NCT01012011已完成不适用
Regulatory Post Marketing Surveillance Study on Nexavar®
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
- 2,845
- 主要终点
- Adverse events collection
研究概览
简要总结
This surveillance are to identify problems/questions regarding adverse events, factors that are considered to affect on safety and efficacy in the clinical practice of using Nexavar
详细描述
The objectives of this surveillance are to identify problems/questions regarding the followings in the clinical practice of using Nexavar®.
- Unknown adverse events (in particular, serious adverse events)
- Identification of adverse events occurred in the real practice.
- Factors that are considered to affect on safety.
- Factors that are considered to affect on effectiveness
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
- 20 Years 至 91 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with diagnosis of advanced RCC or HCC and decision taken by the physician to prescribe Nexavar.
排除标准
- •Exclusion criteria must be read in conjunction with the local product information but patients who are participating in other interventional studies currently will be excluded.
研究组 & 干预措施
Group 1
干预措施: Sorafenib (Nexavar, BAY43-9006) (Drug)
结局指标
主要结局
Adverse events collection
时间窗: From start of treatment to 4 weeks after discontinuation of treatment
次要结局
- Duration of treatment, dosage and indication(Whole treatment period)
- Tumor status(Whole treatment period)
- Performance status(Whole treatment period)
研究者
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