Trial Objectives

These series of trials were designed to compare the safety, efficacy, and pharmacoki-netics of standard filgrastim administered daily with pegfilgrastim administered once per cycle. The primary endpoint was the duration of grade 4 neutropenia (days of severe neutropenia [DSN]), defined as days the ANC was <0.5 x 109/L during the first course of chemotherapy. The secondary endpoints were DSN in courses 2-4; the granulocyte profile; and the time to ANC recovery defined as granulocytes > 2.0 x 109/L. Another objective was to evaluate the rates of FN in each group. The study was not powered for this endpoint, which was collected to evaluate trends.

0 0

Post a comment