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. Grand Totals

Grand Totals

The system provides the totals and grand totals in out-of-the-box PBRER tabulations as follows:

  • Subtotal per System Organ Class (SOC) per study medication category (IMP, Blinded, Active Comparator, Placebo, No Study Drug Given).

  • Grand total for all SOCs per study medication category (IMP, Blinded, Active Comparator, Placebo, No Study Drug Given).

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