NCT01411423已完成不适用
Special Drug Use Investigation of Nexavar (Unresectable or Advanced Renal Cell Carcinoma)
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
- 3,305
- 主要终点
- Incidence of adverse drug reactions and serious adverse events in subjects who received Nexavar
研究概览
简要总结
This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have been administered with Nexavar for unresectable or advanced renal cell carcinoma (RCC). The objective of this study is to assess safety and effectiveness of Nexavar under real-life practice conditions. This study is an all case investigation of which the enrollment period is 15 months, and all patients who received Nexavar will be recruited and followed one year since starting Nexavar administration.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who received Nexavar for unresectable or advanced renal cell carcinoma
排除标准
- •Patients who are contraindicated based on the product label
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
Incidence of adverse drug reactions and serious adverse events in subjects who received Nexavar
时间窗: After Nexavar administration, up to 1 year
次要结局
- Incidence of adverse drug reactions in subpopulation in a variety of baseline data [such as demographic data, concomitant disease, medical history data, clinical staging, etiology of HCC, Eastern Cooperative Oncology Group-Performance Status (ECOG-PS)](After Nexavar administration, up to 1 year)
- Effectiveness evaluation assessment [overall survival, response rate, stable disease rate, progression disease rate] by investigator-determined overall best response [according to the General rule for clinical and pathological studies on RCC](After Nexavar administration, up to 1 year)
- The status of therapy with Nexavar [duration of treatment, daily dose](After Nexavar administration, up to 1 year)
研究者
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