" /> Life Threatening Adverse Event - CISMeF





Preferred Label : Life Threatening Adverse Event;

NCIt related terms : life-threatening adverse event/ experience; AESLIFE; Grade 4; Life-threatening adverse experience;

NCIt definition : An adverse event that has life-threatening consequences; for which urgent intervention is indicated; that puts the patient at risk of death at the time of the event if immediate intervention is not undertaken.;

Alternative definition : CDISC-GLOSS: Any adverse drug experience that places the patient or subject, in the view of the investigator, at immediate risk of death from the reaction as it occurred (i.e., it does not include a reaction that, had it occurred in a more severe form, might have caused death). [FDA 21 CFR 312.32; ICH-E2A];

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11/05/2024


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