Procedures
Chemotherapy was administered on the first day of each 21-day chemotherapy cycle for up to 4 cycles. Approximately 24 h after chemotherapy administration in each cycle, the subject was subcutaneously injected 20 mg efbemalenograstim alfa or placebo. Subjects who randomized to placebo group received placebo injection only in cycle 1. In the following cycles 2, 3, and 4, all subjects received efbemalenograstim alfa. Efbemalenograstim alfa and placebo were provided in single pre-filled syringes.Clinical assessments, including blood sampling, physical examination, vital signs, and symptom/toxicity assessment, occurred for all subjects during screening and at cycle-specific times throughout the study.Oral temperature and absolute neutrophil count (ANC) behavior post-chemotherapy was tracked with daily blood draws in cycle 1 and blood draws every other day in cycles 2, 3, and 4 until ANC levels reached ≥ 2.0 × 10