FAERS Pharmacovigilance Study of ICI-Associated Myocarditis-Myositis-Myasthenia Overlap

A pharmacovigilance study analyzes reports from the FDA Adverse Event Reporting System (FAERS) from 2015Q1 to 2025Q4. It focuses on the rare but severe myocarditis–myositis–myasthenia gravis overlap syndrome associated with immune checkpoint inhibitors. The dataset includes 151 reports meeting the strict overlap definition, with disproportionality analysis and time-to-onset characterization.

Use Cases

• Assessing disproportionality signals for rare adverse event patterns based on reporting odds ratios and Information Component metrics.
• Estimating time-to-onset profiles for drug-specific toxicities based on linked therapy start and event dates.
• Analyzing reported death outcomes within specific adverse event cohorts based on the 37.4% mortality rate in ICI-exposed reports.

Strengths

• Analysis is based on 15,187,311 deduplicated FAERS reports, providing a large-scale pharmacovigilance context.
• Includes specific statistical results, such as a reporting odds ratio of 397.29 and a median time-to-onset of 25 days.
• Defines a strict, report-level case definition for the overlap syndrome, enhancing specificity.

Limitations

• Column-level documentation is absent; field semantics must be inferred after download.
• Row count for the core dataset is unknown, which may limit suitability assessment.
• The dataset is a 65.6 KB DOCX file, indicating limited scope and likely containing summary results rather than raw data.

Provenance

Source

FDA Adverse Event Reporting System (FAERS)

Collection Method

Retrospective pharmacovigilance study with disproportionality analysis and time-to-onset estimation.

Time Range

2015Q1 to 2025Q4

Freshness

Last updated 2026-05-18 04:10:29; freshness should be verified.