Safety and Effectiveness Assessment of PeGagen® (Pegfilgrastim) in the Prevention of Chemotherapy-induced Febrile Neutropenia in Iranian Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Cinnagen
- 入组人数
- 654
- 主要终点
- Safety assessment, using incidence according to SOC and PT of AEs and SAEs
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- 未提供
结局指标
主要结局
Safety assessment, using incidence according to SOC and PT of AEs and SAEs
时间窗: 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.
次要结局
- 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.)