NCT02106858已完成不适用
Stivarga® Regulatory Post-Marketing Surveillance Study in Korea
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
- 发起方
- Bayer
- 入组人数
- 316
- 主要终点
- Percentage of patients with serious adverse events
研究概览
简要总结
To investigate and collect post-marketing data on the safety of Stivarga in real world practice in its registered indication(s) as required by Health Authority.
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
- •Signed and dated informed consent
- •Patients diagnosed with histologically confirmed metastatic colorectal cancer and/or metastatic or unresectable locally advanced gastrointestinal stromal tumors and/or HCC who have been previously treated with sorafenib by physician
- •Patients who are prescribed with Stivarga tablet 40mg(Regorafenib) for the first time
排除标准
- •Patients participating in an investigational program with interventions outside of routine clinical practice
- •All contra-indications according to the local marketing authorization have to be considered.
研究组 & 干预措施
Group 1
Patients treated by Physician with Stivarga under approved local prescriptions
干预措施: Regorafenib (Stivarga,BAY73-4506) (Drug)
结局指标
主要结局
Percentage of patients with serious adverse events
时间窗: Up to 30 days after terminating treatment
Every 2 months (monthly safety assessment within first two cycles)
Percentage of patients with adverse drug reactions (ADRs)
时间窗: Up to 30 days after terminating treatment
Every 2 months (monthly safety assessment within first two cycles)
次要结局
- Overall survival (OS)(Up to 6 years)
- Overall response(Up to 6 years)
- Progression free survival (PFS)(Up to 6 years)
研究者
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