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

Basic Details
Date Posted
Tuesday, November 17, 2020
Status
Complete
Medical Product
armodafinil
modafinil
Health Outcome(s)
congenital cardiac malformations
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). We distributed this request to six Sentinel Data Partners on June 20, 2020. The study period included data from January 1, 2000 to December 31, 2019.

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.

Additional Details
FDA Center
CDER
Time Period
January 1, 2000 - December 31, 2019
Study Type
Modular Program
Assessment Type
Safety Analyses
Population / Cohort
Females 10 to 54 years of age
Data Sources
Sentinel Distributed Database (SDD)