AESEQ Duplicate Error SD0005

Pinnacle 21 Support SDTM
1

Hi David,

The SD0005 check reports only duplicate records, but it does not provide a reference to original “baseline” records. Therefore it’s quite difficult to perform a diagnostic only with a validation report.

I would recommend to take the original data and sort it by USUBJID and AESEQ. Then look for reported values to ensure that no duplicate records are present.

Please let us know if the false-positive messages do really exist?

Regards,

Sergiy

2

Hello Sergiy,

I think that these false positives may exist see below

STUDYID DOMAIN USUBJID AESEQ AETERM
EMTP AE EMTP-000006 1 GRADE 2 SYSTEMIC ALLERGIC REACTION
EMTP AE EMTP-000006 2 DYSPNEA
EMTP AE EMTP-000006 3 SWELLING OF TONGUE
EMTP AE EMTP-000006 4 SWELLING OF FACE

I get this error numerous times

I will send you the dataset and validation report so you can see

Thanks

Dave Borbas

3

Hello Sergiy,

Based on your email I thought it would be worth reviewing everything.

So I checked the xpt file and noted only 922 records – OK there

Then I re-ran validation with my current version (same as before) of OpenCDISC Validator. However this time I did not see the duplicate AESEQ error.

Good – not sure what happened here. We can close this issue if it should occur again I will let you know

Thank you very much,

4

David,

Some potential source for this issue could be your validation set-up process. E.g., if you included the same AE file twice, then the validator could consider them as two separate split datasets and combine records from two the same sources before a validation.

Regards,

Sergiy

5

OK, I’ve run validation with adding AE two times. That resulted in the same validation report as you sent me. It includes AESEQ dups for all records.

Be careful when adding datasets for validation. When you re-runnig validation within the same session, be sure that you “Clear”-ed datasets used previously.

Regards,

Sergiy

6

I just ran an SDTM validation for ver 3.1.2 and got a Duplicate AESEQ error. But this does not seem correct. I looked at the data and for this subject there are no duplicated AESEQ values.

Here is what the validator report shows:

AESEQ, USUBJID 1, EMTP-000006 SD0005 Duplicate AESEQ
AESEQ, USUBJID 2, EMTP-000006 SD0005 Duplicate AESEQ
AESEQ, USUBJID 3, EMTP-000006 SD0005 Duplicate AESEQ
AESEQ, USUBJID 4, EMTP-000006 SD0005 Duplicate AESEQ

And here is the dataset values

USUBJID AESEQ
EMTP-000006 1
EMTP-000006 2
EMTP-000006 3
EMTP-000006 4
Is something not working correctly?

Thanks

Dave Borbas