Primary Efficacy Endpoint definition

Primary Efficacy Endpoint has the meaning set forth on Appendix 1.134.
Sample 1Sample 2Sample 3
Primary Efficacy Endpoint means achieving the [**] by [**] defined according to standard criteria as <[**]% of [**] to [**] on the [**], measured by [**]. The primary analysis of the primary endpoint will be performed using [**]. The study will be stratified by [**] at baseline (>[**] versus <[**]) and [**]) to compare the MMR rate by [**] between patients receiving either dose level of ponatinib (initial dose: [**] or [**]) and patients receiving nilotinib (initial dose: [**]) and will follow a testing procedure to ensure an [**]. An efficacy interim analysis is planned after the first [**] have at least [**] of [**]. To maintain an overall [**] of [**] (2-sided), an [**] will be used which requires a [**]. Thus, with 2 treatment comparisons significance will be declared for [**]. For each dose comparison, if this boundary is not crossed at the time of the interim analysis, then the primary analysis will be conducted [**] following the [**]. A [**] will be used to adjust for comparisons of Cohorts A and B to Cohort C, with a dose considered significant if the [**] is <[**].
Sample 1Sample 2Sample 3
Primary Efficacy Endpoint means the [ * ].
Sample 1

Examples of Primary Efficacy Endpoint in a sentence

  • Study 201: Results for Primary Efficacy Endpoint According to Applicant’s Multiple Testing Procedure CategorySource: ReviewerNote: * Results reported in this table are from the FAS with Flovent Diskus data excluded.

  • The Clinical Utility of a Blood Test Incorporating Age, Sex, and Gene Expression in the Evaluation of Women Presenting with Stable Symptoms Suggestive of Obstructive Coronary Artery Disease in a Large Primary Care Registry (PRESET): Subgroup Analysis of the Primary Efficacy Endpoint.

  • Analysis of continuous endpoints 49 Analyses using ANCOVA 49 C.1.1. Primary Analysis 49 C.1.2. Select Sensitivity Analyses for the Primary Efficacy Endpoint 50 C.1.3. Analysis of Continuous Secondary Endpoint 50 C.1.4. Analysis of Additional Continuous Endpoints 51 Analyses Using MMRM 51 Appendix D.

  • Primary Efficacy Endpoint Results in Study 07 Change from Baseline in Weekly Pain Score at Week 12NKTR-181 N = 309CI = confidence interval; LS = least squares; SE = standard error The magnitude of pain reduction attributed to NKTR-181 in Study 07 is similar to that of other opioids used for the treatment of chronic pain (see Section 6.2.8, Figure 30) (Meske et al.

  • It stands to reason, therefore, that the only way to consolidate non-NRRS sites into the NRRS prior to the anticipated 2004 solicitation is to modify intervenor’s contract on a sole source basis.

  • Clinical Cure at TOC Visit – Primary Efficacy Endpoint In Study C-10-018, at the TOC visit, for the ITT pathogen positive subset, 71.7% (104/145) of the patients in the Finafloxacin group had a clinical cure compared with 33.3% (46/138) of the patients in the Vehicle group; the treatment difference (38.4%) was statistically significant 4(p<0.001) with a 95% CI of (27.6%, 49.1%).

  • Primary Efficacy Endpoint Results in Study 07‌ Change from Baseline in Weekly Pain Score at Week 12NKTR-181 N = 309Placebo N = 301LS mean (SE)0.92 (0.112)1.46 (0.114)Treatment difference, LS mean (SE) 95% CIp-valueCI = confidence interval; LS = least squares; SE = standard error At screening, the mean (SD) Weekly Pain Score among patients eventually randomized to NKTR-181 and placebo was 6.7 (1.0) and 6.8 (0.9), respectively, which decreased during the open-label Titration Period.

  • If the final CSR for the OPTIC 2L Clinical Trial demonstrates Superiority on the Primary Efficacy Endpoint, ARIAD SWISSCO shall submit a variation application to the Regulatory Authority to support the approval of the Second Line CML indication within [**] of ARIAD SWISSCO’S receipt of the final CSR.

  • Table 12 Primary Efficacy Endpoint – Overall Clinical Success at Week 48SubjectPopulationOverall Clinical Success(%) Based on All Lesions (Number of Subjects)Source: Modified from BLA 125659 original submission.

  • Table 5: Results for Primary Efficacy Endpoint (All Treated) TDF (N=60)Placebo (N=29)Treatment DifferenceDifference (95% CI1)Source: Table15 in Study GS-US-174-0144 Interim Week 48 Clinical Study Report1The exact 95% CI based on inverting a two-sided test was calculated by the statistical reviewer2based on 2-sided CMH test adjusted for age at baseline and region The applicant’s results for selected secondary efficacy endpoints are summarized inError! Reference source not found.


More Definitions of Primary Efficacy Endpoint

Primary Efficacy Endpoint has the meaning set forth in Schedule 7.
Sample 1

Related to Primary Efficacy Endpoint

  • Endpoint means any Federal Reserve Bank, financial institution, local clearing house, courier or other entity or location for the delivery of cash letters or other presentment of Imaged Items or Substitute Checks.

  • Clinical evaluation means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer;

  • Phase I Trial means a Clinical Trial, the principal purpose of which is preliminary determination of safety of an investigational product in healthy individuals or patients or that otherwise meets the requirements described in 21 C.F.R. §312.21(a), or similar Clinical Trial in a country other than the United States.

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.

  • Clinical Trial means any human clinical trial of a Product.

  • Pivotal Clinical Trial means a human clinical trial in any country that is prospectively designed to generate data intended to satisfy the requirements of 21 C.F.R. § 312.21(c) (as amended) in the U.S. or a similar clinical study prescribed by a Regulatory Authority from another country, from time to time, pursuant to Applicable Law.

  • Phase II Trial means a clinical trial of a Licensed Product on patients, including possibly pharmacokinetic and dose ranging studies, the principal purposes of which are to make a preliminary determination that such Licensed Product is safe for its intended use and to obtain sufficient information about such Licensed Product’s efficacy to permit the design of further clinical trials, and generally consistent with 21 CFR §312.21(b), or its successor regulation, or the equivalent in any foreign country.

  • Phase 2 Clinical Trial means a human clinical trial, for which the primary endpoints include a determination of dose ranges or an indication of efficacy in patients being studied as described in 21 C.F.R. §312.21(b), or an equivalent clinical trial in a country in the Territory other than the United States.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • COVID-19 symptoms means fever of 100.4 degrees Fahrenheit or higher, chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, or diarrhea, unless a licensed health care professional determines the person’s symptoms were caused by a known condition other than COVID-19.

  • Monitoring Indicator means a measure of HSP performance that may be monitored against provincial results or provincial targets, but for which no Performance Target is set;

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • Phase III Trial means a Clinical Trial of an investigational product in subjects that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to generate data and results that can be submitted to obtain Regulatory Approval as described in 21 C.F.R. 312.21(c), or a comparable Clinical Trial prescribed by the relevant Regulatory Authority in a country other than the United States.

  • Phase IV Clinical Trial means a product support clinical trial of a Product commenced after receipt of Regulatory Approval in the country where such trial is conducted. A Phase IV Clinical Trial may include epidemiological studies, modeling and pharmacoeconomic studies, and investigator-sponsored clinical trials studying Product that are approved by the JDC and that otherwise fit the foregoing definition.

  • Clinical nurse specialist means a registered nurse with relevant post-basic qualifications and 12 months’ experience working in the clinical area of his/her specified post-basic qualification, or a minimum of four years’ post-basic registration experience, including three years’ experience in the relevant specialist field and who satisfies the local criteria.

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • System Impact Study means an assessment by the Transmission Provider of (i) the adequacy of the Transmission System to accommodate a Completed Application, an Interconnection Request or an Upgrade Request, (ii) whether any additional costs may be incurred in order to provide such transmission service or to accommodate an Interconnection Request, and (iii) with respect to an Interconnection Request, an estimated date that an Interconnection Customer’s Customer Facility can be interconnected with the Transmission System and an estimate of the Interconnection Customer’s cost responsibility for the interconnection; and (iv) with respect to an Upgrade Request, the estimated cost of the requested system upgrades or expansion, or of the cost of the system upgrades or expansion, necessary to provide the requested incremental rights. “System Protection Facilities” shall refer to the equipment required to protect (i) the Transmission System, other delivery systems and/or other generating systems connected to the Transmission System from faults or other electrical disturbance occurring at or on the Customer Facility, and (ii) the Customer Facility from faults or other electrical system disturbance occurring on the Transmission System or on other delivery systems and/or other generating systems to which the Transmission System is directly or indirectly connected. System Protection Facilities shall include such protective and regulating devices as are identified in the Applicable Technical Requirements and Standards or that are required by Applicable Laws and Regulations or other Applicable Standards, or as are otherwise necessary to protect personnel and equipment and to minimize deleterious effects to the Transmission System arising from the Customer Facility.

  • Adverse drug reaction means any undesirable or unexpected medication related event that requires discontinuing a medication or modifying the dose, requires or prolongs hospitalization, results in disability, requires supportive treatment, is life-threatening or results in death, results in congenital anomalies, or occurs following vaccination.

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • Phase 2 Trial means a human clinical trial conducted on study subjects with the disease or condition being studied for the principal purpose of achieving a preliminary determination of efficacy or appropriate dosage ranges, as further described in 21 C.F.R. §312.21(b) (including any such clinical study in any country other than the United States).

  • Phase 1 Clinical Trial means a Clinical Trial of a Product on sufficient numbers of normal volunteers and/or patients that is designed to establish that such Product is safe for its intended use and to support its continued testing in Phase 2 Clinical Trials. For purposes of this Agreement, ‘initiation’ of a Phase 1 Clinical Trial for a Product means the first dosing of such Product in a human subject in a Phase 1 Clinical Trial.

  • Data Subjects means all individuals whose Personal Information we receive in the course of our banking relationship with you, including your direct and indirect beneficial owners, directors, officers and authorized persons.

  • Dose profile means the dose as a function of position along a line.