A Post-marketing Surveillance to Monitor the Safety of HEPSERA(Adefovir Dipivoxil 10mg) Adminstered in Korean Subjects According to the Prescribing Information
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,393
- 主要终点
- Number of Participants With an Adverse Event
研究概览
简要总结
An open label, multi-centre, non-interventional post-marketing surveillance to monitor the safety and/or efficacy of adefovir dipivoxil administered in Korean CHB patients according to the prescribing information
详细描述
This study is a post-marketing surveillance to monitor safety and efficacy of adefovir dipivoxil and identify SAEs, adverse drug reactions (ADRs), and unexpected AEs not described as precautions or warnings and to identify possible factors that have an effect on the AEs and to assess effectiveness of adefovir dipivoxil in real clinical practices after marketing. The subjects are patients prescribed for adefovir dipivoxil by the investigators at the sites based on prescription information in normal clinical practices.
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
- •Patients administrated adefovir dipivoxil at the site
排除标准
- •Patients administrated adefovir dipivoxil before center initiated date
研究组 & 干预措施
adefovir dipivoxil
Patients administrated adefovir at the site
干预措施: adefovir dipivoxil (Drug)
结局指标
主要结局
Number of Participants With an Adverse Event
时间窗: 12 weeks
An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. For a list of all adverse events occurring during the course of the study, please see the table entitled "Other (non-serious) adverse events" in the Adverse Event section of the results record.
次要结局
- Number of Participants With the Indicated Unexpected Adverse Events(12 weeks)
- Number of Participants With a Serious Adverse Event(12 weeks)