Serious Adverse Event (SAE) Serious Adverse Event (SAE)
A health issue that happens during a study, and can lead to hospital care, lasting medical problems, life-threatening conditions, or death.
Example of Serious Adverse Event (SAE) in a sentence
A Serious Adverse Event in a study is usually something very concerning that was not expected.
More Info
Serious Adverse Events (SAEs) are health problems that may result in death, an inpatient hospital stay or longer hospitalization, a life-threatening event, a disability happening, or a birth defect in a baby. An SAE may or may not be related to the study treatment.
There are sometimes new SAEs that could occur that even the study team does not know about yet. The study staff will collect this information from participants to keep track and figure out if it needs to be included in future study informed consent forms.
In contrast to a Serious Adverse Event, an “adverse reaction” is determined to be related to a study treatment.
Other info to think about when joining a study
You may learn about potential Serious Adverse Events during the consent process if they are known. You could also learn about them during or after the research study if they are discovered later.
When you are in a research study, it is important to contact the study team if you have any new health problems whether or not they are serious. This is important for your safety and allows the study team to also monitor the other study participants. You can ask about adverse events, and Serious Adverse Events, before joining or during a study.
