Definition of Adverse Event Sample Clauses

Definition of Adverse Event. Adverse event means any untoward medical occurrence associated with the use of an investigational product in humans, whether or not considered product-related. An adverse event (also referred to as an adverse experience) can be any unfavourable and unintended sign (e.g. an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product and does not imply any judgment about causality. An adverse event can arise with any use of the investigational product (e.g. off-label use, use in combination with another product) and with any route of administration, formulation, or dose, including an overdose. Medical conditions that exist prior to administration of the study vaccine (pre-existing conditions) will be recorded in the participant’s medical history to establish baseline. Day-to-day fluctuations in pre-existing conditions that do not represent a clinically significant change in the participant’s status will not necessarily be reported as adverse events. Any adverse change from the participant’s baseline condition (determined from screening evaluations conducted to confirm study eligibility) that occurs following the administration of the study vaccine will be considered an adverse event. This includes the occurrence of a new adverse event or the worsening of a baseline condition, whether or not considered related to the study vaccine. Intermittent conditions such as headaches in adults or irritability in infants may be present on study Day 0 but may represent an adverse event if the intensity or duration of the event is worse than usual following receipt of study vaccine. Adverse events include but are not limited to: adverse changes from baseline that represent increases in severity, adverse changes in the general condition of the participant, signs and symptoms noted by the participant, concomitant disease with onset or increased severity after study vaccine administration, and clinically significant changes in laboratory safety parameters occurring after study vaccine administration. 3.1. Solicited adverse events will be reported using pre-defined terms. Unsolicited adverse events will be reported using a recognised medical term or diagnosis that accurately reflects the event. Adverse event evaluations will be reviewed by the Principal Investigator or by a designated medically qualified practitioner. Adverse event information is to be completed by members of the study team designated in writing by the Pri...
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Definition of Adverse Event. An AE is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, whether or not the event has a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug. This definition includes intercurrent illnesses, accidents or injuries, exacerbations or preexisting conditions, changes on physical examination or physiological testing, abuse of drugs, or withdrawal reactions. [***] [***] Confidential Information Protocol version 1.1, 21 Aug 2012 Protocol XX-000-000 XX-000 [***]
Sample 1
Definition of Adverse Event. A "Serious Adverse Event" for the Product shall have the meaning set forth in 21 C.F.R. Section 314.80(a), as amended from time to time and a "Non-Serious Adverse Event" is defined as an untoward medical occurrence at any dose for the Product that is not a Serious Adverse Event.
Sample 1
Definition of Adverse Event. Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom (including an AE occurring from drug abuse, an AE occurring from drug withdrawal and any failure of expected pharmacological action), or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. An elective surgery/procedure scheduled to occur during a study will not be considered an adverse event if the surgery/procedure is being performed for a pre-existing condition and the surgery/procedure has been pre-planned prior to study entry. However, if the pre-existing condition deteriorates unexpectedly during the study (e.g. surgery performed earlier than planned), then the deterioration of the condition for which the elective surgery/procedure is being done will be considered an adverse event.
Sample 1

Related to Definition of Adverse Event

  • Determination of Adverse Consequences The Parties shall take into account the time cost of money (using the Applicable Rate as the discount rate) in determining Adverse Consequences for purposes of this §8. All indemnification payments under this §8 shall be deemed adjustments to the Purchase Price.

  • Absence of Adverse Changes From the date hereof until the Closing, there will have been no material adverse change in the financial or business condition of the Company.21

  • Notice of Adverse Change Recipient shall promptly notify OBDD of any adverse change in the activities, prospects or condition (financial or otherwise) of Recipient or the Project related to the ability of Recipient to perform all obligations required by this Contract.

  • No Adverse Events Between the date hereof and the Closing Date, neither the business, assets or condition, financial or otherwise, of the Company taken as a whole shall have been materially adversely affected in any manner.

  • Financial Statements; No Material Adverse Effect; No Internal Control Event (a) (i) The Audited Financial Statements (i) were prepared in accordance with GAAP consistently applied throughout the period covered thereby, except as otherwise expressly noted therein; (ii) fairly present the financial condition of Borrower and its Consolidated Subsidiaries as of the date thereof and their results of operations for the period covered thereby in accordance with GAAP consistently applied throughout the period covered thereby, except as otherwise expressly noted therein; and (iii) show all material indebtedness and other liabilities, direct or contingent, of Borrower and its Consolidated Subsidiaries as of the date thereof, including liabilities for taxes, material commitments and Indebtedness. (b) The unaudited consolidated balance sheets of Borrower and its Consolidated Subsidiaries dated August 31, 2006, and the related consolidated statements of income or operations, shareholders’ equity and cash flows for the fiscal quarter ended on that date (i) were prepared in accordance with GAAP consistently applied throughout the period covered thereby, except as otherwise expressly noted therein, and (ii) fairly present the financial condition of Borrower and its Consolidated Subsidiaries as of the date thereof and their results of operations for the period covered thereby, subject, in the case of clauses (i) and (ii), to the absence of footnotes and to normal year-end audit adjustments. (c) Since the date of the Audited Financial Statements, there has been no event or circumstance, either individually or in the aggregate, that has had or could reasonably be expected to have a Material Adverse Effect. (d) To the best knowledge of Borrower, no Internal Control Event exists or has occurred since the date of the Audited Financial Statements that has resulted in or could reasonably be expected to result in a misstatement in any material respect, in any financial information delivered or to be delivered to Agent or Lenders, of (i) covenant compliance calculations provided hereunder or (ii) the assets, liabilities, financial condition or results of operations of Borrower and its Subsidiaries on a consolidated basis. (e) The forecasted balance sheet and statements of income and cash flows of Borrower and its Consolidated Subsidiaries delivered pursuant to Section 6.01(c) were prepared in good faith on the basis of the assumptions stated therein, which assumptions were fair in light of the conditions existing at the time of delivery of such forecasts, and represented, at the time of delivery, Borrower’s best estimate of its future financial condition and performance.

  • No Adverse Interpretation of Other Agreements This Indenture may not be used to interpret another indenture, loan or debt agreement of the Company or any of its Subsidiaries. Any such indenture, loan or debt agreement may not be used to interpret this Indenture.

  • Absence of Material Adverse Changes No material adverse change in the business, assets, financial condition, or prospects of the Company shall have occurred, no substantial part of the assets of the Company not substantially covered by insurance shall have been destroyed due to fire or other casualty, and no event shall have occurred which has had or will have a material adverse effect on the business, assets, financial condition or prospects of the Company.

  • Notice of Adverse Claims Except for the claims and interests of the Secured Party and the Lien Grantor in the Securities, the Issuer does not know of any claim to, or interest in, the Securities. If any person asserts any lien, encumbrance or adverse claim (including any writ, garnishment, judgment, attachment, execution or similar process) against the Securities, the Issuer will promptly notify the Secured Party and the Lien Grantor thereof.

  • Absence of Material Adverse Change On the Closing Date, no circumstance shall exist that constitutes a REIT II Material Adverse Effect.

  • No Material Adverse Event Since the respective dates as of which information is disclosed in the Registration Statement, the Prospectus and the Incorporated Documents, except as otherwise stated therein, there shall not have been (i) any change or decrease in previously reported results specified in the letter or letters referred to in paragraph (d) of this Section 6 or (ii) any change, or any development involving a prospective change, in or affecting the condition (financial or otherwise), earnings, business or properties of the Company and its subsidiaries taken as a whole, whether or not arising from transactions in the ordinary course of business, except as set forth in or contemplated in the Registration Statement, the Prospectus and the Incorporated Documents (exclusive of any amendment or supplement thereto) the effect of which, in any case referred to in clause (i) or (ii) above, is, in the sole judgment of the Manager, so material and adverse as to make it impractical or inadvisable to proceed with the offering or delivery of the Shares as contemplated by the Registration Statement (exclusive of any amendment thereof), the Incorporated Documents and the Prospectus (exclusive of any amendment or supplement thereto).

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