Cancer
Conditions
Brief 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).
Detailed 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).
Interventions
DRUGProtein Kinase Inhibitor
This retrospective pharmacovigilance study will include protein kinase inhibitor and exclude those drugs known to cause hepatotoxicities
Sponsors
Central South University
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hepatotoxicities cases reports related to PKIs (from FAERS database). | From 2004 to Sep, 2021 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Description of the time to onset of hepatotoxicities after PKIs exposure. | From 2004 to Sep, 2021 | The investigators plan to conduct a time to onset analysis of PKIs-related hepatotoxicities using weibull distribution |
| Description of the fatality cases. | From 2004 to Sep, 2021 | Fatality cases of PKIs-related hepatotocities will be described. |
Countries
China
Contacts
Primary ContactMiao Yan, PhD
Outcome results
None listed