Healthcare Resource Utilization in Adults Diagnosed With Acute Myeloid Leukemia (AML)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Acute Myeloid Leukemia (AML)

Intervention / Treatment
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* Drug: Midostaurin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: - AML patients with no treatment information

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Midostaurin<br>Midostaurin was administered in two different dosing options. Either as 2x25mg daily or 2x50mg daily. | Drug: Midostaurin<br>* Midostaurin was administered in two different dosing options. Either as 2x25mg daily or 2x50mg daily.<br>* Other names: Rydapt;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients initiating midostaurin treatment | Number of patients initiating midostaurin treatment were reported. | throughout the study, approximately 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who received Midostaurin at induction and consolidation phases | Number of patients who received Midostaurin at induction and consolidation phases were reported. | throughout the study, approximately 5 years | 
| Duration of Midostaurin at induction and consolidation phase | Duration of Midostaurin at induction and consolidation phase were reported. | throughout the study, approximately 5 years | 
| Median average dose intensity in midostaurin treatment in induction and consolidation phase | Median average dose intensity in midostaurin treatment were reported. | throughout the study, approximately 5 years | 
| Most frequent comorbidities at the time of AML diagnosis | Most frequent comorbidities at the time of AML diagnosis were reported. | throughout the study, approximately 5 years | 
| Number of patients at the time of diagnosis (All treated AML patients) | Number of patients at the time of diagnosis (All treated AML patients) were reported. | throughout the study, approximately 5 years | 
| Number of AML patients receiving midostaurin consolidation treatment in inpatient or outpatient care (based on given prescriptions) | Number of AML patients receiving midostaurin consolidation treatment in inpatient or outpatient care (based on given prescriptions) were reported. | throughout the study, approximately 5 years | 
| Mean HCRU and related costs in different disease stages | Estimate HCRU and related costs in different disease stages were reported. | throughout the study, approximately 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute myeloid leukemia,, midostaurin,, healthcare resource utilization