1. BIP 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. Generate the Case Series for Section 6.2
  5. Non-Company or Non-Configured Study Cases

Non-Company or Non-Configured Study Cases

If the case being evaluated is a non-company or non-configured study case, the system prints the suspect products with the product type as Investigational Medicinal Product and follows the rules of Investigational Medical Product and Blinded.

  • The report prints the count for medicinal products in the first column in the report, followed by the Blinded, Active Comparator, and Placebo columns.

  • The report does not suppress the Blinded, Active Comparator, and Placebo columns when there are 0 counts against them. It prints the event count as 0 in each column as long as at least one of the four columns has an event count greater than 0. When PBRER is generated for a product that is a comparator in some studies, and no case qualifies for the report in which that product is a medicinal study drug, the system prints the medical product column with 0 event counts.

  • If the event count is 0 in the Medicinal Product, Blinded, Active Comparator and Placebo columns for a given SOC, the system does not print that SOC in the report.

Parent topic: Generate the Case Series for Section 6.2