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ID

43349

Description

CALGB: 10603 On-Study Form Daunorubicin, Cytarabine, and Midostaurin in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=437820BA-0A20-2BB7-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=437820BA-0A20-2BB7-E044-0003BA3F9857

Keywords

  1. 9/19/12 9/19/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

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Creative Commons BY-NC 3.0 Legacy

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    Leukemia DRKS00003845 NCT00651261 On-Study - CALGB: 10603 On-Study Form - 2719613v1.0

    No Instruction available.

    1. StudyEvent: CALGB: 10603 On-Study Form
      1. No Instruction available.
    Header
    Description

    Header

    CALGB Form (C-1619)
    Description

    Form ID CALGB

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C3262252
    NCI Thesaurus ObjectClass
    C19464
    UMLS CUI-2
    C1516238
    NCI Thesaurus Property
    C25364
    NCI Thesaurus ObjectClass-2
    C25442
    CALGB Study No
    Description

    Protocol ID CALGB

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C3274381
    NCI Thesaurus ObjectClass
    C25320
    UMLS CUI-2
    C1516238
    NCI Thesaurus Property
    C25364
    NCI Thesaurus Property-2
    C25442
    CALGB Patient ID
    Description

    Trial subject ID CALGB

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C2348585
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-2
    C1516238
    NCI Thesaurus Property
    C25364
    NCI Thesaurus Property-2
    C25442
    Are data amended
    Description

    Data amended

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS CUI-1
    C0680532
    NCI Thesaurus ObjectClass
    C25474
    NCI Thesaurus Property
    C25416
    Ccrr Module For Calgb 90202: Prostate Specific Antigen Form
    Description

    Ccrr Module For Calgb 90202: Prostate Specific Antigen Form

    Patient Initials (Last, First Middle)
    Description

    Patient Initials

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C2986440
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25536
    Patient Hospital No.
    Description

    Medical Record Number

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C1301894
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25261
    NCI Thesaurus Property-2
    C25198
    Institution/Affiliate
    Description

    Institution Name

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C25454
    UMLS CUI-1
    C1301943
    NCI Thesaurus ObjectClass-2
    C21541
    NCI Thesaurus Property
    C25364
    NCI Thesaurus ValueDomain
    C25191
    NCI Thesaurus ValueDomain-2
    C21541
    Participating Group (Country Name for International site:)
    Description

    Participating Group

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C2347449
    NCI Thesaurus ObjectClass
    C25608
    NCI Thesaurus ObjectClass-2
    C17005
    NCI Thesaurus Property
    C25364
    Participating Group Protocol Number
    Description

    Study Number Participating Group

    Data type

    text

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

    Trial subject ID Participating Group

    Data type

    text

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

    Patient Description

    Date of Initial Pathologic Diagnosis
    Description

    CancerInitialDiagnosisDate

    Data type

    date

    Alias
    NCI Thesaurus ObjectClass
    C9305
    UMLS 2011AA ObjectClass
    C0006826
    NCI Thesaurus Property
    C25509
    UMLS 2011AA Property
    C1279901
    NCI Thesaurus Property-2
    C15220
    UMLS 2011AA Property-2
    C0011900
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ValueDomain-2
    C25367
    MedDRA disease code
    Description

    MedDRACode

    Data type

    float

    Alias
    NCI Thesaurus ValueDomain
    C25162
    UMLS 2011AA ValueDomain
    C0805701
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Metathesaurus ObjectClass
    CL104089
    Date of first abnormal bone marrow for antecedent myelodysplasia
    Description

    FirstAbnormalBoneMarrowPriorMyelodysplasticSyndromeFindingDate

    Data type

    date

    Alias
    NCI Thesaurus ObjectClass
    C25401
    UMLS 2011AA ObjectClass
    C0205161
    NCI Thesaurus ObjectClass-2
    C12431
    UMLS 2011AA ObjectClass-2
    C0005953
    NCI Thesaurus ObjectClass-3
    C25509
    UMLS 2011AA ObjectClass-3
    C1279901
    NCI Thesaurus Property
    C3247
    UMLS 2011AA Property
    C3463824
    NCI Thesaurus Property-2
    C25629
    UMLS 2011AA Property-2
    C0332152
    NCI Thesaurus Property-3
    C61036
    UMLS 2011AA Property-3
    C0243095
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    Patient/Participant Age
    Description

    PatientAgeValue

    Data type

    float

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25150
    UMLS 2011AA Property
    C0001779
    Leukemia Classification (who/fab)
    Description

    Leukemia Classification (who/fab)

    WHO Diagnosis
    Description

    DiseaseDiagnosisHematopoieticType

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C2991
    UMLS 2011AA ObjectClass
    C0012634
    NCI Thesaurus ValueDomain-2
    C13324
    UMLS 2011AA ValueDomain-2
    C0229601
    NCI Thesaurus Property
    C15220
    UMLS 2011AA Property
    C0011900
    Other specify
    Description

    DiseaseDiagnosisHematopoieticSpecify

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS 2011AA ValueDomain
    C1521902
    NCI Thesaurus ObjectClass
    C2991
    UMLS 2011AA ObjectClass
    C0012634
    NCI Thesaurus ValueDomain-2
    C13324
    UMLS 2011AA ValueDomain-2
    C0229601
    NCI Thesaurus Property
    C15220
    UMLS 2011AA Property
    C0011900
    Leukemia Classification (FAB)
    Description

    LeukemiaFrench-American-BritishClassificationCategory

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C3161
    UMLS 2011AA ObjectClass
    C0023418
    NCI Thesaurus Property
    C43854
    UMLS 2011AA Property
    C1556084
    NCI Thesaurus Property-2
    C25161
    UMLS 2011AA Property-2
    C0008902
    NCI Metathesaurus Property
    C0596227
    NCI Metathesaurus Property-2
    C0596070
    NCI Thesaurus ValueDomain
    C25372
    UMLS 2011AA ValueDomain
    C0683312
    Other specify
    Description

    LeukemiaFrench-American-BritishClassificationSpecify

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C3161
    UMLS 2011AA ObjectClass
    C0023418
    NCI Thesaurus Property
    C43854
    UMLS 2011AA Property
    C1556084
    NCI Thesaurus Property-2
    C25161
    UMLS 2011AA Property-2
    C0008902
    NCI Metathesaurus Property
    C0596227
    NCI Metathesaurus Property-2
    C0596070
    NCI Thesaurus ValueDomain
    C25685
    UMLS 2011AA ValueDomain
    C1521902
    Clinical Onset Of Aml
    Description

    Clinical Onset Of Aml

    Clinical Onset of AML
    Description

    ClinicalEtiologyAcuteMyeloidLeukemiaDiagnosisType

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C25398
    UMLS 2011AA ObjectClass
    C0205210
    NCI Thesaurus ObjectClass-2
    C16390
    UMLS 2011AA ObjectClass-2
    C1524003
    NCI Thesaurus Property
    C3171
    UMLS 2011AA Property
    C0023467
    NCI Thesaurus Property-2
    C15220
    UMLS 2011AA Property-2
    C0011900
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    Prior treatment for leukemia or myelodysplasia
    Description

    PriorTherapyMDSLeukemiaAdministeredInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C25629
    UMLS 2011AA ObjectClass
    C0332152
    NCI Thesaurus ObjectClass-2
    C15368
    NCI Thesaurus Property
    C3247
    UMLS 2011AA Property
    C3463824
    NCI Thesaurus Property-2
    C3161
    UMLS 2011AA Property-2
    C0023418
    NCI Thesaurus Property-3
    C25382
    UMLS 2011AA Property-3
    C1521801
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Did the patient receive cytotoxic treatment for the MDS (If the patient had antecedent MDS,)
    Description

    PriorChemotherapyMyelodysplasticSyndromeAdministeredInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C15632
    UMLS 2011AA ObjectClass
    C0392920
    NCI Thesaurus ObjectClass-2
    C25629
    UMLS 2011AA ObjectClass-2
    C0332152
    NCI Thesaurus Property
    C3247
    UMLS 2011AA Property
    C3463824
    NCI Thesaurus Property-2
    C25382
    UMLS 2011AA Property-2
    C1521801
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Number of days hydroxyurea received
    Description

    HydroxyureaAgentAdministeredDayCount

    Data type

    float

    Alias
    NCI Thesaurus ObjectClass
    C560
    UMLS 2011AA ObjectClass
    C0020402
    NCI Thesaurus ObjectClass-2
    C1708
    UMLS 2011AA ObjectClass-2
    C0450442
    NCI Thesaurus Property
    C25382
    UMLS 2011AA Property
    C1521801
    NCI Thesaurus ValueDomain
    C25301
    UMLS 2011AA ValueDomain
    C0439228
    NCI Thesaurus ValueDomain-2
    C25463
    UMLS 2011AA ValueDomain-2
    C0750480
    Extramedullary Disease Involvement
    Description

    Extramedullary Disease Involvement

    Extramedullary Disease Involvement
    Description

    DiseaseExtramedullaryInvolvementSite

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C13717
    UMLS 2011AA ValueDomain
    C1515974
    NCI Thesaurus ObjectClass
    C2991
    UMLS 2011AA ObjectClass
    C0012634
    NCI Thesaurus Property
    C25548
    UMLS 2011AA Property
    C1314939
    NCI Thesaurus Property-2
    C25503
    UMLS 2011AA Property-2
    C1517060
    Other specify
    Description

    DiseaseExtramedullaryInvolvementOtherSite

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C13717
    UMLS 2011AA ValueDomain
    C1515974
    NCI Thesaurus ObjectClass
    C2991
    UMLS 2011AA ObjectClass
    C0012634
    NCI Thesaurus Property
    C25548
    UMLS 2011AA Property
    C1314939
    NCI Thesaurus Property-2
    C25503
    UMLS 2011AA Property-2
    C1517060
    Are auer rods present?
    Description

    LaboratoryProcedureAuerRodsOutcomeStatus

    Data type

    text

    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
    C25287
    UMLS 2011AA Property-3
    C0333828
    NCI Thesaurus ValueDomain
    C25688
    UMLS 2011AA ValueDomain
    C0449438
    Not done
    Description

    AssessmentMethodText

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS 2011AA ValueDomain
    C1527021
    NCI Thesaurus ObjectClass
    C20989
    UMLS 2011AA ObjectClass
    C0031809
    NCI Thesaurus Property
    C16847
    UMLS 2011AA Property
    C0449851
    Organ Involvement
    Description

    Organ Involvement

    Palpable splenomegaly
    Description

    SplenomegalyPalpationDocumentedInd

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25180
    UMLS 2011AA ValueDomain
    C1522602
    NCI Thesaurus Property
    C16950
    UMLS 2011AA Property
    C0030247
    NCI Thesaurus ObjectClass
    C3384
    UMLS 2011AA ObjectClass
    C0038002
    NCI Thesaurus ValueDomain-2
    C25356
    UMLS 2011AA ValueDomain-2
    C1301725
    Splenomegaly by scan (or X-ray)
    Description

    SplenomegalyImageDocumentedInd

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25180
    UMLS 2011AA ValueDomain
    C1522602
    NCI Thesaurus ObjectClass
    C3384
    UMLS 2011AA ObjectClass
    C0038002
    NCI Thesaurus Property
    C19477
    UMLS 2011AA Property
    C1704254
    NCI Thesaurus ValueDomain-2
    C25356
    UMLS 2011AA ValueDomain-2
    C1301725
    Palpable hepatomegaly
    Description

    HepatomegalyPalpationDocumentedInd

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25180
    UMLS 2011AA ValueDomain
    C1522602
    NCI Thesaurus Property
    C16950
    UMLS 2011AA Property
    C0030247
    NCI Thesaurus ObjectClass
    C3100
    UMLS 2011AA ObjectClass
    C0017924
    NCI Thesaurus ValueDomain-2
    C25356
    UMLS 2011AA ValueDomain-2
    C1301725
    Hepatomegaly by scan (or X-ray)
    Description

    HepatomegalyImageDocumentedInd

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25180
    UMLS 2011AA ValueDomain
    C1522602
    NCI Thesaurus ObjectClass
    C3100
    UMLS 2011AA ObjectClass
    C0017924
    NCI Thesaurus Property
    C19477
    UMLS 2011AA Property
    C1704254
    NCI Thesaurus ValueDomain-2
    C25356
    UMLS 2011AA ValueDomain-2
    C1301725
    Palpable lymphadenopathy
    Description

    LymphadenopathyPalpationDocumentedInd

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25180
    UMLS 2011AA ValueDomain
    C1522602
    NCI Thesaurus Property
    C16950
    UMLS 2011AA Property
    C0030247
    NCI Thesaurus ObjectClass
    C3206
    UMLS 2011AA ObjectClass
    C0024228
    NCI Thesaurus ValueDomain-2
    C25356
    UMLS 2011AA ValueDomain-2
    C1301725
    Lymphadenopathy by scan
    Description

    LymphadenopathyImageDocumentedInd

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25180
    UMLS 2011AA ValueDomain
    C1522602
    NCI Thesaurus ObjectClass
    C3206
    UMLS 2011AA ObjectClass
    C0024228
    NCI Thesaurus Property
    C19477
    UMLS 2011AA Property
    C1704254
    NCI Thesaurus ValueDomain-2
    C25356
    UMLS 2011AA ValueDomain-2
    C1301725
    Current Symptoms
    Description

    Current Symptoms

    Current Infection
    Description

    InfectionSeverityType

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C26726
    UMLS 2011AA ObjectClass
    C0009450
    NCI Thesaurus Property
    C25676
    UMLS 2011AA Property
    C0439793
    Bleeding/Hemorrage
    Description

    AdverseEventHemorrhageSymptomStatus

    Data type

    text

    Alias
    NCI Thesaurus Property
    C26791
    UMLS 2011AA Property
    C0019080
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus Property-2
    C4876
    UMLS 2011AA Property-2
    C1457887
    NCI Thesaurus ValueDomain
    C25688
    UMLS 2011AA ValueDomain
    C0449438
    Lab Data At Study Entry
    Description

    Lab Data At Study Entry

    Chest X-Ray Result
    Description

    ChestX-RayResultType

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C25389
    UMLS 2011AA ObjectClass
    C0817096
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus ObjectClass-2
    C17261
    Abnormal, specify
    Description

    ChestX-rayResultAbnormalSpecify

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C25389
    UMLS 2011AA ObjectClass
    C0817096
    NCI Thesaurus ObjectClass-2
    C17261
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus ValueDomain
    C25685
    UMLS 2011AA ValueDomain
    C1521902
    NCI Thesaurus ValueDomain-2
    C25401
    UMLS 2011AA ValueDomain-2
    C0205161
    Date of Chest X-ray
    Description

    ChestX-RayAssessmentDate

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus Property
    C20989
    UMLS 2011AA Property
    C0031809
    NCI Thesaurus ObjectClass
    C25389
    UMLS 2011AA ObjectClass
    C0817096
    NCI Thesaurus ObjectClass-2
    C17261
    Bilirubin
    Description

    HepaticBilirubinLabValue

    Data type

    float

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

    HepaticBilirubinLabUpperLimitNormalValue

    Data type

    float

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

    CardiacEvaluationDiagnosticProcedure

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C25214
    UMLS 2011AA ObjectClass
    C0220825
    NCI Thesaurus Property
    C15368
    NCI Thesaurus ValueDomain
    C25218
    UMLS 2011AA ValueDomain
    C1948041
    Specify nature of abnormalities
    Description

    AbnormalElectrocardiographyAdverseEventPresentSpecify

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C25401
    UMLS 2011AA ObjectClass
    C0205161
    NCI Thesaurus ObjectClass-2
    C41331
    UMLS 2011AA ObjectClass-2
    C0877248
    NCI Thesaurus ObjectClass-3
    C38053
    UMLS 2011AA ObjectClass-3
    C1623258
    NCI Thesaurus Property
    C25626
    UMLS 2011AA Property
    C0150312
    NCI Thesaurus ValueDomain
    C25685
    UMLS 2011AA ValueDomain
    C1521902
    Date of EKG
    Description

    DiagnosticElectrocardiogramPerformedDate

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus Property
    C38000
    UMLS 2011AA Property
    C0884358
    NCI Thesaurus ObjectClass
    C25482
    UMLS 2011AA ObjectClass
    C0348026
    NCI Metathesaurus ObjectClass
    C0013798
    LVEF (%)
    Description

    HeartLVEFTestPercentageValue

    Data type

    float

    Measurement units
    • %
    Alias
    NCI Thesaurus ObjectClass
    C12727
    UMLS 2011AA ObjectClass
    C0018787
    NCI Thesaurus Property
    C25294
    UMLS 2011AA Property
    C0022885
    NCI Thesaurus Property-2
    C37946
    UMLS 2011AA Property-2
    C2700377
    NCI Thesaurus ValueDomain
    C25613
    UMLS 2011AA ValueDomain
    C0439165
    NCI Thesaurus ValueDomain-2
    C25712
    UMLS 2011AA ValueDomain-2
    C1522609
    %
    Method to determine ejection fraction
    Description

    LeftVentricularEjectionFractionAssessmentType

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus Property
    C20989
    UMLS 2011AA Property
    C0031809
    NCI Thesaurus ObjectClass
    C37946
    UMLS 2011AA ObjectClass
    C2700377
    Overall Response
    Description

    Overall Response

    Completed by (print or type name)
    Description

    Person Completing Form

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C1550483
    NCI Thesaurus ObjectClass
    C25657
    NCI Thesaurus Property
    C25364
    Date Form Completed (MM DD YYYY)
    Description

    Date Form Completed

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C1115437
    NCI Thesaurus ObjectClass
    C40988
    NCI Thesaurus Property
    C25250
    NCI Thesaurus ValueDomain-2
    C25367

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    1. StudyEvent: CALGB: 10603 On-Study Form
      1. No Instruction available.
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Header
    Form ID CALGB
    Item
    CALGB Form (C-1619)
    text
    C25337 (NCI Thesaurus ValueDomain)
    C3262252 (UMLS CUI-1)
    C19464 (NCI Thesaurus ObjectClass)
    C1516238 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25442 (NCI Thesaurus ObjectClass-2)
    Protocol ID CALGB
    Item
    CALGB Study No
    text
    C25337 (NCI Thesaurus ValueDomain)
    C3274381 (UMLS CUI-1)
    C25320 (NCI Thesaurus ObjectClass)
    C1516238 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25442 (NCI Thesaurus Property-2)
    Trial subject ID CALGB
    Item
    CALGB Patient ID
    text
    C25337 (NCI Thesaurus ValueDomain)
    C2348585 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C1516238 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25442 (NCI Thesaurus Property-2)
    Data amended
    Item
    Are data amended
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C0680532 (UMLS CUI-1)
    C25474 (NCI Thesaurus ObjectClass)
    C25416 (NCI Thesaurus Property)
    Item Group
    Ccrr Module For Calgb 90202: Prostate Specific Antigen Form
    Patient Initials
    Item
    Patient Initials (Last, First Middle)
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2986440 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25536 (NCI Thesaurus Property)
    Medical Record Number
    Item
    Patient Hospital No.
    text
    C25337 (NCI Thesaurus ValueDomain)
    C1301894 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25261 (NCI Thesaurus Property)
    C25198 (NCI Thesaurus Property-2)
    Institution Name
    Item
    Institution/Affiliate
    text
    C25454 (NCI Thesaurus ObjectClass)
    C1301943 (UMLS CUI-1)
    C21541 (NCI Thesaurus ObjectClass-2)
    C25364 (NCI Thesaurus Property)
    C25191 (NCI Thesaurus ValueDomain)
    C21541 (NCI Thesaurus ValueDomain-2)
    Participating Group
    Item
    Participating Group (Country Name for International site:)
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2347449 (UMLS CUI-1)
    C25608 (NCI Thesaurus ObjectClass)
    C17005 (NCI Thesaurus ObjectClass-2)
    C25364 (NCI Thesaurus Property)
    Study Number Participating Group
    Item
    Participating Group Protocol Number
    text
    C25337 (NCI Thesaurus ValueDomain)
    C3274381 (UMLS CUI-1)
    C25320 (NCI Thesaurus ObjectClass)
    C2347449 (UMLS CUI-2)
    C25608 (NCI Thesaurus Property)
    C25364 (NCI Thesaurus Property-2)
    Trial subject ID Participating Group
    Item
    Participating Group Patient ID
    text
    C25337 (NCI Thesaurus ValueDomain)
    C2348585 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C2347449 (UMLS CUI-2)
    C25608 (NCI Thesaurus Property)
    C25364 (NCI Thesaurus Property-2)
    Item Group
    Patient Description
    CancerInitialDiagnosisDate
    Item
    Date of Initial Pathologic Diagnosis
    date
    C9305 (NCI Thesaurus ObjectClass)
    C0006826 (UMLS 2011AA ObjectClass)
    C25509 (NCI Thesaurus Property)
    C1279901 (UMLS 2011AA Property)
    C15220 (NCI Thesaurus Property-2)
    C0011900 (UMLS 2011AA Property-2)
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25367 (NCI Thesaurus ValueDomain-2)
    MedDRACode
    Item
    MedDRA disease code
    float
    C25162 (NCI Thesaurus ValueDomain)
    C0805701 (UMLS 2011AA ValueDomain)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    CL104089 (NCI Metathesaurus ObjectClass)
    FirstAbnormalBoneMarrowPriorMyelodysplasticSyndromeFindingDate
    Item
    Date of first abnormal bone marrow for antecedent myelodysplasia
    date
    C25401 (NCI Thesaurus ObjectClass)
    C0205161 (UMLS 2011AA ObjectClass)
    C12431 (NCI Thesaurus ObjectClass-2)
    C0005953 (UMLS 2011AA ObjectClass-2)
    C25509 (NCI Thesaurus ObjectClass-3)
    C1279901 (UMLS 2011AA ObjectClass-3)
    C3247 (NCI Thesaurus Property)
    C3463824 (UMLS 2011AA Property)
    C25629 (NCI Thesaurus Property-2)
    C0332152 (UMLS 2011AA Property-2)
    C61036 (NCI Thesaurus Property-3)
    C0243095 (UMLS 2011AA Property-3)
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    PatientAgeValue
    Item
    Patient/Participant Age
    float
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25150 (NCI Thesaurus Property)
    C0001779 (UMLS 2011AA Property)
    Item Group
    Leukemia Classification (who/fab)
    Item
    WHO Diagnosis
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C2991 (NCI Thesaurus ObjectClass)
    C0012634 (UMLS 2011AA ObjectClass)
    C13324 (NCI Thesaurus ValueDomain-2)
    C0229601 (UMLS 2011AA ValueDomain-2)
    C15220 (NCI Thesaurus Property)
    C0011900 (UMLS 2011AA Property)
    Code List
    WHO Diagnosis
    CL Item
    Acute Basophilic Leukemia (Acute basophilic leukemia)
    C3164 (NCI Thesaurus)
    C0023437 (UMLS 2011AA)
    CL Item
    Acute Erythroid Leukemia (Acute erythroid leukemia)
    C8923 (NCI Thesaurus)
    C0023440 (UMLS 2011AA)
    CL Item
    Acute Megakaryoblastic Leukemia (Acute megakaryoblastic leukemia)
    C3170 (NCI Thesaurus)
    C0023462 (UMLS 2011AA)
    CL Item
    Acute Myelomonocytic Leukemia (Acute myelomonocytic leukemia)
    C7463 (NCI Thesaurus)
    C0023479 (UMLS 2011AA)
    CL Item
    Acute Panmyelosis With Myelofibrosis (Acute panmyelosis with myelofibrosis)
    C4344 (NCI Thesaurus)
    C0334674 (UMLS 2011AA)
    CL Item
    Acute Myeloid Leukemia With 11q23 (mll) Abnormalities (AML with 11q23 (MLL) abnormalities)
    C6924 (NCI Thesaurus)
    C2825116 (UMLS 2011AA)
    CL Item
    Acute Myeloid Leukemia With Inv(16)(p13q22) Or T(16;16)(p13;q22), (cbf-beta/myh11) (AML with inv(16)(p13q22) or t(16;16)(p13;q22))
    CL Item
    Acute Myeloid Leukemia With Maturation (AML with maturation)
    C3250 (NCI Thesaurus)
    C0473527 (UMLS 2011AA)
    CL Item
    Acute Myeloid Leukemia With Multilineage Dysplasia Without Prior Myelodysplastic Syndrome (AML with multilineage dysplasia w/o prior MDS)
    CL Item
    Acute Myeloid Leukemia With Multilineage Dysplasia With Prior Myelodysplastic Syndrome (AML with multilineage dysplasia with prior MDS)
    CL Item
    Acute Myeloid Leukemia With T(8;21)(q22;q22), (aml1/eto) (AML with t(8;21)(q22;q22))
    CL Item
    Acute Myeloid Leukemia Without Maturation (AML without maturation)
    C3249 (NCI Thesaurus)
    C0026998 (UMLS 2011AA)
    CL Item
    Acute Myeloid Leukemia, Minimally Differentiated (AML, minimally differentiated)
    C8460 (NCI Thesaurus)
    C0522631 (UMLS 2011AA)
    CL Item
    Myeloid Sarcoma (Myeloid sarcoma)
    C3520 (NCI Thesaurus)
    C0151714 (UMLS 2011AA)
    CL Item
    Other Specify (Other)
    DiseaseDiagnosisHematopoieticSpecify
    Item
    Other specify
    text
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
    C2991 (NCI Thesaurus ObjectClass)
    C0012634 (UMLS 2011AA ObjectClass)
    C13324 (NCI Thesaurus ValueDomain-2)
    C0229601 (UMLS 2011AA ValueDomain-2)
    C15220 (NCI Thesaurus Property)
    C0011900 (UMLS 2011AA Property)
    Item
    Leukemia Classification (FAB)
    text
    C3161 (NCI Thesaurus ObjectClass)
    C0023418 (UMLS 2011AA ObjectClass)
    C43854 (NCI Thesaurus Property)
    C1556084 (UMLS 2011AA Property)
    C25161 (NCI Thesaurus Property-2)
    C0008902 (UMLS 2011AA Property-2)
    C0596227 (NCI Metathesaurus Property)
    C0596070 (NCI Metathesaurus Property-2)
    C25372 (NCI Thesaurus ValueDomain)
    C0683312 (UMLS 2011AA ValueDomain)
    Code List
    Leukemia Classification (FAB)
    CL Item
    Disease Classified As Acute Erythroblastic Leukemia (fab M6) (Acute erythroblastic leukemia (FAB M6))
    CL Item
    Disease Classified As Acute Megakaryoblastic Leukemia (fab M7) (Acute megakaryoblastic leukemia (FAB M7))
    CL Item
    Disease Classified As Acute Monocytic Leukemia (fab M5) (Acute monocytic leukemia (FAB M5))
    CL Item
    Disease Classified As Acute Myeloid Leukemia W/ Maturation (fab M2) (Acute myeloid leukemia w/ maturation (FAB M2))
    CL Item
    Disease Classified As Acute Myeloid Leukemia W/o Maturation (fab M1) (Acute myeloid leukemia w/o maturation (FAB M1))
    CL Item
    Disease Classified As Acute Myelomonocytic Leukemia (fab M4) (Acute myelomonocytic leukemia (FAB M4))
    CL Item
    Other Specify (Other specify)
    CL Item
    Disease Classified As Undifferentiated Acute Myeloid Leukemia (fab M0) (Undifferentiated acute myeloid leukemia (FAB M0))
    LeukemiaFrench-American-BritishClassificationSpecify
    Item
    Other specify
    text
    C3161 (NCI Thesaurus ObjectClass)
    C0023418 (UMLS 2011AA ObjectClass)
    C43854 (NCI Thesaurus Property)
    C1556084 (UMLS 2011AA Property)
    C25161 (NCI Thesaurus Property-2)
    C0008902 (UMLS 2011AA Property-2)
    C0596227 (NCI Metathesaurus Property)
    C0596070 (NCI Metathesaurus Property-2)
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
    Item Group
    Clinical Onset Of Aml
    Item
    Clinical Onset of AML
    text
    C25398 (NCI Thesaurus ObjectClass)
    C0205210 (UMLS 2011AA ObjectClass)
    C16390 (NCI Thesaurus ObjectClass-2)
    C1524003 (UMLS 2011AA ObjectClass-2)
    C3171 (NCI Thesaurus Property)
    C0023467 (UMLS 2011AA Property)
    C15220 (NCI Thesaurus Property-2)
    C0011900 (UMLS 2011AA Property-2)
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    Code List
    Clinical Onset of AML
    CL Item
    Aml Without Prior Clinical History Of Mds Or Potentially Leukemogenic Treatment (de novo)
    CL Item
    Aml Related To/associated With Prior Clinical History Of Potentially Leukemogenic Treatment (Treatment related)
    CL Item
    Aml Related To/associated With Prior Clinical History Of Mds (MDS-related)
    PriorTherapyMDSLeukemiaAdministeredInd-2
    Item
    Prior treatment for leukemia or myelodysplasia
    boolean
    C25629 (NCI Thesaurus ObjectClass)
    C0332152 (UMLS 2011AA ObjectClass)
    C15368 (NCI Thesaurus ObjectClass-2)
    C3247 (NCI Thesaurus Property)
    C3463824 (UMLS 2011AA Property)
    C3161 (NCI Thesaurus Property-2)
    C0023418 (UMLS 2011AA Property-2)
    C25382 (NCI Thesaurus Property-3)
    C1521801 (UMLS 2011AA Property-3)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    PriorChemotherapyMyelodysplasticSyndromeAdministeredInd-2
    Item
    Did the patient receive cytotoxic treatment for the MDS (If the patient had antecedent MDS,)
    boolean
    C15632 (NCI Thesaurus ObjectClass)
    C0392920 (UMLS 2011AA ObjectClass)
    C25629 (NCI Thesaurus ObjectClass-2)
    C0332152 (UMLS 2011AA ObjectClass-2)
    C3247 (NCI Thesaurus Property)
    C3463824 (UMLS 2011AA Property)
    C25382 (NCI Thesaurus Property-2)
    C1521801 (UMLS 2011AA Property-2)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    HydroxyureaAgentAdministeredDayCount
    Item
    Number of days hydroxyurea received
    float
    C560 (NCI Thesaurus ObjectClass)
    C0020402 (UMLS 2011AA ObjectClass)
    C1708 (NCI Thesaurus ObjectClass-2)
    C0450442 (UMLS 2011AA ObjectClass-2)
    C25382 (NCI Thesaurus Property)
    C1521801 (UMLS 2011AA Property)
    C25301 (NCI Thesaurus ValueDomain)
    C0439228 (UMLS 2011AA ValueDomain)
    C25463 (NCI Thesaurus ValueDomain-2)
    C0750480 (UMLS 2011AA ValueDomain-2)
    Item Group
    Extramedullary Disease Involvement
    Item
    Extramedullary Disease Involvement
    text
    C13717 (NCI Thesaurus ValueDomain)
    C1515974 (UMLS 2011AA ValueDomain)
    C2991 (NCI Thesaurus ObjectClass)
    C0012634 (UMLS 2011AA ObjectClass)
    C25548 (NCI Thesaurus Property)
    C1314939 (UMLS 2011AA Property)
    C25503 (NCI Thesaurus Property-2)
    C1517060 (UMLS 2011AA Property-2)
    Code List
    Extramedullary Disease Involvement
    CL Item
    Central Nervous System (Central nervous system)
    C12438 (NCI Thesaurus)
    C3714787 (UMLS 2011AA)
    CL Item
    Peripheral Nervous System (Peripheral nervous system)
    C12465 (NCI Thesaurus)
    C0206417 (UMLS 2011AA)
    CL Item
    Gingival Hypertrophy (Gingival hypertrophy)
    CL Item
    Mediastinal Mass (Mediastinal mass)
    CL Item
    Leukaemia Cutis (Skin (leukemia cutis))
    CL049753 (NCI Metathesaurus)
    CL Item
    Other Specify (Other)
    DiseaseExtramedullaryInvolvementOtherSite
    Item
    Other specify
    text
    C13717 (NCI Thesaurus ValueDomain)
    C1515974 (UMLS 2011AA ValueDomain)
    C2991 (NCI Thesaurus ObjectClass)
    C0012634 (UMLS 2011AA ObjectClass)
    C25548 (NCI Thesaurus Property)
    C1314939 (UMLS 2011AA Property)
    C25503 (NCI Thesaurus Property-2)
    C1517060 (UMLS 2011AA Property-2)
    Item
    Are auer rods present?
    text
    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)
    C25287 (NCI Thesaurus Property-3)
    C0333828 (UMLS 2011AA Property-3)
    C25688 (NCI Thesaurus ValueDomain)
    C0449438 (UMLS 2011AA ValueDomain)
    Code List
    Are auer rods present?
    CL Item
    Auer Rods Absent From Bone Marrow (Absent)
    CL Item
    Auer Rods Present In Bone Marrow (Present)
    AssessmentMethodText
    Item
    Not done
    text
    C25704 (NCI Thesaurus ValueDomain)
    C1527021 (UMLS 2011AA ValueDomain)
    C20989 (NCI Thesaurus ObjectClass)
    C0031809 (UMLS 2011AA ObjectClass)
    C16847 (NCI Thesaurus Property)
    C0449851 (UMLS 2011AA Property)
    Item Group
    Organ Involvement
    Item
    Palpable splenomegaly
    text
    C25180 (NCI Thesaurus ValueDomain)
    C1522602 (UMLS 2011AA ValueDomain)
    C16950 (NCI Thesaurus Property)
    C0030247 (UMLS 2011AA Property)
    C3384 (NCI Thesaurus ObjectClass)
    C0038002 (UMLS 2011AA ObjectClass)
    C25356 (NCI Thesaurus ValueDomain-2)
    C1301725 (UMLS 2011AA ValueDomain-2)
    Code List
    Palpable splenomegaly
    CL Item
    Examination Performed And Splenomegaly Absent (No)
    CL Item
    Examination Of Spleen Not Performed (Not examined)
    CL Item
    Spleen Removed Via Prior Surgery (Surgically absent)
    CL Item
    Examination Performed And Splenomegaly Present (Yes)
    Item
    Splenomegaly by scan (or X-ray)
    text
    C25180 (NCI Thesaurus ValueDomain)
    C1522602 (UMLS 2011AA ValueDomain)
    C3384 (NCI Thesaurus ObjectClass)
    C0038002 (UMLS 2011AA ObjectClass)
    C19477 (NCI Thesaurus Property)
    C1704254 (UMLS 2011AA Property)
    C25356 (NCI Thesaurus ValueDomain-2)
    C1301725 (UMLS 2011AA ValueDomain-2)
    Code List
    Splenomegaly by scan (or X-ray)
    CL Item
    Examination Performed And Splenomegaly Absent (No)
    CL Item
    Examination Of Spleen Not Performed (Not examined)
    CL Item
    Spleen Removed Via Prior Surgery (Surgically absent)
    CL Item
    Examination Performed And Splenomegaly Present (Yes)
    Item
    Palpable hepatomegaly
    text
    C25180 (NCI Thesaurus ValueDomain)
    C1522602 (UMLS 2011AA ValueDomain)
    C16950 (NCI Thesaurus Property)
    C0030247 (UMLS 2011AA Property)
    C3100 (NCI Thesaurus ObjectClass)
    C0017924 (UMLS 2011AA ObjectClass)
    C25356 (NCI Thesaurus ValueDomain-2)
    C1301725 (UMLS 2011AA ValueDomain-2)
    Code List
    Palpable hepatomegaly
    CL Item
    Examination Performed And Hepatomegaly Absent (No)
    CL Item
    Examination Of Liver Not Performed (Not examined)
    CL Item
    Examination Performed And Hepatomegaly Present (Yes)
    Item
    Hepatomegaly by scan (or X-ray)
    text
    C25180 (NCI Thesaurus ValueDomain)
    C1522602 (UMLS 2011AA ValueDomain)
    C3100 (NCI Thesaurus ObjectClass)
    C0017924 (UMLS 2011AA ObjectClass)
    C19477 (NCI Thesaurus Property)
    C1704254 (UMLS 2011AA Property)
    C25356 (NCI Thesaurus ValueDomain-2)
    C1301725 (UMLS 2011AA ValueDomain-2)
    Code List
    Hepatomegaly by scan (or X-ray)
    CL Item
    Examination Performed And Hepatomegaly Absent (No)
    CL Item
    Examination Of Liver Not Performed (Not examined)
    CL Item
    Examination Performed And Hepatomegaly Present (Yes)
    Item
    Palpable lymphadenopathy
    text
    C25180 (NCI Thesaurus ValueDomain)
    C1522602 (UMLS 2011AA ValueDomain)
    C16950 (NCI Thesaurus Property)
    C0030247 (UMLS 2011AA Property)
    C3206 (NCI Thesaurus ObjectClass)
    C0024228 (UMLS 2011AA ObjectClass)
    C25356 (NCI Thesaurus ValueDomain-2)
    C1301725 (UMLS 2011AA ValueDomain-2)
    Code List
    Palpable lymphadenopathy
    CL Item
    Examination Performed And Lymphadenopathy Absent (No)
    CL Item
    Examination Of Lymph Nodes Not Performed (Not examined)
    CL Item
    Examination Performed And Lymphadenopathy Present (Yes)
    Item
    Lymphadenopathy by scan
    text
    C25180 (NCI Thesaurus ValueDomain)
    C1522602 (UMLS 2011AA ValueDomain)
    C3206 (NCI Thesaurus ObjectClass)
    C0024228 (UMLS 2011AA ObjectClass)
    C19477 (NCI Thesaurus Property)
    C1704254 (UMLS 2011AA Property)
    C25356 (NCI Thesaurus ValueDomain-2)
    C1301725 (UMLS 2011AA ValueDomain-2)
    Code List
    Lymphadenopathy by scan
    CL Item
    Examination Performed And Lymphadenopathy Absent (No)
    CL Item
    Examination Of Lymph Nodes Not Performed (Not examined)
    CL Item
    Examination Performed And Lymphadenopathy Present (Yes)
    Item Group
    Current Symptoms
    Item
    Current Infection
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C26726 (NCI Thesaurus ObjectClass)
    C0009450 (UMLS 2011AA ObjectClass)
    C25676 (NCI Thesaurus Property)
    C0439793 (UMLS 2011AA Property)
    Code List
    Current Infection
    CL Item
    None (None)
    C41132 (NCI Thesaurus)
    C0549184 (UMLS 2011AA)
    CL Item
    Life Threatening Or Disabling Adverse Event (Life-threatening)
    C41337 (NCI Thesaurus)
    C1517874 (UMLS 2011AA)
    CL Item
    Moderate Adverse Event (Moderate)
    C41339 (NCI Thesaurus)
    C1513374 (UMLS 2011AA)
    CL Item
    Severe Adverse Event (Severe)
    C41340 (NCI Thesaurus)
    C1519275 (UMLS 2011AA)
    Item
    Bleeding/Hemorrage
    text
    C26791 (NCI Thesaurus Property)
    C0019080 (UMLS 2011AA Property)
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C4876 (NCI Thesaurus Property-2)
    C1457887 (UMLS 2011AA Property-2)
    C25688 (NCI Thesaurus ValueDomain)
    C0449438 (UMLS 2011AA ValueDomain)
    Code List
    Bleeding/Hemorrage
    CL Item
    Active, Requiring Transfusion (Active, requiring transfusion)
    CL Item
    Mild, Not Requiring Transfusion (Mild, not requiring transfusion)
    CL Item
    None (None)
    C41132 (NCI Thesaurus)
    C0549184 (UMLS 2011AA)
    Item Group
    Lab Data At Study Entry
    Item
    Chest X-Ray Result
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C25389 (NCI Thesaurus ObjectClass)
    C0817096 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C17261 (NCI Thesaurus ObjectClass-2)
    Code List
    Chest X-Ray Result
    CL Item
    Normal (Normal)
    C14165 (NCI Thesaurus)
    C0205307 (UMLS 2011AA)
    CL Item
    Abnormal (Abnormal)
    C25401 (NCI Thesaurus)
    C0205161 (UMLS 2011AA)
    ChestX-rayResultAbnormalSpecify
    Item
    Abnormal, specify
    text
    C25389 (NCI Thesaurus ObjectClass)
    C0817096 (UMLS 2011AA ObjectClass)
    C17261 (NCI Thesaurus ObjectClass-2)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
    C25401 (NCI Thesaurus ValueDomain-2)
    C0205161 (UMLS 2011AA ValueDomain-2)
    ChestX-RayAssessmentDate
    Item
    Date of Chest X-ray
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C20989 (NCI Thesaurus Property)
    C0031809 (UMLS 2011AA Property)
    C25389 (NCI Thesaurus ObjectClass)
    C0817096 (UMLS 2011AA ObjectClass)
    C17261 (NCI Thesaurus ObjectClass-2)
    HepaticBilirubinLabValue
    Item
    Bilirubin
    float
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C305 (NCI Thesaurus Property-2)
    C0005437 (UMLS 2011AA Property-2)
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    HepaticBilirubinLabUpperLimitNormalValue
    Item
    Bilirubin ULN
    float
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C305 (NCI Thesaurus Property-2)
    C0005437 (UMLS 2011AA Property-2)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C25706 (NCI Thesaurus ValueDomain-2)
    C1519815 (UMLS 2011AA ValueDomain-2)
    Item
    EKG result
    text
    C25214 (NCI Thesaurus ObjectClass)
    C0220825 (UMLS 2011AA ObjectClass)
    C15368 (NCI Thesaurus Property)
    C25218 (NCI Thesaurus ValueDomain)
    C1948041 (UMLS 2011AA ValueDomain)
    Code List
    EKG result
    CL Item
    Normal (Normal)
    C14165 (NCI Thesaurus)
    C0205307 (UMLS 2011AA)
    CL Item
    Abnormal (Abnormal)
    C25401 (NCI Thesaurus)
    C0205161 (UMLS 2011AA)
    CL Item
    Not Done (Not done)
    CL281691 (NCI Metathesaurus)
    AbnormalElectrocardiographyAdverseEventPresentSpecify
    Item
    Specify nature of abnormalities
    text
    C25401 (NCI Thesaurus ObjectClass)
    C0205161 (UMLS 2011AA ObjectClass)
    C41331 (NCI Thesaurus ObjectClass-2)
    C0877248 (UMLS 2011AA ObjectClass-2)
    C38053 (NCI Thesaurus ObjectClass-3)
    C1623258 (UMLS 2011AA ObjectClass-3)
    C25626 (NCI Thesaurus Property)
    C0150312 (UMLS 2011AA Property)
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
    DiagnosticElectrocardiogramPerformedDate
    Item
    Date of EKG
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C38000 (NCI Thesaurus Property)
    C0884358 (UMLS 2011AA Property)
    C25482 (NCI Thesaurus ObjectClass)
    C0348026 (UMLS 2011AA ObjectClass)
    C0013798 (NCI Metathesaurus ObjectClass)
    HeartLVEFTestPercentageValue
    Item
    LVEF (%)
    float
    C12727 (NCI Thesaurus ObjectClass)
    C0018787 (UMLS 2011AA ObjectClass)
    C25294 (NCI Thesaurus Property)
    C0022885 (UMLS 2011AA Property)
    C37946 (NCI Thesaurus Property-2)
    C2700377 (UMLS 2011AA Property-2)
    C25613 (NCI Thesaurus ValueDomain)
    C0439165 (UMLS 2011AA ValueDomain)
    C25712 (NCI Thesaurus ValueDomain-2)
    C1522609 (UMLS 2011AA ValueDomain-2)
    Item
    Method to determine ejection fraction
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C20989 (NCI Thesaurus Property)
    C0031809 (UMLS 2011AA Property)
    C37946 (NCI Thesaurus ObjectClass)
    C2700377 (UMLS 2011AA ObjectClass)
    Code List
    Method to determine ejection fraction
    CL Item
    Echocardiogram (Echocardiogram)
    C37945 (NCI Thesaurus)
    C2243117 (UMLS 2011AA)
    CL Item
    Radionuclide Ventriculogram Scan (Multiple Gated Acquisition (MUGA))
    C38073 (NCI Thesaurus)
    C0521317 (UMLS 2011AA)
    Item Group
    Overall Response
    Person Completing Form
    Item
    Completed by (print or type name)
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1550483 (UMLS CUI-1)
    C25657 (NCI Thesaurus ObjectClass)
    C25364 (NCI Thesaurus Property)
    Date Form Completed
    Item
    Date Form Completed (MM DD YYYY)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C1115437 (UMLS CUI-1)
    C40988 (NCI Thesaurus ObjectClass)
    C25250 (NCI Thesaurus Property)
    C25367 (NCI Thesaurus ValueDomain-2)

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