Observational Retrospective Cohort Study in Patients With Relapsed Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer Treated With Olaparib Following Response to Platinium-based Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 28
- 主要终点
- progression free survival (PFS)
研究概览
简要总结
This is a national, multi center, retrospective observational cohort study that will be carried out by reviewing the medical records of patients with relapsed epithelial ovarian, fallopian tube, or peritoneal cancer treated with olaparib following response to platinum-based chemotherapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients must be female ≥18 years of age
- •Patients with histologically confirmed ovarian cancer, primary peritoneal cancer and / or fallopian-tube cancer that were treated with olaparib in a real life-setting, between May 2014 to March 2017, whatever the line of therapy
- •Patients can be either alive or deceased at the time of medical record abstraction
- •Patients should not have any objection that anonymized data will be collected and subjected to automated processing.
排除标准
- •Patient that were given olaparib within a clinical trial
结局指标
主要结局
progression free survival (PFS)
时间窗: through study completion, an average of 1 year
PFS (days) = date of progression - date of treatment start + 1
overall Survival (OS)
时间窗: through study completion, an average of 1 year
OS (days) = date of death - date of treatment start + 1
incidence of events of clinical interest
时间窗: through study completion, an average of 1 year
the following events: anemia, thrombopenia, nausea and vomiting, fatigue, myelodysplastic syndrome, upper respiratory infections, diarrhea, decreased appetite, dysgeusia and headache will be formally retrieved from the source documents.
次要结局
未报告次要终点