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, Medical Imaging 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 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.
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Serious AE. A serious AE is defined by AHPC 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.
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Examples of Serious AE in a sentence

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

  • In addition, all subjects will be followed up for 30 days after their last dose of study medication for the occurrence of any Serious AE.

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

  • Serious AE reports that are unrelated to the Activase will be transmitted to Genentech within thirty (30) calendar days of the Awareness Date.

  • Reasons for early termination may include the following:• Subject withdrew consent.• Significant AE that led the Investigator or subject to withdraw for safety reasons.• Serious AE, regardless of relationship to study medication.

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

  • The operating characteristics of the stopping rule are given in the Table 8 and are based on 5000 simulations: Toxicity stopping rule:• Serious AE in 2 out of 2 patients.

  • All AEs will be documented including• Severity (see 8.3.1: Severity for details)• Start and stop date• Causality assessment with study medication• Measures / action taken• Serious AE (yes/no)All AEs will be followed-up until resolution or the End of Study Visit and documented in CRF and subject’s medical file.

  • 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.

  • Any observed or reported Adverse Event (AE) regardless of treatment group or suspected causal relationship to the ClariVein RES investigational product will be reported as described in Section 10.7.For all AEs, the Investigator must pursue and obtain information adequate to determine the outcome of the AE; and to assess whether it meets the criteria for classification as a Serious AE (SAE).


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 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 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 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 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 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:

  • 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.

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

  • 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.