An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance to Monitor the Safety and/or Efficacy of Avandamet® Administered in Korean Diabetic Patients According to the Prescribing Information
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 717
- 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 rosiglitazone/metformin administered in Korean Diabetic patients according to the prescribing information
详细描述
An open label, multi-centre, non-interventional post-marketing surveillance to monitor the safety and/or efficacy of rosiglitazone/metformin administered in Korean Diabetic patients according to the prescribing information
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
rosiglitazone/metformin group
Korean subjects who are administered rosiglitazone/metformin according to the prescription information
干预措施: Administration of rosiglitazone/metformin (Drug)
结局指标
主要结局
Number of Participants With an Adverse Event
时间窗: 41.4 weeks
An adverse event 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 a Serious Adverse Event(41.4 weeks)
- Number of Participants With the Indicated Unexpected Adverse Events(41.4 weeks)