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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
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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
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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.
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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
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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.”
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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.
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Expert
Working Group (Efficacy) of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). (August 25, 2007).
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Expert working group (efficacy) of the international conference on harmonization of technical requirements for registration of pharmaceuticals for human use (August 25, 2007).
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255:, O'Neill RT, Altman DG, Schulz K, Moher D, CONSORT Group (2004). "Better reporting of harms in randomized trials: an extension of the CONSORT statement".
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Ioannidis JP, Lau J (2001). "Completeness of safety reporting in randomized trials: an evaluation of 7 medical areas".
147:"Guideline for Industry - Clinical safety data management: definitions and standards for expedited reporting"
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Chou R, Helfand M (2005). "Challenges in systematic reviews that assess treatment harms".
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is an adverse event which is believed to be caused by a health intervention.
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165:"Guideline for Industry Structure and Content of Clinical Study Reports"
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358:, a drug that had SAEs, including a fatality, in a clinical trial
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Requires intervention to prevent permanent impairment or damage
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Results in persistent or significant disability/incapacity
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Negative medical occurrence during a human drug trial
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55:May have caused a congenital anomaly/birth defect
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230:10.7326/0003-4819-142-12_part_2-200506211-00009
170:. FDA Center for Drug Evaluation and Research.
152:. FDA Center for Drug Evaluation and Research.
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269:10.7326/0003-4819-141-10-200411160-00009
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125:"What is a Serious Adverse Event?"
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370:What Is A Serious Adverse Event?
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380:National Library of Medicine
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320:Data Monitoring Committees
251:Ioannidis JP, Evans SJ,
98:Investigator’s Brochure
314:Good clinical practice
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195:10.1001/jama.285.4.437
25:serious adverse event
340:Directive 2001/20/EC
224:(12 Pt 2): 1090–0.
131:. 9 September 2020.
45:Requires inpatient
42:Is life-threatening
376:ClinicalTrials.gov
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400:Clinical research
325:Pharmacovigilance
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410:Drug safety
385:ICH Website
356:BIA 10-2474
253:Gøtzsche PC
77:conducting
394:Categories
372:(MedWatch)
33:drug trial
111:Footnotes
378:from US
296:See also
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203:11242428
72:Research
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281:S2CID
168:(PDF)
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273:PMID
234:PMID
199:PMID
183:JAMA
265:doi
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103:An
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