: Public Class
Created: 7/26/2007 12:05:41 PM
Modified: 8/26/2017 2:57:13 AM
Project:
Advanced:
DEFINITION: <br/>Any sign, symptom, disease, or other medical occurrence.<br/><br/>EXAMPLE(S):<br/>death, back pain, headache, pulmonary embolism, heart attack, pregnancy, flu, broken bone, menstrual period, depression<br/><br/>OTHER NAME(S):<br/>Clinical Events<br/>Medical History<br/><br/>NOTE(S):<br/>This condition may have been recalled by the subject or a caregiver or provided in their medical record.<br/>
Attribute
Public IVL<TS.DATETIME>
  occurrenceDateRange
Details:
Map:CDASHv1.1=MH.MHSTDAT
Map:CDASHv1.1=MH.MHENDAT
Map:CDMHv1.0=PerformedMedicalConditionResult.occurrenceDateRange
Map:CTRv1.0=PerformedMedicalConditionResult.occurrenceDateRange
Map:HCTv1.0=CDE 2960491:Adverse Events.Date of graft failure:
Map:HCTv1.0=CDE 2871898:Occurrences.Date fungal infection occurred
Map:HCTv1.0=CDE 2787854:Adverse Events.Date engraftment syndrome occurred:
Map:LSDAMv2.2.3Plus=PerformedMedicalHistoryResult.occurrenceDateRange
Map:NCI CRF Standard=CDE 2736881v1.0: Personal Medical History Ongoing Indicator
Map:SDTM IGv3.1.1=MH.MHSTDTC
Map:SDTM IGv3.1.1=MH.MHENDTC
Map:SDTM IGv3.1.2=MH.MHENDTC
Map:SDTM IGv3.1.2=CE.CESTDTC
Map:SDTM IGv3.1.2=MH.MHSTDTC
Map:SDTM IGv3.1.2=MH.MHENRTPT
Map:SDTM IGv3.1.2=MH.MHENRF
Map:SDTM IGv3.1.2=CE.CEENDTC
Notes: DEFINITION:<br/>The date and time span in which the medical condition 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 <br/>IVL#lt;TS#gt; datatype).<br/><br/>A condition may be considered to have ended when a subject returns to their <br/>baseline state.<br/>
Public CD
  occurrenceDateRangeValidationCode
Details:
Map:HCTv1.0=CDE 2795658:Lab Results.If necessary, please validate the neutrophil recovery date response.
Notes: DEFINITION:<br/>A coded value specifying the degree of authoritativeness or certitude of the occurrence date. <br/><br/>EXAMPLE(S):<br/>"date estimated"<br/>"date #gt; 100 days, date is correct"<br/>"date #lt; 100 days, date is correct"<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>The concept of "date unknown" is captured by a nullFlavor of "UNK" on the dateRange attribute, rather than a code in this attribute.<br/>A patient might have recovered from neutrophil in the past, but isn't sure of the exact date and state "I think it was in January of 2005".  This would be recorded with an occuranceDateRange of "January 2005" and an uncertainOccuranceDateCode of "estimated". <br/>
Public IVL<INT>
  occurrenceStudyDayRange
Details:
Map:SDTM IGv3.1.3=MH.MHDY
Notes: DEFINITION:<br/>The relative timing for a medical condition 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/>Study Day<br/><br/>NOTE(S):<br/>Derived from the occurrenceDateRange of this medical condition result  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
  endRelativeToReferenceCode
Details:
Map:CTRv1.0=PerformedMedicalConditionResult.endRelativeToReferenceCode
Map:LSDAMv2.2.3Plus=PerformedMedicalHistoryResult.endRelativeToReferenceCode
Map:SDTM IGv3.1.1=MH.MHENRF
Notes: DEFINITION:<br/>A coded value specifying the end of the medical condition 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/>Derived from comparing PerformedSubstanceAdministration.dateRange(IVL#lt;TS.DATETIME#gt;).high and PerformedStudySubjectMilestone.studyReferenceDateRange.<br/><br/>Sponsors should define the reference period in the study metadata.<br/><br/>This may be populated when a start date is not collected. <br/>
Public CD
  severityCode
Details:
Map:HCTv1.0=CDE 3021198:Diagnosis.Specify the severity of the valvular insufficiency:
Notes: DEFINITION:<br/>A coded value specifying the intensity of the condition.<br/><br/>EXAMPLE(S):<br/>Moderate could be used to describe acne. <br/><br/>Values of: none,mild or trivial,moderate or severe,valve replacement,unknown could be used for a aorta valvular insufficiency<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>Derived from PerformedClinicalInterpretation.value(ANY=#gt;CD) WHERE PerformedClinicalInterpretation  #gt; PerformedObservation [severity assessment] #gt; DefinedObservation.nameCode = "assess severity" AND PerformedObservation [severity assessment] #gt; AssessedResultRelationship #gt; PerformedMedicalConditionResult<br/>
Public BL
  clinicallySignificantIndicator
Details:
Map:HCTv1.0=CDE 2759600:Diagnosis.Was there a coexisting significant hemorrhage?
Notes: DEFINITION:<br/>Specifies whether a subject's clinical condition is important based on judgment.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>Derived from PerformedClinicalInterpretation.value(ANY=#gt; BL) WHERE PerformedClinicalInterpretation #gt; PerformedObservation #gt; DefinedObservation.nameCode = "assess clinical significance".<br/>
Public BL
  medicalHistoryIndicator
Details:
Map:CTRv1.0=PerformedMedicalConditionResult.medicalHistoryIndicator
Map:SDTM IGv3.1.2=MH.DOMAIN
Notes: DEFINITION: <br/>Specifies whether the condition is considered part of the historical record of a subject, that is, it did not occur within the bounds of the study.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>Derived from the medical history indicator on the activity (PerformedActivity.medicalHistoryIndicator) which produced this result.<br/>
Public CD
  conditionStatusCode
Details:
Map:CDMHv1.0=PerformedMedicalConditionResult.conditionStatusCode
Notes: DEFINITION:<br/>A coded value specifying the state of the condition.<br/><br/>EXAMPLE(S):   <br/>AC = Active<br/>RS = Resolved<br/>IN = Inactive<br/>NI = No information<br/>UN = Unknown<br/>OT = Other<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Public ST
  conditionStatusChangeReason
Details:
Map:CDMHv1.0=PerformedMedicalConditionResult.conditionStatusChangeReason
Notes: DEFINITION:<br/>The text and/or code that describes why a condition was no longer present.<br/><br/>EXAMPLE(S):   <br/>Discharged<br/>Resolved<br/><br/>OTHER NAME(S):<br/>Condition Occurrence Stop Reason<br/><br/>NOTE(S):<br/>Note that a value in this attribute does not<br/>necessarily imply that the condition is no longer occurring.<br/>
Element Source Role Target Role
PerformedSubstanceAdministration
Class   		Name: addressingPerformedSubstanceAdministration
  		Name: addressedPerformedMedicalConditionResult
 
Details:
DESCRIPTION:<br/>Each PerformedSubstanceAdministration might address one or more PerformedMedicalConditionResult. Each PerformedMedicalConditionResult might be addressed by one or more PerformedSubstanceAdministration.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
Tag Value
Map:caAERSv2.2 StudyParticipantPreExistingCondition
Details:
 
Map:CDMHv1.0 PerformedMedicalConditionResult
Details:
 
Map:CTRv1.0 PerformedMedicalConditionResult
Details:
 
Map:NCI CRF Standard MedicalHistory
Details:
 
Map:SDTM IGv3.1.3 CE
Details:
 
Object Type Connection Direction Notes
PerformedObservationResult Class Generalization To DESCRIPTION: Each PerformedMedicalConditionResult always specializes one PerformedObservationResult. Each PerformedObservationResult might be specialized by one PerformedMedicalConditionResult. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):