Post Marketing Surveillance To Assess The Safety And Efficacy Of Fesoterodine (Toviaz) On Filipino Patients Diagnosed With Over-Active Bladder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 508
- 试验地点
- 24
- 主要终点
- Number of Participants With Adverse Events (AEs) by Seriousness, Severity and Relationship to Treatment
研究概览
简要总结
This is an observational study and will determine the safety profile of fesoterodine in Filipino patients prescribed the drug. This is in compliance with the requirements of the Philippine Food and Drug Administration.
详细描述
Sampling method is not applicable in this study. Only patients prescribed Fesoterodine will be enrolled.
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
- •Over-active bladder
- •Prescribed with Fesoterodine
排除标准
- •Hypersensitivity
- •Urinary retention
研究组 & 干预措施
Patients prescribed with Fesoterodine
Patients diagnosed with Over-active bladder and prescribed with fesoterodine.
干预措施: Fesoterodine (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs) by Seriousness, Severity and Relationship to Treatment
时间窗: Baseline up to 28 days after last dose
Counts of participants who had treatment-emergent AEs (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to fesoterodine fumarate (Toviaz) was assessed by the investigator. Participants with multiple occurrences of an AE within a category were counted once within the category. Seriousness of an AE was assessed under the criteria of serious adverse event (SAE). AE was assessed according to severity; mild (not causing any significant problem, dose adjustment not required), moderate (caused problem that does not interfere significantly with usual activities or the clinical status, dose adjustment needed due to AE) and severe (caused problem that interferes significantly with usual activities or the clinical status, study drug stopped due to AE).
次要结局
未报告次要终点