Table 2.

Adverse Events.^*

Event	Nivolumab plus Chemotherapy (N = 176)		Chemotherapy Alone (N = 176)
	Any Grade	Grade 3 or 4	Any Grade	Grade 3 or 4
Adverse events of any cause — no. (%)†
All	163 (92.6)	72 (40.9)	171 (97.2)	77 (43.8)
Leading to discontinuation of treatment	18 (10.2)	10 (5.7)	20 (11.4)	7 (4.0)
Serious	30 (17.0)	19 (10.8)	24 (13.6)	17 (9.7)
Treatment-related adverse events — no. (%)†
All	145 (82.4)	59 (33.5)	156 (88.6)	65 (36.9)
Leading to discontinuation of treatment	18 (10.2)	10 (5.7)	17 (9.7)	6 (3.4)
Serious	21 (11.9)	15 (8.5)	18 (10.2)	14 (8.0)
Death‡	0	—	3 (1.7)	—
Surgery-related adverse events — no./total no. (%)§	62/149 (41.6)	17/149 (11.4)	63/135 (46.7)	20/135 (14.8)

^*Adverse events were coded according to the Medical Dictionary for Regulatory Activities, version 24.0, and were graded according to the Common Terminology Criteria for Adverse Events, version 4.0.

^†Included are events reported between the first neoadjuvant dose and 30 days after the last neoadjuvant dose.

^‡Treatment-related deaths in the chemotherapy-alone group were due to pancytopenia, diarrhea, acute kidney injury (all in one patient), enterocolitis, and pneumonia.

^§The denominators are based on patients who underwent definitive surgery. Included are events reported up to 90 days after definitive surgery. Grade 5 surgery-related adverse events (defined as events that led to death ≤24 hours after the onset of an adverse event) were reported in two patients in the nivolumab-plus-chemotherapy group and were deemed by the investigator to be unrelated to the trial drugs (one each due to pulmonary embolism and aortic rupture).