UPGRADE Registry Utility of PharmacoGenomics for Reducing Adverse Drug Effects • UPGRADE is a multicenter single-arm trial (Registry) that will include up to 279,000 patients enrolled at up to 2,000 clinical sites. • The primary study objective is to assess whether PGx testing leads to clinically-meaningful changes in a patient’s medication regimen, defined when at least one drug regimen change is made in accordance with the recommendations of the PGx test. • The study is registered on ClinicalTrials.gov and the protocol has been approved by the Copernicus Group Independent Review Board • Data collected is firewalled from CompanionDx and meets 21 CFR Part 11 and HIPAA compliance. Data may be entered or modified by office staff and SMT only. • Patients meeting the inclusion and exclusion criteria are consented and enrolled after the clinical specimen for PGx testing has been obtained by the physician. • An honorarium is available upon completion of research case report forms for an enrolled patient. Question: What is an acceptable frequency for meaningful change? An acceptable rate of meaningful change is specific to a particular drug and the therapeutic goals. For instance, a lower rate of meaningful change would be acceptable for drug where poor metabolism is associated with dire consequences for patients. There will be two study periods compared for each patient: The 90 day period preceding the receipt of the PGx information The 90 day period following the receipt of the PGx information The following comparisons will be made over the two study periods: 1. Number of Target Drug related Adverse Events (TDAE), where TDAE are defined as those adverse events related to a medication that has genetic implications, including PRN medications, OTC medications, and nutritional supplements 2. Emergency department visits and hospitalizations A member of our research team will be contacting you shortly to begin your enrollment into this one-ofa-kind Clinical Research Study. If you do not hear from a Syntactx member within 48 hours, please call: Syntactx UPGRADE Team Phone: 212.266.0164 Email: [email protected] Personalized Medicine. It’s written in your DNA.™ companiondxlab.com • 888.482.5327