NCT02196194已完成不适用
A Prescription-Event Monitoring (PEM) Study of Tiotropium Based on Prescription Data Collected by the Prescription Pricing Authority (PPA) in England for Tiotropium (Spiriva®)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13,891
- 主要终点
- incidence density of events
研究概览
简要总结
This prescription-event monitoring study was based upon 'event' monitoring and so capable of identifying signals of events that might be associated with the use of tiotropium, which none of the participating general practitioners (GPs) suspected to be an adverse drug reaction. The methodology of this study readily permits follow up of specific events and the obtaining of additional data as appropriate.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who were prescribed tiotropium
排除标准
- •not applicable
研究组 & 干预措施
tiotropium
干预措施: Tiotropium (Drug)
结局指标
主要结局
incidence density of events
时间窗: up to sixth month of treatment
incidence density per 1000 patient-months of treatment
次要结局
未报告次要终点
研究者
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