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).