PAREXEL
Topic 1 | Section 4.2

Change 8: Baseline Documentation of Target Lesions

RECIST 1.0:

  • All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions and recorded and measured at baseline.
  • Target lesions should be selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements.

RECIST 1.1:

  • All lesions up to a maximum of five lesions total (and a maximum of two lesions per organ) representative of all involved organs should be identified as target lesions
  • It may be the case that, on occasion, the largest lesion does not lend itself to reproducible measurement in which circumstance the next largest lesion which can be measured reproducibly should be selected