research:angioedema
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research:angioedema [2016/05/25 14:00] schuemie |
research:angioedema [2017/12/14 05:54] (current) schuemie |
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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, George Hripcsak, [?Adler], Christian Reich, Yuriy Khoma, Marie-Sophie Schwalm, Yonghui Hu, [Stanford- Juan?], Martijn Schuemie. |
| - | **Coordinating Institution(s):** Regenstrief Institute | + | **Coordinating Institution(s):** Regenstrief Institute / Georgia Tech |
| - | ** Additional Participants (currently seeking additional collaborators):** | + | **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. |
| - | * George Hripcsak | + | |
| - | + | ||
| - | Any interested collaborators please contact Jon Duke at [email protected] and I will be happy to add you to the collaborator list. | + | |
| - | + | ||
| - | **Participating Institution(s):** Regenstrief Institute, Janssen Research and Development, Columbia University, University of California, Los Angeles | + | |
| - | **Full Protocol:** [[https://drive.google.com/file/d/0BzotZ5gIRvegT3Y5djBOUldzaVE/view?usp=sharing|Keppra and Angioedema Risk Protocol]] | + | **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 | **Initial Proposal Date:** 5/3/2016 | ||
| Line 26: | Line 21: | ||
| **Receive Results for Analysis Date:** 7/15/2016 | **Receive Results for Analysis Date:** 7/15/2016 | ||
| - | **Study Closure Date:** TBD | + | **Study Closure Date:** 12/1/2016 (**Study closed**) |
| **Results Submission:** Via the OHDSI Sharing module embedded in study or via [[mailto:[email protected]|Email]]. | **Results Submission:** Via the OHDSI Sharing module embedded in study or via [[mailto:[email protected]|Email]]. | ||
| Line 49: | Line 44: | ||
| ===== 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 ===== | ||
| - | * IMEDS MCDR | ||
| - | * INPC (Regenstrief) | ||
| * CCAE (Janssen) | * CCAE (Janssen) | ||
| * MDCD (Janssen) | * MDCD (Janssen) | ||
| * MDCR (Janssen) | * MDCR (Janssen) | ||
| * Optum (Janssen) | * Optum (Janssen) | ||
| + | * Columbia University | ||
| + | * IMS (French) | ||
| + | * IMS Ambulatory | ||
| + | * IMS PPLUS | ||
| + | * Stanford | ||
| + | * UT Blue Cross Blue Shield | ||
| + | * UT Cerner | ||
| ===== Waiting for Datasets From ===== | ===== Waiting for Datasets From ===== | ||
| - | * Columbia University | ||
| * CPRD (Janssen) | * CPRD (Janssen) | ||
| + | |||
| + | |||
| + | ===== Results ===== | ||
| + | |||
| + | Results will be posted here shortly. | ||
| + | |||
| + | |||
| ~~NOTOC~~ | ~~NOTOC~~ | ||
research/angioedema.1464184802.txt.gz · Last modified: 2016/05/25 14:00 by schuemie
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