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research:angioedema [2016/12/13 17:18] 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]] | ||
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- | ===== Discussion ===== | ||
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===== Datasets Run ===== | ===== Datasets Run ===== | ||
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===== Waiting for Datasets From ===== | ===== Waiting for Datasets From ===== | ||
* CPRD (Janssen) | * CPRD (Janssen) | ||
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+ | ===== Results ===== | ||
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+ | Results will be posted here shortly. | ||
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~~NOTOC~~ | ~~NOTOC~~ |