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Outcome Monitoring Following Baloxavir Use: A Signal Identification Analysis

    Basic Details
    Date Posted
    In progress
    Medical Product

    This analysis performed signal identification by monitoring non-pregnancy and non-cancer outcomes among new users of baloxavir compared to new users of oseltamivir in the Sentinel Distributed Database (SDD).

    The study period includes data from October 24, 2018 to April 30, 2023. We distributed this request to six Sentinel Data Partners on October 20, 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
    October 24, 2018 – April 30, 2023
    Analysis Type
    Signal Identification
    Population / Cohort
    Individuals 12 years of age and older
    Data Sources
    Sentinel Distributed Database (SDD)