Reproducibility package for Comparator- and provenance-aware disproportionality analysis of early ensifentrine safety reports in the FDA Adverse Event Reporting System

This record contains the versioned reproducibility package accompanying the manuscript “Comparator- and provenance-aware disproportionality analysis of early ensifentrine safety reports in the FDA Adverse Event Reporting System.” The package contains analysis code, aggregated CSV and JSON outputs, figure source data, submission-ready figures, checksums, a file manifest, and independent verification procedures for analyses of nine quarterly FDA FAERS/AEMS releases from 2024Q2 through 2026Q2. Raw FDA FAERS/AEMS archives, report-level identifiers, MedDRA 29.0 terminology files, and SMQ membership data are not redistributed. Report-level reproduction requires users to download the FDA archives identified by the checksums supplied in the package and to provide a licensed local copy of MedDRA 29.0. The publicly archived materials support verification of the reported aggregate results and deterministic regeneration of Figures 1–5. Version DOI: https://doi.org/10.5281/zenodo.21996489