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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Midostaurin | Midostaurin was administered in two different dosing options. Either as 2x25mg daily or 2x50mg daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midostaurin | Drug | Midostaurin was administered in two different dosing options. Either as 2x25mg daily or 2x50mg daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients initiating midostaurin treatment | Number of patients initiating midostaurin treatment were reported. | throughout the study, approximately 5 years |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
- AML patients with no treatment information
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Adult patients (18 years or older) with Acute Myeloid Lukemia
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Helsinki | Finland |
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| Label | URL |
|---|---|
| Results for CPKC412AFI02 from the Novartis Clinical Trials Website | View source |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C059539 | midostaurin |
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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 |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |