Forxiga Tablets 5mg, 10mgGeneral Drug Use-Results Study n in Chronic Kidney Disease (CKD) Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 1,029
- 试验地点
- 1
- 主要终点
- Incidence of ADRs which are unexpected from the precautions for use in our JPI
研究概览
简要总结
To capture safety when Forxige is administrated to CKD patients in the real world setting
详细描述
The purpose of the study is to review the following points during use of Forxiga Tablets (hereinafter referred to as Forxiga) in the real world setting after launch for treatment of CKD.
- ADRs which are unexpected from the precautions for use in our JPI
- Understanding of incidence of ADRs during use of Forxiga in the real world setting
- Factors (ie demography, treatment) possibly having an impact on the safety.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with CKD except for dialysis and/or renal failure chronic
排除标准
- 未提供
结局指标
主要结局
Incidence of ADRs which are unexpected from the precautions for use in our JPI
时间窗: from baseline to 1 year
To be calculated incidence of ADRs related to Forxiga during the observation period not expected from the precautions for use of Forxiga JPI
Incidence of ADRs during use of Forxiga in the real world setting
时间窗: from baseline of 1year
To be calculated incidence of ADRs related to Forxiga during the observation period
Factors (ie demography, treatment) possibly having an impact on the safety
时间窗: from baseline to 1 year
Factors which may impact incidence of ADRs analysed by patient demographic characteristic (past medical history and concomitant disease etc)
次要结局
未报告次要终点