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E2B Tag <drugrecuraction> Populates the Company Verbatim, Not the LLT. (Doc ID 458188.1)

Last updated on FEBRUARY 03, 2019

Applies to:

Adverse Event Reporting System - Version:
This problem can occur on any platform.


When setting the 'Reappeared' flag to 'Y' under Events--> Event-to-Product Assessment within a case, the E2B report is populating the tag <drugrecuraction> with the company verbatim and the EMEA (European regulatory agency) is expecting the LLT

The E2B fields for the event should include the LLT for the reappearing event

-- Steps To Reproduce:
The issue can be reproduced at will with the following steps:
1. Log into AERS.
2. Open a Case--> Events--> Event-to-Product Assessment, check the 'Reappeared' flag
3. Run/Monitor Reports--> Run an E2B Report

-- Business Impact:
The issue has the following business impact:
Due to this issue, the European regulatory agency, EMEA, is rejecting cases sent to them.

The case is rejected due to the following:

SECTION drugrecuraction: .... is not a valid MedDRA code”


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