life-threatening adverse event

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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.

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References in periodicals archive ?

SIADH is a rare side effect of amiodarone and high index of suspicion is required to suspect this life threatening adverse event.

Corrigendum to "Amiodarone Induced Hyponatremia Masquerading as Syndrome of Inappropriate Antidiuretic Hormone Secretion by Anaplastic Carcinoma of Prostate"

Possible etiological reasons of this clinically significant and life threatening adverse event have been discussed.

Hyponatremia with olanzapine - A suspected association

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.

Asterias to distribute 3.15 million warrants to purchase common shares

MultiStem treatment was associated also with lower rates of mortality and life threatening adverse events (AEs), infections and pulmonary events.

Interim Phase 2 study shows Athersys' MultiStem stroke therapy is ineffective; law firm launches investigation after stock tanks on study results