Cutaneous Adverse Events with Antibody-Drug Conjugates: A 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 spans from Q1 2004 to Q2 2025 and was analyzed by Huiwen Sun using disproportionality methods. It identifies 31 positive safety signals, reports a median time-to-onset of 15 days, and details clinical outcomes including hospitalization and death rates.

Use Cases

• Identify drug-specific safety signals for cutaneous adverse events based on disproportionality analysis results.
• Analyze time-to-onset patterns for adverse reactions across different antibody-drug conjugates.
• Assess clinical outcome risks, such as hospitalization and death rates, associated with reported events.
• Investigate demographic risk factors, such as age and gender susceptibility, for ADC-related skin reactions.

Strengths

• Contains 3,631 specific adverse event reports with detailed patient baseline characteristics.
• Identifies 31 positive safety signals at the preferred term level, including rare severe events.
• Provides a defined time range from Q1 2004 to Q2 2025 for longitudinal analysis.
• Reports concrete clinical outcome statistics, including a 23.4% hospitalization rate and a 7.7% death rate.

Limitations

• Column-level documentation is absent; field semantics must be inferred after download.
• Row count for the underlying FAERS data is unknown, which may limit suitability assessment.
• Data may reflect reporting bias inherent to spontaneous 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 04:32:59; freshness should be verified.