TabsDetailsBasic DetailsDate Posted: Saturday, March 3, 2018Status: CompleteMedical 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. Read More Deliverables (1)Sentinel Modular Program Report: Combined Oral Contraceptives Containing Ethinyl Estradiol and Levonorgestrel and Venous ThromboembolismAdditional InformationAdditional DetailsFDA Center: CDERTime Period: 2007-2015Study Type: Modular ProgramAssessment Type: Safety AnalysesPopulation / Cohort: Females 18 to 50 years of ageData Sources: Sentinel Distributed Database (SDD)Related Links: Venous Thromboembolism Following Combined Oral Contraceptives Compared with Cyclic Oral Contraceptives2017 ICPE Symposium: Integrating Sentinel into Routine Regulatory Drug Review: A Snapshot of the First Year
