Adverse Event Hospitalization Required Indicator

Specifies whether the subject requires hospitalization or prolongation of existing hospitalization as a result of the adverse event. (NCI Thesaurus)

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Adverse Event Highlighted Indicator

Specifies whether the adverse event or reaction term is a major concern or reason for reporting the adverse event.

Adverse Event Group Identifier

A character or string that represents an adverse event group.

Adverse Event Grade Code

A coded value specifying the level of injury suffered by the subject for whom the event is reported.

Adverse Event Following Immunization

Any unfavorable or unintended symptom, sign, or disease including an abnormal laboratory finding) temporally associated with the previous administration of vaccine(s) that…

Adverse Event Expected Indicator

Specifies whether the specificity (nature), frequency, or severity of an adverse event is consistent with the applicable study documentation (e.g., investigator's brochure,…

Adverse Event End Timepoint

A point in time that indicates the conclusion of an adverse event.