临床试验/NCT03232593

NCT03232593已完成不适用

Post-Marketing Surveillance of Tecentriq in MFDS-Approved Indication(s)

Hoffmann-La Roche55 个研究点分布在 1 个国家目标入组 1,758 人开始时间: 2017年11月29日最近更新: 2022年8月24日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Hoffmann-La Roche
入组人数: 1,758
试验地点: 55
主要终点: Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This Phase 4, prospective, multicenter, non-interventional, regulatory post-marketing surveillance study will collect information on the the safety and effectiveness of atezolizumab under the clinical practice, and update the drug label approved by the MFDS in Korea.

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

•Participants who are administered with atezolizumab for the locally approved indications

排除标准

•Participants with a known hypersensitivity to atezolizumab or to any of the excipients

研究组 & 干预措施

Participants who Receive Atezolizumab

Participants who are administered with atezolizumab as per the local label and standard of care at physician's discretion will be observed for approximately 6 years.

干预措施: Atezolizumab (Drug)

结局指标

主要结局

Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)

时间窗: Approximately 6 years

次要结局

Percentage of Participants With Progressive Disease (PD) Assessed per RECIST 1.1(Approximately 6 years)
Percentage of Participants With Complete Response (CR) Assessed per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)(Approximately 6 years)
Percentage of Participants With Stable Disease (SD) Assessed per RECIST 1.1(Approximately 6 years)
Percentage of Participants With Partial Response (PR) Assessed per RECIST 1.1(Approximately 6 years)

研究者

发起方

Hoffmann-La Roche

申办方类型

Industry

责任方

Sponsor

研究点 (55)

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