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ID

43379

Description

ANHL01P1: Reporting Period Rituximab, Rasburicase, and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Advanced B-Cell Leukemia or Lymphoma NCT00057811 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=BA568824-31F6-08D7-E034-0003BA12F5E7

Lien

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

Mots-clés

Versions (6)
  1. 27/08/2012 27/08/2012 -
  2. 08/01/2015 08/01/2015 - Martin Dugas
  3. 09/01/2015 09/01/2015 - Martin Dugas
  4. 09/01/2015 09/01/2015 - Martin Dugas
  5. 21/03/2015 21/03/2015 - Martin Dugas
  6. 20/09/2021 20/09/2021 -
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20 septembre 2021

DOI

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Licence

Creative Commons BY-NC 3.0 Legacy
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    Advanced B-Cell Leukemia or Lymphoma (NCT00057811)

    Anglais

    No Instruction available.

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

    Header

    Alias
    UMLS CUI-1
    C1320722
    Institution
    Description

    Institution Name

    Type de données

    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

    Protocol ID COG

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C3274381
    NCI Thesaurus ObjectClass
    C25320
    UMLS CUI-2
    C1516477
    NCI Thesaurus Property
    C25364
    COG Number
    Description

    PatientCOGIdentifierNumber

    Type de données

    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
    Patient Name
    Description

    Patient Name

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C1299487
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25364
    Today's date
    Description

    Form Completion Date

    Type de données

    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

    Type de données

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

    TreatmentReportingPeriodNumber

    Type de données

    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
    Course Number
    Description

    TreatmentCurrentCourseNumber

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus ObjectClass
    C15368
    day number
    Description

    TreatmentDayCount

    Type de données

    integer

    Alias
    NCI Thesaurus ValueDomain
    C25301
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus ValueDomain-2
    C25463
    UMLS CUI-1
    C1547352
    Reporting Period Start date (Required field)
    Description

    Reporting Period Start Date

    Type de données

    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

    Type de données

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C2361259
    NCI Thesaurus Property
    C25616
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus Property-2
    C25651
    Patient characteristics
    Description

    Patient characteristics

    Alias
    UMLS CUI-1
    C0815172
    Patient's Height (in cm at beginning of Reporting Period)
    Description

    Patient's Height (in cm at beginning of Reporting Period)

    Type de données

    float

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

    Patient Weight

    Type de données

    float

    Unités de mesure
    • Kg
    Alias
    NCI Thesaurus ValueDomain
    C25209
    UMLS CUI-1
    C0005910
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25208
    Kg
    Was the patient's disease status evaluated during this reporting period? (Required for reporting periods 1, 2, 3, 4)
    Description

    DiseaseExaminedDiseaseResponseInd-2

    Type de données

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    NCI Thesaurus Property
    C25500
    NCI Thesaurus ObjectClass
    C2991
    UMLS CUI-1
    C1516048
    COP Phase (Required only for Reduction Phase)
    Description

    LeukemiaDiseaseResponseType

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    NCI Thesaurus Property
    C25755
    NCI Thesaurus ObjectClass
    C2991
    NCI Thesaurus ObjectClass-2
    C3161
    UMLS CUI-1
    C1704632
    Did the patient have a bone marrow evaluation during this reporting period? (Required field)
    Description

    BoneMarrowEvaluationInd-3

    Type de données

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    NCI Thesaurus Property
    C25214
    NCI Thesaurus ObjectClass
    C12431
    UMLS CUI-1
    C0005953
    If bone marrow evaluation not done, specify reason (Required if above answer is not done)
    Description

    BoneMarrowNotEvaluationReason

    Type de données

    text

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

    BoneMarrowEvaluationDate

    Type de données

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    NCI Thesaurus Property
    C25214
    NCI Thesaurus ObjectClass
    C12431
    UMLS CUI-1
    C0005953
    UMLS CUI-2
    C0011008
    does the patient have bone marrow involvement? (If yes,)
    Description

    BoneMarrowInvolvementInd-3

    Type de données

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    NCI Thesaurus ObjectClass
    C12431
    NCI Thesaurus Property
    C25548
    UMLS CUI-1
    C1517677
    percent (%) malignant blasts in bone marrow
    Description

    percent (%) malignant blasts in bone marrow

    Type de données

    float

    Unités de mesure
    • %
    Alias
    NCI Thesaurus ObjectClass
    C25294
    NCI Thesaurus Property
    C12431
    NCI Thesaurus Property-2
    C20200
    NCI Thesaurus Property-3
    C12918
    NCI Thesaurus ValueDomain
    C25613
    NCI Thesaurus ValueDomain-2
    C25712
    UMLS CUI-1
    C1982687
    %
    CNS involvement
    Description

    CNS involvement

    Alias
    UMLS CUI-1
    C0449389
    Was patient's CNS status evaluated during this reporting period? (Required field)
    Description

    CNSEvaluationReportingInd-2

    Type de données

    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
    C3714787
    Does patient have CNS involvement? (Required if above answer is 'yes')
    Description

    CNSInvolvedInd-3

    Type de données

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ObjectClass
    C12438
    UMLS 2011AA ObjectClass
    C3714787
    NCI Thesaurus Property
    C25547
    Was cerebrospinal fluid cell count done? (Required if CNS involvement yes)
    Description

    CSFCellCountInd-3

    Type de données

    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

    Type de données

    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

    Leukocytes (WBC)

    Type de données

    float

    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS CUI-1
    C0023508
    NCI Thesaurus Property
    C12529
    NCI Thesaurus Property-2
    C20200
    NCI Thesaurus ValueDomain
    C38046
    NCI Thesaurus ValueDomain-2
    C25712
    Number of red cells counted (Required if CNS involvement yes)
    Description

    LaboratoryProcedureErythrocyteResultSpecifiedValue

    Type de données

    float

    Unités de mesure
    • /ul
    Alias
    NCI Thesaurus ObjectClass
    C25294
    NCI Thesaurus Property
    C12521
    NCI Thesaurus Property-2
    C20200
    NCI Thesaurus ValueDomain
    C25712
    NCI Thesaurus ValueDomain-2
    C38024
    UMLS CUI-1
    C0014772
    /ul
    Blasts present in cytocentrifuge (Required if CNS involvement yes)
    Description

    HematologyBlastsLabValue

    Type de données

    float

    Alias
    NCI Thesaurus Property
    C20200
    NCI Thesaurus ObjectClass
    C25294
    UMLS CUI-1
    C0523113
    total number of cells counted
    Description

    SpecimenCellCountTotalValue

    Type de données

    float

    Alias
    NCI Thesaurus ObjectClass
    C19157
    NCI Thesaurus Property
    C12508
    NCI Thesaurus Property-2
    C25256
    NCI Thesaurus ValueDomain
    C25304
    NCI Thesaurus ValueDomain-2
    C25712
    UMLS CUI-1
    C0427872
    Diagnostics and treatment
    Description

    Diagnostics and treatment

    was an Echocardiogram performed during this reporting period? (If Echocardiogram was not able to be performed prior to starting treatment,)
    Description

    EchocardiogramAssessmentPerformedReportingInd-2

    Type de données

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    NCI Thesaurus ObjectClass
    C25367
    NCI Thesaurus Property
    C38000
    UMLS CUI-1
    C0013516
    Imaging Studies Following Reporting Period (Required field)
    Description

    ReportingAssessmentMethodType

    Type de données

    integer

    Alias
    NCI Thesaurus ObjectClass
    C20989
    NCI Thesaurus Property
    C16847
    UMLS CUI-1
    C0011923
    results of imaging studies
    Description

    AssessmentResultType

    Type de données

    integer

    Alias
    NCI Thesaurus ValueDomain
    C25284
    NCI Thesaurus ObjectClass
    C20989
    NCI Thesaurus Property
    C20200
    UMLS CUI-1
    C1287399
    Is the patient off protocol therapy at the end of this reporting period? (Required field)
    Description

    PatientOff-treatmentInd-3

    Type de données

    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

    Type de données

    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

    Type de données

    text

    Alias
    NCI Thesaurus ObjectClass
    C25601
    UMLS CUI-1
    C1518544
    NCI Thesaurus Property
    C25365
    UMLS CUI-2
    C0566251
    was the patient switched to Sub-pilot Group C or pilot Group C, respectively? (If there was evidence of disease,)
    Description

    Treatment Modification

    Type de données

    boolean

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

    TreatmentAssignmentText

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus Property
    C25426
    UMLS CUI-1
    C1522541
    Was there evidence of residual disease on diagnostic tests?
    Description

    ResidualDiseaseStatusType

    Type de données

    integer

    Alias
    NCI Thesaurus ValueDomain
    C25284
    NCI Thesaurus ObjectClass
    C2991
    NCI Thesaurus ObjectClass-2
    C37895
    NCI Thesaurus Property
    C25365
    UMLS CUI-1
    C0543478
    was a biopsy performed? (If yes,)
    Description

    TumorBiopsyInd-3

    Type de données

    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

    Type de données

    text

    Alias
    NCI Thesaurus ObjectClass
    C15189
    NCI Thesaurus Property
    C20200
    UMLS CUI-1
    C0005558
    UMLS CUI-2
    C1274040
    Tumor lysis syndrome? (Required during reduction phase only)
    Description

    CTCAdverseEventLysisGrade

    Type de données

    float

    Alias
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus Property
    C25365
    UMLS 2011AA Property
    C0678257
    Did renal dysfunction occur during the reduction phase? (Required for reduction phase only.)
    Description

    RenalAbnormalityInd-3

    Type de données

    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
    Maximal grade of renal dysfunction (Choose One)
    Description

    CTCAdverseEventRenalFailureGrade

    Type de données

    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

    Type de données

    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
    type of renal support
    Description

    RenalSupportAdministeredType

    Type de données

    integer

    Alias
    NCI Thesaurus ObjectClass
    C37902
    NCI Thesaurus Property
    C25382
    UMLS CUI-1
    C0011946
    please specify [type of renal support] (Text)
    Description

    RenalSupportAdministeredSpecify

    Type de données

    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
    agent name
    Description

    agent name

    Type de données

    text

    Alias
    NCI Thesaurus Property
    C25364
    NCI Thesaurus ObjectClass
    C1708
    NCI Thesaurus ValueDomain
    C1708
    NCI Thesaurus ValueDomain-2
    C42614
    UMLS CUI-1
    C1521826
    Was rasburicase utilized prior to Day 0 of the reduction phase? (Required only for Reduction Phase)
    Description

    AgentPriorAdministeredReportingInd-2

    Type de données

    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

    number of days given prior to Day 0 (If yes,)

    Type de données

    integer

    Alias
    NCI Thesaurus ValueDomain
    C25301
    NCI Thesaurus ObjectClass
    C1708
    NCI Thesaurus Property
    C25382
    NCI Thesaurus ValueDomain-2
    C25330
    UMLS CUI-1
    C0450442
    UMLS CUI-2
    C0449238
    number of doses given prior to Day 0 (If yes,)
    Description

    AgentCourseCount

    Type de données

    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
    Did the patient receive rituximab in this cycle?
    Description

    Agent administered during reporting period

    Type de données

    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

    Type de données

    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

    Type de données

    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

    Type de données

    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

    Life status at end of this reporting period (Required field)

    Type de données

    text

    Alias
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus ValueDomain
    C18003
    NCI Thesaurus ValueDomain-2
    C25688
    NCI Thesaurus Property
    C25365
    UMLS CUI-1
    C3846084
    Was patient confirmed lost to follow-up at the end of this reporting period? (Required field)
    Description

    PatientLostFollow-upInd-2

    Type de données

    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

    Type de données

    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

    Type de données

    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

    Type de données

    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

    Type de données

    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
    Lab values
    Description

    Lab values

    Alias
    UMLS CUI-1
    C2346633
    uric acid level, 4 Hours Post-Treatment
    Description

    RenalUricAcidLabSpecifiedValue

    Type de données

    float

    Unités de mesure
    • mg/dL
    Alias
    NCI Thesaurus ObjectClass
    C25225
    NCI Thesaurus Property
    C37984
    NCI Thesaurus ValueDomain
    C25712
    UMLS CUI-1
    C0365228
    mg/dL
    Potassium
    Description

    LaboratoryProcedurePotassiumElectrolytesOutcomeSpecifiedValue

    Type de données

    float

    Unités de mesure
    • mmol/L
    Alias
    NCI Thesaurus ObjectClass
    C25294
    NCI Thesaurus Property
    C20200
    NCI Thesaurus Property-2
    C464
    NCI Thesaurus Property-3
    C765
    NCI Thesaurus ValueDomain
    C25712
    UMLS CUI-1
    C0032821
    mmol/L
    Phosphate
    Description

    LaboratoryProcedurePhosphateMeasurementResultSpecifiedValue

    Type de données

    float

    Unités de mesure
    • mg/dL
    Alias
    NCI Thesaurus Property
    C20200
    NCI Thesaurus ObjectClass
    C25294
    NCI Thesaurus ValueDomain
    C25712
    NCI Thesaurus Property-2
    C64857
    UMLS CUI-1
    C0523826
    mg/dL
    Calcium
    Description

    ElectrolytesCalciumLabSpecifiedValue

    Type de données

    float

    Unités de mesure
    • mg/dL
    Alias
    NCI Thesaurus ObjectClass
    C25294
    NCI Thesaurus Property
    C331
    NCI Thesaurus Property-2
    C20200
    NCI Thesaurus Property-3
    C464
    NCI Thesaurus ValueDomain
    C25712
    UMLS CUI-1
    C0201925
    mg/dL
    BUN
    Description

    BUN

    Type de données

    float

    Unités de mesure
    • mg/dL
    Alias
    NCI Thesaurus Property
    C20200
    NCI Thesaurus ObjectClass
    C25294
    NCI Thesaurus Property-2
    C61019
    NCI Thesaurus ValueDomain
    C25712
    UMLS CUI-1
    C0005845
    mg/dL
    Creatinine
    Description

    RenalCreatinineLabSpecifiedValue

    Type de données

    float

    Unités de mesure
    • mg/dL
    Alias
    NCI Thesaurus ObjectClass
    C25225
    NCI Thesaurus Property
    C399
    NCI Thesaurus Property-2
    C25294
    NCI Thesaurus ValueDomain
    C25712
    UMLS CUI-1
    C0201976
    mg/dL
    LDH (Required field)
    Description

    LDH

    Type de données

    float

    Unités de mesure
    • U/L
    Alias
    NCI Thesaurus Property
    C20200
    UMLS CUI-1
    C0202113
    NCI Thesaurus ObjectClass
    C25294
    NCI Thesaurus ValueDomain
    C25712
    NCI Thesaurus Property-2
    C25184
    U/L
    Institutional upper limits of normal for LDH (Required field)
    Description

    LDH ULN

    Type de données

    float

    Unités de mesure
    • U/L
    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS CUI-1
    C0202113
    NCI Thesaurus Property
    C20200
    UMLS CUI-2
    C1519815
    NCI Thesaurus Property-2
    C25184
    NCI Thesaurus ValueDomain
    C25712
    NCI Thesaurus ValueDomain-2
    C38024
    NCI Thesaurus ValueDomain-3
    C25706
    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

    Type de données

    float

    Alias
    NCI Thesaurus Property
    C37984
    NCI Thesaurus ObjectClass
    C16414
    UMLS CUI-1
    C0202113
    UMLS CUI-2
    C3163633
    ANC
    Description

    LaboratoryProcedureNeutrophilResultSpecifiedValue

    Type de données

    float

    Unités de mesure
    • 1000/uL
    Alias
    NCI Thesaurus Property
    C12533
    NCI Thesaurus Property-2
    C20200
    NCI Thesaurus ObjectClass
    C25294
    NCI Thesaurus ValueDomain
    C25712
    UMLS CUI-1
    C0948762
    1000/uL
    Platelets/uL (Required field)
    Description

    Platelets

    Type de données

    float

    Unités de mesure
    • 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
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    1 Formulaires
    1. StudyEvent: ANHL01P1: Reporting Period [reload]
      1. No Instruction available.
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    Header
    C1320722 (UMLS CUI-1)
    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)
    Protocol ID COG
    Item
    Study
    text
    C25337 (NCI Thesaurus ValueDomain)
    C3274381 (UMLS CUI-1)
    C25320 (NCI Thesaurus ObjectClass)
    C1516477 (UMLS CUI-2)
    C25364 (NCI Thesaurus 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)
    Patient Name
    Item
    Patient Name
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1299487 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25364 (NCI Thesaurus Property)
    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
    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)
    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)
    day number
    Item
    day number
    integer
    C25301 (NCI Thesaurus ValueDomain)
    C15368 (NCI Thesaurus ObjectClass)
    C25463 (NCI Thesaurus ValueDomain-2)
    C1547352 (UMLS CUI-1)
    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)
    Item Group
    Patient characteristics
    C0815172 (UMLS CUI-1)
    Patient Height
    Item
    Patient's Height (in cm at beginning of Reporting Period)
    float
    C25209 (NCI Thesaurus ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C25347 (NCI Thesaurus Property)
    C0489786 (UMLS CUI-1)
    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)
    assessment
    Item
    Was the patient's disease status evaluated during this reporting period? (Required for reporting periods 1, 2, 3, 4)
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C25500 (NCI Thesaurus Property)
    C2991 (NCI Thesaurus ObjectClass)
    C1516048 (UMLS CUI-1)
    Item
    COP Phase (Required only for Reduction Phase)
    text
    C25284 (NCI Thesaurus ValueDomain)
    C25755 (NCI Thesaurus Property)
    C2991 (NCI Thesaurus ObjectClass)
    C3161 (NCI Thesaurus ObjectClass-2)
    C1704632 (UMLS CUI-1)
    CL.16
    Code List
    COP Phase (Required only for Reduction Phase)
    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)
    CL Item
    20% tumor reduction (>)
    Bone marrow
    Item
    Did the patient have a bone marrow evaluation during this reporting period? (Required field)
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C25214 (NCI Thesaurus Property)
    C12431 (NCI Thesaurus ObjectClass)
    C0005953 (UMLS CUI-1)
    Reason no bone marrow
    Item
    If bone marrow evaluation not done, specify reason (Required if above answer is not done)
    text
    C25214 (NCI Thesaurus Property)
    C12431 (NCI Thesaurus ObjectClass)
    Bone marrow date
    Item
    what was the date of the exam? [bone marrow evaluation] (If yes,)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C25214 (NCI Thesaurus Property)
    C12431 (NCI Thesaurus ObjectClass)
    C0005953 (UMLS CUI-1)
    C0011008 (UMLS CUI-2)
    Bone Marrow Involvement
    Item
    does the patient have bone marrow involvement? (If yes,)
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C12431 (NCI Thesaurus ObjectClass)
    C25548 (NCI Thesaurus Property)
    C1517677 (UMLS CUI-1)
    Blasts, Bone Marrow
    Item
    percent (%) malignant blasts in bone marrow
    float
    C25294 (NCI Thesaurus ObjectClass)
    C12431 (NCI Thesaurus Property)
    C20200 (NCI Thesaurus Property-2)
    C12918 (NCI Thesaurus Property-3)
    C25613 (NCI Thesaurus ValueDomain)
    C25712 (NCI Thesaurus ValueDomain-2)
    C1982687 (UMLS CUI-1)
    Item Group
    CNS involvement
    C0449389 (UMLS CUI-1)
    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)
    C3714787 (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)
    C3714787 (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)
    Leukocytes (WBC)
    Item
    Number of white cells counted (Required if CNS involvement yes)
    float
    C25294 (NCI Thesaurus ObjectClass)
    C0023508 (UMLS CUI-1)
    C12529 (NCI Thesaurus Property)
    C20200 (NCI Thesaurus Property-2)
    C38046 (NCI Thesaurus ValueDomain)
    C25712 (NCI Thesaurus ValueDomain-2)
    Erythrocyte
    Item
    Number of red cells counted (Required if CNS involvement yes)
    float
    C25294 (NCI Thesaurus ObjectClass)
    C12521 (NCI Thesaurus Property)
    C20200 (NCI Thesaurus Property-2)
    C25712 (NCI Thesaurus ValueDomain)
    C38024 (NCI Thesaurus ValueDomain-2)
    C0014772 (UMLS CUI-1)
    Blasts
    Item
    Blasts present in cytocentrifuge (Required if CNS involvement yes)
    float
    C20200 (NCI Thesaurus Property)
    C25294 (NCI Thesaurus ObjectClass)
    C0523113 (UMLS CUI-1)
    Total number of cells
    Item
    total number of cells counted
    float
    C19157 (NCI Thesaurus ObjectClass)
    C12508 (NCI Thesaurus Property)
    C25256 (NCI Thesaurus Property-2)
    C25304 (NCI Thesaurus ValueDomain)
    C25712 (NCI Thesaurus ValueDomain-2)
    C0427872 (UMLS CUI-1)
    Item Group
    Diagnostics and treatment
    Echocardiogram
    Item
    was an Echocardiogram performed during this reporting period? (If Echocardiogram was not able to be performed prior to starting treatment,)
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C25367 (NCI Thesaurus ObjectClass)
    C38000 (NCI Thesaurus Property)
    C0013516 (UMLS CUI-1)
    Item
    Imaging Studies Following Reporting Period (Required field)
    integer
    C20989 (NCI Thesaurus ObjectClass)
    C16847 (NCI Thesaurus Property)
    C0011923 (UMLS CUI-1)
    CL.12
    Code List
    Imaging Studies Following Reporting Period (Required field)
    CL Item
    Chest X-ray (1)
    C0039985 (UMLS CUI-1)
    CL Item
    Abdominal Ultrasound (2)
    C2348813 (UMLS CUI-1)
    CL Item
    Abdominal CT or MRI (3)
    CL Item
    Bone Scan (4)
    C0203668 (UMLS CUI-1)
    CL Item
    PET Scan (5)
    C0032743 (UMLS CUI-1)
    CL Item
    Gallium Scan (6)
    C0521316 (UMLS CUI-1)
    CL Item
    Head or spine CT or MRI (7)
    CL Item
    Testicular ultrasound (8)
    Item
    results of imaging studies
    integer
    C25284 (NCI Thesaurus ValueDomain)
    C20989 (NCI Thesaurus ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1287399 (UMLS CUI-1)
    CL.13
    Code List
    results of imaging studies
    CL Item
    Evidence of disease (1)
    C0332120 (UMLS CUI-1)
    CL Item
    No evidence of disease (2)
    C1518340 (UMLS CUI-1)
    CL Item
    Equivocal (3)
    C0332241 (UMLS CUI-1)
    CL Item
    Not done (4)
    C1272696 (UMLS CUI-1)
    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)
    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
    treatment assignment (If the treatment assignment is Group B Sub-Pilot or Group B Pilot)
    text
    C25704 (NCI Thesaurus ValueDomain)
    C15368 (NCI Thesaurus ObjectClass)
    C25426 (NCI Thesaurus Property)
    C1522541 (UMLS CUI-1)
    CL.19
    Code List
    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?
    integer
    C25284 (NCI Thesaurus ValueDomain)
    C2991 (NCI Thesaurus ObjectClass)
    C37895 (NCI Thesaurus ObjectClass-2)
    C25365 (NCI Thesaurus Property)
    C0543478 (UMLS CUI-1)
    CL.20
    Code List
    Was there evidence of residual disease on diagnostic tests?
    CL Item
    Yes (1)
    C1705108 (UMLS CUI-1)
    CL Item
    No (2)
    C1298908 (UMLS CUI-1)
    CL Item
    Gross Disease (3)
    C0267604 (UMLS CUI-1)
    CL Item
    Microscopic Disease (4)
    C0278939 (UMLS CUI-1)
    CL Item
    Unknown/not Documented (5)
    C0439673 (UMLS CUI-1)
    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)
    C20200 (NCI Thesaurus Property)
    C0005558 (UMLS CUI-1)
    C1274040 (UMLS CUI-2)
    CL.13
    Code List
    what were the results? (If yes,)
    CL Item
    Evidence of disease (1)
    C0332120 (UMLS CUI-1)
    CL Item
    No evidence of disease (2)
    C1518340 (UMLS CUI-1)
    CL Item
    Equivocal (3)
    C0332241 (UMLS CUI-1)
    CL Item
    Not done (4)
    C1272696 (UMLS CUI-1)
    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)
    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)
    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
    type of renal support
    integer
    C37902 (NCI Thesaurus ObjectClass)
    C25382 (NCI Thesaurus Property)
    C0011946 (UMLS CUI-1)
    CL.29
    Code List
    type of renal support
    CL Item
    Hemodialysis (1)
    C0019004 (UMLS CUI-1)
    CL Item
    Peritoneal dialysis (2)
    C0031139 (UMLS CUI-1)
    CL Item
    CVVH (3)
    C0472684 (UMLS CUI-1)
    CL Item
    CVAH (4)
    C0007474 (UMLS CUI-1)
    CL Item
    Other, Specify (5)
    C3844311 (UMLS CUI-1)
    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)
    Agent
    Item
    agent name
    text
    C25364 (NCI Thesaurus Property)
    C1708 (NCI Thesaurus ObjectClass)
    C1708 (NCI Thesaurus ValueDomain)
    C42614 (NCI Thesaurus ValueDomain-2)
    C1521826 (UMLS CUI-1)
    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,)
    integer
    C25301 (NCI Thesaurus ValueDomain)
    C1708 (NCI Thesaurus ObjectClass)
    C25382 (NCI Thesaurus Property)
    C25330 (NCI Thesaurus ValueDomain-2)
    C0450442 (UMLS CUI-1)
    C0449238 (UMLS CUI-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)
    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)
    C18003 (NCI Thesaurus ValueDomain)
    C25688 (NCI Thesaurus ValueDomain-2)
    C25365 (NCI Thesaurus Property)
    C3846084 (UMLS CUI-1)
    CL.35
    Code List
    Life status at end of this reporting period (Required field)
    CL Item
    Alive (Alive)
    C2584946 (UMLS CUI-1)
    CL Item
    Dead (Dead)
    C0011065 (UMLS CUI-1)
    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
    Lab values
    C2346633 (UMLS CUI-1)
    uric acid
    Item
    uric acid level, 4 Hours Post-Treatment
    float
    C25225 (NCI Thesaurus ObjectClass)
    C37984 (NCI Thesaurus Property)
    C25712 (NCI Thesaurus ValueDomain)
    C0365228 (UMLS CUI-1)
    Potassium
    Item
    Potassium
    float
    C25294 (NCI Thesaurus ObjectClass)
    C20200 (NCI Thesaurus Property)
    C464 (NCI Thesaurus Property-2)
    C765 (NCI Thesaurus Property-3)
    C25712 (NCI Thesaurus ValueDomain)
    C0032821 (UMLS CUI-1)
    Phosphate
    Item
    Phosphate
    float
    C20200 (NCI Thesaurus Property)
    C25294 (NCI Thesaurus ObjectClass)
    C25712 (NCI Thesaurus ValueDomain)
    C64857 (NCI Thesaurus Property-2)
    C0523826 (UMLS CUI-1)
    Calcium
    Item
    Calcium
    float
    C25294 (NCI Thesaurus ObjectClass)
    C331 (NCI Thesaurus Property)
    C20200 (NCI Thesaurus Property-2)
    C464 (NCI Thesaurus Property-3)
    C25712 (NCI Thesaurus ValueDomain)
    C0201925 (UMLS CUI-1)
    Blood Urea Nitrogen
    Item
    BUN
    float
    C20200 (NCI Thesaurus Property)
    C25294 (NCI Thesaurus ObjectClass)
    C61019 (NCI Thesaurus Property-2)
    C25712 (NCI Thesaurus ValueDomain)
    C0005845 (UMLS CUI-1)
    Creatinine
    Item
    Creatinine
    float
    C25225 (NCI Thesaurus ObjectClass)
    C399 (NCI Thesaurus Property)
    C25294 (NCI Thesaurus Property-2)
    C25712 (NCI Thesaurus ValueDomain)
    C0201976 (UMLS CUI-1)
    LDH
    Item
    LDH (Required field)
    float
    C20200 (NCI Thesaurus Property)
    C0202113 (UMLS CUI-1)
    C25294 (NCI Thesaurus ObjectClass)
    C25712 (NCI Thesaurus ValueDomain)
    C25184 (NCI Thesaurus Property-2)
    LDH ULN
    Item
    Institutional upper limits of normal for LDH (Required field)
    float
    C25294 (NCI Thesaurus ObjectClass)
    C0202113 (UMLS CUI-1)
    C20200 (NCI Thesaurus Property)
    C1519815 (UMLS CUI-2)
    C25184 (NCI Thesaurus Property-2)
    C25712 (NCI Thesaurus ValueDomain)
    C38024 (NCI Thesaurus ValueDomain-2)
    C25706 (NCI Thesaurus ValueDomain-3)
    LDH elevated
    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)
    C16414 (NCI Thesaurus ObjectClass)
    C0202113 (UMLS CUI-1)
    C3163633 (UMLS CUI-2)
    ANC
    Item
    ANC
    float
    C12533 (NCI Thesaurus Property)
    C20200 (NCI Thesaurus Property-2)
    C25294 (NCI Thesaurus ObjectClass)
    C25712 (NCI Thesaurus ValueDomain)
    C0948762 (UMLS CUI-1)
    Platelets
    Item
    Platelets/uL (Required field)
    float
    C20200 (NCI Thesaurus Property)
    C0005821 (UMLS CUI-1)
    C12520 (NCI Thesaurus Property-2)
    C25294 (NCI Thesaurus ObjectClass)
    C25712 (NCI Thesaurus ValueDomain)
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