Seven cumulative subset data mining runs are performed to determine new and significantly changed reports relative to prior time periods.

Data mining runs for new or changed cases consist of the following:

• One run computing new counts for all reports in JADER.
• A second new run restricted to Spontaneous-only reports.
• Five additional new runs corresponding to the following areas of interest: elderly, fatal, female, male, and pediatric.

For all of the runs described in this section, the events are at the preferred term or narrow-algorithmic SMQ level of the MedDRA hierarchy.

• JADER All new
  This data mining run computes all new or changed counts for all reports in JADER Signal Management.
• JADER New Spontaneous
  This data mining run computes all new or changed counts for reports from the Spontaneous.
• JADER New Elderly
  This data mining run computes all new or changed counts for elderly reports.
• JADER New Fatal
  This data mining run computes all new or changed counts for reports with a fatal outcome.
• JADER New Female
  This data mining run computes all new or changed counts for female reports.
• JADER New Male
  This data mining run computes all new or changed counts for male reports.
• JADER New Pediatric
  This data mining run computes all new or changed counts for pediatric reports..