Hepatotoxicity Related to Protein Kinase Inhibitors

Central South University

Status: Enrolling

Conditions: Cancer

Treatments: Drug: Protein Kinase Inhibitor

Study type: Observational

Funder types: Other

Identifiers

NCT05430126

CSU20220619

Details and patient eligibility

About

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).

Full 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).

Enrollment: 600,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Case reported in the FAERS database of individual safety case reports at the time of the extraction,
• Patients treated with at least 1 PKIs.

Exclusion criteria

• Chronology not compatible between the PKIs and hepatotoxicities