Lynparza Tablets 100mg, 150mg Clinical Experience Investigation (All Case Investigation) in Patients With Platinum-sensitive Relapsed Ovarian Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 846
- 主要终点
- Incidence of ADRs regarding Bone marrow depression, ILD, new primary malignancies, Embryo-foetal toxicity and exposure in patient with renal impairment
研究概览
简要总结
[Objectives] Objectives include following to capture safety and efficacy of LYNPARZA in actual clinical use.
- ADR development in actual clinical use
- Factors which may affect safety and efficacy
- ADRs not expected from "Precautions for Use"
详细描述
The objective of the Clinical Experience Investigation (CEI) is to collect following data to characterise safety and efficacy of LYMPARZA Tablets 100mg and 150mg (LYMPARZA) in usual post-marketing use.
- Development of adverse drug reactions (ADRs)
- Factors which may affect safety and efficacy of LYMPARZA
- Development of adverse drug reactions (ADRs) unexpected from "Precautions for Use" of the LYMPARZA JPI
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Maintenance treatment for patients with recurrent ovarian cancer, who are sensitive to platinum based chemotherapy
排除标准
- 未提供
结局指标
主要结局
Incidence of ADRs regarding Bone marrow depression, ILD, new primary malignancies, Embryo-foetal toxicity and exposure in patient with renal impairment
时间窗: from baseline to 1 year
To be calculated incidence of ADRs related to LYMPARZA during the observation period regarding Bone marrow depression, ILD, new primary malignancies, Embryo-foetal toxicity and exposure in patient with renal impairment
Factors which may impact incidence of ADRs related to LYMPARZA during the observation period, analysed by patient demographic characteristics
时间窗: from baseline to 1 year
Factors which may impact incidence of ADRs, analysed by patient demographic characteristic(past medical history, and concomitant disease etc)
Incidence of ADRs not expected from "Precautions for Use" of LYNPARZA JPI
时间窗: from baseline to 1 year
To be calculated incidence of ADRs related to LYMPARZA during the observation period not expected from "Precautions for Use" of LYNPARZA JPI
次要结局
未报告次要终点