Completeness of spontaneously reported adverse drug reactions in 4 databases.

ABSTRACT:

Aims

To assess the completeness of information provided in adverse drug reaction (ADR) reports in 4 spontaneous report databases.

Methods

The study was conducted using freely accessible ADR reports from the Canada Vigilance Adverse Reaction Online Database, the US Food and Drug Administration Adverse Event Reporting System (FAERS) database, the UK Yellow Card Scheme and the Danish Medicines Agency ADR Database, covering the period 2014-2023. The variables used to evaluate the completeness of ADR reports were selected based on the vigiGrade completeness tool. Descriptive statistics were used to report the completeness of information in each ADR report, while chi-square tests were used to analyse differences in completeness by seriousness of report.

Results

In total, 29

SUBMITTER: Dedefo MG 

PROVIDER: S-EPMC12648374 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature