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Occurrence of Absolute Neutrophil Count (ANC) Monitoring and Neutropenia Following Clozapine Use in Patients from Sentinel Data Partners that Curate ANC Laboratory Results: 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 examined counts of individuals with clozapine use in the Sentinel Distributed Database (SDD) and examined evidence of Absolute Neutrophil Count (ANC) monitoring and occurrence of neutropenia among these individuals.

    Data for Tables 1a-1d and 3a-3b were obtained from a distribution to 13 Sentinel Data Partners on July 8, 2024. Data from individuals having Medicare fee-for-service medical coverage, Medicare Part D drug coverage, and Medicaid coverage are included. Data for all other tables were obtained from a second distribution to eight Sentinel Data Partners on July 17, 2024. These Data Partners are a subset of the SDD that populate ANC laboratory results and do not include patients with fee-for-service Medicare coverage or Medicaid coverage. The study period for both requests includes data from January 1, 2010 to January 1, 2024.

    Additional Details
    FDA Center
    CDER
    Time Period
    January 1, 2010 – January 1, 2024
    Analysis Type
    Descriptive
    Population / Cohort
    Individuals 12 years of age and older
    Data Sources
    Sentinel Distributed Database (SDD)