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Outcome Monitoring Following Zarxio Use: An Updated Signal Identification Analysis

    Basic Details
    Date Posted
    Medical Product
    Zarxio (filgrastim-sndz)

    This analysis performed signal identification for Zarxio (filgrastim-sndz) compared with Neupogen (filgrastim) by monitoring non-pregnancy and non-cancer outcomes among new users of Zarxio or Neupogen. This is a follow up to a previous analysis to add a propensity score model without calendar year.

    The study period includes data from November 5, 2016 to December 9, 2022. We distributed this request to five Sentinel Data Partners on December 9, 2022.

    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
    November 5, 2016 - December 9, 2022
    Analysis Type
    Signal Identification
    Population / Cohort
    Individuals 18 years of age and older
    Data Sources
    Sentinel Distributed Database (SDD)