life-threatening adverse event

(redirected from life threatening adverse event)

life-threatening adverse event

In the context of a clinical trail, any adverse drug response that the investigator believes places the patient or subject at immediate risk of death from the reaction as it occurred. This does not include a reaction that might have caused death had it occurred in a more severe form.
References in periodicals archive ?
STOCRIN should not be administered concurrently with astemizole, cisapride, triazolam, midazolam, or ergot derivatives because competition for CYP3A4 by efavirenz could result in inhibition of metabolism of these drugs and create the potential for serious and/or life threatening adverse events (e.