NCT02050594已完成不适用
Ipilimumab 12-month Intensive Pharmacovigilance Protocol
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2014年2月最近更新:
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
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Descriptive statistics of observed adverse events (AEs) while on treatment with Ipilimumab for advanced melanoma in Venezuela
研究概览
简要总结
The primary objective of the protocol is to identify and describe observed adverse events (AEs) while on treatment with Ipilimumab for advanced melanoma in Venezuela during the study period
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 18 years or older on date of first dose of Ipilimumab
- •Subjects who received at least 1 dose of Ipilimumab for the treatment of unresectable, recurrent or metastatic melanoma in Venezuela
排除标准
- •Subjects who received Ipilimumab as part of a clinical trial
- •Subjects who received Ipilimumab for any indication other than local approval (ie, unresectable or metastatic melanoma)
研究组 & 干预措施
Melanoma patients on Ipilimumab
All unresectable, recurrent or metastatic melanoma patients
干预措施: Ipilimumab (Drug)
结局指标
主要结局
Descriptive statistics of observed adverse events (AEs) while on treatment with Ipilimumab for advanced melanoma in Venezuela
时间窗: Up to 12 months of treatment
次要结局
未报告次要终点
研究者
研究点 (1)
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