Question on 'skipped' treatments

s Stephen

on May 17, 2012

Hi, it's unclear to me how skips (e.g., subject scheduled for dosing at visits 1, 2, & 3 instead only have actual dosing at 1 & 3) are to be represented in TRxxSDT/TRxxEDT and TRTSEQA. My inclination thus far has been that even though the nominal visit for the 2nd sequence of doses comes from the 3rd visit, I should still only populate TR01SDT & TR02SDT (rather than leaving TR02SDT missing and instead populate TR03SDT). Seems like this sets things up better for APERIOD in the BDS, but I'm open to suggestions.

Depending on the answer to the above, is there an acceptable controlled-terminology insertion into TRTSEQA to represent this (e.g., "Drug X+<skipped>+Drug Y")?

Thanks in Advance.

Forums: ADaM

s Sergiy

on May 21, 2012

Hi Stephen, Please note,

Hi Stephen,

Please note, that TRxxSDT variable is start date/time of Treatment Period, not each particular dose administration.

It looks like you need to use only the first and the last doses in you example to populate TRxxSDT/TRxxENDT.

Therefore TRxxSDT is dose #1, TRxxEDT is dose #3, regardless of dose #2 occurrence. Please refer to your study protocol and SAP or ask the study statistician.

Best Regards,

Sergiy Sirichenko

b Barath

on November 29, 2012

Try using the CNSR variable

Hi Stephen,

I am not sure if this is what you are looking for but still based on my understanding of your question. I hope you can use the censor variable (CNSR) in this case. Kindly have a look at page 62 of the ADaMIG so that you may get a better idea on how to go about it.

Best Regards,

Barath R B