跳至主要内容
临床试验/NCT04178317
NCT04178317已完成不适用

Venetoclax (Venclexta Tablet) Post-Marketing Surveillance for CLL Patients

AbbVie13 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2020年4月2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
14
试验地点
13
主要终点
Number of Participants With Adverse Events

研究概览

简要总结

This observational study will evaluate the safety and effectiveness of Venetoclax used in routine clinical practice for participants diagnosed with chronic lymphocytic leukemia (CLL).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants diagnosed with chronic lymphocytic leukemia who have been prescribed Venetoclax for the first time according to the approved label
  • Participants (and/or legal representative) who voluntarily agree to participate in this study and sign informed consent

排除标准

  • Participants with contraindications to venetoclax as listed on the approved local label

结局指标

主要结局

Number of Participants With Adverse Events

时间窗: Up to Approximately 7 Years

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. For more details on adverse events please see the Adverse Event section.

次要结局

  • Overall Response(Up to Approximately 7 Years)

研究者

发起方
AbbVie
申办方类型
Industry
责任方
Sponsor

研究点 (13)

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