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Life-threatening adverse event

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A life-threatening adverse event is defined by the Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP), and the Food and Drug Administration (FDA) as follows:

Life-threatening adverse event (DHHS OHRP): An Adverse Event (AE) that places the subject at immediate risk of death from the event as it occurred. OHRP: Unanticipated Problems Involving Risks & Adverse Events Guidance

Life-threatening adverse event (FDA IND): An adverse event or a suspected adverse reaction is considered life-threatening if, in the view of either the investigator or sponsor, its occurrence places the patient or subject at immediate risk of death. It does not include an adverse event or suspected adverse reaction that, had it occurred in a more severe form, might have caused death. FDA: 21 CFR 312.32, IND Safety Reporting; FDA: Safety Reporting Requirements for INDs and BA/BE Studies

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