Analysis Subsets Clause Samples

Analysis Subsets. 10.2.4.1 Intent-to-treat (ITT) Analysis Set 10.2.4.2 Safety Analysis Set
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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.
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Related to Analysis Subsets

  • Investment Analysis and Implementation In carrying out its obligations under Section 1 hereof, the Advisor shall: (a) supervise all aspects of the operations of the Funds; (b) obtain and evaluate pertinent information about significant developments and economic, statistical and financial data, domestic, foreign or otherwise, whether affecting the economy generally or the Funds, and whether concerning the individual issuers whose securities are included in the assets of the Funds or the activities in which such issuers engage, or with respect to securities which the Advisor considers desirable for inclusion in the Funds' assets; (c) determine which issuers and securities shall be represented in the Funds' investment portfolios and regularly report thereon to the Board of Trustees; (d) formulate and implement continuing programs for the purchases and sales of the securities of such issuers and regularly report thereon to the Board of Trustees; and (e) take, on behalf of the Trust and the Funds, all actions which appear to the Trust and the Funds necessary to carry into effect such purchase and sale programs and supervisory functions as aforesaid, including but not limited to the placing of orders for the purchase and sale of securities for the Funds.

  • Statistical Sampling Documentation a. A copy of the printout of the random numbers generated by the “Random Numbers” function of the statistical sampling software used by the IRO.‌ b. A description or identification of the statistical sampling software package used by the IRO.‌

  • ANALYSIS AND MONITORING The Custodian shall (a) provide the Fund (or its duly-authorized investment manager or investment adviser) with an analysis of the custody risks associated with maintaining assets with the Eligible Securities Depositories set forth on Schedule B hereto in accordance with section (a)(1)(i)(A) of Rule 17f-7, and (b) monitor such risks on a continuing basis, and promptly notify the Fund (or its duly-authorized investment manager or investment adviser) of any material change in such risks, in accordance with section (a)(1)(i)(B) of Rule 17f-7.

  • Analysis An analysis of the types, quantity, and availability of labor required to perform all of the Work;

  • Tests 7.7.1 If the Contract Documents, laws, ordinances, rules, regulations or orders of any public authority having jurisdiction require any portion of the Work to be inspected, tested or approved, the Contractor shall give the Architect timely notice of its readiness so the Architect may observe such inspection, testing or approval. The Contractor shall bear all costs of such inspections, tests or approvals conducted by public authorities. 7.7.2 If the Architect determines that any Work requires special inspection, testing, or approval which Subparagraph 7.7.1 does not include, he or she will, upon written authorization from the State, instruct the Contractor to order such special inspection, testing or approval, and the Contractor shall give notice as provided in Subparagraph 7.7.1. If such special inspection or testing reveals a failure of the Work to comply with the requirements of the Contract Documents, the Contractor shall bear all costs thereof, including compensation for the Architect's additional services made necessary by such failure; otherwise the State shall bear such costs, and an appropriate Change Order shall be issued. 7.7.3 Required certificates of inspection, testing or approval shall be secured by the Contractor and promptly delivered by him to the Architect. 7.7.4 If the Architect is to observe inspections, tests or approvals required by the Contract Documents, he will do so promptly.