Interim Analysis definition

Interim Analysis means the Interim Efficacy Analysis, as described in Section 5.3 of the DSMB Charter.
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Interim Analysis is defined in Subsection 4.1.2.
Sample 1
Interim Analysis means the Required Top Line Data corresponding to a potential six (6) month analysis of new surgically eligible tumor development in all vehicle-treated vs. all patidegib topical gel-treated subjects, as defined in the Phase III Protocol [***] and Statistical Analysis Plan.
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Examples of Interim Analysis in a sentence

  • The statistical design foresees the conduct of two interim analyses, as follows: ▪ Interim Analysis for futility after 100 DFS events have occurred▪ Interim Analysis of overall survival which coincides with the Final Analysis of DFS after 360 DFS have been reported by the investigational sitesThe execution of the interim analysis for futility is a completely confidential process assigned to the Independent Data Monitoring Committee (IDMC, also see section 11.10).

  • Objective 5 Interim Analysis Report, TRADOC Analysis Center, December 2008.

  • Pfizer and BioNTech Announce Vaccine Candidate Against COVID-19 Achieved Success in First Interim Analysis from Phase 3 Study.

  • Institution and/or Principal Investigator agree to conduct expedited data entry and query resolution for Interim Analysis as defined in the Protocol in addition to final database lock.

  • Upon the Successful Completion of the Interim Analysis of the Pivotal Clinical Trial/Phase IIb Proof of Concept, or, failing that, upon the Successful Completion of the Pivotal Clinical Trial, Ikaria shall, within [***] days thereafter, submit a formal written request for a reimbursement price for one or more Product(s) to the applicable governmental agency in one or more of the following countries: [***].

  • The 25% Interim Analysis was prospectively designed to enable an early and preliminary assessment of safety to support regulatory approval.

  • For the purpose of this study, the Interim Analysis section of the protocol (12.2.10) describes the planned analysis of data that will be performed upon completion of the double-blind treatment period (Study Period II).

  • A Randomized, Double- Blind, Placebo-Controlled Clinical Trial of Four Oral Dosing Regimens of VT-1161 in the Treatment of Patients with Moderate-Severe Toenail Onychomycosis (RENOVATE): Results of a Planned Week 24 Interim Analysis.

  • That data was followed by a reiteration that “[i]t is important to emphasize” two things.100 First, “[t]he U.S. package insert for Contrave states that the effect of Contrave on CV morbidity and mortality has not been established.”101 And second, “[t]he 25% Interim Analysis was prospectively designed to enable an early and preliminary assessment of safety to support regulatory approval.

  • Within the enrolled Cohort 1 population, the primary efficacy analysis set is comprised of 108 patients identified as having FGFR2 rearrangements (Interim Analysis Set 2).


More Definitions of Interim Analysis

Interim Analysis has the meaning set forth in Section 3.10.
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Interim Analysis means the completion of either of the two interim analyses for efficacy (to be performed when approximately 150 and 250 subjects have had a positively adjudicated primary endpoint event) as described in Borrower’s Clinical Study Protocol TRCA-303 (VALOR- CKD) for TRC 101 (a/k/a “Veverimer”), Amendment 2, dated November 18, 2020. “Investment” means any beneficial ownership (including stock, partnership or limited liability company interests) of or in any Person, or any loan, advance or capital contribution to any Person or the acquisition of any asset of another Person. “Joinder Agreements” means for each Qualified Subsidiary, a completed and executed Joinder Agreement in substantially the form attached hereto as Exhibit G. “Lender” has the meaning given to it in the preamble to this Agreement. “License” means any Copyright License, Patent License, Trademark License or other license of rights or interests. “Lien” means any mortgage, deed of trust, pledge, hypothecation, assignment for security, security interest, encumbrance, xxxx, xxxx or charge of any kind, whether voluntarily incurred or arising by operation of law or otherwise, against any property, any conditional sale or other title retention agreement, and any lease in the nature of a security interest. “Loan” means the Advances made under this Agreement. “Loan Documents” means this Agreement, the Notes (if any), the ACH Authorization, the Account Control Agreements, the Joinder Agreements, all UCC financing statements, the Warrant and any other documents executed in connection with the Secured Obligations or the transactions contemplated hereby, as the same may from time to time be amended, modified, supplemented or restated. “Material Adverse Effect” means a material adverse effect upon:
Sample 1
Interim Analysis means the pre-specified futility and safety analysis, as defined in the Special Protocol Assessment, on the first 70 adjudicated events which evaluate the probability of the PRESENT Trial to achieve its pre-specified objectives.
Sample 1

Related to Interim Analysis

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