Created: | 6/29/2010 11:32:59 AM |
Modified: | 8/26/2017 1:19:10 AM |
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Attribute | ||
Public CD seriousnessCode |
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![]() 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
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Element | Source Role | Target Role |
AdverseEvent Class |
Name: describingAdverseEventSeriousness |
Name: describedAdverseEvent |
![]() 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/>
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Tag | Value |
Map:caAERSv2.2 | Outcome |
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Map:CTRv1.0 | AdverseEventSeriousness |
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Map:SDTM IGv3.1.3 | AE.AESER |
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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. |