PropertyValue
?:definition
  • Specifies whether the treatment plan actually received by the experimental unit, as determined retrospectively, was not only NOT what was assigned, but was not even defined as a valid treatment plan. EXAMPLE(S): If an A/B cross-over study only has arms \'A-B\' and \'B-A\' and a given experimental unit has a treatment that is effectively \'A-A\', then unplannedTreatmentIndicator = \'true\'. In SDTM, if DM.ACTARM = \'Unplanned Treatment\' or DM.ACTARMCD = \'UNPLAN\', then unplannedTreatmentIndicator = \'true\'. OTHER NAME(S): NOTE(S): If the treatment plan received by an experimental unit actually is a valid treatment plan, whether or not it was what was assigned in the experimental unit allocation activity, this is represented as an association from the ExperimentalUnit to the Arm, with unplannedTreatmentIndicator = \'false\'. Note that this attribute has a retrospective nature - i.e. you might not know what treatment an experimental unit was actually on until after all treatments have been completed and the blind, if any, has been broken. This is typically the case for studies in which there may be more than one randomization.
?:hasCUIAnnotation
?:hasGeneratedBy
?:type

Metadata

Anon_0  
expand all