Clinical trial · Observational
A Real-world Study About the Impact of Adverse Events (AEs) on Treatment Adjustments, Healthcare Resource Use, and Costs Among Chronic Myeloid Leukemia Patients
Association of Adverse Events in the Real World With Treatment Adjustments, and Burden of AEs in Patients With Chronic Myeloid Leukemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia, Chronic Myeloid | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- First Generation (1G) TKI Cohort
- description
- Adult CML patients who received imatinib, a 1G TKI.
- label
- Second Generation (2G) TKI Cohort
- description
- Adult CML patients who received the following 2G TKIs: dasatinib, nilotinib, or bosutinib.
Primary outcomes (2)
- measure
- Number of Patients With AEs of Interest During the Study Period Among Those Without the Specific Event During the Baseline Period
- timeFrame
- Up to approximately 7 years and 3 months
- description
- 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.
- measure
- Number of Patients With AEs of Interest Among All Patients During the Study Period
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: Patients who met all of the following criteria were considered for inclusion: * Had at least two diagnoses for CML- International Classification of Disease, 10th revision, Clinical Modification (ICD-10-CM) code: C92.1x * Aged 18 years or older at the time of first CML diagnosis * Received a 1G or 2G TKI after the first CML diagnosis * Had continuous health plan enrollment (pharmacy and medical benefits) for at least 6 months before the index date (baseline) and 6 months after the index date Exclusion criteria: Patients who met any of the following criteria were excluded: * Patients had 2 or more diagnoses of gastrointestinal stromal tumor (\[GIST\], ICD-10: C49.Ax) or chronic myelomonocytic leukemia (\[CMML\], ICD-10: C93.1x) at any time * Patients had a hematopoietic stem cell transplantation (HSCT) during the baseline period * Patients had CML-related chemotherapy treatment for accelerated phase (AP)/blast crisis (BC) during the baseline period * Patients had medical claims associated with a clinical trial during the baseline period up to the end of the observation period
References
Publications (0)
Data not yet available