Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 1:11 AM
NCT ID:
NCT06148493
Eligibility Criteria:
Inclusion criteria:
Patients meeting the below inclusion criteria were included in the study.
* Patients with ≥ 1 claim for asciminib (asciminib cohort) or another third-line TKI used to treat CML (imatinib mesylate, dasatinib, nilotinib, bosutinib, ponatinib) in the open-source pharmacy claims database occurring during the index period. All patients with at least one claim for asciminib during the index window were placed into the asciminib cohort and the index date was date of the first asciminib claim. Patients with no claims for asciminib were placed in the other TKI cohort. These patients were indexed on their third-line TKI (i.e., 2 prior TKIs must have been observed at any time prior to the index date) and the index date was the date of the first claim observed during the index period.
* Age ≥ 18 years on the index date.
* Patients with ≥ 6 months of continuous pre-index data availability. This was defined as:
* The index pharmacy was a stable provider for each of the 6 months prior to the index date; and
* The patient had at least 1 claim (for any drug) in the open-source pharmacy claims database more than 6 months prior to the index date.
In Phase 2, patients were required to meet the following criteria:
* Patients with linkage to the open-source medical claims database.
* Patients with ≥ 3 months of post-index data availability. Post-index data availability was defined as:
* The index pharmacy was a stable provider for each of the 3 months after the index date; and
* The patient had at least 1 claim (for any drug) in the open-source pharmacy claims database more than 3 months after the index date.
Exclusion criteria:
• Patients with data quality issues, defined as missing or invalid age. In order to retain the maximum sample of asciminib patients for the primary objectives, no additional exclusion criteria were applied.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06148493
Study Brief:
Protocol Section:
NCT06148493