试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 2,521
- 主要终点
- Clinical Efficacy Rate
研究概览
简要总结
The purpose of this study is to collect effectiveness and safety information of fesoterodine related to their appropriate use in daily practice.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients prescribed fesoterodine (Toviaz).
排除标准
- •There are no exclustion criteria
研究组 & 干预措施
Fesoterodine (Toviaz)
干预措施: Fesoterodine (Toviaz) (Drug)
结局指标
主要结局
Clinical Efficacy Rate
时间窗: 12 Weeks
Clinical efficacy rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Overall effectiveness of fesoterodine fumarate was determined by the investigator based on clinical symptoms and examinations. Clinical effectiveness was assessed according to the following categories: (1) effective, (2) ineffective, or (3) unassessable at week 12 of the treatment.
Number of Participants With Treatment-Related Adverse Events
时间窗: 12 Weeks
A treatment-related adverse event was any untoward medical occurrence attributed to fesoterodine fumarate in a participant who received fesoterodine fumarate. Relatedness to fesoterodine fumarate was assessed by the investigator.
次要结局
- Number of Participants With Treatment-Related Adverse Events Among Whose Dose Was Increased From 4 mg to 8 mg(12 Weeks)
- Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert(12 Weeks)
- Satisfaction Rate(12 Weeks)
- Change From Baseline in the Overactive Bladder Symptom Score (OABSS) at 12 Weeks(Baseline, 12 Weeks)
- Number of Participants With Treatment-Related Adverse Events Among Whom Received Concomitant CYP2D6 Inhibitors(12 Weeks)
- Number of Participants With Treatment-Related Serious Adverse Events(12 Weeks)
- Number of Participants With Treatment-Related Adverse Events Among Whom Received Concomitant CYP3A4 Inhibitors(12 Weeks)
- Number of Participants With Adverse Events Related to Cognitive Function Disorder(12 Weeks)
- Change From Baseline in the Mini-Mental State Examination (MMSE) Score at 12 Weeks(Baseline, 12 Weeks)