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10863

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E4A03 Multiple Myeloma On-Study Form - Form 2055 NCT00098475 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

Keywords

Versions (3)
  1. 9/19/12 9/19/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 6/9/15 6/9/15 -
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June 9, 2015

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Creative Commons BY-NC 3.0 Legacy
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    E4A03 Multiple Myeloma On-Study Form - Form 2055 NCT00098475

    English

    No Instruction available.

    1 forms  
    1. StudyEvent: E4A03 Multiple Myeloma On-Study Form - Form 2055
      1. No Instruction available.
    Header
    Description

    Header

    ECOG Protocol Number
    Description

    Protocol Number ECOG

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C3274381
    NCI Thesaurus ObjectClass
    C25320
    UMLS CUI-2
    C1512162
    NCI Thesaurus Property
    C25364
    NCI Thesaurus Property-2
    C25491
    ECOG Patient ID
    Description

    Patient ID ECOG

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C2348585
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-2
    C1512162
    NCI Thesaurus Property
    C25364
    NCI Thesaurus Property-2
    C25491
    DCI Name
    Description

    Generic drug form

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C3242750
    NCI Thesaurus Property
    C19464
    NCI Thesaurus ObjectClass
    C25474
    NCI Thesaurus ObjectClass-2
    C25452
    Registration Step
    Description

    Registration Number

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C1514821
    NCI Thesaurus ObjectClass
    C25646
    UMLS CUI-2
    C0237753
    NCI Thesaurus Property
    C16154
    NCI Thesaurus ValueDomain-2
    C16154
    Report Period (Place ID Label Here)
    Description

    ReportingPeriod

    Data type

    text

    Patient Initials
    Description

    Patient Initials

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C2986440
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25536
    Participating Group Protocol Number
    Description

    Study Number Participating Group

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C3274381
    NCI Thesaurus ObjectClass
    C25320
    UMLS CUI-2
    C2347449
    NCI Thesaurus Property
    C25608
    NCI Thesaurus Property-2
    C25364
    Participating Group Patient ID
    Description

    Trial subject ID Participating Group

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C2348585
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-2
    C2347449
    NCI Thesaurus Property
    C25608
    NCI Thesaurus Property-2
    C25364
    Institution/Affiliate
    Description

    Institution Name

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C25454
    UMLS CUI-1
    C1301943
    NCI Thesaurus ObjectClass-2
    C21541
    NCI Thesaurus Property
    C25364
    NCI Thesaurus ValueDomain
    C25191
    NCI Thesaurus ValueDomain-2
    C21541
    Are data amended
    Description

    Data amended

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS CUI-1
    C0680532
    NCI Thesaurus ObjectClass
    C25474
    NCI Thesaurus Property
    C25416
    Disease Description - Initial Diagnosis
    Description

    Disease Description - Initial Diagnosis

    Date of Initial Pathologic Diagnosis
    Description

    CancerInitialDiagnosisDate

    Data type

    date

    Alias
    NCI Thesaurus ObjectClass
    C9305
    UMLS 2011AA ObjectClass
    C0006826
    NCI Thesaurus Property
    C25509
    UMLS 2011AA Property
    C1279901
    NCI Thesaurus Property-2
    C15220
    UMLS 2011AA Property-2
    C0011900
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ValueDomain-2
    C25367
    Durie-Salmon Stage (at initial diagnosis - see attached)
    Description

    MyelomaDiagnosisStage

    Data type

    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)
    Description

    MyelomaDiagnosisRenalStage

    Data type

    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-2
    C16899
    UMLS 2011AA ValueDomain-2
    C1300072
    Pre-registration Hematology/chemistry
    Description

    Pre-registration Hematology/chemistry

    Peripheral WBC Count LLN (/mm3 x1000)
    Description

    LaboratoryProcedureLeukocyteResultLowerLimitofNormalValue

    Data type

    float

    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C12529
    UMLS 2011AA Property
    C0023516
    NCI Thesaurus Property-2
    C20200
    UMLS 2011AA Property-2
    C1274040
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus ValueDomain-2
    C25555
    UMLS 2011AA ValueDomain-2
    C1518030
    Peripheral WBC Count
    Description

    Leukocytes (WBC)

    Data type

    float

    Measurement units
    • 1000/uL
    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS CUI-1
    C0023508
    NCI Thesaurus Property
    C12529
    NCI Thesaurus Property-2
    C20200
    NCI Thesaurus ValueDomain
    C25712
    NCI Thesaurus ValueDomain-2
    C38024
    1000/uL
    Peripheral Granulocytes Count LLN (AGC.ANC /mm3)
    Description

    LaboratoryProcedureGranulocyteResultLowerLimitofNormalCount

    Data type

    float

    Measurement units
    • mm3
    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property-2
    C12530
    UMLS 2011AA Property-2
    C0018183
    NCI Thesaurus ValueDomain
    C25463
    UMLS 2011AA ValueDomain
    C0750480
    NCI Thesaurus ValueDomain-2
    C25555
    UMLS 2011AA ValueDomain-2
    C1518030
    mm3
    Peripheral Granulocytes Count
    Description

    Granulocyte count

    Data type

    float

    Measurement units
    • 1000/uL
    Alias
    NCI Thesaurus Property
    C20200
    UMLS CUI-1
    C0857490
    NCI Thesaurus Property-2
    C12530
    NCI Thesaurus ValueDomain
    C25463
    NCI Thesaurus ObjectClass
    C25294
    1000/uL
    Peripheral platelet count LLN (/mm3 x1000)
    Description

    Platelets LLN

    Data type

    float

    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS CUI-1
    C0005821
    NCI Thesaurus Property
    C20200
    UMLS CUI-2
    C1518030
    NCI Thesaurus Property-2
    C12520
    NCI Thesaurus ValueDomain
    C25712
    NCI Thesaurus ValueDomain-2
    C25555
    Peripheral platelet count
    Description

    Platelets

    Data type

    float

    Measurement units
    • 1000/uL
    Alias
    NCI Thesaurus Property
    C20200
    UMLS CUI-1
    C0005821
    NCI Thesaurus Property-2
    C12520
    NCI Thesaurus ObjectClass
    C25294
    NCI Thesaurus ValueDomain
    C25712
    1000/uL
    Alkaline Phosphatase ULN (U/L)
    Description

    Alkaline Phosphatase ULN

    Data type

    float

    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS CUI-1
    C0151420
    NCI Thesaurus Property
    C20200
    NCI Thesaurus Property-2
    C16276
    NCI Thesaurus ValueDomain
    C25712
    NCI Thesaurus ValueDomain-2
    C25706
    Alkaline Phosphatase
    Description

    HepaticAlkalinePhosphataseLabValue

    Data type

    float

    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-2
    C16276
    UMLS 2011AA Property-2
    C0002059
    Bilirubin ULN (mg/dl)
    Description

    HepaticBilirubinLabUpperLimitNormalValue

    Data type

    float

    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property-2
    C305
    UMLS 2011AA Property-2
    C0005437
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus ValueDomain-2
    C25706
    UMLS 2011AA ValueDomain-2
    C1519815
    Bilirubin
    Description

    HepaticBilirubinLabValue

    Data type

    float

    Measurement units
    • mg/dL
    Alias
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property-2
    C305
    UMLS 2011AA Property-2
    C0005437
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    mg/dL
    Creatinine ULN (mg/dl)
    Description

    Creatinine, serum ULN

    Data type

    float

    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS CUI-1
    C0201976
    NCI Thesaurus Property
    C20200
    UMLS CUI-2
    C1519815
    NCI Thesaurus Property-2
    C399
    NCI Thesaurus ValueDomain
    C25712
    NCI Thesaurus ValueDomain-2
    C25706
    Creatinine
    Description

    RenalCreatinineLabSpecifiedValue

    Data type

    float

    Measurement units
    • mg/dL
    Alias
    NCI Thesaurus ObjectClass
    C25225
    UMLS 2011AA ObjectClass
    C0022646
    NCI Thesaurus Property
    C399
    UMLS 2011AA Property
    C0010294
    NCI Thesaurus Property-2
    C25294
    UMLS 2011AA Property-2
    C0022885
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    mg/dL
    Hemoglobin (Hgb), LLN (g/dl)
    Description

    Hemoglobin LLN

    Data type

    float

    Measurement units
    • g/dL
    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS CUI-1
    C0019046
    NCI Thesaurus Property
    C16676
    UMLS CUI-2
    C1518030
    NCI Thesaurus Property-2
    C20200
    NCI Thesaurus ValueDomain
    C25712
    NCI Thesaurus ValueDomain-2
    C38024
    NCI Thesaurus ValueDomain-3
    C25555
    g/dL
    Hemoglobin (Hgb)
    Description

    LaboratoryProcedureHemoglobinResultSpecifiedValue

    Data type

    float

    Measurement units
    • g/dL
    Alias
    NCI Thesaurus Property
    C16676
    UMLS 2011AA Property
    C0019046
    NCI Thesaurus Property-2
    C20200
    UMLS 2011AA Property-2
    C1274040
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    g/dL
    SGOT (AST) ULN
    Description

    LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedUpperLimitofNormalValue

    Data type

    float

    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C25202
    UMLS 2011AA Property
    C0242192
    NCI Thesaurus Property-2
    C20200
    UMLS 2011AA Property-2
    C1274040
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus ValueDomain-2
    C25706
    UMLS 2011AA ValueDomain-2
    C1519815
    SGOT (AST)
    Description

    HepaticSGOT(AST)LabUnspecifiedValue

    Data type

    float

    Alias
    NCI Thesaurus ObjectClass
    C13308
    UMLS 2011AA ObjectClass
    C0205054
    NCI Thesaurus Property
    C25202
    UMLS 2011AA Property
    C0242192
    NCI Thesaurus Property-2
    C37984
    UMLS 2011AA Property-2
    C0022877
    NCI Thesaurus ValueDomain
    C38046
    UMLS 2011AA ValueDomain
    C0205370
    NCI Thesaurus ValueDomain-2
    C25712
    UMLS 2011AA ValueDomain-2
    C1522609
    SGPT (ALT) ULN
    Description

    LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultUpperLimitofNormalValue

    Data type

    float

    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property-2
    C25293
    UMLS 2011AA Property-2
    C0376147
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus ValueDomain-2
    C25706
    UMLS 2011AA ValueDomain-2
    C1519815
    SGPT (ALT)
    Description

    HepaticSGPT(ALT)LabUnspecifiedValue

    Data type

    float

    Alias
    NCI Thesaurus ObjectClass
    C13308
    UMLS 2011AA ObjectClass
    C0205054
    NCI Thesaurus Property
    C37984
    UMLS 2011AA Property
    C0022877
    NCI Thesaurus Property-2
    C25293
    UMLS 2011AA Property-2
    C0376147
    NCI Thesaurus ValueDomain
    C38046
    UMLS 2011AA ValueDomain
    C0205370
    NCI Thesaurus ValueDomain-2
    C25712
    UMLS 2011AA ValueDomain-2
    C1522609
    Albumin LLN (g/dl)
    Description

    LaboratoryProcedureAlbuminResultLowerLimitofNormalValue

    Data type

    float

    Alias
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property-2
    C214
    UMLS 2011AA Property-2
    C0001924
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus ValueDomain-2
    C25555
    UMLS 2011AA ValueDomain-2
    C1518030
    Albumin
    Description

    LaboratoryProcedureAlbuminResultUnspecifiedValue

    Data type

    float

    Alias
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property-2
    C214
    UMLS 2011AA Property-2
    C0001924
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    Calcium LLN (Ca mg/dl)
    Description

    LaboratoryProcedureCalciumElectrolytesOutcomeLowerLimitofNormalValue

    Data type

    float

    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C331
    UMLS 2011AA Property
    C0006675
    NCI Thesaurus Property-2
    C20200
    UMLS 2011AA Property-2
    C1274040
    NCI Thesaurus Property-3
    C464
    UMLS 2011AA Property-3
    C0013832
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus ValueDomain-2
    C25555
    UMLS 2011AA ValueDomain-2
    C1518030
    Calcium ULN
    Description

    LaboratoryProcedureCalciumElectrolytesOutcomeUpperLimitofNormalValue

    Data type

    float

    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C331
    UMLS 2011AA Property
    C0006675
    NCI Thesaurus Property-2
    C20200
    UMLS 2011AA Property-2
    C1274040
    NCI Thesaurus Property-3
    C464
    UMLS 2011AA Property-3
    C0013832
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus ValueDomain-2
    C25706
    UMLS 2011AA ValueDomain-2
    C1519815
    Calcium
    Description

    ElectrolytesCalciumLabSpecifiedValue

    Data type

    float

    Measurement units
    • mg/dL
    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C331
    UMLS 2011AA Property
    C0006675
    NCI Thesaurus Property-2
    C20200
    UMLS 2011AA Property-2
    C1274040
    NCI Thesaurus Property-3
    C464
    UMLS 2011AA Property-3
    C0013832
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    mg/dL
    Glucose LLN (mg/dl)
    Description

    LaboratoryProcedureGlucoseElectrolytesOutcomeLowerLimitofNormalValue

    Data type

    float

    Measurement units
    • mg/dL
    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property-2
    C2831
    UMLS 2011AA Property-2
    C0017725
    NCI Thesaurus Property-3
    C464
    UMLS 2011AA Property-3
    C0013832
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus ValueDomain-2
    C25555
    UMLS 2011AA ValueDomain-2
    C1518030
    mg/dL
    Glucose ULN
    Description

    LaboratoryProcedureGlucoseElectrolytesOutcomeUpperLimitNormalValue

    Data type

    float

    Measurement units
    • mg/dL
    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property-2
    C2831
    UMLS 2011AA Property-2
    C0017725
    NCI Thesaurus Property-3
    C464
    UMLS 2011AA Property-3
    C0013832
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus ValueDomain-2
    C25706
    UMLS 2011AA ValueDomain-2
    C1519815
    mg/dL
    Glucose
    Description

    LaboratoryProcedureGlucoseElectrolytesOutcomeUnspecifiedValue

    Data type

    float

    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property-2
    C2831
    UMLS 2011AA Property-2
    C0017725
    NCI Thesaurus Property-3
    C464
    UMLS 2011AA Property-3
    C0013832
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    Potassium LLN (K mmol/L)
    Description

    LaboratoryProcedurePotassiumElectrolytesOutcomeLowerLimitNormalValue

    Data type

    float

    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property-2
    C464
    UMLS 2011AA Property-2
    C0013832
    NCI Thesaurus Property-3
    C765
    UMLS 2011AA Property-3
    C0032821
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus ValueDomain-2
    C25555
    UMLS 2011AA ValueDomain-2
    C1518030
    Potassium ULN
    Description

    LaboratoryProcedurePotassiumElectrolytesOutcomeUpperLimitNormalValue

    Data type

    float

    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property-2
    C464
    UMLS 2011AA Property-2
    C0013832
    NCI Thesaurus Property-3
    C765
    UMLS 2011AA Property-3
    C0032821
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus ValueDomain-2
    C25706
    UMLS 2011AA ValueDomain-2
    C1519815
    Potassium
    Description

    LaboratoryProcedurePotassiumElectrolytesOutcomeSpecifiedValue

    Data type

    float

    Measurement units
    • mmol/L
    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property-2
    C464
    UMLS 2011AA Property-2
    C0013832
    NCI Thesaurus Property-3
    C765
    UMLS 2011AA Property-3
    C0032821
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    mmol/L
    Sodium LLN (Na mmol/L)
    Description

    LaboratoryProcedureSodiumElectrolytesOutcomeLowerLimitofNormalValue

    Data type

    float

    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property-2
    C830
    UMLS 2011AA Property-2
    C0037473
    NCI Thesaurus Property-3
    C464
    UMLS 2011AA Property-3
    C0013832
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus ValueDomain-2
    C25555
    UMLS 2011AA ValueDomain-2
    C1518030
    Sodium ULN
    Description

    LaboratoryProcedureSodiumElectrolytesOutcomeUpperLimitofNormalValue

    Data type

    float

    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property-2
    C830
    UMLS 2011AA Property-2
    C0037473
    NCI Thesaurus Property-3
    C464
    UMLS 2011AA Property-3
    C0013832
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus ValueDomain-2
    C25706
    UMLS 2011AA ValueDomain-2
    C1519815
    Sodium
    Description

    LaboratoryProcedureSodiumElectrolytesOutcomeSpecifiedValue

    Data type

    float

    Measurement units
    • mmol/L
    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property-2
    C830
    UMLS 2011AA Property-2
    C0037473
    NCI Thesaurus Property-3
    C464
    UMLS 2011AA Property-3
    C0013832
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    mmol/L
    Uric acid LLN (mg/dl)
    Description

    LaboratoryProcedureUricAcidResultSpecifiedLowerLimitofNormalValue

    Data type

    float

    Measurement units
    • mg/dL
    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property-2
    C62652
    UMLS 2011AA Property-2
    C0041980
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus ValueDomain-2
    C38024
    UMLS 2011AA ValueDomain-2
    C0205369
    NCI Thesaurus ValueDomain-3
    C25555
    UMLS 2011AA ValueDomain-3
    C1518030
    mg/dL
    Uric acid ULN
    Description

    LaboratoryProcedureUricAcidResultUpperLimitofNormalValue

    Data type

    float

    Measurement units
    • mg/dL
    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property-2
    C62652
    UMLS 2011AA Property-2
    C0041980
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus ValueDomain-2
    C25706
    UMLS 2011AA ValueDomain-2
    C1519815
    mg/dL
    Uric acid
    Description

    LaboratoryProcedureUricAcidResultSpecifiedValue

    Data type

    float

    Measurement units
    • 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-2
    C62652
    UMLS 2011AA Property-2
    C0041980
    mg/dL
    Date Hematology (Blood) Sample Obtained
    Description

    HematologyLabCollectedDate

    Data type

    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-2
    C25452
    Current Infections (last 6 Months)
    Description

    Current Infections (last 6 Months)

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

    CommonToxicityCriteriaAdverseEventShortNameType

    Data type

    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-2
    C25249
    UMLS 2011AA Property-2
    C1806781
    Specify site
    Description

    CTCAdverseEventSiteSpecify

    Data type

    text

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

    CommonToxicityCriteriaAdverseEventGrade

    Data type

    float

    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
    Description

    Current Clinical Date

    Performance status
    Description

    PerformanceStatusScale

    Data type

    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
    Description

    TestPregnancyInd

    Data type

    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
    Description

    PatientMostRecentPregnancyTestDate

    Data type

    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
    Description

    PainBoneSymptomType

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C3303
    UMLS 2011AA ObjectClass
    C0030193
    NCI Thesaurus ObjectClass-2
    C12366
    UMLS 2011AA ObjectClass-2
    C0262950
    NCI Thesaurus Property
    C4876
    UMLS 2011AA Property
    C1457887
    Is severe osteoporosis present?
    Description

    DiseaseSevereOsteoporosisDiagnosisInd-3

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C2991
    UMLS 2011AA ObjectClass
    C0012634
    NCI Thesaurus Property
    C3298
    UMLS 2011AA Property
    C0029456
    NCI Thesaurus Property-2
    C70667
    UMLS 2011AA Property-2
    C0205082
    NCI Thesaurus Property-3
    C15220
    UMLS 2011AA Property-3
    C0011900
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    Number of bones with lytic lesions present
    Description

    LyticLesionBoneDetectedType

    Data type

    text

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

    LyticLesionMediumDetectedType

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C3824
    UMLS 2011AA ObjectClass
    C0221198
    NCI Thesaurus ObjectClass-2
    C27963
    UMLS 2011AA ObjectClass-2
    C0439680
    NCI Thesaurus Property
    C49507
    UMLS 2011AA Property
    C0439536
    NCI Thesaurus Property-2
    C25481
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    Pathologic fracture during previous 1 month (including compression and rib fractures)
    Description

    BonePathologicFractureInd-3

    Data type

    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-2
    C3046
    UMLS 2011AA Property-2
    C0016658
    Is patient on anti-coagulation therapy?
    Description

    Anticoagulation therapy daily

    Data type

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C263
    UMLS CUI-1
    C0003280
    NCI Thesaurus Property
    C25473
    UMLS CUI-2
    C0332173
    NCI Thesaurus Property-2
    C25629
    NCI Thesaurus Property-3
    C25409
    NCI Thesaurus ValueDomain
    C38148
    Prior Therapy
    Description

    Prior Therapy

    Prior corticosteroids?
    Description

    CorticosteroidPriorAdministeredInd-3

    Data type

    boolean

    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-2
    C25382
    UMLS 2011AA Property-2
    C1521801
    Specify (If yes,)
    Description

    PriorCorticosteroidAdministeredSpecify

    Data type

    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-2
    C25382
    UMLS 2011AA Property-2
    C1521801
    Prior bisphosphanate therapy?
    Description

    Bisphosphonates

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS CUI-1
    C0012544
    NCI Thesaurus ObjectClass
    C443
    NCI Thesaurus ObjectClass-2
    C37902
    NCI Thesaurus Property
    C25382
    Bisphosphanate type(s) received (If yes,)
    Description

    Bisphosphonates type

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS CUI-1
    C0012544
    NCI Thesaurus ObjectClass
    C443
    UMLS CUI-2
    C0683312
    NCI Thesaurus ObjectClass-2
    C37902
    NCI Thesaurus Property
    C25382
    Prior radiation therapy?
    Description

    Prior Radiation Therapy

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS CUI-1
    C1522449
    NCI Thesaurus ObjectClass
    C15313
    UMLS CUI-2
    C0332152
    NCI Thesaurus ObjectClass-2
    C25629
    NCI Thesaurus Property
    C25382
    Sites of prior RT (If yes,)
    Description

    SitesofpriorRT

    Data type

    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.)
    Description

    RTPriorEndDate

    Data type

    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
    Description

    Baseline Abnormalities

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

    CommonToxicityCriteriaAdverseEventTermType

    Data type

    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
    Comments
    Description

    Comments

    Comments
    Description

    Research Comments

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS CUI-1
    C0947611
    NCI Thesaurus ObjectClass
    C15319
    NCI Thesaurus Property
    C25393
    Investigator Signature
    Description

    Investigator Signature

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS CUI-1
    C2346576
    NCI Thesaurus Property
    C25678
    NCI Thesaurus ObjectClass
    C17089
    Investigator Signature Date
    Description

    Investigator Signature Date

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C2346576
    NCI Thesaurus Property
    C25678
    UMLS CUI-2
    C0011008
    NCI Thesaurus ValueDomain-2
    C25367
    NCI Thesaurus ObjectClass
    C17089
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    1 forms
    1. StudyEvent: E4A03 Multiple Myeloma On-Study Form - Form 2055
      1. No Instruction available.
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Header
    Protocol Number ECOG
    Item
    ECOG Protocol Number
    text
    C25337 (NCI Thesaurus ValueDomain)
    C3274381 (UMLS CUI-1)
    C25320 (NCI Thesaurus ObjectClass)
    C1512162 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25491 (NCI Thesaurus Property-2)
    Patient ID ECOG
    Item
    ECOG Patient ID
    text
    C25337 (NCI Thesaurus ValueDomain)
    C2348585 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C1512162 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25491 (NCI Thesaurus Property-2)
    Generic drug form
    Item
    DCI Name
    text
    C25191 (NCI Thesaurus ValueDomain)
    C3242750 (UMLS CUI-1)
    C19464 (NCI Thesaurus Property)
    C25474 (NCI Thesaurus ObjectClass)
    C25452 (NCI Thesaurus ObjectClass-2)
    Registration Number
    Item
    Registration Step
    text
    C25337 (NCI Thesaurus ValueDomain)
    C1514821 (UMLS CUI-1)
    C25646 (NCI Thesaurus ObjectClass)
    C0237753 (UMLS CUI-2)
    C16154 (NCI Thesaurus Property)
    C16154 (NCI Thesaurus ValueDomain-2)
    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)
    Patient Initials
    Item
    Patient Initials
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2986440 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25536 (NCI Thesaurus Property)
    Study Number Participating Group
    Item
    Participating Group Protocol Number
    text
    C25337 (NCI Thesaurus ValueDomain)
    C3274381 (UMLS CUI-1)
    C25320 (NCI Thesaurus ObjectClass)
    C2347449 (UMLS CUI-2)
    C25608 (NCI Thesaurus Property)
    C25364 (NCI Thesaurus Property-2)
    Trial subject ID Participating Group
    Item
    Participating Group Patient ID
    text
    C25337 (NCI Thesaurus ValueDomain)
    C2348585 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C2347449 (UMLS CUI-2)
    C25608 (NCI Thesaurus Property)
    C25364 (NCI Thesaurus Property-2)
    Institution Name
    Item
    Institution/Affiliate
    text
    C25454 (NCI Thesaurus ObjectClass)
    C1301943 (UMLS CUI-1)
    C21541 (NCI Thesaurus ObjectClass-2)
    C25364 (NCI Thesaurus Property)
    C25191 (NCI Thesaurus ValueDomain)
    C21541 (NCI Thesaurus ValueDomain-2)
    Data amended
    Item
    Are data amended
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C0680532 (UMLS CUI-1)
    C25474 (NCI Thesaurus ObjectClass)
    C25416 (NCI Thesaurus Property)
    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-2)
    C0011900 (UMLS 2011AA Property-2)
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25367 (NCI Thesaurus ValueDomain-2)
    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-2)
    C1300072 (UMLS 2011AA ValueDomain-2)
    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)
    float
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C12529 (NCI Thesaurus Property)
    C0023516 (UMLS 2011AA Property)
    C20200 (NCI Thesaurus Property-2)
    C1274040 (UMLS 2011AA Property-2)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C25555 (NCI Thesaurus ValueDomain-2)
    C1518030 (UMLS 2011AA ValueDomain-2)
    Leukocytes (WBC)
    Item
    Peripheral WBC Count
    float
    C25294 (NCI Thesaurus ObjectClass)
    C0023508 (UMLS CUI-1)
    C12529 (NCI Thesaurus Property)
    C20200 (NCI Thesaurus Property-2)
    C25712 (NCI Thesaurus ValueDomain)
    C38024 (NCI Thesaurus ValueDomain-2)
    LaboratoryProcedureGranulocyteResultLowerLimitofNormalCount
    Item
    Peripheral Granulocytes Count LLN (AGC.ANC /mm3)
    float
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C12530 (NCI Thesaurus Property-2)
    C0018183 (UMLS 2011AA Property-2)
    C25463 (NCI Thesaurus ValueDomain)
    C0750480 (UMLS 2011AA ValueDomain)
    C25555 (NCI Thesaurus ValueDomain-2)
    C1518030 (UMLS 2011AA ValueDomain-2)
    Granulocyte count
    Item
    Peripheral Granulocytes Count
    float
    C20200 (NCI Thesaurus Property)
    C0857490 (UMLS CUI-1)
    C12530 (NCI Thesaurus Property-2)
    C25463 (NCI Thesaurus ValueDomain)
    C25294 (NCI Thesaurus ObjectClass)
    Platelets LLN
    Item
    Peripheral platelet count LLN (/mm3 x1000)
    float
    C25294 (NCI Thesaurus ObjectClass)
    C0005821 (UMLS CUI-1)
    C20200 (NCI Thesaurus Property)
    C1518030 (UMLS CUI-2)
    C12520 (NCI Thesaurus Property-2)
    C25712 (NCI Thesaurus ValueDomain)
    C25555 (NCI Thesaurus ValueDomain-2)
    Platelets
    Item
    Peripheral platelet count
    float
    C20200 (NCI Thesaurus Property)
    C0005821 (UMLS CUI-1)
    C12520 (NCI Thesaurus Property-2)
    C25294 (NCI Thesaurus ObjectClass)
    C25712 (NCI Thesaurus ValueDomain)
    Alkaline Phosphatase ULN
    Item
    Alkaline Phosphatase ULN (U/L)
    float
    C25294 (NCI Thesaurus ObjectClass)
    C0151420 (UMLS CUI-1)
    C20200 (NCI Thesaurus Property)
    C16276 (NCI Thesaurus Property-2)
    C25712 (NCI Thesaurus ValueDomain)
    C25706 (NCI Thesaurus ValueDomain-2)
    HepaticAlkalinePhosphataseLabValue
    Item
    Alkaline Phosphatase
    float
    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-2)
    C0002059 (UMLS 2011AA Property-2)
    HepaticBilirubinLabUpperLimitNormalValue
    Item
    Bilirubin ULN (mg/dl)
    float
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C305 (NCI Thesaurus Property-2)
    C0005437 (UMLS 2011AA Property-2)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C25706 (NCI Thesaurus ValueDomain-2)
    C1519815 (UMLS 2011AA ValueDomain-2)
    HepaticBilirubinLabValue
    Item
    Bilirubin
    float
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C305 (NCI Thesaurus Property-2)
    C0005437 (UMLS 2011AA Property-2)
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    Creatinine, serum ULN
    Item
    Creatinine ULN (mg/dl)
    float
    C25294 (NCI Thesaurus ObjectClass)
    C0201976 (UMLS CUI-1)
    C20200 (NCI Thesaurus Property)
    C1519815 (UMLS CUI-2)
    C399 (NCI Thesaurus Property-2)
    C25712 (NCI Thesaurus ValueDomain)
    C25706 (NCI Thesaurus ValueDomain-2)
    RenalCreatinineLabSpecifiedValue
    Item
    Creatinine
    float
    C25225 (NCI Thesaurus ObjectClass)
    C0022646 (UMLS 2011AA ObjectClass)
    C399 (NCI Thesaurus Property)
    C0010294 (UMLS 2011AA Property)
    C25294 (NCI Thesaurus Property-2)
    C0022885 (UMLS 2011AA Property-2)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    Hemoglobin LLN
    Item
    Hemoglobin (Hgb), LLN (g/dl)
    float
    C25294 (NCI Thesaurus ObjectClass)
    C0019046 (UMLS CUI-1)
    C16676 (NCI Thesaurus Property)
    C1518030 (UMLS CUI-2)
    C20200 (NCI Thesaurus Property-2)
    C25712 (NCI Thesaurus ValueDomain)
    C38024 (NCI Thesaurus ValueDomain-2)
    C25555 (NCI Thesaurus ValueDomain-3)
    LaboratoryProcedureHemoglobinResultSpecifiedValue
    Item
    Hemoglobin (Hgb)
    float
    C16676 (NCI Thesaurus Property)
    C0019046 (UMLS 2011AA Property)
    C20200 (NCI Thesaurus Property-2)
    C1274040 (UMLS 2011AA Property-2)
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedUpperLimitofNormalValue
    Item
    SGOT (AST) ULN
    float
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C25202 (NCI Thesaurus Property)
    C0242192 (UMLS 2011AA Property)
    C20200 (NCI Thesaurus Property-2)
    C1274040 (UMLS 2011AA Property-2)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C25706 (NCI Thesaurus ValueDomain-2)
    C1519815 (UMLS 2011AA ValueDomain-2)
    HepaticSGOT(AST)LabUnspecifiedValue
    Item
    SGOT (AST)
    float
    C13308 (NCI Thesaurus ObjectClass)
    C0205054 (UMLS 2011AA ObjectClass)
    C25202 (NCI Thesaurus Property)
    C0242192 (UMLS 2011AA Property)
    C37984 (NCI Thesaurus Property-2)
    C0022877 (UMLS 2011AA Property-2)
    C38046 (NCI Thesaurus ValueDomain)
    C0205370 (UMLS 2011AA ValueDomain)
    C25712 (NCI Thesaurus ValueDomain-2)
    C1522609 (UMLS 2011AA ValueDomain-2)
    LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultUpperLimitofNormalValue
    Item
    SGPT (ALT) ULN
    float
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C25293 (NCI Thesaurus Property-2)
    C0376147 (UMLS 2011AA Property-2)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C25706 (NCI Thesaurus ValueDomain-2)
    C1519815 (UMLS 2011AA ValueDomain-2)
    HepaticSGPT(ALT)LabUnspecifiedValue
    Item
    SGPT (ALT)
    float
    C13308 (NCI Thesaurus ObjectClass)
    C0205054 (UMLS 2011AA ObjectClass)
    C37984 (NCI Thesaurus Property)
    C0022877 (UMLS 2011AA Property)
    C25293 (NCI Thesaurus Property-2)
    C0376147 (UMLS 2011AA Property-2)
    C38046 (NCI Thesaurus ValueDomain)
    C0205370 (UMLS 2011AA ValueDomain)
    C25712 (NCI Thesaurus ValueDomain-2)
    C1522609 (UMLS 2011AA ValueDomain-2)
    LaboratoryProcedureAlbuminResultLowerLimitofNormalValue
    Item
    Albumin LLN (g/dl)
    float
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C214 (NCI Thesaurus Property-2)
    C0001924 (UMLS 2011AA Property-2)
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C25555 (NCI Thesaurus ValueDomain-2)
    C1518030 (UMLS 2011AA ValueDomain-2)
    LaboratoryProcedureAlbuminResultUnspecifiedValue
    Item
    Albumin
    float
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C214 (NCI Thesaurus Property-2)
    C0001924 (UMLS 2011AA Property-2)
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    LaboratoryProcedureCalciumElectrolytesOutcomeLowerLimitofNormalValue
    Item
    Calcium LLN (Ca mg/dl)
    float
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C331 (NCI Thesaurus Property)
    C0006675 (UMLS 2011AA Property)
    C20200 (NCI Thesaurus Property-2)
    C1274040 (UMLS 2011AA Property-2)
    C464 (NCI Thesaurus Property-3)
    C0013832 (UMLS 2011AA Property-3)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C25555 (NCI Thesaurus ValueDomain-2)
    C1518030 (UMLS 2011AA ValueDomain-2)
    LaboratoryProcedureCalciumElectrolytesOutcomeUpperLimitofNormalValue
    Item
    Calcium ULN
    float
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C331 (NCI Thesaurus Property)
    C0006675 (UMLS 2011AA Property)
    C20200 (NCI Thesaurus Property-2)
    C1274040 (UMLS 2011AA Property-2)
    C464 (NCI Thesaurus Property-3)
    C0013832 (UMLS 2011AA Property-3)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C25706 (NCI Thesaurus ValueDomain-2)
    C1519815 (UMLS 2011AA ValueDomain-2)
    ElectrolytesCalciumLabSpecifiedValue
    Item
    Calcium
    float
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C331 (NCI Thesaurus Property)
    C0006675 (UMLS 2011AA Property)
    C20200 (NCI Thesaurus Property-2)
    C1274040 (UMLS 2011AA Property-2)
    C464 (NCI Thesaurus Property-3)
    C0013832 (UMLS 2011AA Property-3)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    LaboratoryProcedureGlucoseElectrolytesOutcomeLowerLimitofNormalValue
    Item
    Glucose LLN (mg/dl)
    float
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C2831 (NCI Thesaurus Property-2)
    C0017725 (UMLS 2011AA Property-2)
    C464 (NCI Thesaurus Property-3)
    C0013832 (UMLS 2011AA Property-3)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C25555 (NCI Thesaurus ValueDomain-2)
    C1518030 (UMLS 2011AA ValueDomain-2)
    LaboratoryProcedureGlucoseElectrolytesOutcomeUpperLimitNormalValue
    Item
    Glucose ULN
    float
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C2831 (NCI Thesaurus Property-2)
    C0017725 (UMLS 2011AA Property-2)
    C464 (NCI Thesaurus Property-3)
    C0013832 (UMLS 2011AA Property-3)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C25706 (NCI Thesaurus ValueDomain-2)
    C1519815 (UMLS 2011AA ValueDomain-2)
    LaboratoryProcedureGlucoseElectrolytesOutcomeUnspecifiedValue
    Item
    Glucose
    float
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C2831 (NCI Thesaurus Property-2)
    C0017725 (UMLS 2011AA Property-2)
    C464 (NCI Thesaurus Property-3)
    C0013832 (UMLS 2011AA Property-3)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    LaboratoryProcedurePotassiumElectrolytesOutcomeLowerLimitNormalValue
    Item
    Potassium LLN (K mmol/L)
    float
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C464 (NCI Thesaurus Property-2)
    C0013832 (UMLS 2011AA Property-2)
    C765 (NCI Thesaurus Property-3)
    C0032821 (UMLS 2011AA Property-3)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C25555 (NCI Thesaurus ValueDomain-2)
    C1518030 (UMLS 2011AA ValueDomain-2)
    LaboratoryProcedurePotassiumElectrolytesOutcomeUpperLimitNormalValue
    Item
    Potassium ULN
    float
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C464 (NCI Thesaurus Property-2)
    C0013832 (UMLS 2011AA Property-2)
    C765 (NCI Thesaurus Property-3)
    C0032821 (UMLS 2011AA Property-3)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C25706 (NCI Thesaurus ValueDomain-2)
    C1519815 (UMLS 2011AA ValueDomain-2)
    LaboratoryProcedurePotassiumElectrolytesOutcomeSpecifiedValue
    Item
    Potassium
    float
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C464 (NCI Thesaurus Property-2)
    C0013832 (UMLS 2011AA Property-2)
    C765 (NCI Thesaurus Property-3)
    C0032821 (UMLS 2011AA Property-3)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    LaboratoryProcedureSodiumElectrolytesOutcomeLowerLimitofNormalValue
    Item
    Sodium LLN (Na mmol/L)
    float
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C830 (NCI Thesaurus Property-2)
    C0037473 (UMLS 2011AA Property-2)
    C464 (NCI Thesaurus Property-3)
    C0013832 (UMLS 2011AA Property-3)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C25555 (NCI Thesaurus ValueDomain-2)
    C1518030 (UMLS 2011AA ValueDomain-2)
    LaboratoryProcedureSodiumElectrolytesOutcomeUpperLimitofNormalValue
    Item
    Sodium ULN
    float
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C830 (NCI Thesaurus Property-2)
    C0037473 (UMLS 2011AA Property-2)
    C464 (NCI Thesaurus Property-3)
    C0013832 (UMLS 2011AA Property-3)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C25706 (NCI Thesaurus ValueDomain-2)
    C1519815 (UMLS 2011AA ValueDomain-2)
    LaboratoryProcedureSodiumElectrolytesOutcomeSpecifiedValue
    Item
    Sodium
    float
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C830 (NCI Thesaurus Property-2)
    C0037473 (UMLS 2011AA Property-2)
    C464 (NCI Thesaurus Property-3)
    C0013832 (UMLS 2011AA Property-3)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    LaboratoryProcedureUricAcidResultSpecifiedLowerLimitofNormalValue
    Item
    Uric acid LLN (mg/dl)
    float
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C62652 (NCI Thesaurus Property-2)
    C0041980 (UMLS 2011AA Property-2)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C38024 (NCI Thesaurus ValueDomain-2)
    C0205369 (UMLS 2011AA ValueDomain-2)
    C25555 (NCI Thesaurus ValueDomain-3)
    C1518030 (UMLS 2011AA ValueDomain-3)
    LaboratoryProcedureUricAcidResultUpperLimitofNormalValue
    Item
    Uric acid ULN
    float
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C62652 (NCI Thesaurus Property-2)
    C0041980 (UMLS 2011AA Property-2)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C25706 (NCI Thesaurus ValueDomain-2)
    C1519815 (UMLS 2011AA ValueDomain-2)
    LaboratoryProcedureUricAcidResultSpecifiedValue
    Item
    Uric acid
    float
    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-2)
    C0041980 (UMLS 2011AA Property-2)
    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-2)
    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-2)
    C1806781 (UMLS 2011AA Property-2)
    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)
    float
    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-2)
    C0262950 (UMLS 2011AA ObjectClass-2)
    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-2)
    C0205082 (UMLS 2011AA Property-2)
    C15220 (NCI Thesaurus Property-3)
    C0011900 (UMLS 2011AA Property-3)
    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-2)
    C0439680 (UMLS 2011AA ObjectClass-2)
    C12366 (NCI Thesaurus Property)
    C0262950 (UMLS 2011AA Property)
    C25481 (NCI Thesaurus Property-2)
    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-2)
    C0439680 (UMLS 2011AA ObjectClass-2)
    C49507 (NCI Thesaurus Property)
    C0439536 (UMLS 2011AA Property)
    C25481 (NCI Thesaurus Property-2)
    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)
    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-2)
    C0016658 (UMLS 2011AA Property-2)
    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)
    Anticoagulation therapy daily
    Item
    Is patient on anti-coagulation therapy?
    boolean
    C263 (NCI Thesaurus ObjectClass)
    C0003280 (UMLS CUI-1)
    C25473 (NCI Thesaurus Property)
    C0332173 (UMLS CUI-2)
    C25629 (NCI Thesaurus Property-2)
    C25409 (NCI Thesaurus Property-3)
    C38148 (NCI Thesaurus ValueDomain)
    Item Group
    Prior Therapy
    CorticosteroidPriorAdministeredInd-3
    Item
    Prior corticosteroids?
    boolean
    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-2)
    C1521801 (UMLS 2011AA Property-2)
    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-2)
    C1521801 (UMLS 2011AA Property-2)
    Bisphosphonates
    Item
    Prior bisphosphanate therapy?
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C0012544 (UMLS CUI-1)
    C443 (NCI Thesaurus ObjectClass)
    C37902 (NCI Thesaurus ObjectClass-2)
    C25382 (NCI Thesaurus Property)
    Item
    Bisphosphanate type(s) received (If yes,)
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0012544 (UMLS CUI-1)
    C443 (NCI Thesaurus ObjectClass)
    C0683312 (UMLS CUI-2)
    C37902 (NCI Thesaurus ObjectClass-2)
    C25382 (NCI Thesaurus 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)
    Prior Radiation Therapy
    Item
    Prior radiation therapy?
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C1522449 (UMLS CUI-1)
    C15313 (NCI Thesaurus ObjectClass)
    C0332152 (UMLS CUI-2)
    C25629 (NCI Thesaurus ObjectClass-2)
    C25382 (NCI Thesaurus Property)
    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)
    Item Group
    Comments
    Research Comments
    Item
    Comments
    text
    C25704 (NCI Thesaurus ValueDomain)
    C0947611 (UMLS CUI-1)
    C15319 (NCI Thesaurus ObjectClass)
    C25393 (NCI Thesaurus Property)
    Investigator Signature
    Item
    Investigator Signature
    text
    C25704 (NCI Thesaurus ValueDomain)
    C2346576 (UMLS CUI-1)
    C25678 (NCI Thesaurus Property)
    C17089 (NCI Thesaurus ObjectClass)
    Investigator Signature Date
    Item
    Investigator Signature Date
    date
    C25164 (NCI Thesaurus ValueDomain)
    C2346576 (UMLS CUI-1)
    C25678 (NCI Thesaurus Property)
    C0011008 (UMLS CUI-2)
    C25367 (NCI Thesaurus ValueDomain-2)
    C17089 (NCI Thesaurus ObjectClass)
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