NCT07151820Completed
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 · Last updated 3 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 2546 (actual)
- First submitted
- 25 Aug 2025
- Start date
- 8 Apr 2024
- Primary completion date
- 22 Oct 2024
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- Chronic myeloid leukaemia
- NCT number
- NCT07151820
What you commit to
- Study type: Observational
- Participants enrolled: 2546
- From 8 Apr 2024 to the primary completion date, 22 Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other
- 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 medical claims associated with a clinical trial during the baseline period up to the end of the observation period
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Novartis Coordinator of this site? Confirm its status | East Hanover | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.