Adverse Event Unexpected Reason Code

Definition 1

A coded value specifying the representation of the criteria for determining whether an adverse event (experience or reaction) is considered unanticipated. (NCI Thesaurus)

Definition 2

A coded value specifying the representation of the criteria for determining whether an adverse event (experience or reaction) is considered unanticipated. EXAMPLE(S): severity, frequency, or specificity from what has been previously documented (NCI Thesaurus/BRIDG)

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Adverse Event Toxicity Grade

The toxicity grade value of the adverse event.

Adverse Event Summary

A description of the adverse event and the treatment of the event.

Adverse Event Subcategory Code

A coded value specifying a subdivision within a larger category of an adverse event.

Adverse Event Subcategory

A subdivision of adverse event data.

Adverse Event Sub-Domain

The Adverse Event sub-domain is intended for those involved in safety related activities; such as detection, evaluation, follow-up and reporting. This includes…

Adverse Event Start Time

The time at which and adverse event starts.