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Outcome Monitoring Following Erenumab Use: A Signal Identification Analysis

    Basic Details
    Date Posted
    Medical Product

    This analysis performed signal identification using a self-controlled risk interval analysis for erenumab by monitoring non-pregnancy and non-cancer outcomes among new users of erenumab in the Sentinel Distributed Database (SDD). The study period includes data from May 17, 2018 to June 30, 2022. We distributed this request to six Sentinel Data Partners on January 17, 2023.

    Statistical alerts generated by this analysis do not on their own represent safety signals. Alerts are triaged in consideration of the study design, existing drug knowledge, therapeutic context, treated population, and potential public health impact. Alerts determined to be newly identified safety signals (NISS) follow the FDA’s Center for Drug Evaluation and Research manual of policies and procedures for NISS (MAPP 4121.3).

    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
    Time Period
    May 17, 2018 - June 30, 2022
    Analysis Type
    Signal Identification
    Population / Cohort
    Individuals 18 years of age and older
    Data Sources
    Sentinel Distributed Database (SDD)