Serious AE definition

Serious AE means any untoward medical occurrence that at any dose: results in death; is life-threatening (defined as an event in which the subject or patient was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe); requires inpatient hospitalization or causes prolongation of existing hospitalizations; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; is an important medical event (defined as a medical event(s) that may not be immediately life-threatening or result in death or hospitalization, but based upon appropriate medical and scientific judgment, may jeopardize the patient/subject or may require intervention, e.g., medical surgical, to prevent one of the other serious outcomes listed in the definition above). Examples of such events include, but are not limited to, intensive treatment in an emergency room or at home for allergic bronchospasm; blood dyscrasias or convulsions that do not result in hospitalization. For reporting purposes, LMI also considers the occurrences of cancer, pregnancy, or overdose (accidental or intentional and regardless of adverse outcome) as events that must be expeditiously reported as important medical events.
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Serious AE. A serious AE is defined by Wyeth as an AE occurring at any dose that: results in death; is life-threatening (see below); requires inpatient hospitalization or prolongation of an existing hospitalization; results in a persistent or significant disability or incapacity (see below); results in cancer; results in a congenital anomaly or birth defect. Additionally, important medical events that may not result in death, be life-threatening, or require hospitalization may be considered a serious AE when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Examples of such medical events include allergic bronchospasm requiring intensive treatment in an emergency room or at home; blood dyscrasias or convulsions that do not result in hospitalization; or the development of drug dependency or abuse. 1.2.1 Life-threatening refers to immediate risk of death as the event occurred. A life-threatening experience does not include an experience that, had it occurred in a more severe form, might have caused death but as it actually occurred did not create an immediate risk of death. For example, hepatitis that resolved without evidence of hepatic failure would not be considered life-threatening even though hepatitis of a more severe nature can be fatal. Similarly, an allergic reaction resulting in angioedema of the face would not be life-threatening, even though angioedema of the larynx, allergic bronchospasm, or anaphylaxis can be fatal. 1.2.2 Disability is defined as a substantial disruption in a person's ability to conduct normal life functions. 1.2.3 For studies, all pregnancies and all overdoses will be reported to GSSE in the same time frame as serious AEs. 1.2.4 A serious AE obtained from tests in laboratory animals includes any experience suggesting a significant risk for human subjects, including any findings of mutagenicity, teratogenicity, or carcinogenicity. 1.2.5 If there is any doubt whether the information constitutes a serious AE, the information will be treated as a serious AE.
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Serious AE. A serious AE is defined by ESI as an AE occurring at any dose that: results in death; is life-threatening (see below); requires inpatient hospitalization or prolongation of an existing hospitalization; results in a persistent or significant disability or incapacity (see below); results in cancer; results in a congenital anomaly or birth defect. Additionally, IMPORTANT MEDICAL EVENTS that may not result in death, be life-threatening, or require hospitalization may be considered a serious AE when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Examples of such medical events include allergic bronchospasm requiring intensive treatment in an emergency room or at home; blood dyscrasias or convulsions that do not result in hospitalization; or the development of drug dependency or abuse. 1 51 1.2.1 Life-threatening refers to immediate risk of death as the event occurred. A life-threatening experience does not include an experience that, had it occurred in a more severe form, might have caused death but as it actually occurred did not create an immediate risk of death. For example, hepatitis that resolved without evidence of hepatic failure would not be considered life-threatening even though hepatitis of a more severe nature can be fatal. Similarly, an allergic reaction resulting in angioedema of the face would not be life-threatening, even though angioedema of the larynx, allergic bronchospasm, or anaphylaxis can be fatal.
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Examples of Serious AE in a sentence

  • In addition, Member shall provide Medical Imaging with immediate (or as soon as practicable) notification of any fatal or life-threatening Serious AE.

  • Member shall insure prompt follow-up as necessary to provide Medical Imaging with reasonably complete information known or otherwise available to Member with respect to any Serious AE, AEs, Product Quality Complaints or Special Situations.

  • If follow-up information is received after reporting a Serious AE, AE, Product Quality Complaint or Special Situation, Member also must report such information.

  • Serious AE (SAE) means any untoward medical occurrence that at any dose: • Results in death.

  • If an answering machine is encountered, a message should be left providing detailed information regarding such Serious AE and further attempts to speak directly with Supplier should be made.

  • All identified AEs must be recorded and described on the appropriate Non-serious or Serious AE page of the CRF.

  • If an answering machine is encountered, a message should be left providing detailed information regarding such Serious AE and further attempts to speak directly with LMI should be made.

  • In addition, Licensee shall provide LMI with immediate (or as soon as practicable) notification by telephone of any fatal or life-threatening Serious AE.

  • Serious AE related to this study could include: angioedema, anaphylactic reaction, and death.

  • Licensee shall insure prompt follow-up as necessary to provide LMI with reasonably complete information known or otherwise available to Licensee with respect to any Serious AE or AEs. If follow-up information is received after reporting an AE, Licensee also must report such information within 24 hours of the date that Licensee first became aware of such information.


More Definitions of Serious AE

Serious AE or “Serious SAR” means an AE or SAR that in the view of either the Investigator or Sponsor, results in any of the following outcomes:
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Serious AE means any adverse drug, biologic, or device experience occurring at any dose that results in any of the following outcomes: death, a life-threatening adverse drug experience, requires or prolongs in-patient hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. An important medical event that may not result in death, be life-threatening, or require hospitalization may be considered a Serious AE when, based upon appropriate medical judgment, it may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Examples of such medical events include allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood dyscrasias or convulsions that do not result in in-patient hospitalization or the development of drug dependency or drug abuse.
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Related to Serious AE

  • Serious harm means harm, whether physical or

  • 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.

  • Serious crime means conduct constituting an offence punishable by a maximum deprivation of liberty of at least four years or a more serious penalty;

  • 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.

  • 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.

  • Serious Breach means any breach defined as a Serious Breach in the Agreement or any breach or breaches which adversely, materially or substantially affect the performance or delivery of the Services or compliance with the terms and conditions of the Agreement or the provision of a safe, healthy and supportive learning environment or a breach of security that adversely affects the Personal Data or privacy of an individual. Failure to comply with Law, or actions or omissions by the Provider that endanger the Health or Safety of Learners, Provider Personnel, and all other persons including members of the public would constitute a Serious Breach;

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

  • serious criminal offence means an offence which corresponds or is equivalent to one of the offences referred to in Article 2(2) of Framework Decision 2002/584/JHA, if it is punishable under national law by a custodial sentence or a detention order for a maximum period of at least three years;

  • Serious damage ’ means any specific defect defined in this section; or an equally objectionable variation of any one of these defects, any other defect, or any combination of defects which se- riously detracts from the appearance, or the edible or marketing quality of the fruit. The following specific defects shall be considered as serious damage:

  • 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);

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

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

  • Serious offense means any of the following felonies or a felony attempt to commit any of the following felonies, as now existing or hereafter amended:

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

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

  • Mysterious Disappearance means any disappearance of Property which, after a reasonable investigation has been conducted, cannot be explained.

  • Serious Mental Illness . means the following mental disorders as classi­

  • Serious Misconduct means any misconduct identified as a ground for termination in the Motorola Code of Business Conduct, or the human resources policies, or other written policies or procedures.

  • Likelihood of serious harm means either: (a) A substantial

  • Infectious Disease means an illness that is capable of being spread from one individual to another.

  • Serious emotional disturbance means a diagnosable mental, behavioral, or emotional disorder affecting a minor that exists or has existed during the past year for a period of time sufficient to meet diagnostic criteria specified in the most recent Diagnostic and Statistical Manual of Mental Disorders published by the American Psychiatric Association and approved by the department and that has resulted in functional impairment that substantially interferes with or limits the minor's role or functioning in family, school, or community activities. The following disorders are included only if they occur in conjunction with another diagnosable serious emotional disturbance:

  • Noxious weed means a weed defined in 7-22-2101.

  • Serious injury means a significant overall impairment in the position of a domestic industry;

  • Felonious Assault means a violent or criminal act reported to the local authorities which was directed at you during the course of, or an attempt of, a physical assault resulting in serious injury, kidnapping, or rape.

  • Serious Medical Condition means, for the purpose of interpreting Overseas Emergency Medical Evacuation and Repatriation cover, a condition which in the opinion of the Company or its authorised representatives constitutes a serious or life threatening medical emergency requiring immediate evacuation to obtain urgent remedial treatment in order to avoid death or serious impairment to an Insured Person’s immediate or long-term health prospects. The seriousness of the medical condition will be judged within the context of the Insured Person’s geographical location and the local availability of appropriate medical care or facilities.