FAERS Pharmacovigilance Study: Hand-Foot Skin Reaction from VEGFR-TKIs (2004-2025)

8,668 reports of hand-foot skin reaction (HFSR) were analyzed from the FDA Adverse Event Reporting System (FAERS). The study by Jinhan Chen, updated in 2026, quantified signals for 11 vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR-TKIs). It found a median onset time of 16 days and identified stronger signals and earlier onset in female patients.

Use Cases

• Compare HFSR signal strength across 11 VEGFR-TKIs based on disproportionality analysis results.
• Analyze patient demographics and clinical outcomes, such as hospitalization rates, mentioned in the results.
• Model time-to-onset patterns for HFSR based on the reported median and subgroup analysis.
• Investigate gender-based differences in adverse event reporting and onset timing highlighted in the study.

Strengths

• Analysis of 8,668 specific adverse event reports provides a substantial case series.
• Uses four established disproportionality analysis algorithms (ROR, PRR, MGPS, BCPNN) for signal detection.
• Includes temporal analysis with a reported median time-to-onset of 16 days and subgroup comparisons.

Limitations

• Row count is unknown, which may limit suitability assessment for large-scale modeling.
• Column-level documentation is absent; field semantics must be inferred after download.
• The 14.8 KB file size suggests the primary data may be summary statistics within a document, not raw patient records.

Provenance

Source

FDA Adverse Event Reporting System (FAERS) database.

Collection Method

Standard data cleaning followed by disproportionality analysis.

Time Range

Q1 2004 to Q2 2025

Freshness

Last updated 2026-06-04 04:30:40; covers data from Q1 2004 to Q2 2025.