: Public Class
Created: 6/29/2010 11:32:59 AM
Modified: 8/26/2017 1:19:10 AM
Project:
Advanced:
DEFINITION:<br/>Specifies the degree or extent of the consequence suffered by the subject.  <br/><br/>EXAMPLE(S):<br/>resulted in death, required hospitalization, was life threatening<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>While often not reported as a separate observation, seriousness codes are technically the result of assessing the subject and the adverse event they are experiencing.  The association to the AdverseEvent should theoretically be derivable via the following path:  AdverseEventSeriousness #gt; PerformedObservation [assess seriousness] #gt; AssessedResultRelationship #gt; AdverseEvent.  However, since this information is often not available, AdverseEventSeriousness has been modeled as both a subclass of PerformedClinicalInterpretation and as having an association directly to the AdverseEvent class.<br/>
Attribute
Public CD
  seriousnessCode
Details:
Map:AE=AdverseEvent.seriousnessCode
Map:caAERSv2.2=Outcome.other
Map:caAERSv2.2=Outcome.type
Map:CDASHv1.1=AE.AESLIFE
Map:CTOM=AdverseEvent.seriousReasonCode
Map:CTRv1.0=AdverseEventSeriousness.code
Map:NCI CRF Standard=CDE 2179679v3.0: Serious Adverse Event Description Reason Text
Map:SDTM IGv3.1.1=AE.AESER
Map:SDTM IGv3.1.1=AE.AESHOSP
Map:SDTM IGv3.1.2=AE.AESLIFE
Map:SDTM IGv3.1.3=AE.AESER
Notes: DEFINITION:<br/>A coded value specifying the degree or extent of the consequence suffered by the subject.  <br/><br/>EXAMPLE(S):<br/>resulted in death, required hospitalization, was life threatening<br/><br/>Results in Death; Is life-threatening; Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent or significant disability/incapacity; Is a congenital anomaly/birth defect; In the medical judgment of the treating physician and/or investigator, it may jeopardize the participant or require intervention to prevent one of these outcomes; Other, specify; Meets criteria per protocol but does not meet other criterion (NCI CRF Standard)<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>This attribute is derivable from AdverseEventSeriousness.value(ANY=#gt;CD).code and is in the model to make the semantic explicit.<br/>
Element Source Role Target Role
AdverseEvent
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/>
Tag Value
Map:caAERSv2.2 Outcome
Details:
 
Map:CTRv1.0 AdverseEventSeriousness
Details:
 
Map:SDTM IGv3.1.3 AE.AESER
Details:
 
Object Type Connection Direction Notes
PerformedClinicalInterpretation Class Generalization To DESCRIPTION: Each AdverseEventSeriousness always specializes one PerformedClinicalInterpretation. Each PerformedClinicalInterpretation might be specialized by one or more AdverseEventSeriousness. DEFINITION: Specifies the degree or extent of the consequence suffered by the subject. EXAMPLE(S): resulted in death, required hospitalization, was life threatening OTHER NAME(S): NOTE(S): While often not reported as a separate observation, seriousness codes are technically the result of assessing the subject and the adverse event they are experiencing. The association to the AdverseEvent should theoretically be derivable via the following path: AdverseEventSeriousness > PerformedObservation [assess seriousness] > AssessedResultRelationship > AdverseEvent. However, since this information is often not available, AdverseEventSeriousness has been modeled as both a subclass of PerformedClinicalInterpretation and as having an association directly to the AdverseEvent class.