Cutaneous Adverse Events with Antibody-Drug Conjugates: FAERS Pharmacovigilance Study

A pharmacovigilance study analyzing 3,631 cutaneous adverse event reports linked to antibody-drug conjugates (ADCs) from the FDA Adverse Event Reporting System (FAERS). The data, authored by Huiwen Sun and published on figshare under CC-BY-4.0, spans reports from Q1 2004 to Q2 2025. It includes disproportionality analyses, time-to-onset, clinical outcomes, and stratified risk assessments.

Use Cases

• Identify drug-specific safety signals for cutaneous adverse events based on disproportionality analysis results
• Analyze time-to-onset patterns for adverse events across different antibody-drug conjugates
• Assess clinical outcome severity, such as hospitalization and death rates, associated with reported events
• Investigate age- and gender-stratified risk profiles for adverse events linked to targeted cancer therapies

Strengths

• Contains 3,631 specific cutaneous adverse event reports
• Covers a long time range from Q1 2004 to Q2 2025
• Reports median time-to-onset (15 days) and specific clinical outcome percentages (23.4% hospitalization, 7.7% death)
• Identifies 31 positive safety signals at the preferred term level

Limitations

• Row count is unknown, which may limit suitability assessment
• Column-level documentation is absent; field semantics must be inferred after download
• Data may reflect reporting bias inherent to voluntary adverse event reporting systems

Provenance

Source

FDA Adverse Event Reporting System (FAERS)

Collection Method

Data extraction and disproportionality analysis (reporting odds ratio, information component)

Time Range

Q1 2004 to Q2 2025

Freshness

Last updated 2026-05-25 04:33:00