Missing some event info in PMDA (INV) Paper report if long event name exists

(Doc ID 2411511.1)

Last updated on JUNE 14, 2018

Applies to:

Oracle Argus Safety Japan - Version 7.0.5 and later
Information in this document applies to any platform.

Symptoms

If the case has several event name and one of the event name has a long name,
some event information such as event assessment information does not populate in PMDA (INV) paper report form-2 page(4).

 

Steps to replicate the issue:

1. Create a case
2. Book-in
3. Go to analysis > PMDA info tab. Confirm that Japan INV license has been displayed.
4. Set the reporting category (I) or (K)
5. Go to the event tab
6. Add the long event name (eg, Aspartate aminotransferase increased)
7. Add one more event name
8. In the event assessment tab, set the causality and listedness


9. Enter the mandatory value for PMDA E2B (R2)
10. Save the case

11. Go to the regulatory report tab
12. Schedule PMDA (INV) paper report or PMDA E2B to the Japan INV license
13. Click draft link
14. Check the output

Some event information (event name/causality/listedness) does not populate in form-2 page(4).

For example:

This is the output of report with reporting category(I).
If long event name exists, the event name displays in two rows.
Due to this, no record for the event assessment of event “Rash” (source: 報告企業) exists.

 

 

This is the output of report with reporting category(K).
If long event name exists, the event name displays in two rows.
Due to this, no record for the event assessment of event “Chills” (source: 報告企業 and 第一情報源) exists.

 

 

Cause

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