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2458

Descrição

E4A03 Multiple Myeloma On-Study Form - Form 2055 Lenalidomide and Dexamethasone With or Without Thalidomide in Treating Patients With Multiple Myeloma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=DD003264-3C16-26D3-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=DD003264-3C16-26D3-E034-0003BA12F5E7

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Versões (3)
  1. 19/09/2012 19/09/2012 -
  2. 09/01/2015 09/01/2015 - Martin Dugas
  3. 09/06/2015 09/06/2015 -
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19 de setembro de 2012

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Creative Commons BY-NC 3.0 Legacy
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    Multiple Myeloma and Plasma Cell Neoplasm NCT00098475 On-Study - E4A03 Multiple Myeloma On-Study Form - Form 2055 - 2284999v3.0

    Inglês

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    1 Formulários  
    1. StudyEvent: E4A03 Multiple Myeloma On-Study Form - Form 2055
      1. No Instruction available.
    Unnamed1
    Descrição

    Unnamed1

    DCI Name
    Descrição

    CollectedDataFormName

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    NCI Thesaurus Property
    C19464
    UMLS 2011AA Property
    C0376315
    NCI Thesaurus ObjectClass
    C25474
    UMLS 2011AA ObjectClass
    C1511726
    NCI Thesaurus ObjectClass
    C25452
    Registration Step
    Descrição

    RegistrationStepNumber

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus ObjectClass
    C25646
    UMLS 2011AA ObjectClass
    C1514821
    NCI Thesaurus Property
    C16154
    UMLS 2011AA Property
    C1704379
    NCI Thesaurus ValueDomain
    C16154
    UMLS 2011AA ValueDomain
    C1704379
    Report Period (Place ID Label Here)
    Descrição

    ReportingPeriod

    Tipo de dados

    text

    Patient Initials
    Descrição

    PatientInitialsName

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25536
    UMLS 2011AA Property
    C1555582
    ECOG Protocol Number
    Descrição

    ProtocolECOGIdentifierNumber

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus ObjectClass
    C25320
    UMLS 2011AA ObjectClass
    C1507394
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus Property
    C25491
    UMLS 2011AA Property
    C1512162
    ECOG Protocol Number
    Descrição

    ProtocolECOGIdentifierNumber

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus ObjectClass
    C25320
    UMLS 2011AA ObjectClass
    C1507394
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus Property
    C25491
    UMLS 2011AA Property
    C1512162
    ECOG Patient ID
    Descrição

    PatientECOGIdentifierNumber

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus Property
    C25491
    UMLS 2011AA Property
    C1512162
    ECOG Patient ID
    Descrição

    PatientECOGIdentifierNumber

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus Property
    C25491
    UMLS 2011AA Property
    C1512162
    Participating Group Protocol Number
    Descrição

    ProtocolParticipatingIdentifierNumber

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus ObjectClass
    C25320
    UMLS 2011AA ObjectClass
    C1507394
    NCI Thesaurus Property
    C25608
    UMLS 2011AA Property
    C0679823
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    Participating Group Patient ID
    Descrição

    PatientParticipatingIdentifierNumber

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25608
    UMLS 2011AA Property
    C0679823
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    Institution/Affiliate
    Descrição

    CombinedInstitutionName

    Tipo de dados

    text

    Alias
    NCI Thesaurus ObjectClass
    C25454
    UMLS 2011AA ObjectClass
    C0205195
    NCI Thesaurus ObjectClass
    C21541
    UMLS 2011AA ObjectClass
    C0018704
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    NCI Thesaurus ValueDomain
    C21541
    UMLS 2011AA ValueDomain
    C0018704
    Unnamed2
    Descrição

    Unnamed2

    Are data amended
    Descrição

    DataAmendedInd-3

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ObjectClass
    C25474
    UMLS 2011AA ObjectClass
    C1511726
    NCI Thesaurus Property
    C25416
    UMLS 2011AA Property
    C1691222
    Disease Description - Initial Diagnosis
    Descrição

    Disease Description - Initial Diagnosis

    Date of Initial Pathologic Diagnosis
    Descrição

    CancerInitialDiagnosisDate

    Tipo de dados

    date

    Alias
    NCI Thesaurus ObjectClass
    C9305
    UMLS 2011AA ObjectClass
    C0006826
    NCI Thesaurus Property
    C25509
    UMLS 2011AA Property
    C1279901
    NCI Thesaurus Property
    C15220
    UMLS 2011AA Property
    C0011900
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ValueDomain
    C25367
    Durie-Salmon Stage (at initial diagnosis - see attached)
    Descrição

    MyelomaDiagnosisStage

    Tipo de dados

    text

    Alias
    NCI Thesaurus ObjectClass
    C3242
    UMLS 2011AA ObjectClass
    C0026764
    NCI Thesaurus Property
    C15220
    UMLS 2011AA Property
    C0011900
    NCI Thesaurus ValueDomain
    C16899
    UMLS 2011AA ValueDomain
    C1300072
    Durie-Salmon Sub-Stage (at initial diagnosis - see attached)
    Descrição

    MyelomaDiagnosisRenalStage

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25225
    UMLS 2011AA ValueDomain
    C0022646
    NCI Thesaurus ObjectClass
    C3242
    UMLS 2011AA ObjectClass
    C0026764
    NCI Thesaurus Property
    C15220
    UMLS 2011AA Property
    C0011900
    NCI Thesaurus ValueDomain
    C16899
    UMLS 2011AA ValueDomain
    C1300072
    Pre-registration Hematology/chemistry
    Descrição

    Pre-registration Hematology/chemistry

    Peripheral WBC Count LLN (/mm3 x1000)
    Descrição

    LaboratoryProcedureLeukocyteResultLowerLimitofNormalValue

    Tipo de dados

    double

    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C12529
    UMLS 2011AA Property
    C0023516
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus ValueDomain
    C25555
    UMLS 2011AA ValueDomain
    C1518030
    Peripheral WBC Count
    Descrição

    LaboratoryProcedureLeukocyteResultSpecifiedValue

    Tipo de dados

    double

    Unidades de medida
    • 1000/uL
    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C12529
    UMLS 2011AA Property
    C0023516
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus ValueDomain
    C38024
    UMLS 2011AA ValueDomain
    C0205369
    1000/uL
    Peripheral Granulocytes Count LLN (AGC.ANC /mm3)
    Descrição

    LaboratoryProcedureGranulocyteResultLowerLimitofNormalCount

    Tipo de dados

    double

    Unidades de medida
    • mm3
    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property
    C12530
    UMLS 2011AA Property
    C0018183
    NCI Thesaurus ValueDomain
    C25463
    UMLS 2011AA ValueDomain
    C0750480
    NCI Thesaurus ValueDomain
    C25555
    UMLS 2011AA ValueDomain
    C1518030
    mm3
    Peripheral Granulocytes Count
    Descrição

    LaboratoryProcedureGranulocyteResultCount

    Tipo de dados

    double

    Unidades de medida
    • 1000/uL
    Alias
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property
    C12530
    UMLS 2011AA Property
    C0018183
    NCI Thesaurus ValueDomain
    C25463
    UMLS 2011AA ValueDomain
    C0750480
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    1000/uL
    Peripheral platelet count LLN (/mm3 x1000)
    Descrição

    LaboratoryProcedurePlateletResultLowerLimitofNormalValue

    Tipo de dados

    double

    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property
    C12520
    UMLS 2011AA Property
    C0005821
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus ValueDomain
    C25555
    UMLS 2011AA ValueDomain
    C1518030
    Peripheral platelet count
    Descrição

    LaboratoryProcedurePlateletResultSpecifiedValue

    Tipo de dados

    double

    Unidades de medida
    • 1000/uL
    Alias
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property
    C12520
    UMLS 2011AA Property
    C0005821
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    1000/uL
    Alkaline Phosphatase ULN (U/L)
    Descrição

    LaboratoryProcedureAlkalinePhosphataseResultUpperLimitNormalValue

    Tipo de dados

    double

    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property
    C16276
    UMLS 2011AA Property
    C0002059
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus ValueDomain
    C25706
    UMLS 2011AA ValueDomain
    C1519815
    Patient Initials
    Descrição

    PatientInitialsName

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25536
    UMLS 2011AA Property
    C1555582
    Alkaline Phosphatase
    Descrição

    HepaticAlkalinePhosphataseLabValue

    Tipo de dados

    double

    Alias
    NCI Thesaurus ObjectClass
    C13308
    UMLS 2011AA ObjectClass
    C0205054
    NCI Thesaurus Property
    C37984
    UMLS 2011AA Property
    C0022877
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus Property
    C16276
    UMLS 2011AA Property
    C0002059
    Bilirubin ULN (mg/dl)
    Descrição

    HepaticBilirubinLabUpperLimitNormalValue

    Tipo de dados

    double

    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property
    C305
    UMLS 2011AA Property
    C0005437
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus ValueDomain
    C25706
    UMLS 2011AA ValueDomain
    C1519815
    ECOG Patient ID
    Descrição

    PatientECOGIdentifierNumber

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus Property
    C25491
    UMLS 2011AA Property
    C1512162
    Bilirubin
    Descrição

    HepaticBilirubinLabValue

    Tipo de dados

    double

    Unidades de medida
    • mg/dL
    Alias
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property
    C305
    UMLS 2011AA Property
    C0005437
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    mg/dL
    Creatinine ULN (mg/dl)
    Descrição

    LaboratoryProcedureCreatinineResultUpperLimitNormalValue

    Tipo de dados

    double

    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property
    C399
    UMLS 2011AA Property
    C0010294
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus ValueDomain
    C25706
    UMLS 2011AA ValueDomain
    C1519815
    Creatinine
    Descrição

    RenalCreatinineLabSpecifiedValue

    Tipo de dados

    double

    Unidades de medida
    • mg/dL
    Alias
    NCI Thesaurus ObjectClass
    C25225
    UMLS 2011AA ObjectClass
    C0022646
    NCI Thesaurus Property
    C399
    UMLS 2011AA Property
    C0010294
    NCI Thesaurus Property
    C25294
    UMLS 2011AA Property
    C0022885
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    mg/dL
    Hemoglobin (Hgb), LLN (g/dl)
    Descrição

    LaboratoryProcedureHemoglobinResultSpecifiedLowerLimitofNormalValue

    Tipo de dados

    double

    Unidades de medida
    • g/dL
    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C16676
    UMLS 2011AA Property
    C0019046
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus ValueDomain
    C38024
    UMLS 2011AA ValueDomain
    C0205369
    NCI Thesaurus ValueDomain
    C25555
    UMLS 2011AA ValueDomain
    C1518030
    g/dL
    Hemoglobin (Hgb)
    Descrição

    LaboratoryProcedureHemoglobinResultSpecifiedValue

    Tipo de dados

    double

    Unidades de medida
    • g/dL
    Alias
    NCI Thesaurus Property
    C16676
    UMLS 2011AA Property
    C0019046
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    g/dL
    SGOT (AST) ULN
    Descrição

    LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedUpperLimitofNormalValue

    Tipo de dados

    double

    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C25202
    UMLS 2011AA Property
    C0242192
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus ValueDomain
    C25706
    UMLS 2011AA ValueDomain
    C1519815
    SGOT (AST)
    Descrição

    HepaticSGOT(AST)LabUnspecifiedValue

    Tipo de dados

    double

    Alias
    NCI Thesaurus ObjectClass
    C13308
    UMLS 2011AA ObjectClass
    C0205054
    NCI Thesaurus Property
    C25202
    UMLS 2011AA Property
    C0242192
    NCI Thesaurus Property
    C37984
    UMLS 2011AA Property
    C0022877
    NCI Thesaurus ValueDomain
    C38046
    UMLS 2011AA ValueDomain
    C0205370
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    SGPT (ALT) ULN
    Descrição

    LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultUpperLimitofNormalValue

    Tipo de dados

    double

    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property
    C25293
    UMLS 2011AA Property
    C0376147
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus ValueDomain
    C25706
    UMLS 2011AA ValueDomain
    C1519815
    SGPT (ALT)
    Descrição

    HepaticSGPT(ALT)LabUnspecifiedValue

    Tipo de dados

    double

    Alias
    NCI Thesaurus ObjectClass
    C13308
    UMLS 2011AA ObjectClass
    C0205054
    NCI Thesaurus Property
    C37984
    UMLS 2011AA Property
    C0022877
    NCI Thesaurus Property
    C25293
    UMLS 2011AA Property
    C0376147
    NCI Thesaurus ValueDomain
    C38046
    UMLS 2011AA ValueDomain
    C0205370
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    Albumin LLN (g/dl)
    Descrição

    LaboratoryProcedureAlbuminResultLowerLimitofNormalValue

    Tipo de dados

    double

    Alias
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property
    C214
    UMLS 2011AA Property
    C0001924
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus ValueDomain
    C25555
    UMLS 2011AA ValueDomain
    C1518030
    Albumin
    Descrição

    LaboratoryProcedureAlbuminResultUnspecifiedValue

    Tipo de dados

    double

    Alias
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property
    C214
    UMLS 2011AA Property
    C0001924
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    Calcium LLN (Ca mg/dl)
    Descrição

    LaboratoryProcedureCalciumElectrolytesOutcomeLowerLimitofNormalValue

    Tipo de dados

    double

    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C331
    UMLS 2011AA Property
    C0006675
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property
    C464
    UMLS 2011AA Property
    C0013832
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus ValueDomain
    C25555
    UMLS 2011AA ValueDomain
    C1518030
    Calcium ULN
    Descrição

    LaboratoryProcedureCalciumElectrolytesOutcomeUpperLimitofNormalValue

    Tipo de dados

    double

    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C331
    UMLS 2011AA Property
    C0006675
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property
    C464
    UMLS 2011AA Property
    C0013832
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus ValueDomain
    C25706
    UMLS 2011AA ValueDomain
    C1519815
    Calcium
    Descrição

    ElectrolytesCalciumLabSpecifiedValue

    Tipo de dados

    double

    Unidades de medida
    • mg/dL
    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C331
    UMLS 2011AA Property
    C0006675
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property
    C464
    UMLS 2011AA Property
    C0013832
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    mg/dL
    Glucose LLN (mg/dl)
    Descrição

    LaboratoryProcedureGlucoseElectrolytesOutcomeLowerLimitofNormalValue

    Tipo de dados

    double

    Unidades de medida
    • mg/dL
    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property
    C2831
    UMLS 2011AA Property
    C0017725
    NCI Thesaurus Property
    C464
    UMLS 2011AA Property
    C0013832
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus ValueDomain
    C25555
    UMLS 2011AA ValueDomain
    C1518030
    mg/dL
    Glucose ULN
    Descrição

    LaboratoryProcedureGlucoseElectrolytesOutcomeUpperLimitNormalValue

    Tipo de dados

    double

    Unidades de medida
    • mg/dL
    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property
    C2831
    UMLS 2011AA Property
    C0017725
    NCI Thesaurus Property
    C464
    UMLS 2011AA Property
    C0013832
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus ValueDomain
    C25706
    UMLS 2011AA ValueDomain
    C1519815
    mg/dL
    Glucose
    Descrição

    LaboratoryProcedureGlucoseElectrolytesOutcomeUnspecifiedValue

    Tipo de dados

    double

    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property
    C2831
    UMLS 2011AA Property
    C0017725
    NCI Thesaurus Property
    C464
    UMLS 2011AA Property
    C0013832
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    Potassium LLN (K mmol/L)
    Descrição

    LaboratoryProcedurePotassiumElectrolytesOutcomeLowerLimitNormalValue

    Tipo de dados

    double

    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property
    C464
    UMLS 2011AA Property
    C0013832
    NCI Thesaurus Property
    C765
    UMLS 2011AA Property
    C0032821
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus ValueDomain
    C25555
    UMLS 2011AA ValueDomain
    C1518030
    Potassium ULN
    Descrição

    LaboratoryProcedurePotassiumElectrolytesOutcomeUpperLimitNormalValue

    Tipo de dados

    double

    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property
    C464
    UMLS 2011AA Property
    C0013832
    NCI Thesaurus Property
    C765
    UMLS 2011AA Property
    C0032821
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus ValueDomain
    C25706
    UMLS 2011AA ValueDomain
    C1519815
    Potassium
    Descrição

    LaboratoryProcedurePotassiumElectrolytesOutcomeSpecifiedValue

    Tipo de dados

    double

    Unidades de medida
    • mmol/L
    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property
    C464
    UMLS 2011AA Property
    C0013832
    NCI Thesaurus Property
    C765
    UMLS 2011AA Property
    C0032821
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    mmol/L
    Sodium LLN (Na mmol/L)
    Descrição

    LaboratoryProcedureSodiumElectrolytesOutcomeLowerLimitofNormalValue

    Tipo de dados

    double

    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property
    C830
    UMLS 2011AA Property
    C0037473
    NCI Thesaurus Property
    C464
    UMLS 2011AA Property
    C0013832
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus ValueDomain
    C25555
    UMLS 2011AA ValueDomain
    C1518030
    Sodium ULN
    Descrição

    LaboratoryProcedureSodiumElectrolytesOutcomeUpperLimitofNormalValue

    Tipo de dados

    double

    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property
    C830
    UMLS 2011AA Property
    C0037473
    NCI Thesaurus Property
    C464
    UMLS 2011AA Property
    C0013832
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus ValueDomain
    C25706
    UMLS 2011AA ValueDomain
    C1519815
    Sodium
    Descrição

    LaboratoryProcedureSodiumElectrolytesOutcomeSpecifiedValue

    Tipo de dados

    double

    Unidades de medida
    • mmol/L
    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property
    C830
    UMLS 2011AA Property
    C0037473
    NCI Thesaurus Property
    C464
    UMLS 2011AA Property
    C0013832
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    mmol/L
    Uric acid LLN (mg/dl)
    Descrição

    LaboratoryProcedureUricAcidResultSpecifiedLowerLimitofNormalValue

    Tipo de dados

    double

    Unidades de medida
    • mg/dL
    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property
    C62652
    UMLS 2011AA Property
    C0041980
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus ValueDomain
    C38024
    UMLS 2011AA ValueDomain
    C0205369
    NCI Thesaurus ValueDomain
    C25555
    UMLS 2011AA ValueDomain
    C1518030
    mg/dL
    Uric acid ULN
    Descrição

    LaboratoryProcedureUricAcidResultUpperLimitofNormalValue

    Tipo de dados

    double

    Unidades de medida
    • mg/dL
    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property
    C62652
    UMLS 2011AA Property
    C0041980
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus ValueDomain
    C25706
    UMLS 2011AA ValueDomain
    C1519815
    mg/dL
    Uric acid
    Descrição

    LaboratoryProcedureUricAcidResultSpecifiedValue

    Tipo de dados

    double

    Unidades de medida
    • mg/dL
    Alias
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus Property
    C62652
    UMLS 2011AA Property
    C0041980
    mg/dL
    Date Hematology (Blood) Sample Obtained
    Descrição

    HematologyLabCollectedDate

    Tipo de dados

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus ValueDomain
    C25452
    Current Infections (last 6 Months)
    Descrição

    Current Infections (last 6 Months)

    CTC Adverse Event Term Type (Specify site for each event)
    Descrição

    CommonToxicityCriteriaAdverseEventShortNameType

    Tipo de dados

    text

    Alias
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus ObjectClass
    C49704
    UMLS 2011AA ObjectClass
    C1516728
    NCI Metathesaurus ValueDomain
    C0332307
    NCI Thesaurus Property
    C25249
    UMLS 2011AA Property
    C1806781
    Specify site
    Descrição

    CTCAdverseEventSiteSpecify

    Tipo de dados

    text

    Alias
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    CTC Adverse Event Grade (Use grade 1-4 per CTCAE v3)
    Descrição

    CommonToxicityCriteriaAdverseEventGrade

    Tipo de dados

    double

    Alias
    NCI Thesaurus ObjectClass
    C49704
    UMLS 2011AA ObjectClass
    C1516728
    NCI Thesaurus ValueDomain
    C18000
    UMLS 2011AA ValueDomain
    C0919553
    NCI Thesaurus Property
    C25365
    UMLS 2011AA Property
    C0678257
    Current Clinical Date
    Descrição

    Current Clinical Date

    Performance status
    Descrição

    PerformanceStatusScale

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25664
    UMLS 2011AA ValueDomain
    C0349674
    NCI Thesaurus ObjectClass
    C25361
    UMLS 2011AA ObjectClass
    C0597198
    NCI Thesaurus Property
    C25365
    UMLS 2011AA Property
    C0678257
    Serum pregnancy test result
    Descrição

    TestPregnancyInd

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25180
    UMLS 2011AA ValueDomain
    C1522602
    NCI Thesaurus Property
    C25742
    UMLS 2011AA Property
    C0032961
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    Date of serum pregnancy test
    Descrição

    PatientMostRecentPregnancyTestDate

    Tipo de dados

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Metathesaurus Property
    C0032976
    NCI Thesaurus Property
    C25577
    UMLS 2011AA Property
    C1513491
    Bone pain on entry to study
    Descrição

    PainBoneSymptomType

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C3303
    UMLS 2011AA ObjectClass
    C0030193
    NCI Thesaurus ObjectClass
    C12366
    UMLS 2011AA ObjectClass
    C0262950
    NCI Thesaurus Property
    C4876
    UMLS 2011AA Property
    C1457887
    Is severe osteoporosis present?
    Descrição

    DiseaseSevereOsteoporosisDiagnosisInd-3

    Tipo de dados

    text

    Alias
    NCI Thesaurus ObjectClass
    C2991
    UMLS 2011AA ObjectClass
    C0012634
    NCI Thesaurus Property
    C3298
    UMLS 2011AA Property
    C0029456
    NCI Thesaurus Property
    C70667
    UMLS 2011AA Property
    C0205082
    NCI Thesaurus Property
    C15220
    UMLS 2011AA Property
    C0011900
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    Number of bones with lytic lesions present
    Descrição

    LyticLesionBoneDetectedType

    Tipo de dados

    text

    Alias
    NCI Thesaurus ObjectClass
    C3824
    UMLS 2011AA ObjectClass
    C0221198
    NCI Thesaurus ObjectClass
    C27963
    UMLS 2011AA ObjectClass
    C0439680
    NCI Thesaurus Property
    C12366
    UMLS 2011AA Property
    C0262950
    NCI Thesaurus Property
    C25481
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    Number of lytic lesions > 2 cm in diameter
    Descrição

    LyticLesionMediumDetectedType

    Tipo de dados

    text

    Alias
    NCI Thesaurus ObjectClass
    C3824
    UMLS 2011AA ObjectClass
    C0221198
    NCI Thesaurus ObjectClass
    C27963
    UMLS 2011AA ObjectClass
    C0439680
    NCI Thesaurus Property
    C49507
    UMLS 2011AA Property
    C0439536
    NCI Thesaurus Property
    C25481
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    Patient Initials
    Descrição

    PatientInitialsName

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25536
    UMLS 2011AA Property
    C1555582
    Pathologic fracture during previous 1 month (including compression and rib fractures)
    Descrição

    BonePathologicFractureInd-3

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus Property
    C25610
    UMLS 2011AA Property
    C1521733
    NCI Thesaurus ObjectClass
    C12366
    UMLS 2011AA ObjectClass
    C0262950
    NCI Thesaurus Property
    C3046
    UMLS 2011AA Property
    C0016658
    ECOG Patient ID
    Descrição

    PatientECOGIdentifierNumber

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus Property
    C25491
    UMLS 2011AA Property
    C1512162
    Is patient on anti-coagulation therapy?
    Descrição

    AnticoagulantAgentPriorDailyAdministrationInd-3

    Tipo de dados

    text

    Alias
    NCI Thesaurus ObjectClass
    C263
    UMLS 2011AA ObjectClass
    C0003280
    NCI Thesaurus Property
    C25473
    UMLS 2011AA Property
    C0332173
    NCI Thesaurus Property
    C25629
    UMLS 2011AA Property
    C0332152
    NCI Thesaurus Property
    C25409
    UMLS 2011AA Property
    C1533734
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    Prior Therapy
    Descrição

    Prior Therapy

    Prior corticosteroids?
    Descrição

    CorticosteroidPriorAdministeredInd-3

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus Property
    C25629
    UMLS 2011AA Property
    C0332152
    NCI Thesaurus ObjectClass
    C2322
    UMLS 2011AA ObjectClass
    C0001617
    NCI Thesaurus Property
    C25382
    UMLS 2011AA Property
    C1521801
    Specify (If yes,)
    Descrição

    PriorCorticosteroidAdministeredSpecify

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS 2011AA ValueDomain
    C1521902
    NCI Thesaurus Property
    C25629
    UMLS 2011AA Property
    C0332152
    NCI Thesaurus ObjectClass
    C2322
    UMLS 2011AA ObjectClass
    C0001617
    NCI Thesaurus Property
    C25382
    UMLS 2011AA Property
    C1521801
    Prior bisphosphanate therapy?
    Descrição

    BisphosphonateSupportAdministeredInd-3

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ObjectClass
    C443
    UMLS 2011AA ObjectClass
    C0012544
    NCI Thesaurus ObjectClass
    C37902
    UMLS 2011AA ObjectClass
    C1521721
    NCI Thesaurus Property
    C25382
    UMLS 2011AA Property
    C1521801
    Bisphosphanate type(s) received (If yes,)
    Descrição

    BisphosphonateSupportAdministeredType

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C443
    UMLS 2011AA ObjectClass
    C0012544
    NCI Thesaurus ObjectClass
    C37902
    UMLS 2011AA ObjectClass
    C1521721
    NCI Thesaurus Property
    C25382
    UMLS 2011AA Property
    C1521801
    Prior radiation therapy?
    Descrição

    PriorRTAdministeredInd-3

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ObjectClass
    C15313
    UMLS 2011AA ObjectClass
    C1522449
    NCI Thesaurus ObjectClass
    C25629
    UMLS 2011AA ObjectClass
    C0332152
    NCI Thesaurus Property
    C25382
    UMLS 2011AA Property
    C1521801
    Sites of prior RT (If yes,)
    Descrição

    SitesofpriorRT

    Tipo de dados

    text

    Date prior RT ended (Record any symptoms, complaints or diagnostic test abnormalities that were present at the time of registration for which a CTCAE term exists.)
    Descrição

    RTPriorEndDate

    Tipo de dados

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C15313
    UMLS 2011AA ObjectClass
    C1522449
    NCI Thesaurus Property
    C25275
    UMLS 2011AA Property
    C2745955
    Baseline Abnormalities
    Descrição

    Baseline Abnormalities

    CTC Adverse Event Term Type (include subterm if applicable Use CTCAE v3 terminology)
    Descrição

    CommonToxicityCriteriaAdverseEventTermType

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C49704
    UMLS 2011AA ObjectClass
    C1516728
    NCI Thesaurus Property
    C45559
    UMLS 2011AA Property
    C1705313
    CTC Adverse Event Grade (Use grade 1-4 per CTCAE v3)
    Descrição

    CommonToxicityCriteriaAdverseEventGrade

    Tipo de dados

    double

    Alias
    NCI Thesaurus ObjectClass
    C49704
    UMLS 2011AA ObjectClass
    C1516728
    NCI Thesaurus ValueDomain
    C18000
    UMLS 2011AA ValueDomain
    C0919553
    NCI Thesaurus Property
    C25365
    UMLS 2011AA Property
    C0678257
    Comments
    Descrição

    Comments

    Comments
    Descrição

    ResearchCommentsText

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS 2011AA ValueDomain
    C1527021
    NCI Thesaurus ObjectClass
    C15319
    NCI Thesaurus Property
    C25393
    UMLS 2011AA Property
    C0282411
    Investigator Signature
    Descrição

    InvestigatorSignatureText

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS 2011AA ValueDomain
    C1527021
    NCI Thesaurus Property
    C25678
    UMLS 2011AA Property
    C1519316
    NCI Thesaurus ObjectClass
    C17089
    UMLS 2011AA ObjectClass
    C0035173
    Investigator Signature Date
    Descrição

    InvestigatorSignatureDate

    Tipo de dados

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus Property
    C25678
    UMLS 2011AA Property
    C1519316
    NCI Thesaurus ValueDomain
    C25367
    NCI Thesaurus ObjectClass
    C17089
    UMLS 2011AA ObjectClass
    C0035173
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    1 Formulários
    1. StudyEvent: E4A03 Multiple Myeloma On-Study Form - Form 2055
      1. No Instruction available.
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Unnamed1
    CollectedDataFormName
    Item
    DCI Name
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    C19464 (NCI Thesaurus Property)
    C0376315 (UMLS 2011AA Property)
    C25474 (NCI Thesaurus ObjectClass)
    C1511726 (UMLS 2011AA ObjectClass)
    C25452 (NCI Thesaurus ObjectClass)
    RegistrationStepNumber
    Item
    Registration Step
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C25646 (NCI Thesaurus ObjectClass)
    C1514821 (UMLS 2011AA ObjectClass)
    C16154 (NCI Thesaurus Property)
    C1704379 (UMLS 2011AA Property)
    C16154 (NCI Thesaurus ValueDomain)
    C1704379 (UMLS 2011AA ValueDomain)
    Item
    Report Period (Place ID Label Here)
    text
    CL.1
    Code List
    Report Period (Place ID Label Here)
    CL Item
    Baseline Step 1 (Baseline Step 1)
    PatientInitialsName
    Item
    Patient Initials
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25536 (NCI Thesaurus Property)
    C1555582 (UMLS 2011AA Property)
    ProtocolECOGIdentifierNumber
    Item
    ECOG Protocol Number
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C25320 (NCI Thesaurus ObjectClass)
    C1507394 (UMLS 2011AA ObjectClass)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C25491 (NCI Thesaurus Property)
    C1512162 (UMLS 2011AA Property)
    ProtocolECOGIdentifierNumber
    Item
    ECOG Protocol Number
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C25320 (NCI Thesaurus ObjectClass)
    C1507394 (UMLS 2011AA ObjectClass)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C25491 (NCI Thesaurus Property)
    C1512162 (UMLS 2011AA Property)
    PatientECOGIdentifierNumber
    Item
    ECOG Patient ID
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C25491 (NCI Thesaurus Property)
    C1512162 (UMLS 2011AA Property)
    PatientECOGIdentifierNumber
    Item
    ECOG Patient ID
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C25491 (NCI Thesaurus Property)
    C1512162 (UMLS 2011AA Property)
    ProtocolParticipatingIdentifierNumber
    Item
    Participating Group Protocol Number
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C25320 (NCI Thesaurus ObjectClass)
    C1507394 (UMLS 2011AA ObjectClass)
    C25608 (NCI Thesaurus Property)
    C0679823 (UMLS 2011AA Property)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    PatientParticipatingIdentifierNumber
    Item
    Participating Group Patient ID
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25608 (NCI Thesaurus Property)
    C0679823 (UMLS 2011AA Property)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    CombinedInstitutionName
    Item
    Institution/Affiliate
    text
    C25454 (NCI Thesaurus ObjectClass)
    C0205195 (UMLS 2011AA ObjectClass)
    C21541 (NCI Thesaurus ObjectClass)
    C0018704 (UMLS 2011AA ObjectClass)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    C21541 (NCI Thesaurus ValueDomain)
    C0018704 (UMLS 2011AA ValueDomain)
    Item Group
    Unnamed2
    Item
    Are data amended
    text
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C25474 (NCI Thesaurus ObjectClass)
    C1511726 (UMLS 2011AA ObjectClass)
    C25416 (NCI Thesaurus Property)
    C1691222 (UMLS 2011AA Property)
    CL.2
    Code List
    Are data amended
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item Group
    Disease Description - Initial Diagnosis
    CancerInitialDiagnosisDate
    Item
    Date of Initial Pathologic Diagnosis
    date
    C9305 (NCI Thesaurus ObjectClass)
    C0006826 (UMLS 2011AA ObjectClass)
    C25509 (NCI Thesaurus Property)
    C1279901 (UMLS 2011AA Property)
    C15220 (NCI Thesaurus Property)
    C0011900 (UMLS 2011AA Property)
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25367 (NCI Thesaurus ValueDomain)
    Item
    Durie-Salmon Stage (at initial diagnosis - see attached)
    text
    C3242 (NCI Thesaurus ObjectClass)
    C0026764 (UMLS 2011AA ObjectClass)
    C15220 (NCI Thesaurus Property)
    C0011900 (UMLS 2011AA Property)
    C16899 (NCI Thesaurus ValueDomain)
    C1300072 (UMLS 2011AA ValueDomain)
    CL.3
    Code List
    Durie-Salmon Stage (at initial diagnosis - see attached)
    CL Item
    I - All Of The Following Must Be Present (hemoglobin >10 G/dl; Serum Calcium <12 Mg/dl; Urine Light Chains <4 G/24 Hrs; Normal Bones On Radiograph Or Solitary Plasmacytoma; Igg <5 G/dl; Iga <3 G/dl) (I)
    CL Item
    Ii - Fitting Neither Stage I Or Stage Iii (II)
    CL Item
    Iii - One Of The Following Must Be Present (hemoglobin <8.5 G/dl; Serum Calcium >12 Mg/dl; Urine Light Chains >12 G/24 Hrs; Advanced Lytic Bone Lesions (>3 Lytic Lesions); Igg >7 G/dl; Iga >5 G/dl) (III)
    CL Item
    Unknown (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    Item
    Durie-Salmon Sub-Stage (at initial diagnosis - see attached)
    text
    C25225 (NCI Thesaurus ValueDomain)
    C0022646 (UMLS 2011AA ValueDomain)
    C3242 (NCI Thesaurus ObjectClass)
    C0026764 (UMLS 2011AA ObjectClass)
    C15220 (NCI Thesaurus Property)
    C0011900 (UMLS 2011AA Property)
    C16899 (NCI Thesaurus ValueDomain)
    C1300072 (UMLS 2011AA ValueDomain)
    CL.4
    Code List
    Durie-Salmon Sub-Stage (at initial diagnosis - see attached)
    CL Item
    A (relatively Normal Renal Function - Serum Creatinine <2.0 Mg/dl) (A)
    CL Item
    B (abnormal Renal Function - Serum Creatinine >= 2.0 Mg/dl) (B)
    CL Item
    Unknown (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    Item Group
    Pre-registration Hematology/chemistry
    LaboratoryProcedureLeukocyteResultLowerLimitofNormalValue
    Item
    Peripheral WBC Count LLN (/mm3 x1000)
    double
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C12529 (NCI Thesaurus Property)
    C0023516 (UMLS 2011AA Property)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C25555 (NCI Thesaurus ValueDomain)
    C1518030 (UMLS 2011AA ValueDomain)
    LaboratoryProcedureLeukocyteResultSpecifiedValue
    Item
    Peripheral WBC Count
    double
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C12529 (NCI Thesaurus Property)
    C0023516 (UMLS 2011AA Property)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C38024 (NCI Thesaurus ValueDomain)
    C0205369 (UMLS 2011AA ValueDomain)
    LaboratoryProcedureGranulocyteResultLowerLimitofNormalCount
    Item
    Peripheral Granulocytes Count LLN (AGC.ANC /mm3)
    double
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C12530 (NCI Thesaurus Property)
    C0018183 (UMLS 2011AA Property)
    C25463 (NCI Thesaurus ValueDomain)
    C0750480 (UMLS 2011AA ValueDomain)
    C25555 (NCI Thesaurus ValueDomain)
    C1518030 (UMLS 2011AA ValueDomain)
    LaboratoryProcedureGranulocyteResultCount
    Item
    Peripheral Granulocytes Count
    double
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C12530 (NCI Thesaurus Property)
    C0018183 (UMLS 2011AA Property)
    C25463 (NCI Thesaurus ValueDomain)
    C0750480 (UMLS 2011AA ValueDomain)
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    LaboratoryProcedurePlateletResultLowerLimitofNormalValue
    Item
    Peripheral platelet count LLN (/mm3 x1000)
    double
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C12520 (NCI Thesaurus Property)
    C0005821 (UMLS 2011AA Property)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C25555 (NCI Thesaurus ValueDomain)
    C1518030 (UMLS 2011AA ValueDomain)
    LaboratoryProcedurePlateletResultSpecifiedValue
    Item
    Peripheral platelet count
    double
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C12520 (NCI Thesaurus Property)
    C0005821 (UMLS 2011AA Property)
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    LaboratoryProcedureAlkalinePhosphataseResultUpperLimitNormalValue
    Item
    Alkaline Phosphatase ULN (U/L)
    double
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C16276 (NCI Thesaurus Property)
    C0002059 (UMLS 2011AA Property)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C25706 (NCI Thesaurus ValueDomain)
    C1519815 (UMLS 2011AA ValueDomain)
    PatientInitialsName
    Item
    Patient Initials
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25536 (NCI Thesaurus Property)
    C1555582 (UMLS 2011AA Property)
    HepaticAlkalinePhosphataseLabValue
    Item
    Alkaline Phosphatase
    double
    C13308 (NCI Thesaurus ObjectClass)
    C0205054 (UMLS 2011AA ObjectClass)
    C37984 (NCI Thesaurus Property)
    C0022877 (UMLS 2011AA Property)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C16276 (NCI Thesaurus Property)
    C0002059 (UMLS 2011AA Property)
    HepaticBilirubinLabUpperLimitNormalValue
    Item
    Bilirubin ULN (mg/dl)
    double
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C305 (NCI Thesaurus Property)
    C0005437 (UMLS 2011AA Property)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C25706 (NCI Thesaurus ValueDomain)
    C1519815 (UMLS 2011AA ValueDomain)
    PatientECOGIdentifierNumber
    Item
    ECOG Patient ID
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C25491 (NCI Thesaurus Property)
    C1512162 (UMLS 2011AA Property)
    HepaticBilirubinLabValue
    Item
    Bilirubin
    double
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C305 (NCI Thesaurus Property)
    C0005437 (UMLS 2011AA Property)
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    LaboratoryProcedureCreatinineResultUpperLimitNormalValue
    Item
    Creatinine ULN (mg/dl)
    double
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C399 (NCI Thesaurus Property)
    C0010294 (UMLS 2011AA Property)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C25706 (NCI Thesaurus ValueDomain)
    C1519815 (UMLS 2011AA ValueDomain)
    RenalCreatinineLabSpecifiedValue
    Item
    Creatinine
    double
    C25225 (NCI Thesaurus ObjectClass)
    C0022646 (UMLS 2011AA ObjectClass)
    C399 (NCI Thesaurus Property)
    C0010294 (UMLS 2011AA Property)
    C25294 (NCI Thesaurus Property)
    C0022885 (UMLS 2011AA Property)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    LaboratoryProcedureHemoglobinResultSpecifiedLowerLimitofNormalValue
    Item
    Hemoglobin (Hgb), LLN (g/dl)
    double
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C16676 (NCI Thesaurus Property)
    C0019046 (UMLS 2011AA Property)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C38024 (NCI Thesaurus ValueDomain)
    C0205369 (UMLS 2011AA ValueDomain)
    C25555 (NCI Thesaurus ValueDomain)
    C1518030 (UMLS 2011AA ValueDomain)
    LaboratoryProcedureHemoglobinResultSpecifiedValue
    Item
    Hemoglobin (Hgb)
    double
    C16676 (NCI Thesaurus Property)
    C0019046 (UMLS 2011AA Property)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedUpperLimitofNormalValue
    Item
    SGOT (AST) ULN
    double
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C25202 (NCI Thesaurus Property)
    C0242192 (UMLS 2011AA Property)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C25706 (NCI Thesaurus ValueDomain)
    C1519815 (UMLS 2011AA ValueDomain)
    HepaticSGOT(AST)LabUnspecifiedValue
    Item
    SGOT (AST)
    double
    C13308 (NCI Thesaurus ObjectClass)
    C0205054 (UMLS 2011AA ObjectClass)
    C25202 (NCI Thesaurus Property)
    C0242192 (UMLS 2011AA Property)
    C37984 (NCI Thesaurus Property)
    C0022877 (UMLS 2011AA Property)
    C38046 (NCI Thesaurus ValueDomain)
    C0205370 (UMLS 2011AA ValueDomain)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultUpperLimitofNormalValue
    Item
    SGPT (ALT) ULN
    double
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C25293 (NCI Thesaurus Property)
    C0376147 (UMLS 2011AA Property)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C25706 (NCI Thesaurus ValueDomain)
    C1519815 (UMLS 2011AA ValueDomain)
    HepaticSGPT(ALT)LabUnspecifiedValue
    Item
    SGPT (ALT)
    double
    C13308 (NCI Thesaurus ObjectClass)
    C0205054 (UMLS 2011AA ObjectClass)
    C37984 (NCI Thesaurus Property)
    C0022877 (UMLS 2011AA Property)
    C25293 (NCI Thesaurus Property)
    C0376147 (UMLS 2011AA Property)
    C38046 (NCI Thesaurus ValueDomain)
    C0205370 (UMLS 2011AA ValueDomain)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    LaboratoryProcedureAlbuminResultLowerLimitofNormalValue
    Item
    Albumin LLN (g/dl)
    double
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C214 (NCI Thesaurus Property)
    C0001924 (UMLS 2011AA Property)
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C25555 (NCI Thesaurus ValueDomain)
    C1518030 (UMLS 2011AA ValueDomain)
    LaboratoryProcedureAlbuminResultUnspecifiedValue
    Item
    Albumin
    double
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C214 (NCI Thesaurus Property)
    C0001924 (UMLS 2011AA Property)
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    LaboratoryProcedureCalciumElectrolytesOutcomeLowerLimitofNormalValue
    Item
    Calcium LLN (Ca mg/dl)
    double
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C331 (NCI Thesaurus Property)
    C0006675 (UMLS 2011AA Property)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C464 (NCI Thesaurus Property)
    C0013832 (UMLS 2011AA Property)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C25555 (NCI Thesaurus ValueDomain)
    C1518030 (UMLS 2011AA ValueDomain)
    LaboratoryProcedureCalciumElectrolytesOutcomeUpperLimitofNormalValue
    Item
    Calcium ULN
    double
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C331 (NCI Thesaurus Property)
    C0006675 (UMLS 2011AA Property)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C464 (NCI Thesaurus Property)
    C0013832 (UMLS 2011AA Property)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C25706 (NCI Thesaurus ValueDomain)
    C1519815 (UMLS 2011AA ValueDomain)
    ElectrolytesCalciumLabSpecifiedValue
    Item
    Calcium
    double
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C331 (NCI Thesaurus Property)
    C0006675 (UMLS 2011AA Property)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C464 (NCI Thesaurus Property)
    C0013832 (UMLS 2011AA Property)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    LaboratoryProcedureGlucoseElectrolytesOutcomeLowerLimitofNormalValue
    Item
    Glucose LLN (mg/dl)
    double
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C2831 (NCI Thesaurus Property)
    C0017725 (UMLS 2011AA Property)
    C464 (NCI Thesaurus Property)
    C0013832 (UMLS 2011AA Property)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C25555 (NCI Thesaurus ValueDomain)
    C1518030 (UMLS 2011AA ValueDomain)
    LaboratoryProcedureGlucoseElectrolytesOutcomeUpperLimitNormalValue
    Item
    Glucose ULN
    double
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C2831 (NCI Thesaurus Property)
    C0017725 (UMLS 2011AA Property)
    C464 (NCI Thesaurus Property)
    C0013832 (UMLS 2011AA Property)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C25706 (NCI Thesaurus ValueDomain)
    C1519815 (UMLS 2011AA ValueDomain)
    LaboratoryProcedureGlucoseElectrolytesOutcomeUnspecifiedValue
    Item
    Glucose
    double
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C2831 (NCI Thesaurus Property)
    C0017725 (UMLS 2011AA Property)
    C464 (NCI Thesaurus Property)
    C0013832 (UMLS 2011AA Property)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    LaboratoryProcedurePotassiumElectrolytesOutcomeLowerLimitNormalValue
    Item
    Potassium LLN (K mmol/L)
    double
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C464 (NCI Thesaurus Property)
    C0013832 (UMLS 2011AA Property)
    C765 (NCI Thesaurus Property)
    C0032821 (UMLS 2011AA Property)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C25555 (NCI Thesaurus ValueDomain)
    C1518030 (UMLS 2011AA ValueDomain)
    LaboratoryProcedurePotassiumElectrolytesOutcomeUpperLimitNormalValue
    Item
    Potassium ULN
    double
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C464 (NCI Thesaurus Property)
    C0013832 (UMLS 2011AA Property)
    C765 (NCI Thesaurus Property)
    C0032821 (UMLS 2011AA Property)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C25706 (NCI Thesaurus ValueDomain)
    C1519815 (UMLS 2011AA ValueDomain)
    LaboratoryProcedurePotassiumElectrolytesOutcomeSpecifiedValue
    Item
    Potassium
    double
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C464 (NCI Thesaurus Property)
    C0013832 (UMLS 2011AA Property)
    C765 (NCI Thesaurus Property)
    C0032821 (UMLS 2011AA Property)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    LaboratoryProcedureSodiumElectrolytesOutcomeLowerLimitofNormalValue
    Item
    Sodium LLN (Na mmol/L)
    double
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C830 (NCI Thesaurus Property)
    C0037473 (UMLS 2011AA Property)
    C464 (NCI Thesaurus Property)
    C0013832 (UMLS 2011AA Property)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C25555 (NCI Thesaurus ValueDomain)
    C1518030 (UMLS 2011AA ValueDomain)
    LaboratoryProcedureSodiumElectrolytesOutcomeUpperLimitofNormalValue
    Item
    Sodium ULN
    double
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C830 (NCI Thesaurus Property)
    C0037473 (UMLS 2011AA Property)
    C464 (NCI Thesaurus Property)
    C0013832 (UMLS 2011AA Property)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C25706 (NCI Thesaurus ValueDomain)
    C1519815 (UMLS 2011AA ValueDomain)
    LaboratoryProcedureSodiumElectrolytesOutcomeSpecifiedValue
    Item
    Sodium
    double
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C830 (NCI Thesaurus Property)
    C0037473 (UMLS 2011AA Property)
    C464 (NCI Thesaurus Property)
    C0013832 (UMLS 2011AA Property)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    LaboratoryProcedureUricAcidResultSpecifiedLowerLimitofNormalValue
    Item
    Uric acid LLN (mg/dl)
    double
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C62652 (NCI Thesaurus Property)
    C0041980 (UMLS 2011AA Property)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C38024 (NCI Thesaurus ValueDomain)
    C0205369 (UMLS 2011AA ValueDomain)
    C25555 (NCI Thesaurus ValueDomain)
    C1518030 (UMLS 2011AA ValueDomain)
    LaboratoryProcedureUricAcidResultUpperLimitofNormalValue
    Item
    Uric acid ULN
    double
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C62652 (NCI Thesaurus Property)
    C0041980 (UMLS 2011AA Property)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C25706 (NCI Thesaurus ValueDomain)
    C1519815 (UMLS 2011AA ValueDomain)
    LaboratoryProcedureUricAcidResultSpecifiedValue
    Item
    Uric acid
    double
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C62652 (NCI Thesaurus Property)
    C0041980 (UMLS 2011AA Property)
    HematologyLabCollectedDate
    Item
    Date Hematology (Blood) Sample Obtained
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C25452 (NCI Thesaurus ValueDomain)
    Item Group
    Current Infections (last 6 Months)
    Item
    CTC Adverse Event Term Type (Specify site for each event)
    text
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C49704 (NCI Thesaurus ObjectClass)
    C1516728 (UMLS 2011AA ObjectClass)
    C0332307 (NCI Metathesaurus ValueDomain)
    C25249 (NCI Thesaurus Property)
    C1806781 (UMLS 2011AA Property)
    CL.5
    Code List
    CTC Adverse Event Term Type (Specify site for each event)
    CL Item
    Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection with Grade 3 or 4 neutrophils)
    CL Item
    Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils)
    CL Item
    Infection With Unknown Anc (Infection with unknown ANC)
    CTCAdverseEventSiteSpecify
    Item
    Specify site
    text
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    CommonToxicityCriteriaAdverseEventGrade
    Item
    CTC Adverse Event Grade (Use grade 1-4 per CTCAE v3)
    double
    C49704 (NCI Thesaurus ObjectClass)
    C1516728 (UMLS 2011AA ObjectClass)
    C18000 (NCI Thesaurus ValueDomain)
    C0919553 (UMLS 2011AA ValueDomain)
    C25365 (NCI Thesaurus Property)
    C0678257 (UMLS 2011AA Property)
    Item Group
    Current Clinical Date
    Item
    Performance status
    text
    C25664 (NCI Thesaurus ValueDomain)
    C0349674 (UMLS 2011AA ValueDomain)
    C25361 (NCI Thesaurus ObjectClass)
    C0597198 (UMLS 2011AA ObjectClass)
    C25365 (NCI Thesaurus Property)
    C0678257 (UMLS 2011AA Property)
    CL.6
    Code List
    Performance status
    CL Item
    Fully Active, Able To Carry On All Pre-disease Performance Without Restriction (karnofsky 90 - 100) (ecog - 0 Asymptomatic) (0)
    CL Item
    Restricted In Physically Strenuous Activity But Ambulatory (k70 - 80) (ecog - 1 Symptomatic - Fully Ambulatory) (1)
    CL Item
    Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities (k 50 - 60) (ecog - 2 Symptomatic; In Bed , 50% Of The Day) (2)
    CL Item
    Capable Of Limited Selfcare, Confined To Bed Or Chair More Than 50% Of Waking Hours. (k 30 - 40) (ecog - 3 Symptomatic; In Bed > 50% Of The Day But Not Bedridden) (3)
    CL Item
    Completely Disabled (k10 - 20) (ecog - 4 Bedridden) (4)
    Item
    Serum pregnancy test result
    text
    C25180 (NCI Thesaurus ValueDomain)
    C1522602 (UMLS 2011AA ValueDomain)
    C25742 (NCI Thesaurus Property)
    C0032961 (UMLS 2011AA Property)
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    CL.7
    Code List
    Serum pregnancy test result
    CL Item
    Negative (negative)
    C25247 (NCI Thesaurus)
    C0205160 (UMLS 2011AA)
    CL Item
    Positive (positive)
    C25246 (NCI Thesaurus)
    C1446409 (UMLS 2011AA)
    CL Item
    Unknown (not done)
    CL Item
    Not Applicable, Not Female Of Child-bearing Potential (not applicable, patient not female of child-bearing potential)
    PatientMostRecentPregnancyTestDate
    Item
    Date of serum pregnancy test
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C0032976 (NCI Metathesaurus Property)
    C25577 (NCI Thesaurus Property)
    C1513491 (UMLS 2011AA Property)
    Item
    Bone pain on entry to study
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C3303 (NCI Thesaurus ObjectClass)
    C0030193 (UMLS 2011AA ObjectClass)
    C12366 (NCI Thesaurus ObjectClass)
    C0262950 (UMLS 2011AA ObjectClass)
    C4876 (NCI Thesaurus Property)
    C1457887 (UMLS 2011AA Property)
    CL.8
    Code List
    Bone pain on entry to study
    CL Item
    None (none)
    C41132 (NCI Thesaurus)
    C0549184 (UMLS 2011AA)
    CL Item
    Mild Requires Only Non-narcotic Medication (mild, requires use of non-narcotic pain relief)
    CL Item
    Requires Occasional Narcotics (requires occasional narcotics)
    CL Item
    Requires Per Os Narcotics (requires p.o. narcotics)
    CL Item
    Requires Parenteral Narcotics Or Patch (requires parenteral narcotics, or patch)
    CL Item
    Uncontrollable Pain (uncontrollable pain)
    CL Item
    Unknown (unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    Item
    Is severe osteoporosis present?
    text
    C2991 (NCI Thesaurus ObjectClass)
    C0012634 (UMLS 2011AA ObjectClass)
    C3298 (NCI Thesaurus Property)
    C0029456 (UMLS 2011AA Property)
    C70667 (NCI Thesaurus Property)
    C0205082 (UMLS 2011AA Property)
    C15220 (NCI Thesaurus Property)
    C0011900 (UMLS 2011AA Property)
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    CL.9
    Code List
    Is severe osteoporosis present?
    CL Item
    Yes (yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    No (no)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Unknown (unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    Item
    Number of bones with lytic lesions present
    text
    C3824 (NCI Thesaurus ObjectClass)
    C0221198 (UMLS 2011AA ObjectClass)
    C27963 (NCI Thesaurus ObjectClass)
    C0439680 (UMLS 2011AA ObjectClass)
    C12366 (NCI Thesaurus Property)
    C0262950 (UMLS 2011AA Property)
    C25481 (NCI Thesaurus Property)
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    CL.10
    Code List
    Number of bones with lytic lesions present
    CL Item
    None (none)
    C41132 (NCI Thesaurus)
    C0549184 (UMLS 2011AA)
    CL Item
    1-3 Bones (1-3 bones)
    CL Item
    More Than 3 Bones (more than 3 bones)
    CL Item
    Unknown (unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    Item
    Number of lytic lesions > 2 cm in diameter
    text
    C3824 (NCI Thesaurus ObjectClass)
    C0221198 (UMLS 2011AA ObjectClass)
    C27963 (NCI Thesaurus ObjectClass)
    C0439680 (UMLS 2011AA ObjectClass)
    C49507 (NCI Thesaurus Property)
    C0439536 (UMLS 2011AA Property)
    C25481 (NCI Thesaurus Property)
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    CL.11
    Code List
    Number of lytic lesions > 2 cm in diameter
    CL Item
    None (none)
    C41132 (NCI Thesaurus)
    C0549184 (UMLS 2011AA)
    CL Item
    1-3 Lesions (1-3 bones)
    CL Item
    More Than 3 Lesions (more than 3 bones)
    CL Item
    Unknown (unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    PatientInitialsName
    Item
    Patient Initials
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25536 (NCI Thesaurus Property)
    C1555582 (UMLS 2011AA Property)
    Item
    Pathologic fracture during previous 1 month (including compression and rib fractures)
    text
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C25610 (NCI Thesaurus Property)
    C1521733 (UMLS 2011AA Property)
    C12366 (NCI Thesaurus ObjectClass)
    C0262950 (UMLS 2011AA ObjectClass)
    C3046 (NCI Thesaurus Property)
    C0016658 (UMLS 2011AA Property)
    CL.12
    Code List
    Pathologic fracture during previous 1 month (including compression and rib fractures)
    CL Item
    Yes (yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    No (no)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Unknown (unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    PatientECOGIdentifierNumber
    Item
    ECOG Patient ID
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C25491 (NCI Thesaurus Property)
    C1512162 (UMLS 2011AA Property)
    Item
    Is patient on anti-coagulation therapy?
    text
    C263 (NCI Thesaurus ObjectClass)
    C0003280 (UMLS 2011AA ObjectClass)
    C25473 (NCI Thesaurus Property)
    C0332173 (UMLS 2011AA Property)
    C25629 (NCI Thesaurus Property)
    C0332152 (UMLS 2011AA Property)
    C25409 (NCI Thesaurus Property)
    C1533734 (UMLS 2011AA Property)
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    CL.13
    Code List
    Is patient on anti-coagulation therapy?
    CL Item
    Yes (yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    No (no)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    Item Group
    Prior Therapy
    Item
    Prior corticosteroids?
    text
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C25629 (NCI Thesaurus Property)
    C0332152 (UMLS 2011AA Property)
    C2322 (NCI Thesaurus ObjectClass)
    C0001617 (UMLS 2011AA ObjectClass)
    C25382 (NCI Thesaurus Property)
    C1521801 (UMLS 2011AA Property)
    CL.14
    Code List
    Prior corticosteroids?
    CL Item
    Yes (yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    No (no)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    PriorCorticosteroidAdministeredSpecify
    Item
    Specify (If yes,)
    text
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
    C25629 (NCI Thesaurus Property)
    C0332152 (UMLS 2011AA Property)
    C2322 (NCI Thesaurus ObjectClass)
    C0001617 (UMLS 2011AA ObjectClass)
    C25382 (NCI Thesaurus Property)
    C1521801 (UMLS 2011AA Property)
    Item
    Prior bisphosphanate therapy?
    text
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C443 (NCI Thesaurus ObjectClass)
    C0012544 (UMLS 2011AA ObjectClass)
    C37902 (NCI Thesaurus ObjectClass)
    C1521721 (UMLS 2011AA ObjectClass)
    C25382 (NCI Thesaurus Property)
    C1521801 (UMLS 2011AA Property)
    CL.15
    Code List
    Prior bisphosphanate therapy?
    CL Item
    Yes (yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    No (no)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    Item
    Bisphosphanate type(s) received (If yes,)
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C443 (NCI Thesaurus ObjectClass)
    C0012544 (UMLS 2011AA ObjectClass)
    C37902 (NCI Thesaurus ObjectClass)
    C1521721 (UMLS 2011AA ObjectClass)
    C25382 (NCI Thesaurus Property)
    C1521801 (UMLS 2011AA Property)
    CL.16
    Code List
    Bisphosphanate type(s) received (If yes,)
    CL Item
    Pamidronate (pamidronate)
    CL Item
    Zoledronic Acid (zoledronic acid)
    CL Item
    Both Pamidronate And Zoledronic Acid (both pamidronate and zoledronic acid)
    Item
    Prior radiation therapy?
    text
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C15313 (NCI Thesaurus ObjectClass)
    C1522449 (UMLS 2011AA ObjectClass)
    C25629 (NCI Thesaurus ObjectClass)
    C0332152 (UMLS 2011AA ObjectClass)
    C25382 (NCI Thesaurus Property)
    C1521801 (UMLS 2011AA Property)
    CL.17
    Code List
    Prior radiation therapy?
    CL Item
    Yes (yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    No (no)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    SitesofpriorRT
    Item
    Sites of prior RT (If yes,)
    text
    RTPriorEndDate
    Item
    Date prior RT ended (Record any symptoms, complaints or diagnostic test abnormalities that were present at the time of registration for which a CTCAE term exists.)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C15313 (NCI Thesaurus ObjectClass)
    C1522449 (UMLS 2011AA ObjectClass)
    C25275 (NCI Thesaurus Property)
    C2745955 (UMLS 2011AA Property)
    Item Group
    Baseline Abnormalities
    Item
    CTC Adverse Event Term Type (include subterm if applicable Use CTCAE v3 terminology)
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C49704 (NCI Thesaurus ObjectClass)
    C1516728 (UMLS 2011AA ObjectClass)
    C45559 (NCI Thesaurus Property)
    C1705313 (UMLS 2011AA Property)
    CL.18
    Code List
    CTC Adverse Event Term Type (include subterm if applicable Use CTCAE v3 terminology)
    CL Item
    Thrombosis Nos (Thrombosis/thrombus/embolism)
    CL Item
    Peripheral Sensory Neuropathy (Neuropathy - sensory)
    C3501 (NCI Thesaurus)
    C0151313 (UMLS 2011AA)
    CommonToxicityCriteriaAdverseEventGrade
    Item
    CTC Adverse Event Grade (Use grade 1-4 per CTCAE v3)
    double
    C49704 (NCI Thesaurus ObjectClass)
    C1516728 (UMLS 2011AA ObjectClass)
    C18000 (NCI Thesaurus ValueDomain)
    C0919553 (UMLS 2011AA ValueDomain)
    C25365 (NCI Thesaurus Property)
    C0678257 (UMLS 2011AA Property)
    Item Group
    Comments
    ResearchCommentsText
    Item
    Comments
    text
    C25704 (NCI Thesaurus ValueDomain)
    C1527021 (UMLS 2011AA ValueDomain)
    C15319 (NCI Thesaurus ObjectClass)
    C25393 (NCI Thesaurus Property)
    C0282411 (UMLS 2011AA Property)
    InvestigatorSignatureText
    Item
    Investigator Signature
    text
    C25704 (NCI Thesaurus ValueDomain)
    C1527021 (UMLS 2011AA ValueDomain)
    C25678 (NCI Thesaurus Property)
    C1519316 (UMLS 2011AA Property)
    C17089 (NCI Thesaurus ObjectClass)
    C0035173 (UMLS 2011AA ObjectClass)
    InvestigatorSignatureDate
    Item
    Investigator Signature Date
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25678 (NCI Thesaurus Property)
    C1519316 (UMLS 2011AA Property)
    C25367 (NCI Thesaurus ValueDomain)
    C17089 (NCI Thesaurus ObjectClass)
    C0035173 (UMLS 2011AA ObjectClass)
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