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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05488613
Other study ID # CPKC412AFI02
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 24, 2020
Est. completion date January 26, 2021

Study information

Verified date November 2022
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 81
Est. completion date January 26, 2021
Est. primary completion date January 26, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
Finland Novartis Investigative Site Helsinki

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients initiating midostaurin treatment Number of patients initiating midostaurin treatment were reported. throughout the study, approximately 5 years
Secondary 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
Secondary Duration of Midostaurin at induction and consolidation phase Duration of Midostaurin at induction and consolidation phase were reported. throughout the study, approximately 5 years
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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