My Oracle Support Banner

PMDA E2B G.K.9.I DRUGEVENTMATRIX APPEARS FOR NON-SUSPECT DRUG (Doc ID 2641234.1)

Last updated on FEBRUARY 24, 2020

Applies to:

Oracle Argus Safety Japan - Version 8.1.2 and later
Information in this document applies to any platform.

Symptoms

Issue
--------------
The case has a suspect company product with Japan license in the case form > product tab.
This company product/license in the product tab has been changed to non-suspect drug.
For example,
   - Changed the drug type to concomitant from suspect
   - Changed to concomitant WHO-Drug

From this case, view the PMDA E2B (R3) .

The G.k.9.i DRUGEVENTMATRIX section with the value of <eventuniversallyuniqueid> populates to this non-suspect drug.


Note that this section appears depends on the number of Japan license for the previous suspect product.
For example, if the previous product in the product tab has 3 Japan licenses, G.k.9.i section tag appears in 3 rows.

 

Steps to replicate
--------------
1. Open the case

2. Go to the case form > product tab
3. Confirm that this case has a suspect products/licenses

4. Go to analysis > PMDA info tab
5. Confirm that Japan license populates to the suspect company product/license you confirmed at step2

6. Go to product tab
7. Change the drug type from suspect to concomitant. Otherwise, change the product to WHO-DRUG as concomitant.
8. Save the case

9. Go to the regulatory report tab
10. Schedule PMDA E2B (R3)
11. View the report

The following dummy tag is populated for the non-suspect product that changed at step7

<drugeventmatrix>
    <eventuniversallyuniqueid>96c5e1c4-455c-74e5-e053-4b09160a9162</eventuniversallyuniqueid>
</drugeventmatrix>

 

 

Changes

 

Cause

To view full details, sign in with your My Oracle Support account.

Don't have a My Oracle Support account? Click to get started!


In this Document
Symptoms
Changes
Cause
Solution
References

My Oracle Support provides customers with access to over a million knowledge articles and a vibrant support community of peers and Oracle experts.