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Untoward Definition & Meaning - Merriam-Webster

    https://www.merriam-webster.com/dictionary/untoward
    untoward: [adjective] difficult to guide, manage, or work with : unruly, intractable.

Untoward - definition of untoward by The Free Dictionary

    https://www.thefreedictionary.com/untoward
    Define untoward. untoward synonyms, untoward pronunciation, untoward translation, English dictionary definition of untoward. adj. 1. Improper; unseemly: untoward …

Untoward Definition & Meaning | Dictionary.com

    https://www.dictionary.com/browse/untoward
    Untoward definition, unfavorable or unfortunate: Untoward circumstances forced him into bankruptcy. See more.

ICH GCP - 1. GLOSSARY

    https://ichgcp.net/1-glossary
    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 …

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

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=312.32
    (a) Definitions. The following definitions of terms apply to this section: Adverse event means any untoward medical occurrence associated with the use of a …

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 …

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 member …

Adverse event | definition of adverse event by Medical …

    https://medical-dictionary.thefreedictionary.com/adverse+event
    adverse event: "Any untoward medical occurrence that may present during treatment with a pharmaceutical product but which does not necessarily have a causal relationship with …

Serious adverse event - Wikipedia

    https://en.wikipedia.org/wiki/Serious_adverse_event
    A serious adverse event ( SAE) in human drug trials is defined as any untoward medical occurrence that at any dose. Results in death. Is life-threatening. Requires inpatient …

Definitions of adverse events, seriousness and causality

    https://www.ncbi.nlm.nih.gov/books/NBK362736/
    Medical judgement may be exercised in deciding seriousness in other situations. Important AEs or reactions that are not immediately life-threatening or do not result in death or hospitalisation may be considered …



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