NCT01420809已完成不适用
Special Drug Use Investigation for ARIXTRA® (Fondaparinux) Injection
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,280
- 主要终点
- Occurrence of adverse events of bleeding
研究概览
简要总结
This post-marketing surveillance study was designed to collect and assess the information on proper use of fondaparinux injection, such as the safety and efficacy under actual use conditions, in subjects undergoing orthopedic surgery of the lower limb at high risk of developing venous thromboembolism.
(ARIXTRA® is a trademark of the GlaxoSmithKline group of companies.)
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects undergo orthopedic surgery of the lower limb at high risk of developing venous thromboembolism
排除标准
- •Not applicable
结局指标
主要结局
Occurrence of adverse events of bleeding
时间窗: 3 months
The number of incidences of adverse events in Japanese subjects undergoing orthopedic surgery of the lower limb
时间窗: 3 months
Presence or absence of venous thromboembolism after treatment of fondaparinux
时间窗: 3 months
次要结局
未报告次要终点
研究者
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