Observational Study of the Effectiveness and Safety of Vismodegib (Erivedge) in Patients Treated in Argentina

Hoffmann-La Roche0 个研究点目标入组 75 人开始时间: 2015年6月30日最近更新: 2018年2月26日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Hoffmann-La Roche
入组人数: 75
主要终点: Response rate as assessed by the treating physician

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

This observational, noninterventional study is designed to further characterize the effectiveness and safety profile of vismodegib (Erivedge) in Argentine patients. Only patients with locally advanced basal cell carcinoma (laBCC) or metastatic basal cell carcinoma (mBCC) will be considered in the effectiveness analysis. Study duration is estimated to be approximately 12 months.

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

•Argetine patients prescribed vismodegib according to standard of care and in line with Summary of Product Characteristics (SPC) and local labeling
•Diagnosis of laBCC or mBCC for the effectiveness analysis

排除标准

•None specified

结局指标

主要结局

Response rate as assessed by the treating physician

时间窗: Approximately 12 months

次要结局

Duration of treatment(Approximately 12 months)
Duration of response as assessed by the treating physician(Approximately 12 months)
Incidence of adverse events(Approximately 12 months)

研究者

发起方

Hoffmann-La Roche

申办方类型

Industry

责任方

Sponsor

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