1. BIP Aggregate Reporting User's Guide
  2. Periodic Benefit Risk Assessment Report
  3. PBRER Section 6.3 - Cumulative and Interval Summary Tabulations from Post-Marketing Data Sources

PBRER Section 6.3 - Cumulative and Interval Summary Tabulations from Post-Marketing Data Sources

Section 6.3 is a background for the appendix that provides cumulative and interval summary tabulations of adverse reactions—from the IBD to the data lock point of the current PBRER.

These adverse reactions are derived from non-interventional studies and spontaneous ICSRs, including reports from healthcare professionals, consumers, scientific literature, and regulatory authorities. Serious and non-serious reactions are presented in a single table, with interval and cumulative data presented side-by-side.

For more information, see:

Parent topic: Periodic Benefit Risk Assessment Report