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

Jinhan Chen's pharmacovigilance study analyzes 8,668 reports of Hand-Foot Skin Reaction (HFSR) associated with Vascular Endothelial Growth Factor Receptor Tyrosine Kinase Inhibitors (VEGFR-TKIs). The dataset, last updated on 2026-06-04, is derived from the FDA Adverse Event Reporting System (FAERS) database covering Q1 2004 to Q2 2025. It includes disproportionality analyses, patient demographics, time-to-onset, and clinical outcomes for 11 VEGFR-TKIs.

Use Cases

• Compare HFSR signal strength across 11 VEGFR-TKIs based on disproportionality analyses using ROR, PRR, MGPS, and BCPNN algorithms.
• Analyze patient demographics and clinical outcomes, such as hospitalization rates, associated with HFSR reports.
• Model time-to-onset patterns for HFSR, including the median onset of 16 days and differences between genders.
• Conduct subgroup analyses to investigate differential reporting signals, such as the stronger signals reported in female patients.

Strengths

• Analysis of 8,668 HFSR reports provides a substantial case volume.
• Covers a long time range from Q1 2004 to Q2 2025.
• Employs four standard disproportionality analysis algorithms (ROR, PRR, MGPS, BCPNN).
• Includes detailed subgroup analyses on patient demographics and time-to-onset.

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 spontaneous reporting systems like FAERS.

Provenance

Source

FDA Adverse Event Reporting System (FAERS) database.

Collection Method

Standard data cleaning and disproportionality analysis performed on FAERS reports.

Time Range

Q1 2004 to Q2 2025.

Freshness

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