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.
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.
Results will be posted here shortly.