CAPIVASERTIB REGULATORY POSTMARKETING SURVEILLANCE IN KOREA
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- AstraZeneca
- 入组人数
- 130
- 试验地点
- 18
- 主要终点
- Adverse Events (AEs)·Adverse Drug Reactions (ADRs) Serious Adverse Events (SAEs)·Adverse Drug Reactions (SADRs) Unexpected Adverse Events (AEs)·Adverse Drug Reactions (ADRs)
研究概览
简要总结
To fulfil the post-approval commitment of MFDS to conduct post-marketing surveillance, this study is designed to assess the known safety profile, identify previously unsuspected adverse reactions and to evaluate the effectiveness of Capivasertib under conditions of routine daily medical practice in Korea.
详细描述
The objectives of this study are to assess the safety and effectiveness of Capivasertib (hereinafter "the study drug") in a real-world practice setting for patients prescribed with the study drug under the approved local label in South Korea.
Primary Objective To assess the safety of the study drug in patients prescribed with the study drug under the approved label(s) in South Korea
Secondary Objective To assess effectiveness of the study drug in patients prescribed with the study drug under the approved label(s) in South Korea
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients eligible for and treated with the study drug according to the approved label in South Korea
- •Patients who provide signed and dated written informed consent, either personally or through a legally acceptable representative.
排除标准
- •Participation in any interventional trial during the treatment of the study drug
- •Other off-label indications according to the approved label in South Korea
结局指标
主要结局
Adverse Events (AEs)·Adverse Drug Reactions (ADRs) Serious Adverse Events (SAEs)·Adverse Drug Reactions (SADRs) Unexpected Adverse Events (AEs)·Adverse Drug Reactions (ADRs)
时间窗: For about 12 months from the first dose of the study drug unless they withdraw consent, are lost to follow-up, experience disease progression, or die. 30 days addtional follow up in case of not completing 12 months.
The safety assessment should include all undesirable changes in medical findings (including clinical test findings) noted during medical visits as required by local practice guidelines, as well as all AEs associated with the study drug administration.
次要结局
- Real-world progression free survival (rwPFS)(For about 12 months from the first dose of the study drug unless they withdraw consent, are lost to follow-up, experience disease progression, or die)