Data Mining Runs for SOC and HLT Scores

Oracle Empirica Signal performs the following data mining runs to compute disproportionality scores at the SOC and HLT levels of the MedDRA event hierarchy for All reports and for US reports. Signal executes these runs on the Data configuration for 2D runs from the signal configuration, and names them in accordance with that Data configuration.

The run names are:

• All reports, SOC
• All reports, HLT
• US reports, SOC
• US reports, HLT

The runs use the Drug variable from the signal configuration as one of the item variables. Also, the runs are stratified using the Stratification variables from the signal configuration.

• All reports, SOC
  This data mining run computes disproportionality scores at the SOC level of the MedDRA hierarchy using all reports in AERS.
• All reports, HLT
  This data mining run computes disproportionality scores at the HLT level of the MedDRA hierarchy using all reports in AERS.
• US reports, SOC
  This SOC-level run is restricted to US reports only.
• US reports, HLT
  This HLT-level run is restricted to US reports only.