DEFINITION OF A SERIOUS ADVERSE EVENT Sample Clauses

DEFINITION OF A SERIOUS ADVERSE EVENT. A Serious Adverse Event (SAE) is defined as an AE that results in any of the following: • Death • Life-threatening • Requires hospitalization or prolongs existing hospitalization • Results in persistent or significant disability or incapacity • Results in a congenital abnormality or birth defect • An important medical event which requires medical intervention to prevent any of the above outcomes Important medical events are those which may not be immediately life-threatening, but may jeopardize the subject and may require intervention to prevent one of the other serious outcomes listed above. Examples of such events are intensive treatment in an emergency room or at home for allergic bronchospasm; blood dyscrasias or convulsions that do not result in hospitalization. Inpatient hospitalization or prolongation of existing hospitalization means that hospital inpatient admission and/or prolongation of hospital stay were required for treatment of AE, or that they occurred as a consequence of the event. It does not refer to pre-planned elective hospital admission for treatment of a pre-existing condition that has not significantly worsened, or to diagnostic procedures. The term "life-threatening" in the definition of "serious" refers to an event in which the subject 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. The term “disability” in the definition of “serious” refers to an event in which the subject’s ability to conduct normal life functions was substantially disrupted.
Sample 1
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Related to DEFINITION OF A SERIOUS ADVERSE EVENT

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