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6713

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ANHL01P1: Reporting Period [reload] Rituximab, Rasburicase, and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Advanced B-Cell Leukemia or Lymphoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=BA568824-31F6-08D7-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=BA568824-31F6-08D7-E034-0003BA12F5E7

Keywords

Versions (6)
  1. 8/27/12 8/27/12 -
  2. 1/8/15 1/8/15 - Martin Dugas
  3. 1/9/15 1/9/15 - Martin Dugas
  4. 1/9/15 1/9/15 - Martin Dugas
  5. 3/21/15 3/21/15 - Martin Dugas
  6. 9/20/21 9/20/21 -
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January 8, 2015

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Creative Commons BY-NC 3.0 Legacy
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    Drug/Agent Toxicity by Tissue/Organ NCT00057811 Treatment - ANHL01P1: Reporting Period [reload] - 2091659v3.0

    English

    No Instruction available.

    1 forms  
    1. StudyEvent: ANHL01P1: Reporting Period [reload]
      1. No Instruction available.
    Header
    Description

    Header

    Institution
    Description

    Institution Name

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C1301943
    NCI Thesaurus ObjectClass
    C21541
    NCI Thesaurus ValueDomain-2
    C21541
    NCI Thesaurus Property
    C25364
    Institution
    Description

    Institution Name

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C1301943
    NCI Thesaurus ObjectClass
    C21541
    NCI Thesaurus ValueDomain-2
    C21541
    NCI Thesaurus Property
    C25364
    Study
    Description

    ProtocolCOGIdentifierNumber

    Data type

    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
    Patient Name
    Description

    PatientName

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    COG Number
    Description

    PatientCOGIdentifierNumber

    Data type

    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-2
    C39353
    UMLS 2011AA Property-2
    C1516477
    Today's date
    Description

    Form Completion Date

    Data type

    date

    Alias
    NCI Thesaurus ObjectClass
    C19464
    UMLS CUI-1
    C1549507
    NCI Thesaurus Property
    C25250
    NCI Thesaurus Property-2
    C25604
    NCI Thesaurus ValueDomain
    C25164
    NCI Thesaurus ValueDomain-2
    C25367
    Date entered into RDE
    Description

    DataEnteredDate

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C25474
    UMLS 2011AA ObjectClass
    C1511726
    NCI Thesaurus Property
    C37949
    UMLS 2011AA Property
    C1521975
    Unnamed2
    Description

    Unnamed2

    Reporting Period (Institution will choose which course their patient is on.)
    Description

    TreatmentReportingPeriodNumber

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus Property
    C25616
    UMLS 2011AA Property
    C1948053
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus Property-2
    C25651
    UMLS 2011AA Property-2
    C0700287
    Reporting Period Start date (Required field)
    Description

    Reporting Period Start Date

    Data type

    date

    Alias
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus Property
    C25616
    UMLS CUI-1
    C2361257
    NCI Thesaurus Property-2
    C25651
    NCI Thesaurus ValueDomain
    C25164
    NCI Thesaurus ValueDomain-2
    C25431
    Reporting Period end date (Denote this field as "DT2")
    Description

    Reporting Period End Date

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C2361259
    NCI Thesaurus Property
    C25616
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus Property-2
    C25651
    Patient's Height (in cm at beginning of Reporting Period)
    Description

    Patient Height

    Data type

    float

    Measurement units
    • cm
    Alias
    NCI Thesaurus ValueDomain
    C25209
    UMLS CUI-1
    C0489786
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25347
    cm
    Patient's Weight (in kg at beginning of Reporting Period)
    Description

    Patient Weight

    Data type

    float

    Measurement units
    • Kg
    Alias
    NCI Thesaurus ValueDomain
    C25209
    UMLS CUI-1
    C0005910
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25208
    Kg
    Unnamed3
    Description

    Unnamed3

    Institution
    Description

    Institution Name

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C1301943
    NCI Thesaurus ObjectClass
    C21541
    NCI Thesaurus ValueDomain-2
    C21541
    NCI Thesaurus Property
    C25364
    Study
    Description

    ProtocolCOGIdentifierNumber

    Data type

    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
    Patient Name
    Description

    PatientName

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    COG Number
    Description

    PatientCOGIdentifierNumber

    Data type

    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-2
    C39353
    UMLS 2011AA Property-2
    C1516477
    Course Number
    Description

    TreatmentCurrentCourseNumber

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus ObjectClass
    C15368
    Date entered into RDE
    Description

    DataEnteredDate

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C25474
    UMLS 2011AA ObjectClass
    C1511726
    NCI Thesaurus Property
    C37949
    UMLS 2011AA Property
    C1521975
    Unnamed4
    Description

    Unnamed4

    Was the patient's disease status evaluated during this reporting period? (Required for reporting periods 1, 2, 3, 4)
    Description

    DiseaseExaminedDiseaseResponseInd-2

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus Property
    C25500
    UMLS 2011AA Property
    C0332128
    NCI Thesaurus ObjectClass
    C2991
    UMLS 2011AA ObjectClass
    C0012634
    COP Phase (Required only for Reduction Phase)
    Description

    LeukemiaDiseaseResponseType

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus Property
    C25755
    UMLS 2011AA Property
    C0871261
    NCI Thesaurus ObjectClass
    C2991
    UMLS 2011AA ObjectClass
    C0012634
    NCI Thesaurus ObjectClass-2
    C3161
    UMLS 2011AA ObjectClass-2
    C0023418
    Did the patient have a bone marrow evaluation during this reporting period? (Required field)
    Description

    BoneMarrowEvaluationInd-3

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus Property
    C25214
    UMLS 2011AA Property
    C0220825
    NCI Thesaurus ObjectClass
    C12431
    UMLS 2011AA ObjectClass
    C0005953
    If bone marrow evaluation not done, specify reason (Required if above answer is not done)
    Description

    BoneMarrowNotEvaluationReason

    Data type

    text

    Alias
    NCI Thesaurus Property
    C25214
    UMLS 2011AA Property
    C0220825
    NCI Thesaurus ObjectClass
    C12431
    UMLS 2011AA ObjectClass
    C0005953
    what was the date of the exam? [bone marrow evaluation] (If yes,)
    Description

    BoneMarrowEvaluationDate

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus Property
    C25214
    UMLS 2011AA Property
    C0220825
    NCI Thesaurus ObjectClass
    C12431
    UMLS 2011AA ObjectClass
    C0005953
    does the patient have bone marrow involvement? (If yes,)
    Description

    BoneMarrowInvolvementInd-3

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ObjectClass
    C12431
    UMLS 2011AA ObjectClass
    C0005953
    NCI Thesaurus Property
    C25548
    UMLS 2011AA Property
    C1314939
    percent (%) malignant blasts in bone marrow (Required field)
    Description

    LaboratoryProcedureBoneMarrowBlastCellOutcomePercentageValue

    Data type

    float

    Measurement units
    • %
    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C12431
    UMLS 2011AA Property
    C0005953
    NCI Thesaurus Property-2
    C20200
    UMLS 2011AA Property-2
    C1274040
    NCI Thesaurus Property-3
    C12918
    UMLS 2011AA Property-3
    C0368761
    NCI Thesaurus ValueDomain
    C25613
    UMLS 2011AA ValueDomain
    C0439165
    NCI Thesaurus ValueDomain-2
    C25712
    UMLS 2011AA ValueDomain-2
    C1522609
    %
    Unnamed5
    Description

    Unnamed5

    Was patient's CNS status evaluated during this reporting period? (Required field)
    Description

    CNSEvaluationReportingInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus Property
    C25214
    UMLS 2011AA Property
    C0220825
    NCI Thesaurus ObjectClass
    C12438
    UMLS 2011AA ObjectClass
    C0927232
    Does patient have CNS involvement? (Required if above answer is 'yes')
    Description

    CNSInvolvedInd-3

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ObjectClass
    C12438
    UMLS 2011AA ObjectClass
    C0927232
    NCI Thesaurus Property
    C25547
    Was cerebrospinal fluid cell count done? (Required if CNS involvement yes)
    Description

    CSFCellCountInd-3

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus Property
    C25256
    UMLS 2011AA Property
    C1265611
    date CSF fluid cell count was done (If yes,)
    Description

    CSFCellCountDate

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus Property
    C25256
    UMLS 2011AA Property
    C1265611
    Number of white cells counted (Required if CNS involvement yes)
    Description

    LaboratoryProcedureLeukocyteResultUnspecifiedValue

    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
    C38046
    UMLS 2011AA ValueDomain
    C0205370
    NCI Thesaurus ValueDomain-2
    C25712
    UMLS 2011AA ValueDomain-2
    C1522609
    Number of red cells counted (Required if CNS involvement yes)
    Description

    LaboratoryProcedureErythrocyteResultSpecifiedValue

    Data type

    float

    Measurement units
    • ul
    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C12521
    UMLS 2011AA Property
    C0014792
    NCI Thesaurus Property-2
    C20200
    UMLS 2011AA Property-2
    C1274040
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus ValueDomain-2
    C38024
    UMLS 2011AA ValueDomain-2
    C0205369
    ul
    Blasts present in cytocentrifuge (Required if CNS involvement yes)
    Description

    HematologyBlastsLabValue

    Data type

    text

    Alias
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    Were total number of cells counted in the cytocentrifuge? (Required if CNS involvement yes)
    Description

    SpecimenCellCountInd-3

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ObjectClass
    C19157
    UMLS 2011AA ObjectClass
    C0370003
    NCI Thesaurus Property
    C25256
    UMLS 2011AA Property
    C1265611
    total number of cells counted (If yes,)
    Description

    SpecimenCellCountTotalValue

    Data type

    float

    Alias
    NCI Thesaurus ObjectClass
    C19157
    UMLS 2011AA ObjectClass
    C0370003
    NCI Thesaurus Property
    C12508
    UMLS 2011AA Property
    C0007634
    NCI Thesaurus Property-2
    C25256
    UMLS 2011AA Property-2
    C1265611
    NCI Thesaurus ValueDomain
    C25304
    UMLS 2011AA ValueDomain
    C0439810
    NCI Thesaurus ValueDomain-2
    C25712
    UMLS 2011AA ValueDomain-2
    C1522609
    was an Echocardiogram performed during this reporting period? (If Echocardiogram was not able to be performed prior to starting treatment,)
    Description

    EchocardiogramAssessmentPerformedReportingInd-2

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus ObjectClass
    C25367
    NCI Thesaurus Property
    C38000
    UMLS 2011AA Property
    C0884358
    Unnamed6
    Description

    Unnamed6

    Imaging Studies Following Reporting Period (Required field)
    Description

    ReportingAssessmentMethodType

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C20989
    UMLS 2011AA ObjectClass
    C0031809
    NCI Thesaurus Property
    C16847
    UMLS 2011AA Property
    C0449851
    Unnamed question [results of imaging studies]
    Description

    AssessmentResultType

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C20989
    UMLS 2011AA ObjectClass
    C0031809
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    COP Phase (Required only for Reduction Phase)
    Description

    LeukemiaDiseaseResponseType

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus Property
    C25755
    UMLS 2011AA Property
    C0871261
    NCI Thesaurus ObjectClass
    C2991
    UMLS 2011AA ObjectClass
    C0012634
    NCI Thesaurus ObjectClass-2
    C3161
    UMLS 2011AA ObjectClass-2
    C0023418
    Is the patient off protocol therapy at the end of this reporting period? (Required field)
    Description

    PatientOff-treatmentInd-3

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25601
    UMLS 2011AA Property
    C1518544
    date last drug or other protocol defined treatment was received (If yes,)
    Description

    Date Last Dose

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C1762893
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus Property
    C25509
    NCI Thesaurus Property-2
    C25256
    reason off protocol therapy (If yes,)
    Description

    Off Treatment Reason

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C25601
    UMLS CUI-1
    C1518544
    NCI Thesaurus Property
    C25365
    UMLS CUI-2
    C0566251
    LDH (Required field)
    Description

    LaboratoryProcedureLactateDehydrogenaseResultSpecifiedValue

    Data type

    float

    Measurement units
    • U/L
    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
    C25184
    UMLS 2011AA Property-2
    C0022917
    U/L
    Institutional upper limits of normal for LDH (Required field)
    Description

    LaboratoryProcedureLactateDehydrogenaseResultSpecifiedUpperLimitofNormalValue

    Data type

    float

    Measurement units
    • U/L
    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property-2
    C25184
    UMLS 2011AA Property-2
    C0022917
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus ValueDomain-2
    C38024
    UMLS 2011AA ValueDomain-2
    C0205369
    NCI Thesaurus ValueDomain-3
    C25706
    UMLS 2011AA ValueDomain-3
    C1519815
    U/L
    If LDH level was elevate above institutional upper limits of normal,: ____ fold increase (Required only if LDH was elevated above institutional upper limits of normal)
    Description

    ChemistryLDHLabElevatedValue

    Data type

    float

    Alias
    NCI Thesaurus Property
    C37984
    UMLS 2011AA Property
    C0022877
    NCI Thesaurus ObjectClass
    C16414
    UMLS 2011AA ObjectClass
    C0007996
    ANC (uL)
    Description

    LaboratoryProcedureNeutrophilResultSpecifiedValue

    Data type

    float

    Measurement units
    • 1000/uL
    Alias
    NCI Thesaurus Property
    C12533
    UMLS 2011AA Property
    C0027950
    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
    1000/uL
    Platelets/uL (Required field)
    Description

    LaboratoryProcedurePlateletResultSpecifiedValue

    Data type

    float

    Measurement units
    • 1000/uL
    Alias
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property-2
    C12520
    UMLS 2011AA Property-2
    C0005821
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    1000/uL
    was the patient switched to Sub-pilot Group C or pilot Group C, respectively? (If there was evidence of disease,)
    Description

    Treatment Modification

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS CUI-1
    C1299575
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus Property
    C25572
    was the patient switched to Sub-pilot Group C or pilot Group C, respectively? (If there was evidence of disease,)
    Description

    Treatment Modification

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS CUI-1
    C1299575
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus Property
    C25572
    was the patient switched to Sub-pilot Group C or pilot Group C, respectively? (If there was evidence of disease,)
    Description

    Treatment Modification

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS CUI-1
    C1299575
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus Property
    C25572
    Unnamed question [treatment assignment] (If the treatment assignment is Group B Sub-Pilot or Group B Pilot)
    Description

    TreatmentAssignmentText

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS 2011AA ValueDomain
    C1527021
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus Property
    C25426
    UMLS 2011AA Property
    C1516050
    Was there evidence of residual disease on diagnostic tests?
    Description

    ResidualDiseaseStatusType

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C2991
    UMLS 2011AA ObjectClass
    C0012634
    NCI Thesaurus ObjectClass-2
    C37895
    UMLS 2011AA ObjectClass-2
    C1609982
    NCI Thesaurus Property
    C25365
    UMLS 2011AA Property
    C0678257
    was a biopsy performed? (If yes,)
    Description

    TumorBiopsyInd-3

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ObjectClass
    C3262
    UMLS 2011AA ObjectClass
    C0027651
    NCI Thesaurus Property
    C15189
    UMLS 2011AA Property
    C0005558
    what were the results? (If yes,)
    Description

    BiopsyResultType

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C15189
    UMLS 2011AA ObjectClass
    C0005558
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    Tumor lysis syndrome? (Required during reduction phase only)
    Description

    CTCAdverseEventLysisGrade

    Data type

    float

    Alias
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus Property
    C25365
    UMLS 2011AA Property
    C0678257
    Unnamed7
    Description

    Unnamed7

    Unnamed question [day number]
    Description

    TreatmentDayCount

    Data type

    float

    Alias
    NCI Thesaurus ValueDomain
    C25301
    UMLS 2011AA ValueDomain
    C0439228
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus ValueDomain-2
    C25463
    UMLS 2011AA ValueDomain-2
    C0750480
    4 Hours Post-Treatment [uric acid level]
    Description

    RenalUricAcidLabSpecifiedValue

    Data type

    float

    Measurement units
    • mg/dL
    Alias
    NCI Thesaurus ObjectClass
    C25225
    UMLS 2011AA ObjectClass
    C0022646
    NCI Thesaurus Property
    C37984
    UMLS 2011AA Property
    C0022877
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    mg/dL
    Potassium (mEq/L)
    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
    Phosphate (mg/dL)
    Description

    LaboratoryProcedurePhosphateMeasurementResultSpecifiedValue

    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
    C64857
    UMLS 2011AA Property-2
    C0523826
    mg/dL
    Calcium (mg/dL)
    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
    BUN (mg/dL)
    Description

    LaboratoryProcedureBloodUreaNitrogenResultUnspecifiedValue

    Data type

    float

    Alias
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property-2
    C61019
    UMLS 2011AA Property-2
    C0005845
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    Creatinine (mg/dL)
    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
    Unnamed8
    Description

    Unnamed8

    Did renal dysfunction occur during the reduction phase? (Required for reduction phase only.)
    Description

    RenalAbnormalityInd-3

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ObjectClass
    C25225
    UMLS 2011AA ObjectClass
    C0022646
    NCI Thesaurus Property
    C9440
    UMLS 2011AA Property
    C1704258
    Unnamed question [agent name]
    Description

    Agent

    Data type

    text

    Alias
    NCI Thesaurus Property
    C25364
    UMLS CUI-1
    C1521826
    NCI Thesaurus ObjectClass
    C1708
    NCI Thesaurus ValueDomain
    C1708
    NCI Thesaurus ValueDomain-2
    C42614
    Unnamed question [agent name]
    Description

    Agent

    Data type

    text

    Alias
    NCI Thesaurus Property
    C25364
    UMLS CUI-1
    C1521826
    NCI Thesaurus ObjectClass
    C1708
    NCI Thesaurus ValueDomain
    C1708
    NCI Thesaurus ValueDomain-2
    C42614
    Unnamed question [agent name]
    Description

    Agent

    Data type

    text

    Alias
    NCI Thesaurus Property
    C25364
    UMLS CUI-1
    C1521826
    NCI Thesaurus ObjectClass
    C1708
    NCI Thesaurus ValueDomain
    C1708
    NCI Thesaurus ValueDomain-2
    C42614
    Maximal grade of renal dysfunction (Choose One)
    Description

    CTCAdverseEventRenalFailureGrade

    Data type

    float

    Alias
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus Property
    C25365
    UMLS 2011AA Property
    C0678257
    Was there assisted renal support?
    Description

    RenalSupportAdministeredInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus ObjectClass
    C37902
    UMLS 2011AA ObjectClass
    C1521721
    NCI Thesaurus Property
    C25382
    UMLS 2011AA Property
    C1521801
    Unnamed question [type of renal support] (If yes for assisted renal support)
    Description

    RenalSupportAdministeredType

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C37902
    UMLS 2011AA ObjectClass
    C1521721
    NCI Thesaurus Property
    C25382
    UMLS 2011AA Property
    C1521801
    please specify [type of renal support] (Text)
    Description

    RenalSupportAdministeredSpecify

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS 2011AA ValueDomain
    C1521902
    NCI Thesaurus ObjectClass
    C37902
    UMLS 2011AA ObjectClass
    C1521721
    NCI Thesaurus Property
    C25382
    UMLS 2011AA Property
    C1521801
    Was rasburicase utilized prior to Day 0 of the reduction phase? (Required only for Reduction Phase)
    Description

    AgentPriorAdministeredReportingInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus ObjectClass
    C1708
    UMLS 2011AA ObjectClass
    C0450442
    NCI Thesaurus Property
    C25382
    UMLS 2011AA Property
    C1521801
    number of days given prior to Day 0 (If yes,)
    Description

    AgentAdministeredDayDuration

    Data type

    float

    Alias
    NCI Thesaurus ValueDomain
    C25301
    UMLS 2011AA ValueDomain
    C0439228
    NCI Thesaurus ObjectClass
    C1708
    UMLS 2011AA ObjectClass
    C0450442
    NCI Thesaurus Property
    C25382
    UMLS 2011AA Property
    C1521801
    NCI Thesaurus ValueDomain-2
    C25330
    UMLS 2011AA ValueDomain-2
    C0449238
    number of doses given prior to Day 0 (If yes,)
    Description

    AgentCourseCount

    Data type

    float

    Alias
    NCI Thesaurus ValueDomain
    C25463
    UMLS 2011AA ValueDomain
    C0750480
    NCI Thesaurus Property
    C25379
    UMLS 2011AA Property
    C0750729
    NCI Thesaurus ObjectClass
    C1708
    UMLS 2011AA ObjectClass
    C0450442
    Unnamed9
    Description

    Unnamed9

    Unnamed question [day number]
    Description

    TreatmentDayCount

    Data type

    float

    Alias
    NCI Thesaurus ValueDomain
    C25301
    UMLS 2011AA ValueDomain
    C0439228
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus ValueDomain-2
    C25463
    UMLS 2011AA ValueDomain-2
    C0750480
    4 Hours Post-Treatment [uric acid level]
    Description

    RenalUricAcidLabSpecifiedValue

    Data type

    float

    Measurement units
    • mg/dL
    Alias
    NCI Thesaurus ObjectClass
    C25225
    UMLS 2011AA ObjectClass
    C0022646
    NCI Thesaurus Property
    C37984
    UMLS 2011AA Property
    C0022877
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    mg/dL
    4 Hours Post-Treatment [uric acid level]
    Description

    RenalUricAcidLabSpecifiedValue

    Data type

    float

    Measurement units
    • mg/dL
    Alias
    NCI Thesaurus ObjectClass
    C25225
    UMLS 2011AA ObjectClass
    C0022646
    NCI Thesaurus Property
    C37984
    UMLS 2011AA Property
    C0022877
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    mg/dL
    Unnamed10
    Description

    Unnamed10

    Unnamed question [agent name]
    Description

    Agent

    Data type

    text

    Alias
    NCI Thesaurus Property
    C25364
    UMLS CUI-1
    C1521826
    NCI Thesaurus ObjectClass
    C1708
    NCI Thesaurus ValueDomain
    C1708
    NCI Thesaurus ValueDomain-2
    C42614
    Did the patient receive rituximab in this cycle?
    Description

    Agent administered during reporting period

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS CUI-1
    C0450442
    NCI Thesaurus ObjectClass
    C1708
    UMLS CUI-2
    C1521801
    NCI Thesaurus Property
    C25382
    did the patient develop clinically significant Steven's Johnson syndrome? (If yes,)
    Description

    CTCAdverseEventStevens-JohnsonSyndromePresentInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus Property
    C25626
    UMLS 2011AA Property
    C0150312
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    Did a second malignant neoplasm (SMN) occur during this Reporting Period? (Required field)
    Description

    NewCancerDiagnosisInd-3

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ObjectClass
    C25586
    UMLS 2011AA ObjectClass
    C0205314
    NCI Thesaurus ObjectClass-2
    C9305
    UMLS 2011AA ObjectClass-2
    C0006826
    NCI Thesaurus Property
    C15220
    UMLS 2011AA Property
    C0011900
    Date SMN diagnosed (If the answer to SMN is yes this field must be supplied. The date must be between the start and end date of this reporting period.)
    Description

    NewCancerDiagnosisDate

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C9305
    UMLS 2011AA ObjectClass
    C0006826
    NCI Thesaurus Property
    C15220
    UMLS 2011AA Property
    C0011900
    Life status at end of this reporting period (Required field)
    Description

    PatientVitalStatus

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus ValueDomain
    C18003
    UMLS 2011AA ValueDomain
    C0442732
    NCI Thesaurus ValueDomain-2
    C25688
    UMLS 2011AA ValueDomain-2
    C0449438
    NCI Thesaurus Property
    C25365
    UMLS 2011AA Property
    C0678257
    Was patient confirmed lost to follow-up at the end of this reporting period? (Required field)
    Description

    PatientLostFollow-upInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25560
    UMLS 2011AA Property
    C0745777
    NCI Thesaurus Property-2
    C16033
    UMLS 2011AA Property-2
    C1522577
    Was patient enrolled on another COG therapeutic study at the end of the reporting period? (Required field)
    Description

    PatientOtherEnrollmentInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25171
    UMLS 2011AA Property
    C0013893
    Did the patient withdraw consent for follow-up at the end of the reporting period? (Note: Withdrawal of consent is to be coded only when the patient no longer wants to participate in the study and asks that data no longer be submitted.)
    Description

    PatientWithdrawFollow-upConsentInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C16033
    UMLS 2011AA Property
    C1522577
    NCI Thesaurus Property-2
    C25460
    UMLS 2011AA Property-2
    C1511481
    NCI Thesaurus Property-3
    C38061
    UMLS 2011AA Property-3
    C2349954
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Did the patient relapse or experience disease progression during the reporting period? (Required field)
    Description

    DiseaseProgressionInd-3

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus Property
    C25331
    NCI Thesaurus ObjectClass
    C2991
    UMLS 2011AA ObjectClass
    C0012634
    date of relapse or progression (If yes,)
    Description

    DiseaseProgressionDate

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ValueDomain-2
    C25367
    NCI Thesaurus Property
    C25331
    NCI Thesaurus ObjectClass
    C2991
    UMLS 2011AA ObjectClass
    C0012634
    Ccrr Module For Anhl01p1: Reporting Period [reload]
    Description

    Ccrr Module For Anhl01p1: Reporting Period [reload]

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    1 forms
    1. StudyEvent: ANHL01P1: Reporting Period [reload]
      1. No Instruction available.
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Header
    Institution Name
    Item
    Institution
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1301943 (UMLS CUI-1)
    C21541 (NCI Thesaurus ObjectClass)
    C21541 (NCI Thesaurus ValueDomain-2)
    C25364 (NCI Thesaurus Property)
    Institution Name
    Item
    Institution
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1301943 (UMLS CUI-1)
    C21541 (NCI Thesaurus ObjectClass)
    C21541 (NCI Thesaurus ValueDomain-2)
    C25364 (NCI Thesaurus Property)
    ProtocolCOGIdentifierNumber
    Item
    Study
    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)
    PatientName
    Item
    Patient Name
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    PatientCOGIdentifierNumber
    Item
    COG Number
    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)
    C39353 (NCI Thesaurus Property-2)
    C1516477 (UMLS 2011AA Property-2)
    Form Completion Date
    Item
    Today's date
    date
    C19464 (NCI Thesaurus ObjectClass)
    C1549507 (UMLS CUI-1)
    C25250 (NCI Thesaurus Property)
    C25604 (NCI Thesaurus Property-2)
    C25164 (NCI Thesaurus ValueDomain)
    C25367 (NCI Thesaurus ValueDomain-2)
    DataEnteredDate
    Item
    Date entered into RDE
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25474 (NCI Thesaurus ObjectClass)
    C1511726 (UMLS 2011AA ObjectClass)
    C37949 (NCI Thesaurus Property)
    C1521975 (UMLS 2011AA Property)
    Item Group
    Unnamed2
    Item
    Reporting Period (Institution will choose which course their patient is on.)
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C25616 (NCI Thesaurus Property)
    C1948053 (UMLS 2011AA Property)
    C15368 (NCI Thesaurus ObjectClass)
    C25651 (NCI Thesaurus Property-2)
    C0700287 (UMLS 2011AA Property-2)
    CL.1
    Code List
    Reporting Period (Institution will choose which course their patient is on.)
    CL Item
    Reduction Phase (Reduction Phase)
    CL Item
    Induction, 1st Cycle (Induction, 1st Cycle)
    CL Item
    Induction, 2nd cycle (Induction, 2nd cycle)
    CL Item
    Consolidation, 1st course (CYM-RM1) (Consolidation, 1st course (CYM-RM1))
    CL Item
    Consolidation, other than CYM-RM1 (Consolidation, other than CYM-RM1)
    CL Item
    Maintenance, Course 1 (Maintenance, Course 1)
    CL Item
    Maintenance, Course 2 (Maintenance, Course 2)
    CL Item
    Maintenance, Course 3 (Maintenance, Course 3)
    CL Item
    Maintenance, Course 4 (Maintenance, Course 4)
    Reporting Period Start Date
    Item
    Reporting Period Start date (Required field)
    date
    C15368 (NCI Thesaurus ObjectClass)
    C25616 (NCI Thesaurus Property)
    C2361257 (UMLS CUI-1)
    C25651 (NCI Thesaurus Property-2)
    C25164 (NCI Thesaurus ValueDomain)
    C25431 (NCI Thesaurus ValueDomain-2)
    Reporting Period End Date
    Item
    Reporting Period end date (Denote this field as "DT2")
    date
    C25164 (NCI Thesaurus ValueDomain)
    C2361259 (UMLS CUI-1)
    C25616 (NCI Thesaurus Property)
    C15368 (NCI Thesaurus ObjectClass)
    C25651 (NCI Thesaurus Property-2)
    Patient Height
    Item
    Patient's Height (in cm at beginning of Reporting Period)
    float
    C25209 (NCI Thesaurus ValueDomain)
    C0489786 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25347 (NCI Thesaurus Property)
    Patient Weight
    Item
    Patient's Weight (in kg at beginning of Reporting Period)
    float
    C25209 (NCI Thesaurus ValueDomain)
    C0005910 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25208 (NCI Thesaurus Property)
    Item Group
    Unnamed3
    Institution Name
    Item
    Institution
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1301943 (UMLS CUI-1)
    C21541 (NCI Thesaurus ObjectClass)
    C21541 (NCI Thesaurus ValueDomain-2)
    C25364 (NCI Thesaurus Property)
    ProtocolCOGIdentifierNumber
    Item
    Study
    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)
    PatientName
    Item
    Patient Name
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    PatientCOGIdentifierNumber
    Item
    COG Number
    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)
    C39353 (NCI Thesaurus Property-2)
    C1516477 (UMLS 2011AA Property-2)
    TreatmentCurrentCourseNumber
    Item
    Course Number
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C15368 (NCI Thesaurus ObjectClass)
    DataEnteredDate
    Item
    Date entered into RDE
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25474 (NCI Thesaurus ObjectClass)
    C1511726 (UMLS 2011AA ObjectClass)
    C37949 (NCI Thesaurus Property)
    C1521975 (UMLS 2011AA Property)
    Item Group
    Unnamed4
    Item
    Was the patient's disease status evaluated during this reporting period? (Required for reporting periods 1, 2, 3, 4)
    text
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C25500 (NCI Thesaurus Property)
    C0332128 (UMLS 2011AA Property)
    C2991 (NCI Thesaurus ObjectClass)
    C0012634 (UMLS 2011AA ObjectClass)
    CL.2
    Code List
    Was the patient's disease status evaluated during this reporting period? (Required for reporting periods 1, 2, 3, 4)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    No (Not Done)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    Item
    COP Phase (Required only for Reduction Phase)
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C25755 (NCI Thesaurus Property)
    C0871261 (UMLS 2011AA Property)
    C2991 (NCI Thesaurus ObjectClass)
    C0012634 (UMLS 2011AA ObjectClass)
    C3161 (NCI Thesaurus ObjectClass-2)
    C0023418 (UMLS 2011AA ObjectClass-2)
    CL.16
    Code List
    COP Phase (Required only for Reduction Phase)
    CL Item
    >=20% tumor reduction (>=20% tumor reduction)
    CL Item
    <20% tumor reduction (<20% tumor reduction)
    CL Item
    Equivocal (Equivocal)
    CL Item
    Not done (Not done)
    CL Item
    Sub-Pilot B or Pilot B <20% reduction (Sub-Pilot B or Pilot B <20% reduction)
    CL Item
    Complete Response (CR)
    CL Item
    Incomplete Response Or Stable Disesase (Incomplete response/SD)
    CL Item
    Insufficient Evaluation (Insufficient evaluation to determine response status)
    CL Item
    Progression; At Least A 20% Increase In The Sum Of Ld Of Target Lesions Taking As References The Smallest Sum Ld Recorded Since The Treatment Started Or The Appearance Of One Or More New Lesions (PD)
    CL Item
    Partial Response (PR)
    C18212 (NCI Thesaurus)
    CL Item
    Stable Disease (SD)
    C18213 (NCI Thesaurus)
    C0677946 (UMLS 2011AA)
    BoneMarrowEvaluationInd-3
    Item
    Did the patient have a bone marrow evaluation during this reporting period? (Required field)
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C25214 (NCI Thesaurus Property)
    C0220825 (UMLS 2011AA Property)
    C12431 (NCI Thesaurus ObjectClass)
    C0005953 (UMLS 2011AA ObjectClass)
    BoneMarrowNotEvaluationReason
    Item
    If bone marrow evaluation not done, specify reason (Required if above answer is not done)
    text
    C25214 (NCI Thesaurus Property)
    C0220825 (UMLS 2011AA Property)
    C12431 (NCI Thesaurus ObjectClass)
    C0005953 (UMLS 2011AA ObjectClass)
    BoneMarrowEvaluationDate
    Item
    what was the date of the exam? [bone marrow evaluation] (If yes,)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25214 (NCI Thesaurus Property)
    C0220825 (UMLS 2011AA Property)
    C12431 (NCI Thesaurus ObjectClass)
    C0005953 (UMLS 2011AA ObjectClass)
    Item
    does the patient have bone marrow involvement? (If yes,)
    text
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C12431 (NCI Thesaurus ObjectClass)
    C0005953 (UMLS 2011AA ObjectClass)
    C25548 (NCI Thesaurus Property)
    C1314939 (UMLS 2011AA Property)
    CL.6
    Code List
    does the patient have bone marrow involvement? (If yes,)
    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)
    LaboratoryProcedureBoneMarrowBlastCellOutcomePercentageValue
    Item
    percent (%) malignant blasts in bone marrow (Required field)
    float
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C12431 (NCI Thesaurus Property)
    C0005953 (UMLS 2011AA Property)
    C20200 (NCI Thesaurus Property-2)
    C1274040 (UMLS 2011AA Property-2)
    C12918 (NCI Thesaurus Property-3)
    C0368761 (UMLS 2011AA Property-3)
    C25613 (NCI Thesaurus ValueDomain)
    C0439165 (UMLS 2011AA ValueDomain)
    C25712 (NCI Thesaurus ValueDomain-2)
    C1522609 (UMLS 2011AA ValueDomain-2)
    Item Group
    Unnamed5
    CNSEvaluationReportingInd-2
    Item
    Was patient's CNS status evaluated during this reporting period? (Required field)
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C25214 (NCI Thesaurus Property)
    C0220825 (UMLS 2011AA Property)
    C12438 (NCI Thesaurus ObjectClass)
    C0927232 (UMLS 2011AA ObjectClass)
    CNSInvolvedInd-3
    Item
    Does patient have CNS involvement? (Required if above answer is 'yes')
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C12438 (NCI Thesaurus ObjectClass)
    C0927232 (UMLS 2011AA ObjectClass)
    C25547 (NCI Thesaurus Property)
    CSFCellCountInd-3
    Item
    Was cerebrospinal fluid cell count done? (Required if CNS involvement yes)
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C25256 (NCI Thesaurus Property)
    C1265611 (UMLS 2011AA Property)
    CSFCellCountDate
    Item
    date CSF fluid cell count was done (If yes,)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25256 (NCI Thesaurus Property)
    C1265611 (UMLS 2011AA Property)
    LaboratoryProcedureLeukocyteResultUnspecifiedValue
    Item
    Number of white cells counted (Required if CNS involvement yes)
    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)
    C38046 (NCI Thesaurus ValueDomain)
    C0205370 (UMLS 2011AA ValueDomain)
    C25712 (NCI Thesaurus ValueDomain-2)
    C1522609 (UMLS 2011AA ValueDomain-2)
    LaboratoryProcedureErythrocyteResultSpecifiedValue
    Item
    Number of red cells counted (Required if CNS involvement yes)
    float
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C12521 (NCI Thesaurus Property)
    C0014792 (UMLS 2011AA Property)
    C20200 (NCI Thesaurus Property-2)
    C1274040 (UMLS 2011AA Property-2)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C38024 (NCI Thesaurus ValueDomain-2)
    C0205369 (UMLS 2011AA ValueDomain-2)
    HematologyBlastsLabValue
    Item
    Blasts present in cytocentrifuge (Required if CNS involvement yes)
    text
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    SpecimenCellCountInd-3
    Item
    Were total number of cells counted in the cytocentrifuge? (Required if CNS involvement yes)
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C19157 (NCI Thesaurus ObjectClass)
    C0370003 (UMLS 2011AA ObjectClass)
    C25256 (NCI Thesaurus Property)
    C1265611 (UMLS 2011AA Property)
    SpecimenCellCountTotalValue
    Item
    total number of cells counted (If yes,)
    float
    C19157 (NCI Thesaurus ObjectClass)
    C0370003 (UMLS 2011AA ObjectClass)
    C12508 (NCI Thesaurus Property)
    C0007634 (UMLS 2011AA Property)
    C25256 (NCI Thesaurus Property-2)
    C1265611 (UMLS 2011AA Property-2)
    C25304 (NCI Thesaurus ValueDomain)
    C0439810 (UMLS 2011AA ValueDomain)
    C25712 (NCI Thesaurus ValueDomain-2)
    C1522609 (UMLS 2011AA ValueDomain-2)
    Item
    was an Echocardiogram performed during this reporting period? (If Echocardiogram was not able to be performed prior to starting treatment,)
    text
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C25367 (NCI Thesaurus ObjectClass)
    C38000 (NCI Thesaurus Property)
    C0884358 (UMLS 2011AA Property)
    CL.11
    Code List
    was an Echocardiogram performed during this reporting period? (If Echocardiogram was not able to be performed prior to starting treatment,)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    No (Not Done)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    Item Group
    Unnamed6
    Item
    Imaging Studies Following Reporting Period (Required field)
    text
    C20989 (NCI Thesaurus ObjectClass)
    C0031809 (UMLS 2011AA ObjectClass)
    C16847 (NCI Thesaurus Property)
    C0449851 (UMLS 2011AA Property)
    CL.12
    Code List
    Imaging Studies Following Reporting Period (Required field)
    CL Item
    Chest X-ray, Pa And Lateral (Chest x-ray)
    CL Item
    Abdominal Ultrasound (Abdominal Ultrasound)
    CL Item
    Abdominal Ct Or Mri (Abdominal CT or MRI)
    CL Item
    Bone Scan (Bone Scan)
    C17646 (NCI Thesaurus)
    C0203668 (UMLS 2011AA)
    CL Item
    Pet Scan (PET Scan)
    CL Item
    Gallium Scan (Gallium Scan)
    C38087 (NCI Thesaurus)
    C0521316 (UMLS 2011AA)
    CL Item
    Head Or Spine Ct Or Mri (Head or spine CT or MRI)
    CL Item
    Testicular Ultrasound (Testicular ultrasound)
    Item
    Unnamed question [results of imaging studies]
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C20989 (NCI Thesaurus ObjectClass)
    C0031809 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    CL.13
    Code List
    Unnamed question [results of imaging studies]
    CL Item
    Evidence Of Disease (Evidence of disease)
    CL Item
    No Evidence Of Disease (No evidence of disease)
    C40413 (NCI Thesaurus)
    C1518340 (UMLS 2011AA)
    CL Item
    Equivocal (Equivocal)
    C86071 (NCI Thesaurus)
    C0332241 (UMLS 2011AA)
    CL Item
    Not Done (Not done)
    CL281691 (NCI Metathesaurus)
    Item
    COP Phase (Required only for Reduction Phase)
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C25755 (NCI Thesaurus Property)
    C0871261 (UMLS 2011AA Property)
    C2991 (NCI Thesaurus ObjectClass)
    C0012634 (UMLS 2011AA ObjectClass)
    C3161 (NCI Thesaurus ObjectClass-2)
    C0023418 (UMLS 2011AA ObjectClass-2)
    CL.16
    Code List
    COP Phase (Required only for Reduction Phase)
    CL Item
    >=20% tumor reduction (>=20% tumor reduction)
    CL Item
    <20% tumor reduction (<20% tumor reduction)
    CL Item
    Equivocal (Equivocal)
    CL Item
    Not done (Not done)
    CL Item
    Sub-Pilot B or Pilot B <20% reduction (Sub-Pilot B or Pilot B <20% reduction)
    CL Item
    Complete Response (CR)
    CL Item
    Incomplete Response Or Stable Disesase (Incomplete response/SD)
    CL Item
    Insufficient Evaluation (Insufficient evaluation to determine response status)
    CL Item
    Progression; At Least A 20% Increase In The Sum Of Ld Of Target Lesions Taking As References The Smallest Sum Ld Recorded Since The Treatment Started Or The Appearance Of One Or More New Lesions (PD)
    CL Item
    Partial Response (PR)
    C18212 (NCI Thesaurus)
    CL Item
    Stable Disease (SD)
    C18213 (NCI Thesaurus)
    C0677946 (UMLS 2011AA)
    PatientOff-treatmentInd-3
    Item
    Is the patient off protocol therapy at the end of this reporting period? (Required field)
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25601 (NCI Thesaurus Property)
    C1518544 (UMLS 2011AA Property)
    Date Last Dose
    Item
    date last drug or other protocol defined treatment was received (If yes,)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C1762893 (UMLS CUI-1)
    C15368 (NCI Thesaurus ObjectClass)
    C25509 (NCI Thesaurus Property)
    C25256 (NCI Thesaurus Property-2)
    Item
    reason off protocol therapy (If yes,)
    text
    C25601 (NCI Thesaurus ObjectClass)
    C1518544 (UMLS CUI-1)
    C25365 (NCI Thesaurus Property)
    C0566251 (UMLS CUI-2)
    CL.15
    Code List
    reason off protocol therapy (If yes,)
    CL Item
    Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
    CL Item
    Disease Progression Before Active Treatment (Disease progression/relapse during active treatment)
    CL Item
    Disease Progression, Relapse During Active Treatment (Group C patients who have biopsy proven residual disease after induction (COPADM2))
    CL Item
    Adverse Event/side Effects/complications (Toxicity/Side Effects/Complications)
    CL Item
    Death On Study (Death)
    CL Item
    Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient withdrawal or refusal after beginning protocol therapy)
    CL Item
    Patient Withdrawal Or Refusal Before Beginning Protocol Therapy (Patient withdrawal or refusal prior to beginning a protocol therapy)
    CL Item
    Alternative Therapy (Alternative therapy)
    CL Item
    Patient Off-treatment For Other Complicating Disease (Patient off-treatment for other complicating disease)
    CL Item
    Cytogenetic Resistance (Cytogenetic resistance)
    CL Item
    Disease Progression Before Active Treatment (Disease progression before active treatment)
    CL Item
    Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient declared ineligible)
    CL Item
    Lost To Follow-up (Lost to follow-up)
    CL310949 (NCI Metathesaurus)
    CL Item
    Other (Other)
    C17649 (NCI Thesaurus)
    C0205394 (UMLS 2011AA)
    LaboratoryProcedureLactateDehydrogenaseResultSpecifiedValue
    Item
    LDH (Required field)
    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)
    C25184 (NCI Thesaurus Property-2)
    C0022917 (UMLS 2011AA Property-2)
    LaboratoryProcedureLactateDehydrogenaseResultSpecifiedUpperLimitofNormalValue
    Item
    Institutional upper limits of normal for LDH (Required field)
    float
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C25184 (NCI Thesaurus Property-2)
    C0022917 (UMLS 2011AA Property-2)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C38024 (NCI Thesaurus ValueDomain-2)
    C0205369 (UMLS 2011AA ValueDomain-2)
    C25706 (NCI Thesaurus ValueDomain-3)
    C1519815 (UMLS 2011AA ValueDomain-3)
    ChemistryLDHLabElevatedValue
    Item
    If LDH level was elevate above institutional upper limits of normal,: ____ fold increase (Required only if LDH was elevated above institutional upper limits of normal)
    float
    C37984 (NCI Thesaurus Property)
    C0022877 (UMLS 2011AA Property)
    C16414 (NCI Thesaurus ObjectClass)
    C0007996 (UMLS 2011AA ObjectClass)
    LaboratoryProcedureNeutrophilResultSpecifiedValue
    Item
    ANC (uL)
    float
    C12533 (NCI Thesaurus Property)
    C0027950 (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)
    LaboratoryProcedurePlateletResultSpecifiedValue
    Item
    Platelets/uL (Required field)
    float
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C12520 (NCI Thesaurus Property-2)
    C0005821 (UMLS 2011AA Property-2)
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    Treatment Modification
    Item
    was the patient switched to Sub-pilot Group C or pilot Group C, respectively? (If there was evidence of disease,)
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C1299575 (UMLS CUI-1)
    C15368 (NCI Thesaurus ObjectClass)
    C25572 (NCI Thesaurus Property)
    Treatment Modification
    Item
    was the patient switched to Sub-pilot Group C or pilot Group C, respectively? (If there was evidence of disease,)
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C1299575 (UMLS CUI-1)
    C15368 (NCI Thesaurus ObjectClass)
    C25572 (NCI Thesaurus Property)
    Treatment Modification
    Item
    was the patient switched to Sub-pilot Group C or pilot Group C, respectively? (If there was evidence of disease,)
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C1299575 (UMLS CUI-1)
    C15368 (NCI Thesaurus ObjectClass)
    C25572 (NCI Thesaurus Property)
    Item
    Unnamed question [treatment assignment] (If the treatment assignment is Group B Sub-Pilot or Group B Pilot)
    text
    C25704 (NCI Thesaurus ValueDomain)
    C1527021 (UMLS 2011AA ValueDomain)
    C15368 (NCI Thesaurus ObjectClass)
    C25426 (NCI Thesaurus Property)
    C1516050 (UMLS 2011AA Property)
    CL.19
    Code List
    Unnamed question [treatment assignment] (If the treatment assignment is Group B Sub-Pilot or Group B Pilot)
    CL Item
    CYM-RM1 (CYM-RM1)
    CL Item
    CYM-RM2 (CYM-RM2)
    Item
    Was there evidence of residual disease on diagnostic tests?
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C2991 (NCI Thesaurus ObjectClass)
    C0012634 (UMLS 2011AA ObjectClass)
    C37895 (NCI Thesaurus ObjectClass-2)
    C1609982 (UMLS 2011AA ObjectClass-2)
    C25365 (NCI Thesaurus Property)
    C0678257 (UMLS 2011AA Property)
    CL.20
    Code List
    Was there evidence of residual disease on diagnostic tests?
    CL Item
    Yes (Yes)
    CL Item
    No Evidence Of Disease (No)
    C40413 (NCI Thesaurus)
    C1518340 (UMLS 2011AA)
    CL Item
    Gross Disease (gross disease)
    CL Item
    Microscopic Disease (microscopic disease)
    CL Item
    Unknown/not Documented (unknown/not documented)
    TumorBiopsyInd-3
    Item
    was a biopsy performed? (If yes,)
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C3262 (NCI Thesaurus ObjectClass)
    C0027651 (UMLS 2011AA ObjectClass)
    C15189 (NCI Thesaurus Property)
    C0005558 (UMLS 2011AA Property)
    Item
    what were the results? (If yes,)
    text
    C15189 (NCI Thesaurus ObjectClass)
    C0005558 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    CL.22
    Code List
    what were the results? (If yes,)
    CL Item
    Evidence Of Disease (Evidence of disease)
    CL Item
    No Evidence Of Disease (No evidence of disease)
    C40413 (NCI Thesaurus)
    C1518340 (UMLS 2011AA)
    CL Item
    Equivocal (Equivocal)
    C86071 (NCI Thesaurus)
    C0332241 (UMLS 2011AA)
    CTCAdverseEventLysisGrade
    Item
    Tumor lysis syndrome? (Required during reduction phase only)
    float
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C25365 (NCI Thesaurus Property)
    C0678257 (UMLS 2011AA Property)
    Item Group
    Unnamed7
    TreatmentDayCount
    Item
    Unnamed question [day number]
    float
    C25301 (NCI Thesaurus ValueDomain)
    C0439228 (UMLS 2011AA ValueDomain)
    C15368 (NCI Thesaurus ObjectClass)
    C25463 (NCI Thesaurus ValueDomain-2)
    C0750480 (UMLS 2011AA ValueDomain-2)
    RenalUricAcidLabSpecifiedValue
    Item
    4 Hours Post-Treatment [uric acid level]
    float
    C25225 (NCI Thesaurus ObjectClass)
    C0022646 (UMLS 2011AA ObjectClass)
    C37984 (NCI Thesaurus Property)
    C0022877 (UMLS 2011AA Property)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    LaboratoryProcedurePotassiumElectrolytesOutcomeSpecifiedValue
    Item
    Potassium (mEq/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)
    LaboratoryProcedurePhosphateMeasurementResultSpecifiedValue
    Item
    Phosphate (mg/dL)
    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)
    C64857 (NCI Thesaurus Property-2)
    C0523826 (UMLS 2011AA Property-2)
    ElectrolytesCalciumLabSpecifiedValue
    Item
    Calcium (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)
    LaboratoryProcedureBloodUreaNitrogenResultUnspecifiedValue
    Item
    BUN (mg/dL)
    float
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C61019 (NCI Thesaurus Property-2)
    C0005845 (UMLS 2011AA Property-2)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    RenalCreatinineLabSpecifiedValue
    Item
    Creatinine (mg/dL)
    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)
    Item Group
    Unnamed8
    RenalAbnormalityInd-3
    Item
    Did renal dysfunction occur during the reduction phase? (Required for reduction phase only.)
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C25225 (NCI Thesaurus ObjectClass)
    C0022646 (UMLS 2011AA ObjectClass)
    C9440 (NCI Thesaurus Property)
    C1704258 (UMLS 2011AA Property)
    Agent
    Item
    Unnamed question [agent name]
    text
    C25364 (NCI Thesaurus Property)
    C1521826 (UMLS CUI-1)
    C1708 (NCI Thesaurus ObjectClass)
    C1708 (NCI Thesaurus ValueDomain)
    C42614 (NCI Thesaurus ValueDomain-2)
    Agent
    Item
    Unnamed question [agent name]
    text
    C25364 (NCI Thesaurus Property)
    C1521826 (UMLS CUI-1)
    C1708 (NCI Thesaurus ObjectClass)
    C1708 (NCI Thesaurus ValueDomain)
    C42614 (NCI Thesaurus ValueDomain-2)
    Agent
    Item
    Unnamed question [agent name]
    text
    C25364 (NCI Thesaurus Property)
    C1521826 (UMLS CUI-1)
    C1708 (NCI Thesaurus ObjectClass)
    C1708 (NCI Thesaurus ValueDomain)
    C42614 (NCI Thesaurus ValueDomain-2)
    CTCAdverseEventRenalFailureGrade
    Item
    Maximal grade of renal dysfunction (Choose One)
    float
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C25365 (NCI Thesaurus Property)
    C0678257 (UMLS 2011AA Property)
    RenalSupportAdministeredInd-2
    Item
    Was there assisted renal support?
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C37902 (NCI Thesaurus ObjectClass)
    C1521721 (UMLS 2011AA ObjectClass)
    C25382 (NCI Thesaurus Property)
    C1521801 (UMLS 2011AA Property)
    Item
    Unnamed question [type of renal support] (If yes for assisted renal support)
    text
    C37902 (NCI Thesaurus ObjectClass)
    C1521721 (UMLS 2011AA ObjectClass)
    C25382 (NCI Thesaurus Property)
    C1521801 (UMLS 2011AA Property)
    CL.29
    Code List
    Unnamed question [type of renal support] (If yes for assisted renal support)
    CL Item
    Hemodialysis (Hemodialysis)
    C15248 (NCI Thesaurus)
    C0019004 (UMLS 2011AA)
    CL Item
    Peritoneal Dialysis (Peritoneal dialysis)
    C15297 (NCI Thesaurus)
    C0031139 (UMLS 2011AA)
    CL Item
    Cvvh (CVVH)
    CL Item
    Cvah (CVAH)
    CL Item
    Other, Specify (Other (please specify below))
    RenalSupportAdministeredSpecify
    Item
    please specify [type of renal support] (Text)
    text
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
    C37902 (NCI Thesaurus ObjectClass)
    C1521721 (UMLS 2011AA ObjectClass)
    C25382 (NCI Thesaurus Property)
    C1521801 (UMLS 2011AA Property)
    AgentPriorAdministeredReportingInd-2
    Item
    Was rasburicase utilized prior to Day 0 of the reduction phase? (Required only for Reduction Phase)
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C1708 (NCI Thesaurus ObjectClass)
    C0450442 (UMLS 2011AA ObjectClass)
    C25382 (NCI Thesaurus Property)
    C1521801 (UMLS 2011AA Property)
    AgentAdministeredDayDuration
    Item
    number of days given prior to Day 0 (If yes,)
    float
    C25301 (NCI Thesaurus ValueDomain)
    C0439228 (UMLS 2011AA ValueDomain)
    C1708 (NCI Thesaurus ObjectClass)
    C0450442 (UMLS 2011AA ObjectClass)
    C25382 (NCI Thesaurus Property)
    C1521801 (UMLS 2011AA Property)
    C25330 (NCI Thesaurus ValueDomain-2)
    C0449238 (UMLS 2011AA ValueDomain-2)
    AgentCourseCount
    Item
    number of doses given prior to Day 0 (If yes,)
    float
    C25463 (NCI Thesaurus ValueDomain)
    C0750480 (UMLS 2011AA ValueDomain)
    C25379 (NCI Thesaurus Property)
    C0750729 (UMLS 2011AA Property)
    C1708 (NCI Thesaurus ObjectClass)
    C0450442 (UMLS 2011AA ObjectClass)
    Item Group
    Unnamed9
    TreatmentDayCount
    Item
    Unnamed question [day number]
    float
    C25301 (NCI Thesaurus ValueDomain)
    C0439228 (UMLS 2011AA ValueDomain)
    C15368 (NCI Thesaurus ObjectClass)
    C25463 (NCI Thesaurus ValueDomain-2)
    C0750480 (UMLS 2011AA ValueDomain-2)
    RenalUricAcidLabSpecifiedValue
    Item
    4 Hours Post-Treatment [uric acid level]
    float
    C25225 (NCI Thesaurus ObjectClass)
    C0022646 (UMLS 2011AA ObjectClass)
    C37984 (NCI Thesaurus Property)
    C0022877 (UMLS 2011AA Property)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    RenalUricAcidLabSpecifiedValue
    Item
    4 Hours Post-Treatment [uric acid level]
    float
    C25225 (NCI Thesaurus ObjectClass)
    C0022646 (UMLS 2011AA ObjectClass)
    C37984 (NCI Thesaurus Property)
    C0022877 (UMLS 2011AA Property)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    Item Group
    Unnamed10
    Agent
    Item
    Unnamed question [agent name]
    text
    C25364 (NCI Thesaurus Property)
    C1521826 (UMLS CUI-1)
    C1708 (NCI Thesaurus ObjectClass)
    C1708 (NCI Thesaurus ValueDomain)
    C42614 (NCI Thesaurus ValueDomain-2)
    Agent administered during reporting period
    Item
    Did the patient receive rituximab in this cycle?
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C0450442 (UMLS CUI-1)
    C1708 (NCI Thesaurus ObjectClass)
    C1521801 (UMLS CUI-2)
    C25382 (NCI Thesaurus Property)
    CTCAdverseEventStevens-JohnsonSyndromePresentInd-2
    Item
    did the patient develop clinically significant Steven's Johnson syndrome? (If yes,)
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C25626 (NCI Thesaurus Property)
    C0150312 (UMLS 2011AA Property)
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    NewCancerDiagnosisInd-3
    Item
    Did a second malignant neoplasm (SMN) occur during this Reporting Period? (Required field)
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C25586 (NCI Thesaurus ObjectClass)
    C0205314 (UMLS 2011AA ObjectClass)
    C9305 (NCI Thesaurus ObjectClass-2)
    C0006826 (UMLS 2011AA ObjectClass-2)
    C15220 (NCI Thesaurus Property)
    C0011900 (UMLS 2011AA Property)
    NewCancerDiagnosisDate
    Item
    Date SMN diagnosed (If the answer to SMN is yes this field must be supplied. The date must be between the start and end date of this reporting period.)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C9305 (NCI Thesaurus ObjectClass)
    C0006826 (UMLS 2011AA ObjectClass)
    C15220 (NCI Thesaurus Property)
    C0011900 (UMLS 2011AA Property)
    Item
    Life status at end of this reporting period (Required field)
    text
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C18003 (NCI Thesaurus ValueDomain)
    C0442732 (UMLS 2011AA ValueDomain)
    C25688 (NCI Thesaurus ValueDomain-2)
    C0449438 (UMLS 2011AA ValueDomain-2)
    C25365 (NCI Thesaurus Property)
    C0678257 (UMLS 2011AA Property)
    CL.35
    Code List
    Life status at end of this reporting period (Required field)
    CL Item
    Alive (Alive)
    CL Item
    Dead (Dead)
    PatientLostFollow-upInd-2
    Item
    Was patient confirmed lost to follow-up at the end of this reporting period? (Required field)
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25560 (NCI Thesaurus Property)
    C0745777 (UMLS 2011AA Property)
    C16033 (NCI Thesaurus Property-2)
    C1522577 (UMLS 2011AA Property-2)
    PatientOtherEnrollmentInd-2
    Item
    Was patient enrolled on another COG therapeutic study at the end of the reporting period? (Required field)
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25171 (NCI Thesaurus Property)
    C0013893 (UMLS 2011AA Property)
    PatientWithdrawFollow-upConsentInd-2
    Item
    Did the patient withdraw consent for follow-up at the end of the reporting period? (Note: Withdrawal of consent is to be coded only when the patient no longer wants to participate in the study and asks that data no longer be submitted.)
    boolean
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C16033 (NCI Thesaurus Property)
    C1522577 (UMLS 2011AA Property)
    C25460 (NCI Thesaurus Property-2)
    C1511481 (UMLS 2011AA Property-2)
    C38061 (NCI Thesaurus Property-3)
    C2349954 (UMLS 2011AA Property-3)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    DiseaseProgressionInd-3
    Item
    Did the patient relapse or experience disease progression during the reporting period? (Required field)
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C25331 (NCI Thesaurus Property)
    C2991 (NCI Thesaurus ObjectClass)
    C0012634 (UMLS 2011AA ObjectClass)
    DiseaseProgressionDate
    Item
    date of relapse or progression (If yes,)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25367 (NCI Thesaurus ValueDomain-2)
    C25331 (NCI Thesaurus Property)
    C2991 (NCI Thesaurus ObjectClass)
    C0012634 (UMLS 2011AA ObjectClass)
    Item Group
    Ccrr Module For Anhl01p1: Reporting Period [reload]
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