adverseevents

Name adverseEvents.txt
Type single
Schema Version 3.34
Description The Adverse Event Template reports adverse events that are recorded for subjects in a study.
Template ColumnRequiredDescription
User Defined ID True The adverse event user defined ID is an identifier chosen by the data provider to refer to a adverse event. The user defined ID is not shared.
Subject ID True Please enter either a subject user defined ID or ImmPort accession for the subject for the reported adverse event.
Study ID True An adverse event may be linked to a single study.
Name Reported True The adverse event name is a display name that is available when the data is shared, but it is not referenced by other data..
Name Preferred False The preferred adverse event name is a term from the MedDRA (www.meddra.org) adverse event classification dictionary. This is an optional term and often updated by ImmPort staff by mapping AE reported names to MedDRA terms.
Severity Reported True The severity value is chosen from a list of preferred terms.
Outcome Reported True Describe the outcome of the adverse event.
Start Study Day False The study day in which the adverse event was initially reported.
End Study Day False The study day in which the adverse event ceased.
Relation To Study Treatment True Was the adverse event believed to be related to a study intervention.
Organ Or Body System Reported False Which portion(s) of the subject was affected by the adverse event.
Description False A lengthier description of the adverse event.
Location Of Reaction Reported False Where on/in the subject was the adverse event reported.
Study Treatment Action Taken False What was done to address the adverse event.
Relation To Nonstudy Treatment False Was the adverse event related to some non-study intervention.
Causality False Was the adverse event believed to be casued by a study intervention.
Start Time False Allows for describing the time during a study day in which an adverse event was reported.
End Time False Allows for describing the time during a study day in which an adverse event was reported.
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