Untoward Medical Occurrence Definition

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CFR - Code of Federal Regulations Title 21 …

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 or not considered drug related....

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 hospitalization, …

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 …

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 …

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 …

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, …

5. Terms, Definitions and Examples for Adverse Event …

https://allaboutpharmacovigilance.org/5-terms-definitions-and-examples-for-adverse-event-reporting/

Serious Adverse Events (SAEs): are defined as any untoward medical occurrence (s) that at any dose results in death, hospitalisation or prolongation of …

Adverse event | European Medicines Agency

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

An untoward medical occurrence after exposure to a medicine, which is not necessarily caused by that medicine. Frequently asked questions Search tips Glossaries About this …

Definitions of adverse events, seriousness and causality

https://www.ncbi.nlm.nih.gov/books/NBK362736/

Any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with the trial intervention. In the context of the PROMISE trial, an AE was considered to be: any …

Serious adverse event - Wikipedia

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

"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 …

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