Standard Vigibase subpopulations

The Signal Management feature of Oracle Empirica Signal reports the results of statistical analysis of all records in the Vigibase database. It also reports the results of statistical analysis performed only on reports with certain shared characteristics; for example, reports involving elderly individuals only, or reports with a fatal outcome only.

To identify different subpopulations and types of cases in the Vigibase database, a set of standard queries is supplied and then used as database restrictions in data mining runs.

The standard subpopulations or types of cases used for Signal Management are:

Population Default Query

Adult

AgeGroup4 equals '18_64'

Elderly

AgeGroup4 equals '65_above'

Fatal

Selection logic: 1 union 2

  1. Seriousness equals 'Death'
  2. Reaction Outcome equals any of the following values: 'Fatal,' 'Died- reaction may be contributory,' 'Died- unrelated to reaction'

Female

Gender equals 'F'

Male

Gender equals 'M'

Pediatric

AgeGroup4 equals '00_17'

Serious

Seriousness equals 'Y'