1. PMDA JADER Signal Management Release Notes
  2. Standard data mining runs
  3. Data mining runs produce disproportionality scores

Data mining runs produce disproportionality scores

JADER signal management information is based on nine data mining runs monthly refreshed to produce the disproportionality scores for drug-event terms.

What you need to know about JADER signal management data mining runs

Oracle Empirica Signal performs the nine data mining runs to calculate disproportionality scores for product-event terms for various subpopulations.

JADER signal management information refreshes quarterly the drug-event terms calculated in the disproportionality scores and include the following runs:

  • One run computed using all reports in JADER.
  • A second run computed on all reports in JADER but is not subsetted and includes RGPS.
  • A third run restricted to Spontaneous-only reports. Additionally, there are six data mining runs that correspond to the following areas of interest: adult, elderly, fatal, female, male, and pediatric.
  • Six additional runs corresponding to the following areas of interest: adult, 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
    Oracle Empirica Signal executes this data mining run using all reports in JADER.
  • JADER Spontaneous only
    This data mining run is restricted to spontaneous-only reports in JADER.
  • JADER Adult only
    This data mining run is restricted to adult reports only.
  • JADER Elderly only
    This data mining run is restricted to elderly reports in JADER.
  • JADER Fatal only
    This data mining run is restricted to reports with a fatal outcome in JADER.
  • JADER Female only
    This data mining run is restricted to female reports in JADER.
  • JADER Male only
    This data mining run is restricted to male reports in JADER.
  • JADER Pediatric only
    This data mining run is restricted to pediatric reports in JADER.

Parent topic: Standard data mining runs