PAREXEL
Topic 1 | Section 4.2

Change 9: Documentation of Non-target Lesions

RECIST 1.0:

  • All other lesions (or sites of disease) should be identified as non-target lesions and should also be recorded at baseline. Measurements of these lesions are not required, but the presence or absence of each should be noted throughout the follow-up.

RECIST 1.1:

  • It is possible to record multiple non-target lesions involving the same organ as a single item on the case record form (e.g. “multiple enlarged pelvic lymph nodes” or “multiple liver metastases”)