AVIDA The Vidaza® (Azacitidine) Patient Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Celgene
- 入组人数
- 479
- 试验地点
- 1
- 主要终点
- Concomitant care and treatment
研究概览
简要总结
This registry is a prospective, multi-center, observational study compiling data on the natural history and management of patients receiving Vidaza, and will provide unique insights into the management of myelodysplastic syndromes (MDS) and other hematological disorders and the impact of these disorders on patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient who is deemed appropriate for treatment with Vidaza® by his or her clinician, but who has not already started receiving Vidaza® treatment.
- •Patient who is able to read and speak English.
- •Patient who is willing and able to provide informed consent.
- •Patient who agrees to complete patient assessment questionnaires.
排除标准
- •Patients who are currently being treated with Vidaza®.
- •Patients who are concurrently participating in a clinical trial.
- •Patients unwilling or unable to complete the baseline and follow-up questionnaires.
- •Patients who are deemed inappropriate for treatment with Vidaza®.
结局指标
主要结局
Concomitant care and treatment
时间窗: Approximately 4 years
Document common concomitant care procedures and treatments used in conjnction wtih Vidaza
Duration and number of cycles
时间窗: Approximately 4 years
Correlate duration and number of Vidaza treatment cycles with clinical response as defined by 2006 International Working Group for Myeleodysplastic Syndrome
Vidaza usage
时间窗: Approximately 4 years
Describe current usage patterns for Vidaza in the community
Publication
时间窗: Approximately 4 years
Produce publications to support further clinical development and disseminate information on treatment best practices
次要结局
未报告次要终点