Change 19: Overall Response Table, Subjects Without Measurable Disease
RECIST 1.0:
- RECIST 1.0 has no specific recommendations. Perceptive has defined modifications for this topic according to our experience and current scientific knowledge.
|
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. |