NCT03232593已完成不适用
Post-Marketing Surveillance of Tecentriq in MFDS-Approved Indication(s)
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 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
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
研究点 (55)
Loading locations...
相似试验
已完成
4 期
Post-Market Surveillance Study of the TM Ardis Interbody Fusion SystemDegenerative Disc DiseaseNCT02429908Zimmer Biomet80
已完成
不适用
An Observational Study of Herceptin SC Safety in Breast CancerBreast CancerNCT02305628Hoffmann-La Roche600
招募中
4 期
A Post Marketing Surveillance to Evaluate the Safety of Desidustat for the Treatment of Anemia in Subjects With Chronic Kidney Disease (CKD).(Real World Evidence Study)Chronic Kidney DiseasesAnemia of Chronic Kidney DiseaseNCT05515367Zydus Lifesciences Limited1,004
终止
不适用
PMCF Study of the CLS Brevius Stem With Kinectiv TechnologyFemoral Neck FracturesProsthesis FailureOsteoarthritisRheumatoid ArthritisAvascular NecrosisNCT03410940Zimmer Biomet223
已完成
不适用
Observational Study of Pertuzumab Safety in Participants With Breast CancerBreast CancerNCT02266173Hoffmann-La Roche1,130