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Negative ACK (Acknowledgement) Received From PMDA and EMA For DTD Elements G.k.9.i.2, G.k.9.i.3 And G.k.9.i.4 (Doc ID 2729854.1)

Last updated on NOVEMBER 30, 2020

Applies to:

Oracle Argus Interchange - Version 8.2.2 and later
Information in this document applies to any platform.

Symptoms

Recently upgraded from Argus Safety 8.2 to Argus Safety 8.2.2

After upgrade have received a number of negative ACK's (Acknowledgements)  - Both From PMDA(Pharmaceuticals and Medical Devices Agency) and EMA (European Medicines Agency) for DTD elements G.k.9.i.2, G.k.9.i.3 and G.k.9.i.4


These are stating that there is an UNKNOWN reference for G.k.9.i.2, G.k.9.i.3 and G.k.9.i.4 is used for the reference IDs.

Error Messages:

 

Safety report not loaded; Validated against 2.18 business rules;

Comments:

1 - [[R814][G.k.9.i][BR.2]] :In section Drug-reaction(s) / Event(s) Matrix on field Drug-Reaction / Reaction -  Value: null Reported error AtLeastOne The message contains at least one drug-reaction G.k.9 which is not mapped to any reaction E.i (UUID);
2 - [[R814][G.k.9.i][BR.2]] :In section Drug-reaction(s) / Event(s) Matrix on field Drug-Reaction / Reaction -  Value: null Reported error AtLeastOne The message contains at least one drug-reaction G.k.9 which is not mapped to any reaction E.i (UUID);
3 - [[R814][G.k.9.i][BR.2]] :In section Drug-reaction(s) / Event(s) Matrix on field Drug-Reaction / Reaction -  Value: null Reported error AtLeastOne The message contains at least one drug-reaction G.k.9 which is not mapped to any reaction E.i (UUID);
4 - [[R814][G.k.9.i][BR.2]] :In section Drug-reaction(s) / Event(s) Matrix on field Drug-Reaction / Reaction -  Value: null Reported error AtLeastOne The message contains at least one drug-reaction G.k.9 which is not mapped to any reaction E.i (UUID);
5 - [[R814][G.k.9.i][BR.2]] :In section Drug-reaction(s) / Event(s) Matrix on field Drug-Reaction / Reaction -  Value: null Reported error AtLeastOne The message contains at least one drug-reaction G.k.9 which is not mapped to any reaction E.i (UUID);
6 - [[R814][G.k.9.i][BR.2]] :In section Drug-reaction(s) / Event(s) Matrix on field Drug-Reaction / Reaction -  Value: null Reported error AtLeastOne The message contains at least one drug-reaction G.k.9 which is not mapped to any reaction E.i (UUID);
7 - [[R814][G.k.9.i][BR.2]] :In section Drug-reaction(s) / Event(s) Matrix on field Drug-Reaction / Reaction -  Value: null Reported error AtLeastOne The message contains at least one drug-reaction G.k.9 which is not mapped to any reaction E.i (UUID);
8 - [[R814][G.k.9.i][BR.2]] :In section Drug-reaction(s) / Event(s) Matrix on field Drug-Reaction / Reaction -  Value: null Reported error AtLeastOne The message contains at least one drug-reaction G.k.9 which is not mapped to any reaction E.i (UUID);


When comparing Argus Safety 8.2.0.6 and Argus Safety 8.2.2 code for DRUGEVENTMATRIX element both for PMDA and EMA, it was noted an outer join condition is added in Argus Safety 8.2.2 code which is causing this issue.

PMDA 8.2.0.6 code (WHERE condition):



Where Clause is contained in AE_SELECT_STMT column returned by query above.



 

Changes

 

Cause

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In this Document
Symptoms
Changes
Cause
Solution
References


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