Suspected Unexpected Serious Adverse Reaction definition

Suspected Unexpected Serious Adverse Reaction. (or “SUSAR”) means all serious adverse events that are suspected to be related to an investigational medicinal product and that are unexpected.
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Suspected Unexpected Serious Adverse Reaction. (SUSAR) – means an adverse reaction, the nature and severity of which is not consistent with the applicable product information:
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Suspected Unexpected Serious Adverse Reaction or “SUSAR” shall mean any Serious Adverse Event, the nature, severity or frequency of which is not consistent with information in the most current investigator’s brochure, or with respect to a marketed product the most current Summary of Product Characteristics (SPC) or Package Insert.
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Examples of Suspected Unexpected Serious Adverse Reaction in a sentence

  • A SUSAR (Suspected, Unexpected Serious Adverse Reaction) is a subset of SAEs and will be reported to the appropriate regulatory authorities and investigators following local and global guidelines and requirements.

  • The focus of Suspected Unexpected Serious Adverse Reaction (SUSAR) reporting will be on those events that, based on a single case, are highly likely to be related to the study medication.

  • In the European Union (EU), an event meeting these criteria is termed a Suspected, Unexpected Serious Adverse Reaction (SUSAR).

  • Suspected Unexpected Serious Adverse Reaction (SUSAR) Any adverse reaction that is classed in nature as serious and which is not consistent with the information about the medicinal product in question set out in the SmPC or the Investigator’s Brochure (IB).

  • Suspected Unexpected Serious Adverse Reaction (SUSAR): any suspected AR related to an IMP that is both unexpected and serious.

  • Suspected Unexpected Serious Adverse Reaction (SUSAR)A serious adverse reaction, the nature and severity of which is not consistent with the information about the medicinal product in question set out in the in the Investigator’s Brochure (IB).

  • Suspected Unexpected Serious Adverse Reaction (SUSAR): any suspected adverse reaction which is both serious and unexpected (the nature or severity of which is not consistent with the information available to date).

  • Often SSIs do not fall within the definition of a Suspected Unexpected Serious Adverse Reaction (SUSAR), thus are not reported as SUSARs but require other action such as the reporting of an urgent safety measure (USM), an amendment, a temporary halt or early termination of a trial.

  • Suspected Unexpected Serious Adverse Reaction (SUSAR): any suspected adverse reaction related to an IMP that is both unexpected and serious.

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


More Definitions of Suspected Unexpected Serious Adverse Reaction

Suspected Unexpected Serious Adverse Reaction means serious adverse reaction that is not identified in practice, severity or frequency by the reference safety information;
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Suspected Unexpected Serious Adverse Reaction. OR “SUSAR”
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Related to Suspected Unexpected Serious 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.

  • Serious health condition means an illness, injury, impairment, or physical or mental condition that involves:

  • Serious harm means harm, whether physical or

  • Serious physical harm means bodily injury that involves a substantial risk of death, extreme physical pain, protracted and obvious disfigurement, or protracted loss or impairment of the function of a bodily member, organ, or mental faculty.

  • 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.

  • serious incident means any incident that directly or indirectly led, might have led or might lead to any of the following:

  • 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.

  • 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.

  • 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.

  • Serious illness means an accident, injury, illness, disease, or physical or mental condition that: poses imminent danger of death; requires inpatient care in a hospital, hospice, or residential medical facility; or requires continuing in-home care under the direction of a physician or health care provider. Related current definitions are summarized in (f) below.

  • 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.

  • Serious violation means OCC has made a valid finding when assessing a serious complaint that alleges:

  • Serious assault means an act that constitutes a felony violation of chapter XI of the Michigan penal code, 1931 PA 328, MCL 750.81 to 750.90h, or that constitutes an assault and infliction of serious or aggravated injury under section 81a of the Michigan penal code, 1931 PA 328, MCL 750.81a.

  • 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.

  • 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 or (b) is reasonably foreseeable, has a reasonable likelihood of occurring, and if it were to occur would reasonably be expected to materially adversely affect the business, properties, prospects or financial condition of the Company.

  • Serious traffic violation means a conviction when operating a commercial motor vehicle of:

  • serious offence means: (a) a crime or offence involving the death of a person; (b) a sex-related offence or a crime, including sexual assault (whether against an adult or child); child pornography, or an indecent act involving a child; (c) fraud, money laundering, insider dealing or any other financial offence or crime, including those under legislation relating to companies, banking, insurance or other financial services; or (d) an attempt to commit a crime or offence described in (a) to (c);

  • 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.