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research:angioedema

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research:angioedema [2016/05/18 16:08] – jdukeresearch: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
  
-**Launch Date:** TBD+**Launch Date:** 5/18/2016
  
-**Receive Results for Analysis Date:**  TBD+**Receive Results for Analysis Date:**  7/15/2016
  
-**Study Closure Date:**  TBD+**Study Closure Date:**  12/1/2016 (**Study closed**)
  
-**Results Submission:** [[mailto:[email protected]|Email]] or SFTP+**Results Submission:** Via the OHDSI Sharing module embedded in study or via [[mailto:[email protected]|Email]].
  
 </WRAP> </WRAP>
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 ===== Requirements ===== ===== Requirements =====
-**CDM:** V4 or V5+**CDM:** V5 only
  
 **Table Accessed:**  CONCEPT, CONCEPT_ANCESTOR, CONDITION_ERA, CONDITION_OCCURRENCE, DRUG_ERA, DRUG_EXPOSURE, MEASUREMENT, OBSERVATION, OBSERVATION_PERIOD, PERSON, PROCEDURE_OCCURRENCE, VISIT_OCCURRENCE **Table Accessed:**  CONCEPT, CONCEPT_ANCESTOR, CONDITION_ERA, CONDITION_OCCURRENCE, DRUG_ERA, DRUG_EXPOSURE, MEASUREMENT, OBSERVATION, OBSERVATION_PERIOD, PERSON, PROCEDURE_OCCURRENCE, VISIT_OCCURRENCE
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 **Database Dialects:** SQL Server, Postgres, Oracle **Database Dialects:** SQL Server, Postgres, Oracle
  
-**Software:** SQL and R +**Software:** R (>= 3.2.2, RTools), Java
  
 +**Hardware:** Recommended 8-core, 32GB memory, 100GB free space
  
-===== Code =====  +**How to Run:** Full installation and run instructions are provided on the GitHub page below.
-[[https://github.com/ohdsi|GitHub code for Proposed Study - Keppra and Angioedema Risk]]+
  
-===== Discussion =====  + 
- +===== Code =====  
 +[[https://github.com/OHDSI/StudyProtocols/tree/master/KeppraAngioedema|GitHub code for Proposed Study - Keppra and Angioedema Risk]]
  
 ===== Datasets Run =====  ===== Datasets Run ===== 
-  * +  * CCAE (Janssen) 
 +  * MDCD (Janssen) 
 +  * MDCR (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 ===== 
-  * +  * CPRD (Janssen) 
 + 
 + 
 +===== Results =====  
 + 
 +Results will be posted here shortly. 
 +  
 + 
 ~~NOTOC~~ ~~NOTOC~~
research/angioedema.1463587719.txt.gz · Last modified: by jduke
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