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rdf:type |
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lifeskim:mentions |
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pubmed:issue |
6
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pubmed:dateCreated |
2009-12-17
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pubmed:abstractText |
Even though adverse event (AE) collection and official accounting are mandatory for clinical trials, there are limited detailed guidelines specifying how to summarize the event for reporting in a timely and expeditious manner. This article details the AE and serious adverse event (SAE) reporting summary developed for a large multi-center National Institutes of Health (NIH)-sponsored clinical trial.
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pubmed:grant |
http://linkedlifedata.com/resource/pubmed/grant/K24AA13736,
http://linkedlifedata.com/resource/pubmed/grant/M01RR-00042,
http://linkedlifedata.com/resource/pubmed/grant/M01RR-00043,
http://linkedlifedata.com/resource/pubmed/grant/M01RR-00051,
http://linkedlifedata.com/resource/pubmed/grant/M01RR-00065,
http://linkedlifedata.com/resource/pubmed/grant/M01RR-00633,
http://linkedlifedata.com/resource/pubmed/grant/M01RR-00827,
http://linkedlifedata.com/resource/pubmed/grant/M01RR-01066,
http://linkedlifedata.com/resource/pubmed/grant/M01RR-06192,
http://linkedlifedata.com/resource/pubmed/grant/N01-DK-9-2318,
http://linkedlifedata.com/resource/pubmed/grant/N01-DK-9-2319,
http://linkedlifedata.com/resource/pubmed/grant/N01-DK-9-2320,
http://linkedlifedata.com/resource/pubmed/grant/N01-DK-9-2321,
http://linkedlifedata.com/resource/pubmed/grant/N01-DK-9-2322,
http://linkedlifedata.com/resource/pubmed/grant/N01-DK-9-2323,
http://linkedlifedata.com/resource/pubmed/grant/N01-DK-9-2324,
http://linkedlifedata.com/resource/pubmed/grant/N01-DK-9-2325,
http://linkedlifedata.com/resource/pubmed/grant/N01-DK-9-2326,
http://linkedlifedata.com/resource/pubmed/grant/N01-DK-9-2327,
http://linkedlifedata.com/resource/pubmed/grant/N01-DK-9-2328
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pubmed:language |
eng
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pubmed:journal |
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pubmed:citationSubset |
IM
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pubmed:chemical |
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pubmed:status |
MEDLINE
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pubmed:month |
Dec
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pubmed:issn |
1740-7753
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pubmed:author |
pubmed-author:BellMargaret CMC,
pubmed-author:CormierMaureenM,
pubmed-author:De SantoJennifer LJL,
pubmed-author:HofmannCharlotteC,
pubmed-author:KelleyMichelleM,
pubmed-author:KingDebra LDL,
pubmed-author:MihovaMarina SMS,
pubmed-author:MilsteinSusan LSL,
pubmed-author:MolchenWallis AWA,
pubmed-author:ParkChoon JCJ,
pubmed-author:ParkYoonY,
pubmed-author:RichtmyerPamela APA,
pubmed-author:RobuckPatricia RPR,
pubmed-author:SheltonJanel LJL,
pubmed-author:WrightElizabeth CEC
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pubmed:issnType |
Electronic
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pubmed:volume |
6
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pubmed:owner |
NLM
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pubmed:authorsComplete |
Y
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pubmed:pagination |
618-27
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pubmed:dateRevised |
2011-11-17
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pubmed:meshHeading |
pubmed-meshheading:19889888-Adverse Drug Reaction Reporting Systems,
pubmed-meshheading:19889888-Antiviral Agents,
pubmed-meshheading:19889888-Automatic Data Processing,
pubmed-meshheading:19889888-Carcinoma, Hepatocellular,
pubmed-meshheading:19889888-Database Management Systems,
pubmed-meshheading:19889888-Disease Progression,
pubmed-meshheading:19889888-Hepatitis C, Chronic,
pubmed-meshheading:19889888-Humans,
pubmed-meshheading:19889888-Interferon-alpha,
pubmed-meshheading:19889888-Liver Cirrhosis,
pubmed-meshheading:19889888-Liver Failure,
pubmed-meshheading:19889888-Liver Neoplasms,
pubmed-meshheading:19889888-Multicenter Studies as Topic,
pubmed-meshheading:19889888-National Institutes of Health (U.S.),
pubmed-meshheading:19889888-Polyethylene Glycols,
pubmed-meshheading:19889888-Randomized Controlled Trials as Topic,
pubmed-meshheading:19889888-Recombinant Proteins,
pubmed-meshheading:19889888-Research Design,
pubmed-meshheading:19889888-United States
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pubmed:year |
2009
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pubmed:articleTitle |
Automated summaries of serious adverse events in the hepatitis C antiviral long-term treatment against cirrhosis trial.
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pubmed:affiliation |
New England Research Institutes, Watertown, MA 02472, USA. mbell@neriscience.com
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pubmed:publicationType |
Journal Article,
Research Support, Non-U.S. Gov't,
Research Support, N.I.H., Extramural
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