跳至主要内容
临床试验/NCT02007655
NCT02007655已完成不适用

Eliquis Safety Surveillance in Japanese Patients With NonValvular Atrial Fibrillation

Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 6,372 人开始时间: 2013年9月1日最近更新:
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
发起方
入组人数
6,372
试验地点
1
主要终点
Incidence rate of unexpected adverse events

研究概览

简要总结

The primary objectives of this study are:

  • To estimate the incidence rate of unexpected adverse events
  • To characterize the bleeding events and assess risk factors of bleeding
  • To identify ancillary baseline variables that may also be associated with adverse outcomes

研究设计

研究类型
Observational
观察模型
Case Only
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

入选标准

  • Patients who are beginning to receive the treatment with this product under the approved indications, dosage, and administration will be included in this study

排除标准

  • Patients who are receiving Eliquis outside of its approved indication will be excluded from this study

研究组 & 干预措施

Eliquis on Nonvalvular Atrial Fibrilliation patients

Patients who are beginning to receive the treatment with Eliquis under the approved indications, dosage, and administration will be included in this study

干预措施: Eliquis (Drug)

结局指标

主要结局

Incidence rate of unexpected adverse events

时间窗: 104 week (discontinuation)

Bleeding events and risk factors of bleeding

时间窗: 104 week (discontinuation)

Ancillary baseline variables that may also be associated with adverse outcomes

时间窗: 104 week (discontinuation)

次要结局

未报告次要终点

研究者

发起方
Bristol-Myers Squibb
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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