Clinical trial · Observational
Hepatotoxicity Related to Protein Kinase Inhibitors
Hepatotoxicity Related to Protein Kinase Inhibitors in Cancer Patients : an Observational and Retrospective Study Using the FDA Adverse Event Reporting System (FAERS)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Protein Kinase Inhibitor | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Hepatotoxicities cases reports related to PKIs (from FAERS database).
- timeFrame
- From 2004 to Sep, 2021
- description
- 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 outcomes (2)
- measure
- Description of the time to onset of hepatotoxicities after PKIs exposure.
- timeFrame
- From 2004 to Sep, 2021
- description
- The investigators plan to conduct a time to onset analysis of PKIs-related hepatotoxicities using weibull distribution
- measure
- Description of the fatality cases.
- timeFrame
- From 2004 to Sep, 2021
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available