Data source
The JADER database, including data from April 2004 to January 2021, was
searched from the PMDA website
(https://www.info.pmda.go.jp/fukusayoudb/CsvDownload.jsp). The JADER
database consisted of four data tables, as follows: 1) DEMO
(patients’ demographic information, including sex, age, and weight); 2)
DRUG (drug name, causality, etc.); 3) REAC (AEs, outcomes, etc.); and 4)
HIST (medical history, primary illness, etc.). We created relational
database from the four data tables according to patient identification
numbers using Microsoft Access 2019 (Microsoft, Redmond, WA, USA).
Because duplicate reports in the SRS database may affect the evaluation
from the relational database, we extracted only the latest of AE reports
based on the DEMO file. Data with inaccurate dates were excluded.