Anti-epileptic Drugs and Angioedema

Project Title Anti-epileptic Drugs and Angioedema
Date Posted
Monday, July 17, 2017
Project ID
to16_cap_mpl1r_wp047_nsdp_v01
Status
Complete
Deliverables
Description

Modular program-based one-time assessment of incidence rates of angioedema among new users of oral levetiracetam and four other oral anti-epileptic drugs (AEDs). This query was run against the Mini-Sentinel Distributed Database (MSDD) for the time period of January 1, 2008 to December 31, 2014. Modular programs are adaptable standardized programs. Results were generated using the Cohort Identification and Analysis (CIDA) tool, version 2.0.8. This query was distributed in October 2015. This report includes data from 15 Data Partners.

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Medical Product
lacosamide
lamotrigine
levetiracetam
oxcarbazepine
phenytoin
Health Outcome
angioedema
Population / Cohort
All individuals
Time Period
January 1, 2008 - December 31, 2014
Assessment Type
Exploratory Analyses
Study Type
Modular Program
Data Sources
Mini-Sentinel Distributed Database (MSDD)
FDA Center
CDER