2 Aggregate Reporting Data Model

The following global temporary tables support the Oracle Analytics Publisher aggregate reporting framework:

• Case Temp

  The case temp table contains one row for each unique case ID from all code lists. The system derives data in the same way for all cases. Different flags in the case temp table help to identify the cases that are included in each section or subsection of the various periodic reports.

• Product Temp

  The product temp table includes one row for each product configured in the report configuration:

  • The system adds a row to the product temp table for each suspect drug configured in the report configuration (spontaneous or non-company cases).
  • For Clinical cases, the system adds all study drugs that are part of the case into the product temp table.
  • Different flags are available in this table to identify a product as medicinal product, blinded, placebo, or comparator.

• Event Temp

  This table contains a row for each event term included in the report. The system uses standard report parameters to remove non-reportable events and symptoms and removes duplicate terms. For example, if the case contains two LLTs for the same PT and you run the report for PT reporting, the system writes only one row to the events temp table. Unless otherwise specified, data for the lower display number term is used in the temp table.

• Event to Drug Temp

  This is an intersect table between events and drugs. It contains the causality and unexpectedness at event to drug level. This table contains all assessment information based on event and product.

Refer to the Oracle Argus Safety Flexible Reporting Extensibility Guide for the Aggregate Reporting Data Model.