Data Mining Runs for New or Changed Cases

The cumulative subset data mining runs identify new and significantly changed reports relative to prior time periods. Oracle Empirica Signal executes these runs on the Data configuration for 2D runs from the signal configuration, and names the runs in accordance with that Data configuration.

The run names are:

• All New
• New Elderly
• New Fatal
• New Female
• New Male
• New Pediatric
• New Serious
• New US

The runs use the Drug and Event variables for the 2D runs from the signal configuration as item variables.

The runs are stratified using the Stratification variables from the signal configuration.

In the descriptions that follow, the values shown in angle brackets (<>) represent values from the AERS signal configuration.

• All New
  This run computes new or changed counts for all reports in AERS.
• New Elderly
  This run computes new or changed counts for elderly reports only.
• New Fatal
  This run computes new or changed counts for reports with a fatal outcome only.
• New Female
  This run computes new or changed counts for female reports only.
• New Pediatric
  This run computes new or changed counts for pediatric reports only.
• New Serious
  This run computes new or changed counts for serious reports only.
• New US
  This run computes new or changed counts for reports from US sources only.