Yervoy® Postmarketing Surveillance for Patients in Japan With Unresectable, Malignant Melanoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 556
- 试验地点
- 1
- 主要终点
- The Overall Survival (OS) Rate
研究概览
简要总结
This study is a local, prospective, non-interventional, non-controlled, multicenter, observational study (regulatory postmarketing surveillance). Each physician will enroll patients who have received at least 1 dose of Yervoy, and each patient will be followed for up to 12 months. All patients will be evaluated for safety and effectiveness during Yervoy use (4 doses) and for 12 months from the first dose of Yervoy to confirm the safety profile of Yervoy under routine, daily practice
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
- •All patients who are initiating treatment with Yervoy
排除标准
- •Not Applicable
- •Other protocol defined inclusion/exclusion criteria could apply
结局指标
主要结局
The Overall Survival (OS) Rate
时间窗: 12 months
The factors that potentially affect safety or effectiveness
时间窗: 12 months
Stratified analysis on the incidence of adverse events (AEs) and effectiveness by patient background
The incidence of adverse events (AEs) by types among the analysis population
时间窗: 12 months
次要结局
未报告次要终点