Analysis Subsets Sample Clauses

Analysis Subsets. KTE-X19 will be administered as a single infusion at a target dose of 2 x 106 anti-CD19 CAR T cells/kg or 1 x 106 anti-CD19 CAR T cells/kg or 0.5 x 106 anti-CD19 CAR T cells/kg . For subjects weighing greater than 100 kg, a maximum flat dose of 2 x 108 or 1 x 108 or 0.5 x 108 anti-CD19 CAR T cells/kg may be administered. Full Analysis Set: the full analysis set will consist of all enrolled subjects and will be used for summaries of subject disposition. Modified Intention-to-treat Set (mITT): the modified intention-to-treat set will consist of all subjects enrolled in Phase 2 and treated with KTE-X19. The mITT analysis set will be used for all efficacy analyses unless otherwise specified. DLT-evaluable set: All Phase 1 subjects treated with the target KTE-X19 dose and followed for at least 28 days, or received a dose of KTE-X19 lower than the target dose but experienced a DLT during the 28 day post infusion period, up to the time at which a dose level has been evaluated for DLT and deemed safe. Additional Phase 1 subjects enrolled and treated subsequently for the purpose of assessment of the overall safety in the same dose level or a lower dose level will not be considered as part of the DLT evaluable set, and DLT will not be assessed for such subjects. Safety analysis set: the safety set is defined as all subjects treated with any dose of KTE-X19.
Sample 1
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Analysis Subsets. 10.2.4.1 Intent-to-treat (ITT) Analysis Set The Intent-to-Treat (ITT) analysis sets will include all participants enrolled (Phase 1b) or randomized (Phase 2a) into the study, irrespective of whether study drug(s) was administered or not. These analysis sets will be used to report participant disposition and to provide a sensitivity analysis of the safety and efficacy endpoints only.
Sample 1

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