Healthcare Resource Utilization in Adults Diagnosed With Acute Myeloid Leukemia (AML) With a Focus on Patients Treated With Rydapt (Midostaurin) in Helsinki and Uusimaa Hospital District
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Number of patients initiating midostaurin treatment
研究概览
简要总结
This was a non-interventional, retrospective registry study, utilizing electronic health record (EHR) data collected in the hospital district of Helsinki and Uusimaa (HUS). Real-world health care resource utilization (HCRU) of AML patients was characterized.
详细描述
Adult patients (18 years or older) with the inclusion diagnosis, AML (ICD-10 C92.0), between 1.1.2013 - 30.6.2020 were followed from the index date (first ever record of the inclusion diagnosis) until the end of follow-up (30.6.2020), or death. This study did not involve any contacts to patients.
The study inclusion period was changed from 1.1.2013 - 30.6.2020 specified in the protocol to 1.1.2016 - 30.6.2020 due to lack of medication data from pre-2016.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are diagnosed with acute myeloid leukemia (ICD-10 C92.0) during 1.1.2016-30.6.2020
- •Adult (18 years or older) at the time of first diagnosis
- •Health registry data is available and accessible
- •Resident in the hospital district HUS at the time of index diagnosis
排除标准
- •AML patients with no treatment information
研究组 & 干预措施
Midostaurin
Midostaurin was administered in two different dosing options. Either as 2x25mg daily or 2x50mg daily.
干预措施: Midostaurin (Drug)
结局指标
主要结局
Number of patients initiating midostaurin treatment
时间窗: throughout the study, approximately 5 years
Number of patients initiating midostaurin treatment were reported.
次要结局
- Mean HCRU and related costs in different disease stages(throughout the study, approximately 5 years)
- Number of patients at the time of diagnosis (All treated AML patients)(throughout the study, approximately 5 years)
- Median average dose intensity in midostaurin treatment in induction and consolidation phase(throughout the study, approximately 5 years)
- Most frequent comorbidities at the time of AML diagnosis(throughout the study, approximately 5 years)
- Number of AML patients receiving midostaurin consolidation treatment in inpatient or outpatient care (based on given prescriptions)(throughout the study, approximately 5 years)
- Number of patients who received Midostaurin at induction and consolidation phases(throughout the study, approximately 5 years)
- Duration of Midostaurin at induction and consolidation phase(throughout the study, approximately 5 years)