Table 2.

Summary of Adverse Events.

Adverse Event	Relatlimab–Nivolumab (N = 355)		Nivolumab (N = 359)
	Any grade	Grade 3 or 4	Any grade	Grade 3 or 4
	number of events (percent)
Any adverse event	345 (97.2)	143 (40.3)	339 (94.4)	120 (33.4)
Treatment-related adverse event	288 (81.1)	67 (18.9)	251 (69.9)	35 (9.7)
Led to discontinuation of treatment	52 (14.6)	30 (8.5)	24 (6.7)	11 (3.1)
Treatment-related adverse event in ≥10% of patients in the relatlimab–nivolumab group
Pruritus	83 (23.4)	0	57 (15.9)	2 (0.6)
Fatigue	82 (23.1)	4 (1.1)	46 (12.8)	1 (0.3)
Rash	55 (15.5)	3 (0.8)	43 (12.0)	2 (0.6)
Arthralgia	51 (14.4)	3 (0.8)	26 (7.2)	1 (0.3)
Hypothyroidism	51 (14.4)	0	43 (12.0)	0
Diarrhea	48 (13.5)	3 (0.8)	33 (9.2)	2 (0.6)
Vitiligo	37 (10.4)	0	35 (9.7)	0
Immune-mediated adverse event*
Hypothyroidism or thyroiditis	64 (18.0)	0	50 (13.9)	0
Rash	33 (9.3)	2 (0.6)	24 (6.7)	5 (1.4)
Diarrhea or colitis	24 (6.8)	4 (1.1)	11 (3.1)	5 (1.4)
Hyperthyroidism	22 (6.2)	0	24 (6.7)	0
Hepatitis	20 (5.6)	14 (3.9)	9 (2.5)	4 (1.1)
Adrenal insufficiency	15 (4.2)	5 (1.4)	3 (0.8)	0
Pneumonitis	13 (3.7)	2 (0.6)	6 (1.7)	2 (0.6)
Hypophysitis	9 (2.5)	1 (0.3)	3 (0.8)	1 (0.3)
Nephritis and renal dysfunction	7 (2.0)	4 (1.1)	5 (1.4)	4 (1.1)
Hypersensitivity	4 (1.1)	0	4 (1.1)	0

^*Immune-mediated adverse events included adverse events of any grade that occurred in at least 1% of patients in the relatlimab–nivolumab group, that were considered by investigators to be potentially immune-mediated, and that met the following criteria: occurred within 100 days after the last dose (regardless of causality) and were treated with immune-modulating medication with no clear alternate cause or had an immune-mediated component.