A serious adverse event (SAE) in human
drug trials is defined as any untoward medical occurrence that at any dose
#Results in death
#Is
life-threatening
#Requires inpatient
hospitalization
A hospital is a health care institution providing patient treatment with specialized health science and auxiliary healthcare staff and medical equipment. The best-known type of hospital is the general hospital, which typically has an emergency ...
or causes prolongation of existing hospitalization
#Results in persistent or significant disability/incapacity
#May have caused a congenital anomaly/birth defect
#Requires intervention to prevent permanent impairment or damage
The term "life-threatening" in the definition of "serious" refers to an event in which the patient was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe.
s are further defined as “Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.”
[
]
Research
Investigators in human clinical trials are obligated to report these events in clinical study reports. Research suggests that these events are often inadequately reported in publicly available reports. Because of the lack of these data and uncertainty about methods for synthesising them, individuals conducting systematic review
A systematic review is a scholarly synthesis of the evidence on a clearly presented topic using critical methods to identify, define and assess research on the topic. A systematic review extracts and interprets data from published studies on t ...
s and meta-analyses of therapeutic interventions often unknowingly overemphasise health benefit. To balance the overemphasis on benefit, scholars have called for more complete reporting of harm from clinical trials.
Related terms
Serious adverse reactions are serious adverse events judged to be related to drug therapy. A SUSAR (suspected unexpected serious adverse reaction) should be reported to a drug regulatory authority under an investigational license by using the CIOMS form (or in some countries an equivalent form). "Unexpected" means that for an authorised (approved) medicinal product that the event is not described in the product's labeling, or in the case of an investigational (unapproved) product that the event is not listed in the Investigator’s Brochure.
An adverse effect
An adverse effect is an undesired harmful effect resulting from a Pharmaceutical drug, medication or other Surgery#Definitions, intervention, such as surgery. An adverse effect may be termed a "side effect", when judged to be secondary to a main ...
is an adverse event which is believed to be caused by a health intervention.
Footnotes
See also
* Adverse event, including mild/minor
* Clinical trial
Clinical trials are prospective biomedical or behavioral research studies on human subject research, human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel v ...
* Good clinical practice (GCP)
* Data Monitoring Committees
* Pharmacovigilance
* EudraVigilance (European Union
The European Union (EU) is a supranational political and economic union of member states that are located primarily in Europe. The union has a total area of and an estimated total population of about 447million. The EU has often been ...
)
* Directive 2001/20/EC (European Union
The European Union (EU) is a supranational political and economic union of member states that are located primarily in Europe. The union has a total area of and an estimated total population of about 447million. The EU has often been ...
)
* TGN1412, a drug that had SAEs in a clinical trial
* BIA 10-2474, a drug that had SAEs, including a fatality, in a clinical trial
External links
What Is A Serious Adverse Event?
(MedWatch)
ClinicalTrials.gov
from US National Library of Medicine
The United States National Library of Medicine (NLM), operated by the United States federal government, is the world's largest medical library.
Located in Bethesda, Maryland, the NLM is an institute within the National Institutes of Health. It ...
ICH Website
{{DEFAULTSORT:Serious Adverse Event
Clinical research
Pharmaceutical industry
Drug safety