Monitoring adverse social and medical events in public health trials: assessing predictors and interpretation against a proposed model of adverse event reporting

BACKGROUND: Although adverse event (AE) monitoring in trials focusses on medical events, social outcomes may be important in public or social care trials. We describe our approach to reporting and categorising medical and other AE reports, using a case study trial. We explore predictors of medical a...

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Detalles Bibliográficos
Publicado en:Trials
Main Authors: Moody, Gwenllian, Addison, Katy, Cannings-John, Rebecca, Sanders, Julia, Wallace, Carolyn, Robling, Michael
Formato: Artigo
Idioma:Inglês
Publicado: BioMed Central 2019
Assuntos:
Methodology
Acceso en liña:https://ncbi.nlm.nih.gov/pmc/articles/PMC6937811/
https://ncbi.nlm.nih.gov/pubmed/31888752
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1186/s13063-019-3961-8
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