Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peg-filgrastim | Drug | PegaGen® was injected as a single subcutaneous dose after completion of cytotoxic chemotherapy |
|
| 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. |
| 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. |
Not provided
Inclusion Criteria:
Not provided
Not provided
Not provided
Patients receiving various tumor types and regimens with chemotherapy regimens of high FN risk, will be included.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Arash Jenabian, Professor | Oncology & Hematology Dep., Booali Hosp., Islamic Azad University, Tehran, Iran | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35792924 | Derived | Jenabian A, Ehsanpour A, Mortazavizadeh SMR, Raafat J, Razavi M, Khosravi A, Seifi S, Salimi B, Anjidani N, Kafi H. Evaluating the safety and effectiveness of PegaGen(R) (pegfilgrastim) for the prevention of chemotherapy-induced febrile neutropenia: a post-marketing surveillance study. Support Care Cancer. 2022 Oct;30(10):8151-8158. doi: 10.1007/s00520-022-07265-2. Epub 2022 Jul 6. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D064147 | Febrile Neutropenia |
| ID | Term |
|---|---|
| D009503 | Neutropenia |
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
Not provided
Not provided
| ID | Term |
|---|---|
| C455861 | pegfilgrastim |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |