: Public Class
Created: 3/3/2008 1:29:07 PM
Modified: 8/26/2017 1:19:09 AM
Project:
Advanced:
DEFINITION: <br/>Any unfavorable and unintended sign, symptom, disease, or other medical occurrence with a temporal association with the use of a medical product, procedure or other therapy, or in conjunction with a research study, regardless of causal relationship. <br/><br/>EXAMPLE(S):<br/>death, back pain, headache, pulmonary embolism, heart attack<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>The BRIDG SCC has a GForge Tracker Issue (#31893) indicating a need to validate the requirement that every AdverseEvent be described by a SafetyReportVersion.<br/>
Attribute
Public CD
  gradeCode
Details:
Map:AE=AdverseEvent.gradeOrSeverity
Map:caAERSv2.2=AdverseEvent.grade
Map:CDASHv1.1=AE.AETOXGR
Map:CTOM=AdverseEvent.ctcGradeCodeSystem
Map:CTOM=AdverseEvent.ctcGradeCode
Map:CTRv1.0=AdverseEvent.gradeCode
Map:NCI CRF Standard=CDE 2944515v1.0: Adverse Event Severity Grade
Map:NCI CRF Standard=CDE 2201188v1.0: Common Toxicity Criteria Adverse Event Reporting Grade
Map:PSCv2.6=AdverseEvent.description
Map:SDTM IGv3.1.1=AE.AETOXGR
Map:SDTM IGv3.1.2=AE.AETOXGR
Map:SDTM IGv3.1.3=AE.AETOXGR
Notes: DEFINITION:<br/>A coded value specifying the level of injury suffered by the subject for whom the event is reported.<br/><br/>EXAMPLE(S):<br/>The gradeCode could be 3 if the CTCAE coding system is being used.<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>Derived from PerformedClinicalInterpretation.value(ANY=#gt;CD).code WHERE PerformedObservationResult #gt; PerformedObservation #gt; DefinedObservation.nameCode = "grade assessment"<br/>
Public CD
  severityCode
Details:
Map:AE=AdverseEvent.gradeOrSeverity
Map:CDASHv1.1=AE.AESEV
Map:CTRv1.0=AdverseEvent.severityCode
Map:PSCv2.6=AdverseEvent.description
Map:SDTM IGv3.1.1=AE.AESEV
Map:SDTM IGv3.1.2=AE.AESEV
Map:SDTM IGv3.1.3=AE.AESEV
Notes: DEFINITION:<br/>A coded value specifying the intensity of the event.<br/><br/>EXAMPLE(S):<br/>Moderate could be used to describe acne.<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>Derived from the maximum severity observed during the course of the AdverseEvent:<br/>PerformedClinicalInterpretation.value(ANY=#gt;CD).code WHERE PerformedClinicalInterpretation #gt; PerformedObservation #gt; DefinedObservation.nameCode = "assess severity" AND PerformedObservation #gt; AssessedResultRelationship #gt; AdverseEvent.<br/>
Public CD
  categoryCode
Details:
Map:CTRv1.0=AdverseEvent.categoryCode
Map:SDTM IGv3.1.1=AE.AECAT
Map:SDTM IGv3.1.2=AE.AECAT
Map:SDTM IGv3.1.3=AE.AECAT
Notes: DEFINITION:<br/>A coded value specifying a classification of the adverse event.<br/><br/>EXAMPLE(S):<br/>bleeding, hypoglycemia<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>Theoretically speaking, the category should be derivable from the subcategory, however if there may only be a category and not a subcategory, then both attributes must be present in the model. <br/>
Public CD
  subcategoryCode
Details:
Map:CTRv1.0=AdverseEvent.subcategoryCode
Map:SDTM IGv3.1.1=AE.AESCAT
Map:SDTM IGv3.1.2=AE.AESCAT
Map:SDTM IGv3.1.3=AE.AESCAT
Notes: DEFINITION:<br/>A coded value specifying a subdivision within a larger category of an adverse event.<br/><br/>EXAMPLE(S):<br/>neurologic<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>Theoretically speaking, the category should be derivable from the subcategory, however if there may only be a category and not a subcategory, then both attributes must be present in the model. <br/>
Public BL
  highlightedIndicator
Details:
Map:AE=AdverseEvent.highlightedIndicator
Map:CTRv1.0=AdverseEvent.highlightedIndicator
Notes: DEFINITION:<br/>Specifies whether the adverse event or reaction term is a major concern or reason for reporting the adverse event.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Public ST
  summary
Details:
Map:caAERSv2.2=AdverseEventResponseDescription.eventDescription
Map:CTRv1.0=AdverseEvent.summary
Notes: DEFINITION:<br/>A description of the adverse event and the treatment of the event.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Public IVL<TS.DATETIME>
  occurrenceDateRange
Details:
Map:AE=AdverseEvent.resolutionDate
Map:AE=AdverseEvent.onsetDate
Map:caAERSv2.2=AdverseEvent.eventApproximateTime
Map:caAERSv2.2=AdverseEvent.startDate
Map:caAERSv2.2=AdverseEvent.endDate
Map:CDASHv1.1=AE.AEENTIM
Map:CDASHv1.1=AE.AESTTIM
Map:CDASHv1.1=AE.AEENDAT
Map:CDASHv1.1=AE.AESTDAT
Map:CDMHv1.0=AdverseEvent.occurrenceDateRange
Map:CTOM=AdverseEvent.resolvedDate
Map:CTOM=AdverseEvent.onsetDate
Map:NCI CRF Standard=CDE 2746301v1.0: Adverse Event Resolution Time
Map:NCI CRF Standard=CDE 2585234v1.0: Adverse Event Onset Time
Map:NCI CRF Standard=CDE 2744993v1.0: Adverse Event Onset Date
Map:NCI CRF Standard=CDE 2189843v1.0: Adverse Event Resolved Alpha DVG Date
Map:SDTM IGv3.1.1=AE.AESTDTC
Map:SDTM IGv3.1.1=AE.AEENDTC
Map:SDTM IGv3.1.1=AE.DUR
Map:SDTM IGv3.1.2=AE.AEENRF
Map:SDTM IGv3.1.2=AE.AESTDTC
Map:SDTM IGv3.1.2=AE.AEDUR
Map:SDTM IGv3.1.2=AE.AEENDTC
Map:SDTM IGv3.1.2=AE.AEENRTPT
Map:SDTM IGv3.1.3=AE.AEENDTC
Map:SDTM IGv3.1.3=AE.AESTDTC
Map:SDTM IGv3.1.3=AE.AEDUR
Notes: DEFINITION:<br/>The date and time span in which the adverse event began and ended. <br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/>onset date, resolution date, duration<br/><br/>NOTE(S):<br/>These may be partial dates or durations (duration is the width property of the IVL#lt;TS#gt; data type).<br/>
Public IVL<INT>
  occurrenceStudyDayRange
Details:
Map:SDTM IGv3.1.3=AE.AESTDY
Map:SDTM IGv3.1.3=AE.AEENDY
Notes: DEFINITION:<br/>The relative timing for an adverse event expressed as the number of days offset from the study-defined reference activity (e.g., date of registration, start of treatment) for this particular experimental unit.<br/><br/>EXAMPLE(S):<br/>Day 1, Days 10-20<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>Derived from the occurrenceDateRange of this adverse event minus the dateRange of the reference activity + 1.<br/><br/>The study-defined reference activity can be different from study to study. The study day for a date after this reference activity is a positive integer calculated as the difference in the two dates + 1.  The study day for dates before the reference activity is a negative integer calculated as the difference between the two dates.  Note that this means there is no "Day 0."<br/>
Public CD
  occurrencePatternCode
Details:
Map:AE=AdverseEvent.patternCode
Map:caAERSv2.2=AdverseEventResponseDescription.eventReappear
Map:CTOM=AdverseEvent.conditionPatternCode
Map:CTRv1.0=AdverseEvent.occurrencePatternCode
Map:NCI CRF Standard=CDE 2008418v1.0: Adverse Event Condition Pattern
Map:PSCv2.6=AdverseEvent.description
Map:SDTM IGv3.1.1=AE.AEPATT
Map:SDTM IGv3.1.2=AE.AEPATT
Map:SDTM IGv3.1.3=AE.AEPATT
Notes: DEFINITION:<br/>A coded value specifying the time recurrence by which an adverse event occurs.  <br/><br/>EXAMPLE(S):<br/>intermittent, continuous, single event<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Public CD
  endRelativeToReferenceCode
Details:
Map:PSCv2.6=AdverseEvent.description
Map:SDTM IGv3.1.1=AE.ENRF
Map:SDTM IGv3.1.2=AE.ENRF
Map:SDTM IGv3.1.3=AE.AEENRF
Notes: DEFINITION: <br/>A coded value specifying the end of the adverse event with respect to the sponsor-defined reference period.  <br/><br/>EXAMPLE(S): <br/>before, during, during/after, after <br/><br/>OTHER NAME(S): <br/><br/>NOTE(S): <br/>Sponsors should define the reference period in the study metadata. This may be populated when a start date is not collected. <br/><br/>Derived from AdverseEvent.occurrenceDateRange.IVL#lt;TS.DATETIME#gt;.high.TS.DATETIME.uncertainRange.IVL#lt;TS.DATETIME#gt;.high = PerformedStudySubjectMilestone.studyReferenceDateRange then "BEFORE" <br/>AND <br/>AdverseEvent.occurenceDateRange.IVL#lt;TS.DATETIME#gt;.low.TS.DATETIME.uncertainRange.IVL#lt;TS.DATETIME#gt;.low = PerformedStudySubjectMilestone.studyReferenceDateRange then "AFTER"<br/>
Public BL
  expectedIndicator
Details:
Map:AE=AdverseEvent.expectedIndicator
Map:caAERSv2.2=AdverseEvent.expected
Map:CTRPv1.0=AdverseEvent.expectedIndicator
Map:CTRv1.0=AdverseEvent.expectedIndicator
Map:NCI CRF Standard=CDE 2183619v1.0: Adverse Event Expected Indicator
Notes: DEFINITION:<br/>Specifies whether the specificity (nature), frequency, or severity of an adverse event is consistent with the applicable study documentation (e.g., investigator's brochure, protocol document, or consent document) or product labeling (package insert). <br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Public DSET<CD>
  unexpectedReasonCode
Details:
Map:AE=AdverseEvent.unexpectedReason
Map:CTRv1.0=AdverseEvent.unexpectedReasonCode
Map:PSCv2.6=AdverseEvent.description
Notes: DEFINITION:<br/>A coded value specifying why an adverse event (experience or reaction) is considered unanticipated. <br/><br/>EXAMPLE(S):<br/>severity, frequency, or specificity from what has been previously documented<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Public ST
  locationDescription
Details:
Map:caAERSv2.2=AdverseEvent.eventLocation
Map:CTRv1.0=AdverseEvent.locationDescription
Notes: DEFINITION:<br/>The textual representation of the physical location of the subject when the adverse event began.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Public BL
  hospitalizationRequiredIndicator
Details:
Map:AE=AdverseEvent.hospitalizationRequiredIndicator
Map:caAERSv2.2=AdverseEvent.hospitalization
Map:CTRv1.0=AdverseEvent.hospitalizationRequiredIndicator
Map:NCI CRF Standard=CDE 2552398v1.0: Patient Toxicity Hospitalization Indicator
Map:SDTM IGv3.1.1=AE.AESHOSP
Notes: DEFINITION:<br/>Specifies whether the subject requires hospitalization or prolongation of existing hospitalization as a result of the adverse event.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Public BL
  treatmentEmergentIndicator
Details:
Map:CTRv1.0=AdverseEvent.treatmentEmergentIndicator
Notes: DEFINITION:<br/>Specifies whether the adverse event is something that first arose or become more severe during the studied treatment.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S): <br/>This may be derivable if a complete subject history exists and it can be known with certainty whether (and with what severity) a condition may have pre-existed.  However, this information is not always available and therefore the attribute has not been marked as derived.<br/>
Public TS.DATETIME
  postReportUpdateDate
Details:
Map:caAERSv2.2=AdverseEvent.postSubmissionUpdatedDate
Map:CTRv1.0=AdverseEvent.postReportUpdateDate
Notes: DEFINITION:<br/>The date (and time) on which the adverse event was updated after it had been submitted.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Element Source Role Target Role
PerformedProductInvestigation
Class   		Name: triggeredPerformedProductInvestigation
  		Name: triggeringAdverseEvent
 
Details:
DESCRIPTION:<br/>Each PerformedProductInvestigation always is triggered by one AdverseEvent.  Each AdverseEvent might trigger one or more PerformedProductInvestigation. <br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
AdverseEventSeriousness
Class   		Name: describingAdverseEventSeriousness
  		Name: describedAdverseEvent
 
Details:
DESCRIPTION:<br/>Each AdverseEventSeriousness always describes one AdverseEvent. Each AdverseEvent might be described by one or more AdverseEventSeriousness.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
AdverseEventOutcomeAssessment
Class   		Name: triggeredAdverseEventOutcomeAssessment
  		Name: triggeringAdverseEvent
 
Details:
DESCRIPTION:<br/>Each AdverseEventOutcomeAssessment always is triggered by one AdverseEvent.  Each AdverseEvent might trigger one or more AdverseEventOutcomeAssessment.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
CausalAssessment
Class   		Name: triggeredCausalAssessment
  		Name: triggeringAdverseEvent
 
Details:
DESCRIPTION:<br/>Each CausalAssessment always is triggered by one AdverseEvent. Each AdverseEvent might trigger one or more CausalAssessment.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
SafetyReportVersion
Class   		Name: describingSafetyReportVersion
  		Name: describedAdverseEvent
 
Details:
DESCRIPTION:<br/>Each SafetyReportVersion might describe one or more AdverseEvent.  Each AdverseEvent might be described by one or more SafetyReportVersion.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
Tag Value
Map:AE AdverseEvent
Details:
 
Map:caAERSv2.2 ReportedAdverseEvent
Details:
 
Map:caAERSv2.2 AdverseEvent
Details:
 
Map:CDMHv1.0 AdverseEvent
Details:
 
Map:CTRv1.0 AdverseEvent
Details:
 
Map:ICSRr2 AdverseEventAssessment (in IndividualCaseSafetyReport)
Details:
 
Map:NCI CRF Standard AdverseEvent
Details:
 
Map:PSCv2.6 AdverseEvent
Details:
 
Map:SDTM IGv3.1.2 AE.DOMAIN
Details:
 
Map:SDTM IGv3.1.3 AE
Details:
 
Map:TDM Incidents
Details:
 
Object Type Connection Direction Notes
PerformedObservationResult Class Generalization To DESCRIPTION: Each AdverseEvent always specializes one PerformedObservationResult. Each PerformedObservationResult might be specialized by one AdverseEvent. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):