PAREXEL
Topic 1 | 

Change 19: Overall Response Table, Subjects Without Measurable Disease

RECIST 1.0:

  • No specific recommendations; in line with PAREXEL’s modifications

RECIST 1.1:

Non-target New Overall Response
CR No CR

Non-CR / non-PD

No

Non-CR / non-PD

Not all evaluated

No NE

Unequivocal PD

Yes or No PD
Any Yes PD

Non-CR/non-PD is preferred over “stable disease” for non-target disease since SD is increasingly used as an endpoint for assessment of efficacy in some trials so to assign this category when no lesions can be measured is not advised.