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A novel standard to evaluate the impact of therapeutic agents on patient safety – The BURDEN OF THERAPY™(©∗)
PURPOSE: Currently, treatment-emergent adverse events (TEAEs) during a clinical study are summarized over the entire study period. OBJECTIVE: Develop and validate a novel methodology, BURDEN OF THERAPY(©∗) (BOTh(©∗)), to quantify presence and severity of TEAEs on each day of study. METHODS: BOTh uti...
| Autores principales: | , , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
Elsevier
2016
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| Materias: | |
| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5935900/ https://www.ncbi.nlm.nih.gov/pubmed/29736481 http://dx.doi.org/10.1016/j.conctc.2016.09.003 |