Post Marketing Surveillance in Japan on Drug Use of JARDIANCE® Tablets in Elderly Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 419
- 试验地点
- 1
- 主要终点
- Percentage of Patients With Adverse Drug Reactions (ADRs)
研究概览
简要总结
Study to investigate the safety and efficacy of daily use of JARDIANCE® Tablets in Japanese elderly patients with type 2 diabetes mellitus.
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
- 65 Years 至 —（Older Adult）
- 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
JARDIANCE®
干预措施: JARDIANCE® (Drug)
结局指标
主要结局
Percentage of Patients With Adverse Drug Reactions (ADRs)
时间窗: From first drug administration until 7 days after last drug adminstration, up to 52 weeks.
ADRs were defined as those adverse events for which the causal relationship was considered "Possibility high " or "Possibility low" or "Unknown" by the principal investigator, where: * Possibility high: There is a reasonable causal relationship between JARDIANCE® tablets administered and the adverse events (AE); * Possibility low: It is probably/possibly that there is a reasonable causal relationship between JARDIANCE® tablets administered and the AE; * Unknown: Cannot be judged because information is insufficient or contradictory. Percentages were rounded to two decimal places.
次要结局
- Change From Baseline in HbA1c (%) at the Last Observation During the Observation Period(Baseline and last observation on treatment, up to week 52.)
- Change From Baseline in Fasting Plasma Glucose at the Last Observation During the Observation Period(Baseline and last observation on treatment, up to week 52.)