1. BIP Aggregate Reporting User's Guide
  2. Development Safety Update Report
  3. Summary Tabulations of Serious Adverse Events
  4. Totals

Totals

The system provides the following totals and subtotals for each tabulation:

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

  • Row-level totals for Total event counts for a preferred term including investigational, blinded, comparator, placebo and No Study Drug Given (Total).

Parent topic: Summary Tabulations of Serious Adverse Events