2026-10-11T19:39:18Z https://api.figshare.com/v2/oai

oai:figshare.com:article/33954820 2026-09-21T14:45:59Z category_24853 item_type_3 month_year_09_2026

Supporting Data and Code for Context-Dependent Pharmacovigilance Reporting Phenotypes Across Pulmonary Arterial Hypertension Therapies Kaixun Zhao (24379391) Junmeng Zeng (25084047) Clinical pharmacology and therapeutics pulmonary arterial hypertension pharmacovigilance FAERS adverse drug reactions disproportionality analysis <p dir="ltr"><b>This repository contains supporting derived data, machine-readable tables, analysis materials, and R code associated with the study “Quantifying context dependence of pharmacovigilance reporting phenotypes across pulmonary arterial hypertension therapies: an indication-matched FAERS study.”</b></p><p dir="ltr">The study analyzed publicly available U.S. FDA Adverse Event Reporting System (FAERS) reports accessed through the openFDA Drug Adverse Event resources, with a frozen data cut of 30 June 2026. The analytic framework used an indication-matched pulmonary arterial hypertension (PAH) reporting universe and evaluated context dependence through conventional disproportionality analyses, sensitivity persistence, sequential persistence, treprostinil route localization, whole-profile reporting divergence, and selected regulatory-time analyses.</p><p dir="ltr">The repository includes derived analytical tables, figure-generation scripts, supplementary analysis scripts, locked inputs where available, quality-control files, manifests, and archived analysis packages used to support the reported results. Raw FAERS source records are not redistributed because they remain publicly available from the FDA/openFDA resources.</p><p dir="ltr">Key quantitative outputs include the three-universe sensitivity persistence score (SPS3), five-stage sequential persistence score (PPS5), route localization index (RLI), and reporting-profile divergence analyses across treprostinil administration routes and pharmacologic comparators.</p><p dir="ltr">The deposited materials are intended to facilitate transparency, reproducibility, and independent verification of the reported analyses. Disproportionality statistics and reporting-profile measures in this repository characterize spontaneous-reporting patterns and should not be interpreted as estimates of incidence, comparative clinical risk, or causality.</p><p dir="ltr"><b>Data cut:</b> 30 June 2026<br><b>Source:</b> FDA Adverse Event Reporting System / openFDA<br><b>Corresponding authors:</b> Kaixun Zhao and Xueqiong Cheng</p> 2026-09-21T14:45:59Z Dataset Dataset 10.6084/m9.figshare.33954820.v1 https://figshare.com/articles/dataset/Supporting_Data_and_Code_for_Context-Dependent_Pharmacovigilance_Reporting_Phenotypes_Across_Pulmonary_Arterial_Hypertension_Therapies/33954820 CC BY 4.0