NCT02178475已完成不适用
Prospective Observational Study of Febrile Neutropenia (FN) and Pegfilgrastim Primary Prophylaxis in Breast Cancer and Non-Hodgkin's Lymphoma Patients Receiving High (>20%) FN-risk Chemotherapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 943
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Febrile Neutropenia
研究概览
简要总结
To estimate the incidence of febrile neutropenia in patients with breast cancer and non-Hodgkin's lymphoma receiving high (> 20%) FN-risk chemotherapy and pegfilgrastim primary prophylaxis.
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
- •Age ≥ 18 years old.
- •Any stage NHL or breast cancer and received the first cycle of a new chemotherapy course.
- •Received the first cycle of a permitted standard dose chemotherapy regimens with an estimated high (> 20%) FN risk according to published data or guidelines (dose modifications +/-10% in Cycle 1 are allowable).
- •Initiated treatment in Cycle 1 with pegfilgrastim according to the pegfilgrastim summary of product characteristics. (SmPC). Enrolment must occur after the first pegfilgrastim dosing in Cycle 1 and before the second day of Cycle 2.
排除标准
- •Ongoing or planned concurrent participation in any clinical study involving Investigational Product that has not been approved by the national competent authorities for any indication.
- •Ongoing or planned concurrent participation in any clinical study where the administration of Colony Stimulating Factor (CSF) is determined by the protocol (clinical trials on an approved drug and observational trials are permitted as long as these do not mandate how neutropenia should be treated).
结局指标
主要结局
Percentage of Participants With Febrile Neutropenia
时间窗: Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.
Febrile neutropenia (FN) was defined as an absolute neutrophil count (ANC) of \< 0.5 x 10\^9/L, or \< 1.0 x 10\^9/L predicted to fall below 0.5 x 10\^9/L within 48 hours with fever or clinical signs of sepsis; fever and ANC were measured the same day or within ± 1 calendar day.
次要结局
- Number of Participants Who Discontinued Pegfilgrastim Prophylaxis(Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.)
- Reasons for Discontinuation of Pegfilgrastim Prophylaxis(Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.)
- Reasons for Discontinuation of G-CSF Prophylaxis(Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.)
- Number of Participants Who Permanently Switched From Pegfilgrastim Prophylaxis to Other G-CSF Prophylaxis(Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.)
- Characteristics of Participants Who Discontinued G-CSF Prophylaxis(Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.)
- Number of Cycles With No G-CSF Prophylaxis in Which Febrile Neutropenia Events Occurred(Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.)
- Number of Febrile Neutropenia Events That Occurred During Cycles With No G-CSF Prophylaxis(Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.)
- Number of Participants Who Experienced Febrile Neutropenia During Cycles With No G-CSF Prophylaxis(Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.)
- Characteristics of Participants Who Received On-schedule Pegfilgrastim Primary Prophylaxis(Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.)
- Number of Participants Who Discontinued G-CSF Prophylaxis(Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.)
- Number of Cycles With no G-CSF Prophylaxis(Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.)
- Percentage of Participants Who Experienced Complications of Febrile Neutropenia(Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.)
- Number of Participants Who Experienced Complications of Febrile Neutropenia During Cycles With No G-CSF Prophylaxis(Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.)
- Characteristics of Participants Who Discontinued Pegfilgrastim Prophylaxis(Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.)
- Number of Cycles With No Pegfilgrastim Prophylaxis(Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.)
- Number of Cycles With No G-CSF Prophylaxis in Which Complications of Febrile Neutropenia Occurred(Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.)
研究者
研究点 (1)
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