Safety and Effectiveness Assessment of PeGagen® (Pegfilgrastim) in the Prevention of Chemotherapy-induced FN

Cinnagen654 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

654

Conditions

Chemotherapy-induced Neutropenia

Interventions

Peg-filgrastimDRUG

PegaGen® was injected as a single subcutaneous dose after completion of cytotoxic chemotherapy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients aged ≥18 years, * with the diagnosis of various types of cancers (such as lymphoma, breast, lung, testicular, prostate, ovary and gastrointestinal cancers), receiving first-line chemotherapy regimens with a high FN risk, which PegaGen® is injected due to physician decision.

Outcomes

Primary Outcomes

Safety assessment, using incidence according to SOC and PT of AEs and SAEs

Safety evaluation was reported using summary statistics. For each AE, data was summarized using incidence according to system organ class and preferred term of AEs and SAEs. Moreover, causality assessment was done and its results was reported by frequency and percentage.

Time frame: This outcome was assessed throughout the study, up to 8 chemotherapy cycles. The duration of treatment was at the physicians' discretion based on the patient's condition.

Secondary Outcomes

Effectiveness assessment: The frequency of neutropenia and neutropenic fever

The frequency of neutropenia and neutropenic fever was reported

Time frame: This outcome was assessed throughout the study, up to 8 chemotherapy cycles. The duration of treatment was at the physicians' discretion based on the patient's condition.

Data from ClinicalTrials.gov

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