NCT06073769招募中不适用
Onureg® (Oral Azacitidine) Post-Marketing Surveillance in Korean Patients With Acute Myeloid Leukemia
Bristol-Myers Squibb2 个研究点 分布在 1 个国家目标入组 154 人开始时间: 2023年11月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 154
- 试验地点
- 2
- 主要终点
- Number of participants with adverse events (AES)
研究概览
简要总结
The purpose of this observational study is to assess the real-world safety of maintenance therapy with oral azacitidine in Korean participants with acute myeloid leukemia (AML) who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following induction chemotherapy with or without consolidation therapy, and who are not eligible for hematopoietic stem cell transplantation (HSCT).
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
- 否
入选标准
- •Adult participants 19 years of age or older
- •Participants who receive oral azacitidine according to the approved label
- •For the first 2 years after marketing authorization, all participants who have received or are receiving oral azacitidine will also be registered
- •Participants who sign the informed consent form
排除标准
- •Participants who are prescribed oral azacitidine for therapeutic indications not approved in Korea
- •Participants for whom oral azacitidine is contraindicated per the Korean prescribing information approved by ministry of food and drug safety
研究组 & 干预措施
Participants receiving oral azacitidine maintenance therapy
干预措施: Oral azacitidine (Drug)
结局指标
主要结局
Number of participants with adverse events (AES)
时间窗: Up to 12 months
The type, frequency, seriousness and severity of adverse events (AEs), and relationship of AEs to oral azacitidine
次要结局
未报告次要终点
研究者
研究点 (2)
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