Imjudo & Imfinzi Post-Marketing Surveillance
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- AstraZeneca
- 入组人数
- 246
- 试验地点
- 1
- 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
Based on the re-review of new drugs article, Korean pharmaceutical act, the objectives of this study are to assess safety and effectiveness of the study drugs(Imjudo & Imfinzi) in a real world setting in patients who treated according to the approved indications in Korea.
详细描述
Primary Objective:
To assess safety of the study drugs for patients treated with the study drugs under the approved indication in Korea
Secondary Objective:
To assess effectiveness of the study drugs for patients treated with the study drugs under the approved indication in Korea
Exploratory Objective:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
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 Imjudo will be conducted for 90 days from the first dose of the treatment. For Imfinzi will be separately conducted for 1 year from the first dose.
To assess safety of the study drugs for patients treated with the study drugs under the approved indication in Korea
次要结局
- Objective Response Rate(ORR)(For 1 year from the first dose of the treatment)