Belgian Real Life Non-interventional Study (NIS) in Patients Treated With Xarelto® Following an Acute Deep Vein Thrombosis (DVT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 131
- 主要终点
- Number of patients with major bleedings
研究概览
简要总结
The objective of this NIS is to assess in a real-life setting, usage patterns and associated outcomes in the management (healthcare resource utilisation and associated costs) of patients with acute deep vein thrombosis treated with Xarelto, in accordance with the terms of the European marketing authorization and the Belgian reimbursement criteria.
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
- •Adult patients with a diagnosis of deep vein thrombosis (DVT) within the past 9 months, enabling at least 3 months of therapy
排除标准
- •Patients who do not fulfil the Belgian reimbursement criteria of deep vein thrombosis (DVT)
研究组 & 干预措施
Rivaroxaban
干预措施: Rivaroxaban (Xarelto, BAY59-7939) (Drug)
结局指标
主要结局
Number of patients with major bleedings
时间窗: up to 1 year or 30 days after end of rivaroxaban
All-cause mortality
时间窗: up to 1 year or 30 days after end of rivaroxaban
Treatment satisfaction measured by means of Anti-clot treatment scale (ACTS)
时间窗: up to 1 year or 30 days after end of rivaroxaban
Adverse events
时间窗: up to 1 year or 30 days after end of rivaroxaban
Number of patients with symptomatic recurrent Venous Thrombus Embolism (VTE)
时间窗: up to 1 year or 30 days after end of rivaroxaban
Quantities of resource use consumption
时间窗: up to 1 year or 30 days after end of rivaroxaban
次要结局
未报告次要终点