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. Author manuscript; available in PMC: 2023 Jan 17.
Published in final edited form as: N Engl J Med. 2022 Apr 11;386(21):1973–1985. doi: 10.1056/NEJMoa2202170

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).

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