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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT05488613

Collaborator

(none)

Enrollment

Location

4.1

Actual Duration (Months)

19.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia (AML)	Drug: Midostaurin

Detailed Description

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.

Study Design

Study Type:

Observational

Actual Enrollment :

81 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Sep 24, 2020

Actual Primary Completion Date :

Jan 26, 2021

Actual Study Completion Date :

Jan 26, 2021

Arms and Interventions

Arm	Intervention/Treatment
Midostaurin Midostaurin was administered in two different dosing options. Either as 2x25mg daily or 2x50mg daily.	Drug: Midostaurin Midostaurin was administered in two different dosing options. Either as 2x25mg daily or 2x50mg daily. Other Names: Rydapt

Arm

Intervention/Treatment

Midostaurin

Midostaurin was administered in two different dosing options. Either as 2x25mg daily or 2x50mg daily.

Drug: Midostaurin

Midostaurin was administered in two different dosing options. Either as 2x25mg daily or 2x50mg daily.

Other Names:

Rydapt

Outcome Measures

Primary Outcome Measures

Number of patients initiating midostaurin treatment [throughout the study, approximately 5 years]
Number of patients initiating midostaurin treatment were reported.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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