====== Levetiracetam and Risk of Angioedema in patients with Seizure Disorder ======

<WRAP box justify round>

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

**Rationale:** The Food and Drug Administration (FDA) has [[http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm491645.htm|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:** [[https://github.com/OHDSI/StudyProtocols/blob/master/KeppraAngioedema/extras/KeppraandAngioedemaRiskStudyProtocolv0.5.docx?raw=true|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 [[mailto:jonduke@regenstrief.org|Email]].

</WRAP>


===== 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 ===== 
[[https://github.com/OHDSI/StudyProtocols/tree/master/KeppraAngioedema|GitHub code for Proposed Study - Keppra and Angioedema Risk]]

===== 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.
 


~~NOTOC~~