PAREXEL
Topic 1 | Section 4.4.2

Change 17: Missing Assessments and Inevaluable Designation

RECIST 1.0:

  • No specific recommendations.

RECIST 1.1:

  • When no imaging/measurement is done at all at a particular time point, the patient is not evaluable (NE) at that time point. If only a subset of lesion measurements are made at an assessment, usually the case is also considered NE at that time point, unless a convincing argument can be made that the contribution of the individual missing lesion(s) would not change the assigned time point response