Status:
COMPLETED
A Real-world Study About the Impact of Adverse Events (AEs) on Treatment Adjustments, Healthcare Resource Use, and Costs Among Chronic Myeloid Leukemia Patients
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Leukemia, Chronic Myeloid
Eligibility:
All Genders
18+ years
Brief 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 impac...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 8 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 22 2024
Estimated Enrollment :
2546 Patients enrolled
Trial Details
Trial ID
NCT07151820
Start Date
April 8 2024
End Date
October 22 2024
Last Update
September 3 2025
Active Locations (1)
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1
Novartis
East Hanover, New Jersey, United States, 07936