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

A pharmacovigilance study analyzing 3,631 reports of cutaneous adverse events (CAEs) linked to antibody-drug conjugates (ADCs). The dataset, created by Huiwen Sun and last updated in May 2026, uses FDA Adverse Event Reporting System (FAERS) data from Q1 2004 to Q2 2025 to identify safety signals, time-to-onset, and clinical outcomes.

Use Cases

• Identify disproportionate safety 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, such as elderly patients and males, based on patient baseline characteristics.

Strengths

• Contains 3,631 reported cutaneous adverse event cases.
• Covers a long time range from Q1 2004 to Q2 2025.
• Identifies 31 positive safety signals at the preferred term level.
• Reports specific 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 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).

Time Range

Q1 2004 to Q2 2025

Freshness

Last updated 2026-05-25 04:33:01; freshness should be verified.