If you have a drug administered that is a combination, say 0.5mg of drug A and 0.75mg of drug B in a single administration, how do you represent this in EXDOSE, which is a numeric field?

[sunilpusarla]

Hi All,

Greetings. I am creating exposure domain SDTM dataset. Our drug is a combination (ex: drug a 0.5 mg + drug b 0.75 mg) which will be administered by adding 3 ml of this solution to 500 ml of saline. At the end of the surgery we will get the remaining solution, based on which we will calculate the usage. Usage of this solution differs from person to person (50 to 500 ml). My question is, what will be carried by EXDOSE (which is numeric and an expected variable)? In other words, do we populate it with total solution used (like 363 ml etc.) or proportion of 3 ml solution used (like 2.43 ml) or any other else?

Thanks,

Sunil

[Tom]

Look at this thread.

http://bbs.cdisc.org/bbs/forums/thread-view.asp?tid=3473