Chemotherapy-induced Neutropenia Clinical Trial
Official title:
Safety and Effectiveness Assessment of PeGagen® (Pegfilgrastim) in the Prevention of Chemotherapy-induced Febrile Neutropenia in Iranian Cancer Patients
The present study was an observational, multicenter, non-interventional, single arm, open
label, PMS study conducted in Iran.
The primary objective of this study was safety assessment, including the rate of AEs. The
secondary objective was the effectiveness evaluation in the prevention of
chemotherapy-induced FN.
The present study was an observational, multicenter, non-interventional, single arm, open
label, PMS study conducted in Iran.
Data was gathered in two booklets, each containing information on four cycles of
chemotherapy, which was filled by the designated physician. The duration of PegaGen®
treatment was at the physicians' discretion based on the patient's condition.
The primary objective of this study was safety assessment, including the rate of AEs. The
secondary objective was the effectiveness evaluation in the prevention of
chemotherapy-induced FN.
This study was single arm and 654 subjects participated across various tumor types and
regimens.
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