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research:angioedema [2016/12/13 17:18]
jduke
research:angioedema [2016/12/13 17:24]
jduke
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 **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. **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, Martijn Schuemie+**Project Lead(s):** Jon Duke, Patrick Ryan, Marc Suchard, Martijn Schuemie, George Hripcsak, Christian Reich, Yuri Khoma, Marie-Sophie Schwalm, ...... more pending
  
-**Coordinating Institution(s):​** Regenstrief Institute+**Coordinating Institution(s):​** Regenstrief Institute ​/ Georgia Tech
  
 ** Additional Participants (currently seeking additional collaborators):​** ​ ** Additional Participants (currently seeking additional collaborators):​** ​
-  * George Hripcsak 
    
 Any interested collaborators please contact Jon Duke at jonduke@regenstrief.org and I will be happy to add you to the collaborator list.  Any interested collaborators please contact Jon Duke at jonduke@regenstrief.org and I will be happy to add you to the collaborator list. 
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 ===== Code =====  ===== Code ===== 
 [[https://​github.com/​OHDSI/​StudyProtocols/​tree/​master/​KeppraAngioedema|GitHub code for Proposed Study - Keppra and Angioedema Risk]] [[https://​github.com/​OHDSI/​StudyProtocols/​tree/​master/​KeppraAngioedema|GitHub code for Proposed Study - Keppra and Angioedema Risk]]
- 
- 
-===== Discussion =====  
-  
  
 ===== Datasets Run =====  ===== Datasets Run ===== 
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 ===== Waiting for Datasets From =====  ===== Waiting for Datasets From ===== 
   * CPRD (Janssen)   * CPRD (Janssen)
 +
 +
 +===== Results ===== 
 +
 +Results will be posted here shortly.
 + 
 +
  
 ~~NOTOC~~ ~~NOTOC~~
research/angioedema.txt ยท Last modified: 2017/12/14 05:54 by schuemie