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NIA Adverse Event and Serious …

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

    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 …

    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 …

    Serious adverse event - Wikipedia

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

      Untoward Definition & Meaning - Merriam-Webster

        https://www.merriam-webster.com/dictionary/untoward
        un· to· ward ˌən-ˈtō-ərd -ˈtȯ (-ə)rd; ˌən-tə-ˈwȯrd Synonyms of untoward 1 : difficult to guide, manage, or work with : unruly, intractable 2 a : marked by trouble or unhappiness : …

      ICH GCP - 1. GLOSSARY

        https://ichgcp.net/1-glossary
        1. GLOSSARY. 1.1 Adverse Drug Reaction (ADR) In the pre-approval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic dose (s) …

      5. Terms, Definitions and Examples for Adverse Event …

        https://allaboutpharmacovigilance.org/5-terms-definitions-and-examples-for-adverse-event-reporting/
        1. Abortion, miscarriage or uterine hemorrhage associated with misoprostol (Cytotec), a Labor-inducing drug (this is a case where the adverse effect has been used …

      Untoward - definition of untoward by The Free Dictionary

        https://www.thefreedictionary.com/untoward
        untoward. ( ˌʌntəˈwɔːd; ʌnˈtəʊəd) adj. 1. characterized by misfortune, disaster, or annoyance. 2. not auspicious; adverse; unfavourable. 3. unseemly or improper. 4. out of …

      Untoward Definition & Meaning | Dictionary.com

        https://www.dictionary.com/browse/untoward
        untoward / ( ˌʌntəˈwɔːd, ʌnˈtəʊəd) / adjective characterized by misfortune, disaster, or annoyance not auspicious; adverse; unfavourable unseemly or improper out of the …

      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 …



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