Untoward Medical Occurrence

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Adverse event - Wikipedia

https://en.wikipedia.org/wiki/Adverse_event

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 can therefore be any …

CFR - Code of Federal Regulations Title 21 - Food and …

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=312.32

The following definitions of terms apply to this section: Adverse event means any untoward medical occurrence associated with the use of a drug in humans, whether …

NIA Adverse Event and Serious Adverse Event …

https://www.nia.nih.gov/sites/default/files/2018-09/nia-ae-and-sae-guidelines-2018.pdf

Any untoward or unfavorable medical occurrence in a human study participant, including any abnormal sign (e.g. abnormal physical exam or laboratory finding), symptom, or …

Serious adverse event - Wikipedia

https://en.wikipedia.org/wiki/Serious_adverse_event

ICH GCP - 1. GLOSSARY

https://ichgcp.net/1-glossary

Any untoward medical occurrence that at any dose: – results in death, – is life-threatening, – requires inpatient hospitalization or prolongation of existing …

Adverse event | European Medicines Agency

https://www.ema.europa.eu/en/glossary/adverse-event

Adverse event | European Medicines Agency Adverse event An untoward medical occurrence after exposure to a medicine, which is not necessarily caused by that …

IND Application Reporting: Safety Reports | FDA

https://www.fda.gov/drugs/investigational-new-drug-ind-application/ind-application-reporting-safety-reports

any findings from tests in laboratory animals that suggest a significant risk for human subjects including reports of mutagenicity, teratogenicity, and …

Adverse event | definition of adverse event by Medical …

https://medical-dictionary.thefreedictionary.com/adverse+event

Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, and which does not necessarily have a …

Untoward incident | definition of untoward incident by …

https://medical-dictionary.thefreedictionary.com/untoward+incident

untoward incident An NHS (UK) term for any event, incident, occurrence or accident, which could have or did lead to unintended harm, loss or damage to a patient, visitor or …

ICH E2A Flashcards | Quizlet

https://quizlet.com/37073247/ich-e2a-flash-cards/

An adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally …

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