All Events Do Not Display In PMDA E2B (R3) Paper Form-2 Page 4 (Doc ID 2783417.1)

Last updated on JULY 13, 2023

Applies to:

Symptoms

There is the section for the "evaluation information(評価に関する情報)" in PMDA E2B R3 Paper report form-2 page(4) and all the case events are supposed to populate in the "event name (評価対象となる副作用/有害事象名)" column which is G.k.9.i.1.

However, only one event appears in this column if the case has several events and each event are coded with the same LLT/PT but it has the different "Description as Reported" value.

Steps to replicate:

1. Open the case which has the Japan license
2. Go to event tab
3. Add a new event e.g., Rash) and enter the value (e.g., Rash 001) in "Description as Reported"
4. Click the new event tab
5. Set the new event (e.g., Rash) and enter the value(e.g., Rash 002) in "Description as Reported"
6. Enter the mandatory value for PMDA E2B
7. Save the case

8. Go to the regulatory report tab
9. Schedule PMDA E2B (R3)
10. Save the case

11. Click the draft link
12. In E2B viewer, change the view format to XML/Decode
13. Confirm that reaction section to see if both events are populated with the value of E.i.1.1a <primarysrcreactinnativelang> and E.i.2.1b
<reactionmeddrallt>

14. Change the view format to Paper report
15. Review the form-2 page#4

In the "evaluation information(評価に関する情報)" section, only one of the events is populated.

Note:

The problem is the output of this G.k.9.i.1 "evaluation information(評価に関する情報)" column only.
The other event information such as source/method/outcome of causality for each event are populated properly.

Changes

Cause

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