Table 3.
Safety summary in the Chinese subpopulation
| Nivolumab plus chemotherapy (n = 43) |
Chemotherapy (n = 53) |
|||
|---|---|---|---|---|
| Any grade | Grade 3-4 | Any grade | Grade 3-4 | |
| Any-cause AEsa,b | ||||
| All | 42 (98) | 20 (46) | 51 (96) | 23 (43) |
| Leading to treatment discontinuation | 4 (9) | 4 (9) | 3 (6) | 0 |
| Serious | 8 (19) | 3 (7) | 4 (8) | 2 (4) |
| TRAEsa,c | ||||
| All | 38 (88) | 18 (42) | 47 (89) | 22 (42) |
| Leading to treatment discontinuation | 4 (9) | 4 (9) | 3 (6) | 0 |
| Serious | 7 (16) | 3 (7) | 4 (8) | 2 (4) |
| Surgery-related AEsd | 28 (78) | 5 (14) | 34 (83) | 9 (22) |
| Treatment-related deaths | 0 | — | 1 (2)e | — |
Data reported as n (%). AEs per CTCAE version 4.0 and MedDRA version 25.0.
AE, adverse event; CTCAE, Common Terminology Criteria for Adverse Events; MedDRA, Medical Dictionary for Regulatory Activities; TRAE, treatment-related adverse event.
Reported events occurred between the first dose and 30 days after the last dose of neoadjuvant study treatment.
No grade 5 AEs were reported in either treatment arm.
No grade 5 TRAEs were reported in either treatment arm.
Reported events occurred within 90 days after definitive surgery. Denominators are based on patients who underwent definitive surgery (nivolumab plus chemotherapy, n = 36; chemotherapy, n = 41). No grade 5 surgery-related AEs were reported in either treatment arm.
Treatment-related death due to pneumonia.