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research:angioedema

Levetiracetam and Risk of Angioedema in patients with Seizure Disorder

Objective: To assess the risk between exposure to Keppra (levetiracetam) and angioedema.

Rationale: The Food and Drug Administration (FDA) has recently announced that they are evaluating the need for regulatory action regarding a potential association between exposure to the anti-seizure drug Keppra and angioedema. OHDSI seeks to support evidence generation for questions of importance to FDA and other stakeholders seeking to protect and promote the public's health.

Project Lead(s): Jon Duke, Patrick Ryan, Marc Suchard, George Hripcsak, [?Adler], Christian Reich, Yuriy Khoma, Marie-Sophie Schwalm, Yonghui Hu, [Stanford- Juan?], Martijn Schuemie.

Coordinating Institution(s): Regenstrief Institute / Georgia Tech

Participating Institution(s): Regenstrief Institute, Georgia Tech, Janssen Research and Development, Columbia University, University of California Los Angeles, University of Texas Houston, Stanford University, QuintilesIMS.

Full Protocol: Keppra and Angioedema Risk Protocol

Initial Proposal Date: 5/3/2016

Launch Date: 5/18/2016

Receive Results for Analysis Date: 7/15/2016

Study Closure Date: 12/1/2016 (Study closed)

Results Submission: Via the OHDSI Sharing module embedded in study or via Email.

Requirements

CDM: V5 only

Table Accessed: CONCEPT, CONCEPT_ANCESTOR, CONDITION_ERA, CONDITION_OCCURRENCE, DRUG_ERA, DRUG_EXPOSURE, MEASUREMENT, OBSERVATION, OBSERVATION_PERIOD, PERSON, PROCEDURE_OCCURRENCE, VISIT_OCCURRENCE

Database Dialects: SQL Server, Postgres, Oracle

Software: R (>= 3.2.2, RTools), Java

Hardware: Recommended 8-core, 32GB memory, 100GB free space

How to Run: Full installation and run instructions are provided on the GitHub page below.

Code

Datasets Run

  • CCAE (Janssen)
  • MDCD (Janssen)
  • MDCR (Janssen)
  • Optum (Janssen)
  • Columbia University
  • IMS (French)
  • IMS Ambulatory
  • IMS PPLUS
  • Stanford
  • UT Blue Cross Blue Shield
  • UT Cerner

Waiting for Datasets From

  • CPRD (Janssen)

Results

Results will be posted here shortly.

research/angioedema.txt · Last modified: 2017/12/14 05:54 by schuemie