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Characterization of Cannabis-Derived Product Users in TriNetX: Five Descriptive Analyses

    Basic Details
    Date Posted
    Status
    Complete
    Medical Product
    cannabis-derived products
    Description

    The goal of these four analyses was to explore the capabilities of the FDA’s Sentinel Electronic Health Record (EHR) data from TriNetX to characterize patients with evidence of cannabis-derived product use, including cannabidiol, Epidiolex, and tetrahydrocannabinol (THC).

    • The first analysis identified counts of patients with cannabis and cannabis-derived product exposures. It additionally assessed the most commonly occurring diagnoses in the baseline and post-exposure period, for each exposure cohort. The study period includes data from January 1, 2018 to February 28, 2022 and contains data from 71 health care organizations (HCOs), provided through the TriNetX Live™ platform in their USA Network. The query was run on April 13, 2022.
    • The second analysis aimed to characterize a cohort of all cannabis and cannabis-derived product users, excluding Epidiolex (brand name cannabidiol). The analysis explored differences between cohorts sourced from the full TriNetX dataset and cohorts sourced from natural language processing (NLP) derived data. The study period includes data from July 1, 2018 to June 30, 2022 and contains data from 76 HCOs, provided through the TriNetX Live™ platform in their USA Network. The query was run on September 7, 2022.
    • The third analysis aimed to characterize a cohort of cannabis-derived product users, excluding Epidiolex, and separately characterize a cohort of patients with a positive lab result for tetrahydrocannabinol (THC). The study period includes data from July 1, 2018 to June 30, 2022 and contains data from 76 HCOs, provided through the TriNetX Live™ platform in their USA Network. The query was run on October 14, 2022.
    • The fourth analysis aimed to characterize a cohort of cannabidiol users, excluding Epidiolex, and separately characterize a cohort of Epidiolex users. The study period includes data from July 1, 2018 to June 30, 2022 and contains data from 76 HCOs, provided through the TriNetX Live™ platform in their USA Network. The query was run on October 28, 2022.
    • The fifth analysis aimed to characterize two cohorts of interest: 1) individuals with evidence of cannabis and cannabis-derived products, other than cannabidiol or Epidiolex, and 2) individuals with evidence of cannabidiol products, excluding the approved cannabidiol product Epidiolex, identified using NLP. We additionally estimated the number of pregnant patients who had evidence of each exposure of interest during pregnancy. The study period includes data from July 1, 2018 to January 26, 2023 and contains data from 75 HCOs, provided through the TriNetX Live™ platform in their USA Network. The query was run on February 28, 2023.
    Additional Details
    FDA Center
    CDER
    Time Period
    January 1, 2018 - February 28, 2022; July 1, 2018 - June 30, 2022; July 1, 2018 - January 26, 2023
    Analysis Type
    TriNetX Analysis
    Population / Cohort
    All individuals
    Data Sources
    TriNetX USA Network