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

Project Title Venous Thromboembolism following Continuous or Extended Cycle Contraceptive Use: A Propensity Score Matched Analysis
Date Posted
Sunday, March 4, 2018
Project ID
cder_mpl2p_wp001_nsdp_v01
Status
Complete
Deliverables
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
Related Links
Combined oral contraceptives containing ethinyl estradiol and levonorgestrel and venous thromboembolism
2017 ICPE Symposium: Integrating Sentinel into Routine Regulatory Drug Review: A Snapshot of the First Year
Venous Thromboembolism Algorithm Defined in "Venous Thromboembolism following Continuous or Extended Cycle Contraceptive Use: A Propensity Score Matched Analysis"
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.
Medical Product
combined oral contraceptive (COC)
Health Outcome
venous thromboembolism (VTE)
Population / Cohort
Females 18-50 years of age
Time Period
2007-2015
Assessment Type
Safety Analyses
Study Type
Modular Program
Data Sources
Sentinel Distributed Database (SDD)
FDA Center
CDER
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