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.
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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.TABLE OF CONTENTSMyoKardia (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.
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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.
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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.

  • 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.

  • 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.

  • Relevant hospital medical records will be collected, sent to the ASPREE-XT Clinical Event Team and presented to adjudicators of the Depression EAC.

  • 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.

  • Therefore, some safety events reported on Day 8 were incorrectly reported as solicited adverse events in the Clinical Event dataset.

  • 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.

  • 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.

  • 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.

  • The Clinical Event Report Form (Appendix A) will be used for documentation and must be completed within 24 hours of the event.

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 large, controlled or uncontrolled Clinical Study that would satisfy the requirements of 21 CFR 312.21(c), intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling.

  • Phase I Clinical Trial means a study in humans which provides for the first introduction into humans of a product, conducted in normal volunteers or patients to generate information on product safety, tolerability, pharmacological activity or pharmacokinetics, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(a) or its foreign equivalents.

  • 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 Study in any country which is conducted after Regulatory Approval of a product has been obtained from an appropriate Regulatory Authority, consisting of trials conducted voluntarily for enhancing marketing or scientific knowledge of an approved indication and trials conducted due to 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 IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.

  • 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 trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.

  • Pivotal Clinical Trial means a pivotal human clinical trial of a Licensed Product with a defined dose or a set of defined doses of such Licensed Product designed to ascertain efficacy and safety of such Licensed Product for the purpose of enabling the preparation and submission of an MAA to the competent Regulatory Authorities in a country of the Territory, as further defined in 21 C.F.R. § 312.21(c) for the U.S., as amended from time to time, or the corresponding foreign regulations.

  • Phase IV Clinical Trial means a product support clinical trial of a Product commenced after receipt of Regulatory Approval in the country where such trial is conducted. A Phase IV Clinical Trial may include epidemiological studies, modeling and pharmacoeconomic studies, and investigator-sponsored clinical trials studying Product that are approved by BMS and that otherwise fit the foregoing definition.

  • 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, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

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

  • Development Milestone Event shall have the meaning set forth in Section 9.2(a).

  • 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, as applicable.

  • 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 Xxxxx 0, Xxxxx 0, Xxxxx 0, Xxxxx 3, and such other tests and studies in human subjects that are required by Applicable Law, or otherwise recommended by the Regulatory Authorities, to obtain or maintain Regulatory Approvals for a Licensed Product for one (1) or more indications, including tests or studies that are intended to expand the Product Labeling for such Licensed Product with respect to such indication.

  • 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.