: Public Class
Created: 3/11/2008 9:23:44 AM
Modified: 9/30/2013 1:43:55 AM
Project:
Advanced:
DEFINITION:<br /></p><p>Specifies the link between an adverse event causal assessment and the activity evaluated as a possible cause.<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p>Administration of cold medicine may be evaluated as a cause of an adverse event.<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
Attribute
Public CD
  probabilityCode
Details:
Map:caAERSv2.2=AdverseEvent.attributionToStudy
Map:caAERSv2.2=AdverseEventAttribution.attribution
Map:CTRv1.0=EvaluatedActivityRelationship.probabilityCode
Map:ICSRr2=CausalityAssessment.value (in IndividualCaseSafetyReport)
Map:NCI CRF Standard=CDE 1285v3.0: CTC Adverse Event Attribution Scale
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying the likelihood of the identified cause of an adverse 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;unrelated, unlikely, possible, probable, definite (for adverse events in respect to CTEP and FAET)#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;related, possibly related, unlikely related, not related (for adverse events in respect to SDTM & E2B)#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;
Public REAL
  probabilityPercent
Details:
Map:AE=CausalAssessment.probability
Map:CTRv1.0=EvaluatedActivityRelationship.probabilityPercent
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A number representing the likelihood of the identified cause of an adverse 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;60% likelihood that an adverse event was caused by an activity that was performed on the subject.#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;
Public CD
  uncertaintyCode
Details:
Map:AE=CausalAssessment.certaintyCode
Map:CDASHv1.1=AE.AEREL
Map:CTOM=AdverseEvent.ctcAttributionCodeSystem
Map:CTOM=AdverseEvent.ctcAttributionCode
Map:CTRv1.0=EvaluatedActivityRelationship.uncertaintyCode
Map:SDTM IGv3.1.2=AE.AEREL
Map:SDTM IGv3.1.2=AE.AERELNST
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying whether and to what degree this evaluation or observation has been asserted to be in doubt in any way. #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;
Public ST
  comment
Details:
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Additional description of the evaluated activity relationship recording the investigator's opinion as to whether the event may have been due to a treatment. #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;More likely related to aspirin use#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;
Element Source Role Target Role
PerformedActivity
Class   		Name: evaluatingEvaluatedActivityRelationship
  		Name: evaluatedPerformedActivity
 
Details:
DESCRIPTION:<br /></p><p>Each EvaluatedActivityRelationship always evaluates one PerformedActivity. Each PerformedActivity might be evaluated by one or more EvaluatedActivityRelationship.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
CausalAssessment
Class   		Name: evaluatedEvaluatedActivityRelationship
  		Name: evaluatingCausalAssessment
 
Details:
DESCRIPTION:<br /></p><p>Each EvaluatedActivityRelationship always is evaluated by one CausalAssessment. Each CausalAssessment might evaluate one or more EvaluatedActivityRelationship.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
Tag Value
Map:caAERSv2.2 SurgeryAttribution
Details:
 
Map:caAERSv2.2 CourseAgentAttribution
Details:
 
Map:caAERSv2.2 RadiationAttribution
Details:
 
Map:caAERSv2.2 ConcomitantMedicationAttribution
Details:
 
Map:caAERSv2.2 DeviceAttribution
Details:
 
Map:caAERSv2.2 AdverseEventAttribution
Details:
 
Map:CTRPv3.8 ActivityRelationship.typeCode
Details:
 
Map:CTRv1.0 EvaluatedActivityRelationship
Details:
 
Map:ICSRr2 Subject11 (in IndividualCaseSafetyReport)
Details:
 
Map:ICSRr2 Subject3 (in IndividualCaseSafetyReport)
Details: