Total Measured Tumor Burden Sample Clauses

Total Measured Tumor Burden. TMTB is established at baseline as the sum of the longest diameters (SOD)—the shortest axes should be used for lymph nodes—of all target lesions (≤ 2 lesions per organ, ≤ 5 lesions total). At each subsequent TA, the SOD of new, measurable lesions (≥ 10 mm [lymph nodes ≥ 15 mm in shortest diameter]; ≤ 2 new lesions per organ, ≤ 5 new lesions total) is added to the SOD of the target lesions to provide the updated TMTB: TMTB = SOD target lesions + SOD new, measurable lesions If there are more than 2 new lesions per organ or more than 5 new lesions total, the lesions added to the TMTB should be selected on the basis of their size (i.e., lesions with the longest diameter should be selected). Percentage changes in TMTB at each TA describe the size and growth kinetics of both old and new, measurable lesions as they appear. At each TA, the response in TMTB is defined as follows: • Complete Response (irCR): Complete disappearance of all target and new, measurable lesions, with the exceptions of lymph nodes which must decrease to < 10 mm in short axis • Partial Response (irPR): Decrease in TMTB ≥ 30% relative to baseline • Stable Disease (irSD): Not meeting criteria for irCR or irPR, in absence of irPD • Progressive Disease (irPD): Increase in TMTB ≥ 20% relative to nadir
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