FAERS Pharmacovigilance Study of Hand-Foot Skin Reaction from VEGFR-TKIs

A pharmacovigilance study by Jinhan Chen analyzed 8,668 reports of hand-foot skin reaction (HFSR) from the FDA Adverse Event Reporting System (FAERS) database covering Q1 2004 to Q2 2025. The study performed disproportionality analyses for 11 vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR-TKIs) to quantify safety signals. It assessed patient demographics, time-to-onset, and clinical outcomes.

Use Cases

• Compare HFSR signal strength across 11 VEGFR-TKIs based on disproportionality analysis results.
• Analyze time-to-onset patterns for HFSR based on the reported median and subgroup onset times.
• Investigate demographic differences in adverse event reporting based on gender subgroup analysis.
• Assess clinical outcomes of HFSR based on reported hospitalization rates.

Strengths

• Analyzes 8,668 specific adverse event reports, providing a substantial case count.
• Covers a long time range from Q1 2004 to Q2 2025, offering over two decades of pharmacovigilance data.
• Employs four standard disproportionality analysis algorithms (ROR, PRR, MGPS, BCPNN) for signal detection.
• Includes detailed subgroup analysis on patient gender and clinical outcomes like hospitalization.

Limitations

• Column-level documentation is absent; field semantics must be inferred after download.
• Row count for the underlying dataset is unknown, which may limit suitability assessment.
• Data may reflect reporting bias inherent to the FAERS spontaneous reporting system.

Provenance

Source

FDA Adverse Event Reporting System (FAERS) database.

Collection Method

Standard data cleaning followed by disproportionality analyses (ROR, PRR, MGPS, BCPNN).

Time Range

Q1 2004 to Q2 2025.

Freshness

Last updated 2026-06-04 04:30:40; freshness should be verified.