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Hepatotoxicity Related to Protein Kinase Inhibitors

Cancer Clinical Trial

Official title:
Hepatotoxicity Related to Protein Kinase Inhibitors in Cancer Patients : an Observational and Retrospective Study Using the FDA Adverse Event Reporting System (FAERS)

Clinical Trial Summary

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).

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05430126
Study type Observational [Patient Registry]
Source Central South University
Contact Miao Yan, PhD
Phone +8615708460624
Email yanmiao@csu.edu.cn
Status Recruiting
Phase
Start date June 19, 2022
Completion date August 10, 2022
View Details
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