Can I add EXSTAT to EX Domain

If you look at section

If you look at section 6.1.2.1 of the IG - Assumptions for Exposure domain model, item 5b suggests not.

If you are wanting to capture meds that are not done, then I think your options are to either:

a - investigate the upcoming 3.1.4 / 3.2 release of the IG - look for the new EC and modified EX domains

b - create a custom domain to capture doses not done.

In the past I have used option b by creating a custom domain XE.  In my analysis datasets I then combined EX and XE to give a complete account of dosing.

Hope this helps

Jon

EXSTAT

Hi Jonathan.

Thanks for your reply!

Yes, in the SDTMIG it says like that. But I am not sure if I can interprete it as if I am not allowed to add it at all.

So you created an EX domain and a XE domain. Could you also put the information into suppex?

Thanks in advance!

To create supplemental

To create supplemental variables was our original though - but as we interpreted the IG as EX only has doses that were given, there would not be a record available that we could link SUPPEX to.  e.g. in SUPPEX you might want to use EXSEQ as the variable in IDVAR - but there would be no record in EX.

Jon

To create supplemental

Yes, correct. That indeed makes sense.So currently, a custom domain would be the most appropriate.

Thanks a lot for your thoughts!