Table 4_Safety signals of perfluorohexyloctane ophthalmic solution in patients with dry ey

A pharmacovigilance analysis of adverse events associated with perfluorohexyloctane ophthalmic solution for dry eye disease. The dataset contains 92 adverse event reports from the FDA Adverse Event Reporting System (FAERS) database from the fourth quarter of 2023 through the fourth quarter of 2024. The study was authored by Zhengtai Sun and posted on figshare.

Use Cases

• Identify common adverse events and device-related issues based on reported Preferred Terms like 'product delivery mechanism issue' and 'eye irritation'.
• Analyze time-to-onset patterns for adverse events based on the reported median of 2 days.
• Compare safety signal strengths for different event types using disproportionality analysis methods (ROR, PRR, BCPNN, MGPS) mentioned in the description.
• Support risk management and clinical guidance for dry eye disease treatment based on real-world evidence from the FAERS database.

Strengths

• Analysis is based on 92 adverse event reports from the FDA Adverse Event Reporting System (FAERS).
• Employs four established disproportionality analysis methods (ROR, PRR, BCPNN, MGPS) for signal detection.
• Provides a specific median time-to-onset of 2 days for reported adverse events.
• Data covers a defined time range from Q4 2023 to Q4 2024.

Limitations

• Row count for the underlying data is unknown, which may limit suitability assessment.
• Column-level documentation is absent; field semantics must be inferred after download.
• The dataset is very small at 16.6 KB, indicating limited scope.

Provenance

Source

FDA Adverse Event Reporting System (FAERS)

Collection Method

Retrospective pharmacovigilance study using disproportionality analysis.

Time Range

Fourth quarter of 2023 through the fourth quarter of 2024

Freshness

Last updated 2026-05-28 04:48:12; freshness should be verified.