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.