: Public Class
Created: 7/25/2007 1:31:57 PM
Modified: 9/27/2013 10:15:52 PM
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DEFINITION:<br /></p><p>An assessment which involves determining the meaning of one or more other observation results.<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p>The results of a white blood cell count may be interpreted as constituting a grade 2 toxicity. <br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
Attribute
Public CD
  toxicityTermCode
Details:
Map:CTRv1.0=PerformedClinicalInterpretation.toxicityTermCode
Map:SDTM IGv3.1.1=LB.LBTOX
Map:SDTM IGv3.1.2=LB.LBTOX
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying the degree to which a substance is able to damage an exposed organism.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;hypocalcaemia#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Similar to CTC Term (short name), e.g., the National Cancer Institute's Common Toxicity Criteria terminology.#lt;br /#gt;#lt;/p#gt;
Public CD
  toxicityGradeCode
Details:
Map:CTRv1.0=PerformedClinicalInterpretation.toxicityGradeCode
Map:SDTM IGv3.1.1=LB.LBTOXGR
Map:SDTM IGv3.1.2=LB.LBTOXGR
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying the numeric grade for the toxicity. #lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Derived from PerformedClinicalInterpretation.value(ANY=#gt;CD).code WHERE PerformedObservationResult #gt; PerformedObservation #gt; DefinedObservation #gt; DefinedObservationResult.typeCode = "toxicity grade code"#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Similar to Common Toxicity Criteria Toxicity Grade #lt;br /#gt;#lt;/p#gt;
Public CD
  severityCode
Details:
Map:CTRv1.0=PerformedClinicalInterpretation.severityCode
Map:HCTv1.0=CDE 2962140:Disease, Disorder or Finding.What was the sensitivity of the CNS tumor to chemotherapy?
Map:SDTM IGv3.1.1=PE.PESEV
Map:SDTM IGv3.1.2=CE.CESEV
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying the intensity of the interpreted event.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Moderate could be used to describe acne. #lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Derived from PerformedClinicalInterpretation.value(ANY=#gt;CD).code WHERE PerformedClinicalInterpretation #gt; PerformedObservation #gt; DefinedObservation.nameCode = "assess severity".#lt;br /#gt;#lt;/p#gt;
Public BL
  abnormalIndicator
Details:
Map:CTOM=ClinicalResult.normalAbnormalIndicator
Map:CTRv1.0=PerformedClinicalInterpretation.abnormalIndicator
Map:NCI CRF Standard=CDE 2841229v1.0: Test Result Reference Object Range Flag Indicator
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Specifies whether an interpreted event is abnormal.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Derived from PerformedClinicalInterpretation.value(ANY=#gt;CD).code WHERE PerformedObservationResult.typeCode = "assess abnormality".#lt;br /#gt;#lt;/p#gt;
Public BL
  clinicallySignificantIndicator
Details:
Map:CDASHv1.1=EG.EGCLSIG
Map:CDASHv1.1=PE.PECLSIG
Map:CDASHv1.1=LB.LBCLSIG
Map:CDASHv1.1=VS.VSCLSIG
Map:CTOM=ClinicalResult.significanceIndicator
Map:CTRv1.0=PerformedClinicalInterpretation.clinicallySignificantIndicator
Map:SDTM IGv3.1.2=LB.SUPPLB.QNAM=LBCLSIG
Map:SDTM IGv3.1.2=VS.SUPPPVS.QNAM=VSCLSIG
Map:SDTM IGv3.1.2=PE.SUPPPE.QNAM=PECLSIG
Map:SDTM IGv3.1.2=EG.SUPPEG.QNAM=EGCLSIG
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Specifies whether a subject's clinical condition is important based on judgment.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Derived from PerformedClinicalInterpretation.value(ANY=#gt;BL) WHERE PerformedClinicalInterpretation #gt; PerformedObservation #gt; DefinedObservation.nameCode = "assess clinical significance".#lt;br /#gt;#lt;/p#gt;
Tag Value
Map:CTRv1.0 PerformedClinicalInterpretation
Details:
 
Map:HCTv1.0 CDE 2871889:Disease, Disorder or Finding.Was there a history of clinically significant fungal infection?
Details:
 
Constraint Type Status
Derived Attribute Exclusive Or Invariant Approved
Details:
Only one of the following attributes will be populated in any given instance: toxicityGradeCode, severityCode, clinicallySignificantIndicator, abnormalIndicator.
Object Type Connection Direction Notes
«Comment_Requested» PerformedObservationResult Class Generalization To DESCRIPTION: Each PerformedClinicalInterpretation always specializes one PerformedObservationResult. Each PerformedObservationResult might be specialized by one PerformedClinicalInterpretation. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):
AdverseEventSeriousness Class Generalization From 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.