Adverse Reaction

Definition 1

Any noxious and unintended response(s) to a medical product or procedure, for which a causal relationship with this product or procedure is at least a reasonable possibility i.e., the relationship cannot be ruled out. (NCI Thesaurus)

Definition 2

An unexpected medical problem that happens during treatment with a drug or other therapy. Adverse effects do not have to be caused by the drug or therapy, and they may be mild, moderate, or severe. (NCI Dictionary)

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Adverse Event Yes No Indicator

An indication of whether an adverse event has occurred.

Adverse Event Verbatim Description

The verbatim description of the adverse event.

Adverse Event Unexpected Reason Code

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

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.