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Bleeding Events and Venous Thromboembolism (VTE) following Enoxaparin Use: A Descriptive Analysis

    Basic Details
    Date Posted
    Status
    Complete
    Medical Product
    enoxaparin
    Health Outcome(s)
    hospitalized bleeding
    major bleeding
    venous thromboembolism (VTE)
    Description

    In this request, we examined bleeding (hospitalized bleeding and major bleeding) and venous thromboembolism (VTE) events following incident use of enoxaparin in the Mini-Sentinel Distributed Database (MSDD). This analysis includes three reports:

    • Report 1: We investigated the use of enoxaparin, by manufacturer (Sanofi, Sandoz, or Amphastar). Bleeding events and venous thromboembolism (VTE) events were used to define incidence. In this report, specifications for bleeding events were relaxed to a seven day period; Report 3 restricts the definition to an inpatient stay.
    • Report 2: We investigated bleeding (hospitalized bleed and major bleed) and VTE events following incident use of enoxaparin (regardless of manufacturer).
    • Report 3: We investigated the use of enoxaparin, by manufacturer (Sanofi, Sandoz, or Amphastar). Bleeding events and venous thromboembolism (VTE) events were used to define incidence. In this report, specifications for bleeding events were restricted to an inpatient stay; Report 1 relaxes the definition to a seven day period.

    This analysis was distributed to 15 Data Partners in the MSDD on April 29, 2015. The query period for this request was August 1, 2010 to December 31, 2013.

    Additional Details
    FDA Center
    CDER
    Time Period
    August 1, 2010 - December 31, 2013
    Analysis Type
    Descriptive
    Population / Cohort
    All individuals 20 years of age and older
    Data Sources
    Mini-Sentinel Distributed Database