NCT02492815已完成不适用
An Observational Study to Evaluate the Effectiveness and Safety of Ipilimumab, Administered During the European Expanded Access Programme in Pretreated Patients With Advanced (Unresectable or Metastatic) Melanoma
Bristol-Myers Squibb3 个研究点 分布在 3 个国家目标入组 1,773 人开始时间: 2013年10月31日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,773
- 试验地点
- 3
- 主要终点
- Overall survival (OS) of patients enrolled in the European ipilimumab EAP
研究概览
简要总结
Observational study to evaluate the effectiveness and safety of ipilimumab, administered during the European expanded access programme (EAP) in pretreated patients with advanced (unresectable or metastatic) melanoma.
详细描述
Minimum age: 18 years old (at time of inclusion in the CA184-367- but 16 for the EAP)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients have been enrolled in the EAPs
- •Patients still alive must provide informed consent if required by local regulations
- •Deceased patients are eligible per local regulations, their legal representatives must provide informed consent if required by local regulations
排除标准
- •There are no specific exclusion criteria in this observational study other than the exclusion criteria of the EAP
结局指标
主要结局
Overall survival (OS) of patients enrolled in the European ipilimumab EAP
时间窗: Upto 60 month study period
次要结局
- Reasons for discontinuing or skipping ipilimumab administrations among patients enrolled in the European ipilimumab EAP collected from medical charts(Upto 60 month study period)
- Demographic characteristics (age, weight, gender, race) of patients enrolled in the European ipilimumab EAP collected from medical charts(Upto 60 month study period)
- Clinical characteristics (biological values, stage of initial diagnosis, primary location of melanoma) of patients enrolled in the European ipilimumab EAP collected from medical charts(Upto 60 month study period)
- Frequency of discontinuing or skipping ipilimumab administrations among patients enrolled in the European ipilimumab EAP collected from medical charts(Upto 60 month study period)
- Treatment outcomes in specific sub-populations of patients enrolled in the European ipilimumab EAP collected from medical charts(Upto 60 month study period)
- Influence of demographic characteristics (age, weight, gender, race) on effectiveness and safety outcomes among patients enrolled in the European ipilimumab EAP collected from medical charts(Upto 60 month study period)
- Influence of clinical characteristics (biological values, stage of initial diagnosis, primary location of melanoma) on effectiveness and safety outcomes among patients enrolled in the European ipilimumab EAP collected from medical charts(Upto 60 month study period)
研究者
研究点 (3)
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