Definition of Serious Adverse Events Sample Clauses

Definition of Serious Adverse Events. A SAE is defined as an AE that meets at least 1 of the following serious criteria:  Fatal  Life threatening (places the subject at immediate risk of death)  Requires in patient hospitalization or prolongation of existing hospitalization  An AE would meet the criterion of “requires hospitalization” if the event necessitated an admission to a healthcare facility (eg, overnight stay).  Events that require an escalation of care when the subject is already hospitalized should be recorded as an SAE. Examples of such events include movement from routine care in the hospital to the intensive care unit (ICU) or if that event resulted in a prolongation of the existing planned hospitalization.  Results in persistent or significant disability/incapacity  Congenital anomaly/birth defect  Other medically important serious event  If an investigator considers an event to be clinically important, but it does not meet any of the serious criteria, the event could be classified as an SAE with the criterion of “other medically important serious event.”  The terms “severe” and “serious” are not synonymous. Severity refers to the intensity of an adverse event according to NCI CTCAE criteria; the event itself may be of relatively minor medical significance and, therefore, may not meet the seriousness criteria. Severity and seriousness need to be independently assessed for each adverse event recorded on the CRF.  Progression of the malignancy during the study should not be reported as a AE. However, signs and sympotms of disease progression may be recorded as AEs or SAEs and indicated as being due to disease progression in the CRF. If the malignancy has a fatal outcome before the end of the SAE reporting period, the the event leading to the death must be recorded as an SAE with the outcome of being fatal.
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Definition of Serious Adverse Events. A serious adverse event (SAE) is defined as an AE that meets at least one of the following serious criteria: • Results in death; • Is life-threatening; • Requires in-participant hospitalization or prolongation of existing hospitalization; • Results in persistent or significant disability / incapacity; • Is a congenital anomaly / birth defect; • Is an important medical event. Death is an outcome of a SAE, and not a SAE in itself. All deaths must be reported for participants on study and for deaths occurring within 30 days of last study drug(s) administration or within 30 days of last study evaluation, whichever is longer, to ensure immediate reporting to all appropriate regulatory bodies within the required timelines as applicable. The Investigator should provide any additional requested information as available (e.g. autopsy reports and terminal medical reports). The term “life-threatening” in the definition of “serious” refers to an event in which the participant was at immediate 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 serious. Hospitalization is defined as the participant being hospitalized overnight, or the participant’s hospital stay being prolonged for at least an additional overnight stay. Hospital admissions for a pre-existing condition or for normal disease management procedures (e.g. chemotherapy) will not be considered a SAE. Complications that occur during hospitalizations, prolonging hospitalization by ≥ 24 hrs are an SAE. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered to be SAEs when, based upon appropriate medical judgment, they may jeopardize the study participant 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, or the development of drug dependency or drug abuse.

Related to Definition of Serious Adverse Events

  • Serious Health Condition An illness, injury, impairment, or physical or mental condition which warrants the participation of a family member to provide care during a period of treatment or supervision and involves either inpatient care in a hospital, hospice or residential health care facility or continuing treatment or continuing supervision by a health care provider (e.g. physician or surgeon) as defined by state and federal law.

  • Definition of Service Fast Post‐Fault Active Power Recovery is the recovery of a Providing Unit’s MW Output to at least 90% of its pre‐Fault Disturbance MW Output within 250ms of the voltage at the Providing Unit’s Connection Point recovering to at least 90% of its pre‐Fault Disturbance value for any Fault Disturbance that is cleared within 900ms. The Providing Unit must be exporting Active Power to the Power System and must remain connected to the Power System for at least 15 minutes following the Fault Disturbance.

  • Mitigation of Harmful Effects To mitigate, to the extent practicable, any harmful effect 8 that is known to CONTRACTOR of a use or disclosure of DHCS PI or PII by CONTRACTOR or its 9 subcontractors in violation of this Personal Information Privacy and Security Contract.

  • Adverse Events Subsequent to the date hereof, there shall not have occurred any of the following: (i) a suspension or material limitation in trading in securities generally on the New York Stock Exchange, the NASDAQ National Market or the NASDAQ Global Market, (ii) a general moratorium on commercial banking activities in the People’s Republic of China or New York, (iii) the outbreak or escalation of hostilities involving the United States or the People’s Republic of China or the declaration by the United States or the People’s Republic of China of a national emergency or war if the effect of any such event specified in this clause (iii) in your reasonable judgment makes it impracticable or inadvisable to proceed with the public offering or the delivery of the Shares on the terms and in the manner contemplated in the Prospectus, or (iv) such a material adverse change in general economic, political, financial or international conditions affecting financial markets in the United States or the People’s Republic of China having a material adverse impact on trading prices of securities in general, as, in your reasonable judgment, makes it impracticable or inadvisable to proceed with the public offering of the Shares or the delivery of the Shares on the terms and in the manner contemplated in the Prospectus.

  • Serious Illness Should a participant be unable to take the leave when scheduled because of serious injury or illness occurring before commencement of the leave, he/she may cancel the leave and receive payment as in Article 12.8.3.9 or, with the consent of the College, defer the leave to a time mutually agreeable, not to exceed one (1) year.

  • Professional Development; Adverse Consequences of School Exclusion; Student Behavior The Board President or Superintendent, or their designees, will make reasonable efforts to provide ongoing professional development to Board members about the adverse consequences of school exclusion and justice-system involvement, effective classroom management strategies, culturally responsive discipline, appropriate and available supportive services for the promotion of student attendance and engagement, and developmentally appropriate disciplinary methods that promote positive and healthy school climates, i.e., Senate Bill 100 training topics. Board Self-Evaluation The Board will conduct periodic self-evaluations with the goal of continuous improvement. New Board Member Orientation The orientation process for newly elected or appointed Board members includes:

  • Definition of Seniority Seniority shall be defined as the length of an employee's continuous service with the Employer, commencing with his/her last date of full-time hire. The application of seniority shall be limited to the preferences specifically recited in this Agreement.

  • Infectious Disease Where an employee produces documentary evidence that:

  • Definition of a Grievance A grievance is defined as a dispute or disagreement as to the interpretation or application of the specific terms and conditions of this Agreement.

  • Effect of cessation or determination of Agreement 35. (1) On the cessation or determination of this Agreement —

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