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Combined Oral Contraceptives Containing Ethinyl Estradiol and Levonorgestrel and Venous Thromboembolism

    Basic Details
    Date Posted
    Status
    Complete
    Medical Product
    combined oral contraceptive (COC)
    Health Outcome(s)
    venous thromboembolism (VTE)
    Description

    This report contains estimates of the risk of venous thromboembolism (VTE) among new users of combined oral contraceptives (COCs) containing ethinyl estradiol and levonorgestrel. Data from May 22, 2007 to September 30, 2015 from 16 health plans contributing to the Sentinel Distributed Database (SDD) were included in this report. This request was distributed on June 24, 2016. 

    Additional Details
    FDA Center
    CDER
    Time Period
    2007-2015
    Analysis Type
    Descriptive
    Population / Cohort
    Females 18 to 50 years of age
    Data Sources
    Sentinel Distributed Database (SDD)