A Real-world Study About the Impact of Adverse Events (AEs) on Treatment Adjustments, Healthcare Resource Use, and Costs Among Chronic Myeloid Leukemia Patients

Completed

Conditions studied: Leukemia, Chronic Myeloid

In brief

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.

Key facts

Study ID

NCT07151820

Run by

Novartis Pharmaceuticals

People needed

2546

Starts

2024-04-08

Expected to finish

2024-10-22

Last updated by the study team

2025-09-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novartis — East Hanover, New Jersey, United States

Full record on ClinicalTrials.gov

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