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).