1. Oracle Analytics Publisher Aggregate Reporting User's Guide
  2. Periodic Benefit Risk Assessment Report
  3. PBRER Section 6.2 - Cumulative Summary Tabulations of Serious Adverse Events from Clinical Trials
  4. Generate the Case Series for Section 6.2

Generate the Case Series for Section 6.2

To generate the case series for Section 6.2, the system:

  1. Identify study cases and serious study cases for the studies that the configured products belong to.
  2. Identify whether a case is serious or not, based on the case level seriousness, primary event seriousness, or a combination of both, as configured in the Oracle Argus Safety Console configuration.

    Seriousness is configured using System Management (Common Profile Switches) > Reporting > Periodic > Case Inclusion criteria for the ICH PSUR or CTPR report based on Seriousness).

  3. Exclude the following cases from the Section 6.2 case series:
    • Cases whose value matches the non-interventional rules (if any) configured in Section 6.3, if Include Section 6.3 is selected.
    • Cases from non-interventional studies (where REPTYPECODE =M in flexible report type code list) selected in the main inclusion criteria.

For each case in the Section 6.2 case series identified, the system prints summary tabulation counts broken down by both System Organ Class (SOC) in the internationally agreed order, followed by preferred terms (PTs) in rows, sorted alphabetically. This is based on the following logic and marked clearly in the temporary tables based on the identified product type:

Parent topic: PBRER Section 6.2 - Cumulative Summary Tabulations of Serious Adverse Events from Clinical Trials