Post-Marketing Surveillance (Usage Results Study) of Fruzaqla Capsule (Fruquintinib) for the Approved Indications in South Korea
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Number of Participants with Any Adverse Events (AEs), Adverse Drug Reaction (ADRs), Expected and Unexpected AEs and ADRs
研究概览
简要总结
The purpose of this study is to estimate the proportion of all adverse events (AEs) including serious adverse events (SAEs) occurring with the use of fruquintinib among adult participants who have been administered fruquintinib as per the approved indications.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than or equal to (>=)18 years.
- •Participants who are initiate treatment or will be treated with Fruzaqla according to the approved label of South Korea.
- •Participant voluntarily consent to participate in the study.
- •Exclusion criteria:
- •Participants for whom Fruzaqla is contraindicated or those with risks that should avoid starting Fruzaqla, as per the product label.
- •Participants actively participating in other interventional clinical trial(s) on mCRC treatments.
- •Pregnant or breastfeeding women.
排除标准
- 未提供
结局指标
主要结局
Number of Participants with Any Adverse Events (AEs), Adverse Drug Reaction (ADRs), Expected and Unexpected AEs and ADRs
时间窗: Up to approximately 6 years
Number of Participants with Any Serious Adverse Events (SAEs), Serious Adverse Drug Reaction (SADRs), Expected and Unexpected SAEs and SADRs, AEs Leading to Death
时间窗: Up to approximately 6 years
Number of Participants with AEs with Grade 3 or Higher
时间窗: Up to approximately 6 years
Number of Participants who Reported the Events Related to Important Risks in the Risk Management Plan (RMP)
时间窗: Up to approximately 6 years
次要结局
- Objective Response Rate (ORR)(Up to 18 treatment cycles (approximately up to 18 months))
- Overall Survival (OS) Rate(Up to 6 months)
- Progression Free Survival (PFS) Rate(Up to 6 months)
- Disease Control Rate (DCR)(Up to 18 treatment cycles (approximately up to 18 months))
- Median Overall Survival (mOS)(Up to 18 treatment cycles (approximately up to 18 months))
- Median Progression Free Survival (mPFS)(Up to 18 treatment cycles (approximately up to 18 months))