Progressive Radiologic Disease Clause Samples

Progressive Radiologic Disease. The designation of progressive radiologic disease (PRD) for CT-based response requires at least 1 of the following: • An individual node/lesion must be abnormal with: ⎯ LDi > 1.5 cm, and ⎯ Increase by ≥ 50% from cross-product of LDi and perpendicular diameter (PPD) nadir, and ⎯ An increase in LDi or shortest axis perpendicular to the LDi from nadir ■ 0.5 cm for lesions ≤ 2 cm ■ 1.0 cm for lesions > 2 cm ⎯ In the setting of splenomegaly, the splenic length must increase by > 50% of the extent of its prior increase beyond baseline (eg, a 15 cm spleen must increase to > 16 cm). If no prior splenomegaly, the increase must be ≥ 2 cm from baseline; ⎯ New or recurrent splenomegaly • New or clear progression of pre-existing non-measured lesions • New lesion ⎯ Regrowth of previously resolved lesions ⎯ A new node > 1.5 cm in any axis ⎯ A new extra-nodal site > 1.0 cm in any axis; if < 1.0 cm in any axis, its presence must be unequivocal and must be attributable to lymphoma ⎯ Assessable disease of any size unequivocally attributable to lymphoma • New or recurrent bone marrow involvement