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 @ 10:57 PM
Ignite Modification Date:
2025-12-24 @ 10:57 PM
NCT ID:
NCT02095769
Eligibility Criteria:
Inclusion Criteria:
* Subject underwent PGx testing for the alleles appropriate to the target drugs within the prior 90 days ('index PGx test')
* Males and females aged ≥65 years or male and females aged ≥18 years who have a disability
* Subject is able and willing to provide written informed consent
* Subject was receiving at least one medication known to be associated with allelic variation at the time of the index PGx test, including over-the-counter medications
* Subject has a history of at least one target drug-related adverse event (TDAE) over the 12-month period preceding receipt of PGx test results, or has experienced inadequate efficacy from a target drug
Exclusion Criteria:
* Subject is currently hospitalized
* Subject's medical and medication history is unavailable over the 90-day period preceding the receipt of PGx test results
* Subject is unable to provide an accurate history due to mental incapacity
* Subject is known to have undergone prior PGx testing for genes specific to the target drug(s), exclusive of the PGx test relating to this Registry
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02095769
Study Brief:
Protocol Section:
NCT02095769