Multi-center, Survival Data Collection in Subjects Previously Enrolled in Celgene Protocol CC-5013-MDS-003
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Celgene
- 入组人数
- 54
- 试验地点
- 15
- 主要终点
- Participants Survival Status as of the Time of the Extension Study Follow-up
研究概览
简要总结
Multi-center, survival data collection in subjects previously enrolled in study NCT00065156 (Celgene Protocol CC-5013-MDS-003).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
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
- •Must have been enrolled in the Celgene protocol CC-5013-MDS-003 study.
- •Must understand and be able to give informed consent (if a subject is deceased, proper legal consent (i.e. next of kin, legal representative) will be obtained prior to collection of data).
排除标准
- •Consent refused for any reason at current or long-term follow up completed in 2007 (long-term follow up: survival data collection completed to obtain further safety information on CC-5013-MDS-003 discontinued subjects from May - October 2007).
结局指标
主要结局
Participants Survival Status as of the Time of the Extension Study Follow-up
时间窗: up to 7 years
Count of participants who were alive or deceased at the time of the extension study follow-up.
Cause of Death for Participants Who Died
时间窗: up to 7 years
Summary of the cause of death for participants from MDS-003 who died as of the time of the extension study follow-up.
Participants Status Regarding Progression to Acute Myeloid Leukemia (AML) as of the Time of the Extension Study Follow-up
时间窗: up to 7 years
Count of participants who progressed to AML at the time of the extension study follow-up.
Kaplan Meier Estimate for Overall Survival
时间窗: up to 7 years
Overall survival was measured from the start of therapy in CC-5013-MDS-003 to the date of death from any cause. Results include data collected during the extension follow-up.
Kaplan Meier Estimate for Progression to Acute Myeloid Leukemia (AML)
时间窗: up to 7 years
Progression to AML was measured from the start of therapy in CC-5013-MDS-003 to the date AML was diagnosed. Results include data collected during the extension follow-up.
次要结局
未报告次要终点