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The aim of this study was to assess the frequency of adverse events (AEs) experienced by chronic myeloid leukemia (CML) patients treated with tyrosine kinase inhibitors (TKIs) and evaluate their impact on treatment adjustments as well as the burden of AEs on healthcare resource use (HRU) and costs.
This study used real-world administrative claims data from the PharMetrics Plus database. AEs of interest were selected based on information obtained from the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines, Chronic Myeloid Leukemia Version 1. 2024 and clinical inputs. Given the nature of claims data, only AEs of interest that required medical attention (i.e., resulted in a claim record) were captured in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First Generation (1G) TKI Cohort | Adult CML patients who received imatinib, a 1G TKI. | ||
| Second Generation (2G) TKI Cohort | Adult CML patients who received the following 2G TKIs: dasatinib, nilotinib, or bosutinib. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With AEs of Interest During the Study Period Among Those Without the Specific Event During the Baseline Period | The Study Period spanned from treatment initiation until treatment discontinuation, one day before treatment switch to another CML treatment, end of data availability, end of health plan coverage, or death, whichever came first. | Up to approximately 7 years and 3 months |
| Number of Patients With AEs of Interest Among All Patients During the Study Period | The Study Period spanned from treatment initiation until treatment discontinuation, one day before treatment switch to another CML treatment, end of data availability, end of health plan coverage, or death, whichever came first. | Up to approximately 7 years and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Treatment Adjustments During the Observation Period | The Observation Period spanned from treatment initiation to the end of data availability, end of health plan coverage, or death, whichever occurred first. Treatment adjustments included:
| Up to approximately 7 years and 3 months |
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Inclusion criteria:
Patients who met all of the following criteria were considered for inclusion:
Exclusion criteria:
Patients who met any of the following criteria were excluded:
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This was a retrospective, noninterventional cohort study.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis | East Hanover | New Jersey | 07936 | United States |
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| Duration of First Treatment Interruption | Up to approximately 7 years and 3 months |
| Time From TKI Initiation to Treatment Adjustment | Treatment adjustments included:
| Up to approximately 7 years and 3 months |
| Number of Patients With AEs of Interest Within 30 Days Before Treatment Adjustment | Treatment adjustments included:
| 6 months |
| Number of AEs of Interest Within 30 Days Before Treatment Adjustment | Treatment adjustments included:
| 6 months |
| Number of Patients by AE of Interest Experienced Within 30 Days Before Treatment Adjustment | Treatment adjustments included:
| 6 months |
| Time Between the Last AE of Interest and Treatment Adjustment | Treatment adjustments included:
| 6 months |
| Number of Patients by Last AE of Interest Experienced Before Treatment Adjustment | Treatment adjustments included:
| 6 months |
| Number of All-cause Healthcare Visits Per-Patient-Per-Year (PPPY) | Healthcare visits included:
| 6 months |
| Number of Patients With One or More All-cause Healthcare Visits | Healthcare visits included:
| 6 months |
| Number of All-cause Inpatient Days | 6 months |
| Number of All-cause Inpatient Days Among Hospitalized Patients | 6 months |
| All-cause Healthcare Costs PPPY | Healthcare costs included:
| 6 months |
| Annual Mean Number of Healthcare Visits Associated With AEs of Interest | Healthcare visits included:
| 6 months |
| Annual Mean Costs of Healthcare Visits Associated With AEs of Interest | Healthcare costs included:
| 6 months |
| ID | Term |
|---|---|
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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