Risk of Congenital Cardiac Malformations Following Armodafinil or Modafinil Use: A Propensity Score Matched Analysis

    Basic Details
    Date Posted
    Tuesday, November 17, 2020
    Status
    Complete
    Medical Product
    armodafinil
    modafinil
    Health Outcome(s)
    congenital cardiac malformations
    Description

    This analysis executed the Cohort Identification and Descriptive Analysis (CIDA) Pregnancy Episodes tool to assess risk of congenital cardiac malformations following armodafinil or modafinil use during the first trimester of pregnancy in the Sentinel Distributed Database (SDD). We distributed this request to six Sentinel Data Partners on June 20, 2020. The study period included data from January 1, 2000 to December 31, 2019.

    The analytic package associated with this analysis can be found externally in Sentinel's Git Repository located here. The Git Repository serves as Sentinel's version control tracking system for analytic packages and technical documentation.

    Additional Details
    FDA Center
    CDER
    Time Period
    January 1, 2000 - December 31, 2019
    Study Type
    Modular Program
    Assessment Type
    Safety Analyses
    Population / Cohort
    Females 10 to 54 years of age
    Data Sources
    Sentinel Distributed Database (SDD)