Chemotherapy-induced Neutropenia
Conditions
Keywords
Febrile neutropenia, Pegfilgrastim, Post-marketing surveillance, Chemotherapy-induced neutropenia, myelosuppressive chemotherapy
Brief summary
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
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.
Interventions
DRUGPeg-filgrastim
PegaGen® was injected as a single subcutaneous dose after completion of cytotoxic chemotherapy
Sponsors
Cinnagen
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety assessment, using incidence according to SOC and PT of AEs and SAEs | 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness assessment: The frequency of neutropenia and neutropenic fever | 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. | The frequency of neutropenia and neutropenic fever was reported |
Outcome results
None listed