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).
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).
Study Type
OBSERVATIONAL
Enrollment
600,000
This retrospective pharmacovigilance study will include protein kinase inhibitor and exclude those drugs known to cause hepatotoxicities
Central South University
Changsha, Hunan, China
RECRUITINGHepatotoxicities cases reports related to PKIs (from FAERS database).
The investigators plan to identify number of cases of hepatotoxicities (especially severe toxicities such as hepatic failure) reports related to PKIs reported in the FAERS database by using reporting odds ratios (ROR) and information component (IC), two common method in disproportionality analysis. Clinical features such as gender, age and indications will be displayed, too.
Time frame: From 2004 to Sep, 2021
Description of the time to onset of hepatotoxicities after PKIs exposure.
The investigators plan to conduct a time to onset analysis of PKIs-related hepatotoxicities using weibull distribution
Time frame: From 2004 to Sep, 2021
Description of the fatality cases.
Fatality cases of PKIs-related hepatotocities will be described.
Time frame: From 2004 to Sep, 2021
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