PAREXEL
Topic 1 | Section 4.3.1

Change 11: Definition of Progressive Disease (PD)

RECIST 1.0:

  • No absolute increase in size required

RECIST 1.1:

  • Target Lesions: > 20% increase in the SLD taking as reference the smallest SLD recorded since the treatment started (nadir) and minimum 5 mm increase over the nadir
    • When sum becomes very small, increases within measurement error (2-3 mm) can lead to 20% increase