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

A pharmacovigilance dataset of 3,631 cutaneous adverse event reports linked to antibody-drug conjugates (ADCs). The data was extracted from the FDA Adverse Event Reporting System (FAERS) from Q1 2004 to Q2 2025 by author Huiwen Sun and includes patient baseline characteristics, disproportionality analysis signals, time-to-onset, and clinical outcomes. The study identifies 31 positive safety signals at the preferred term level, highlighting events like rash, alopecia, and severe conditions such as Stevens-Johnson syndrome.

Use Cases

• Identify disproportionate reporting signals for specific ADCs based on reporting odds ratio (ROR) and information component (IC) analyses.
• Analyze time-to-onset patterns for cutaneous adverse events across different antibody-drug conjugates.
• Assess clinical outcomes, such as hospitalization and death rates, associated with ADC-related skin reactions.
• Conduct stratified risk analyses for demographic groups like elderly patients and males mentioned in the study.

Strengths

• Contains 3,631 specific adverse event reports, providing a substantial case count for analysis.
• Covers a long time range from Q1 2004 to Q2 2025, allowing for longitudinal safety signal detection.
• Employs established pharmacovigilance methods, including disproportionality analyses and stratified risk assessments.

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 reporting systems like FAERS.

Provenance

Source

FDA Adverse Event Reporting System (FAERS)

Collection Method

Data extraction and disproportionality analysis (reporting odds ratio, information component) performed on spontaneous reports.

Time Range

Q1 2004 to Q2 2025

Freshness

Last updated 2026-05-25 04:32:59; freshness should be verified.