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All Patient Historical Drugs Do Not Populate In PMDA E2B R2 Paper Form-2 (Doc ID 2742537.1)

Last updated on JANUARY 08, 2021

Applies to:

Oracle Argus Safety Japan - Version 8.2.1 to 8.2.1 [Release 8.2]
Information in this document applies to any platform.



When Patient drug indication (MedDRA term for B.1.8f.2 PATIENTDRUGINDICATION) term has 11 characters or multiple of 11 characters in length,

all the patient history information does not populate in PMDA E2B (R2) Paper form-2 "Relevant drug-using history in the past (関連する過去の医薬品使用歴)" section.

Steps to replicate the issue:

1. Create a new case which has the Japan license

2. Go to patient tab

3. In "Other Relevant History" section, add a record with condition type as Historical drugs and enter Drug name and Indication. The Japanese indication name has 11 characters (or multiple of 11 characters) in length.

For example: Add 2 Historical Drugs records

#1: Condition Type (Historical Drug) / Drug Name (A) / Indication (Drain site complication/ドレーン留置部位合併症)
#2: Condition Type (Historical Drug) / Drug Name (B) / Indication (Serum procollagen type III N-terminal propeptide decreased/血清3型プロコラーゲン-N-プロペプチド減少)

       Japanese Indication "ドレーン留置部位合併症" has 11 characters and "血清3型プロコラーゲン-N-プロペプチド減少" has 22 characters.


4. Enter the mandatory value for PMDA E2B (R2)

5. Save the case

6. Schedule PMDA E2B (R2) against Japan license

7. Click the DRAFT link and view the report

8. In E2B viewer, change the view format to Paper Report form-1/2

9. Review the form-2 "Relevant drug-using history in the past (関連する過去の医薬品使用歴)" section.


At step3, two Historical Drugs records set in this case. However, only one information is displayed.


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