NCT07151820

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,546 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

• Leukemia, Chronic Myeloid

Timeline

• Start date: 2024-04-08
• Primary completion: 2024-10-22
• Completion: 2024-10-22
• First posted: 2025-09-03
• Last updated: 2025-09-03

Locations

1 site across 1 country: United States