Primary Efficacy Endpoint definition

Primary Efficacy Endpoint has the meaning set forth on Appendix 1.134.
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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 <[**].
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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 <[***].
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Examples of Primary Efficacy Endpoint in a sentence

  • 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.

  • 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.


More Definitions of Primary Efficacy Endpoint

Primary Efficacy Endpoint has the meaning set forth in Schedule 7.
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Primary Efficacy Endpoint means the [ * ].
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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 designated as a Phase I Trial and conducted primarily for the purpose of determining the safety of and/or the metabolism and pharmacologic actions of the Licensed Product in humans, as described under 21 CFR § 312.21(a) (as hereafter modified or amended) and any of its foreign equivalents. For purposes of this definition, Phase I Trial shall specifically exclude trials in healthy volunteers.

  • 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, with respect to a Licensed Product, (a) a phase 3 Clinical Trial or (b) any other clinical trial that is intended (as of the time the study is initiated) to obtain the results and data to support (without the need to conduct any additional clinical trial) the filing of an application for Regulatory Approval for such product.