Clinical Event definition

Clinical Event means the occurrence of at least one patient being treated under the Phase II b clinical trial sponsored by the Company pursuant to Protocol VEGF2-CAD-CL-007, entitled “A Multicenter, Randomized, Double-Blind, Dose Ranging Placebo-Controlled Study Evaluating Defined Doses Of Percutaneously Delivered Via Boston Scientific Corporation Stiletto(tm) Endocardial Injection Catheter pVGI.1 (VEGF2) (Placebo, 20, 200, Or 800µG) In Patients With Class III Or IV Angina.
Sample 1Sample 2
Clinical Event means any action, or any adverse inspection or audit finding that would reasonably be expected to result in an action, by a governmental authority to place a clinical hold order on, or otherwise terminate, suspend or restrict in any material respect, any ongoing clinical trial conducted by MyoKardia or any of its subsidiaries with respect to any mavacamten, danicamtiv, MYK-224, LUS-1, ACT-1 and the early stage targets covered by MyoKardia’s genetic cardiomyopathy programs (each, a “Product”) which would reasonably be expected to result in a material delay or material impairment in the ability of MyoKardia to obtain any regulatory authorizations from any governmental authority relating to such Product. MyoKardia (a) will (i) give Parent the opportunity to participate in, but not control, the defense and settlement of any Transaction Litigation against MyoKardia or its directors relating to the Merger Agreement or the Transactions (to the extent that the attorney-client privilege is not undermined or otherwise adversely affected) and (ii) keep Parent reasonably informed with respect to the status thereof, and (b) will not offer or propose to settle, settle or agree to settle any such Transaction Litigation without Parent’s prior written consent (which will not be unreasonably withheld, conditioned or delayed).Lawsuits arising out of or relating to the Offer, the Merger or any other transactions referenced herein may be filed in the future.
Sample 1
Clinical Event means any action, or any adverse inspection or audit finding that would reasonably be expected to result in an action, by a Governmental Authority to place a clinical hold order on, or otherwise terminate, suspend or restrict in any material respect, any ongoing clinical trial conducted by the Company or any of its Subsidiaries with respect to any Product which would reasonably be expected to result in a material delay or material impairment in the ability of the Company to obtain any Regulatory Authorizations from any Governmental Authority relating to such Product.
Sample 1

Examples of Clinical Event in a sentence

  • Examples include Local Adverse Event Reviews (LAERs), Significant Clinical Event Analysis (SCEAs), action plans, and terms of reference.

  • Vertex shall provide CRISPR with reasonably detailed updates, in accordance with the notice procedures set forth in the Pharmacovigilance Agreement, about any such Specified Clinical Event.

  • Source information from clinical case notes and hospital medical records related to these events will be collected, sent to the ASPREE-XT Clinical Event Team and presented to adjudicators on the Cancer EAC.

  • Notwithstanding anything to the contrary in this Agreement or the Pharmacovigilance Agreement, Vertex will promptly notify CRISPR (and, in any event, within [***] Business Day), in accordance with the notice procedures set forth in the Pharmacovigilance Agreement, after Vertex or any Affiliate thereof becomes aware of the occurrence of any Specified Clinical Event (as hereinafter defined), and Vertex will provide CRISPR with reasonably detailed information regarding such Specified Clinical Event.

  • The primary safety endpoint was freedom from Major Adverse Events (MAE) through a 30-day follow-up period, as adjudicated by the Clinical Event Committee (CEC), defined as clinically driven target lesion revascularization (CDTLR), unplanned target limb amputation above the ankle, and cardiovascular deaths.

  • Clinical Event Review Process For any issues that are identified, regardless of how the issues are determined (i.e., whether found reactively or proactively), the process is as follows: • EMS Coordinator initiates an investigation and determines if there is reasonable cause to proceed.

  • Plans for the analysis of the quality of life and economic endpoints are addressed below in Sections 12.2.4 and 12.2.5. For other secondary endpoints, analysis will be similar to the primary endpoint, using time from randomization until the first occurrence of the specific secondary endpoint as the response variable.Unambiguous operational definitions of each study endpoint will be documented in the Clinical Event Committee Charter and statistical analysis plan before performing unblinded analysis.

  • Two of the other three independent directors also possess extensive banking experience, having held top executive and director positions at banks and financial institutions.

  • Clinical Event Monitoring (Pharmacovigilance) Mechanisms for surveillance of adverse events associated with the use of new TB control medicines and vaccines should be developed within the systems for monitoring adverse events for other medicines and vaccines, where they exist.

  • For this review, the reviewer utilized both the study reports, including the details of the proceedings of the SC, Clinical Event Review Committee [CERC] and DSMC in the appendices, as well as the data sets provided to us by the sponsor.

Related to Clinical Event

  • Medical event means an event that meets the criteria in 12VAC5-481-2080.

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • clinical evidence means clinical data and clinical evaluation results pertaining to a device of a sufficient amount and quality to allow a qualified assessment of whether the device is safe and achieves the intended clinical benefit(s), when used as intended by the manufacturer;

  • Phase III Clinical Trial means a human clinical trial, the principal purpose of which is to demonstrate clinically and statistically the efficacy and safety of a Licensed Product for one or more indications in order to obtain Marketing Approval of such Licensed Product for such indication(s), as further defined in 21 C.F.R. §312.21 or a similar clinical study in a country other than the United States.

  • Phase I Clinical Trial means a clinical trial conducted in healthy humans or patients, which clinical trial is designed to establish the safety, drug-drug interactions and/or pharmacokinetics of an investigational drug given its intended use, and to support continued testing of such drug in Phase II Clinical Trials.

  • 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.

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.

  • Phase 1 Clinical Trial means a Clinical Trial of a Product on sufficient numbers of normal volunteers and/or patients that is designed to establish that such Product is safe for its intended use and to support its continued testing in Phase 2 Clinical Trials. For purposes of this Agreement, ‘initiation’ of a Phase 1 Clinical Trial for a Product means the first dosing of such Product in a human subject in a Phase 1 Clinical Trial.

  • Phase III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]

  • 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.

  • Phase IV Clinical Trial means a Clinical Trial conducted after a Product achieves Regulatory Approval, carried out for purposes of conducting safety surveillance and ongoing technical support of the Product.

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Milestone Event has the meaning set forth in Section 8.4.

  • Development Milestone Event has the meaning set forth in Section 7.1.

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • 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;

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, or Pivotal Study, as applicable; but excluding any Post-Approval Studies.

  • Phase III Study means a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Clinical means having a significant relationship, whether real or potential, direct or indirect, to the actual rendering or outcome of dental care, the practice of dentistry, or the quality of dental care being rendered to a patient;

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • Clinical experience means providing direct services to individuals with mental illness or the provision of direct geriatric services or special education services. Experience may include supervised internships, practicums, and field experience.

  • Approved clinical trial means a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or Condition and is described in any of the following: