ADC Peripheral Nervous System Safety Signals from FAERS, JADER, and CVARD

A multi-database pharmacovigilance study analyzed spontaneous adverse event reports from the FDA Adverse Event Reporting System (FAERS; Q1-2025Q3), the Japanese Adverse Drug Event Report (JADER; 2004Q1–2025 Q3), and the Canada Vigilance Adverse Reaction Database (CVARD; January 1965 - October 2025). It identified 31,592 post-marketing reports where an antibody-drug conjugate was the primary suspect, including 1,395 involving peripheral nervous system-related adverse events. The analysis, authored by Xiaojie Feng and shared on figshare in April 2026, used disproportionality analyses to characterize safety signal strength and cross-database reproducibility.

Use Cases

• Assess the strength of peripheral nervous system safety signals for antibody-drug conjugates based on reporting odds ratios and other disproportionality metrics.
• Compare signal reproducibility across different national pharmacovigilance databases (FAERS, JADER, CVARD) as described in the study.
• Analyze time-to-onset patterns for neuropathic adverse events based on the reported median onset times of 20-40 days or delayed presentations beyond 80-100 days.
• Identify labeling gaps by comparing post-marketing surveillance signals with current prescribing information for antibody-drug conjugates.

Strengths

• Analysis spans three major international pharmacovigilance databases with overlapping time ranges up to Q3 2025.
• Includes 31,592 total reports and 1,395 specific peripheral nervous system adverse event reports from FAERS.
• Reports specific statistical measures like reporting odds ratios (e.g., 4.62 in FAERS, 42.84 in JADER, 20.79 in CVARD) with confidence intervals.
• Provides time-to-onset analysis with median values for several antibody-drug conjugates.

Limitations

• The underlying dataset is a 102.7 KB PDF, suggesting it contains summary results rather than the raw adverse event report data.
• Row count and column-level documentation for any underlying tabular data are unknown, limiting suitability assessment.
• Data may reflect reporting biases inherent to spontaneous adverse event reporting systems.

Provenance

Source

Spontaneous adverse event reports from FDA Adverse Event Reporting System (FAERS), Japanese Adverse Drug Event Report (JADER), and Canada Vigilance Adverse Reaction Database (CVARD).

Collection Method

Multi-database pharmacovigilance study using disproportionality analyses (reporting odds ratio, proportional reporting ratio, empirical Bayes geometric mean, information component).

Time Range

FAERS: Q1-2025Q3; JADER: 2004Q1–2025 Q3; CVARD: January 1965 - October 2025.

Freshness

Last updated 2026-04-21 05:34:06; includes data up to Q3 2025.

Geography

Reports originate from the United States (FAERS), Japan (JADER), and Canada (CVARD).