Efficacy Endpoints Sample Clauses

Efficacy Endpoints. [*] to be quantified in [*]. In the case, that no [*] are available, [*] are to be quantified in the peripheral blood. Any one of the following three endpoints: - [*] fold enrichment of gene modified T cells [*] weeks after treatment [*], or - proportion of [*] > [*], [*] weeks after treatment, or - [*] of [*] over the course of the clinical trial. [*] Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. In addition, the following endpoint must also be met: -[*] from [*] following treatment. Efficacy endpoints shall apply for at least [*] out of [*] patients treated in Phase I/II Clinical Trial. [*] Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. (1) License and Supply Agreement dated October 15, 1999 by and between XCYTE and Diaclone S.A., as amended (2) Non-Exclusive License Agreement dated October 20, 1999 by and between XCYTE and Xxxx Xxxxxxxxxx Cancer Research Center, as amended (3) License Agreement dated July 8, 1998 by and between XCYTE and Genetics Institute, L.L.C. (“GI”), as amended, including the exhibits: (A) License Agreement between GI and the Secretary of the Navy dated December 10, 1996, as amended, (B) License Agreement dated May 28, 1992 between GI and the University of Michigan, as amended, (C) License Agreement dated July 20, 1993 between GI (as successor-in-interest to Repligen Corporation) and Xxxx Xxxxxx Cancer Institute, as amended. Xcyte™ Dynabeads® Volume: Storage: Storage buffer: 10 ml Store at 2-8°C [*]
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Efficacy Endpoints. The secondary endpoint of disease response will be evaluated according to RECIST 1.11 (advanced solid malignancies) or Lugano Classification2 (NHL) and will include the following: • Overall response rate (XXX): XXX = proportion of patients who have a response of partial response (PR) or complete response (CR) • Duration of response (DOR): the duration of time from first meeting CR or PR measurement criteria (whichever occurs first) until the first date that PD recurrence is objectively documented. • Disease control rate (DCR): DCR = proportion of patients who have a response of CR, PR, and Stable Disease (SD) ≥ 16 weeks. • Duration of disease control: the duration of time from date of first study treatment until the first date that PD is objectively documented. • Progression-free survival (PFS): the duration of time from date of first study treatment until the first date that PD is objectively documented or death due to any cause. KPT-9274 Karyopharm Therapeutics Inc. Clinical Study Protocol: KCP-9274-901 11 March 2020 Part A and Part B:The sample size for Dose Escalation Phase is based on a standard 3+3 design for the purpose of determining the RP2D and MTD (Part A) and the RP2D and MTD of KPT-9274 co- administered with niacin ER (Part B). Each cohort in Parts A and B of the Escalation Phase will consist of 3 or 6 patients per cohort. For the Dose Expansion Phase, up to 65 additional patients may be enrolled at the RP2D for KPT-9274 single agent or KPT-9274 + niacin ER (up to 45 patients in the KPT-9274 ± niacin ER cohort; if Dose Expansion is conducted with KPT-9274 + niacin ER then an optional cohort of up to 20 additional patients in the KPT-9274 single agent cohort). Assuming that 9 dose levels of KPT-9274 are evaluated during both Part A and Part B of the Dose Escalation Phase and up to 65 additional patients are enrolled in the Dose Expansion Phase, the total combined enrollment is estimated to be 175 patients. Part C: For Part C, two dose levels of KPT-9274 (30 and 40 mg) + nivolumab will be tested. A maximum of 10 patients may be enrolled at each dose level. Additional dose levels (20 mg or 60 mg) might be evaluated if an optimal dose is not identified and the safety review committee is in agreement. Analysis methods for efficacy endpoints:Disease response will be assessed according to RECIST 1.11 (advanced solid malignancies) and the Lugano Classification for response assessment2 (NHL). XXX, DOR, DCR, duration of disease control, PFS, OS, and TTP...
Sample 1
Efficacy Endpoints. The primary efficacy endpoint is:  Percent change from baseline in liver fat at Week 12, as determined by MRI-PDFF. The key secondary efficacy endpoint is:  The percentage of subjects with at least a 30% reduction in liver fat at Week 12, as determined by MRI-PDFF. Additional efficacy endpoints are:  Percent change from baseline in liver fat at Week 16, as determined by MRI-PDFF.  Percentage of subjects with at least a 30% reduction in liver fat at Week 16, as determined by MRI-PDFF.  Change from baseline over the 12-week treatment period in: – Liver aminotransferases. – Lipid and lipoprotein parameters. – XXXX and fibrosis markers. – Eicosanoids. Exploratory efficacy endpoints are:  Change from baseline over the 12-week treatment period in: – Liver fibrosis, as determined by VCTE. – Metabolic parameters. – Anthropometric parameters. – Lipidomic analyses for DNL.  Proportion of subjects with <5% liver fat (normalized) at Week 12.
Sample 1
Efficacy Endpoints. The primary efficacy endpoint of the Phase 2a is the proportion of evaluable participants (i.e. in the PP set) with a response of ≥ 5 letter gain in BCVA from baseline to week 12 according to ETDRS criteria in the combination aflibercept + OPT-302 group. Based on the results of 72 evaluable participants in the aflibercept + OPT-302 arm the combination therapy will be considered to have clinical activity if ≥ 27 of 72 participants have a ≥ 5 letter gain in BCVA from baseline to week 12 according to ETDRS criteria in the aflibercept + OPT-302 group. Likewise the combination therapy will be considered to have insufficient clinical activity if ≤ 25 of 72 participants have a ≥ 5 letter gain in BCVA from baseline to week 12 according to ETDRS criteria in the aflibercept + OPT-302 group. The difference in the mean change from baseline to week 12 between treatments will be tested for three secondary efficacy endpoints: mean BCVA, mean CST and mean macular volume. A model for repeated measures, fitted by restricted maximum likelihood method, will be used for the analysis. This model takes into account the presence of missing data and yields valid estimates under the assumption of data missing at random. In addition, the following secondary outcomes will be estimated in the Phase 2a by treatment arm, and their 95% confidence intervals will be obtained: • Percent of eyes with ≥ 50% reduction in excess foveal thickness from baseline to week 12 on SD-OCT • Percent of eyes with CST < 300 µm on SD-OCT through week 12 • Percent of participants with a ≥ 2 step improvement from baseline to week 12 in ETDRS Diabetic Retinopathy Severity Score • The mean time to, and number of, retreatment injections of aflibercept anti-VEGF-A therapy based on protocol specified criteria during week 12 to week 24 follow-up Further details of the analysis methods will be provided in the statistical analysis plan.
Sample 1
Efficacy Endpoints. The primary endpoints are the differences between *** and *** groups in mean percent loss of baseline body weight, determined by weight at randomization (baseline) and weight at end of treatment (week 56), and percent of subjects with weight loss of 5% or more at end of treatment (week 56). Percent weight loss will be calculated as ***. Secondary efficacy endpoints are: · The difference in absolute weight loss between randomization (baseline) and end of treatment (week 56) for *** and *** groups; · The difference in percent of subjects who achieve a reduction in total body weight of at least 10% between randomization (baseline) and end of treatment (week 56) for *** and *** groups; and · The difference in change in waist circumference (randomization to week 56) for *** and *** groups. Additional efficacy endpoints include: · Effect on ***; · Effect on body composition as indicated by ***. *** assessments will be performed at only at a ***. · Effect on *** of *** and ***; · Change from baseline to week 28 and week 56 in BMI; · The change in obesity-associated risk factors (HgbA1c, total cholesterol, triglycerides, LDL-C, HDL-C, fasting glucose, fasting insulin, a measure of insulin sensitivity, systolic blood pressure, diastolic blood pressure, C-reactive protein); · Change in urinary microalbumin and albumin/creatinine ratio (ACR) from screening to week 28 and week 56; · Change from baseline in medication number and dosages for medication to treat cardiovascular or metabolic risk factors; · Difference between *** and *** groups in the rate of progression to type 2 diabetes (subjects non-diabetic at screening); and · Baseline adjusted change in Framingham 10-year risk score at weeks 28 and 56. The change in weight loss (absolute, percent, percent of subjects achieving weight loss of > 5% and > 10% of starting weight), waist circumference and obesity associated risk factors will also be assessed over time. Subgroup analyses, including but not limited to analysis by gender, age and race, may be performed. *** will also be evaluated. Data will be obtained using a multiple trough sampling scheme with samples collected at *** and ***. Effects of various cofactors including (but not limited to) ***, gender, race, *** and age will be evaluated.
Sample 1

Related to Efficacy Endpoints

  • Clinical 1.1 Provides comprehensive evidence based nursing care and individual case management to a specific group of patients/clients including assessment, intervention and evaluation. 1.2 Undertakes clinical shifts at the direction of senior staff and the Nursing Director including participation on the on-call/after-hours/weekend roster if required. 1.3 Responsible and accountable for patient safety and quality of care through planning, coordinating, performing, facilitating, and evaluating the delivery of patient care relating to a particular group of patients, clients or staff in the practice setting. 1.4 Monitors, reviews and reports upon the standard of nursing practice to ensure that colleagues are working within the scope of nursing practice, following appropriate clinical pathways, policies, procedures and adopting a risk management approach in patient care delivery. 1.5 Participates in xxxx rounds/case conferences as appropriate. 1.6 Educates patients/carers in post discharge management and organises discharge summaries/referrals to other services, as appropriate. 1.7 Supports and liaises with patients, carers, colleagues, medical, nursing, allied health, support staff, external agencies and the private sector to provide coordinated multidisciplinary care. 1.8 Completes clinical documentation and undertakes other administrative/management tasks as required. 1.9 Participates in departmental and other meetings as required to meet organisational and service objectives. 1.10 Develops and seeks to implement change utilising expert clinical knowledge through research and evidence based best practice. 1.11 Monitors and maintains availability of consumable stock. 1.12 Complies with and demonstrates a positive commitment to Regulations, Acts and Policies relevant to nursing including the Code of Ethics for Nurses in Australia, the Code of Conduct for Nurses in Australia, the National Competency Standards for the Registered Nurse and the Poisons Act 2014 and Medicines and Poisons Regulations 2016. 1.13 Promotes and participates in team building and decision making. 1.14 Responsible for the clinical supervision of nurses at Level 1 and/or Enrolled Nurses/ Assistants in Nursing under their supervision.

  • Study An application for leave of absence for professional study must be supported by a written statement indicating what study or research is to be undertaken, or, if applicable, what subjects are to be studied and at what institutions.

  • Target Population TREATMENT FOR ADULT (TRA) Target Population

  • Study Population Infants who underwent creation of an enterostomy receiving postoperative care and awaiting enterostomy closure: to be assessed for eligibility: n = 201 to be assigned to the study: n = 106 to be analysed: n = 106 Duration of intervention per patient of the intervention group: minimum 21 days/3 weeksuntil patient's weight >2000g, averaged 6 weeks between enterostomy creation and enterostomy closure Follow-up per patient: 3 months, 6 months and 12 months following enterostomy closure (12- month follow-up only applicable for patients that are recruited early enough to complete this follow-up within the 48 months of overall study duration).

  • Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.

  • Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

  • Tests and Preclinical and Clinical Trials The studies, tests and preclinical and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder (collectively, “FFDCA”); the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the General Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the General Disclosure Package and the Prospectus, the Company is not aware of any studies, tests or trials, the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, neither the Company nor any Subsidiary has received any notices or correspondence from the FDA or any Governmental Entity requiring the termination or suspension of any studies, tests or preclinical 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.

  • Population The Population shall be defined as all Paid Claims during the 12-month period covered by the Claims Review.

  • RE-WEIGHING PRODUCT Deliveries are subject to re- weighing at the point of destination by the Authorized User. If shrinkage occurs which exceeds that normally allowable in the trade, the Authorized User shall have the option to require delivery of the difference in quantity or to reduce the payment accordingly. Such option shall be exercised in writing by the Authorized User.

  • Product Quality Isoprene, (hereinafter referred to as “Product”) supplied and maintained on consignment at Belpre in accordance with Article 6, and will be in accordance with specifications set forth in Exhibit A. Seller will facsimile to the Buyer at time of shipment a Certificate of Analysis (COA). Seller will provide Buyer six (6) months advanced notification if there is a change in the manufacturing process that will affect the material specifications of Product provided to the Buyer. Product produced by the Seller in different plants is viewed as coming from different supply sources and requires separate qualifications. Product to be shipped for the Seller from third parties must be from a third party qualified by the Buyer based on Buyer’s criteria as specified in Exhibit B. Buyer will have the right to confirm each such shipment-conforms to the agreed specification; Seller must obtain approval prior to shipment any material that does not meet the Buyers specifications. If Seller deliveries Product failing to comply with the specifications set out in Exhibit A, Seller will reimburse Buyer for freight expenses associated with such shipment and be entitled at its option to i) require Seller to replace such defective Product at a price not to exceed the invoice value or ii) to reimburse the invoice value of the defective Product. If, Buyer has cause to complain that the quality of Product delivered to it pursuant to the Contract does not comply with the specification set out in Exhibit A, Buyer will give written notice specifying the nature of its complaint and the parties will promptly meet so as to resolve that complaint. In absence of any agreement to resolve the complaint the parties will appoint at their joint cost a mutually acceptable independent surveyor to examine whether the quality of Product as delivered complied with the specifications set forth in Exhibit A. In the absence of any written notice from Buyer to Seller within 30 days after delivery of the Product, the Product shall be deemed to have been delivered and accepted by Buyer in a satisfactory condition and in all respects in accordance with the specifications and Seller shall have no liability to Buyer with respect to that delivery.

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