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

Groupings

Main and Cumulative DSUR Tabulations are grouped in the following order:

  1. Initial or Follow-up

  2. Study ID

  3. SOC

Fatal or Death Cases and Fatal Cumulative DSUR Tabulations are grouped in the following order:

  1. Initial or Follow-up

  2. Study ID

  3. SOC

Parent topic: Summary Tabulations of Serious Adverse Events