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Nintedanib and ischemic colitis: Signal assessment with the integrated use of two types of real‐world evidence, spontaneous reports of suspected adverse drug reactions, and observational data from large health‐care databases
PURPOSE: Statistical screening of Vigibase, the global database of individual case safety reports, highlighted an association between the MedDRA Preferred Term (PT) “colitis” and nintedanib. Nintedanib is a protein kinase inhibitor authorized in accelerated regulatory procedures for the treatment of...
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
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John Wiley & Sons, Inc.
2020
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| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7496543/ https://www.ncbi.nlm.nih.gov/pubmed/32399991 http://dx.doi.org/10.1002/pds.5022 |