Adverse Event Outcome ICSR Terminology

Terminology used in Individual Case Safety Reports for description of adverse event outcomes, section B2 of FDA MedWatch Form. (NCI Thesaurus)

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Adverse Event Outcome

A condition or event that is attributed to the adverse event and is the result or conclusion of the adverse event. …

Adverse Event Onset Date

The date (and time) on which an adverse event began.

Adverse Event Ongoing

An indication or description that an adverse event is continuing.

Adverse Event Occurrence Pattern Code

A coded value specifying the time recurrence by which an adverse event occurs.

Adverse Event Occurrence

An indication or description of an adverse event occurrence.

Adverse Event Occurred with Overdose

An indication or description that an adverse event occurred with an overdose.