Serious Infections following Ustekinumab Use: A Descriptive Analysis

    Basic Details
    Date Posted
    Tuesday, November 24, 2020
    Status
    Complete
    Medical Product
    ustekinumab
    Description

    The purpose of this request was to evaluate dispensing patterns among patients with exposure to ustekinumab (Stelara) or four comparator drugs in the Sentinel Distributed Database (SDD). We distributed this request to 17 Sentinel Data Partners on September 18, 2019. The study period included data from January 1, 2010 to April 30, 2019.

    Additional Details
    FDA Center
    CDER
    Time Period
    January 1, 2010 - April 30, 2019
    Study Type
    Modular Program
    Assessment Type
    Safety Analyses
    Population / Cohort
    All individuals
    Data Sources
    Sentinel Distributed Database (SDD)