Lynparza Tablet (Olaparib) 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
- 661
- 试验地点
- 18
- 主要终点
- Safety (adverse events (AEs), serious AEs (SAEs), adverse drug reactions(ADRs), serious ADRs (SADRs), unexpected AEs/ADRs)
研究概览
简要总结
The objectives of this study are to assess safety and effectiveness of Lynparza tablet (olaparib, hereinafter "the study drug") in a real world setting in patients who are prescribed with the study drug according to the approved indications in South Korea
详细描述
Primary Objective: To assess the safety of the study drug for patients prescribed with the study drug under the approved indications in South Korea Secondary Objective: To assess effectiveness of the study drug for patients prescribed with the study drug under the approved indication in South Korea Exploratory Objective: To assess effectiveness of the study drug for ovarian cancer patients diagnosed as Homologous Recombination Deficiency (HRD) positive via locally available validated HRD test and prescribed with the study drug under the approved indication 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 150 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible for the study drug treatment according to the approved label in South Korea
- •Provision of signed and dated written informed consent by the patient or legally acceptable representative
排除标准
- •History of hypersensitivity to excipients of the study drug or to drugs with a similar chemical structure or class to the study drug
- •Prior exposure to any Polyadenosine 5'diphosphoribose polymerase (PARP) inhibitors, including the study drug
- •Pregnant and/or breast feeding
- •Current participation in any interventional trial
- •Other off-label indications according to the approved label
结局指标
主要结局
Safety (adverse events (AEs), serious AEs (SAEs), adverse drug reactions(ADRs), serious ADRs (SADRs), unexpected AEs/ADRs)
时间窗: For about 1 year since the first dose of the study drug
次要结局
- 6-month real-world Progression free survival (rwPFS)(For about 1 year since the first dose of the study drug)