Event assessment tab—user actions

User Action	Result
Click Datasheet column's + icon	The system does the following: Datasheet revision name and number, along with the activation date that was used for listedness determination is displayed against the licenses. On the License column, all licenses that are associated with the datasheet are displayed. Labelling information that corresponds to the Product licenses is displayed. The License column also displays an icon. You can click the icon to hide individual product licenses, datasheet revisions and labelling information and only the overall listedness for the datasheet is displayed.
Click Product Name link	You can navigate to Case Form > Products > selected Product.
Click Event Description link	You can navigate to Case Form > Events > selected Event.
Click Datasheet Description link	Displays the activation date, revision name, revision number of the latest datasheet revision on which the listedness assessment was made. Click Export to get a listing of all labeled terms in an Excel file.
Click Datasheet revision number/name link	Displays the activation date, revision name, revision number of the latest datasheet revision on which the listedness assessment was made. Click Export to get a listing of all labeled terms in an Excel file.

Event assessment—field descriptions

Field or Control Name	Description
Recalculate	Refreshes the Event Assessment section with the newly entered data if new suspect products or events are entered, or the Event Relationship is modified.
Product	Populated when events are entered in the Products tab and appears as: First Line - Product Name Second Line - Generic Name
Causality as Reported/Source/ Method/ Result	Provides the source of causality as reported such as Investigator, Healthcare Professional, and so on. Provides the method used for causality determination. Provides the result of the causality assessment.
Causality as Determined/Source/ Method/ Result	Provides the source of causality as determined such as Sponsor, MAH, and so on. Provides the method used for causality determination. Provides the result of the causality assessment.
Other Causality /Source/ Method/ Result	Provides the source of causality from any additional source such as NCA. Provides the method used for causality determination. Provides the result of the causality assessment. Note: The previous three causality fields can be set up for: Company suspect products in all cases. Suspect non-company products in study and non-study cases.
Event	Populated when events are encoded and appears as: First Line - Event PT (Verbatim) Second Line - LLT
D/S	Displays the Diagnosis/Symptom details by D or S.
Seriousness Severity Duration	Displays the seriousness, severity, and the duration of the event.
Listedness	Indicates whether the system found the event on the datasheet for this product. This field is enabled for company products and non-company study drugs.