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