TabsDetailsBasic DetailsDate Posted: Thursday, July 30, 2020Status: In progressMedical Product: armodafinil, modafinilHealth Outcome(s): congenital cardiac malformationsDescription: 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. Read More Deliverables (1)Sentinel Analytic Package: Risk of Congenital Cardiac Malformations Following Armodafinil or Modafinil Use: A Propensity Score Matched AnalysisAdditional InformationAdditional DetailsFDA Center: CDERTime Period: January 1, 2000 - December 31, 2019Study Type: Modular ProgramAssessment Type: Safety AnalysesPopulation / Cohort: Females 10 to 54 years of ageData Sources: Sentinel Distributed Database (SDD)Related Links: Congenital Cardiac Malformations Algorithm Defined in "Risk of Congenital Cardiac Malformations Following Armodafinil or Modafinil Use: A Propensity Score Matched Analysis"
