Source and weighting sensitivity of diarrhoea reporting with CDK4/6 inhibitors in breast cancer — aggregate data and analysis code

This dataset contains aggregate data and analysis code supporting an exploratory study of diarrhoea reporting with palbociclib, ribociclib and abemaciclib in breast cancer using FAERS and EudraVigilance.The analysis covers reports from 2018Q1 through 2026Q1. EudraVigilance exports were downloaded on 19 September 2026. The study examines how reporting comparisons vary by database, geographic context, shared calendar-year and reporter support, and standardization weights.The package includes stratum-specific contingency counts, target weights, analysis estimates, sensitivity-analysis outputs, R scripts for computational verification and figure generation, and provenance documentation. Raw individual report listings, the master database and clinical patient records are not redistributed.Reporting odds ratios and reporting fractions do not estimate clinical incidence, causal effects or comparative treatment safety. FAERS and EudraVigilance may contain overlapping reports and are not treated as independent validation cohorts. The analyses are exploratory, and computational reproducibility from aggregate counts does not establish completeness of source acquisition or resolve cross-database duplication. Data access: Public Level 1 ADRreports exports; no restricted Level 2A extract was used. EudraVigilance data were obtained from the European Medicines Agency’s publicly accessible ADRreports portal. The analyses and interpretations are those of the authors and do not necessarily reflect the views of the European Medicines Agency.