TabsDetailsBasic DetailsDate Posted: Sunday, March 4, 2018Status: CompleteMedical Product: combined oral contraceptive (COC)Health Outcome(s): venous thromboembolism (VTE)Description: These reports investigated the association between new continuous or extended combined oral contraceptive (COC) use and venous thromboembolism (VTE), with new cyclic COC use as the comparison exposure. These reports also contain results from six sensitivity analyses with varying exposure incidence criteria, stroke definitions, follow-up periods, or exposure groups. Data from May 22, 2007 to September 30, 2015 from 12 Data Partners contributing to the Sentinel Distributed Database were included in this report. This request was distributed to Data Partners on March 28, 2017. The analytic package associated with these reports can be found externally in Sentinel's Git Repository located here. The Git Repository serves as Sentinel's version control tracking system for analytic packages and technical documentation. Read More Deliverables (8)Sentinel Modular Program Report: Venous Thromboembolism Following Continuous or Extended Cycle Contraceptive Use: A Propensity Score Matched Analysis, Report 1Sentinel Modular Program Report: Venous Thromboembolism Following Continuous or Extended Cycle Contraceptive Use: A Propensity Score Matched Analysis, Report 2Sentinel Modular Program Report: Venous Thromboembolism Following Continuous or Extended Cycle Contraceptive Use: A Propensity Score Matched Analysis, Report 3Sentinel Modular Program Report: Venous Thromboembolism Following Continuous or Extended Cycle Contraceptive Use: A Propensity Score Matched Analysis, Report 4Sentinel Modular Program Report: Venous Thromboembolism Following Continuous or Extended Cycle Contraceptive Use: A Propensity Score Matched Analysis, Report 5Sentinel Modular Program Report: Venous Thromboembolism Following Continuous or Extended Cycle Contraceptive Use: A Propensity Score Matched Analysis, Report 6Sentinel Modular Program Report: Venous Thromboembolism Following Continuous or Extended Cycle Contraceptive Use: A Propensity Score Matched Analysis, Report 7Sentinel Analytic Package: Venous Thromboembolism Following Continuous or Extended Cycle Contraceptive Use: A Propensity Score Matched AnalysisAdditional InformationAdditional DetailsFDA Center: CDERTime Period: 2007-2015Study Type: Modular ProgramAssessment Type: Safety AnalysesPopulation / Cohort: Females 18-50 years of ageData Sources: Sentinel Distributed Database (SDD)Related Links: Combined oral contraceptives containing ethinyl estradiol and levonorgestrel and venous thromboembolism2017 ICPE Symposium: Integrating Sentinel into Routine Regulatory Drug Review: A Snapshot of the First YearVenous Thromboembolism Algorithm Defined in "Venous Thromboembolism Following Continuous or Extended Cycle Contraceptive Use: A Propensity Score Matched Analysis"
