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6400

Beschrijving

NSABP Protocol B-40 - Tumor Response Form A Randomized Phase III Trial of Neoadjuvant Therapy in Patients With Palpable and Operable Breast Cancer Evaluating the Effect on Pathologic Complete Response (pCR) of Adding Capecitabine or Gemcitabine to Docetaxel When Administered Before AC With or Without Bevacizumab and Correlative Science Studies Attempting to Identify Predictors of High Likelihood for pCR With Each of the Regimens Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=1B7DC2CF-E4EE-1B7D-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=1B7DC2CF-E4EE-1B7D-E044-0003BA3F9857

Trefwoorden

Versies (3)
  1. 18-12-14 18-12-14 - Martin Dugas
  2. 09-01-15 09-01-15 - Martin Dugas
  3. 05-07-15 05-07-15 -
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18 december 2014

DOI

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Licentie

Creative Commons BY-NC 3.0 Legacy
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    Breast Cancer NCT00408408 Response - NSABP Protocol B-40 - Tumor Response Form - 2512024v1.0

    Engels

    No Instruction available.

    1 Formulieren  
    1. StudyEvent: NSABP Protocol B-40 - Tumor Response Form
      1. No Instruction available.
    Unnamed1
    Beschrijving

    Unnamed1

    Patient Initials (Last First Middle)
    Beschrijving

    PatientInitialsName

    Datatype

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25536
    UMLS 2011AA Property
    C1555582
    NSABP Patient ID
    Beschrijving

    PatientNationalSurgicalAdjuvantBreastProjectIdentifierNumber

    Datatype

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus Property
    C15818
    UMLS 2011AA Property
    C1513905
    Unnamed2
    Beschrijving

    Unnamed2

    Institution/Affiliate
    Beschrijving

    CombinedInstitutionName

    Datatype

    text

    Person Completing Form, Last Name
    Beschrijving

    ResponsiblePersonLastName

    Datatype

    text

    Person Completing Form, First Name
    Beschrijving

    ResponsiblePersonFirstName

    Datatype

    text

    Person Completing Form, Phone
    Beschrijving

    ResponsiblePersonPhoneNumber

    Datatype

    text

    Are data amended
    Beschrijving

    DataAmendedInd-3

    Datatype

    text

    Unnamed3
    Beschrijving

    Unnamed3

    Reason Form Submitted
    Beschrijving

    SubmittedFormDescriptionReason

    Datatype

    text

    Alias
    NCI Thesaurus ValueDomain
    C25638
    UMLS 2011AA ValueDomain
    C0392360
    NCI Thesaurus ObjectClass
    C19464
    UMLS 2011AA ObjectClass
    C0376315
    NCI Thesaurus ObjectClass
    C25695
    UMLS 2011AA ObjectClass
    C1515023
    NCI Thesaurus Property
    C25365
    UMLS 2011AA Property
    C0678257
    Target Lesions
    Beschrijving

    Target Lesions

    Were the target lesions measured on this evaluation
    Beschrijving

    TargetLesionDimensionInd-2

    Datatype

    text

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus ObjectClass
    C3824
    UMLS 2011AA ObjectClass
    C0221198
    NCI Thesaurus ObjectClass
    C25702
    UMLS 2011AA ObjectClass
    C1521840
    NCI Thesaurus Property
    C25483
    UMLS 2011AA Property
    C0439534
    Date of Evaluation
    Beschrijving

    LesionAssessmentDate

    Datatype

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C3824
    UMLS 2011AA ObjectClass
    C0221198
    NCI Thesaurus Property
    C20989
    UMLS 2011AA Property
    C0031809
    NCI Thesaurus ValueDomain
    C25367
    Response status of Target lesion (s)
    Beschrijving

    TargetLesionResponseStatus

    Datatype

    text

    Alias
    NCI Thesaurus ObjectClass
    C3824
    UMLS 2011AA ObjectClass
    C0221198
    NCI Thesaurus Property
    C25755
    UMLS 2011AA Property
    C0871261
    NCI Thesaurus ObjectClass
    C25702
    UMLS 2011AA ObjectClass
    C1521840
    NCI Thesaurus ValueDomain
    C25688
    UMLS 2011AA ValueDomain
    C0449438
    Lesion Number
    Beschrijving

    LesionSiteNumber

    Datatype

    double

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus ObjectClass
    C3824
    UMLS 2011AA ObjectClass
    C0221198
    NCI Thesaurus Property
    C25341
    UMLS 2011AA Property
    C0450429
    Target Lesion Site
    Beschrijving

    LesionTargetLocationType

    Datatype

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C3824
    UMLS 2011AA ObjectClass
    C0221198
    NCI Thesaurus Property
    C25341
    UMLS 2011AA Property
    C0450429
    NCI Thesaurus Property
    C25702
    UMLS 2011AA Property
    C1521840
    Longest Diameter of Lesion (s)
    Beschrijving

    LesionLongestDiameterMeasurement

    Datatype

    double

    Maateenheden
    • cm
    Alias
    NCI Thesaurus ObjectClass
    C3824
    UMLS 2011AA ObjectClass
    C0221198
    NCI Thesaurus Property
    C25285
    UMLS 2011AA Property
    C1301886
    NCI Thesaurus Property
    C25558
    UMLS 2011AA Property
    C1522425
    NCI Thesaurus ValueDomain
    C25209
    UMLS 2011AA ValueDomain
    C0242485
    NCI Thesaurus ValueDomain
    C25285
    UMLS 2011AA ValueDomain
    C1301886
    cm
    Sum of longest diameters of all target lesions (cm)
    Beschrijving

    LongestLesionSumDiameterMeasurement

    Datatype

    double

    Alias
    NCI Thesaurus ObjectClass
    C25558
    UMLS 2011AA ObjectClass
    C1522425
    NCI Thesaurus ObjectClass
    C3824
    UMLS 2011AA ObjectClass
    C0221198
    NCI Thesaurus Property
    C25285
    UMLS 2011AA Property
    C1301886
    NCI Thesaurus Property
    C25697
    UMLS 2011AA Property
    C1515051
    NCI Thesaurus ValueDomain
    C25209
    UMLS 2011AA ValueDomain
    C0242485
    Smallest Sum of Longest Diameters of all Target Lesions
    Beschrijving

    LesionLowestSumLongestDiameterMeasurement

    Datatype

    double

    Maateenheden
    • cm
    Alias
    NCI Thesaurus ObjectClass
    C3824
    UMLS 2011AA ObjectClass
    C0221198
    NCI Thesaurus Property
    C25285
    UMLS 2011AA Property
    C1301886
    NCI Thesaurus Property
    C25558
    UMLS 2011AA Property
    C1522425
    NCI Thesaurus Property
    C25697
    UMLS 2011AA Property
    C1515051
    NCI Thesaurus Property
    C43517
    UMLS 2011AA Property
    C1708760
    NCI Thesaurus ValueDomain
    C25209
    UMLS 2011AA ValueDomain
    C0242485
    NCI Thesaurus ValueDomain
    C25285
    UMLS 2011AA ValueDomain
    C1301886
    cm
    Date Smallest Sum Observed
    Beschrijving

    LesionLowestSumLongestDiameterDate

    Datatype

    date

    Alias
    NCI Thesaurus ObjectClass
    C3824
    UMLS 2011AA ObjectClass
    C0221198
    NCI Thesaurus Property
    C25285
    UMLS 2011AA Property
    C1301886
    NCI Thesaurus Property
    C25558
    UMLS 2011AA Property
    C1522425
    NCI Thesaurus Property
    C25697
    UMLS 2011AA Property
    C1515051
    NCI Thesaurus Property
    C43517
    UMLS 2011AA Property
    C1708760
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    Nontarget Lesions
    Beschrijving

    Nontarget Lesions

    Were nontarget lesions identified on the baseline evaluation
    Beschrijving

    NontargetLesionBaselinePresentInd-2

    Datatype

    text

    Alias
    NCI Thesaurus ObjectClass
    C3824
    UMLS 2011AA ObjectClass
    C0221198
    NCI Thesaurus ObjectClass
    C25592
    UMLS 2011AA ObjectClass
    C1518389
    NCI Thesaurus Property
    C25626
    UMLS 2011AA Property
    C0150312
    NCI Thesaurus Property
    C25213
    UMLS 2011AA Property
    C1442488
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Were the nontarget lesions assessed on this evaluation
    Beschrijving

    NontargetLesionFollow-upAssessmentInd-2

    Datatype

    text

    Alias
    NCI Thesaurus ObjectClass
    C3824
    UMLS 2011AA ObjectClass
    C0221198
    NCI Thesaurus ObjectClass
    C25592
    UMLS 2011AA ObjectClass
    C1518389
    NCI Thesaurus Property
    C25367
    NCI Thesaurus Property
    C16033
    UMLS 2011AA Property
    C1522577
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Date of Evaluation
    Beschrijving

    LesionAssessmentDate

    Datatype

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C3824
    UMLS 2011AA ObjectClass
    C0221198
    NCI Thesaurus Property
    C20989
    UMLS 2011AA Property
    C0031809
    NCI Thesaurus ValueDomain
    C25367
    Response Status of NONTARGET Lesions
    Beschrijving

    Non-TargetLesionResponseStatus

    Datatype

    text

    Alias
    NCI Thesaurus ObjectClass
    C3824
    UMLS 2011AA ObjectClass
    C0221198
    NCI Thesaurus ObjectClass
    C25592
    UMLS 2011AA ObjectClass
    C1518389
    NCI Thesaurus Property
    C25755
    UMLS 2011AA Property
    C0871261
    NCI Thesaurus ValueDomain
    C25688
    UMLS 2011AA ValueDomain
    C0449438
    New Lesions
    Beschrijving

    New Lesions

    Was the appearance of any new lesions documented
    Beschrijving

    NewLesionAppearanceInd-2

    Datatype

    text

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus ObjectClass
    C3824
    UMLS 2011AA ObjectClass
    C0221198
    NCI Thesaurus ObjectClass
    C25586
    UMLS 2011AA ObjectClass
    C0205314
    NCI Thesaurus Property
    C25377
    UMLS 2011AA Property
    C0700364
    New Lesion Site
    Beschrijving

    LesionNewLocationType

    Datatype

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C3824
    UMLS 2011AA ObjectClass
    C0221198
    NCI Thesaurus Property
    C25586
    UMLS 2011AA Property
    C0205314
    NCI Thesaurus Property
    C25341
    UMLS 2011AA Property
    C0450429
    Specify
    Beschrijving

    LesionNewLocationSpecify

    Datatype

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS 2011AA ValueDomain
    C1521902
    NCI Thesaurus ObjectClass
    C3824
    UMLS 2011AA ObjectClass
    C0221198
    NCI Thesaurus Property
    C25586
    UMLS 2011AA Property
    C0205314
    NCI Thesaurus Property
    C25341
    UMLS 2011AA Property
    C0450429
    Date of Evaluation
    Beschrijving

    LesionAssessmentDate

    Datatype

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C3824
    UMLS 2011AA ObjectClass
    C0221198
    NCI Thesaurus Property
    C20989
    UMLS 2011AA Property
    C0031809
    NCI Thesaurus ValueDomain
    C25367
    Was there any other manifestation of disease progression (other than progression of target lesions, progression of nontarget lesions, or the appearance of a new lesion)
    Beschrijving

    DiseaseOtherIndicationProgressionInd-2

    Datatype

    text

    Alias
    NCI Thesaurus ObjectClass
    C2991
    UMLS 2011AA ObjectClass
    C0012634
    NCI Thesaurus Property
    C17649
    UMLS 2011AA Property
    C0205394
    NCI Thesaurus Property
    C25331
    NCI Thesaurus Property
    C41184
    UMLS 2011AA Property
    C0392360
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Specify (If yes)
    Beschrijving

    DiseaseOtherIndicationProgressionSpecify

    Datatype

    text

    Alias
    NCI Thesaurus ObjectClass
    C2991
    UMLS 2011AA ObjectClass
    C0012634
    NCI Thesaurus Property
    C17649
    UMLS 2011AA Property
    C0205394
    NCI Thesaurus Property
    C25331
    NCI Thesaurus Property
    C41184
    UMLS 2011AA Property
    C0392360
    NCI Thesaurus ValueDomain
    C25685
    UMLS 2011AA ValueDomain
    C1521902
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    1 Formulieren
    1. StudyEvent: NSABP Protocol B-40 - Tumor Response Form
      1. No Instruction available.
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    Unnamed1
    PatientInitialsName
    Item
    Patient Initials (Last First Middle)
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25536 (NCI Thesaurus Property)
    C1555582 (UMLS 2011AA Property)
    PatientNationalSurgicalAdjuvantBreastProjectIdentifierNumber
    Item
    NSABP Patient ID
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C15818 (NCI Thesaurus Property)
    C1513905 (UMLS 2011AA Property)
    Item Group
    Unnamed2
    CombinedInstitutionName
    Item
    Institution/Affiliate
    text
    ResponsiblePersonLastName
    Item
    Person Completing Form, Last Name
    text
    ResponsiblePersonFirstName
    Item
    Person Completing Form, First Name
    text
    ResponsiblePersonPhoneNumber
    Item
    Person Completing Form, Phone
    text
    Item
    Are data amended
    text
    CL.1
    Code List
    Are data amended
    CL Item
    No (no)
    CL Item
    Yes (yes)
    Item Group
    Unnamed3
    Item
    Reason Form Submitted
    text
    C25638 (NCI Thesaurus ValueDomain)
    C0392360 (UMLS 2011AA ValueDomain)
    C19464 (NCI Thesaurus ObjectClass)
    C0376315 (UMLS 2011AA ObjectClass)
    C25695 (NCI Thesaurus ObjectClass)
    C1515023 (UMLS 2011AA ObjectClass)
    C25365 (NCI Thesaurus Property)
    C0678257 (UMLS 2011AA Property)
    CL.2
    Code List
    Reason Form Submitted
    CL Item
    Required Assessment At The End Of The Docetaxel Regimen (Required assessment at the end of the docetaxel regimen)
    CL Item
    Required Assessment At The End Of The Ac Cycles (Required assessment at the end of the AC cycles)
    CL Item
    Discretionary Assessment Which Identified Protocol-defined Progressive Disease (Discretionary assessment which identified protocol-defined Progressive Disease)
    Item
    Were the target lesions measured on this evaluation
    text
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C3824 (NCI Thesaurus ObjectClass)
    C0221198 (UMLS 2011AA ObjectClass)
    C25702 (NCI Thesaurus ObjectClass)
    C1521840 (UMLS 2011AA ObjectClass)
    C25483 (NCI Thesaurus Property)
    C0439534 (UMLS 2011AA Property)
    CL.3
    Code List
    Were the target lesions measured on this evaluation
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    LesionAssessmentDate
    Item
    Date of Evaluation
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C3824 (NCI Thesaurus ObjectClass)
    C0221198 (UMLS 2011AA ObjectClass)
    C20989 (NCI Thesaurus Property)
    C0031809 (UMLS 2011AA Property)
    C25367 (NCI Thesaurus ValueDomain)
    Item
    Response status of Target lesion (s)
    text
    C3824 (NCI Thesaurus ObjectClass)
    C0221198 (UMLS 2011AA ObjectClass)
    C25755 (NCI Thesaurus Property)
    C0871261 (UMLS 2011AA Property)
    C25702 (NCI Thesaurus ObjectClass)
    C1521840 (UMLS 2011AA ObjectClass)
    C25688 (NCI Thesaurus ValueDomain)
    C0449438 (UMLS 2011AA ValueDomain)
    CL.4
    Code List
    Response status of Target lesion (s)
    CL Item
    Complete Response (Complete Response)
    CL Item
    Partial Response (Partial Response)
    CL Item
    Incomplete Response Or Stable Disease (Incomplete Response or Stable Disease)
    LesionSiteNumber
    Item
    Lesion Number
    double
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C3824 (NCI Thesaurus ObjectClass)
    C0221198 (UMLS 2011AA ObjectClass)
    C25341 (NCI Thesaurus Property)
    C0450429 (UMLS 2011AA Property)
    Item
    Target Lesion Site
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C3824 (NCI Thesaurus ObjectClass)
    C0221198 (UMLS 2011AA ObjectClass)
    C25341 (NCI Thesaurus Property)
    C0450429 (UMLS 2011AA Property)
    C25702 (NCI Thesaurus Property)
    C1521840 (UMLS 2011AA Property)
    CL.5
    Code List
    Target Lesion Site
    CL Item
    Breast (Breast)
    C12971 (NCI Thesaurus)
    C0006141 (UMLS 2011AA)
    CL Item
    Axilla (Axilla)
    C12674 (NCI Thesaurus)
    C0004454 (UMLS 2011AA)
    LesionLongestDiameterMeasurement
    Item
    Longest Diameter of Lesion (s)
    double
    C3824 (NCI Thesaurus ObjectClass)
    C0221198 (UMLS 2011AA ObjectClass)
    C25285 (NCI Thesaurus Property)
    C1301886 (UMLS 2011AA Property)
    C25558 (NCI Thesaurus Property)
    C1522425 (UMLS 2011AA Property)
    C25209 (NCI Thesaurus ValueDomain)
    C0242485 (UMLS 2011AA ValueDomain)
    C25285 (NCI Thesaurus ValueDomain)
    C1301886 (UMLS 2011AA ValueDomain)
    LongestLesionSumDiameterMeasurement
    Item
    Sum of longest diameters of all target lesions (cm)
    double
    C25558 (NCI Thesaurus ObjectClass)
    C1522425 (UMLS 2011AA ObjectClass)
    C3824 (NCI Thesaurus ObjectClass)
    C0221198 (UMLS 2011AA ObjectClass)
    C25285 (NCI Thesaurus Property)
    C1301886 (UMLS 2011AA Property)
    C25697 (NCI Thesaurus Property)
    C1515051 (UMLS 2011AA Property)
    C25209 (NCI Thesaurus ValueDomain)
    C0242485 (UMLS 2011AA ValueDomain)
    LesionLowestSumLongestDiameterMeasurement
    Item
    Smallest Sum of Longest Diameters of all Target Lesions
    double
    C3824 (NCI Thesaurus ObjectClass)
    C0221198 (UMLS 2011AA ObjectClass)
    C25285 (NCI Thesaurus Property)
    C1301886 (UMLS 2011AA Property)
    C25558 (NCI Thesaurus Property)
    C1522425 (UMLS 2011AA Property)
    C25697 (NCI Thesaurus Property)
    C1515051 (UMLS 2011AA Property)
    C43517 (NCI Thesaurus Property)
    C1708760 (UMLS 2011AA Property)
    C25209 (NCI Thesaurus ValueDomain)
    C0242485 (UMLS 2011AA ValueDomain)
    C25285 (NCI Thesaurus ValueDomain)
    C1301886 (UMLS 2011AA ValueDomain)
    LesionLowestSumLongestDiameterDate
    Item
    Date Smallest Sum Observed
    date
    C3824 (NCI Thesaurus ObjectClass)
    C0221198 (UMLS 2011AA ObjectClass)
    C25285 (NCI Thesaurus Property)
    C1301886 (UMLS 2011AA Property)
    C25558 (NCI Thesaurus Property)
    C1522425 (UMLS 2011AA Property)
    C25697 (NCI Thesaurus Property)
    C1515051 (UMLS 2011AA Property)
    C43517 (NCI Thesaurus Property)
    C1708760 (UMLS 2011AA Property)
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    Item
    Were nontarget lesions identified on the baseline evaluation
    text
    C3824 (NCI Thesaurus ObjectClass)
    C0221198 (UMLS 2011AA ObjectClass)
    C25592 (NCI Thesaurus ObjectClass)
    C1518389 (UMLS 2011AA ObjectClass)
    C25626 (NCI Thesaurus Property)
    C0150312 (UMLS 2011AA Property)
    C25213 (NCI Thesaurus Property)
    C1442488 (UMLS 2011AA Property)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    CL.6
    Code List
    Were nontarget lesions identified on the baseline evaluation
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    Item
    Were the nontarget lesions assessed on this evaluation
    text
    C3824 (NCI Thesaurus ObjectClass)
    C0221198 (UMLS 2011AA ObjectClass)
    C25592 (NCI Thesaurus ObjectClass)
    C1518389 (UMLS 2011AA ObjectClass)
    C25367 (NCI Thesaurus Property)
    C16033 (NCI Thesaurus Property)
    C1522577 (UMLS 2011AA Property)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    CL.7
    Code List
    Were the nontarget lesions assessed on this evaluation
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    LesionAssessmentDate
    Item
    Date of Evaluation
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C3824 (NCI Thesaurus ObjectClass)
    C0221198 (UMLS 2011AA ObjectClass)
    C20989 (NCI Thesaurus Property)
    C0031809 (UMLS 2011AA Property)
    C25367 (NCI Thesaurus ValueDomain)
    Item
    Response Status of NONTARGET Lesions
    text
    C3824 (NCI Thesaurus ObjectClass)
    C0221198 (UMLS 2011AA ObjectClass)
    C25592 (NCI Thesaurus ObjectClass)
    C1518389 (UMLS 2011AA ObjectClass)
    C25755 (NCI Thesaurus Property)
    C0871261 (UMLS 2011AA Property)
    C25688 (NCI Thesaurus ValueDomain)
    C0449438 (UMLS 2011AA ValueDomain)
    CL.8
    Code List
    Response Status of NONTARGET Lesions
    CL Item
    Complete Response (Complete Response)
    CL Item
    Incomplete Response/sd (Incomplete Response/SD)
    CL Item
    Progressive Disease (Progressive Disease)
    C35571 (NCI Thesaurus)
    C1335499 (UMLS 2011AA)
    Item
    Was the appearance of any new lesions documented
    text
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C3824 (NCI Thesaurus ObjectClass)
    C0221198 (UMLS 2011AA ObjectClass)
    C25586 (NCI Thesaurus ObjectClass)
    C0205314 (UMLS 2011AA ObjectClass)
    C25377 (NCI Thesaurus Property)
    C0700364 (UMLS 2011AA Property)
    CL.9
    Code List
    Was the appearance of any new lesions documented
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    Item
    New Lesion Site
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C3824 (NCI Thesaurus ObjectClass)
    C0221198 (UMLS 2011AA ObjectClass)
    C25586 (NCI Thesaurus Property)
    C0205314 (UMLS 2011AA Property)
    C25341 (NCI Thesaurus Property)
    C0450429 (UMLS 2011AA Property)
    CL.10
    Code List
    New Lesion Site
    CL Item
    Breast (Breast)
    C12971 (NCI Thesaurus)
    C0006141 (UMLS 2011AA)
    CL Item
    Axilla (Axilla)
    C12674 (NCI Thesaurus)
    C0004454 (UMLS 2011AA)
    CL Item
    Other (Other)
    C17649 (NCI Thesaurus)
    C0205394 (UMLS 2011AA)
    C17649 (NCI Thesaurus)
    C0205394 (UMLS 2011AA)
    LesionNewLocationSpecify
    Item
    Specify
    text
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
    C3824 (NCI Thesaurus ObjectClass)
    C0221198 (UMLS 2011AA ObjectClass)
    C25586 (NCI Thesaurus Property)
    C0205314 (UMLS 2011AA Property)
    C25341 (NCI Thesaurus Property)
    C0450429 (UMLS 2011AA Property)
    LesionAssessmentDate
    Item
    Date of Evaluation
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C3824 (NCI Thesaurus ObjectClass)
    C0221198 (UMLS 2011AA ObjectClass)
    C20989 (NCI Thesaurus Property)
    C0031809 (UMLS 2011AA Property)
    C25367 (NCI Thesaurus ValueDomain)
    Item
    Was there any other manifestation of disease progression (other than progression of target lesions, progression of nontarget lesions, or the appearance of a new lesion)
    text
    C2991 (NCI Thesaurus ObjectClass)
    C0012634 (UMLS 2011AA ObjectClass)
    C17649 (NCI Thesaurus Property)
    C0205394 (UMLS 2011AA Property)
    C25331 (NCI Thesaurus Property)
    C41184 (NCI Thesaurus Property)
    C0392360 (UMLS 2011AA Property)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    CL.11
    Code List
    Was there any other manifestation of disease progression (other than progression of target lesions, progression of nontarget lesions, or the appearance of a new lesion)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    DiseaseOtherIndicationProgressionSpecify
    Item
    Specify (If yes)
    text
    C2991 (NCI Thesaurus ObjectClass)
    C0012634 (UMLS 2011AA ObjectClass)
    C17649 (NCI Thesaurus Property)
    C0205394 (UMLS 2011AA Property)
    C25331 (NCI Thesaurus Property)
    C41184 (NCI Thesaurus Property)
    C0392360 (UMLS 2011AA Property)
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
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