Suspected Adverse Reaction definition

Suspected Adverse Reaction means any AE for which there is a reasonable possibility that the drug caused the event. “Reasonable possibility” means there is evidence to suggest a causal relationship between the drug and the adverse event.
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Suspected Adverse Reaction means any adverse event for which there is a reasonable possibility that the drug caused the adverse event. For the purposes of IND safety reporting, “reasonable possibility” means there is evidence to suggest a causal relationship between the drug and the adverse event. Suspected Adverse Reaction is further defined in 21 C.F.R. 312.32. [COMMENT: Check to make sure Suspected Adverse Reaction is the same definition as in the Protocol.]
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Suspected Adverse Reaction or “SAR” means an Adverse Event associated with the use of the Test Article pursuant to Section 21 C.F.R. Part 312.32.
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Examples of Suspected Adverse Reaction in a sentence

  • Agency Fund – funds used to report assets held by the municipal reporting entity in a purely custodial capacity (payroll clearing fund, county treasurer tax collection accounts, etc.).

  • Unexpected Suspected Adverse Reaction (21 CFR 312.32(a))An adverse event or suspected adverse reaction is considered “unexpected” if it is not listed in the investigator brochure or is not listed at the specificity or severity that has been observed; or, if an investigator brochure is not required or available, is not consistent with the risk information described in the general investigational plan or elsewhere in the current application, as amended.

  • Serious and Unexpected Suspected Adverse Reaction (SUSAR)Definition: A suspected adverse reaction to study treatment that is both serious and unexpected.

  • For expedited AEs, if applicable, the PI will submit follow up reports on additional expedited report forms.The PI or designee must comply with the specific reporting requirement(s) of the ethics committee, reporting as a minimum any Serious Unexpected Suspected Adverse Reaction (SUSAR) which is an unexpected SAE that may be related to study product or procedure.

  • Suspected Adverse Reaction: Any adverse event for which there is a reasonable possibility that the drug caused the adverse event.

  • An Unexpected Adverse Event or Unexpected Suspected Adverse Reaction is an adverse event or suspected adverse reaction that is not listed in the investigator brochure or is not listed at the specificity or severity that has been observed; or, if an investigator brochure is not required or available, is not consistent with the risk information described in the general investigational plan or elsewhere in the current application, as amended.

  • Suspected Adverse Reaction (SAR)An adverse event for which there is a reasonable possibility that the investigational agent caused the adverse event.

  • Suspected Adverse Reactions (SARs) 🛈A Suspected Adverse Reaction (SAR) is a harmful and unintended reaction which may be due to exposure to a veterinary medicine administered to an animal at its normal dose.

  • Serious and Unexpected Suspected Adverse Reaction (SUSAR)A SUSAR is a Suspected Adverse Reaction that is both Serious and Unexpected.

  • Adverse reactions are a subset of all suspected adverse reactions for which there is reason to conclude that the drug caused the event.Definition of Suspected Adverse Reaction: Any AE for which there is a reasonable possibility that the drug caused the AE.


More Definitions of Suspected Adverse Reaction

Suspected Adverse Reaction or “SAR” means any AE for which there is a reasonable possibility that the drug caused the AE. For the purposes of IND safety reporting, “reasonable possibility” means there is evidence to suggest a causal relationship between the drug and the AE. Suspected Adverse Reaction is further defined in 21 C.F.R. § 312.32.
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Suspected Adverse Reaction means the definition as stated in the Protocol.
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Suspected Adverse Reaction means any AE for which there is a reasonable possibility that the study drug caused the AE. “Reasonable possibility” means there is evidence to suggest a causal relationship between the study drug and the AE. Types of evidence that would suggest a causal relationship between the study drug and the AE include: a single occurrence of an event that is uncommon and known to be strongly associated with drug exposure (e.g. angioedema, hepatic injury, Stevens-Johnson Syndrome); one or more occurrences of an event that is not commonly associated with drug exposure, but is otherwise uncommon in the population exposed to the drug (e.g. tendon rupture); an aggregate analysis of specific events observed in a clinical trial (such as known consequences of the underlying disease or condition under investigation or other events that commonly occur in the study population independent of drug therapy) that indicates those events occur more frequently in the drug treatment group than in a concurrent or historical control group.
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Suspected Adverse Reaction means any AE for which there is a reasonable possibility that the IP caused the AE. “Reasonable possibility” means there is evidence to suggest a causal relationship between the IP and the AE. Types of evidence that would suggest a causal relationship between the IP and the AE include: a single occurrence of an event that is uncommon and known to be strongly associated with IP exposure (e.g., angioedema, hepatic injury, Stevens-Johnson Syndrome); one or more occurrences of an event that is not commonly
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Suspected Adverse Reaction means an Adverse Reaction from which either the reporter or Xxxxxxx believes there is at least a reasonable possibility of there being a causal relationship between the Adverse Reaction and the IMP in question.
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Suspected Adverse Reaction. (SAR) means any AE for which there is a reasonable possibility that the drug caused the AE. For purposes of IND safety reporting, "reasonable possibility" means there is evidence to suggest a causal relationship between the drug and the AE. “Suspected adverse reaction” implies a lesser degree of certainty about causality than “adverse reaction”, which means any AE caused by a drug.
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Related to Suspected Adverse Reaction

  • Serious Adverse Event means any adverse event that led to any of the following:

  • Adverse reaction means an unexpected outcome that threatens the health or safety of a patient as a result of a medical service, nursing service, or health-related service provided to the patient.

  • Material Adverse Event means an occurrence having a consequence that either (a) is materially adverse as to the business, properties, prospects or financial condition of the Company taken as a whole or (b) is reasonably foreseeable, has a reasonable likelihood of occurring and, if it were to occur, would materially adversely affect the business, properties, prospects or financial condition of the Company taken as a whole.

  • Adverse Event means any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with the treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.

  • Adverse impact means any deleterious effect on waters or wetlands, including their quality, quantity, surface area, species composition, aesthetics or usefulness for human or natural uses which are or may potentially be harmful or injurious to human health, welfare, safety or property, to biological productivity, diversity, or stability or which unreasonably interfere with the enjoyment of life or property, including outdoor recreation.

  • Company Material Adverse Change means a change (or circumstance involving a prospective change) in the business, operations, assets, liabilities, results of operations, cash flows, condition (financial or otherwise) or prospects of the Company which is materially adverse.

  • Adverse impact on visibility means visibility impairment which interferes with the management, protection, preservation or enjoyment of the visi- tor’s visual experience of the Federal Class I area. This determination must be made on a case-by-case basis taking into account the geographic extent, in- tensity, duration, frequency and time of visibility impairment, and how these factors correlate with (1) times of vis- itor use of the Federal Class I area, and(2) the frequency and timing of natural conditions that reduce visibility.

  • Deemed Material and Adverse Representation Each representation and warranty identified as such in Section 9.02 of this Agreement.

  • Adverse System Impact means a negative effect that compromises the safety or reliability of the electric distribution system or materially affects the quality of electric service provided by the electric distribution company (EDC) to other customers.

  • Adverse drug reaction means any undesirable or unexpected medication related event that requires discontinuing a medication or modifying the dose, requires or prolongs hospitalization, results in disability, requires supportive treatment, is life-threatening or results in death, results in congenital anomalies, or occurs following vaccination.

  • Final Adverse Benefit Determination means an adverse benefit determination that is upheld at the completion of a health plan issuer’s internal appeals process.

  • Serious means violations that either result in one or more neg- ative outcomes and significant actual harm to residents that does not constitute imminent danger, or there is a reasonable predictability of recurring actions, practices, situations, or incidents with potential for causing significant harm to a resident, or both.

  • Final Internal Adverse Benefit Determination means an Adverse Benefit Determination that has been upheld by BCBSTX at the completion of BCBSTX’s internal review/appeal process.

  • Unreasonable adverse effects on the environment means any unreasonable risk to humans or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide.

  • Buyer Material Adverse Effect means any material adverse change, event, circumstance or development with respect to, or any material adverse effect on, (a) the business, financial condition or results of operations of the Buyer and its Subsidiaries, taken as a whole, or (b) the ability of the Buyer or the Transitory Subsidiary to consummate the transactions contemplated by this Agreement.

  • Purchaser Material Adverse Effect means any material and adverse effect on (i) the ability of a Purchaser to meet its obligations under the Basic Documents on a timely basis or (ii) the ability of a Purchaser to consummate the transactions under any Basic Document.

  • Acute toxicity means concurrent and delayed adverse effects that result from an acute exposure and occur within any short observation period, which begins when the exposure begins, may extend beyond the exposure period, and usually does not constitute a substantial portion of the life span of the organism.

  • Final Adverse Determination means an Adverse Determination involving a Covered Service that has been upheld by Blue Cross and Blue Shield or its designated utilization review organization, at the completion of Blue Cross and Blue Shield's internal grievance process procedures.

  • Seller Material Adverse Effect means any event, change or effect that would reasonably be expected to prevent or materially delay the consummation by the applicable Seller of the Contemplated Transactions.

  • Company Material Adverse Effect means a material adverse effect on the assets, business, condition (financial or otherwise), results of operations or future prospects of the Company.

  • Competitively Sensitive Information means non-public information and data specific to a utility customer which the utility acquired or developed in the course of its provision of utility services. This includes, without limitation, information about which customers have or have not chosen to opt out of community choice aggregation service. (See D.97-12-088, App. A, Part I.D.)

  • SPAC Material Adverse Effect means any Effect that, individually or in the aggregate with all other Effects, is or would reasonably be expected to (a) have a material adverse effect on the business, condition (financial or otherwise), assets, liabilities or operations of the SPAC; or (b) prevent, materially delay or materially impede the performance by the SPAC or Merger Sub of their respective obligations under this Agreement or the consummation of the Merger or any of the other Transactions; provided, however, that none of the following shall be deemed to constitute, alone or in combination, or be taken into account in the determination of whether, there has been or will be a SPAC Material Adverse Effect: (i) any change or proposed change in or change in the interpretation of any Law (including any COVID-19 Measures) or GAAP; (ii) events or conditions generally affecting the industries or geographic areas in which the SPAC operates; (iii) any downturn in general economic conditions, including changes in the credit, debt, securities, financial or capital markets (including changes in interest or exchange rates, prices of any security or market index or commodity or any disruption of such markets); (iv) acts of war, sabotage, civil unrest, terrorism, epidemics, pandemics or disease outbreaks (including COVID-19) or any escalation or worsening of any such acts of war, sabotage, civil unrest, terrorism, epidemics, pandemics or disease outbreaks, or changes in global, national, regional, state or local political or social conditions; (v) any hurricane, tornado, flood, earthquake, natural disaster, or other acts of God; (vi) any actions taken or not taken by the SPAC as required by this Agreement or any Ancillary Agreement; (vii) any Effect attributable to the announcement or execution, pendency, negotiation or consummation of the Merger or any of the other Transactions (including any redemptions by any stockholders of the SPAC); or (viii) any actions or failures to take action, in each case, which the Company has requested or to which it has consented or which actions are contemplated by this Agreement, except in the cases of the foregoing clauses (i) through (iii), to the extent that the SPAC is materially and disproportionately affected thereby as compared with other participants in the industries in which the SPAC operates.

  • Adverse action means a home or remote state action.

  • Subscriber Material Adverse Effect means an event, change, development, occurrence, condition or effect with respect to Subscriber that would reasonably be expected to have a material adverse effect on Subscriber’s ability to consummate the transactions contemplated hereby, including the purchase of the Subscribed Shares.

  • Company Adverse Recommendation Change shall have the meaning set forth in Section 5.3(c).

  • Threatened species means any species which is likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range.