Safety of Potential Paediatric Patients Treated With Idarucizumab: a Non-internventional Chart Review Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Safety outcomes until hospital discharge * Incidence of thromboembolic events (ie. obstruction of a blood vessel by the formation of a thrombus - e.g. ischemic stroke, MI, DVT, PE) after administration
研究概览
简要总结
Idarucizumab is a humanized monoclonal antibody fragment (Fab) that binds to dabigatran with very high affinity. Idarucizumab potently and specifically binds to dabigatran and its metabolites and neutralises its anticoagulant effect. A clinical development program is ongoing to support marketing authorisation submissions for idarucizumab indicated in patients treated with dabigatran who require emergency surgery/urgent procedures or who have a life-threatening or uncontrolledbleeding when rapid reversal of the anticoagulant effects of dabigatran is required.
详细描述
Purpose:
Study Design:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 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
All patients treated with idarucizumab
干预措施: idarucizumab (Drug)
结局指标
主要结局
Safety outcomes until hospital discharge * Incidence of thromboembolic events (ie. obstruction of a blood vessel by the formation of a thrombus - e.g. ischemic stroke, MI, DVT, PE) after administration
时间窗: Up to 33 months
Safety outcomes until hospital discharge * Incidence of hypersensitivity/anaphylactic reactions
时间窗: Up to 33 months
Safety outcomes until hospital discharge * Incidence of AE, SAE, ADR, SADR reporting
时间窗: Up to 33 months
Safety outcomes until hospital discharge * Cause of death and in-hospital mortality rate
时间窗: Up to 33 months
次要结局
- Comparison of patient characteristics of paediatric patients with & without outcome events * Incidence of thromboembolic events (ie. obstruction of a blood vessel by the formation of a thrombus - e.g. ischemic stroke, MI, DVT, PE) after administration(Up to 33 months)
- Comparison of patient characteristics of paediatric patients with & without outcome events * Incidence of hypersensitivity/anaphylactic reactions(Up to 33 months)
- Comparison of patient characteristics of paediatric patients with & without outcome events * Incidence of AE, SAE, ADR, SADR reporting(Up to 33 months)
- Comparison of patient characteristics of paediatric patients with & without outcome events * Cause of death and in-hospital mortality rate(Up to 33 months)