Main Line Listing

Table 6-2 Main Line Listing Fields

Field Name	Description
Unique Patient ID	Unique patient identifier based on the format selected by the user while running the report. This value depends upon the UNIQUE_PATIENT_ID_FORMAT parameter.
Case Number	Case Number is printed. If the Oracle Business Intelligence Publisher report parameter Indicate if case was expedited previously is Y, the symbol specified in the Oracle Business Intelligence Publisher parameter Symbol for expedited cases appears with the case number as a superscript. A footnote appears at the end of the page as follows: <symbol>: Expedited Case. Refer to the temp table sheet for the logic of Expedited case. If the Oracle Business Intelligence Publisher report parameter Indicate if case was expedited previously is Y, the footnote for Expedited Cases appears even though there may not be any cases marked as Expedited.
Report Type	Reporter type is displayed from the flex bucketing code list field REPTYEPGRP for the report type entered in the case.
Sex and Age	PATIENTSEXTEXT is populated using global language decode of PATIENTSEXCODE field. If Patient Age is missing, Patient age group appears. If Patient Age or Age group is not entered, text entered for the Oracle Business Intelligence Publisher parameter Default for NULL Values appears.
Concomitant Disease and Relevant History	Concatenation of the patient relevant medical history in a table format.
Case Outcome	Case level outcome.
Case Onset Date	Case level event onset date.
Seriousness Criteria	Seriousness Criteria for primary events appears.
Other Medication	List of all suspect drugs and concomitant drugs in the case except the drug for which the report is being run.
Study Product	The logic provided in summary tabulations is used to populate this field.
First or Last Dose to Onset	Duration from the first or last dose until the first onset of the adverse event. It is calculated at the case level using all doses for all drugs in the drug list and the case level onset date.
Action Taken	Action taken appears with the respective company suspect drug. If action taken is not specified in the case, then <> appears.
Indication	Concatenation of reported indications for a product in the case. The report displays a list of indications for products that are configured for current periodic run.
Start and Stop Dates of Reaction	Date of Onset (only from Primary Serious event). Time of Onset (only from Primary Serious event).
Event Outcome	Event outcome for each event present in the case.
Event Reported or Determined Causality	Causality as per reporter and company is printed with the corresponding Product and Events in the format: <Causality as per reporter> or <Causality as per company>.
Event Listedness	Listedness information for the event appears. Listedness appears based on the Oracle Business Intelligence Publisher Report parameter Labeling Algorithm if the report is executed from Oracle Business Intelligence Publisher. If this report is executed from Oracle Argus Safety, the following report parameters are considered: · Use Assessment in Cases. · Re-assess cases against datasheet in effect at beginning. · Re-assess cases against datasheet in effect at end.
Reaction as Reported (PREFERRED TERM)	Reaction as Reported (PT) with diagnosis or signs and symptoms, and company added term behavior.
Dose String	Default format is DoFoRt - Print Dose, Formulation, and Route of administration.
Dates of Treatment	-
Treatment Duration	-
Line listing Comments	-

In DSUR line listings:

• The system displays all Serious and Unexpected Adverse Reactions (SUSAR) events with an asterisk *. The SUSAR event term (PT or LLT) appears with an asterisk to the right of the term. For example, SEPTIMCEMIA*.

• The system displays all special interest events with a superscript †. For example, OEDEMA†.

You configure the list of special interest events for a report using the Oracle Argus Safety CTPR configuration screen.

• The system displays primary events in bold and underlines them.