A new version of the JADER (Japanese Adverse Drug Event Report) database is now available for subscribers in Oracle Cloud.

This database includes all data from 2004 through January 2023, as released by the Japanese authority PMDA (Pharmaceutical and Medical Devices Agency). Oracle refers to this data set as JADER 3.0.0.1.100. The purpose of these release notes is to describe the procedures taken by Oracle to prepare the JADER data for use with Oracle Empirica Signal version 9.2.3 and above. The standard configurations delivered with the data and the recommended parameters for periodic data mining runs are also described.

Usage of the JADER adverse event data is subject to the PMDA terms of use, as well as the Oracle Empirica Signal Cloud Service Description available at www.oracle.com/contracts. The PMDA web site can be viewed at www.pmda.go.jp (limited information available in English).

None of the fixes we have applied to the 9.2.3 release affect the user workflow or the application's functionality. No new features have been added and the upgrade does not affect users working with JADER Signal Management for use with Oracle Empirica Signal.