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ID

43502

Descrição

Z1041: Tumor Measurement Report (TMR) NCT00513292 Combination Chemotherapy and Paclitaxel Plus Trastuzumab in Treating Women With Palpable Breast Cancer That Can Be Removed by Surgery Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=214B3C72-1BE1-3F2B-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=214B3C72-1BE1-3F2B-E044-0003BA3F9857

Palavras-chave

Versões (4)
  1. 26/08/2012 26/08/2012 -
  2. 09/01/2015 09/01/2015 - Martin Dugas
  3. 21/06/2015 21/06/2015 -
  4. 20/09/2021 20/09/2021 -
Transferido a

20 de setembro de 2021

DOI

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Licença

Creative Commons BY-NC 3.0 Legacy
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    Z1041: Tumor Measurement Report (TMR) NCT00513292

    Inglês

    No Instruction available.

    1 Formulários  
    1. StudyEvent: Z1041: Tumor Measurement Report (TMR)
      1. No Instruction available.
    Header Module
    Descrição

    Header Module

    Visit
    Descrição

    AmericanCollegeofSurgeonsOncologyGroupVisitPeriodAmericanCollegeofSurgeonsOncologyGroupVisitPeriodType

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus Property
    C25616
    UMLS 2011AA Property
    C1948053
    NCI Thesaurus ObjectClass
    C19712
    UMLS 2011AA ObjectClass
    C1515944
    NCI Thesaurus ObjectClass-2
    C25716
    UMLS 2011AA ObjectClass-2
    C0545082
    Date
    Descrição

    PatientNotScheduleVisitDate

    Tipo de dados

    date

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25594
    UMLS 2011AA Property
    C1518422
    NCI Thesaurus Property-2
    C25211
    UMLS 2011AA Property-2
    C0086960
    NCI Thesaurus Property-3
    C25716
    UMLS 2011AA Property-3
    C0545082
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    Patient Study ID
    Descrição

    Patient Study ID

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C2348585
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25462
    NCI Thesaurus Property-2
    C25364
    Patient Initials
    Descrição

    Patient Initials

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C2986440
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25536
    Institution No.
    Descrição

    Institution Number

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C1301943
    NCI Thesaurus ObjectClass
    C21541
    UMLS CUI-2
    C0805701
    NCI Thesaurus Property
    C25364
    Institution Name
    Descrição

    Institution Name

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C1301943
    NCI Thesaurus ObjectClass
    C21541
    NCI Thesaurus ValueDomain-2
    C21541
    NCI Thesaurus Property
    C25364
    Header
    Descrição

    Header

    Was a tumor assessment performed at this visit (for target lesions?)
    Descrição

    MalignantNeoplasmAssessmentInd-2

    Tipo de dados

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus Property
    C20989
    UMLS 2011AA Property
    C0031809
    NCI Thesaurus ObjectClass
    C9305
    UMLS 2011AA ObjectClass
    C0006826
    Date of Evaluation
    Descrição

    LesionAssessmentDate

    Tipo de dados

    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-2
    C25367
    Lesion Number
    Descrição

    LesionSiteNumber

    Tipo de dados

    float

    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
    Organ
    Descrição

    LesionTargetLocationType

    Tipo de dados

    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-2
    C25702
    UMLS 2011AA Property-2
    C1521840
    Target Lesion Site (Describe specific location)
    Descrição

    LesionTargetSite

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C13717
    UMLS 2011AA ValueDomain
    C1515974
    NCI Thesaurus ObjectClass
    C3824
    UMLS 2011AA ObjectClass
    C0221198
    NCI Thesaurus Property
    C25341
    UMLS 2011AA Property
    C0450429
    NCI Thesaurus Property-2
    C25702
    UMLS 2011AA Property-2
    C1521840
    Longest Diameter of Lesion(s) (cm)
    Descrição

    Longest Diameter of Lesion

    Tipo de dados

    float

    Unidades de medida
    • cm
    Alias
    NCI Thesaurus ObjectClass
    C3824
    UMLS CUI-1
    C0221198
    NCI Thesaurus Property
    C25285
    UMLS CUI-2
    C1301886
    NCI Thesaurus Property-2
    C25558
    UMLS CUI-3
    C1522425
    NCI Thesaurus ValueDomain
    C25209
    NCI Thesaurus ValueDomain-2
    C25285
    cm
    Header
    Descrição

    Header

    TARGET LESIONS
    Descrição

    TARGET LESIONS

    Sum of Longest Diameters of All Target Lesions (Sum of both breast and axilla target lesions - cm)
    Descrição

    LongestLesionSumDiameterMeasurement

    Tipo de dados

    float

    Alias
    NCI Thesaurus ObjectClass
    C25558
    UMLS 2011AA ObjectClass
    C1522425
    NCI Thesaurus ObjectClass-2
    C3824
    UMLS 2011AA ObjectClass-2
    C0221198
    NCI Thesaurus Property
    C25285
    UMLS 2011AA Property
    C1301886
    NCI Thesaurus Property-2
    C25697
    UMLS 2011AA Property-2
    C1515051
    NCI Thesaurus ValueDomain
    C25209
    UMLS 2011AA ValueDomain
    C0242485
    Baseline sum of the longest diameter (cm)
    Descrição

    BaselineMalignantNeoplasmLongestDiameterSumMeasurement

    Tipo de dados

    float

    Alias
    NCI Thesaurus ObjectClass
    C25213
    UMLS 2011AA ObjectClass
    C1442488
    NCI Thesaurus ObjectClass-2
    C9305
    UMLS 2011AA ObjectClass-2
    C0006826
    NCI Thesaurus Property
    C25285
    UMLS 2011AA Property
    C1301886
    NCI Thesaurus Property-2
    C25558
    UMLS 2011AA Property-2
    C1522425
    NCI Thesaurus ValueDomain
    C25209
    UMLS 2011AA ValueDomain
    C0242485
    NCI Thesaurus ValueDomain-2
    C25697
    UMLS 2011AA ValueDomain-2
    C1515051
    Percent change ([Current - Baseline/Baseline] X 100)
    Descrição

    BaselineMalignantNeoplasmChangeLongestDiameterPercentageValue

    Tipo de dados

    float

    Alias
    NCI Thesaurus ObjectClass
    C25213
    UMLS 2011AA ObjectClass
    C1442488
    NCI Thesaurus ObjectClass-2
    C9305
    UMLS 2011AA ObjectClass-2
    C0006826
    NCI Thesaurus Property
    C25285
    UMLS 2011AA Property
    C1301886
    NCI Thesaurus Property-2
    C25558
    UMLS 2011AA Property-2
    C1522425
    NCI Thesaurus Property-3
    C25446
    UMLS 2011AA Property-3
    C0392747
    NCI Thesaurus ValueDomain
    C25613
    UMLS 2011AA ValueDomain
    C0439165
    NCI Thesaurus ValueDomain-2
    C25712
    UMLS 2011AA ValueDomain-2
    C1522609
    Percent change
    Descrição

    BaselineMalignantNeoplasmChangeLongestDiameterType

    Tipo de dados

    text

    Alias
    NCI Thesaurus ObjectClass
    C25213
    UMLS 2011AA ObjectClass
    C1442488
    NCI Thesaurus ObjectClass-2
    C9305
    UMLS 2011AA ObjectClass-2
    C0006826
    NCI Thesaurus Property
    C25285
    UMLS 2011AA Property
    C1301886
    NCI Thesaurus Property-2
    C25558
    UMLS 2011AA Property-2
    C1522425
    NCI Thesaurus Property-3
    C25446
    UMLS 2011AA Property-3
    C0392747
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    Smallest previous sum of the longest diameter (cm)
    Descrição

    MalignantNeoplasmLesserPreviousLongestDiameterSumMeasurement

    Tipo de dados

    float

    Alias
    NCI Thesaurus ObjectClass
    C9305
    UMLS 2011AA ObjectClass
    C0006826
    NCI Thesaurus Property
    C25285
    UMLS 2011AA Property
    C1301886
    NCI Thesaurus Property-2
    C25558
    UMLS 2011AA Property-2
    C1522425
    NCI Thesaurus Property-3
    C25627
    UMLS 2011AA Property-3
    C0205156
    NCI Thesaurus Property-4
    C61422
    UMLS 2011AA Property-4
    C0547044
    NCI Thesaurus ValueDomain
    C25209
    UMLS 2011AA ValueDomain
    C0242485
    NCI Thesaurus ValueDomain-2
    C25697
    UMLS 2011AA ValueDomain-2
    C1515051
    Percent change ([Current - Smallest previous sum/Smallest previous sum] X 100)
    Descrição

    MalignantNeoplasmChangeLesserPreviousLongestDiameterPercentageValue

    Tipo de dados

    float

    Alias
    NCI Thesaurus ObjectClass
    C9305
    UMLS 2011AA ObjectClass
    C0006826
    NCI Thesaurus Property
    C25285
    UMLS 2011AA Property
    C1301886
    NCI Thesaurus Property-2
    C25558
    UMLS 2011AA Property-2
    C1522425
    NCI Thesaurus Property-3
    C25627
    UMLS 2011AA Property-3
    C0205156
    NCI Thesaurus Property-4
    C25446
    UMLS 2011AA Property-4
    C0392747
    NCI Thesaurus Property-5
    C61422
    UMLS 2011AA Property-5
    C0547044
    NCI Thesaurus ValueDomain
    C25613
    UMLS 2011AA ValueDomain
    C0439165
    NCI Thesaurus ValueDomain-2
    C25712
    UMLS 2011AA ValueDomain-2
    C1522609
    Percent change
    Descrição

    MalignantNeoplasmChangeLesserPreviousLongestDiameterType

    Tipo de dados

    text

    Alias
    NCI Thesaurus ObjectClass
    C9305
    UMLS 2011AA ObjectClass
    C0006826
    NCI Thesaurus Property
    C25285
    UMLS 2011AA Property
    C1301886
    NCI Thesaurus Property-2
    C25558
    UMLS 2011AA Property-2
    C1522425
    NCI Thesaurus Property-3
    C25627
    UMLS 2011AA Property-3
    C0205156
    NCI Thesaurus Property-4
    C25446
    UMLS 2011AA Property-4
    C0392747
    NCI Thesaurus Property-5
    C61422
    UMLS 2011AA Property-5
    C0547044
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    Non-target Lesions
    Descrição

    Non-target Lesions

    Was an assessment performed for non-target lesions at this visit?
    Descrição

    NontargetLesionFollow-upAssessmentInd-2

    Tipo de dados

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C3824
    UMLS 2011AA ObjectClass
    C0221198
    NCI Thesaurus ObjectClass-2
    C25592
    UMLS 2011AA ObjectClass-2
    C1518389
    NCI Thesaurus Property
    C25367
    NCI Thesaurus Property-2
    C16033
    UMLS 2011AA Property
    C1522577
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Are there any nontarget lesions?
    Descrição

    NontargetLesionPresentInd-2

    Tipo de dados

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus ObjectClass
    C3824
    UMLS 2011AA ObjectClass
    C0221198
    NCI Thesaurus ObjectClass-2
    C25592
    UMLS 2011AA ObjectClass-2
    C1518389
    NCI Thesaurus Property
    C25626
    UMLS 2011AA Property
    C0150312
    Organ
    Descrição

    LesionNontargetLocationType

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C3824
    UMLS 2011AA ObjectClass
    C0221198
    NCI Thesaurus Property
    C25592
    UMLS 2011AA Property
    C1518389
    NCI Thesaurus Property-2
    C25341
    UMLS 2011AA Property-2
    C0450429
    Nontarget Lesion Site (Describe specific location)
    Descrição

    LesionNontargetSite

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C13717
    UMLS 2011AA ValueDomain
    C1515974
    NCI Thesaurus ObjectClass
    C3824
    UMLS 2011AA ObjectClass
    C0221198
    NCI Thesaurus Property
    C25592
    UMLS 2011AA Property
    C1518389
    NCI Thesaurus Property-2
    C25341
    UMLS 2011AA Property-2
    C0450429
    Method of Evaluation
    Descrição

    Evaluation method

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS CUI-1
    C2911685
    NCI Thesaurus ObjectClass
    C20989
    NCI Thesaurus Property
    C16847
    Lesion status
    Descrição

    DiseaseResponseSiteStatus

    Tipo de dados

    text

    Alias
    NCI Thesaurus Property
    C25755
    UMLS 2011AA Property
    C0871261
    NCI Thesaurus Property-2
    C25341
    UMLS 2011AA Property-2
    C0450429
    NCI Thesaurus ObjectClass
    C2991
    UMLS 2011AA ObjectClass
    C0012634
    NCI Thesaurus ValueDomain
    C25688
    UMLS 2011AA ValueDomain
    C0449438
    Was the non-target lesion identified on the baseline evaluation
    Descrição

    NontargetLesionBaselinePresentInd-2

    Tipo de dados

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C3824
    UMLS 2011AA ObjectClass
    C0221198
    NCI Thesaurus ObjectClass-2
    C25592
    UMLS 2011AA ObjectClass-2
    C1518389
    NCI Thesaurus Property
    C25626
    UMLS 2011AA Property
    C0150312
    NCI Thesaurus Property-2
    C25213
    UMLS 2011AA Property-2
    C1442488
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Has the patient been diagnosed with a distant metastatic progression that has not been previously reported
    Descrição

    DistantMetastasisProgressionInd-3

    Tipo de dados

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus Property
    C25331
    NCI Thesaurus ObjectClass
    C25321
    UMLS 2011AA ObjectClass
    C0443203
    NCI Thesaurus ObjectClass-2
    C19151
    UMLS 2011AA ObjectClass-2
    C0027627
    Follow-up Status Of Target Lesions
    Descrição

    Follow-up Status Of Target Lesions

    Target Lesion Response Status
    Descrição

    TargetLesionNegationEvaluationPerformedIndicator

    Tipo de dados

    text

    Alias
    NCI Thesaurus ObjectClass
    C3824
    UMLS 2011AA ObjectClass
    C0221198
    NCI Thesaurus ObjectClass-2
    C25702
    UMLS 2011AA ObjectClass-2
    C1521840
    NCI Thesaurus Property
    C25214
    UMLS 2011AA Property
    C0220825
    NCI Thesaurus Property-2
    C25594
    UMLS 2011AA Property-2
    C1518422
    NCI Thesaurus Property-3
    C38000
    UMLS 2011AA Property-3
    C0884358
    NCI Thesaurus ValueDomain
    C25180
    UMLS 2011AA ValueDomain
    C1522602
    Target Lesion Response Status
    Descrição

    TargetLesionResponseStatus

    Tipo de dados

    text

    Alias
    NCI Thesaurus ObjectClass
    C3824
    UMLS 2011AA ObjectClass
    C0221198
    NCI Thesaurus Property
    C25755
    UMLS 2011AA Property
    C0871261
    NCI Thesaurus ObjectClass-2
    C25702
    UMLS 2011AA ObjectClass-2
    C1521840
    NCI Thesaurus ValueDomain
    C25688
    UMLS 2011AA ValueDomain
    C0449438
    Non-Target Lesion Response Status
    Descrição

    Non-TargetLesionNegationEvaluationPerformedIndicator

    Tipo de dados

    text

    Alias
    NCI Thesaurus ObjectClass
    C3824
    UMLS 2011AA ObjectClass
    C0221198
    NCI Thesaurus ObjectClass-2
    C25592
    UMLS 2011AA ObjectClass-2
    C1518389
    NCI Thesaurus Property
    C25214
    UMLS 2011AA Property
    C0220825
    NCI Thesaurus Property-2
    C25594
    UMLS 2011AA Property-2
    C1518422
    NCI Thesaurus Property-3
    C38000
    UMLS 2011AA Property-3
    C0884358
    NCI Thesaurus ValueDomain
    C25180
    UMLS 2011AA ValueDomain
    C1522602
    Non-Target Lesion Response Status
    Descrição

    Non-TargetLesionResponseStatus

    Tipo de dados

    text

    Alias
    NCI Thesaurus ObjectClass
    C3824
    UMLS 2011AA ObjectClass
    C0221198
    NCI Thesaurus ObjectClass-2
    C25592
    UMLS 2011AA ObjectClass-2
    C1518389
    NCI Thesaurus Property
    C25755
    UMLS 2011AA Property
    C0871261
    NCI Thesaurus ValueDomain
    C25688
    UMLS 2011AA ValueDomain
    C0449438
    Overall Response
    Descrição

    OverallLesionNegationEvaluationPerformedIndicator

    Tipo de dados

    text

    Alias
    NCI Thesaurus ObjectClass
    C3824
    UMLS 2011AA ObjectClass
    C0221198
    NCI Thesaurus ObjectClass-2
    C25605
    UMLS 2011AA ObjectClass-2
    C1561607
    NCI Thesaurus Property
    C25214
    UMLS 2011AA Property
    C0220825
    NCI Thesaurus Property-2
    C25594
    UMLS 2011AA Property-2
    C1518422
    NCI Thesaurus Property-3
    C38000
    UMLS 2011AA Property-3
    C0884358
    NCI Thesaurus ValueDomain
    C25180
    UMLS 2011AA ValueDomain
    C1522602
    Overall Response Status at This Assessment
    Descrição

    OverallTumorResponseType

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C3262
    UMLS 2011AA ObjectClass
    C0027651
    NCI Thesaurus ObjectClass-2
    C25605
    UMLS 2011AA ObjectClass-2
    C1561607
    NCI Thesaurus Property
    C25755
    UMLS 2011AA Property
    C0871261
    Footer
    Descrição

    Footer

    Completed by
    Descrição

    Person Completing Form

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C1550483
    NCI Thesaurus ObjectClass
    C25657
    NCI Thesaurus Property
    C25364
    Date Form Completed
    Descrição

    Date Form Completed

    Tipo de dados

    date

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

    Research Comments

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS CUI-1
    C0947611
    NCI Thesaurus ObjectClass
    C15319
    NCI Thesaurus Property
    C25393
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    1 Formulários
    1. StudyEvent: Z1041: Tumor Measurement Report (TMR)
      1. No Instruction available.
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Header Module
    Item
    Visit
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C25616 (NCI Thesaurus Property)
    C1948053 (UMLS 2011AA Property)
    C19712 (NCI Thesaurus ObjectClass)
    C1515944 (UMLS 2011AA ObjectClass)
    C25716 (NCI Thesaurus ObjectClass-2)
    C0545082 (UMLS 2011AA ObjectClass-2)
    CL.1
    Code List
    Visit
    CL Item
    C1d21 (C1D21)
    CL Item
    C2d21 (C2D21)
    CL Item
    C3d21 (C3D21)
    CL Item
    C4d21 (C4D21)
    CL Item
    C5d21 (C5D21)
    CL Item
    C6d21 (C6D21)
    CL Item
    C7d21 (C7D21)
    CL Item
    C8d21 (C8D21)
    CL Item
    Unscheduled (Unscheduled)
    PatientNotScheduleVisitDate
    Item
    Date
    date
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25594 (NCI Thesaurus Property)
    C1518422 (UMLS 2011AA Property)
    C25211 (NCI Thesaurus Property-2)
    C0086960 (UMLS 2011AA Property-2)
    C25716 (NCI Thesaurus Property-3)
    C0545082 (UMLS 2011AA Property-3)
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    Patient Study ID
    Item
    Patient Study ID
    text
    C25337 (NCI Thesaurus ValueDomain)
    C2348585 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25462 (NCI Thesaurus Property)
    C25364 (NCI Thesaurus Property-2)
    Patient Initials
    Item
    Patient Initials
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2986440 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25536 (NCI Thesaurus Property)
    Institution Number
    Item
    Institution No.
    text
    C25337 (NCI Thesaurus ValueDomain)
    C1301943 (UMLS CUI-1)
    C21541 (NCI Thesaurus ObjectClass)
    C0805701 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    Institution Name
    Item
    Institution Name
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1301943 (UMLS CUI-1)
    C21541 (NCI Thesaurus ObjectClass)
    C21541 (NCI Thesaurus ValueDomain-2)
    C25364 (NCI Thesaurus Property)
    Item Group
    Header
    MalignantNeoplasmAssessmentInd-2
    Item
    Was a tumor assessment performed at this visit (for target lesions?)
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C20989 (NCI Thesaurus Property)
    C0031809 (UMLS 2011AA Property)
    C9305 (NCI Thesaurus ObjectClass)
    C0006826 (UMLS 2011AA ObjectClass)
    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-2)
    LesionSiteNumber
    Item
    Lesion Number
    float
    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
    Organ
    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-2)
    C1521840 (UMLS 2011AA Property-2)
    CL.4
    Code List
    Organ
    CL Item
    Axilla (Axilla)
    C12674 (NCI Thesaurus)
    C0004454 (UMLS 2011AA)
    LesionTargetSite
    Item
    Target Lesion Site (Describe specific location)
    text
    C13717 (NCI Thesaurus ValueDomain)
    C1515974 (UMLS 2011AA ValueDomain)
    C3824 (NCI Thesaurus ObjectClass)
    C0221198 (UMLS 2011AA ObjectClass)
    C25341 (NCI Thesaurus Property)
    C0450429 (UMLS 2011AA Property)
    C25702 (NCI Thesaurus Property-2)
    C1521840 (UMLS 2011AA Property-2)
    Longest Diameter of Lesion
    Item
    Longest Diameter of Lesion(s) (cm)
    float
    C3824 (NCI Thesaurus ObjectClass)
    C0221198 (UMLS CUI-1)
    C25285 (NCI Thesaurus Property)
    C1301886 (UMLS CUI-2)
    C25558 (NCI Thesaurus Property-2)
    C1522425 (UMLS CUI-3)
    C25209 (NCI Thesaurus ValueDomain)
    C25285 (NCI Thesaurus ValueDomain-2)
    Item Group
    Header
    Item Group
    TARGET LESIONS
    LongestLesionSumDiameterMeasurement
    Item
    Sum of Longest Diameters of All Target Lesions (Sum of both breast and axilla target lesions - cm)
    float
    C25558 (NCI Thesaurus ObjectClass)
    C1522425 (UMLS 2011AA ObjectClass)
    C3824 (NCI Thesaurus ObjectClass-2)
    C0221198 (UMLS 2011AA ObjectClass-2)
    C25285 (NCI Thesaurus Property)
    C1301886 (UMLS 2011AA Property)
    C25697 (NCI Thesaurus Property-2)
    C1515051 (UMLS 2011AA Property-2)
    C25209 (NCI Thesaurus ValueDomain)
    C0242485 (UMLS 2011AA ValueDomain)
    BaselineMalignantNeoplasmLongestDiameterSumMeasurement
    Item
    Baseline sum of the longest diameter (cm)
    float
    C25213 (NCI Thesaurus ObjectClass)
    C1442488 (UMLS 2011AA ObjectClass)
    C9305 (NCI Thesaurus ObjectClass-2)
    C0006826 (UMLS 2011AA ObjectClass-2)
    C25285 (NCI Thesaurus Property)
    C1301886 (UMLS 2011AA Property)
    C25558 (NCI Thesaurus Property-2)
    C1522425 (UMLS 2011AA Property-2)
    C25209 (NCI Thesaurus ValueDomain)
    C0242485 (UMLS 2011AA ValueDomain)
    C25697 (NCI Thesaurus ValueDomain-2)
    C1515051 (UMLS 2011AA ValueDomain-2)
    BaselineMalignantNeoplasmChangeLongestDiameterPercentageValue
    Item
    Percent change ([Current - Baseline/Baseline] X 100)
    float
    C25213 (NCI Thesaurus ObjectClass)
    C1442488 (UMLS 2011AA ObjectClass)
    C9305 (NCI Thesaurus ObjectClass-2)
    C0006826 (UMLS 2011AA ObjectClass-2)
    C25285 (NCI Thesaurus Property)
    C1301886 (UMLS 2011AA Property)
    C25558 (NCI Thesaurus Property-2)
    C1522425 (UMLS 2011AA Property-2)
    C25446 (NCI Thesaurus Property-3)
    C0392747 (UMLS 2011AA Property-3)
    C25613 (NCI Thesaurus ValueDomain)
    C0439165 (UMLS 2011AA ValueDomain)
    C25712 (NCI Thesaurus ValueDomain-2)
    C1522609 (UMLS 2011AA ValueDomain-2)
    Item
    Percent change
    text
    C25213 (NCI Thesaurus ObjectClass)
    C1442488 (UMLS 2011AA ObjectClass)
    C9305 (NCI Thesaurus ObjectClass-2)
    C0006826 (UMLS 2011AA ObjectClass-2)
    C25285 (NCI Thesaurus Property)
    C1301886 (UMLS 2011AA Property)
    C25558 (NCI Thesaurus Property-2)
    C1522425 (UMLS 2011AA Property-2)
    C25446 (NCI Thesaurus Property-3)
    C0392747 (UMLS 2011AA Property-3)
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    CL.5
    Code List
    Percent change
    CL Item
    % Decrease (% decrease)
    CL Item
    % Increase (% increase)
    MalignantNeoplasmLesserPreviousLongestDiameterSumMeasurement
    Item
    Smallest previous sum of the longest diameter (cm)
    float
    C9305 (NCI Thesaurus ObjectClass)
    C0006826 (UMLS 2011AA ObjectClass)
    C25285 (NCI Thesaurus Property)
    C1301886 (UMLS 2011AA Property)
    C25558 (NCI Thesaurus Property-2)
    C1522425 (UMLS 2011AA Property-2)
    C25627 (NCI Thesaurus Property-3)
    C0205156 (UMLS 2011AA Property-3)
    C61422 (NCI Thesaurus Property-4)
    C0547044 (UMLS 2011AA Property-4)
    C25209 (NCI Thesaurus ValueDomain)
    C0242485 (UMLS 2011AA ValueDomain)
    C25697 (NCI Thesaurus ValueDomain-2)
    C1515051 (UMLS 2011AA ValueDomain-2)
    MalignantNeoplasmChangeLesserPreviousLongestDiameterPercentageValue
    Item
    Percent change ([Current - Smallest previous sum/Smallest previous sum] X 100)
    float
    C9305 (NCI Thesaurus ObjectClass)
    C0006826 (UMLS 2011AA ObjectClass)
    C25285 (NCI Thesaurus Property)
    C1301886 (UMLS 2011AA Property)
    C25558 (NCI Thesaurus Property-2)
    C1522425 (UMLS 2011AA Property-2)
    C25627 (NCI Thesaurus Property-3)
    C0205156 (UMLS 2011AA Property-3)
    C25446 (NCI Thesaurus Property-4)
    C0392747 (UMLS 2011AA Property-4)
    C61422 (NCI Thesaurus Property-5)
    C0547044 (UMLS 2011AA Property-5)
    C25613 (NCI Thesaurus ValueDomain)
    C0439165 (UMLS 2011AA ValueDomain)
    C25712 (NCI Thesaurus ValueDomain-2)
    C1522609 (UMLS 2011AA ValueDomain-2)
    Item
    Percent change
    text
    C9305 (NCI Thesaurus ObjectClass)
    C0006826 (UMLS 2011AA ObjectClass)
    C25285 (NCI Thesaurus Property)
    C1301886 (UMLS 2011AA Property)
    C25558 (NCI Thesaurus Property-2)
    C1522425 (UMLS 2011AA Property-2)
    C25627 (NCI Thesaurus Property-3)
    C0205156 (UMLS 2011AA Property-3)
    C25446 (NCI Thesaurus Property-4)
    C0392747 (UMLS 2011AA Property-4)
    C61422 (NCI Thesaurus Property-5)
    C0547044 (UMLS 2011AA Property-5)
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    CL.6
    Code List
    Percent change
    CL Item
    % Decrease (% decrease)
    CL Item
    % Increase (% increase)
    Item Group
    Non-target Lesions
    NontargetLesionFollow-upAssessmentInd-2
    Item
    Was an assessment performed for non-target lesions at this visit?
    boolean
    C3824 (NCI Thesaurus ObjectClass)
    C0221198 (UMLS 2011AA ObjectClass)
    C25592 (NCI Thesaurus ObjectClass-2)
    C1518389 (UMLS 2011AA ObjectClass-2)
    C25367 (NCI Thesaurus Property)
    C16033 (NCI Thesaurus Property-2)
    C1522577 (UMLS 2011AA Property)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    NontargetLesionPresentInd-2
    Item
    Are there any nontarget lesions?
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C3824 (NCI Thesaurus ObjectClass)
    C0221198 (UMLS 2011AA ObjectClass)
    C25592 (NCI Thesaurus ObjectClass-2)
    C1518389 (UMLS 2011AA ObjectClass-2)
    C25626 (NCI Thesaurus Property)
    C0150312 (UMLS 2011AA Property)
    Item
    Organ
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C3824 (NCI Thesaurus ObjectClass)
    C0221198 (UMLS 2011AA ObjectClass)
    C25592 (NCI Thesaurus Property)
    C1518389 (UMLS 2011AA Property)
    C25341 (NCI Thesaurus Property-2)
    C0450429 (UMLS 2011AA Property-2)
    CL.9
    Code List
    Organ
    CL Item
    Ascites (Ascites)
    C2885 (NCI Thesaurus)
    C0003962 (UMLS 2011AA)
    CL Item
    Bone (Bone)
    C12366 (NCI Thesaurus)
    C0262950 (UMLS 2011AA)
    CL Item
    Brain (Brain)
    C12439 (NCI Thesaurus)
    C0006104 (UMLS 2011AA)
    CL Item
    Breast (Breast)
    C12971 (NCI Thesaurus)
    C0006141 (UMLS 2011AA)
    CL Item
    Cervix Uteri (Cervix)
    C12311 (NCI Thesaurus)
    C0007874 (UMLS 2011AA)
    CL Item
    Fallopian Tube (Fallopian tube)
    C12403 (NCI Thesaurus)
    C0015560 (UMLS 2011AA)
    CL Item
    Gastrointestinal Tract (GI)
    C34082 (NCI Thesaurus)
    C0017189 (UMLS 2011AA)
    CL Item
    Genitourinary (GU)
    C25350 (NCI Thesaurus)
    C0042066 (UMLS 2011AA)
    CL Item
    Head And Neck (Head and Neck)
    C12418 (NCI Thesaurus)
    C0460004 (UMLS 2011AA)
    CL Item
    Liver (Liver)
    C12392 (NCI Thesaurus)
    C0023884 (UMLS 2011AA)
    CL Item
    Lung (Lung)
    C12468 (NCI Thesaurus)
    C0024109 (UMLS 2011AA)
    CL Item
    Lymph Node (Lymph node)
    C12745 (NCI Thesaurus)
    C0024204 (UMLS 2011AA)
    CL Item
    Other (Other)
    C17649 (NCI Thesaurus)
    C0205394 (UMLS 2011AA)
    C17649 (NCI Thesaurus-3)
    C0205394 (UMLS 2011AA-4)
    CL Item
    Soft Tissue (Other soft tissue)
    C12471 (NCI Thesaurus)
    C0225317 (UMLS 2011AA)
    CL Item
    Ovary (Ovary)
    C12404 (NCI Thesaurus)
    C0029939 (UMLS 2011AA)
    CL Item
    Peritoneum (Peritoneum)
    C12770 (NCI Thesaurus)
    C0031153 (UMLS 2011AA)
    CL Item
    Pleural/pericardial Effusion (Pleural/pericardial effusion)
    CL Item
    Skin (Skin)
    C12470 (NCI Thesaurus)
    C1123023 (UMLS 2011AA)
    CL Item
    Uterus (Uterus)
    C12405 (NCI Thesaurus)
    C0042149 (UMLS 2011AA)
    LesionNontargetSite
    Item
    Nontarget Lesion Site (Describe specific location)
    text
    C13717 (NCI Thesaurus ValueDomain)
    C1515974 (UMLS 2011AA ValueDomain)
    C3824 (NCI Thesaurus ObjectClass)
    C0221198 (UMLS 2011AA ObjectClass)
    C25592 (NCI Thesaurus Property)
    C1518389 (UMLS 2011AA Property)
    C25341 (NCI Thesaurus Property-2)
    C0450429 (UMLS 2011AA Property-2)
    Item
    Method of Evaluation
    text
    C25284 (NCI Thesaurus ValueDomain)
    C2911685 (UMLS CUI-1)
    C20989 (NCI Thesaurus ObjectClass)
    C16847 (NCI Thesaurus Property)
    CL.10
    Code List
    Method of Evaluation
    CL Item
    Physical Exam (Physical exam)
    CL Item
    X-ray (X-ray)
    CL Item
    Ct Scan (CT scan)
    CL Item
    Spiral Ct Scan (Spiral CT scan)
    CL Item
    Mri Scan (MRI scan)
    CL Item
    Ultrasound (Ultrasound)
    C64384 (NCI Thesaurus)
    C1456803 (UMLS 2011AA)
    CL Item
    Other (Other)
    C17649 (NCI Thesaurus)
    C0205394 (UMLS 2011AA)
    Item
    Lesion status
    text
    C25755 (NCI Thesaurus Property)
    C0871261 (UMLS 2011AA Property)
    C25341 (NCI Thesaurus Property-2)
    C0450429 (UMLS 2011AA Property-2)
    C2991 (NCI Thesaurus ObjectClass)
    C0012634 (UMLS 2011AA ObjectClass)
    C25688 (NCI Thesaurus ValueDomain)
    C0449438 (UMLS 2011AA ValueDomain)
    CL.11
    Code List
    Lesion status
    CL Item
    Absent (Absent)
    C48190 (NCI Thesaurus)
    C0332197 (UMLS 2011AA)
    CL Item
    Present (Present)
    C25626 (NCI Thesaurus)
    C0150312 (UMLS 2011AA)
    CL Item
    Progressive Disease (Progressive)
    C35571 (NCI Thesaurus)
    C1335499 (UMLS 2011AA)
    CL Item
    New (New)
    C25586 (NCI Thesaurus)
    C0205314 (UMLS 2011AA)
    NontargetLesionBaselinePresentInd-2
    Item
    Was the non-target lesion identified on the baseline evaluation
    boolean
    C3824 (NCI Thesaurus ObjectClass)
    C0221198 (UMLS 2011AA ObjectClass)
    C25592 (NCI Thesaurus ObjectClass-2)
    C1518389 (UMLS 2011AA ObjectClass-2)
    C25626 (NCI Thesaurus Property)
    C0150312 (UMLS 2011AA Property)
    C25213 (NCI Thesaurus Property-2)
    C1442488 (UMLS 2011AA Property-2)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    DistantMetastasisProgressionInd-3
    Item
    Has the patient been diagnosed with a distant metastatic progression that has not been previously reported
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C25331 (NCI Thesaurus Property)
    C25321 (NCI Thesaurus ObjectClass)
    C0443203 (UMLS 2011AA ObjectClass)
    C19151 (NCI Thesaurus ObjectClass-2)
    C0027627 (UMLS 2011AA ObjectClass-2)
    Item Group
    Follow-up Status Of Target Lesions
    Item
    Target Lesion Response Status
    text
    C3824 (NCI Thesaurus ObjectClass)
    C0221198 (UMLS 2011AA ObjectClass)
    C25702 (NCI Thesaurus ObjectClass-2)
    C1521840 (UMLS 2011AA ObjectClass-2)
    C25214 (NCI Thesaurus Property)
    C0220825 (UMLS 2011AA Property)
    C25594 (NCI Thesaurus Property-2)
    C1518422 (UMLS 2011AA Property-2)
    C38000 (NCI Thesaurus Property-3)
    C0884358 (UMLS 2011AA Property-3)
    C25180 (NCI Thesaurus ValueDomain)
    C1522602 (UMLS 2011AA ValueDomain)
    CL.14
    Code List
    Target Lesion Response Status
    CL Item
    Not Applicable (NA)
    C48660 (NCI Thesaurus)
    C1272460 (UMLS 2011AA)
    Item
    Target Lesion Response Status
    text
    C3824 (NCI Thesaurus ObjectClass)
    C0221198 (UMLS 2011AA ObjectClass)
    C25755 (NCI Thesaurus Property)
    C0871261 (UMLS 2011AA Property)
    C25702 (NCI Thesaurus ObjectClass-2)
    C1521840 (UMLS 2011AA ObjectClass-2)
    C25688 (NCI Thesaurus ValueDomain)
    C0449438 (UMLS 2011AA ValueDomain)
    CL.15
    Code List
    Target Lesion Response Status
    CL Item
    Complete Response (Complete Response)
    CL Item
    Partial Response (Partial Response)
    CL Item
    Progressive Disease (Progressive Disease)
    C35571 (NCI Thesaurus)
    C1335499 (UMLS 2011AA)
    CL Item
    Stable Disease (Stable Disease)
    C18213 (NCI Thesaurus)
    C0677946 (UMLS 2011AA)
    Item
    Non-Target Lesion Response Status
    text
    C3824 (NCI Thesaurus ObjectClass)
    C0221198 (UMLS 2011AA ObjectClass)
    C25592 (NCI Thesaurus ObjectClass-2)
    C1518389 (UMLS 2011AA ObjectClass-2)
    C25214 (NCI Thesaurus Property)
    C0220825 (UMLS 2011AA Property)
    C25594 (NCI Thesaurus Property-2)
    C1518422 (UMLS 2011AA Property-2)
    C38000 (NCI Thesaurus Property-3)
    C0884358 (UMLS 2011AA Property-3)
    C25180 (NCI Thesaurus ValueDomain)
    C1522602 (UMLS 2011AA ValueDomain)
    CL.16
    Code List
    Non-Target Lesion Response Status
    CL Item
    Not Applicable (NA)
    C48660 (NCI Thesaurus)
    C1272460 (UMLS 2011AA)
    Item
    Non-Target Lesion Response Status
    text
    C3824 (NCI Thesaurus ObjectClass)
    C0221198 (UMLS 2011AA ObjectClass)
    C25592 (NCI Thesaurus ObjectClass-2)
    C1518389 (UMLS 2011AA ObjectClass-2)
    C25755 (NCI Thesaurus Property)
    C0871261 (UMLS 2011AA Property)
    C25688 (NCI Thesaurus ValueDomain)
    C0449438 (UMLS 2011AA ValueDomain)
    CL.17
    Code List
    Non-Target Lesion Response Status
    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
    Overall Response
    text
    C3824 (NCI Thesaurus ObjectClass)
    C0221198 (UMLS 2011AA ObjectClass)
    C25605 (NCI Thesaurus ObjectClass-2)
    C1561607 (UMLS 2011AA ObjectClass-2)
    C25214 (NCI Thesaurus Property)
    C0220825 (UMLS 2011AA Property)
    C25594 (NCI Thesaurus Property-2)
    C1518422 (UMLS 2011AA Property-2)
    C38000 (NCI Thesaurus Property-3)
    C0884358 (UMLS 2011AA Property-3)
    C25180 (NCI Thesaurus ValueDomain)
    C1522602 (UMLS 2011AA ValueDomain)
    CL.18
    Code List
    Overall Response
    CL Item
    Not Applicable (NA)
    C48660 (NCI Thesaurus)
    C1272460 (UMLS 2011AA)
    Item
    Overall Response Status at This Assessment
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C3262 (NCI Thesaurus ObjectClass)
    C0027651 (UMLS 2011AA ObjectClass)
    C25605 (NCI Thesaurus ObjectClass-2)
    C1561607 (UMLS 2011AA ObjectClass-2)
    C25755 (NCI Thesaurus Property)
    C0871261 (UMLS 2011AA Property)
    CL.19
    Code List
    Overall Response Status at This Assessment
    CL Item
    Complete Response (CR)
    CL Item
    Partial Response (PR)
    C18212 (NCI Thesaurus)
    CL Item
    Progressive Disease (PD)
    C35571 (NCI Thesaurus)
    C1335499 (UMLS 2011AA)
    CL Item
    Stable Disease (SD)
    C18213 (NCI Thesaurus)
    C0677946 (UMLS 2011AA)
    CL Item
    Insufficient Evaluation (Insufficient evaluation to determine response status)
    Item Group
    Footer
    Person Completing Form
    Item
    Completed by
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1550483 (UMLS CUI-1)
    C25657 (NCI Thesaurus ObjectClass)
    C25364 (NCI Thesaurus Property)
    Date Form Completed
    Item
    Date Form Completed
    date
    C25164 (NCI Thesaurus ValueDomain)
    C1115437 (UMLS CUI-1)
    C40988 (NCI Thesaurus ObjectClass)
    C25250 (NCI Thesaurus Property)
    C25367 (NCI Thesaurus ValueDomain-2)
    Research Comments
    Item
    Comments
    text
    C25704 (NCI Thesaurus ValueDomain)
    C0947611 (UMLS CUI-1)
    C15319 (NCI Thesaurus ObjectClass)
    C25393 (NCI Thesaurus Property)
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