Event information—field descriptions

Field or Control Name	Description
Relationships	Click the Relationships button to view the Diagnosis-Event Relationships dialog box. This allows you to group symptoms and signs with diagnoses. This requires at least two events and a diagnosis.
Description as Reported	Enter the verbatim term used by the reporter, or patient, to describe the adverse event. As you type, the term is copied under Description to be Coded. Verbatim English translations of foreign languages may also be entered here.
Term Highlighted by Reporter	Indicate whether the primary source reporting the event considered it a major concern. If the information was not explicitly provided, the term is not considered a highlighted term. The seriousness of the reaction/event must be based on the ICH E2A criteria. Selecting Yes does not mark this case as Serious.
Description to be Coded	You can modify the verbatim term in this field. For the example: The original term can be split, or enhanced with an anatomical location. Contact your system administrator to prevent manual encoding of the description. If automatic encoding is enabled, the term can be auto-encoded to the included term level.
Onset Date/Time	Enter the date/time when the event started. Enter a partial date if the full date is not available.
Onset from Last Dose	This field is calculated from the event onset date and most recent stop date listed in the dosage regimen details of the suspect drug(s). You can also enter or modify the field manually. This field is removed if the dosage regimen is ongoing.
Duration	This field is calculated from the event start and stop dates. You can also enter or modify the duration manually.
Onset Latency	This field is calculated from the earliest first dose date of the suspect drug(s) to onset date. You can also enter or modify the duration manually. Onset Latency = Onset Date - First Dose.
Receipt Date	Enter the date on which information about this event was received by your company. In Flexible Aggregate Reporting, this field is used to filter the events that fall out of the reporting period.
Patient Has Prior History?	Indicate whether the patient has had a prior history or has suffered from the same event in the past.
Intensity	Select the category of severity of the event. Contact your system administrator to adjust this list.
Frequency	Select the frequency of the event from the list. Contact your system administrator to adjust this list.
Outcome of Event	Select the outcome of the event. Contact your system administrator to adjust this list. If Fatal is selected, Death is selected in the list of seriousness criteria. If the Death checkbox is subsequently cleared, the outcome still remains fatal.