2.1 Data source
Data reported in the JADER database from April 2004 to July 2022 were obtained from the PMDA website.3 In Japan, drug adverse events and the clinical outcomes are spontaneously reported to the JADER database by pharmaceutical companies and healthcare workers. Any patient deaths during pharmacotherapy are reportable adverse events for the database. As of July 2022, the JADER database has 1 280 060 adverse event reports, including 86 138 deaths, for 775 566 reported patients.3 The JADER database consists of four data tables linked by unique identification numbers: DEMO (patient demographics), DRUG (drug names, administration routes, and start and end date of administration), HIST (primary diseases), and REAC (adverse events, onset date, and clinical outcomes).