Ondexxya for Intravenous Injection 200mg Drug Use Result Investigation (All Case Investigation)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- AstraZeneca
- 入组人数
- 300
- 试验地点
- 53
- 主要终点
- Incidence of adverse drug reactions, Incidence of safety specifications, Incidence of adverse drug reactions by patient background factor
研究概览
简要总结
This survey will be conducted to investigate the status of occurrence of the safety specifications set for "Safety specification" in patients who received Ondexxya Intravenous Injection 200 mg. In addition, this survey will be implemented to understand the followings by collecting safety and effectiveness information under actual use conditions.
详细描述
This survey will be conducted to investigate the status of occurrence of the safety specifications set for "Safety specification" in patients who received Ondexxya Intravenous Injection 200 mg. In addition, this survey will be implemented to understand the followings by collecting safety and effectiveness information under actual use conditions.
- Detection of unknown adverse drug reactions
- Incidence of adverse drug reactions under actual use conditions of the drug
- Factors that may affect the safety or effectiveness
"Safety specification" Thrombotic events, Infusion reaction, re-bleeding
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
- •All patients treated with this drug to neutralize the anticoagulant effect of a FXa inhibitor (apixaban, rivaroxaban, or edoxaban) at onset of a life-threatening bleeding episode or a unarrestable bleeding episode.
排除标准
- 未提供
结局指标
主要结局
Incidence of adverse drug reactions, Incidence of safety specifications, Incidence of adverse drug reactions by patient background factor
时间窗: 30days
Incidence of adverse drug reactions, Incidence of safety specifications, Incidence of adverse drug reactions by patient background factor
次要结局
未报告次要终点