Health / Medical Topics

    Defined Adverse Event

    A reusable, template description of any unfavorable and unintended sign, symptom, disease, or other medical occurrence with a temporal association with the use of a medical product, procedure or other therapy, or in conjunction with a research study, regardless of causal relationship. EXAMPLE(S):death, back pain, headache, pulmonary embolism, heart attack. (NCI Thesaurus/BRIDG)




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    An activity defined at a global library level that is not directly related to hypothesis evaluation or testing, but is typically essential…
    A coded value specifying a subdivision within a larger category of activities.
    The date (and time) on which the status is assigned to the activity.
    A coded value specifying the phase in the lifecycle of the activity as part of a global library.
    The number of times the activity occurs.
    A ratio representing the number of occurrences of an activity within a given time period.

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