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临床试验/NCT02921802
NCT02921802已完成不适用

Revlimid 5 mg Capsules Special Use-results Surveillance (All-case Surveillance)

Celgene1 个研究点 分布在 1 个国家目标入组 4,626 人开始时间: 2010年7月20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
Celgene
入组人数
4,626
试验地点
1
主要终点
Adverse Events (AEs)

研究概览

简要总结

To understand the safety and efficacy of Revlimid® 5 mg Capsules (hereinafter referred to as Revlimid) in all patients who are treated with it under the actual condition of use pursuant to the conditions of approval.

  1. Planned registration period This period started on the date of initial marketing of Revlimid and will end at the time when the planned number of patients to be enrolled is reached.
  2. Planned surveillance period This period started on the date of initial marketing of Revlimid and will end on the day when the approval condition related to all-case surveillance is terminated.

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

入选标准

  • Among relapsed or refractory multiple myeloma and Myelodysplastic syndrome (MDS) with a deletion 5q cytogenetic abnormality patients, all patients who received Revlimid will be targeted in this surveillance.

排除标准

  • 未提供

结局指标

主要结局

Adverse Events (AEs)

时间窗: Up to 6 months

Number of participants with adverse events for 6 month treatment

次要结局

未报告次要终点

研究者

发起方
Celgene
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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