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 @ 4:56 AM
Ignite Modification Date:
2025-12-25 @ 4:56 AM
NCT ID:
NCT03093818
Eligibility Criteria:
Inclusion Criteria:
* Subject must be ≥ 18 years old
* Subject must receive a first prescription (meaning no known prescription for this drug in the preceding 12 months) for one or more of 42 drugs, for which a Dutch Pharmacogenomic Working Group guideline is available, which is prescribed to them in routine care
* Subject is able and willing to take part and be followed-up for at least 12 weeks
* Subject is able to donate blood or saliva
* Subject has signed informed consent
* The study limit of enrolment (200 per arm, per 18-month block) for that drug has not been reached
Exclusion Criteria:
* Subject has previous (direct-to-consumer, or clinical) genetic testing for a gene important to the drug of inclusion
* Subject is pregnant or lactating
* Subject has a life expectancy estimated to be less than three months by treating clinical team
* Duration of the drug of inclusion total treatment length is planned to be less than seven consecutive days. A drug whose route of administration changes during the first seven days (e.g. intravenous to oral flucloxacillin) but whose total treatment duration is seven days or longer, is still eligible.
* For inpatients: hospital admission is expected to be less than 72 hours
* Subject is unable to consent to the study
* Subject is unwilling to take part
* Subject has no fixed address
* Subject has no current general practitioner
* Subject is, in the opinion of the Investigator, not suitable to participate in the study
* Subject has existing impaired hepatic or renal function for which a lower dose or alternate drug selection are already part of current routine care. This would not apply to any drugs specifically given to manage liver/renal impairment/transplantation.
* Subject has an estimated glomerular filtration rate (MDRD) of less than 15 ml/min per 1,73m2 in a subject with a functioning graft
* Subject has advanced liver failure (stage Child-Pugh C)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03093818
Study Brief:
Protocol Section:
NCT03093818