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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
Autores principales:	Moody, Gwenllian, Addison, Katy, Cannings-John, Rebecca, Sanders, Julia, Wallace, Carolyn, Robling, Michael
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	BioMed Central 2019
Materias:	Methodology
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6937811/ https://www.ncbi.nlm.nih.gov/pubmed/31888752 http://dx.doi.org/10.1186/s13063-019-3961-8

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