adverseevents

Name	adverseEvents.txt
JSON File Name	adverseEvents.json
Type	single
Schema Version	3.37
Description	The Adverse Event Template reports adverse events that are recorded for subjects in a study.
Download	⬇️ adverseEvents.xlsx ⬇️ adverseEvents.txt ⬇️ adverseEvents.json This top-level schema references companion files (e.g. adverseEvents.Datum.json) in the same json-templates folder — download the all_templates.zip to get them all together.

Reading this table: see How to read the template documentation for what Required / Conditionally required / Optional mean and how to read the Type & Constraints column.

Template Column	Requirement	Type & Constraints	Description
User Defined ID	Required	Text, max 150 characters JSON: userDefinedId (string)	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. The identifier should be unique to the ImmPort workspace to which the data will be uploaded.
Subject ID	Required	Text, max 15 characters Reference — must already exist (in this package or the workspace) as a subject JSON: subjectId (string)	Please enter either a subject user defined ID or ImmPort accession for the subject for the reported adverse event.
Study ID	Required	Text, max 15 characters Reference — must already exist (in this package or the workspace) as a study JSON: studyId (string)	An adverse event may be linked to a single study. Please enter either a study user defined ID or ImmPort accession for the study in which the reported adverse event occurred.
Name Reported	Required	Text, max 126 characters JSON: nameReported (string)	The adverse event name is a display name that is available when the data is shared, but it is not referenced by other data.. The adverse event name is an alternate identifier that is visible when the adverse event is shared.
Name Preferred	Optional	Text, max 126 characters JSON: namePreferred (string)	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	Required	Text, max 60 characters Preferred vocabulary — reported value is kept; a preferred term from lk_adverse_event_severity is filled in when it matches JSON: severityReported (enum)	The severity value is chosen from a list of preferred terms.
Outcome Reported	Required	Text, max 40 characters JSON: outcomeReported (string)	Describe the outcome of the adverse event. The outcome of the adverse event.
Start Study Day	Optional	Number JSON: startStudyDay (number)	The study day in which the adverse event was initially reported.
End Study Day	Optional	Number JSON: endStudyDay (number)	The study day in which the adverse event ceased.
Relation To Study Treatment	Required	Text, max 250 characters JSON: relationToStudyTreatment (string)	Was the adverse event believed to be related to a study intervention.
Organ Or Body System Reported	Optional	Text, max 126 characters JSON: organOrBodySystemReported (string)	Which portion(s) of the subject was affected by the adverse event.
Description	Optional	Text, max 4000 characters JSON: description (string)	A lengthier description of the adverse event.
Location Of Reaction Reported	Optional	Text, max 126 characters JSON: locationOfReactionReported (string)	Where on/in the subject was the adverse event reported.
Study Treatment Action Taken	Optional	Text, max 250 characters JSON: studyTreatmentActionTaken (string)	What was done to address the adverse event.
Relation To Nonstudy Treatment	Optional	Text, max 250 characters JSON: relationToNonstudyTreatment (string)	Was the adverse event related to some non-study intervention.
Causality	Optional	Text, max 250 characters JSON: causality (string)	Was the adverse event believed to be casued by a study intervention. Was the adverse event believed to be caused by a study intervention.
Start Time	Optional	Text, max 40 characters JSON: startTime (string)	Allows for describing the time during a study day in which an adverse event was reported.
End Time	Optional	Text, max 40 characters JSON: endTime (string)	Allows for describing the time during a study day in which an adverse event was reported.