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

  • Primary Efficacy Endpoint –All-Available Efficacy Population 32Table 14.

  • 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 Primary Efficacy Endpoint is defined as the proportion of subjects who have a recurrence of uveitis in the study eye within 6 months following treatment.

  • Moderna’s COVID-19 Vaccine Candidate Meets its Primary Efficacy Endpoint in the First Interim Analysis of the Phase 3 COVE Study, 2020.

  • As such, we do not think this is an area that should be regulated by national legislation.

  • 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.

  • CHARGES ON ASSETSAs at 30 June 2016, none of the Group’s assets was pledged to secure any facilities and borrowings granted to the Group.

  • 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.

  • Press Release, AstraZeneca, AZD1222 Vaccine Met Primary Efficacy Endpoint in Preventing COVID-19 (Nov.

  • Primary Efficacy Endpoint #1The Model 4798 LV lead has sixteen (16) programmable pacing vectors.


More Definitions of Primary Efficacy Endpoint

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 <[***]. Portions of this Exhibit, indicated by the mxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Sample 1
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 of a Licensed Product in human patients conducted primarily for the purpose of determining the safety, tolerability and preliminary activity of the Licensed Product, including, without limitation, for determining the maximum tolerated dose, or optimal dose. For purposes of this Agreement, a Phase I trial shall specifically exclude a study in healthy volunteers.

  • 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 a Phase I Clinical Trial, Phase II Clinical Trial or Phase III Clinical Trial, or any post-approval human clinical trial, as applicable.

  • Pivotal Clinical Trial means a pivotal human clinical trial of a Licensed Product with a defined dose or a set of defined doses of such Licensed Product designed to ascertain efficacy and safety of such Licensed Product for the purpose of enabling the preparation and submission of an MAA to the competent Regulatory Authorities in a country of the Territory, as further defined in 21 C.F.R. § 312.21(c) for the U.S., as amended from time to time, or the corresponding foreign regulations.

  • 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 of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country 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 study in humans which provides for the first introduction into humans of a product, conducted in normal volunteers or patients to generate information on product safety, tolerability, pharmacological activity or pharmacokinetics, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(a) or its foreign equivalents.

  • 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 human Clinical Trial of the Licensed Product, which trial is designed (a) to establish that the Licensed Product is safe and efficacious for its intended use; (b) to define warnings, precautions and adverse reactions that are associated with the Licensed Product in the dosage range to be prescribed; and (c) consistent with 21 CFR § 312.21(c).

  • 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 BMS 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, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

  • 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: “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. Transmission Facilities:

  • 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 Study in any country which is conducted after Regulatory Approval of a product has been obtained from an appropriate Regulatory Authority, consisting of trials conducted voluntarily for enhancing marketing or scientific knowledge of an approved indication and trials conducted due to 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.