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 ?
Treatment with MultiStem was well tolerated and safe, and there was reduction in life threatening adverse events, infections and mortality among subjects receiving cell therapy, in comparison to placebo.
MultiStem treatment was associated also with lower rates of mortality and life threatening adverse events (AEs), infections and pulmonary events.
No potentially life threatening adverse events were reported as of February 24.