Serious Adverse Event definition

Serious Adverse Event means any adverse event that led to any of the following:

Serious Adverse Event has the meaning given in the TGA document “Access to Unapproved Therapeutic Goods – Clinical Trials in Australia” (October 2004) or its replacement.

Serious Adverse Event means an adverse event that may significantly compromise clinical outcomes or an adverse event for which a facility fails to take appropriate corrective action in a timely manner.

Examples of Serious Adverse Event in a sentence

• Information about all SAEs is collected and recorded on the Serious Adverse Event Report Form.

• Serious Adverse Event SAE is generally defined as any untoward medical occurrence that ● results in death● is life threatening● requires inpatient hospitalization or prolongation of existing hospitalization● results in persistent or significant disability/incapacity, or is● a congenital anomaly or birth defect.

• Any Serious Adverse Event (SAE) that occurs must be reported to the University of Michigan IRB (IRBMED) according to the IRBMED reporting guidelines.

• Any Serious Adverse Event that occurs more than 30 days after the last administration of the investigational agent/intervention and has an attribution of a possible, probable, or definite relationship to the study therapy must be reported according to the CTEP-AERS reporting tables in this protocol.

• Any death occurring through the end of the study (30 days following the intervention), regardless of the degree of relationship to study, must be reported as a Serious Adverse Event.

More Definitions of Serious Adverse Event

Serious Adverse Event means an adverse drug experience or circumstance that results in any of the following outcomes (a) death, (b) life-threatening condition, (c) inpatient hospitalization or a significant prolongation of existing hospitalization, (d) persistent or significant disability or incapacity or substantial disruption of the ability to conduct normal life functions, (e) or a congenital anomaly/birth defect or (f) significant intervention required to prevent permanent impairment or damage.

Serious Adverse Event means any untoward medical occurrences that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly or birth defect.

Serious Adverse Event means any untoward medical occurrence that at any dose:

Serious Adverse Event means any untoward medical occurrence that at any dose requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, results in a congenital anomaly or birth defect, is life-threatening, or results in death;

Serious Adverse Event. (“SAE”) and “Serious Adverse Drug Reaction” (“SADR”) shall have the meanings provided to such terms in the International Conference on Harmonization (“ICH”) guideline for industry on Clinical Safety Data Management (E2A, Definitions and Standards for Expedited Reporting).

Serious Adverse Event means any untoward occurrence associated with the collection, testing, processing, storage and distribution, of blood and blood components that might lead to death or life-threatening, disabling or incapacitating conditions for patients or which results in, or prolongs, hospitalisation or morbidity;

Serious Adverse Event has the meaning given in the TGA document 'Australian Guideline for Pharmacovigilance Responsibilities of Sponsors of Registered Medicines Regulated by Drug Safety and Evaluation Branch' or its replacement.