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Combined Oral Contraceptives Containing Ethinyl Estradiol and Levonorgestrel and Venous Thromboembolism

    Basic Details
    Date Posted
    Saturday, March 3, 2018
    Medical Product
    combined oral contraceptive (COC)
    Health Outcome(s)
    venous thromboembolism (VTE)

    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
    Time Period
    Study Type
    Modular Program
    Assessment Type
    Safety Analyses
    Population / Cohort
    Females 18 to 50 years of age
    Data Sources
    Sentinel Distributed Database (SDD)