Forxiga (Dapagliflozin) Regulatory Post Marketing Surveillance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 1,001
- 试验地点
- 1
- 主要终点
- Annual incidence rate and proportions of AE, SAE, and sAR within 24 weeks
研究概览
简要总结
This study is conducted to meet the requirements of the Drug Administration of Vietnam (DAV) on conducting necessary safety evaluations in routine clinical practice for a new medication within 3 years from its date of approval. For the case of the study treatment (dapagliflozin - Forxiga), safety and drug utilization reports have been regularly submitted by AstraZeneca to DAV every 6 months since its date of approval on 25th May 2016. To provide additional evidence on the safety profile of dapagliflozin in real-life settings and support renewing marketing authorizations for Forxiga, AstraZeneca collaborated with eight hospitals across Vietnam to implement this study.
详细描述
This study is a longitudinal observation on a cohort of 1001 patients with type 2 diabetes mellitus (T2DM), newly treated with dapagliflozin at eight hospitals across Vietnam. Adult T2DM patients who were newly treated with dapagliflozin and signed the informed consent form were eligibly recruited. For each recruited subject, the maximum duration of observation was 24 weeks, divided into 4 visits. In the first visit, data on subjects' baseline characteristics was collected. In the later visits, the presence, and the patterns of adverse events during the time treated with dapagliflozin were investigated.
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
- •Adult patients (≥ 18 years)
- •Diagnosed with T2DM, and eligible for initiating treatment with dapagliflozin according to indications of the approved summary of product characteristics of Forxiga in Vietnam.
- •Provision of signed and dated written informed consent form by the potential study subject or the subject's legal guardian to demonstrate that s/he was informed necessary information of this study, prior to any mandatory study specific procedures
排除标准
- •Patients who were prescribed dapaglifozin for off-label use (not mentioned in the approved summary of product characteristics of Forxiga in Vietnam)
- •Patients who had contraindications with Forxiga
结局指标
主要结局
Annual incidence rate and proportions of AE, SAE, and sAR within 24 weeks
时间窗: 24 weeks
Monitoring and reporting data on adverse events (AEs) and serious adverse events (SAEs) during the treatment with dapagliflozin was implemented consistently with routine care in each studied site. For the patients discontinued dapagliflozin before completing the standard follow-up period (24 weeks), data would be collected via phone calls or emails. Decisions of continuing or discontinuing dapagliflozin treatment, either related or unrelated with safety issues, were completely depended on the medical doctor's opinion, with the patient's agreement
次要结局
未报告次要终点