5 Periodic Benefit Risk Assessment Report

In this chapter:

• Report Objective
  
• Configure Oracle Argus Safety for PBRER
  
• PBRER Section 6.2 - Cumulative Summary Tabulations of Serious Adverse Events from Clinical Trials
  
• PBRER Section 6.3 - Cumulative and Interval Summary Tabulations from Post-Marketing Data Sources
  
• Sample Report
  
• Execute the PBRER from Oracle Analytics Publisher