NCT02946931已完成不适用
The Drug Use-results Survey (All-Case Surveillance) on Prizbind® for Intravenous Solution 2.5 g in Japan
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,402
- 主要终点
- Number of Patients With Adverse Drug Reactions (ADRs)
研究概览
简要总结
To evaluate safety and effectiveness of Prizbind® for Intravenous Solution 2.5 g under Japanese clinical condition.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Prizbind® for Intravenous Solution
Patients treated with dabigatran etexilate who have uncontrolled bleeding or require emergency surgery or procedures.
干预措施: Prizbind® (Drug)
结局指标
主要结局
Number of Patients With Adverse Drug Reactions (ADRs)
时间窗: From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Adverse reaction was defined as a response to the medicinal product which was noxious and unintended. Number of participants with Adverse Drug Reactions (ADRs) is reported.
次要结局
- Maximum Reversal of Anticoagulation as Measured by Activated Partial Thromboplastin Time (aPTT)(From the end of the first infusion up to 4 hours after the last infusion on Day 1.)
- Number of Patients in Each Category of Maximum Reversal of Anticoagulation as Measured by Activated Partial Thromboplastin Time (aPTT)(From the end of the first infusion up to 4 hours after the last infusion on Day 1.)
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