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The local unexpectedness value does not output for the blind product in DSUR line listing (Doc ID 1526954.1)

Last updated on MAY 07, 2014

Applies to:

Adverse Event Reporting System - Version 4.6.1 and later
Information in this document applies to any platform.

Symptoms

When printed the DSUR with report parameter: "Rule name to determine event-level labeledness" = LOCAL_UNLABELED,

the local unexpectedness value does not output for the blind product in the Event Expectedness column.


Steps to reproduce:
-----------------------
1. Navigate to AERS Global Maintenance > Products > Select the product / modifier (eg., XUMALITE / CAPSULE)
2. On Approvals tab, confirm the configurations (Country, License Type and License Number)
(eg., Agency: USA, License Type: BLA, License Number: VAC123)

3. Open the Case > Products tab
4. Set the product and modifier (eg., XUMALITE / CAPSULE)
5. Checked the "Blinded" flag
6. Open the Events tab
7. On Event-to-Product Assessment tab, confirm the value is set for the Unlistedness
8. Navigate to (menu) Case Info > Local Unexpectedness
9. Confirmed that the records that you confirmed in step2 are displayed
(eg., Agency: USA, License Type: BLA, License Number: VAC123)
10. Set the value in Unexpectedness Override (eg., Y )  ---> Local Unexpectedness= Yes (UnExepected)


11. Open the Submissions tab
12. Confirmed that the records that you confirmed in step2 are scheduled.
(eg., Agency: USA, License Type: BLA, License Number: VAC123)
13. Save the configuration.


14. Run the DSUR (draft) with the following parameters
- Agency/Country (use * to update all)  : (eg., USA)
- License type? : (eg., BLA)
- License Number : (eg., VAC123)
- Rule name to determine event-level labeledness = LOCAL_UNLABELED ---> Use the "Local Unexpectedness"

15. Confirm the report  > DSUR Main Line Listing page

The value "Expected" was displayed in the "Event Expectedness" field even though the Local Unexpectedness= Yes(UnExepected) for the blinded product.



Cause

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