Disproportionality Analysis of Fondaparinux-Associated Adverse Events Based on the FDA Adverse Event Reporting System (FAERS)

This dataset contains the minimal underlying data used to reproduce the findings of the study titled “Safety profile of fondaparinux based on the FAERS database: a disproportionality analysis”. The data were derived from the publicly accessible FDA Adverse Event Reporting System (FAERS) and processed to generate a clean analytical dataset suitable for reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayesian Geometric Mean (EBGM) analyses.The dataset includes essential variables required to replicate all statistical analyses and figures in the manuscript, including drug information, reaction terms, patient demographic characteristics, outcomes, indications, therapy dates, and report sources. All personally identifiable information has been removed, and only de-identified data fields are retained.<br>Raw FAERS data are not included here because they are publicly available from the FDA website. Instead, this dataset provides the cleaned and structured data that were used as input for the statistical algorithms in the paper.File contents include:• Drug file (drug role, product name, substance name)• Reaction file (MedDRA preferred terms)• Indication file• Outcome file• Therapy file (start/stop dates)• Report source• Consolidated minimal dataset for analysis<br>This repository supports full reproducibility in accordance with PLOS ONE’s data availability requirements.