Table 6_Safety signals of perfluorohexyloctane ophthalmic solution in patients with dry ey

92 adverse event reports for a novel dry eye disease treatment were analyzed from the FDA Adverse Event Reporting System (FAERS) between Q4 2023 and Q4 2024. Zhengtai Sun authored this pharmacovigilance study, which identified the top reported events and calculated safety signals using four disproportionality analysis methods. The median time-to-onset for reported adverse events was 2 days.

Use Cases

• Identify common adverse events associated with a specific ophthalmic solution based on FAERS report counts.
• Calculate disproportionality safety signals for drug-event pairs using methods like ROR and MGPS mentioned in the description.
• Analyze the time-to-onset profile for adverse reactions based on the reported median of 2 days.
• Compare user experience and device-related issues (e.g., delivery mechanism problems) against direct drug effects.

Strengths

• Analysis is based on 92 adverse event reports from the authoritative FAERS database.
• Employs four established disproportionality analysis methods (ROR, PRR, BCPNN, MGPS) for signal detection.
• Provides a specific median time-to-onset figure of 2 days for reported events.

Limitations

• Row count and column-level documentation are unknown, limiting suitability assessment.
• The dataset is very small at 18.1 KB, representing a limited scope of reports.
• Description metadata is limited; actual data structure and quality require manual inspection after download.

Provenance

Source

FDA Adverse Event Reporting System (FAERS)

Collection Method

Retrospective pharmacovigilance study employing 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.