Grouping

Table 6-1 Grouping Information

Field Name Description

Initial or Follow-up.

Cases are listed under Initial or Follow-up based on the classification in the temp table.

Initial case listing is printed followed by Follow-up cases.

Case Expectedness (Listed or Unlisted)

Case is grouped based on Listed or Unlisted cases.

Unlisted case listing is printed followed by Listed cases.

Project Drug (Primary Study Drug)

Cases are grouped based on the primary study drug.

Study ID

After Project Drug, line listing cases are grouped based on the study ID.

EudRactID

Line listing is grouped by EudRactID, if available. The EudRact number is the unique identifier for trials authorized in the European Economic Area.

Grouping based on SOC (as per event order specified in the case form event tab)

Cases are grouped by the SOC of the Primary Event. SOC group header is displayed in the internationally agreed order as specified in the code list SOC_DISPLAY_ORDER.

If the Oracle Business Intelligence Publisher Report parameter List cases in the line listing under SOC for each diagnosis is Y and List Cases under all events, details under the primary event is selected, cases can appear under multiple SOCs.

If the Oracle Business Intelligence Publisher Report parameter List cases in the line listing under SOC for each diagnosis is N and List Cases only once, under the primary event is selected, a case appears under the SOC of the Primary event, and a reference to this information appears under the SOCs of other events.

Country of Incidence

The last level of grouping is based on country of incidence.