Safety
neutropenia, fatigue, febrile neutropenia, diarrhea, thrombocytopenia, splenic rupture, population)Bone pain, alopecia, nausea, vomiting
NEUTROPENIA, FEBRILE NEUTROPENIA, ADVERSE EVENTS, ADVERSE EVENT, THROMBOCYTOPENIA, EVENT, SICKLE CELL ANEMIA WITH CRISIS, ADVERSE EVENT, EVENTS, ALOPECIA, ACUTE RESPIRATORY DISTRESS SYNDROME
Adverse events occurred in most of the subjects; most AEs were expected from the chemotherapy regimen such as nausea, vomiting, diarrhea, alopecia, fatigue. During cycle 1, febrile neutropenia and severe neutropenia was much more frequently observed in placebo group than in efbemalenograstim alfa group; thrombocytopenia was more frequently reported in efbemalenograstim alfa group compared to placebo group but most were mild to moderate and manageable (Table Summary of adverse events in cycle 1 (incidence ≥ 5% in any treatment group) (safety population)Bone pain, as the major consistently observed adverse event associated with G-CSF prophylaxis[In all chemotherapy cycles, there were 17 SAEs reported in 15 (12.3%) subjects. All SAEs were assessed as unrelated to the study drug except for one event of FN that occurred on C1D9 in a subject randomized to receive placebo in cycle 1, which was assessed with a causality of unlikely. All SAEs were resolved by the end of study, with most resolving within 1–5 days of onset.Other adverse events, which generally accepted as being attributable to G-CSF and derivatives, were not reported in this study, such as splenic rupture, sickle cell anemia with crisis, acute respiratory distress syndrome, and other events listed in the section of Precautions and Warnings on the label of G-CSFs [