Primary Endpoints Clause Samples

Primary Endpoints. ‌ Safety provided by the evaluation of peri-procedural device related adverse events produced by the ANET device used to ablate a target pulmonary nodule/tumor.
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Primary Endpoints. Primary safety endpoints include: · occurrence of all adverse events including but not limited to · all MIs · cardiovascular hospitalization · serious ventricular arrhythmias sustained · VT (symptomatic or sustained VT [duration longer than 30 seconds or 100 beats, or associated with hemodynamic collapse]) · VF · symptomatic bradycardia, pauses of longer than 3.0 seconds, complete atrioventricular block, Mobitz II atrioventricular block · symptomatic heart failure (NYHA criteria + physical examination OR hospitalization because of heart failure) · renal failure · stroke · death
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Primary Endpoints. The following PK parameters will be calculated whenever possible, based on the plasma concentrations of LOXO-305: • Cmax • tmax • area under the concentration-time curve (AUC) from hour 0 to the last measurable concentration (AUC0-t) • AUC from hour 0 extrapolated to infinity (AUC0-inf) • percentage extrapolation for AUC0-inf (%AUCextrap) • apparent terminal elimination rate constant (λz) • apparent plasma terminal elimination half-life (t½) • apparent systemic clearance (CL/F) • apparent volume of distribution during the terminal phase (Vz/F) • mean residence time (MRT). In addition, a single blood sample will be collected predose to determine the fraction unbound (fu) of LOXO-305 in plasma and, whenever possible, the following PK parameters will be calculated for unbound LOXO-305 using fu: unbound Cmax (Cmax,u), unbound AUC0-t (AUC0-t,u), unbound AUC0-inf (AUC0-inf,u), unbound CL/F (CL/F,u), and unbound Vz/F (Vz/F,u).
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Primary Endpoints. Safety Adverse event -information will be collected daily and ▇▇▇▇▇ ▇▇▇▇▇ will be measured before and after each infusion. Blood and urine sample for clinical laboratory analysis will be collected periodically throughout the study and there will be [*]. Pharmacokinetic Blood and urine samples will be collected at predetermined times throughout the study for pharmacokinetic analysis. [ ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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Primary Endpoints. The following PK parameters will be calculated whenever possible, based on the plasma concentrations of LOXO-305: • Cmax • tmax • AUC from hour 0 to the last measurable concentration (AUC0-t) • AUC from hour 0 extrapolated to infinity (AUC0-inf) • percentage extrapolation for AUC0-inf (%AUCextrap) • apparent terminal elimination rate constant (λz) • apparent plasma terminal elimination half-life (t½) • apparent systemic clearance (CL/F) • apparent volume of distribution during the terminal phase (Vz/F) • mean residence time (MRT). In addition, a single blood sample will be collected predose to determine the unbound fraction (fu) of LOXO-305 in plasma and, whenever possible, the following PK parameters will be calculated for unbound LOXO-305 using fu: unbound Cmax (Cmax,u), unbound AUC0-t (AUC0-t,u), unbound AUC0-inf (AUC0-inf,u), unbound CL/F (CL/F,u), and unbound Vz/F (Vz/F,u).
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Primary Endpoints. The percent of patients with radiographic disease progression according to RECIST 1.1 at 6 months.
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Primary Endpoints. [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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Related to Primary Endpoints

  • Evaluation Criteria 5.2.1. The responses will be evaluated based on the following: (edit evaluation criteria below as appropriate for your project)

  • Evaluation, Testing, and Monitoring 1. The System Agency may review, test, evaluate and monitor Grantee’s Products and services, as well as associated documentation and technical support for compliance with the Accessibility Standards. Review, testing, evaluation and monitoring may be conducted before and after the award of a contract. Testing and monitoring may include user acceptance testing. Neither the review, testing (including acceptance testing), evaluation or monitoring of any Product or service, nor the absence of review, testing, evaluation or monitoring, will result in a waiver of the State’s right to contest the Grantee’s assertion of compliance with the Accessibility Standards. 2. Grantee agrees to cooperate fully and provide the System Agency and its representatives timely access to Products, records, and other items and information needed to conduct such review, evaluation, testing, and monitoring.

  • 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.

  • Program Evaluation The School District and the College will develop a plan for the evaluation of the Dual Credit program to be completed each year. The evaluation will include, but is not limited to, disaggregated attendance and retention rates, GPA of high-school-credit-only courses and college courses, satisfactory progress in college courses, state assessment results, SAT/ACT, as applicable, TSIA readiness by grade level, and adequate progress toward the college-readiness of the students in the program. The School District commits to collecting longitudinal data as specified by the College, and making data and performance outcomes available to the College upon request. HB 1638 and SACSCOC require the collection of data points to be longitudinally captured by the School District, in collaboration with the College, will include, at minimum: student enrollment, GPA, retention, persistence, completion, transfer and scholarships. School District will provide parent contact and demographic information to the College upon request for targeted marketing of degree completion or workforce development information to parents of Students. School District agrees to obtain valid FERPA releases drafted to support the supply of such data if deemed required by counsel to either School District or the College. The College conducts and reports regular and ongoing evaluations of the Dual Credit program effectiveness and uses the results for continuous improvement.

  • Tests and Preclinical and Clinical Trials The preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company, that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, and are intended to be or have been submitted to FDA or other comparable governmental entities, were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, applicable Authorizations, and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and, for studies submitted to regulatory authorities for approval, in all material respects, current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete and fairly present the data derived from such studies and trials in all material respects; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or trials, the results of which the Company believes materially call into question the study or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any written notices or correspondence from the FDA or any governmental entity requiring the termination or suspension of any preclinical studies or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.