Dataset for "Post-Approval Changes to Risk Management Plans, Safety Labeling, and Regulatory Reassessment: A Safety Issue-Level Analysis of Antineoplastic Agents in Japan"

This dataset supports a study examining the relationships among risk management plan changes, safety labeling, and regulatory reassessment of antineoplastic agents in Japan. The study was a retrospective observational analysis of publicly available re-examination reports and related regulatory documents published by the Pharmaceuticals and Medical Devices Agency (PMDA), Japan. The dataset includes information at five analytical levels: drugs, re-examination reports, indications, individual safety issues, and post-marketing studies. It contains data on 80 antineoplastic drugs, 99 re-examination reports, 170 oncology indication records, 1,017 safety issues, and 267 post-marketing studies. The public dataset contains the coded variables used to reproduce the principal descriptive and safety issue-level analyses reported in the manuscript. Detailed free-text extraction fields, source-document narratives, and internal researcher notes were excluded from the public version. All source information was derived from publicly available PMDA regulatory documents.