Table 2.

Treatment-related severe adverse events (SAEs)^a within 12 months after initiation of combination therapy

	NICT (n = 81)	PCT (n = 162)	P value
Number of patients with SAEs, (%)	28 (34.6)	50 (30.9)	0.560
SAEs leading to discontinuation, n (%)	15 (18.5)	31 (19.1)	0.908
Treatment related death, n (%)b	2 (2.5)	6 (3.7)	0.722
SAEs occurring in ≥ 3 patients, n (%)
Pneumonitis	5 (6.2)	16 (9.9)	0.333
Skin toxicity	6 (7.4)	3 (1.9)	0.064
Colitis	4 (4.9)	7 (4.3)	1.000
Hepatobiliary toxicity	6 (7.4)	3 (1.9)	0.064
Renal toxicity	2 (2.5)	3 (1.9)	1.000
Adrenal pituitary disorder	6 (7.4)	4 (2.5)	0.088
Febrile neutropenia	2 (2.5)	5 (3.1)	1.000
Others (details unknown)	1 (1.2)	7 (4.3)

^a Severe adverse events indicate grade 3 or higher

^b Treatment related deaths include one pneumonitis case and one steroid-related infection in the NICT group and four pneumonitis cases and two colitis cases in the PCT group

Abbreviations: NICT, nivolumab plus ipilimumab with chemotherapy; PCT, pembrolizumab with chemotherapy