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Life Threatening or Disabling Adverse Event
Definition 1
Any adverse event that places the patient, in the view of the initial reporter, at immediate risk of death from the adverse event as it occurred, i.e., it does not include an adverse experience that, had it occurred in a more severe form, might have caused death. (NCI Thesaurus)
Definition 2
An adverse event, and/or its immediate sequelae, which is associated with an imminent risk of death or which is associated with physical or mental disabilities that affect or limit the ability of a person to perform activities of daily living (eating, ambulation, toileting, etc.) See NCI Common Terminology Criteria for Adverse Events. (NCI Thesaurus/CDISC)
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