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Venous Thromboembolism Following Continuous or Extended Cycle Contraceptive Use: A Propensity Score Matched Analysis

Basic Details
Date Posted
Status
Complete
Medical 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.
Deliverables (8)
Sentinel Modular Program Report: Venous Thromboembolism Following Continuous or Extended Cycle Contraceptive Use: A Propensity Score Matched Analysis, Report 1 Sentinel Modular Program Report: Venous Thromboembolism Following Continuous or Extended Cycle Contraceptive Use: A Propensity Score Matched Analysis, Report 2 Sentinel Modular Program Report: Venous Thromboembolism Following Continuous or Extended Cycle Contraceptive Use: A Propensity Score Matched Analysis, Report 3 Sentinel Modular Program Report: Venous Thromboembolism Following Continuous or Extended Cycle Contraceptive Use: A Propensity Score Matched Analysis, Report 4 Sentinel Modular Program Report: Venous Thromboembolism Following Continuous or Extended Cycle Contraceptive Use: A Propensity Score Matched Analysis, Report 5 Sentinel Modular Program Report: Venous Thromboembolism Following Continuous or Extended Cycle Contraceptive Use: A Propensity Score Matched Analysis, Report 6 Sentinel Modular Program Report: Venous Thromboembolism Following Continuous or Extended Cycle Contraceptive Use: A Propensity Score Matched Analysis, Report 7 Sentinel Analytic Package: Venous Thromboembolism Following Continuous or Extended Cycle Contraceptive Use: A Propensity Score Matched Analysis
Additional Details
FDA Center
CDER
Time Period
2007-2015
Analysis Type
Retrospective Inferential
Population / Cohort
Females 18 to 50 years of age
Data Sources
Sentinel Distributed Database (SDD)
Related Links
Sentinel Drug Study: Continuous or Extended Cycle Oral Contraceptives & Venous Thromboembolism (VTE)
Venous Thromboembolism Algorithm Defined in "Venous Thromboembolism Following Continuous or Extended Cycle Contraceptive Use: A Propensity Score Matched Analysis"