Endpoints
neutropenia
ADVERSE EVENTS, ADVERSE EVENT, NEUTROPENIA
The primary efficacy endpoint was the duration of severe (grade 4) neutropenia (DSN) during cycle 1.ANC measurement was scheduled for days 1–8, 11, and 15 of cycle 1 (10 time points in total). If ANC was <1000/mmThe safety endpoints were adverse events (AEs) across all cycles and the presence of antidrug antibodies (ADAs). AEs were defined by the Japanese version of the Medical Dictionary for Regulatory Activities (MedDRA) (version 24.1) and graded using the Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0).