Clinical Adverse Event (AE)
A Clinical Adverse Event (AE) is a negative health event that occurs during clinical treatment.
- Context:
- It can be reported by a Adverse Event Reporting System.
- It can range from being a Clinical Research AE to being a Clinical Treatment AE.
- It can be predicted by a Clinical Adverse Event Prediction System (that solves an AE prediction task).
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- Example(s):
- Counter-Example(s):
- See: Clinical Trial, Clinical Research, Good Clinical Practice (GCP), Yellow Card Scheme, Manufacturer and User Facility Device Experience (MAUDE) Database.
References
2021a
- (Davis, 2021) ⇒ https://www.medicinenet.com/adverse_event/definition.htm Reviewed on 3/29/2021.
- QUOTE: In pharmacology, any unexpected or dangerous reaction to a drug or vaccine.
2021b
- (Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/Adverse_event Retrieved:2021-11-13.
- An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
AEs in patients participating in clinical trials must be reported to the study sponsor and if required could be reported to local ethics committee. Adverse events categorized as "serious" (results in death, illness requiring hospitalization, events deemed life-threatening, results in persistent or significant disability/incapacity, a congenital anomaly/birth defect or medically important condition) must be reported to the regulatory authorities immediately, whereas non-serious adverse events are merely documented in the annual summary sent to the regulatory authority.
The sponsor collects AE reports from the local researchers, and notifies all participating sites of the AEs at the other sites, as well as both the local investigators' and the sponsors' judgment of the seriousness of the AEs. This process allows the sponsor and all the local investigators access to a set of data that might suggest potential problems with the study treatment while the study is still ongoing.
- An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
2021c
- (Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/Glossary_of_clinical_research Retrieved:2021-11-13.
- Adverse event
- An unexpected medical problem that happens during treatment with a drug or other therapy. Adverse events do not have to be caused by the drug or therapy, and they may be mild, moderate, or severe. (NCI)
- An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product (see the ICH guidance for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting). (ICH E6)
- Adverse event
2021d
- (ClinicalTrials.gov, 2021) ⇒ https://www.clinicaltrials.gov/ct2/about-studies/glossary Retrieved:2021-11-13.
- QUOTE: Adverse event
- An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of time after the study has ended. This change may or may not be caused by the intervention/treatment being studied.
- QUOTE: Adverse event
2021e
- (Novartis, 2021) ⇒ https://www.novartis.com/clinicaltrials/glossary-clinical-trial-terms Retrieved:2021-11-13.
- QUOTE: Adverse Event
- A negative change or medical occurance that happens during a clinical trial or within a certain time period after the trial has ended. An adverse event may or may not be caused by the treatment being studied.
- QUOTE: Adverse Event