Primary Efficacy Endpoint definition
Primary Efficacy Endpoint has the meaning set forth on Appendix 1.134.
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 <[**].
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 <[***].
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.
Primary Efficacy Endpoint means the [ * ].