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43474

Description

NSABP C-11 OPEN Worksheet for Form Entry Combination Chemotherapy Before or After Surgery in Treating Patients With Colorectal Cancer With Liver Metastases That Could Be Removed By Surgery Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=8836C32C-ED52-3A5B-E040-BB89AD436D98

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=8836C32C-ED52-3A5B-E040-BB89AD436D98

Keywords

Versions (5)
  1. 8/27/12 8/27/12 -
  2. 8/8/14 8/8/14 - Martin Dugas
  3. 1/9/15 1/9/15 - Martin Dugas
  4. 1/9/15 1/9/15 - Martin Dugas
  5. 9/20/21 9/20/21 -
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September 20, 2021

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Creative Commons BY-NC 3.0 Legacy
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    Colorectal Cancer NCT01189227 Registration - NSABP C-11 OPEN Worksheet for Form Entry - 3105627v1.0

    English

    No Instruction available.

    1 forms  
    1. StudyEvent: NSABP C-11 OPEN Worksheet for Form Entry
      1. No Instruction available.
    Header
    Description

    Header

    Patient Initials
    Description

    Patient Initials

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C2986440
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25536
    Site Name
    Description

    ClinicalTrialSiteNameText

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS 2011AA ValueDomain
    C1527021
    NCI Thesaurus ObjectClass
    C15207
    NCI Thesaurus Property
    C37901
    UMLS 2011AA Property
    C0205145
    NCI Thesaurus ValueDomain-2
    C42614
    UMLS 2011AA ValueDomain-2
    C0027365
    Patient Birth Date (Month Day Year)
    Description

    Patient Birth Date

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C0421451
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus ValueDomain-2
    C25367
    NCI Thesaurus Property
    C25155
    Treating physician
    Description

    TreatingPhysicianName

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus ObjectClass
    C25741
    UMLS 2011AA ObjectClass
    C0031831
    NCI Thesaurus ObjectClass-2
    C25705
    UMLS 2011AA ObjectClass-2
    C1522326
    Race
    Description

    Race

    Race
    Description

    RaceCategoryText

    Data type

    text

    Alias
    NCI Thesaurus Property
    C25372
    UMLS 2011AA Property
    C0683312
    NCI Thesaurus ValueDomain
    C25372
    UMLS 2011AA ValueDomain
    C0683312
    NCI Thesaurus ObjectClass
    C17049
    UMLS 2011AA ObjectClass
    C0034510
    Person Completing Form, Last Name
    Description

    Person Completing Form, Last Name

    Method of Payment (mark primary method only)
    Description

    PatientPaymentType

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25371
    UMLS 2011AA Property
    C0680264
    Ethnicity
    Description

    Ethnic Group

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25372
    UMLS CUI-1
    C0015031
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C16564
    Country of residence
    Description

    PersonAddressCountryCode

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25162
    UMLS 2011AA ValueDomain
    C0805701
    NCI Thesaurus ObjectClass
    C25190
    UMLS 2011AA ObjectClass
    C0027361
    NCI Thesaurus Property
    C25407
    UMLS 2011AA Property
    C1442065
    Other
    Description

    OtherPatientAddressCountrySpecify

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C17649
    UMLS 2011AA ObjectClass
    C0205394
    NCI Thesaurus ObjectClass-2
    C16960
    UMLS 2011AA ObjectClass-2
    C0030705
    NCI Thesaurus Property
    C25407
    UMLS 2011AA Property
    C1442065
    NCI Thesaurus ValueDomain
    C25685
    UMLS 2011AA ValueDomain
    C1521902
    NCI Thesaurus ValueDomain-2
    C25464
    UMLS 2011AA ValueDomain-2
    C0454664
    Patient Zip Code (USA)
    Description

    PersonAddressPostalCode

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25162
    UMLS 2011AA ValueDomain
    C0805701
    NCI Thesaurus ObjectClass
    C25190
    UMLS 2011AA ObjectClass
    C0027361
    NCI Thesaurus Property
    C25407
    UMLS 2011AA Property
    C1442065
    Patient Social Security Number (USA only)
    Description

    Social Security Number

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C1301821
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25686
    Patient gender
    Description

    PersonGenderTextType

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C25190
    UMLS 2011AA ObjectClass
    C0027361
    NCI Thesaurus Property
    C17357
    UMLS 2011AA Property
    C0079399
    Unnamed4
    Description

    Unnamed4

    Did the patient consent to use of blood samples for testing related to C-11?
    Description

    PatientBloodSpecimenConsentInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C12434
    UMLS 2011AA Property
    C0229664
    NCI Thesaurus Property-2
    C19157
    UMLS 2011AA Property-2
    C0370003
    NCI Thesaurus Property-3
    C25460
    UMLS 2011AA Property-3
    C1511481
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Did the patient consent to use of tissue and blood samples for future research to learn about, prevent, or treat cancer?
    Description

    PatientMalignantNeoplasmConsentInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C9305
    UMLS 2011AA Property
    C0006826
    NCI Thesaurus Property-2
    C25460
    UMLS 2011AA Property-2
    C1511481
    Did the patient consent to use of tissue and blood samples for research about other problems?
    Description

    BloodTissueSpecimenOtherDiseasesandDisordersResearchConsentInd-3

    Data type

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C12801
    UMLS 2011AA ObjectClass
    C0040300
    NCI Thesaurus ObjectClass-2
    C12434
    UMLS 2011AA ObjectClass-2
    C0229664
    NCI Thesaurus ObjectClass-3
    C19157
    UMLS 2011AA ObjectClass-3
    C0370003
    NCI Thesaurus Property
    C17649
    UMLS 2011AA Property
    C0205394
    NCI Thesaurus Property-2
    C15319
    NCI Thesaurus Property-3
    C2991
    UMLS 2011AA Property-2
    C0012634
    NCI Thesaurus Property-4
    C25460
    UMLS 2011AA Property-3
    C1511481
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    Did the patient consent to future contact about more research?
    Description

    TissueSpecimenMalignantNeoplasmRelatedResearchConsentInd-3

    Data type

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C12801
    UMLS 2011AA ObjectClass
    C0040300
    NCI Thesaurus ObjectClass-2
    C19157
    UMLS 2011AA ObjectClass-2
    C0370003
    NCI Thesaurus Property
    C15319
    NCI Thesaurus Property-2
    C25648
    UMLS 2011AA Property
    C0439849
    NCI Thesaurus Property-3
    C9305
    UMLS 2011AA Property-2
    C0006826
    NCI Thesaurus Property-4
    C25460
    UMLS 2011AA Property-3
    C1511481
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    Has the patient authorized the release of Protected Health Information to the NSABP?
    Description

    PatientPHIConsentIndicator

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C25180
    UMLS 2011AA ValueDomain
    C1522602
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25460
    UMLS 2011AA Property
    C1511481
    Date Informed Consent Signed (Month Day Year)
    Description

    InformedConsentFormSignedDate

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ValueDomain-2
    C25367
    NCI Thesaurus ObjectClass
    C16468
    UMLS 2011AA ObjectClass
    C0009797
    NCI Thesaurus Property
    C25679
    Number of liver metastases on pre-entry evaluation
    Description

    HepaticMetastasisPriorClinicalStudyDiagnosisCount

    Data type

    float

    Alias
    NCI Thesaurus ObjectClass
    C13308
    UMLS 2011AA ObjectClass
    C0205054
    NCI Thesaurus ObjectClass-2
    C19151
    UMLS 2011AA ObjectClass-2
    C0027627
    NCI Thesaurus Property
    C25629
    UMLS 2011AA Property
    C0332152
    NCI Thesaurus Property-2
    C15220
    UMLS 2011AA Property-2
    C0011900
    NCI Thesaurus Property-3
    C15206
    UMLS 2011AA Property-3
    C0008972
    NCI Thesaurus ValueDomain
    C25463
    UMLS 2011AA ValueDomain
    C0750480
    Has the patient received prior oxaliplatin therapy?
    Description

    ChemotherapyPreoperativeOxaliplatinAdministeredInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C15632
    UMLS 2011AA ObjectClass
    C0392920
    NCI Thesaurus Property
    C1181
    UMLS 2011AA Property
    C0069717
    NCI Thesaurus Property-2
    C54732
    UMLS 2011AA Property-2
    C0445204
    NCI Thesaurus Property-3
    C25382
    UMLS 2011AA Property-3
    C1521801
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Page Headers
    Description

    Page Headers

    Patient Initials
    Description

    Patient Initials

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C2986440
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25536
    NSABP Patient ID
    Description

    Patient ID NSABP

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C2348585
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-2
    C1513905
    NCI Thesaurus Property
    C25364
    NCI Thesaurus Property-2
    C15818
    Surgery For Primary Colorectal Tumor
    Description

    Surgery For Primary Colorectal Tumor

    Was a diagnosis of colorectal adenocarcinoma confirmed histologically?
    Description

    ColorectalAdenocarcinomaHistologicConfirmationDiagnosisInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C2852
    UMLS 2011AA ObjectClass
    C0001418
    NCI Thesaurus ObjectClass-2
    C13363
    UMLS 2011AA ObjectClass-2
    C0555952
    NCI Thesaurus Property
    C25458
    UMLS 2011AA Property
    C0750484
    NCI Thesaurus Property-2
    C25526
    UMLS 2011AA Property-2
    C0205462
    NCI Thesaurus Property-3
    C15220
    UMLS 2011AA Property-3
    C0011900
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Date of Report (A copy of the pathology report must be provided.)
    Description

    LaboratoryFindingReportDate

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus Property
    C25375
    UMLS 2011AA Property
    C0684224
    NCI Thesaurus ObjectClass
    C38470
    When were suspicious liver metastases first detected on imaging?
    Description

    ComputedTomographyDiagnosticImagingLiverMetastasisPresentDate

    Data type

    date

    Alias
    NCI Thesaurus ObjectClass
    C16502
    UMLS 2011AA ObjectClass
    C0011923
    NCI Thesaurus ObjectClass-2
    C17204
    UMLS 2011AA ObjectClass-2
    C0040405
    NCI Thesaurus Property
    C25626
    UMLS 2011AA Property
    C0150312
    NCI Thesaurus Property-2
    C12392
    UMLS 2011AA Property-2
    C0023884
    NCI Thesaurus Property-3
    C19151
    UMLS 2011AA Property-3
    C0027627
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    Have the primary tumor and regional nodes been resected?
    Description

    PrimaryTumorRegionalLymphNodeExcisionInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C3262
    UMLS 2011AA ObjectClass
    C0027651
    NCI Thesaurus ObjectClass-2
    C25251
    UMLS 2011AA ObjectClass-2
    C0205225
    NCI Thesaurus Property
    C15232
    UMLS 2011AA Property
    C0728940
    NCI Thesaurus Property-2
    C49018
    UMLS 2011AA Property-2
    C1184738
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Is there a plan to resect the primary tumor and the liver metastases in a single surgical procedure?
    Description

    PrimaryTumorRegionalLymphNodeSingleSurgicalProcedureExcisionInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C3262
    UMLS 2011AA ObjectClass
    C0027651
    NCI Thesaurus ObjectClass-2
    C25251
    UMLS 2011AA ObjectClass-2
    C0205225
    NCI Thesaurus Property
    C15329
    UMLS 2011AA Property
    C0543467
    NCI Thesaurus Property-2
    C15232
    UMLS 2011AA Property-2
    C0728940
    NCI Thesaurus Property-3
    C48440
    UMLS 2011AA Property-3
    C0205171
    NCI Thesaurus Property-4
    C49018
    UMLS 2011AA Property-4
    C1184738
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Were the surgical margins clear?
    Description

    RadialSurgicalMarginNoMicroscopicInvolvementInd-3

    Data type

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C41227
    UMLS 2011AA ObjectClass
    C0229985
    NCI Thesaurus ObjectClass-2
    C25314
    UMLS 2011AA ObjectClass-2
    C0442038
    NCI Thesaurus Property
    C25252
    UMLS 2011AA Property
    C0205288
    NCI Thesaurus Property-2
    C25548
    UMLS 2011AA Property-2
    C1314939
    NCI Metathesaurus Property
    C0028423
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    Was there evidence of extrahepatic disease?
    Description

    ExtrahepaticMetastasisDiagnosisInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus ObjectClass
    C19151
    UMLS 2011AA ObjectClass
    C0027627
    NCI Thesaurus Property
    C15220
    UMLS 2011AA Property
    C0011900
    NCI Thesaurus ObjectClass-2
    C28358
    UMLS 2011AA ObjectClass-2
    C1517058
    Did the patient have chemotherapy for the primary colorectal disease?
    Description

    PriorNeoadjuvantTherapyChemotherapyColorectalNeoplasmReceiveInd-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 ObjectClass-3
    C15665
    UMLS 2011AA ObjectClass-3
    C0600558
    NCI Thesaurus Property
    C13363
    UMLS 2011AA Property
    C0555952
    NCI Thesaurus Property-2
    C25639
    UMLS 2011AA Property-2
    C1514756
    NCI Metathesaurus Property
    CL053268
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Approximately when was the last dose of chemotherapy?
    Description

    ChemotherapyLastAdministeredValue

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C15632
    UMLS 2011AA ObjectClass
    C0392920
    NCI Thesaurus Property
    C25551
    UMLS 2011AA Property
    C1517741
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus Property-2
    C25382
    UMLS 2011AA Property-2
    C1521801
    In the past four weeks, has a hepatic surgeon determined that the patient's liver metastases are resectable based on the following criteria? (- A complete resection can be performed in a single operation AND - There are at least two uninvolved contiguous segments of the liver)
    Description

    LiverMetastasisPatientSurgeonDecisionEligibilityDeterminationInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus ObjectClass-2
    C12392
    UMLS 2011AA ObjectClass-2
    C0023884
    NCI Thesaurus ObjectClass-3
    C19151
    UMLS 2011AA ObjectClass-3
    C0027627
    NCI Thesaurus Property
    C18071
    UMLS 2011AA Property
    C0582175
    NCI Thesaurus Property-2
    C25171
    UMLS 2011AA Property-2
    C0013893
    NCI Thesaurus Property-3
    C53285
    UMLS 2011AA Property-3
    C0679006
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Date of Assessment (Month Day Year)
    Description

    Assessment Date

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C2985720
    NCI Thesaurus ObjectClass
    C25367
    NCI Thesaurus ValueDomain-2
    C25367
    NCI Thesaurus Property
    C38000
    Section 2
    Description

    Section 2

    List of Imaging Evaluations Performed
    Description

    ImagingMethodType

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus Property
    C16847
    UMLS 2011AA Property
    C0449851
    NCI Thesaurus ObjectClass
    C16502
    UMLS 2011AA ObjectClass
    C0011923
    Evaluation Performed?
    Description

    EvaluationPerformedInd-3

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ObjectClass
    C25214
    UMLS 2011AA ObjectClass
    C0220825
    NCI Thesaurus Property
    C38000
    UMLS 2011AA Property
    C0884358
    Date of Assessment (Month Day Year)
    Description

    Assessment Date

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C2985720
    NCI Thesaurus ObjectClass
    C25367
    NCI Thesaurus ValueDomain-2
    C25367
    NCI Thesaurus Property
    C38000
    Section 2 (continued)
    Description

    Section 2 (continued)

    Were hepatic metastases evident on one or more scans?
    Description

    HepaticMetastasisMedicalImagingDiagnosisInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C13308
    UMLS 2011AA ObjectClass
    C0205054
    NCI Thesaurus ObjectClass-2
    C19151
    UMLS 2011AA ObjectClass-2
    C0027627
    NCI Thesaurus Property
    C15220
    UMLS 2011AA Property
    C0011900
    NCI Thesaurus Property-2
    C16831
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Were extrahepatic metastases evident on one or more scans?
    Description

    ExtrahepaticMetastasisMedicalImagingDiagnosisInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C19151
    UMLS 2011AA ObjectClass
    C0027627
    NCI Thesaurus ObjectClass-2
    C28358
    UMLS 2011AA ObjectClass-2
    C1517058
    NCI Thesaurus Property
    C15220
    UMLS 2011AA Property
    C0011900
    NCI Thesaurus Property-2
    C16831
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Patient Characteristics
    Description

    Patient Characteristics

    Patient Height (cm)
    Description

    Patient Height

    Data type

    float

    Measurement units
    • cm
    Alias
    NCI Thesaurus ValueDomain
    C25209
    UMLS CUI-1
    C0489786
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25347
    cm
    Patient Weight (kg)
    Description

    Patient Weight

    Data type

    float

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

    ECOG Performance Status

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25664
    UMLS CUI-1
    C1520224
    NCI Thesaurus Property
    C25367
    NCI Thesaurus ValueDomain-2
    C25491
    NCI Thesaurus ObjectClass
    C20641
    Blood Pressure, Systolic
    Description

    Systolic blood pressure

    Data type

    float

    Alias
    NCI Thesaurus ValueDomain
    C25209
    UMLS CUI-1
    C0871470
    NCI Thesaurus Property
    C25214
    NCI Thesaurus ObjectClass
    C25298
    Blood pressure, Diastolic
    Description

    Diastolic blood pressure

    Data type

    float

    Alias
    NCI Thesaurus ValueDomain
    C25209
    UMLS CUI-1
    C0428883
    NCI Thesaurus Property
    C25214
    NCI Thesaurus ObjectClass
    C25299
    Section 3 (continued)
    Description

    Section 3 (continued)

    AST
    Description

    LaboratoryProcedureAspartateAminotransferaseMeasurementAssessmentsInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus Property
    C25367
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property-2
    C64467
    UMLS 2011AA Property
    C0201899
    SGOT (AST) (Patient Value units/L)
    Description

    SGOT (AST)

    Data type

    float

    Measurement units
    • U/L
    Alias
    NCI Thesaurus Property
    C25202
    UMLS CUI-1
    C0201899
    NCI Thesaurus Property-2
    C20200
    NCI Thesaurus ObjectClass
    C25294
    NCI Thesaurus ValueDomain
    C25712
    U/L
    SGOT (AST) ULN
    Description

    LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedUpperLimitofNormalValue

    Data type

    float

    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C25202
    UMLS 2011AA Property
    C0242192
    NCI Thesaurus Property-2
    C20200
    UMLS 2011AA Property-2
    C1274040
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus ValueDomain-2
    C25706
    UMLS 2011AA ValueDomain-2
    C1519815
    Date of Collection (Month Day Year)
    Description

    LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultDate

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus Property
    C25202
    UMLS 2011AA Property
    C0242192
    NCI Thesaurus Property-2
    C20200
    UMLS 2011AA Property-2
    C1274040
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    Alkaline Phosphatase
    Description

    LaboratoryProcedureAlkalinePhosphataseAssessmentInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus Property
    C25367
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property-2
    C16276
    UMLS 2011AA Property
    C0002059
    Alkaline Phosphatase (Patient Value units/L)
    Description

    Alkaline Phosphatase

    Data type

    float

    Alias
    NCI Thesaurus Property
    C20200
    UMLS CUI-1
    C0201850
    NCI Thesaurus ObjectClass
    C25294
    NCI Thesaurus ValueDomain
    C25712
    NCI Thesaurus Property-2
    C16276
    Alkaline Phosphatase ULN
    Description

    Alkaline Phosphatase ULN

    Data type

    float

    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS CUI-1
    C0151420
    NCI Thesaurus Property
    C20200
    NCI Thesaurus Property-2
    C16276
    NCI Thesaurus ValueDomain
    C25712
    NCI Thesaurus ValueDomain-2
    C25706
    Date of Collection (Month Day Year)
    Description

    LaboratoryProcedureAlkalinePhosphataseResultDate

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property-2
    C16276
    UMLS 2011AA Property-2
    C0002059
    Total Bilirubin
    Description

    LaboratoryProcedureBilirubinAssessmentInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus Property
    C25367
    NCI Thesaurus Property-2
    C305
    UMLS 2011AA Property
    C0005437
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    Total Bilirubin (Patient Value mg/dL)
    Description

    LaboratoryProcedureTotalBilirubinResultSpecifiedValue

    Data type

    float

    Measurement units
    • 1000/uL
    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property-2
    C38037
    UMLS 2011AA Property-2
    C0201913
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus ValueDomain-2
    C38024
    UMLS 2011AA ValueDomain-2
    C0205369
    1000/uL
    Total bilirubin ULN
    Description

    Bilirubin, Total ULN

    Data type

    float

    Measurement units
    • mg/dL
    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS CUI-1
    C0201913
    NCI Thesaurus Property
    C20200
    UMLS CUI-2
    C1519815
    NCI Thesaurus Property-2
    C38037
    NCI Thesaurus ValueDomain
    C25712
    NCI Thesaurus ValueDomain-2
    C38024
    NCI Thesaurus ValueDomain-3
    C25706
    mg/dL
    Date of Collection (Month Day Year)
    Description

    LaboratoryProcedureBilirubinOutcomeDate

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    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
    Serum Creatinine
    Description

    LaboratoryProcedureCreatinineAssessmentInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus Property
    C25367
    NCI Thesaurus Property-2
    C399
    UMLS 2011AA Property
    C0010294
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    Serum creatinine (Patient Value mg/dL)
    Description

    Creatinine, Serum

    Data type

    float

    Measurement units
    • mg/dL
    Alias
    NCI Thesaurus Property
    C20200
    UMLS CUI-1
    C0201976
    NCI Thesaurus Property-2
    C399
    NCI Thesaurus ObjectClass
    C25294
    NCI Thesaurus ValueDomain
    C25712
    mg/dL
    Serum Creatinine ULN
    Description

    Creatinine, serum ULN

    Data type

    float

    Measurement units
    • mg/dL
    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS CUI-1
    C0201976
    NCI Thesaurus Property
    C20200
    UMLS CUI-2
    C1519815
    NCI Thesaurus Property-2
    C399
    NCI Thesaurus ValueDomain
    C25712
    NCI Thesaurus ValueDomain-2
    C25706
    mg/dL
    Date of Collection (Month Day Year )
    Description

    LaboratoryProcedureCreatinineClearanceOutcomeDate

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property-2
    C25747
    UMLS 2011AA Property-2
    C0373595
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    Section 3 (continued)
    Description

    Section 3 (continued)

    ANC
    Description

    LaboratoryProcedureAbsoluteNeutrophilCountAssessmentInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus Property
    C25367
    NCI Thesaurus Property-2
    C63321
    UMLS 2011AA Property
    C0948762
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    ANC (Patient Value thousand/mm^3)
    Description

    ANC

    Data type

    float

    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS CUI-1
    C0948762
    NCI Thesaurus Property
    C20200
    NCI Thesaurus Property-2
    C63321
    NCI Thesaurus ValueDomain
    C38046
    NCI Thesaurus ValueDomain-2
    C25712
    Date of Collection (Month Day Year )
    Description

    LaboratoryProcedureAbsoluteNeutrophilCountResultDate

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property-2
    C63321
    UMLS 2011AA Property-2
    C0948762
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    Platelet Count
    Description

    LaboratoryProcedurePlateletAssessmentInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus Property
    C25367
    NCI Thesaurus Property-2
    C12520
    UMLS 2011AA Property
    C0005821
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    Platelet count (Patient Value thousand/mm^3)
    Description

    Platelets

    Data type

    float

    Measurement units
    • 1000/uL
    Alias
    NCI Thesaurus Property
    C20200
    UMLS CUI-1
    C0005821
    NCI Thesaurus Property-2
    C12520
    NCI Thesaurus ObjectClass
    C25294
    NCI Thesaurus ValueDomain
    C25712
    1000/uL
    Date of Collection (Month Day Year )
    Description

    Platelets date

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C0005821
    NCI Thesaurus Property
    C20200
    UMLS CUI-2
    C0011008
    NCI Thesaurus Property-2
    C12520
    NCI Thesaurus ObjectClass
    C25294
    Hemoglobin
    Description

    LaboratoryProcedureHemoglobinAssessmentInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus Property
    C25367
    NCI Thesaurus Property-2
    C16676
    UMLS 2011AA Property
    C0019046
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    Hemoglobin (Patient Value g/dL)
    Description

    Hemoglobin

    Data type

    float

    Measurement units
    • g/dL
    Alias
    NCI Thesaurus Property
    C16676
    UMLS CUI-1
    C0019046
    NCI Thesaurus Property-2
    C20200
    NCI Thesaurus ObjectClass
    C25294
    NCI Thesaurus ValueDomain
    C25712
    g/dL
    Date of Collection (Month Day Year )
    Description

    Hemoglobin Date

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C0019046
    NCI Thesaurus Property
    C16676
    UMLS CUI-2
    C0011008
    NCI Thesaurus Property-2
    C20200
    NCI Thesaurus ObjectClass
    C25294
    CEA
    Description

    LaboratoryProcedureCarcinoembryonicAntigenAssessmentInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus Property
    C25367
    NCI Thesaurus Property-2
    C25159
    UMLS 2011AA Property
    C0007082
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    CEA (Patient Value ng/mL)
    Description

    LaboratoryProcedureCarcinoembryonicAntigenOutcomeValue

    Data type

    text

    Alias
    NCI Thesaurus Property
    C25159
    UMLS 2011AA Property
    C0007082
    NCI Thesaurus Property-2
    C20200
    UMLS 2011AA Property-2
    C1274040
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    Date of Collection (Month Day Year )
    Description

    LaboratoryProcedureCarcinoembryonicAntigenOutcomeDate

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus Property
    C25159
    UMLS 2011AA Property
    C0007082
    NCI Thesaurus Property-2
    C20200
    UMLS 2011AA Property-2
    C1274040
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    Calculated Creatinine Clearance
    Description

    LaboratoryProcedureCreatinineClearanceAssessmentInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus Property
    C25367
    NCI Thesaurus Property-2
    C25747
    UMLS 2011AA Property
    C0373595
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    Calculated creatinine clearance (Patient Value mL/min)
    Description

    LaboratoryProcedureCreatinineClearanceOutcomeEstimateValue

    Data type

    float

    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property-2
    C25747
    UMLS 2011AA Property-2
    C0373595
    NCI Thesaurus ValueDomain
    C25498
    UMLS 2011AA ValueDomain
    C0750572
    NCI Thesaurus ValueDomain-2
    C25712
    UMLS 2011AA ValueDomain-2
    C1522609
    Date of Collection (Month Day Year )
    Description

    LaboratoryProcedureCreatinineClearanceOutcomeDate

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property-2
    C25747
    UMLS 2011AA Property-2
    C0373595
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    Section 4
    Description

    Section 4

    Does the patient have a history of diabetes mellitus?
    Description

    DiabetesMellitusPersonalMedicalHistoryInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus ObjectClass
    C2985
    UMLS 2011AA ObjectClass
    C0011849
    NCI Thesaurus Property
    C18772
    UMLS 2011AA Property
    C0262926
    Does the patient have a diagnosis of anal, small bowel or appendiceal carcinoma?
    Description

    AnalSmallBowelAppendixCarcinomaDiagnosisInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C12386
    UMLS 2011AA ObjectClass
    C0021852
    NCI Thesaurus ObjectClass-2
    C2916
    UMLS 2011AA ObjectClass-2
    C0007097
    NCI Thesaurus ObjectClass-3
    C12380
    UMLS 2011AA ObjectClass-3
    C0003617
    NCI Thesaurus ObjectClass-4
    C28048
    NCI Thesaurus Property
    C15220
    UMLS 2011AA Property
    C0011900
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Has the patient been diagnosed with colorectal malignant diseases other than adenocarcinoma, e.g., sarcoma, lymphoma, carcinoid?
    Description

    PatientColorectalMalignantNeoplasmEligibilityDeterminationInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C13363
    UMLS 2011AA Property
    C0555952
    NCI Thesaurus Property-2
    C9305
    UMLS 2011AA Property-2
    C0006826
    NCI Thesaurus Property-3
    C25171
    UMLS 2011AA Property-3
    C0013893
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Does the patient have an unresected primary tumor in the colon or rectum with significant symptoms related to obstruction or that will require radiation therapy?
    Description

    ColorectalNeoplasmPatientObstructionRadiationTherapyEligibilityDeterminationInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus ObjectClass-2
    C3262
    UMLS 2011AA ObjectClass-2
    C0027651
    NCI Thesaurus ObjectClass-3
    C13363
    UMLS 2011AA ObjectClass-3
    C0555952
    NCI Thesaurus Property
    C15313
    UMLS 2011AA Property
    C1522449
    NCI Thesaurus Property-2
    C3284
    UMLS 2011AA Property-2
    C0028778
    NCI Thesaurus Property-3
    C25171
    UMLS 2011AA Property-3
    C0013893
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Does the patient have a history of or current evidence of extrahepatic metastases? (Exclude regional nodes that are suspicious on imaging and associated with the primary colorectal cancer if the nodes will be resected with the primary tumor after randomization.)
    Description

    ExtrahepaticMetastasisPersonalMedicalHistoryInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus ObjectClass
    C19151
    UMLS 2011AA ObjectClass
    C0027627
    NCI Thesaurus ObjectClass-2
    C28358
    UMLS 2011AA ObjectClass-2
    C1517058
    NCI Thesaurus Property
    C18772
    UMLS 2011AA Property
    C0262926
    Does the patient's disease demonstrate radiographic evidence of metastases to portal lymph nodes (node > 1 cm in diameter) not proven by biopsy to be negative?
    Description

    PatientLymphNodeMetastasisEligibilityDeterminationInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C12745
    UMLS 2011AA Property
    C0024204
    NCI Thesaurus Property-2
    C19151
    UMLS 2011AA Property-2
    C0027627
    NCI Thesaurus Property-3
    C25171
    UMLS 2011AA Property-3
    C0013893
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Has the patient received previous hepatic-directed therapy including hepatic resection and/or ablation, hepatic arterial infusion therapy, or hepatic radiation therapy (exluding incisional or excisional biopsy)?
    Description

    PatientPriorHepaticTreatmentEligibilityDeterminationInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C13308
    UMLS 2011AA Property
    C0205054
    NCI Thesaurus Property-2
    C25629
    UMLS 2011AA Property-2
    C0332152
    NCI Thesaurus Property-3
    C15368
    NCI Thesaurus Property-4
    C25171
    UMLS 2011AA Property-3
    C0013893
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Has the patient received previous chemotherapy or any other systemic therapy for metastatic colorectal cancer?
    Description

    PatientChemotherapyMetastasisColorectalCarcinomaPersonalMedicalHistoryInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C15632
    UMLS 2011AA Property
    C0392920
    NCI Thesaurus Property-2
    C19151
    UMLS 2011AA Property-2
    C0027627
    NCI Thesaurus Property-3
    C2955
    UMLS 2011AA Property-3
    C0009402
    NCI Thesaurus Property-4
    C18772
    UMLS 2011AA Property-4
    C0262926
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Has the patient had a portal vein embolization (PVE) or other hepatic preconditioning techniques already performed or are preconditioning techniques such as PVE planned for this patient?
    Description

    SurgicalProcedurePortalVeinExcisionPerformedInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C15329
    UMLS 2011AA ObjectClass
    C0543467
    NCI Thesaurus Property
    C38000
    UMLS 2011AA Property
    C0884358
    NCI Thesaurus Property-2
    C15232
    UMLS 2011AA Property-2
    C0728940
    NCI Thesaurus Property-3
    C33343
    UMLS 2011AA Property-3
    C0032718
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Is there intent to use ablation to treat any hepatic lesion for this patient?
    Description

    HepaticLesionAblationTherapyIntentInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C3824
    UMLS 2011AA ObjectClass
    C0221198
    NCI Thesaurus ObjectClass-2
    C13308
    UMLS 2011AA ObjectClass-2
    C0205054
    NCI Thesaurus ObjectClass-3
    C20985
    UMLS 2011AA ObjectClass-3
    C0547070
    NCI Thesaurus Property
    C25725
    UMLS 2011AA Property
    C1283828
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Does the patient have pre-existing chronic hepatic disease (e.g., chronic active hepatitis, cirrhosis) that, in the opinion of the investigator and hepatic surgeon, would limit the patient's ability to undergo hepatic metastasectomy?
    Description

    PatientPriorChronicHepaticDiseaseorDisorderEligibilityDeterminationInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C13308
    UMLS 2011AA Property
    C0205054
    NCI Thesaurus Property-2
    C25629
    UMLS 2011AA Property-2
    C0332152
    NCI Thesaurus Property-3
    C2991
    UMLS 2011AA Property-3
    C0012634
    NCI Thesaurus Property-4
    C25171
    UMLS 2011AA Property-4
    C0013893
    NCI Thesaurus Property-5
    C14141
    UMLS 2011AA Property-5
    C0205191
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Does the patient have grade 3 or 4 anorexia, grade 3 nausea, or >= grade 2 vomiting (per CTCAE v4.0) related to metastatic disease?
    Description

    AdverseEventMetastasisAssociatedInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus Property
    C19151
    UMLS 2011AA Property
    C0027627
    NCI Thesaurus Property-2
    C25281
    UMLS 2011AA Property-2
    C0332281
    Does the patient have paresthesias, peripheral sensory neuropathy, or peripheral motor neuropathy >= grade 2 per CTCAE v4.0 (Exclude grade 2 neuropathy in patients who will receive FOLFIRI in this study)?
    Description

    AdverseEventNeuropathyAssociatedInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus Property
    C4731
    UMLS 2011AA Property
    C0031117
    NCI Thesaurus Property-2
    C25281
    UMLS 2011AA Property-2
    C0332281
    Does the patient have a documented history of congestive heart failure requiring chronic medical therapy?
    Description

    CongestiveHeartFailureHistoryInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus ObjectClass
    C3080
    UMLS 2011AA ObjectClass
    C0018802
    NCI Thesaurus Property
    C18772
    UMLS 2011AA Property
    C0262926
    Does the patient require therapeutic doses of coumadin or equivalent?
    Description

    PatientWarfarinTreatmentInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C15368
    NCI Metathesaurus Property
    C0043031
    Does the patient have active inflammatory bowel disease?
    Description

    PatientInflammatoryBowelDiseasePersonalMedicalHistoryInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C3138
    UMLS 2011AA Property
    C0021390
    NCI Thesaurus Property-2
    C18772
    UMLS 2011AA Property-2
    C0262926
    Does the patient have an active infection or chronic infection requiring chronic suppressive antibiotics?
    Description

    PatientInfectionInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C26726
    UMLS 2011AA Property
    C0009450
    Does the patient have any known bleeding diathesis or coagulopathy?
    Description

    PatientHemorrhagePre-ExistingConditionEligibilityInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C26791
    UMLS 2011AA Property
    C0019080
    NCI Metathesaurus Property
    CL232826
    Does the patient have symptomatic interstitial pneumonitis or is the patient asymptomatic with definitive evidence of interstitial pneumonitis described on CT scan, MRI, or chest x-ray?
    Description

    PatientInterstitialDiseaseLungPersonalMedicalHistoryInd-3

    Data type

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C12468
    UMLS 2011AA Property
    C0024109
    NCI Thesaurus Property-2
    C18772
    UMLS 2011AA Property-2
    C0262926
    NCI Thesaurus Property-3
    C62410
    UMLS 2011AA Property-3
    C1881236
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    Has the patient had other malignancies (other than carcinoma in situ of the cervix, colorectal carcinoma in situ, melanoma in situ, or basal cell or squamous cell carcinoma of the skin that has been treated)?
    Description

    PatientNeoplasmPersonalMedicalHistoryInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C3262
    UMLS 2011AA Property
    C0027651
    NCI Thesaurus Property-2
    C18772
    UMLS 2011AA Property-2
    C0262926
    Is patient considered to be disease-free?
    Description

    DiseaseStatusIndicator

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C25180
    UMLS 2011AA ValueDomain
    C1522602
    NCI Thesaurus ObjectClass
    C2991
    UMLS 2011AA ObjectClass
    C0012634
    NCI Metathesaurus Property
    C0449438
    Did the patient complete therapy for the malignancies >= 1 year ago?
    Description

    PriorTherapyCompleteRegimenInd-3

    Data type

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C25629
    UMLS 2011AA ObjectClass
    C0332152
    NCI Thesaurus ObjectClass-2
    C15368
    NCI Thesaurus Property
    C25250
    UMLS 2011AA Property
    C0205197
    NCI Thesaurus Property-2
    C15697
    UMLS 2011AA Property-2
    C0040808
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    Is the patient known to have Gilbert's Syndrome?
    Description

    PatientElevatedBilirubinPersonalMedicalHistoryInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C27088
    UMLS 2011AA Property
    C0311468
    NCI Thesaurus Property-2
    C18772
    UMLS 2011AA Property-2
    C0262926
    Is the patient known to be homozygous for the UGT1A1 28 allele?
    Description

    HomozygousUGT1A1*28AlleleGenePresentInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C45826
    UMLS 2011AA ObjectClass
    C0019904
    NCI Thesaurus ObjectClass-2
    C16612
    UMLS 2011AA ObjectClass-2
    C0017337
    NCI Thesaurus ObjectClass-3
    C72564
    UMLS 2011AA ObjectClass-3
    C2825127
    NCI Thesaurus Property
    C25626
    UMLS 2011AA Property
    C0150312
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Has the patient experienced a previous serious hypersensitivity reaction to any of the agents the patient will receive as part of the C-11 trial?
    Description

    PatientClinicalStudyAgentHypersensitivityPersonalMedicalHistoryInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C3114
    UMLS 2011AA Property
    C0020517
    NCI Thesaurus Property-2
    C1708
    UMLS 2011AA Property-2
    C0450442
    NCI Thesaurus Property-3
    C15206
    UMLS 2011AA Property-3
    C0008972
    NCI Thesaurus Property-4
    C18772
    UMLS 2011AA Property-4
    C0262926
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Does the patient have any other serious concomitant medical condition that, in the opinion of the investigator, would compromise the safety of the patient, compromise the patient's ability to participate in the study, or cause a delay in the initiation of therapy (surgery or chemotherapy) longer than 4 weeks following randomization?
    Description

    ConcomitantDiseasePersonalMedicalHistoryInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus ObjectClass
    C2991
    UMLS 2011AA ObjectClass
    C0012634
    NCI Thesaurus ObjectClass-2
    C25730
    UMLS 2011AA ObjectClass-2
    C0521115
    NCI Thesaurus Property
    C18772
    UMLS 2011AA Property
    C0262926
    Does the patient have psychiatric or addictive disorders or other condition that, in the opinion of the investigator, would preclude the patient from meeting the study requirements?
    Description

    PatientStudyRequirementInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C38015
    Has the patient taken any investigational product within the past 30 days?
    Description

    PriorInvestigationalTherapiesAdministeredInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus ObjectClass
    C25629
    UMLS 2011AA ObjectClass
    C0332152
    NCI Metathesaurus ObjectClass
    C0949266
    NCI Thesaurus Property
    C25382
    UMLS 2011AA Property
    C1521801
    Is the patient a woman of child-bearing potential? (The following questions are to be completed for female patients only.)
    Description

    FemalePatientPotentialPregnancyInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus ObjectClass-2
    C16576
    UMLS 2011AA ObjectClass-2
    C0086287
    NCI Thesaurus Property
    C25742
    UMLS 2011AA Property
    C0032961
    NCI Metathesaurus Property
    C0237399
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Was a pregnancy test performed?
    Description

    PatientPregnancyTestIndicator

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C25180
    UMLS 2011AA ValueDomain
    C1522602
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Metathesaurus Property
    C0032976
    Date of pregnancy test
    Description

    PatientMostRecentPregnancyTestDate

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Metathesaurus Property
    C0032976
    NCI Thesaurus Property
    C25577
    UMLS 2011AA Property
    C1513491
    Is the patient pregnant or lactating at time of study entry?
    Description

    PatientPregnancyInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25742
    UMLS 2011AA Property
    C0032961
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    1 forms
    1. StudyEvent: NSABP C-11 OPEN Worksheet for Form Entry
      1. No Instruction available.
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Header
    Patient Initials
    Item
    Patient Initials
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2986440 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25536 (NCI Thesaurus Property)
    ClinicalTrialSiteNameText
    Item
    Site Name
    text
    C25704 (NCI Thesaurus ValueDomain)
    C1527021 (UMLS 2011AA ValueDomain)
    C15207 (NCI Thesaurus ObjectClass)
    C37901 (NCI Thesaurus Property)
    C0205145 (UMLS 2011AA Property)
    C42614 (NCI Thesaurus ValueDomain-2)
    C0027365 (UMLS 2011AA ValueDomain-2)
    Patient Birth Date
    Item
    Patient Birth Date (Month Day Year)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0421451 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25367 (NCI Thesaurus ValueDomain-2)
    C25155 (NCI Thesaurus Property)
    TreatingPhysicianName
    Item
    Treating physician
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C25741 (NCI Thesaurus ObjectClass)
    C0031831 (UMLS 2011AA ObjectClass)
    C25705 (NCI Thesaurus ObjectClass-2)
    C1522326 (UMLS 2011AA ObjectClass-2)
    Item Group
    Race
    Item
    Race
    text
    C25372 (NCI Thesaurus Property)
    C0683312 (UMLS 2011AA Property)
    C25372 (NCI Thesaurus ValueDomain)
    C0683312 (UMLS 2011AA ValueDomain)
    C17049 (NCI Thesaurus ObjectClass)
    C0034510 (UMLS 2011AA ObjectClass)
    CL.1
    Code List
    Race
    CL Item
    A Person Having Origins In Any Of The Original Peoples Of Europe, The Middle East, Or North Africa. (White)
    C41261 (NCI Thesaurus)
    C0007457 (UMLS 2011AA)
    CL Item
    A Person Having Origins In Any Of The Black Racial Groups Of Africa. Terms Such As "haitian" Or "negro" Can Be Used In Addition To "black Or African American." (Black or African American)
    C16352 (NCI Thesaurus)
    C0085756 (UMLS 2011AA)
    CL Item
    A Person Having Origins In Any Of The Original Peoples Of Hawaii, Guam, Samoa, Or Other Pacific Islands. (Native Hawaiian or other Pacific Islander)
    C41219 (NCI Thesaurus)
    C1513907 (UMLS 2011AA)
    CL Item
    A Person Having Origins In Any Of The Original Peoples Of The Far East, Southeast Asia, Or The Indian Subcontinent Including, For Example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, The Philippine Islands, Thailand, And Vietnam. (Asian)
    C41260 (NCI Thesaurus)
    C0078988 (UMLS 2011AA)
    CL Item
    A Person Having Origins In Any Of The Original Peoples Of North And South America (including Central America), And Who Maintains Tribal Affiliation Or Community Attachment. (American Indian or Alaska Native)
    C41259 (NCI Thesaurus)
    C1515945 (UMLS 2011AA)
    CL Item
    Could Not Be Determined Or Unsure (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    Item Group
    Person Completing Form, Last Name
    Item
    Method of Payment (mark primary method only)
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25371 (NCI Thesaurus Property)
    C0680264 (UMLS 2011AA Property)
    CL.2
    Code List
    Method of Payment (mark primary method only)
    CL Item
    Private Insurance (Private Insurance)
    CL Item
    Medicare (Medicare)
    C16665 (NCI Thesaurus)
    C0018717 (UMLS 2011AA)
    CL Item
    Medicare And Private Insurance (Medicare and Private Insurance)
    CL Item
    Medicaid (Medicaid)
    C0025071 (NCI Metathesaurus)
    CL Item
    Medicaid And Medicare (Medicaid and Medicare)
    CL Item
    Other (Other)
    C17649 (NCI Thesaurus)
    C0205394 (UMLS 2011AA)
    CL Item
    Military Or Veterans Sponsored Nos (Military or Veterans Sponsored, Not Otherwise Specified (NOS))
    CL Item
    Military Sponsored (including Champus & Tricare) (Military Sponsored (including CHAMPUS & TRICARE))
    CL Item
    Veterans Sponsored (Veterans Sponsored)
    CL Item
    Self Pay (no Insurance) (Self Pay (No Insurance))
    CL Item
    No Means Of Payment (no Insurance) (No means of payment (no insurance))
    CL Item
    Unknown (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    Item
    Ethnicity
    text
    C25372 (NCI Thesaurus ValueDomain)
    C0015031 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C16564 (NCI Thesaurus Property)
    CL.3
    Code List
    Ethnicity
    CL Item
    A Person Of Mexican, Puerto Rican, Cuban, Central Or South American Or Other Spanish Culture Or Origin, Regardless Of Race. (HISPANIC OR LATINO)
    C17459 (NCI Thesaurus)
    C0086409 (UMLS 2011AA)
    CL Item
    A Person Not Meeting The Definition For Hispanic Or Latino. (NOT HISPANIC OR LATINO)
    C41222 (NCI Thesaurus)
    C1518424 (UMLS 2011AA)
    CL Item
    Could Not Be Determined Or Unsure (UNKNOWN)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    Item
    Country of residence
    text
    C25162 (NCI Thesaurus ValueDomain)
    C0805701 (UMLS 2011AA ValueDomain)
    C25190 (NCI Thesaurus ObjectClass)
    C0027361 (UMLS 2011AA ObjectClass)
    C25407 (NCI Thesaurus Property)
    C1442065 (UMLS 2011AA Property)
    CL.4
    Code List
    Country of residence
    CL Item
    Usa (US)
    CL Item
    Canada (CA)
    C16380 (NCI Thesaurus)
    C0006823 (UMLS 2011AA)
    CL Item
    Puerto Rico (PR)
    C17043 (NCI Thesaurus)
    C0034044 (UMLS 2011AA)
    CL Item
    Other (Other)
    OtherPatientAddressCountrySpecify
    Item
    Other
    text
    C17649 (NCI Thesaurus ObjectClass)
    C0205394 (UMLS 2011AA ObjectClass)
    C16960 (NCI Thesaurus ObjectClass-2)
    C0030705 (UMLS 2011AA ObjectClass-2)
    C25407 (NCI Thesaurus Property)
    C1442065 (UMLS 2011AA Property)
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
    C25464 (NCI Thesaurus ValueDomain-2)
    C0454664 (UMLS 2011AA ValueDomain-2)
    PersonAddressPostalCode
    Item
    Patient Zip Code (USA)
    text
    C25162 (NCI Thesaurus ValueDomain)
    C0805701 (UMLS 2011AA ValueDomain)
    C25190 (NCI Thesaurus ObjectClass)
    C0027361 (UMLS 2011AA ObjectClass)
    C25407 (NCI Thesaurus Property)
    C1442065 (UMLS 2011AA Property)
    Social Security Number
    Item
    Patient Social Security Number (USA only)
    text
    C25337 (NCI Thesaurus ValueDomain)
    C1301821 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25686 (NCI Thesaurus Property)
    Item
    Patient gender
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C25190 (NCI Thesaurus ObjectClass)
    C0027361 (UMLS 2011AA ObjectClass)
    C17357 (NCI Thesaurus Property)
    C0079399 (UMLS 2011AA Property)
    CL.5
    Code List
    Patient gender
    CL Item
    Male Gender (Male)
    C46109 (NCI Thesaurus)
    C1706180 (UMLS 2011AA)
    CL Item
    Female Gender (Female)
    C46110 (NCI Thesaurus)
    C0086287 (UMLS 2011AA)
    Item Group
    Unnamed4
    PatientBloodSpecimenConsentInd-2
    Item
    Did the patient consent to use of blood samples for testing related to C-11?
    boolean
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C12434 (NCI Thesaurus Property)
    C0229664 (UMLS 2011AA Property)
    C19157 (NCI Thesaurus Property-2)
    C0370003 (UMLS 2011AA Property-2)
    C25460 (NCI Thesaurus Property-3)
    C1511481 (UMLS 2011AA Property-3)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    PatientMalignantNeoplasmConsentInd-2
    Item
    Did the patient consent to use of tissue and blood samples for future research to learn about, prevent, or treat cancer?
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C9305 (NCI Thesaurus Property)
    C0006826 (UMLS 2011AA Property)
    C25460 (NCI Thesaurus Property-2)
    C1511481 (UMLS 2011AA Property-2)
    BloodTissueSpecimenOtherDiseasesandDisordersResearchConsentInd-3
    Item
    Did the patient consent to use of tissue and blood samples for research about other problems?
    boolean
    C12801 (NCI Thesaurus ObjectClass)
    C0040300 (UMLS 2011AA ObjectClass)
    C12434 (NCI Thesaurus ObjectClass-2)
    C0229664 (UMLS 2011AA ObjectClass-2)
    C19157 (NCI Thesaurus ObjectClass-3)
    C0370003 (UMLS 2011AA ObjectClass-3)
    C17649 (NCI Thesaurus Property)
    C0205394 (UMLS 2011AA Property)
    C15319 (NCI Thesaurus Property-2)
    C2991 (NCI Thesaurus Property-3)
    C0012634 (UMLS 2011AA Property-2)
    C25460 (NCI Thesaurus Property-4)
    C1511481 (UMLS 2011AA Property-3)
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    TissueSpecimenMalignantNeoplasmRelatedResearchConsentInd-3
    Item
    Did the patient consent to future contact about more research?
    boolean
    C12801 (NCI Thesaurus ObjectClass)
    C0040300 (UMLS 2011AA ObjectClass)
    C19157 (NCI Thesaurus ObjectClass-2)
    C0370003 (UMLS 2011AA ObjectClass-2)
    C15319 (NCI Thesaurus Property)
    C25648 (NCI Thesaurus Property-2)
    C0439849 (UMLS 2011AA Property)
    C9305 (NCI Thesaurus Property-3)
    C0006826 (UMLS 2011AA Property-2)
    C25460 (NCI Thesaurus Property-4)
    C1511481 (UMLS 2011AA Property-3)
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    PatientPHIConsentIndicator
    Item
    Has the patient authorized the release of Protected Health Information to the NSABP?
    boolean
    C25180 (NCI Thesaurus ValueDomain)
    C1522602 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25460 (NCI Thesaurus Property)
    C1511481 (UMLS 2011AA Property)
    InformedConsentFormSignedDate
    Item
    Date Informed Consent Signed (Month Day Year)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25367 (NCI Thesaurus ValueDomain-2)
    C16468 (NCI Thesaurus ObjectClass)
    C0009797 (UMLS 2011AA ObjectClass)
    C25679 (NCI Thesaurus Property)
    HepaticMetastasisPriorClinicalStudyDiagnosisCount
    Item
    Number of liver metastases on pre-entry evaluation
    float
    C13308 (NCI Thesaurus ObjectClass)
    C0205054 (UMLS 2011AA ObjectClass)
    C19151 (NCI Thesaurus ObjectClass-2)
    C0027627 (UMLS 2011AA ObjectClass-2)
    C25629 (NCI Thesaurus Property)
    C0332152 (UMLS 2011AA Property)
    C15220 (NCI Thesaurus Property-2)
    C0011900 (UMLS 2011AA Property-2)
    C15206 (NCI Thesaurus Property-3)
    C0008972 (UMLS 2011AA Property-3)
    C25463 (NCI Thesaurus ValueDomain)
    C0750480 (UMLS 2011AA ValueDomain)
    ChemotherapyPreoperativeOxaliplatinAdministeredInd-2
    Item
    Has the patient received prior oxaliplatin therapy?
    boolean
    C15632 (NCI Thesaurus ObjectClass)
    C0392920 (UMLS 2011AA ObjectClass)
    C1181 (NCI Thesaurus Property)
    C0069717 (UMLS 2011AA Property)
    C54732 (NCI Thesaurus Property-2)
    C0445204 (UMLS 2011AA Property-2)
    C25382 (NCI Thesaurus Property-3)
    C1521801 (UMLS 2011AA Property-3)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    Item Group
    Page Headers
    Patient Initials
    Item
    Patient Initials
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2986440 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25536 (NCI Thesaurus Property)
    Patient ID NSABP
    Item
    NSABP Patient ID
    text
    C25337 (NCI Thesaurus ValueDomain)
    C2348585 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C1513905 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C15818 (NCI Thesaurus Property-2)
    Item Group
    Surgery For Primary Colorectal Tumor
    ColorectalAdenocarcinomaHistologicConfirmationDiagnosisInd-2
    Item
    Was a diagnosis of colorectal adenocarcinoma confirmed histologically?
    boolean
    C2852 (NCI Thesaurus ObjectClass)
    C0001418 (UMLS 2011AA ObjectClass)
    C13363 (NCI Thesaurus ObjectClass-2)
    C0555952 (UMLS 2011AA ObjectClass-2)
    C25458 (NCI Thesaurus Property)
    C0750484 (UMLS 2011AA Property)
    C25526 (NCI Thesaurus Property-2)
    C0205462 (UMLS 2011AA Property-2)
    C15220 (NCI Thesaurus Property-3)
    C0011900 (UMLS 2011AA Property-3)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    LaboratoryFindingReportDate
    Item
    Date of Report (A copy of the pathology report must be provided.)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25375 (NCI Thesaurus Property)
    C0684224 (UMLS 2011AA Property)
    C38470 (NCI Thesaurus ObjectClass)
    ComputedTomographyDiagnosticImagingLiverMetastasisPresentDate
    Item
    When were suspicious liver metastases first detected on imaging?
    date
    C16502 (NCI Thesaurus ObjectClass)
    C0011923 (UMLS 2011AA ObjectClass)
    C17204 (NCI Thesaurus ObjectClass-2)
    C0040405 (UMLS 2011AA ObjectClass-2)
    C25626 (NCI Thesaurus Property)
    C0150312 (UMLS 2011AA Property)
    C12392 (NCI Thesaurus Property-2)
    C0023884 (UMLS 2011AA Property-2)
    C19151 (NCI Thesaurus Property-3)
    C0027627 (UMLS 2011AA Property-3)
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    PrimaryTumorRegionalLymphNodeExcisionInd-2
    Item
    Have the primary tumor and regional nodes been resected?
    boolean
    C3262 (NCI Thesaurus ObjectClass)
    C0027651 (UMLS 2011AA ObjectClass)
    C25251 (NCI Thesaurus ObjectClass-2)
    C0205225 (UMLS 2011AA ObjectClass-2)
    C15232 (NCI Thesaurus Property)
    C0728940 (UMLS 2011AA Property)
    C49018 (NCI Thesaurus Property-2)
    C1184738 (UMLS 2011AA Property-2)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    PrimaryTumorRegionalLymphNodeSingleSurgicalProcedureExcisionInd-2
    Item
    Is there a plan to resect the primary tumor and the liver metastases in a single surgical procedure?
    boolean
    C3262 (NCI Thesaurus ObjectClass)
    C0027651 (UMLS 2011AA ObjectClass)
    C25251 (NCI Thesaurus ObjectClass-2)
    C0205225 (UMLS 2011AA ObjectClass-2)
    C15329 (NCI Thesaurus Property)
    C0543467 (UMLS 2011AA Property)
    C15232 (NCI Thesaurus Property-2)
    C0728940 (UMLS 2011AA Property-2)
    C48440 (NCI Thesaurus Property-3)
    C0205171 (UMLS 2011AA Property-3)
    C49018 (NCI Thesaurus Property-4)
    C1184738 (UMLS 2011AA Property-4)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    RadialSurgicalMarginNoMicroscopicInvolvementInd-3
    Item
    Were the surgical margins clear?
    boolean
    C41227 (NCI Thesaurus ObjectClass)
    C0229985 (UMLS 2011AA ObjectClass)
    C25314 (NCI Thesaurus ObjectClass-2)
    C0442038 (UMLS 2011AA ObjectClass-2)
    C25252 (NCI Thesaurus Property)
    C0205288 (UMLS 2011AA Property)
    C25548 (NCI Thesaurus Property-2)
    C1314939 (UMLS 2011AA Property-2)
    C0028423 (NCI Metathesaurus Property)
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    ExtrahepaticMetastasisDiagnosisInd-2
    Item
    Was there evidence of extrahepatic disease?
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C19151 (NCI Thesaurus ObjectClass)
    C0027627 (UMLS 2011AA ObjectClass)
    C15220 (NCI Thesaurus Property)
    C0011900 (UMLS 2011AA Property)
    C28358 (NCI Thesaurus ObjectClass-2)
    C1517058 (UMLS 2011AA ObjectClass-2)
    PriorNeoadjuvantTherapyChemotherapyColorectalNeoplasmReceiveInd-2
    Item
    Did the patient have chemotherapy for the primary colorectal disease?
    boolean
    C15632 (NCI Thesaurus ObjectClass)
    C0392920 (UMLS 2011AA ObjectClass)
    C25629 (NCI Thesaurus ObjectClass-2)
    C0332152 (UMLS 2011AA ObjectClass-2)
    C15665 (NCI Thesaurus ObjectClass-3)
    C0600558 (UMLS 2011AA ObjectClass-3)
    C13363 (NCI Thesaurus Property)
    C0555952 (UMLS 2011AA Property)
    C25639 (NCI Thesaurus Property-2)
    C1514756 (UMLS 2011AA Property-2)
    CL053268 (NCI Metathesaurus Property)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    Item
    Approximately when was the last dose of chemotherapy?
    text
    C15632 (NCI Thesaurus ObjectClass)
    C0392920 (UMLS 2011AA ObjectClass)
    C25551 (NCI Thesaurus Property)
    C1517741 (UMLS 2011AA Property)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C25382 (NCI Thesaurus Property-2)
    C1521801 (UMLS 2011AA Property-2)
    CL.18
    Code List
    Approximately when was the last dose of chemotherapy?
    CL Item
    0-6 Months Ago (0-6 months ago)
    CL Item
    7-12 Months Ago (7-12 months ago)
    CL Item
    13-24 Months Ago (13-24 months ago)
    CL Item
    >24 Months Ago (>24 months ago)
    LiverMetastasisPatientSurgeonDecisionEligibilityDeterminationInd-2
    Item
    In the past four weeks, has a hepatic surgeon determined that the patient's liver metastases are resectable based on the following criteria? (- A complete resection can be performed in a single operation AND - There are at least two uninvolved contiguous segments of the liver)
    boolean
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C12392 (NCI Thesaurus ObjectClass-2)
    C0023884 (UMLS 2011AA ObjectClass-2)
    C19151 (NCI Thesaurus ObjectClass-3)
    C0027627 (UMLS 2011AA ObjectClass-3)
    C18071 (NCI Thesaurus Property)
    C0582175 (UMLS 2011AA Property)
    C25171 (NCI Thesaurus Property-2)
    C0013893 (UMLS 2011AA Property-2)
    C53285 (NCI Thesaurus Property-3)
    C0679006 (UMLS 2011AA Property-3)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    Assessment Date
    Item
    Date of Assessment (Month Day Year)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C2985720 (UMLS CUI-1)
    C25367 (NCI Thesaurus ObjectClass)
    C25367 (NCI Thesaurus ValueDomain-2)
    C38000 (NCI Thesaurus Property)
    Item Group
    Section 2
    Item
    List of Imaging Evaluations Performed
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C16847 (NCI Thesaurus Property)
    C0449851 (UMLS 2011AA Property)
    C16502 (NCI Thesaurus ObjectClass)
    C0011923 (UMLS 2011AA ObjectClass)
    CL.20
    Code List
    List of Imaging Evaluations Performed
    CL Item
    Computed Tomography Contrast Positron Emission Tomography (PET-CT scan with contrast)
    C17007 (NCI Thesaurus)
    C0032743 (UMLS 2011AA)
    C17204 (NCI Thesaurus-3)
    C0040405 (UMLS 2011AA-4)
    C70754 (NCI Thesaurus-5)
    C1979874 (UMLS 2011AA-6)
    CL Item
    Positron Emission Tomography (PET scan)
    C17007 (NCI Thesaurus)
    C0032743 (UMLS 2011AA)
    CL Item
    Computed Tomography No Contrast Positron Emission Tomography (PET-CT scan without contrast)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    C17007 (NCI Thesaurus-3)
    C0032743 (UMLS 2011AA-4)
    C17204 (NCI Thesaurus-5)
    C0040405 (UMLS 2011AA-6)
    C70754 (NCI Thesaurus-7)
    C1979874 (UMLS 2011AA-8)
    CL Item
    Contrast Chest Computed Tomography (CT scan with contrast, chest)
    C17204 (NCI Thesaurus)
    C0040405 (UMLS 2011AA)
    C25389 (NCI Thesaurus-3)
    C0817096 (UMLS 2011AA-4)
    C70754 (NCI Thesaurus-5)
    C1979874 (UMLS 2011AA-6)
    CL Item
    Contrast Abdominal Cavity Computed Tomography (CT scan with contrast, abdomen)
    C17204 (NCI Thesaurus)
    C0040405 (UMLS 2011AA)
    C12664 (NCI Thesaurus-3)
    C0230168 (UMLS 2011AA-4)
    C70754 (NCI Thesaurus-5)
    C1979874 (UMLS 2011AA-6)
    CL Item
    Contrast Abdominal Cavity Magnetic Resonance Imaging (MRI with contrast, abdomen)
    C12664 (NCI Thesaurus)
    C0230168 (UMLS 2011AA)
    C16809 (NCI Thesaurus-3)
    C0024485 (UMLS 2011AA-4)
    C70754 (NCI Thesaurus-5)
    C1979874 (UMLS 2011AA-6)
    CL Item
    Contrast Pelvis Computed Tomography (CT scan with contrast, pelvis)
    C17204 (NCI Thesaurus)
    C0040405 (UMLS 2011AA)
    C12767 (NCI Thesaurus-3)
    C0030797 (UMLS 2011AA-4)
    C70754 (NCI Thesaurus-5)
    C1979874 (UMLS 2011AA-6)
    CL Item
    Contrast Pelvis Magnetic Resonance Imaging (MRI with contrast, pelvis)
    C12767 (NCI Thesaurus)
    C0030797 (UMLS 2011AA)
    C16809 (NCI Thesaurus-3)
    C0024485 (UMLS 2011AA-4)
    C70754 (NCI Thesaurus-5)
    C1979874 (UMLS 2011AA-6)
    EvaluationPerformedInd-3
    Item
    Evaluation Performed?
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C25214 (NCI Thesaurus ObjectClass)
    C0220825 (UMLS 2011AA ObjectClass)
    C38000 (NCI Thesaurus Property)
    C0884358 (UMLS 2011AA Property)
    Assessment Date
    Item
    Date of Assessment (Month Day Year)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C2985720 (UMLS CUI-1)
    C25367 (NCI Thesaurus ObjectClass)
    C25367 (NCI Thesaurus ValueDomain-2)
    C38000 (NCI Thesaurus Property)
    Item Group
    Section 2 (continued)
    HepaticMetastasisMedicalImagingDiagnosisInd-2
    Item
    Were hepatic metastases evident on one or more scans?
    boolean
    C13308 (NCI Thesaurus ObjectClass)
    C0205054 (UMLS 2011AA ObjectClass)
    C19151 (NCI Thesaurus ObjectClass-2)
    C0027627 (UMLS 2011AA ObjectClass-2)
    C15220 (NCI Thesaurus Property)
    C0011900 (UMLS 2011AA Property)
    C16831 (NCI Thesaurus Property-2)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    ExtrahepaticMetastasisMedicalImagingDiagnosisInd-2
    Item
    Were extrahepatic metastases evident on one or more scans?
    boolean
    C19151 (NCI Thesaurus ObjectClass)
    C0027627 (UMLS 2011AA ObjectClass)
    C28358 (NCI Thesaurus ObjectClass-2)
    C1517058 (UMLS 2011AA ObjectClass-2)
    C15220 (NCI Thesaurus Property)
    C0011900 (UMLS 2011AA Property)
    C16831 (NCI Thesaurus Property-2)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    Item Group
    Patient Characteristics
    Patient Height
    Item
    Patient Height (cm)
    float
    C25209 (NCI Thesaurus ValueDomain)
    C0489786 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25347 (NCI Thesaurus Property)
    Patient Weight
    Item
    Patient Weight (kg)
    float
    C25209 (NCI Thesaurus ValueDomain)
    C0005910 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25208 (NCI Thesaurus Property)
    Item
    ECOG Performance Status
    text
    C25664 (NCI Thesaurus ValueDomain)
    C1520224 (UMLS CUI-1)
    C25367 (NCI Thesaurus Property)
    C25491 (NCI Thesaurus ValueDomain-2)
    C20641 (NCI Thesaurus ObjectClass)
    CL.24
    Code List
    ECOG Performance Status
    CL Item
    Fully Active, Able To Carry On All Pre-disease Performance Without Restriction. (0)
    CL Item
    Restricted In Physically Strenuous Activity But Ambulatory And Able To Carry Out Work Of A Light Or Sedentary Nature, E.g., Light Housework, Office Work. (1)
    CL Item
    Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities. Up And About More Than 50% Of Waking Hours. (2)
    CL Item
    Capable Of Only Limited Selfcare, Confined To Bed Or Chair More Than 50% Of Waking Hours. (3)
    CL Item
    Completely Disabled. Cannot Carry On Any Selfcare. Totally Confined To Bed Or Chair. (4)
    Systolic blood pressure
    Item
    Blood Pressure, Systolic
    float
    C25209 (NCI Thesaurus ValueDomain)
    C0871470 (UMLS CUI-1)
    C25214 (NCI Thesaurus Property)
    C25298 (NCI Thesaurus ObjectClass)
    Diastolic blood pressure
    Item
    Blood pressure, Diastolic
    float
    C25209 (NCI Thesaurus ValueDomain)
    C0428883 (UMLS CUI-1)
    C25214 (NCI Thesaurus Property)
    C25299 (NCI Thesaurus ObjectClass)
    Item Group
    Section 3 (continued)
    LaboratoryProcedureAspartateAminotransferaseMeasurementAssessmentsInd-2
    Item
    AST
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C25367 (NCI Thesaurus Property)
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C64467 (NCI Thesaurus Property-2)
    C0201899 (UMLS 2011AA Property)
    SGOT (AST)
    Item
    SGOT (AST) (Patient Value units/L)
    float
    C25202 (NCI Thesaurus Property)
    C0201899 (UMLS CUI-1)
    C20200 (NCI Thesaurus Property-2)
    C25294 (NCI Thesaurus ObjectClass)
    C25712 (NCI Thesaurus ValueDomain)
    LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedUpperLimitofNormalValue
    Item
    SGOT (AST) ULN
    float
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C25202 (NCI Thesaurus Property)
    C0242192 (UMLS 2011AA Property)
    C20200 (NCI Thesaurus Property-2)
    C1274040 (UMLS 2011AA Property-2)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C25706 (NCI Thesaurus ValueDomain-2)
    C1519815 (UMLS 2011AA ValueDomain-2)
    LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultDate
    Item
    Date of Collection (Month Day Year)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25202 (NCI Thesaurus Property)
    C0242192 (UMLS 2011AA Property)
    C20200 (NCI Thesaurus Property-2)
    C1274040 (UMLS 2011AA Property-2)
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    LaboratoryProcedureAlkalinePhosphataseAssessmentInd-2
    Item
    Alkaline Phosphatase
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C25367 (NCI Thesaurus Property)
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C16276 (NCI Thesaurus Property-2)
    C0002059 (UMLS 2011AA Property)
    Alkaline Phosphatase
    Item
    Alkaline Phosphatase (Patient Value units/L)
    float
    C20200 (NCI Thesaurus Property)
    C0201850 (UMLS CUI-1)
    C25294 (NCI Thesaurus ObjectClass)
    C25712 (NCI Thesaurus ValueDomain)
    C16276 (NCI Thesaurus Property-2)
    Alkaline Phosphatase ULN
    Item
    Alkaline Phosphatase ULN
    float
    C25294 (NCI Thesaurus ObjectClass)
    C0151420 (UMLS CUI-1)
    C20200 (NCI Thesaurus Property)
    C16276 (NCI Thesaurus Property-2)
    C25712 (NCI Thesaurus ValueDomain)
    C25706 (NCI Thesaurus ValueDomain-2)
    LaboratoryProcedureAlkalinePhosphataseResultDate
    Item
    Date of Collection (Month Day Year)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C16276 (NCI Thesaurus Property-2)
    C0002059 (UMLS 2011AA Property-2)
    LaboratoryProcedureBilirubinAssessmentInd-2
    Item
    Total Bilirubin
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C25367 (NCI Thesaurus Property)
    C305 (NCI Thesaurus Property-2)
    C0005437 (UMLS 2011AA Property)
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    LaboratoryProcedureTotalBilirubinResultSpecifiedValue
    Item
    Total Bilirubin (Patient Value mg/dL)
    float
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C38037 (NCI Thesaurus Property-2)
    C0201913 (UMLS 2011AA Property-2)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C38024 (NCI Thesaurus ValueDomain-2)
    C0205369 (UMLS 2011AA ValueDomain-2)
    Bilirubin, Total ULN
    Item
    Total bilirubin ULN
    float
    C25294 (NCI Thesaurus ObjectClass)
    C0201913 (UMLS CUI-1)
    C20200 (NCI Thesaurus Property)
    C1519815 (UMLS CUI-2)
    C38037 (NCI Thesaurus Property-2)
    C25712 (NCI Thesaurus ValueDomain)
    C38024 (NCI Thesaurus ValueDomain-2)
    C25706 (NCI Thesaurus ValueDomain-3)
    LaboratoryProcedureBilirubinOutcomeDate
    Item
    Date of Collection (Month Day Year)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    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)
    LaboratoryProcedureCreatinineAssessmentInd-2
    Item
    Serum Creatinine
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C25367 (NCI Thesaurus Property)
    C399 (NCI Thesaurus Property-2)
    C0010294 (UMLS 2011AA Property)
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    Creatinine, Serum
    Item
    Serum creatinine (Patient Value mg/dL)
    float
    C20200 (NCI Thesaurus Property)
    C0201976 (UMLS CUI-1)
    C399 (NCI Thesaurus Property-2)
    C25294 (NCI Thesaurus ObjectClass)
    C25712 (NCI Thesaurus ValueDomain)
    Creatinine, serum ULN
    Item
    Serum Creatinine ULN
    float
    C25294 (NCI Thesaurus ObjectClass)
    C0201976 (UMLS CUI-1)
    C20200 (NCI Thesaurus Property)
    C1519815 (UMLS CUI-2)
    C399 (NCI Thesaurus Property-2)
    C25712 (NCI Thesaurus ValueDomain)
    C25706 (NCI Thesaurus ValueDomain-2)
    LaboratoryProcedureCreatinineClearanceOutcomeDate
    Item
    Date of Collection (Month Day Year )
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C25747 (NCI Thesaurus Property-2)
    C0373595 (UMLS 2011AA Property-2)
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    Item Group
    Section 3 (continued)
    LaboratoryProcedureAbsoluteNeutrophilCountAssessmentInd-2
    Item
    ANC
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C25367 (NCI Thesaurus Property)
    C63321 (NCI Thesaurus Property-2)
    C0948762 (UMLS 2011AA Property)
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    ANC
    Item
    ANC (Patient Value thousand/mm^3)
    float
    C25294 (NCI Thesaurus ObjectClass)
    C0948762 (UMLS CUI-1)
    C20200 (NCI Thesaurus Property)
    C63321 (NCI Thesaurus Property-2)
    C38046 (NCI Thesaurus ValueDomain)
    C25712 (NCI Thesaurus ValueDomain-2)
    LaboratoryProcedureAbsoluteNeutrophilCountResultDate
    Item
    Date of Collection (Month Day Year )
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C63321 (NCI Thesaurus Property-2)
    C0948762 (UMLS 2011AA Property-2)
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    LaboratoryProcedurePlateletAssessmentInd-2
    Item
    Platelet Count
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C25367 (NCI Thesaurus Property)
    C12520 (NCI Thesaurus Property-2)
    C0005821 (UMLS 2011AA Property)
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    Platelets
    Item
    Platelet count (Patient Value thousand/mm^3)
    float
    C20200 (NCI Thesaurus Property)
    C0005821 (UMLS CUI-1)
    C12520 (NCI Thesaurus Property-2)
    C25294 (NCI Thesaurus ObjectClass)
    C25712 (NCI Thesaurus ValueDomain)
    Platelets date
    Item
    Date of Collection (Month Day Year )
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0005821 (UMLS CUI-1)
    C20200 (NCI Thesaurus Property)
    C0011008 (UMLS CUI-2)
    C12520 (NCI Thesaurus Property-2)
    C25294 (NCI Thesaurus ObjectClass)
    LaboratoryProcedureHemoglobinAssessmentInd-2
    Item
    Hemoglobin
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C25367 (NCI Thesaurus Property)
    C16676 (NCI Thesaurus Property-2)
    C0019046 (UMLS 2011AA Property)
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    Hemoglobin
    Item
    Hemoglobin (Patient Value g/dL)
    float
    C16676 (NCI Thesaurus Property)
    C0019046 (UMLS CUI-1)
    C20200 (NCI Thesaurus Property-2)
    C25294 (NCI Thesaurus ObjectClass)
    C25712 (NCI Thesaurus ValueDomain)
    Hemoglobin Date
    Item
    Date of Collection (Month Day Year )
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0019046 (UMLS CUI-1)
    C16676 (NCI Thesaurus Property)
    C0011008 (UMLS CUI-2)
    C20200 (NCI Thesaurus Property-2)
    C25294 (NCI Thesaurus ObjectClass)
    LaboratoryProcedureCarcinoembryonicAntigenAssessmentInd-2
    Item
    CEA
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C25367 (NCI Thesaurus Property)
    C25159 (NCI Thesaurus Property-2)
    C0007082 (UMLS 2011AA Property)
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    LaboratoryProcedureCarcinoembryonicAntigenOutcomeValue
    Item
    CEA (Patient Value ng/mL)
    text
    C25159 (NCI Thesaurus Property)
    C0007082 (UMLS 2011AA Property)
    C20200 (NCI Thesaurus Property-2)
    C1274040 (UMLS 2011AA Property-2)
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    LaboratoryProcedureCarcinoembryonicAntigenOutcomeDate
    Item
    Date of Collection (Month Day Year )
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25159 (NCI Thesaurus Property)
    C0007082 (UMLS 2011AA Property)
    C20200 (NCI Thesaurus Property-2)
    C1274040 (UMLS 2011AA Property-2)
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    LaboratoryProcedureCreatinineClearanceAssessmentInd-2
    Item
    Calculated Creatinine Clearance
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C25367 (NCI Thesaurus Property)
    C25747 (NCI Thesaurus Property-2)
    C0373595 (UMLS 2011AA Property)
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    LaboratoryProcedureCreatinineClearanceOutcomeEstimateValue
    Item
    Calculated creatinine clearance (Patient Value mL/min)
    float
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C25747 (NCI Thesaurus Property-2)
    C0373595 (UMLS 2011AA Property-2)
    C25498 (NCI Thesaurus ValueDomain)
    C0750572 (UMLS 2011AA ValueDomain)
    C25712 (NCI Thesaurus ValueDomain-2)
    C1522609 (UMLS 2011AA ValueDomain-2)
    LaboratoryProcedureCreatinineClearanceOutcomeDate
    Item
    Date of Collection (Month Day Year )
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C25747 (NCI Thesaurus Property-2)
    C0373595 (UMLS 2011AA Property-2)
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    DiabetesMellitusPersonalMedicalHistoryInd-2
    Item
    Does the patient have a history of diabetes mellitus?
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C2985 (NCI Thesaurus ObjectClass)
    C0011849 (UMLS 2011AA ObjectClass)
    C18772 (NCI Thesaurus Property)
    C0262926 (UMLS 2011AA Property)
    AnalSmallBowelAppendixCarcinomaDiagnosisInd-2
    Item
    Does the patient have a diagnosis of anal, small bowel or appendiceal carcinoma?
    boolean
    C12386 (NCI Thesaurus ObjectClass)
    C0021852 (UMLS 2011AA ObjectClass)
    C2916 (NCI Thesaurus ObjectClass-2)
    C0007097 (UMLS 2011AA ObjectClass-2)
    C12380 (NCI Thesaurus ObjectClass-3)
    C0003617 (UMLS 2011AA ObjectClass-3)
    C28048 (NCI Thesaurus ObjectClass-4)
    C15220 (NCI Thesaurus Property)
    C0011900 (UMLS 2011AA Property)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    PatientColorectalMalignantNeoplasmEligibilityDeterminationInd-2
    Item
    Has the patient been diagnosed with colorectal malignant diseases other than adenocarcinoma, e.g., sarcoma, lymphoma, carcinoid?
    boolean
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C13363 (NCI Thesaurus Property)
    C0555952 (UMLS 2011AA Property)
    C9305 (NCI Thesaurus Property-2)
    C0006826 (UMLS 2011AA Property-2)
    C25171 (NCI Thesaurus Property-3)
    C0013893 (UMLS 2011AA Property-3)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    ColorectalNeoplasmPatientObstructionRadiationTherapyEligibilityDeterminationInd-2
    Item
    Does the patient have an unresected primary tumor in the colon or rectum with significant symptoms related to obstruction or that will require radiation therapy?
    boolean
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C3262 (NCI Thesaurus ObjectClass-2)
    C0027651 (UMLS 2011AA ObjectClass-2)
    C13363 (NCI Thesaurus ObjectClass-3)
    C0555952 (UMLS 2011AA ObjectClass-3)
    C15313 (NCI Thesaurus Property)
    C1522449 (UMLS 2011AA Property)
    C3284 (NCI Thesaurus Property-2)
    C0028778 (UMLS 2011AA Property-2)
    C25171 (NCI Thesaurus Property-3)
    C0013893 (UMLS 2011AA Property-3)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    ExtrahepaticMetastasisPersonalMedicalHistoryInd-2
    Item
    Does the patient have a history of or current evidence of extrahepatic metastases? (Exclude regional nodes that are suspicious on imaging and associated with the primary colorectal cancer if the nodes will be resected with the primary tumor after randomization.)
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C19151 (NCI Thesaurus ObjectClass)
    C0027627 (UMLS 2011AA ObjectClass)
    C28358 (NCI Thesaurus ObjectClass-2)
    C1517058 (UMLS 2011AA ObjectClass-2)
    C18772 (NCI Thesaurus Property)
    C0262926 (UMLS 2011AA Property)
    PatientLymphNodeMetastasisEligibilityDeterminationInd-2
    Item
    Does the patient's disease demonstrate radiographic evidence of metastases to portal lymph nodes (node > 1 cm in diameter) not proven by biopsy to be negative?
    boolean
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C12745 (NCI Thesaurus Property)
    C0024204 (UMLS 2011AA Property)
    C19151 (NCI Thesaurus Property-2)
    C0027627 (UMLS 2011AA Property-2)
    C25171 (NCI Thesaurus Property-3)
    C0013893 (UMLS 2011AA Property-3)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    PatientPriorHepaticTreatmentEligibilityDeterminationInd-2
    Item
    Has the patient received previous hepatic-directed therapy including hepatic resection and/or ablation, hepatic arterial infusion therapy, or hepatic radiation therapy (exluding incisional or excisional biopsy)?
    boolean
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C13308 (NCI Thesaurus Property)
    C0205054 (UMLS 2011AA Property)
    C25629 (NCI Thesaurus Property-2)
    C0332152 (UMLS 2011AA Property-2)
    C15368 (NCI Thesaurus Property-3)
    C25171 (NCI Thesaurus Property-4)
    C0013893 (UMLS 2011AA Property-3)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    PatientChemotherapyMetastasisColorectalCarcinomaPersonalMedicalHistoryInd-2
    Item
    Has the patient received previous chemotherapy or any other systemic therapy for metastatic colorectal cancer?
    boolean
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C15632 (NCI Thesaurus Property)
    C0392920 (UMLS 2011AA Property)
    C19151 (NCI Thesaurus Property-2)
    C0027627 (UMLS 2011AA Property-2)
    C2955 (NCI Thesaurus Property-3)
    C0009402 (UMLS 2011AA Property-3)
    C18772 (NCI Thesaurus Property-4)
    C0262926 (UMLS 2011AA Property-4)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    SurgicalProcedurePortalVeinExcisionPerformedInd-2
    Item
    Has the patient had a portal vein embolization (PVE) or other hepatic preconditioning techniques already performed or are preconditioning techniques such as PVE planned for this patient?
    boolean
    C15329 (NCI Thesaurus ObjectClass)
    C0543467 (UMLS 2011AA ObjectClass)
    C38000 (NCI Thesaurus Property)
    C0884358 (UMLS 2011AA Property)
    C15232 (NCI Thesaurus Property-2)
    C0728940 (UMLS 2011AA Property-2)
    C33343 (NCI Thesaurus Property-3)
    C0032718 (UMLS 2011AA Property-3)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    HepaticLesionAblationTherapyIntentInd-2
    Item
    Is there intent to use ablation to treat any hepatic lesion for this patient?
    boolean
    C3824 (NCI Thesaurus ObjectClass)
    C0221198 (UMLS 2011AA ObjectClass)
    C13308 (NCI Thesaurus ObjectClass-2)
    C0205054 (UMLS 2011AA ObjectClass-2)
    C20985 (NCI Thesaurus ObjectClass-3)
    C0547070 (UMLS 2011AA ObjectClass-3)
    C25725 (NCI Thesaurus Property)
    C1283828 (UMLS 2011AA Property)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    PatientPriorChronicHepaticDiseaseorDisorderEligibilityDeterminationInd-2
    Item
    Does the patient have pre-existing chronic hepatic disease (e.g., chronic active hepatitis, cirrhosis) that, in the opinion of the investigator and hepatic surgeon, would limit the patient's ability to undergo hepatic metastasectomy?
    boolean
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C13308 (NCI Thesaurus Property)
    C0205054 (UMLS 2011AA Property)
    C25629 (NCI Thesaurus Property-2)
    C0332152 (UMLS 2011AA Property-2)
    C2991 (NCI Thesaurus Property-3)
    C0012634 (UMLS 2011AA Property-3)
    C25171 (NCI Thesaurus Property-4)
    C0013893 (UMLS 2011AA Property-4)
    C14141 (NCI Thesaurus Property-5)
    C0205191 (UMLS 2011AA Property-5)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    AdverseEventMetastasisAssociatedInd-2
    Item
    Does the patient have grade 3 or 4 anorexia, grade 3 nausea, or >= grade 2 vomiting (per CTCAE v4.0) related to metastatic disease?
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C19151 (NCI Thesaurus Property)
    C0027627 (UMLS 2011AA Property)
    C25281 (NCI Thesaurus Property-2)
    C0332281 (UMLS 2011AA Property-2)
    AdverseEventNeuropathyAssociatedInd-2
    Item
    Does the patient have paresthesias, peripheral sensory neuropathy, or peripheral motor neuropathy >= grade 2 per CTCAE v4.0 (Exclude grade 2 neuropathy in patients who will receive FOLFIRI in this study)?
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C4731 (NCI Thesaurus Property)
    C0031117 (UMLS 2011AA Property)
    C25281 (NCI Thesaurus Property-2)
    C0332281 (UMLS 2011AA Property-2)
    CongestiveHeartFailureHistoryInd-2
    Item
    Does the patient have a documented history of congestive heart failure requiring chronic medical therapy?
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C3080 (NCI Thesaurus ObjectClass)
    C0018802 (UMLS 2011AA ObjectClass)
    C18772 (NCI Thesaurus Property)
    C0262926 (UMLS 2011AA Property)
    PatientWarfarinTreatmentInd-2
    Item
    Does the patient require therapeutic doses of coumadin or equivalent?
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C15368 (NCI Thesaurus Property)
    C0043031 (NCI Metathesaurus Property)
    PatientInflammatoryBowelDiseasePersonalMedicalHistoryInd-2
    Item
    Does the patient have active inflammatory bowel disease?
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C3138 (NCI Thesaurus Property)
    C0021390 (UMLS 2011AA Property)
    C18772 (NCI Thesaurus Property-2)
    C0262926 (UMLS 2011AA Property-2)
    PatientInfectionInd-2
    Item
    Does the patient have an active infection or chronic infection requiring chronic suppressive antibiotics?
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C26726 (NCI Thesaurus Property)
    C0009450 (UMLS 2011AA Property)
    PatientHemorrhagePre-ExistingConditionEligibilityInd-2
    Item
    Does the patient have any known bleeding diathesis or coagulopathy?
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C26791 (NCI Thesaurus Property)
    C0019080 (UMLS 2011AA Property)
    CL232826 (NCI Metathesaurus Property)
    PatientInterstitialDiseaseLungPersonalMedicalHistoryInd-3
    Item
    Does the patient have symptomatic interstitial pneumonitis or is the patient asymptomatic with definitive evidence of interstitial pneumonitis described on CT scan, MRI, or chest x-ray?
    boolean
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C12468 (NCI Thesaurus Property)
    C0024109 (UMLS 2011AA Property)
    C18772 (NCI Thesaurus Property-2)
    C0262926 (UMLS 2011AA Property-2)
    C62410 (NCI Thesaurus Property-3)
    C1881236 (UMLS 2011AA Property-3)
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    PatientNeoplasmPersonalMedicalHistoryInd-2
    Item
    Has the patient had other malignancies (other than carcinoma in situ of the cervix, colorectal carcinoma in situ, melanoma in situ, or basal cell or squamous cell carcinoma of the skin that has been treated)?
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C3262 (NCI Thesaurus Property)
    C0027651 (UMLS 2011AA Property)
    C18772 (NCI Thesaurus Property-2)
    C0262926 (UMLS 2011AA Property-2)
    DiseaseStatusIndicator
    Item
    Is patient considered to be disease-free?
    boolean
    C25180 (NCI Thesaurus ValueDomain)
    C1522602 (UMLS 2011AA ValueDomain)
    C2991 (NCI Thesaurus ObjectClass)
    C0012634 (UMLS 2011AA ObjectClass)
    C0449438 (NCI Metathesaurus Property)
    PriorTherapyCompleteRegimenInd-3
    Item
    Did the patient complete therapy for the malignancies >= 1 year ago?
    boolean
    C25629 (NCI Thesaurus ObjectClass)
    C0332152 (UMLS 2011AA ObjectClass)
    C15368 (NCI Thesaurus ObjectClass-2)
    C25250 (NCI Thesaurus Property)
    C0205197 (UMLS 2011AA Property)
    C15697 (NCI Thesaurus Property-2)
    C0040808 (UMLS 2011AA Property-2)
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    PatientElevatedBilirubinPersonalMedicalHistoryInd-2
    Item
    Is the patient known to have Gilbert's Syndrome?
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C27088 (NCI Thesaurus Property)
    C0311468 (UMLS 2011AA Property)
    C18772 (NCI Thesaurus Property-2)
    C0262926 (UMLS 2011AA Property-2)
    HomozygousUGT1A1*28AlleleGenePresentInd-2
    Item
    Is the patient known to be homozygous for the UGT1A1 28 allele?
    boolean
    C45826 (NCI Thesaurus ObjectClass)
    C0019904 (UMLS 2011AA ObjectClass)
    C16612 (NCI Thesaurus ObjectClass-2)
    C0017337 (UMLS 2011AA ObjectClass-2)
    C72564 (NCI Thesaurus ObjectClass-3)
    C2825127 (UMLS 2011AA ObjectClass-3)
    C25626 (NCI Thesaurus Property)
    C0150312 (UMLS 2011AA Property)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    PatientClinicalStudyAgentHypersensitivityPersonalMedicalHistoryInd-2
    Item
    Has the patient experienced a previous serious hypersensitivity reaction to any of the agents the patient will receive as part of the C-11 trial?
    boolean
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C3114 (NCI Thesaurus Property)
    C0020517 (UMLS 2011AA Property)
    C1708 (NCI Thesaurus Property-2)
    C0450442 (UMLS 2011AA Property-2)
    C15206 (NCI Thesaurus Property-3)
    C0008972 (UMLS 2011AA Property-3)
    C18772 (NCI Thesaurus Property-4)
    C0262926 (UMLS 2011AA Property-4)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    ConcomitantDiseasePersonalMedicalHistoryInd-2
    Item
    Does the patient have any other serious concomitant medical condition that, in the opinion of the investigator, would compromise the safety of the patient, compromise the patient's ability to participate in the study, or cause a delay in the initiation of therapy (surgery or chemotherapy) longer than 4 weeks following randomization?
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C2991 (NCI Thesaurus ObjectClass)
    C0012634 (UMLS 2011AA ObjectClass)
    C25730 (NCI Thesaurus ObjectClass-2)
    C0521115 (UMLS 2011AA ObjectClass-2)
    C18772 (NCI Thesaurus Property)
    C0262926 (UMLS 2011AA Property)
    PatientStudyRequirementInd-2
    Item
    Does the patient have psychiatric or addictive disorders or other condition that, in the opinion of the investigator, would preclude the patient from meeting the study requirements?
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C38015 (NCI Thesaurus Property)
    PriorInvestigationalTherapiesAdministeredInd-2
    Item
    Has the patient taken any investigational product within the past 30 days?
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C25629 (NCI Thesaurus ObjectClass)
    C0332152 (UMLS 2011AA ObjectClass)
    C0949266 (NCI Metathesaurus ObjectClass)
    C25382 (NCI Thesaurus Property)
    C1521801 (UMLS 2011AA Property)
    FemalePatientPotentialPregnancyInd-2
    Item
    Is the patient a woman of child-bearing potential? (The following questions are to be completed for female patients only.)
    boolean
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C16576 (NCI Thesaurus ObjectClass-2)
    C0086287 (UMLS 2011AA ObjectClass-2)
    C25742 (NCI Thesaurus Property)
    C0032961 (UMLS 2011AA Property)
    C0237399 (NCI Metathesaurus Property)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    PatientPregnancyTestIndicator
    Item
    Was a pregnancy test performed?
    boolean
    C25180 (NCI Thesaurus ValueDomain)
    C1522602 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C0032976 (NCI Metathesaurus Property)
    PatientMostRecentPregnancyTestDate
    Item
    Date of pregnancy test
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C0032976 (NCI Metathesaurus Property)
    C25577 (NCI Thesaurus Property)
    C1513491 (UMLS 2011AA Property)
    PatientPregnancyInd-2
    Item
    Is the patient pregnant or lactating at time of study entry?
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25742 (NCI Thesaurus Property)
    C0032961 (UMLS 2011AA Property)
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