Combined Oral Contraceptives Containing Ethinyl Estradiol and Levonorgestrel and Venous Thromboembolism

Project Title Combined Oral Contraceptives Containing Ethinyl Estradiol and Levonorgestrel and Venous Thromboembolism
Date Posted
Sunday, March 4, 2018
Project ID
cder_mpl1r_wp032
Status
Complete
Deliverables
Sentinel Modular Program Report: Combined Oral Contraceptives Containing Ethinyl Estradiol and Levonorgestrel and Venous Thromboembolism
Related Links
Venous Thromboembolism Following Combined Oral Contraceptives Compared with Cyclic Oral Contraceptives
2017 ICPE Symposium: Integrating Sentinel into Routine Regulatory Drug Review: A Snapshot of the First Year
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. 

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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