Line Listing Columns

Table 7-2 Main Line Listing Columns

Column Name	Field Description
Case Number	If the Oracle Analytics Publisher report parameter Indicate if case was expedited previously is Y, the symbol specified in the Oracle Analytics Publisher parameter Symbol for Expedited cases appears as a superscript. A footnote appears at the end of the page as: <symbol>: Expedited Case. If the Oracle Analytics 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.
Country	Country of Occurrence.
Report Type	Report type is displayed from the flex bucketing codelist field RPTTYEPGRP for the report type entered in the case.
Unique PatientID	Unique Patient ID as per the Oracle Analytics Publisher report configuration parameter UNIQUE_PATIENT_ID_FORMAT, which has the following options: Pt - Patient ID CePt - Center ID, Patient ID InPt - Investigator Name, Patient ID StCeInPt - Study ID, Center ID, Investigator Name, Patient ID StCePt - Study ID, Center ID, Patient ID StCnCeInPt - Study ID, Country name, Center ID, Investigator Name, Patient ID StCnCePt - Study ID, Country name, Center ID, Patient ID StCoCeInPt - Study ID, Country ISO Code, Center ID, Investigator Name, Patient ID StCoCePt - Study ID, Country ISO code, Center ID, Patient ID StInPt - Study ID, Investigator Name, Patient ID
Sex	Patient Sex. PATIENTSEXTEXT is populated using the decode context GL of the PATIENTSEXCODE field.
Age	Patient Age; if this data is missing, the Patient age group is printed.
Company Suspect Products	Company suspect products that match the Product specified in the Report configuration. If the Oracle Analytics Publisher report parameter Print Unblinded Data is Y, the system prints the Unblinded Study Product. If the Oracle Analytics Publisher report parameter Print Unblinded Data is N, the system prints the Blinded Study name instead of the actual study product.
Strength	Strength and Strength units.
Dosing Regime	If the Report parameter Print Dose Text in place of Regimen Dose is checked, then Regimen Dose data is printed. Otherwise, Daily dose and Route data are printed with the respective company suspect drug based on the Oracle Analytics Publisher report parameter Dosage String Format with the options: Do - Print Dose Only. DoFo - Print Dose, and Formulation. DoFoFr - Print Dose, Formulation, and Frequency. DoFoFrRt - Print Dose, Formulation, Frequency, and Route of administration. DoFoFrRt - Print Dose, Formulation, Frequency, and Route of administration. DoFoRt - Print Dose, Formulation, and Route of administration. DoFr - Print Dose, and Frequency. DoRt - Print Dose, and Route of administration. Multiple components are separated by semicolons. If a suspect drug has multiple dosage regimens, the dosage information for each record is printed in a separate line.
Action Taken	Action taken is printed for the company suspect drug.
Treatment Date	Dates of the First and Last dose are printed in DD-MON-YYYY format.
Treatment Duration	Dosage duration is printed with units. If duration is not available, the text entered for the Oracle Analytics Publisher parameter Default for NULL Values is printed.
Event Start and Stop Date	Event Onset and Stop dates are printed for the corresponding Reactions in the DD-MON-YYYY format.
First Dose to Onset	Onset Latency data is printed for the corresponding suspect product and events.
Outcome	Event Outcome is printed for the corresponding events. If Event Outcome is not entered, nothing is printed.
Event as Reported (Preferred term)	Description as Reported and LLT or PT of Event is printed in the format: <Desc. As reported> (<LLT or PT>). If Description as Reported is not entered, LLT or PT is printed with brackets. LLT or PT are based on the Oracle Analytics Publisher report parameter Print LLT instead of PT. If the Oracle Analytics Publisher Report Parameter Print only the Term (LLT or PT) is Y, only the LLT or PT is displayed. Description as reported is not printed. The system prints the Diagnosis if the Oracle Analytics Publisher report parameter Use Only Diagnosis Events is Y. If this parameter is N, the Diagnosis and Symptoms are printed. The system prints diagnosis and symptoms separately and marks them clearly using symbols provided in the Oracle Analytics Publisher parameter Symbol for Diagnosis Symptoms, if the Oracle Analytics Publisher report parameter Print Diagnosis Symptoms Separately is Y. If this parameter is N, then they are printed without any identification symbol. For Unlisted events, the system prints the text specified in the Oracle Analytics Publisher parameter Symbol for Unlisted Events. For SUSAR events, the system prints the text specified in the Oracle Analytics Publisher parameter Symbol for SUSAR Events. For events marked as Special Interest Events in the Report parameter, the system prints the text specified in the Oracle Analytics Publisher parameter Symbol for Special Interest Events.
Causality Rpt/Cmp	Causality as per reporter and Company are printed for the corresponding Product and Events in the format: <Causality as per reporter> / <Causality as per company>.
Seriousness	Event seriousness is printed against each event. Serious, Non-Serious, and Seriousness not determined are printed based on the data in CASE_EVENT.SERIOUSNESS.
Listedness	Listedness information of the event. Listedness is printed based on the Oracle Analytics Publisher Report parameter Labeling Algorithm if the PMAR is executed from Oracle Analytics Publisher. If the PMAR 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.
Line listing Comments	Text from the Company comment fields.
Other Medications	Other Medication(s): <List of Concomitant Products and Treatment Products separated by comma>
Death date and cause of death (Verified? Y/N):	Patient Death date and Cause of death are printed in the following format only for Death cases: Death date and cause of death (Verified? Y/N): DD-MON-YYYY <Cause of death > (<Y/N>) For example, Death date and cause of death (Verified? Y/N): 01-JAN-2014 cholera (Y). If cause of death is populated from autopsy results, then cause of death verified is Y; otherwise it is N.