ELIQUIS (APIXABAN) Regulatory Post-Marketing Surveillance In Clinical Practice for Venous Thromboembolism (VTE) Treatment and Prevention Of Recurrent VTE
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,134
- 试验地点
- 1
- 主要终点
- The incidence of all treatment-related adverse events ( AE)
研究概览
简要总结
The primary objectives of this study is to estimate the real-world safety profile of Eliquis in Japanese Venous Thromboembolism patients and to estimate the risk factors likely to affect the incidence of bleeding. Lastly, the secondary objective of this study is to estimate the real-world effectiveness profile of Eliquis in Japanese Venous Thromboembolism patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are initiating Eliquis for the treatment of VTE or prevention of recurrent VTE for the first time
排除标准
- •Prior treatment with Eliquis for nonvalvular atrial fibrillation or VTE
- •Patients initiating Eliquis for the treatment of atrial fibrillation
- •Off-label use of Eliquis
- •Other protocol defined inclusion/exclusion criteria could apply
结局指标
主要结局
The incidence of all treatment-related adverse events ( AE)
时间窗: 52 Weeks
The incidence of serious adverse events (SAE)
时间窗: 52 Weeks
The incidence of unexpected treatment-related adverse events
时间窗: 52 Weeks
The incidence of unexpected treatment-related adverse events will be analyzed by seriousness, causality, and outcomes of adverse events
The incidence of bleeding
时间窗: 52 Weeks
The incidence of bleeding will be analyzed by seriousness, causality, and outcomes of adverse events
次要结局
- The incidence of venous thromboembolism (VTE)(52 Weeks)