Post-marketing Surveillance on the Safety of CabometyxTM in Korean Patients Based on "Guideline for Re-examination of New Drugs"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 347
- 试验地点
- 47
- 主要终点
- Proportion of patients who had AEs/SAE after Cabometyx™ administration
研究概览
简要总结
The objective of this Post Marketing Surveillance (PMS) is to collect and describe safety and effectiveness profile of Cabometyx™ in real clinical practice setting, according to the approved labelling after the approval of marketing authorization.
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
- •Patients who meet 'Indications' of label for Cabometyx™ as monotherapy
- •Patients who are treated with Cabometyx™ for the first time according to label for Cabometyx™ as monotherapy
- •Patients who are aged 18 years or older
- •Patients who are willing to provide written consent after being informed of this surveillance
排除标准
- •Patients who are contraindicated for Cabometyx™ based on Cabometyx™ label
结局指标
主要结局
Proportion of patients who had AEs/SAE after Cabometyx™ administration
时间窗: From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks)
Number of patients experiencing Adverse Events (AEs)/ Serious Adverse Events (SAEs) after Cabometyx™ administration
时间窗: From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks)
Number of AEs/SAEs after Cabometyx™ administration
时间窗: From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks)
次要结局
- Progression Free Survival(From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks))
- Objective response rate(From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks))