A Post-marketing Surveillance Study Evaluating the Safety and Tolerability of the Labeled Use of Hetero-Darbepoetin Alfa in Indian Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 18
- 主要终点
- Clinical and laboratory adverse events including incidence, severity duration, outcome, action taken and causality parameters of serious and non-serious adverse events
研究概览
简要总结
This is an Open-labelled, prospective, observational, post-marketing surveillance study in patients prescribed with Hetero-Darbepoetin alfa. All patients prescribed Hetero-Darbepoetin alfa by their treating physician will constitute the target patient population. Each treating doctor will report his/ her experience with patient(s) treated with Hetero-Darbepoetin alfa. Hetero- Darbepoetin alfa will be prescribed in the dosage and for the duration as recommended in the package insert or as per the discretion of the prescribing investigator and as per the inclusion and exclusion criteria.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 11.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female adult patients.
- •Patients need to be administered Hetero-Darbepoetin alfa in order to be enrolled in the surveillance.
- •Patients of (CKD) suffering from renal anemia.
- •Treatment of anemia due to the effect of concomitantly administered chemotherapy in patients that have shown a reduction in the need for RBC transfusions in patients with metastatic, non-myeloid malignancies.
- •Any other patient to be prescribed Hetero-Darbepoetin alfa as per prescribing physician’s discretion as per prescribing information.
排除标准
- •Patients not administered/ contraindicated Hetero-Darbepoetin alfa.
- •Patients who are likely to be pregnant or lactating patients.
- •Patients with clinical history/ evidence of allergy/ hypersensitivity to components of Hetero-Darbepoetin alfa.
- •Patients receiving hormonal agents, therapeutic biologic products, or radiotherapy unless receiving concomitant myelosuppressive chemotherapy
- •Patients receiving myelosuppressive therapy when the anticipated outcome is cure.
结局指标
主要结局
Clinical and laboratory adverse events including incidence, severity duration, outcome, action taken and causality parameters of serious and non-serious adverse events
时间窗: All visits
次要结局
- Not applicable(Not applicable)