Serious adverse event
{{short description|Negative medical occurrence during a human drug trial}}
In drug development, serious adverse event (SAE) is defined as any untoward medical occurrence during a human drug trial that at any dose
- Results in death
- Is life-threatening
- Requires inpatient hospitalization 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{{Cite journal|url=https://www.fda.gov/safety/reporting-serious-problems-fda/what-serious-adverse-event|title = What is a Serious Adverse Event?|journal = FDA|date = 9 September 2020}}
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.{{cite web | author=Expert Working Group (Efficacy) of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). | title=Guideline for Industry - Clinical safety data management: definitions and standards for expedited reporting. | url=https://www.fda.gov/cder/guidance/iche2a.pdf | archive-url=https://web.archive.org/web/19961018232631/http://www.fda.gov/cder/guidance/iche2a.pdf | url-status=dead | archive-date=October 18, 1996 | date=August 25, 2007 | publisher=FDA Center for Drug Evaluation and Research}} Adverse events are more broadly defined by international regulation 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.{{cite web | author=Expert working group (efficacy) of the international conference on harmonization of technical requirements for registration of pharmaceuticals for human use | title=Guideline for Industry Structure and Content of Clinical Study Reports. | url=https://www.fda.gov/cder/guidance/iche3.pdf | archive-url=https://web.archive.org/web/19970225083926/http://www.fda.gov/cder/guidance/iche3.pdf | url-status=dead | archive-date=February 25, 1997 | date=August 25, 2007 | publisher=FDA Center for Drug Evaluation and Research}} Research suggests that these events are often inadequately reported in publicly available reports.{{cite journal |vauthors=Ioannidis JP, Lau J | title=Completeness of safety reporting in randomized trials: an evaluation of 7 medical areas. | journal=JAMA | year=2001 | volume=285 | pages=437–43 | pmid=11242428| doi=10.1001/jama.285.4.437 | issue=4 | doi-access= }} Because of the lack of these data and uncertainty about methods for synthesising them, individuals conducting systematic reviews and meta-analyses of therapeutic interventions often unknowingly overemphasise health benefit.{{cite journal |vauthors=Chou R, Helfand M | title=Challenges in systematic reviews that assess treatment harms. | journal=Ann Intern Med | year=2005 | volume=142 | pages=1090–0 | pmid=15968034 | issue=12 Pt 2 | doi=10.7326/0003-4819-142-12_part_2-200506211-00009| doi-access= }} To balance the overemphasis on benefit, scholars have called for more complete reporting of harm from clinical trials.{{cite journal | vauthors=Ioannidis JP, Evans SJ, Gøtzsche PC, O'Neill RT, Altman DG, Schulz K, Moher D, ((CONSORT Group)) | author3-link=Peter C. Gøtzsche | title=Better reporting of harms in randomized trials: an extension of the CONSORT statement. | journal=Ann Intern Med | year=2004 | volume=141 | pages=781–8 | pmid=15545678 | issue=10 | doi=10.7326/0003-4819-141-10-200411160-00009| s2cid=17032571 }}
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 (yet to be approved or disapproved) product that the event is not listed in the Investigator’s Brochure. That is, the AE is unexpected for the drug or device.{{cn|date=November 2023}}
An adverse effect is an adverse event which is believed to be caused by a health intervention.{{cn|date=November 2023}}
Footnotes
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See also
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- Adverse event, including mild/minor
- Clinical trial
- Good clinical practice (GCP)
- Data Monitoring Committees
- Pharmacovigilance
- EudraVigilance (European Union)
- Directive 2001/20/EC (European Union)
- 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
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External links
- [https://www.fda.gov/medwatch/report/DESK/advevnt.htm What Is A Serious Adverse Event?]{{dead link|date=May 2025|bot=medic}}{{cbignore|bot=medic}} (MedWatch)
- [http://www.clinicaltrials.gov/ ClinicalTrials.gov] from US National Library of Medicine
- [http://www.ich.org ICH Website]
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