Outcome Monitoring Following Zarxio Use: A Signal Identification Analysis

    Basic Details
    Date Posted
    Thursday, November 10, 2022
    Status
    In progress
    Medical Product
    Zarxio (filgrastim-sndz)
    Description

    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.

    The study period included data from November 5, 2016 through June 30, 2021.

    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
    November 5, 2016 - June 30, 2021
    Study Type
    Modular Program
    Assessment Type
    Exploratory Analyses
    Population / Cohort
    Individuals 18 years of age and older
    Data Sources
    Sentinel Distributed Database (SDD)