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

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT05488613
Collaborator
(none)
81
1
4.1
19.9

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

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
  • Outcome Measures

    Primary Outcome Measures

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

      Number of patients initiating midostaurin treatment were reported.

    Secondary Outcome Measures

    1. 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.

    2. Duration of Midostaurin at induction and consolidation phase [throughout the study, approximately 5 years]

      Duration of Midostaurin at induction and consolidation phase were reported.

    3. 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.

    4. 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.

    5. 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.

    6. 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.

    7. 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:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Novartis Investigative Site Helsinki Finland

    Sponsors and Collaborators

    • Novartis Pharmaceuticals

    Investigators

    • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT05488613
    Other Study ID Numbers:
    • CPKC412AFI02
    First Posted:
    Aug 4, 2022
    Last Update Posted:
    Aug 4, 2022
    Last Verified:
    Aug 1, 2022
    Keywords provided by Novartis Pharmaceuticals
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 4, 2022