Adverse Event Seriousness Due to Congenital Anomaly

An indication or description that the seriousness of an adverse event was due to a congenital abnormality. (NCI Thesaurus)

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Adverse Event Seriousness Date

The date (and time) on which the seriousness code was assigned to the adverse event.

Adverse Event Seriousness Code

A coded value specifying the degree or extent of the consequence suffered by the subject.

Adverse Event Sequence

An identifier that describes the relative position of adverse event data within a series.

Adverse Event Resolution Date

The date (and time) when the adverse event ends or returns to baseline.

Adverse Event Relationship to Non Study Treatment

An indication or description of the relationship of an adverse event to a non-study treatment.

Adverse Event Reference Identifier

A character or string used to name, or characterize an adverse event reference.