NCT04068168已完成不适用
Open Label, Multicenter, Real World Practice of Durvalumab (Imfinzi PMS)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 712
- 试验地点
- 1
- 主要终点
- Dose interruptions
研究概览
简要总结
The objectives of this study are to assess safety and efficacy of Imfinzi (durvalumab) in a real world setting in patients treated with Imfinzi under the approved indication in Korea.
详细描述
Primary objective : To assess safety of Imfinzi for patients treated with Imfinzi under the approved indication in Korea
Outcome Measure:
- Safety (adverse event (AE), serious adverse events (SAE), adverse drug reaction (ADR), serious adverse drug reaction (SADR), adverse events of special interest (AESI), adverse events leading to discontinuation (DAE), and adverse events leading to deaths (fatal AE))
- Dose interruptions
- Duration of treatment
- Reason for treatment discontinuation Secondary objective: To assess efficacy of Imfinzi for patients treated with Imfinzi under the approved indication in Korea
Outcome Measure:
- Progression free survival (PFS)
- Objective response rate (ORR)
- Duration of response (DoR)
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
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible for Imfinzi treatment according to the approved label
- •Provision of signed and dated written informed consent by the patient or legally acceptable representative
排除标准
- •Current participation in any interventional trial
- •Other off-label indications according to the approved label
结局指标
主要结局
Dose interruptions
时间窗: for up to 1 year after the first dose of Imfinzi
Safety outcome
Duration of treatment
时间窗: for up to 1 year after the first dose of Imfinzi
Safety outcome
Safety (AE, SAE, ADR, SADR, AESI, DAE, fatal AE)
时间窗: for up to 1 year after the first dose of Imfinzi
safety outcome
次要结局
- Objective response rate (ORR)(for up to 1 year after the first dose of Imfinzi)
- Duration of response (DoR)(for up to 1 year after the first dose of Imfinzi)
- Progression free survival (PFS)(for up to 1 year after the first dose of Imfinzi)
研究者
研究点 (1)
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