A Non-interventional Observational Post Authorization Study to Evaluate Safety and Efficacy in Patients Receiving Azacitidine in Daily Clinical Practice in the Netherlands (OCEAN)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Celgene
- 入组人数
- 209
- 主要终点
- Adverse Events (AEs)
研究概览
简要总结
The study design is a prospective, non-interventional, observational single arm study.
A minimum of 150 patients will be recruited from approximately 30 haematology/oncology sites in the Netherlands. In all cases, the decision to treat the patient with azacitidine was already made prior to the decision to enter the subject into the study.
Recruitment will continue until end of June 2015, provided a minimum of 150 patients have been included in the study. When this date is reached, all patients on azacitidine will continue to be followed until the last patient enrolled has been followed for 12 months.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years of age who understand and voluntarily sign an informed consent form.
- •Patients who are treated with azacitidine in accordance with registered indication and clinical practice.
排除标准
- •Refusal to participate in the study.
- •Participation in an interventional clinical study.
- •Patients previously treated with azacitidine except when given as induction therapy for a maximum of three courses.
- •Women who are pregnant or breast-feeding.
- •Hypersensitivity to the active substance or to any of the excipients.
- •Advanced malignant hepatic tumors.
结局指标
主要结局
Adverse Events (AEs)
时间窗: Up to approximately 4 years
Adverse events will be classified using the Medical Drug Regulatory Activities (MedDRA) classification system. The severity of the toxicities will be graded according to the NCI CTCAE VERSION 4.03 whenever possible
次要结局
- Percentage of patients with a Hematologic Improvement Using International Working Group (IWG Criteria for Hematologic Improvement Cheson 2000) Criteria for Myelodysplastic Syndrome (MDS) and Assessed by the investigator in daily clinical practice(Up to approximately 4 years)
- Fact-Anemia Quality of life questionnaire(Up to approximately 4 years)
- Percentage of patients with a Haematological Response in daily clinical practice using the International Work Group Criteria in Myelodysplastic Syndrome Assessed by the Investigator(Up to approximately 4 years)
- Time to treatment Failure daily clinical practice(Up to approximately 4 years)
- Overall Survival in daily clinical practice(Up to approximately 4 years)