NCT05218902已完成不适用
A Prospective/Retrospective Non-Interventional Study of Vidaza® (Azacitidine) in Patients With International Prognostic Scoring System (IPSS) Intermediate-2 and High-risk Myelodysplastic Syndromes, or Chronic Myelomonocytic Leukemia, or Acute Myeloid Leukemia With 20-30% Blasts and Multi-lineage Dysplasia in China
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 290 人开始时间: 2022年2月25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
- 290
- 试验地点
- 1
- 主要终点
- Incidence of Serious Adverse Events (SAEs)
研究概览
简要总结
The purpose of this study is to assess the safety and effectiveness in the real-world setting among participants who are treated with Azacitidine in accordance with the China Product Label.
详细描述
This study will have participants both enrolled retrospectively and prospectively for azacitidine (AZA) treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Documented diagnosis of intermediate-2/ high-risk myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML) or acute myeloid leukemia (AML) with 20-30% bone marrow blasts and multi-lineage dysplasia
- •Initiated azacitidine (AZA) treatment per approved China Product Label after April 2017
排除标准
- •Contraindicated for the use of AZA according to China Product Label
- •Simultaneously participating in a treatment intervention study
- •Other protocol-defined inclusion/exclusion criteria apply.
结局指标
主要结局
Incidence of Serious Adverse Events (SAEs)
时间窗: Up to 12 Months
Incidence of Adverse Drug Reactions (ADRs)
时间窗: Up to 12 Months
Incidence of Adverse Events (AEs)
时间窗: Up to 12 Months
次要结局
- Best Overall response rate (ORR) defined as the proportion of participants who achieved best response of superior to stable disease(Up to 12 Months)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Application of Ectoin Containing Lozenges (EHT02) in Patients With Acute, Viral Pharyngitis.Acute Viral PharyngitisNCT03943186Bitop AG102
已完成
不适用
Non-interventional Study of Ectoin Nasal Douche (END01) in Patients With Acute Viral RhinosinusitisAcute RhinosinusitisNCT03480100Bitop AG120
已完成
不适用
Observational Study of Vismodegib (Erivedge) in Patients Treated in ArgentinaBasal Cell CarcinomaNCT02438644Hoffmann-La Roche75
已完成
不适用
Non-interventional Study With NOVOCART® Basic in Patients Treated for Cartilage Defects in the Knee With MACCartilage DiseasesNCT03808623Tetec AG41
尚未招募
不适用
Real-world Study Evaluating the Efficacy and Safety of Azvudine in Nursing Home PatientsCOVID-19NCT05675748Shanghai Henlius Biotech400