This shows you the differences between two versions of the page.
Both sides previous revision Previous revision Next revision | Previous revision Next revision Both sides next revision | ||
research:angioedema [2016/05/25 14:00] schuemie |
research:angioedema [2016/12/13 17:24] jduke |
||
---|---|---|---|
Line 7: | Line 7: | ||
**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. | ||
Line 26: | Line 25: | ||
**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:jonduke@regenstrief.org|Email]]. | **Results Submission:** Via the OHDSI Sharing module embedded in study or via [[mailto:jonduke@regenstrief.org|Email]]. | ||
Line 49: | Line 48: | ||
===== 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~~ |