Add PBRER Section 6.2 - Cumulative Summary Tabulations of SAEs from clinical trials

Field	Description
Include Section 6.2	Check this checkbox to include Section 6.2. By default, this is unchecked.
Cumulative Start Date	Enter the cumulative start date in this field. This field specifies the Start Date of the Cumulative date range. If not specified, the start date is picked from the date specified in the Inclusion Criteria. If specified, the application ensures that the date entered is a valid date, and is before the Start Date specified in the Inclusion Criteria.
Identify Study Cases using Report Type	Allows you to select the study cases that use report type from the multi-select list box. The values that are populated here, come from the Report Type codelist where the values display the This type includes cases from clinical trials as checked.
Group by Comparator	If the Product Type attribute is present in the Study Configuration for the Product being evaluated, this option is displayed. By default, this is unchecked. If this checkbox is selected, it displays sub columns based on Active Comparator names if Group by Comparator is selected. If Group by Comparator is not selected, the count is displayed under the name of the respective active comparator.

PBRER 6.2 Output for the non-company or non-configured study cases is fetched based on the following:

• When the case being evaluated is a non-company or non-configured study case, the suspect company products are printed with the product type as Medicinal Product.

  The name of the medicinal product(s) is printed along with the counts:

  • If the case and the study are not blinded, and the product type is identified as Investigational Product.

  • If the case is unblinded (but the study is blinded), and the user has privilege to view the unblinded data.

  • If the study is blinded but the case is unblinded, and you do not have privilege to view the unblinded data, the count is printed under Blinded.

• Counts for Active Comparator and Placebo are not expected for a non-company study cases as the comparator or placebo information cannot be determined for the non-company studies.Non-company study cases that do not have any company suspect products are not included in the case series and cumulative tabulations.

• If counts for Blinded, Active Compactor and Placebo are Zero, these columns are still displayed in the report with zero counts as the value.

• The report also prints SOCs with zero counts if there are no events reported.