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 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 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, which is toxicity, will be assessed by number of adverse events (AEs).
For this and more comprehensive risks related to Innovate’s intellectual property, please see “Risk Factors — Risks Related to Innovate’s Intellectual Property.” CeD PRO: Copyrighted Primary Endpoint for Celiac Disease Tested in a Successful Clinical Trial The patient reported outcome (PRO) primary end point for celiac disease (CeD PRO).
More Definitions of Primary Endpoint
Primary Endpoint means the primary endpoint specified in the protocol for […***…], as the same may be amended from time-to-time.
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 the primary endpoint specified in the protocol for [*], as the same may be amended from time-to-time. [*] 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. CONFIDENTIAL – EXECUTION VERSION (b) Notwithstanding the foregoing, if following the achievement of milestone [*], ASLAN elects to discontinue all further development of the Product for [*], then provided that ASLAN promptly notifies Array of such decision (which notice must in any event be provided prior to the date upon which the payment for milestone [*] is due), then ASLAN’s payment obligation with respect to such milestone will be suspended, provided that should ASLAN elect at any point in the future to resume development of the Product [*], the corresponding $[*] payment associated with such milestone shall become immediately due and payable.
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, with respect to Part 2 of the PERSIST Trial, [ * * *].
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 the primary efficacy endpoint, which is the mean post-filter activated clotting time (ACT) composed of measurements made at 1, 4, 16, and 24 hours post-CRRT initiation for the Niyad group as compared to the mean activated clotting time (ACT) composed of measurements made at 1, 4, 16, and 24 hours post-CRRT initiation for the placebo group.