An adverse event that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect. Medical events that do not result in death, are not life-threateni...
Found on
https://clinicaltrials.gov/ct2/about-studies/glossary
A regulatory term defined as any untoward medical occurrence that at any dose: results in death; requires inpatient hospitalisation or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or, is life-threatening. For more information, see here.
Found on
https://vaccine-safety-training.org/glossary.html
This is not a regulatory term. It refers to vaccine reactions that usually do not result in long-term problems, but can be disabling and, rarely, life threatening. Severe reactions include serious reactions but also include other severe reactions.
Found on
https://www.futurelearn.com/info/courses/the-role-of-vaccines-in-preventing
An adverse event that is life-threatening, requires hospitalization or extended hospital stay, results in ongoing or significant incapacity, causes congenital anomalies or birth defects, or results in death.
Found on
https://www.novartis.com/clinicaltrials/glossary-clinical-trial-terms
No exact match found.
