Events tab—field descriptions

Field	Calculation
Total Dosage	The sum of all Total Regimen Dosages.
First Dose to Onset	The system calculates this value based on the First Dose Stop date and the event onset date if present. If any regimen start date is null, the system sets the First Dose to Onset to null. The system uses only complete date entries for the regimen start and stop date/time fields to calculate First Dose to Onset. The user can overwrite this field.
Last Dose to Onset	The system calculates this value based on the last dose stop date and the event onset date if present. If the regimen start date is null, the system sets the Last Dose to Onset is to null. The system uses only complete date entries for regimen start and stop date/time fields to calculate the Last Dose to Onset. The user can overwrite this field.

• You can change the listedness for a drug at the individual level.
• The field labels for the Event Assessment tab can be updated and configured on the Argus Console.
• If the Death Seriousness criteria on the Event tab are unchecked, the event outcome reverts to empty and is not set to fatal.
• The MedDRA LLT term selection behavior across the Case Form is based on the profile switch value configured in the Allow User to Add Non-Current MedDRA Terms for and On change of LLT Term Sync English and Japan LLTs, irrespective of the currency.
• The system populates the To be coded value on the MedDRA pop-up window when you check the green checkbox for the MedDRA hierarchy. This applies to the areas where the MedDRA dialog box appears.

• The Event to Exclude from Report field enables you to identify information to not include in a PMDA Expedited report.

  • When this checkbox is checked, enter a justification for this action in the Reason to Exclude from the Report dialog box.

    The system places a symbol to the right of the field.

  • The system does not retrieve events that are excluded from a report as part of CSPSR (Clinical Study Periodic Safety Report) unless it has been configured to include them.

When you click the Recalculate button, the system does not recalculate listedness where the Event Assessment Listedness already has a case justification (generated automatically or manually overwritten).