	311 (99.4)	136 (43.5)	312 (99.7)	215 (68.7)	308 (99.0)	173 (55.6)
Treatment-related adverse event†	257 (82.1)	51 (16.3)	299 (95.5)	172 (55.0)	268 (86.2)	85 (27.3)
Diarrhea	60 (19.2)	7 (2.2)	138 (44.1)	29 (9.3)	103 (33.1)	19 (6.1)
Fatigue	107 (34.2)	4 (1.3)	110 (35.1)	13 (4.2)	87 (28.0)	3 (1.0)
Pruritus	59 (18.8)	0	104 (33.2)	6 (1.9)	110 (35.4)	1 (0.3)
Rash	81 (25.9)	2 (0.6)	126 (40.3)	15 (4.8)	102 (32.8)	6 (1.9)
Nausea	41 (13.1)	0	81 (25.9)	7 (2.2)	50 (16.1)	2 (0.6)
Pyrexia	18 (5.8)	0	58 (18.5)	2 (0.6)	21 (6.8)	1 (0.3)
Decreased appetite	34 (10.9)	0	56 (17.9)	4 (1.3)	39 (12.5)	1 (0.3)
Increase in alanine aminotransferase	12 (3.8)	4 (1.3)	55 (17.6)	26 (8.3)	12 (3.9)	5 (1.6)
Vomiting	20 (6.4)	1 (0.3)	48 (15.3)	8 (2.6)	23 (7.4)	1 (0.3)
Increase in aspartate aminotransferase	12 (3.8)	3 (1.0)	48 (15.3)	19 (6.1)	11 (3.5)	2 (0.6)
Hypothyroidism	27 (8.6)	0	47 (15.0)	1 (0.3)	13 (4.2)	0
Colitis	4 (1.3)	2 (0.6)	37 (11.8)	24 (7.7)	36 (11.6)	27 (8.7)
Arthralgia	24 (7.7)	0	33 (10.5)	1 (0.3)	19 (6.1)	0
Headache	23 (7.3)	0	32 (10.2)	1 (0.3)	24 (7.7)	1 (0.3)
Dyspnea	14 (4.5)	1 (0.3)	32 (10.2)	2 (0.6)	13 (4.2)	0
Treatment-related adverse event leading to discontinuation	24 (7.7)	16 (5.1)	114 (36.4)	92 (29.4)	46 (14.8)	41 (13.2)

^*The severity of adverse events was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0.

^†The treatment-related adverse events listed here were reported in at least 10% of the patients in any of the three study groups.