Follow-up Data of Patients Treated With XIGRIS® DROTRECOGIN ALFA (ACTIVATED) in France
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,004
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
The transparency commission wishes that the laboratory Lilly France sets up a follow-up study describing the conditions of use of Xigris® in France.
The purpose of this study is to describe the characteristics of the treated patients, the conditions of drug use, in particular the conditions of treatment initiation and the clinical development of the patients during normal clinical practice, in particular rate and cause of mortality within one month.
详细描述
The objectives of the study as defined by the specific requirements of Transparency Commission are as follows:
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To describe the characteristics of the patients treated with Xigris®
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socio-demographic characteristics,
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clinical profile
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To determine the conditions of use of Xigris®
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To describe previous treatments,
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To observe delay before Xigris® initiation,
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To describe dose, duration of treatment,
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To study the concomitant treatments and the associated treatments
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To describe the clinical evolution of the patients
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To observe mortality after 1 month
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To describe reasons of death
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Mortality
时间窗: 28 and 31 days
次要结局
- Severe bleeding events(28 and 31 days)
- Length of hospital stay(28 and 31 days)