ACTARM for Withdrawn subject

a Ashok

on May 12, 2015

Hi,

A subject is randomised to treatment sequence ABC, the subject has withdrawn the study after taking first treatment(A).

What would be the value of ACTARMCD/ACTARM for this subject ?

Regards

Ashok

Forums: SDTM

j Jozef

on May 14, 2015

ACTARM for Withdrawn subject

So the planned arm is "ABC" if I understand it well.
If the subject retreated after randomization but before actual treatment, the value for ACTARMCD is "NOTTRT" ("not treated").
If however the subject retreated after first treatment, ACTARMCD is still "ABC" and there will be a record in DS with the reason for / explanation of the discontinuation.

See SDTM-IG 3.2 page 64.