Venous Thromboembolism after Continuous or Extended Cycle Contraceptive Use

Project Title Venous Thromboembolism after Continuous or Extended Cycle Contraceptive Use
Date Posted
Sunday, March 4, 2018
Project ID
cder_mpl2p_wp001_nsdp_v01
Status
Complete
Deliverables
Related Links
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.
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