Primary Endpoint means the primary endpoint specified in the protocol for […***…], as the same may be amended from time-to-time.
Primary Endpoint means, with respect to a clinical trial, the point at which the primary efficacy objective has been achieved with respect to a clinical or microbiological outcome as specified in the protocol for such trial, unless otherwise agreed by the Parties in writing.
Primary Endpoint means, with respect to a clinical trial, the point at which equivalence to the comparator agent has been achieved with respect to a clinical or microbiological outcome as specified in the protocol for such trial as set forth in Exhibit A, unless otherwise agreed by the Parties in writing.
Examples of Primary Endpoint in a sentence
Recruitment and enrollment will continue until 76 participants have completed the Primary Endpoint.
Subject perceptions about experimental sessions will be collected from each active dose subject at the Primary Endpoint after unblinding and the two-month follow-up in Stage 1.
Primary Endpoint: Safety and Tolerability Results OV935 achieved the primary endpoint of safety and tolerability as measured by incidence of AEs. AEs in patients treated with OV935 were similar to those who received placebo in Part 1.
The Primary Endpoint of the trial is the Total Symptom Score (TSS) response rate of momelotinib compared to danazol at Week 24 (99% power; p-value < 0.05).
Primary Endpoint Analysis Plan: Confirmed PSA response rates and the corresponding binomial confidence intervals will be reported for each arm.
More Definitions of Primary Endpoint
Primary Endpoint means, with respect to a Phase II Clinical Trial, the point at which positive statistical significance has been achieved with respect to the primary endpoint specified in the protocol for such trial.
Primary Endpoint means, with respect to Part 2 of the PERSIST Trial, [ * * *].
Primary Endpoint means the main result that is measured at the end of a Clinical Trial to determine whether a given treatment has worked (e.g., the difference in survival between a treatment group and a control group), which shall be predefined in the protocol for such Clinical Trial.
Primary Endpoint means, upon an analysis of the intent-to-treat population, either (a) (i) with respect to XPORT-MF-034 (NCT04562389), the proportion of participants with spleen volume reduction shall be at least 35% at week 24 and the proportion of participants with total symptom score reduction shall be at least 50% at week 24 (as measured by Myelofibrosis Symptom Assessment Form V4.0) and (ii) with respect to XPORT-EC-042 (NCT05611931), the investigator has assessed Progression Free Survival in accordance with Response Evaluation Criteria in Solid Tumors v1.1., (b) prior to the statistical analysis assessment and upon written request by the Company to the Lenders, such other endpoint as the Requisite Lenders may agree or (c) with respect to XPORT-MF-034 (NCT04562389) and prior to the statistical analysis assessment, such other primary endpoint that the Company has publicly updated pursuant to a Form 8-K filed with or furnished to the SEC.
Primary Endpoint. The primary endpoint is based on the mean reduction in total length of operative time. Operative time will be determined by the official recorded operative notes. Secondary Endpoints: Secondary endpoints include: • Length of stay o Aim: Decrease length of hospital stay o Measured: Time (Hours) • Length of time for initial image processing o Aim: Decrease disturbance to surgeon workflow o Measured: Time (Minutes) • Length of time to place all screws o Aim: Reduce the time for screw placement o Measured: Time (Minutes) • Length of time to confirm screw placement o Aim: Reduce the time needed for confirmation of screw location o Measured: Time (Minutes) • Length of time to register images o Aim: To reduce time for registration of reference images o Measured: Time (Seconds) • Estimated Blood Loss (EBL) o Aim: To reduce the EBL of each case o Measured: Milliliters (mL) • Incidence of Malalignment o Aim: To decrease the incidence of pedicle screw malalignment o Measured: Misalignment angle between pilot hole and screw trajectory (degrees) • Complications: Neurological Deficits, Dural Tears, deep wound infections, etc. o Aim: To decrease the incidence of intraoperative complications o Measured: number of reported complications while hospitalized • Measurement of 2D fluoroscopy radiation exposure o Aim: to reduce patient and surgeon exposure to radiation o Measured: Exposure measured by Dose Area Product (DAP)
Primary Endpoint means each of the primary efficacy endpoints within the PIN Trial and ADT Trial, respectively, as set forth in the respective SPA approved by the FDA for each such trial and the protocol for each such trial encompassed within each such SPA. [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
Primary Endpoint means that Xxxxxxxx’s EDP 2939 Product demonstrates superiority over a placebo on the portion of patients participating in Borrower’s EDP Trial who achieve a fifty percent (50%) improvement over the baseline in Psoriasis Area and Severity Index score (also known as a PASI-50 response) after sixteen (16) weeks of administration of such EDP 2939 Product in the EDP Trial for at least one dose level evaluated.”