Real-World CML drug side effects examined in 2,500 patients
NCT ID NCT07151820
First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This study analyzed insurance claims from over 2,500 people with chronic myeloid leukemia (CML) to see how often side effects from tyrosine kinase inhibitors (TKIs) occur and how they affect treatment changes and healthcare costs. Researchers looked at side effects that required medical attention. The goal was to understand the real-world burden of these side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tyrosine kinase inhibitors (TKIs)
- What this could lead to
- If successful, this could help doctors better manage side effects and reduce treatment disruptions for CML patients.
- What could go wrong
- This is an observational study using insurance claims data, not a controlled trial. It cannot prove cause and effect, and may miss side effects not recorded in claims.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
2,546 people
The number who actually took part.
- Started
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Apr 2024
- Finished
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Oct 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
This was a retrospective, noninterventional cohort study.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Novartis
East Hanover, New Jersey, 07936, United States
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