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Occurrence of Absolute Neutrophil Count (ANC) Monitoring, ANC Laboratory Results, and Neutropenia Following Clozapine Use: A Descriptive Analysis

    Basic Details
    Date Posted
    Status
    Complete
    Medical Product
    clozapine
    Health Outcome(s)
    adherence to absolute neutrophil count (ANC) monitoring
    neutropenia
    Description

    In this analysis, we identified incident users of clozapine in the pre-Risk Evaluation and Mitigation Strategies (REMS) (1/1/10-9/30/15), post-REMS (10/1/15-12/31/19), and COVID-REMS (1/1/20-7/31/23) time periods in the Sentinel Distributed Database (SDD). Among these new use episodes, we present information on absolute neutrophil count (ANC) procedures and laboratory results as well as diagnoses of neutropenia. 

    We distributed this request to 13 Sentinel Data Partners on March 11, 2024. The study period includes data from January 1, 2010 to March 31, 2024. This analysis contains two reports.

    • Report 1 includes data from ten Data Partners (a subset of the SDD) that include ANC laboratory results in the Laboratory Results table within their Sentinel Common Data Model (SCDM) and does not include data from patients with Medicare.
    • Report 2 contains data from all 13 Data Partners, regardless of ANC presence.
    Additional Details
    FDA Center
    CDER
    Time Period
    January 1, 2010 – March 31, 2024
    Analysis Type
    Descriptive
    Population / Cohort
    Individuals 12 years of age and older
    Data Sources
    Sentinel Distributed Database (SDD)