NCT01491178已完成不适用
Post-Marketing Surveillance on the Long-Term Use of Prazaxa® Capsules in Patients With Nonvalvular Atrial Fibrillation
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
- 6,772
- 试验地点
- 1,164
- 主要终点
- Frequency (Percentage) of Participants With Adverse Drug Reactions
研究概览
简要总结
To investigate the safety and efficacy of long-term use of Prazaxa® Capsules in patients with nonvalvular atrial fibrillation for preventing the occurrence of ischemic stroke or systemic embolism (SEE).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 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
Patients with NVAF
干预措施: Prazaxa (Drug)
结局指标
主要结局
Frequency (Percentage) of Participants With Adverse Drug Reactions
时间窗: Up to 104 weeks from first administration of study drug
Percentage of participants with adverse drug reactions (ADRs) is presented. An ADR is defined as an adverse event (AE) for which either the investigator or the sponsor (or both) assess the causal relationship to Prazaxa® Capsules either as "Related", "Probably related", or "Cannot be denied".
次要结局
- Incidences of Stroke and Systemic Embolism (SEE)(Up to 104 weeks from first administration of study drug)
研究者
研究点 (1164)
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