New lesions Sample Clauses

New lesions. New lesions should be assessed and measured as they appear using RECIST 1.1 criteria (maximum of 5 lesions, no more than 2 per site, at least 10 mm in long axis (or 15 mm in short axis for nodal lesions), and recorded as New Lesions-Target (NLT) and New Lesion-Non-Target (NLNT) to allow clear differentiation from baseline target and non-target lesions. New lesions may either meet the criteria of NLT or NLNT to drive iUPD (or iCPD). However, the measurements of target lesions should NOT be included in the sum of measures of original target lesions identified at baseline. Rather, these measurements will be collected on a separate table in the case record form. PD is confirmed in the New Lesion category if the next imaging assessment, conducted at least 4 weeks (but not more than 8 weeks) after iUPD confirms further progression from iUPD with either an increase of at least 5 mm in the absolute value of the sum of NLT OR an increase (but not necessarily unequivocal increase) in the size of NLNT lesions OR the appearance of additional new lesions. Table S2: Time-point (TP) iResponse Target Lesions* Non-Target Lesions* New Lesions* Time Point Response No prior iUPD** Prior iUPD**; *** iCR iCR No iCR iCR iCR Non-iCR/Non- iUPD No iPR iPR iPR Non-iCR/Non- iUPD No iPR iPR iSD Non-iCR/Non- iUPD No iSD iSD iUPD with no change OR decrease from last TP iUPD with no changeO R decrease from last TP Yes NA NLs confirms iCPD if NLs were previously identified and increase in size (≥5 mm in SOM for NLT or any increase for NLNT) or number. If no change in NLs (size or number) from last TP, remains iUPD iSD iUPD No iUPD Remains iUPD unless iCPD confirmed based in further increase in size of NT disease (need not meet RECIST 1.1 criteria for unequivocal PD) iUPD Non-iCR/Non- iUPD No iUPD Remains iUPD unless iCPD confirmed based on: o further increase in SOM of at least 5 mm, otherwise remains iUPD iUPD iUPD No iUPD Remains iUPD unless iCPD confirmed based on further increase in: o previously identified T lesion iUPD SOM ≥5 mm and / or o NT lesion iUPD (prior assessment - need not be unequivocal PD) iUPD iUPD Yes iUPD Remains iUPD unless iCPD confirmed based on further increase in: o previously identified T lesion iUPD ≥5 mm and / or o previously identified NT lesion iUPD (need not be unequivocal) and /or o size or number of new lesions previously identified Non- iUPD/PD Non-iUPD/PD Yes iUPD Remains iUPD unless iCPD confirmed based on o increase in size or number of new lesions pr...
Sample 1
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New lesions. New lesions will be identified via a Yes/No tick box. If new lesion response (yes/no) is missing and the new lesion details are blank it should be treated as NE.
Sample 1

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