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:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-24 @ 6:38 PM
NCT ID:
NCT05366257
Eligibility Criteria:
Inclusion Criteria:
CAR-T cohort:
* Patients had at least one International Classification of Diseases, Tenth Revision (ICD- 10) diagnosis code for DLBCL.
* Patients received CAR-T therapy following DLBCL diagnosis. The administration date of CAR-T therapy was defined as the index date. Patients who received both CAR-T therapy and allo-HSCT were classified based on the first treatment that the patient received
* Patients were at least 18 years of age as of the index date
* Patients had at least three months of continuous eligibility in the Medicare Part A and Part B data before the index date. Since 2019 Part D data is not available in the current data cut, eligibility requirement in the Part D data was not required
Patients were further classified into CAR-T IP and CAR-T OP cohorts depending on where the administration occurred.
Allo-HSCT cohort:
* Patients had at least one ICD-10 diagnosis code for DLBCL.
* Patients received allo-HSCT following DLBCL diagnosis. The date of allo-HSCT procedure was defined as the index date. Patients who received both CAR-T therapy and allo-HSCT were classified based on the first treatment the patient received
* Patients were at least 18 years of age as of the index date
* Patients had at least three months of continuous eligibility in the Medicare Part A and Part B data before the index date. Since 2019 Part D data is not available in the current data cut, eligibility requirement in the Part D data was not required
Exclusion Criteria:
\- Patients had a medical claim associated with a clinical trial (ICD-9 CM code V70.7; ICD-10 CM code Z00.6) during one month before and after the index date
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT05366257
Study Brief:
Protocol Section:
NCT05366257