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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Safety and Effectiveness Assessment of PeGagen® (Pegfilgrastim) in the Prevention of Chemotherapy-induced Febrile Neutropenia in Iranian Cancer Patients

Conditions
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Chemotherapy-induced Neutropenia

Intervention / Treatment
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* Drug: Peg-filgrastim


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Peg-filgrastim|PegaGen® was injected as a single subcutaneous dose after completion of cytotoxic chemotherapy|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness assessment: The frequency of neutropenia and neutropenic fever | The frequency of neutropenia and neutropenic fever was reported | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Febrile neutropenia, Pegfilgrastim, Post-marketing surveillance, Chemotherapy-induced neutropenia, myelosuppressive chemotherapy