Observational Health Data Sciences and Informatics

User Tools

Site Tools

Trace: • amt • data_etl • loinc • atc • cim10 • meeting_notes_2017_apr_04 • largescalepred • sus • meeting_notes_2017_jul-25 • icdo3
research:angioedema

Differences

This shows you the differences between two versions of the page.

Link to this comparison view

Both sides previous revisionPrevious revision
Next revision		Previous revision
research:angioedema [2016/05/18 16:26] – jdukeresearch:angioedema [2017/12/14 05:54] (current) – schuemie
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, 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 
- 
- 
-===== Waiting for Datasets From =====  
-  * INPC (Regenstrief) 
-  * Columbia University 
   * 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 ===== 
   * CPRD (Janssen)   * CPRD (Janssen)
 +
 +
 +===== Results ===== 
 +
 +Results will be posted here shortly.
 + 
 +
  
 ~~NOTOC~~ ~~NOTOC~~
research/angioedema.1463588775.txt.gz · Last modified: by jduke
Donate Powered by PHP Valid HTML5 Valid CSS Driven by DokuWiki