An observational study in Leukemia, Chronic Myeloid, sponsored by Novartis Pharmaceuticals. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-03.
Sponsored by Novartis Pharmaceuticals · Observational
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.
964 studies on the registry are indexed under Leukemia, Myelogenous, Chronic, BCR-ABL Positive; 109 are open to participants now.
This study's enrollment of 2,546 is above the median of 141 across 149 observational studies indexed under Leukemia, Myelogenous, Chronic, BCR-ABL Positive.
Browse Leukemia, Myelogenous, Chronic, BCR-ABL Positive studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
This was a retrospective, noninterventional cohort study.
Patients who met all of the following criteria were considered for inclusion:
Exclusion criteria:
Patients who met any of the following criteria were excluded:
Adult CML patients who received imatinib, a 1G TKI.
Adult CML patients who received the following 2G TKIs: dasatinib, nilotinib, or bosutinib.
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.
Time frame: 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.
Time frame: Up to approximately 7 years and 3 months
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: * Treatment discontinuation * Treatment interruption * Switching treatment * Dose reduction
Time frame: Up to approximately 7 years and 3 months
Duration of First Treatment Interruption
Time frame: Up to approximately 7 years and 3 months
Time From TKI Initiation to Treatment Adjustment
Treatment adjustments included: * Treatment discontinuation * Treatment interruption * Switching treatment * Dose reduction
Time frame: Up to approximately 7 years and 3 months
Number of Patients With AEs of Interest Within 30 Days Before Treatment Adjustment
Treatment adjustments included: * Treatment discontinuation * Treatment interruption * Dose reduction
Time frame: 6 months
Number of AEs of Interest Within 30 Days Before Treatment Adjustment
Treatment adjustments included: * Treatment discontinuation * Treatment interruption * Dose reduction
Time frame: 6 months
Number of Patients by AE of Interest Experienced Within 30 Days Before Treatment Adjustment
Treatment adjustments included: * Treatment discontinuation * Treatment interruption * Dose reduction
Time frame: 6 months
Time Between the Last AE of Interest and Treatment Adjustment
Treatment adjustments included: * Treatment discontinuation * Treatment interruption * Dose reduction
Time frame: 6 months
Number of Patients by Last AE of Interest Experienced Before Treatment Adjustment
Treatment adjustments included: * Treatment discontinuation * Treatment interruption * Dose reduction
Time frame: 6 months
Number of All-cause Healthcare Visits Per-Patient-Per-Year (PPPY)
Healthcare visits included: * Inpatient admissions * Emergency department visits * Outpatient visits * Other visits
Time frame: 6 months
Number of Patients With One or More All-cause Healthcare Visits
Healthcare visits included: * Inpatient admissions * Emergency department visits * Outpatient admissions * Other visits
Time frame: 6 months
Number of All-cause Inpatient Days
Time frame: 6 months
Number of All-cause Inpatient Days Among Hospitalized Patients
Time frame: 6 months
All-cause Healthcare Costs PPPY
Healthcare costs included: * Total costs * Medical costs * Inpatient costs * Emergency department costs * Outpatient costs * Other costs * Pharmacy costs
Time frame: 6 months
Annual Mean Number of Healthcare Visits Associated With AEs of Interest
Healthcare visits included: * Inpatient admissions * Emergency department visits * Outpatient admissions * Other visits
Time frame: 6 months
Annual Mean Costs of Healthcare Visits Associated With AEs of Interest
Healthcare costs included: * Total costs * Medical costs * Inpatient costs * Emergency department costs * Outpatient costs * Other costs * Pharmacy costs
Time frame: 6 months
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Leukemia, Myelogenous, Chronic, BCR-ABL Positive→
Novartis Pharmaceuticals