Treatment Patterns and Key Healthcare Resource Use in Acute Myeloid Leukemia With and Without FLT3 Mutation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,027
- 试验地点
- 1
- 主要终点
- Treatment patterns assessed by whether remission was achieved.
研究概览
简要总结
The purpose of this study is to retrospectively evaluate the treatment patterns and AML-related key healthcare resource use among AML patients, stratified by FLT3 mutation status, intensive chemotherapy (IC) eligibility, and relapsed or refractory (R/R) status.
详细描述
The current study is a retrospective non-interventional study using real-world data collected from existing medical records to evaluate descriptively the treatment patterns and key healthcare resource use among AML patients with or without FLT3 mutation. The current study relies on secondary use of existing data, and there is no intervention involved. Patients who received the first AML treatment after the initial diagnosis, or were classified as relapsed/refractory (R/R), between January 1, 2013 and December 31, 2015 will be randomly selected to be included in this study, and the data from their existing medical records will be extracted. Eligible patients will be grouped based on FLT3 mutation status, intensive chemotherapy (IC) eligibility, and R/R status.
For newly diagnosed patients, the index date will be defined as the initiation date of the first AML treatment following initial diagnosis. For the R/R patients, the index date will be defined as the date of the patient being classified as R/R. The study period will be the period from the index date to last follow-up date or death, whichever comes earlier. The endpoint measurements of this study are treatment patterns and key AML-related healthcare resources used during the study period.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of AML but NOT acute promyelocytic leukemia (APL)
- •Known FLT3 mutation status
- •Under the care of the participating physician during the past 3 years OR from the initial diagnosis of AML
- •The medical records related to AML for the patient are available to the physician and can be abstracted for this study
- •The medical records contains complete information on treatments and AML-related hospitalization, including admission date, length of stay, and reason of hospitalization
- •Initiation date of first treatment after AML diagnosis OR date of being classified as relapsed from or being refractory to initial treatment (R/R) is between January 1, 2013 and December 31, 2015
排除标准
- •Not applicable
结局指标
主要结局
Treatment patterns assessed by whether remission was achieved.
时间窗: Up to 3 years
Treatment patterns assessed by an event
时间窗: Up to 3 years
Reported death, failure of treatment or relapse of any type
AML-related healthcare resource use assessed by number of hospitalizations and lengths of ICU hospital stay
时间窗: Up to 3 years
AML-related healthcare resource use assessed by number of emergency department (ED) visits
时间窗: Up to 3 years
AML-related healthcare resource use assessed by number of infections and associated treatments
时间窗: Up to 3 years
AML-related healthcare resource use assessed by lengths of hospital stay (ICU and non-ICU)
时间窗: Up to 3 years
Treatment patterns assessed by drugs initiated
时间窗: Up to 3 years
Treatment patterns assessed by dosage
时间窗: Up to 3 years
Treatment patterns assessed by duration of treatment
时间窗: Up to 3 years
AML-related healthcare resource use assessed by number of outpatient visits
时间窗: Up to 3 years
AML-related healthcare resource use assessed by number of relevant concomitant medications
时间窗: Up to 3 years
AML-related healthcare resource use assessed by length of hospice care
时间窗: Up to 3 years
AML-related healthcare resource use assessed by number of blood transfusions
时间窗: Up to 3 years
AML-related healthcare resource use assessed by number of lab tests
时间窗: Up to 3 years
Lab tests include bone marrow biopsy
AML-related healthcare resource use assessed by number of diagnostic procedures
时间窗: Up to 3 years
AML-related healthcare resource use assessed by use of mechanical ventilation
时间窗: Up to 3 years
AML-related healthcare resource use assessed by use of parenteral feeding
时间窗: Up to 3 years
AML-related healthcare resource use assessed by number of hospitalizations (ICU and non-ICU)
时间窗: Up to 3 years
次要结局
未报告次要终点