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:
2025-12-26 @ 5:21 PM
Ignite Modification Date:
2025-12-26 @ 5:21 PM
NCT ID:
NCT05848206
Eligibility Criteria:
Inclusion Criteria:
Primary IQVIA Longitudinal Access and Adjudication Data (LAAD) Cohort (for primary objective)
* Patients with ≥1 transaction for SAC/VAL in LAAD between 01 January 2017 and 30 November 2019 (index period). Date of the 1st SAC/VAL prescription transaction during this period was the index date.
* Patients from the Novartis-provided list of 21 plans and formularies of interest (mapping to LAAD data was based data elements such as plan name, payer name, and pharmacy benefit manager \[PBM\] name) as of the index date.
* Patients aged ≥18 years on the index date.
* Patients with 12-months of data visibility pre-index.
* Patients with 3-months of data visibility post-index (to allow for final adjudication/abandonment status confirmation).
For comorbidity data only:
* Patients with linkage of LAAD FIA to LAAD Dx by patient ID.
* Patients with ≥2 non-ancillary medical claims ≥30 days apart within the 12 months pre-index period.
Secondary LAAD Cohort (for secondary objective)
* Among patients from the Primary LAAD Cohort remaining in Step 6, patients who abandoned their 1st SAC/VAL prescription or did not receive SAC/VAL due to claim rejection in LAAD between 01 January 2017 and 28 February 2019 (index period). Date of the 1st abandoned/rejected SAC/VAL prescription transaction during this period is the index date.
* Patients aged ≥18 years on the index date.
* Patients with 12-months of data visibility pre-index.
* Patients with 12-months of data visibility post-index.
* For comorbidity data only:
* Patients with linkage of LAAD FIA to LAAD Dx by patient ID.
* Patients with ≥2 non-ancillary medical claims ≥30 days apart within the 12 months pre-index period.
Exclusion Criteria:
* Patients with a SAC/VAL transaction during the 12-month pre-index period.
* Patients with data quality issues (e.g., missing gender).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05848206
Study Brief:
Protocol Section:
NCT05848206