Risk of Congenital Cardiac Malformations Following Armodafinil or Modafinil Use: A Propensity Score Matched Analysis

Project Title Risk of Congenital Cardiac Malformations Following Armodafinil or Modafinil Use: A Propensity Score Matched Analysis
Date Posted
Thursday, July 30, 2020
Project ID
cder_mpl2p_wp023
Status
In progress
Deliverables
Related Links
Description

This analysis executed the Cohort Identification and Descriptive Analysis (CIDA) Pregnancy Episodes tool to assess risk of congenital cardiac malformations following armodafinil or modafinil use during the first trimester of pregnancy in the Sentinel Distributed Database (SDD).

The analytic package associated with this analysis 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
armodafinil
modafinil
Health Outcome
congenital cardiac malformations
Population / Cohort
Females 10 to 54 years of age
Time Period
January 1, 2000 - December 31, 2019
Assessment Type
Safety Analyses
Study Type
Modular Program
Data Sources
Sentinel Distributed Database (SDD)
FDA Center
CDER
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