Table 1_Cutaneous adverse events with antibody-drug conjugates: a FAERS-based pharmacovigi

From Q1 2004 to Q2 2025, this dataset contains 3,631 reports of cutaneous adverse events linked to antibody-drug conjugates, extracted from the FDA Adverse Event Reporting System (FAERS). It was created by Huiwen Sun and includes disproportionality analysis results for 31 positive safety signals. The dataset was last updated on May 25, 2026.

Use Cases

• Identify drug-specific safety signals 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 outcome severity, such as hospitalization and death rates, associated with these events
• Investigate demographic risk factors based on age- and gender-stratified analyses mentioned in the description

Strengths

• Contains 3,631 adverse event reports, providing a substantial case count for analysis
• Covers a long time range from Q1 2004 to Q2 2025
• Includes results for 31 positive safety signals at the preferred term level
• Provides specific median time-to-onset (15 days) and outcome percentages (23.4% hospitalization, 7.7% death)

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 the FAERS spontaneous reporting system

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