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Although protein kinase inhibitors (PKIs) have proved effective in treating many cancers, few patients receiving PKIs may experience rare but life-threatening hepatotoxicity such as hepatic failure. Today, there is no large-scale retrospective pharmacovigilance study focusing on protein kinase inhibitors-related hepatotoxicity.
The objective was to investigate reports of hepatotoxicity related to protein kinase inhibitors using FDA Adverse Event Reporting System (FAERS).
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The investigators plan to include FDA approved PKIs from PKIDB, a curated, annotated and updated database of protein kinase inhibitors (https://www.icoa.fr/pkidb/).
The search terms of hepatotoxicities will be extracted from "Drug related hepatic disorders-comprehensive search (SMQ)" in MedDRA (Medical Dictionary for Regulatory Activities).
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Miao Yan, PhD
Data sourced from clinicaltrials.gov
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