SD1141 No Treatment Emergent info for Adverse Event

Pinnacle 21 Support SDTM
1

Hi Kristen,

SD1141 check looks to all records in AE domain and tries to find their matching records in SUPPAE with the same USUBJID, QNAM=‘AETRTEM’ and IDVARVAL=AESEQ.

So, there are several options what could go wrong:

  • For example, not all AE records have corresponding records in SUPPAE dataset.
  • You have unusual implementation of SUPPAE dataset by using other than AESEQ variable to linked records ( IDVAR != ‘AESEQ’)

Regards,

Sergiy

2

As an additional test to find out what might have gone wrong, you can transform the datasets to Dataset-XML format (see Log In - Wiki) and then use the free open-source “Smart Dataset-XML Viewer” (Smart Dataset-XML Viewer (outdated) - Browse Files at SourceForge.net). If your define.xml is set up correctly, and the SUPPAE records are set up correctly, and you use the option “bring SUPPQUAL data back to original dataset”, the software will create the AETRTEM in the AE table view and populate it with the information from SUPPAE.

You can of course also program such a “bring back” in SAS (as you work for SAS …).
For SUPPxx variables “bringing back” is always a good test - in IT we call this “roundtripping”…

3

Dear Sergiy,

I have all AE records have corresponding records in SUPPAE for AETRTEM and I have used AESEQ in IDVAR, this update it is resolving the issue in PMDA checks but it is hitting in FDA checks (SD1097).

Regards,

Pradeep

4

Hi,

Got a SUPPAE with the QNAM/QLABEL = AETRTEM /TREATMENT EMERGENT FLAG but the P21 validation rule says ‘No Treatment Emergent info for Adverse Event’.

Why does my validation report have hits on this rule?

br Kirsten