NCT01574235已完成不适用
Safety of Nivestim® in Patients Treated With Neutropenia-inducing Anticancer Chemotherapy in Routine Practice
Hospira, now a wholly owned subsidiary of Pfizer84 个研究点 分布在 1 个国家目标入组 2,114 人开始时间: 2011年10月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,114
- 试验地点
- 84
- 主要终点
- Safety of Nivestim® to reduce or prevent febrile neutropenia in patients treated with neutropenia-inducing chemotherapy for a malignant disease, solid tumor or a malignant hemopathy.
研究概览
简要总结
The main aim of the study is to assess the safety of Nivestim® treatment in patients treated with neutropenia-inducing chemotherapy for a malignant disease, solid tumor or a malignant hemopathy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Age ≥ 18 years
- •Patients presenting with a solid tumor or a malignant hemopathy,
- •Patients treated with or beginning treatment with neutropenia-inducing chemotherapy (regardless of the cycle),
- •Patients in whom treatment with Nivestim® is instituted for the purpose of reducing the duration of the neutropenias and the incidence of the chemotherapy-induced febrile neutropenias
排除标准
- •Patients presenting with a chronic myeloproliferative syndrome,
- •Patients presenting with a myelodysplastic syndrome,
- •Patients showing hypersensitivity to any of the ingredients of Nivestim®,
- •Patients not receiving chemotherapy,
- •Patients who were already included in the study during a previous chemotherapy line
结局指标
主要结局
Safety of Nivestim® to reduce or prevent febrile neutropenia in patients treated with neutropenia-inducing chemotherapy for a malignant disease, solid tumor or a malignant hemopathy.
时间窗: Each patient will be followed for the duration of his chemotherapy regimen (the current one at the time of the Nivestim® treatment initiation) up to a maximum of six months
The safety will be assessed by the record of all treatment emergent adverse events and all data about hospitalization due to any febrile neutropenia or infection.
次要结局
- Efficacy of treatment with Nivestim®(Each patient will be followed for the duration of his chemotherapy regimen (the current one at the time of the Nivestim® treatment initiation) up to a maximum of six months)
- Characteristics of the patients treated with Nivestim® in real-life practice(At Visit 1)
- Methods of treatment with Nivestim®(Each patient will be followed for the duration of his chemotherapy regimen (the current one at the time of the Nivestim® treatment initiation) up to a maximum of six months)
- Profiles of the physicians participating in the study(At visit 1)
- General practice of these physicians with regard to prescription of Granulocyte-Colony Stimulating Factors (G-CSF)(At visit 1)
研究者
研究点 (84)
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