Life-threatening means that the subject was at immediate risk of death from the AE as it occurred or it is suspected that use or continued use of the product would result in the subject’s death. ‘Life-threatening’ does not mean that had an AE occurred in a more severe form it might have caused death (eg, hepatitis that resolved without hepatic failure).
Life-threatening means either or both of the following:
Life-threatening means a condition which is diagnosed by a physician as creating a substantial risk of death.
More Definitions of Life-threatening
Life-threatening means that the subject was at immediate risk of death from the event as it occurred. This does not include an event that might have led to death if it had occurred with greater severity.
Life-threatening means a disease or condition where the likelihood of death is high unless the course of the disease is interrupted or that has a potentially fatal outcome where the end point of clinical intervention is survival.
Life-threatening means any Acute Illness or Bodily Injury that is deemed immediately life- or limb- threatening by Specialty Emergency Services.
Life-threatening means that the subject was at immediate risk of death at the time of the serious adverse event; it does not refer to a serious adverse event that hypothetically might have caused death if it were more severe.
Life-threatening means a disease or condition from which the likelihood of death is probable unless the course of the disease or condition is interrupted.
Life-threatening. A disease or condition for which the likelihood of death is probable unless the course if the disease or condition is interrupted.
Life-threatening means a condition that is diagnosed by a physician as creating a substantial risk of death.