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7974

Beschreibung

CALGB Solid Tumor Evaluation Form (RECIST 1.1) Sorafenib Tosylate With or Without Doxorubicin Hydrochloride in Treating Patients With Locally Advanced or Metastatic Liver Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=746D8651-FF47-E158-E040-BB89AD4366AF

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=746D8651-FF47-E158-E040-BB89AD4366AF

Stichworte

Versionen (2)
  1. 19.09.12 19.09.12 -
  2. 09.01.15 09.01.15 - Martin Dugas
Hochgeladen am

9. Januar 2015

DOI

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    Liver Cancer NCT01015833 On-Study - CALGB Solid Tumor Evaluation Form (RECIST 1.1) - 2946223v1.0

    Englisch

    INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink.

    1 Formulare  
    Header
    Beschreibung

    Header

    CALGB Form
    Beschreibung

    Form ID CALGB

    Datentyp

    text

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

    Protocol ID CALGB

    Datentyp

    text

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

    Trial subject ID CALGB

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C2348585
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-2
    C1516238
    NCI Thesaurus Property
    C25364
    NCI Thesaurus Property-2
    C25442
    Date of Evaluation (MM DD YYYY)
    Beschreibung

    LesionAssessmentDate

    Datentyp

    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
    Are data amended
    Beschreibung

    Data amended

    Datentyp

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS CUI-1
    C0680532
    NCI Thesaurus ObjectClass
    C25474
    NCI Thesaurus Property
    C25416
    Unnamed2
    Beschreibung

    Unnamed2

    Patient Initials (Last, First Middle)
    Beschreibung

    Patient Initials

    Datentyp

    text

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

    Medical Record Number

    Datentyp

    text

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

    Institution Name

    Datentyp

    text

    Alias
    NCI Thesaurus ObjectClass
    C25454
    UMLS CUI-1
    C1301943
    NCI Thesaurus ObjectClass-2
    C21541
    NCI Thesaurus Property
    C25364
    NCI Thesaurus ValueDomain
    C25191
    NCI Thesaurus ValueDomain-2
    C21541
    Participating Group
    Beschreibung

    Participating Group

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C2347449
    NCI Thesaurus ObjectClass
    C25608
    NCI Thesaurus ObjectClass-2
    C17005
    NCI Thesaurus Property
    C25364
    Participating Group Study No
    Beschreibung

    Study Number Participating Group

    Datentyp

    text

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

    Trial subject ID Participating Group

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C2348585
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-2
    C2347449
    NCI Thesaurus Property
    C25608
    NCI Thesaurus Property-2
    C25364
    Report Period
    Beschreibung

    Report Period

    Report Period (Mark one with an X.)
    Beschreibung

    Clinical Trial Period

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS CUI-1
    C2347804
    NCI Thesaurus ObjectClass
    C25214
    NCI Thesaurus Property
    C25616
    NCI Thesaurus ObjectClass-2
    C25651
    Cycle Number (if applicable)
    Beschreibung

    Cycle Number

    Datentyp

    integer

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C2045829
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus Property
    C25379
    Reporting Period
    Beschreibung

    Reporting Period

    Are there any target lesions?
    Beschreibung

    TargetLesionPresentInd-2

    Datentyp

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus ObjectClass
    C3824
    UMLS 2011AA ObjectClass
    C0221198
    NCI Thesaurus Property
    C25626
    UMLS 2011AA Property
    C0150312
    NCI Thesaurus ObjectClass-2
    C25702
    UMLS 2011AA ObjectClass-2
    C1521840
    Target Lesion Site
    Beschreibung

    LesionTargetSite

    Datentyp

    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
    Method of Evaluation (Mark one with an X.)
    Beschreibung

    Evaluation method

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS CUI-1
    C2911685
    NCI Thesaurus ObjectClass
    C20989
    NCI Thesaurus Property
    C16847
    Lesion size (mm)
    Beschreibung

    LesionSizeNumber

    Datentyp

    float

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus ObjectClass
    C3824
    UMLS 2011AA ObjectClass
    C0221198
    NCI Thesaurus Property
    C25681
    UMLS 2011AA Property
    C0456389
    Lesion type (Mark one with an X.)
    Beschreibung

    LesionTargetSite

    Datentyp

    text

    Alias
    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
    NCI Thesaurus ValueDomain
    C37901
    UMLS 2011AA ValueDomain
    C0205145
    Lesion status (Mark one with an X.)
    Beschreibung

    DiseaseResponseSiteStatus

    Datentyp

    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
    Baseline Sum (mm)
    Beschreibung

    BaselineMalignantNeoplasmLongestDiameterSumMeasurement

    Datentyp

    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
    Smallest sum since baseline (mm)
    Beschreibung

    MalignantNeoplasmLesserPreviousLongestDiameterSumMeasurement

    Datentyp

    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
    Total tumor size (mm)
    Beschreibung

    PersonLesionLongestMeasurementSumMeasurement

    Datentyp

    float

    Alias
    NCI Thesaurus ObjectClass
    C25190
    UMLS 2011AA ObjectClass
    C0027361
    NCI Thesaurus ObjectClass-2
    C3824
    UMLS 2011AA ObjectClass-2
    C0221198
    NCI Thesaurus Property
    C25209
    UMLS 2011AA Property
    C0242485
    NCI Thesaurus Property-2
    C25558
    UMLS 2011AA Property-2
    C1522425
    NCI Thesaurus Property-3
    C25697
    UMLS 2011AA Property-3
    C1515051
    NCI Thesaurus ValueDomain
    C25209
    UMLS 2011AA ValueDomain
    C0242485
    Percent change from baseline (%)
    Beschreibung

    BaselineMalignantNeoplasmChangeLongestDiameterPercentageValue

    Datentyp

    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 from smallest sum (%)
    Beschreibung

    MalignantNeoplasmChangeLesserPreviousLongestDiameterPercentageValue

    Datentyp

    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
    Comments
    Beschreibung

    Comments

    Comments
    Beschreibung

    Research Comments

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS CUI-1
    C0947611
    NCI Thesaurus ObjectClass
    C15319
    NCI Thesaurus Property
    C25393
    Non-target Lesion(s) Follow-up Evaluation
    Beschreibung

    Non-target Lesion(s) Follow-up Evaluation

    Are there any non-target lesions
    Beschreibung

    NontargetLesionPresentInd-2

    Datentyp

    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
    Nontarget Lesion Site
    Beschreibung

    LesionNontargetSite

    Datentyp

    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 (Mark one with an X.)
    Beschreibung

    Evaluation method

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS CUI-1
    C2911685
    NCI Thesaurus ObjectClass
    C20989
    NCI Thesaurus Property
    C16847
    Overall response at this assessment (tumor Mark one with an X.)
    Beschreibung

    OverallLesionResponseStatus

    Datentyp

    text

    Alias
    NCI Thesaurus ObjectClass
    C3824
    UMLS 2011AA ObjectClass
    C0221198
    NCI Thesaurus ObjectClass-2
    C25605
    UMLS 2011AA ObjectClass-2
    C1561607
    NCI Thesaurus Property
    C25755
    UMLS 2011AA Property
    C0871261
    NCI Thesaurus ValueDomain
    C25688
    UMLS 2011AA ValueDomain
    C0449438
    Lesion status (Mark one with an X.)
    Beschreibung

    DiseaseResponseSiteStatus

    Datentyp

    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 appearance of any new lesions documented
    Beschreibung

    NewLesionAppearanceInd-2

    Datentyp

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus ObjectClass
    C3824
    UMLS 2011AA ObjectClass
    C0221198
    NCI Thesaurus ObjectClass-2
    C25586
    UMLS 2011AA ObjectClass-2
    C0205314
    NCI Thesaurus Property
    C25377
    UMLS 2011AA Property
    C0700364
    Specify
    Beschreibung

    LesionNewLocationSpecify

    Datentyp

    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-2
    C25341
    UMLS 2011AA Property-2
    C0450429
    Is there symptomatic deterioration of the patient's health status
    Beschreibung

    ResponseSymptomaticDeteriorationInd-3

    Datentyp

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ObjectClass
    C25755
    UMLS 2011AA ObjectClass
    C0871261
    NCI Thesaurus Property
    C25269
    UMLS 2011AA Property
    C0231220
    NCI Thesaurus Property-2
    C25751
    UMLS 2011AA Property-2
    C0868945
    Overall Response
    Beschreibung

    Overall Response

    Completed by (Last name, First name)
    Beschreibung

    Person Completing Form

    Datentyp

    text

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

    Form Completion Date

    Datentyp

    date

    Alias
    NCI Thesaurus ObjectClass
    C19464
    UMLS CUI-1
    C1549507
    NCI Thesaurus Property
    C25250
    NCI Thesaurus Property-2
    C25604
    NCI Thesaurus ValueDomain
    C25164
    NCI Thesaurus ValueDomain-2
    C25367
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    Ähnliche Modelle

    INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink.

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Header
    Form ID CALGB
    Item
    CALGB Form
    text
    C25337 (NCI Thesaurus ValueDomain)
    C3262252 (UMLS CUI-1)
    C19464 (NCI Thesaurus ObjectClass)
    C1516238 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25442 (NCI Thesaurus ObjectClass-2)
    Protocol ID CALGB
    Item
    CALGB Study No.
    text
    C25337 (NCI Thesaurus ValueDomain)
    C3274381 (UMLS CUI-1)
    C25320 (NCI Thesaurus ObjectClass)
    C1516238 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25442 (NCI Thesaurus Property-2)
    Trial subject ID CALGB
    Item
    CALGB Patient ID
    text
    C25337 (NCI Thesaurus ValueDomain)
    C2348585 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C1516238 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25442 (NCI Thesaurus Property-2)
    LesionAssessmentDate
    Item
    Date of Evaluation (MM DD YYYY)
    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)
    Data amended
    Item
    Are data amended
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C0680532 (UMLS CUI-1)
    C25474 (NCI Thesaurus ObjectClass)
    C25416 (NCI Thesaurus Property)
    Item Group
    Unnamed2
    Patient Initials
    Item
    Patient Initials (Last, First Middle)
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2986440 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25536 (NCI Thesaurus Property)
    Medical Record Number
    Item
    Patient Hospital No.
    text
    C25337 (NCI Thesaurus ValueDomain)
    C1301894 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25261 (NCI Thesaurus Property)
    C25198 (NCI Thesaurus Property-2)
    Institution Name
    Item
    Institution/Affiliate
    text
    C25454 (NCI Thesaurus ObjectClass)
    C1301943 (UMLS CUI-1)
    C21541 (NCI Thesaurus ObjectClass-2)
    C25364 (NCI Thesaurus Property)
    C25191 (NCI Thesaurus ValueDomain)
    C21541 (NCI Thesaurus ValueDomain-2)
    Participating Group
    Item
    Participating Group
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2347449 (UMLS CUI-1)
    C25608 (NCI Thesaurus ObjectClass)
    C17005 (NCI Thesaurus ObjectClass-2)
    C25364 (NCI Thesaurus Property)
    Study Number Participating Group
    Item
    Participating Group Study No
    text
    C25337 (NCI Thesaurus ValueDomain)
    C3274381 (UMLS CUI-1)
    C25320 (NCI Thesaurus ObjectClass)
    C2347449 (UMLS CUI-2)
    C25608 (NCI Thesaurus Property)
    C25364 (NCI Thesaurus Property-2)
    Trial subject ID Participating Group
    Item
    Participating Group Patient ID
    text
    C25337 (NCI Thesaurus ValueDomain)
    C2348585 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C2347449 (UMLS CUI-2)
    C25608 (NCI Thesaurus Property)
    C25364 (NCI Thesaurus Property-2)
    Item Group
    Report Period
    Item
    Report Period (Mark one with an X.)
    text
    C25284 (NCI Thesaurus ValueDomain)
    C2347804 (UMLS CUI-1)
    C25214 (NCI Thesaurus ObjectClass)
    C25616 (NCI Thesaurus Property)
    C25651 (NCI Thesaurus ObjectClass-2)
    CL.2
    Code List
    Report Period (Mark one with an X.)
    CL Item
    Baseline (Baseline)
    C25213 (NCI Thesaurus)
    C1442488 (UMLS 2011AA)
    CL Item
    Restaging (Restaging)
    CL Item
    Post-treatment (Post-Treatment)
    CL024863 (NCI Metathesaurus)
    Cycle Number
    Item
    Cycle Number (if applicable)
    integer
    C25337 (NCI Thesaurus ValueDomain)
    C2045829 (UMLS CUI-1)
    C15368 (NCI Thesaurus ObjectClass)
    C25379 (NCI Thesaurus Property)
    Item Group
    Reporting Period
    TargetLesionPresentInd-2
    Item
    Are there any target lesions?
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C3824 (NCI Thesaurus ObjectClass)
    C0221198 (UMLS 2011AA ObjectClass)
    C25626 (NCI Thesaurus Property)
    C0150312 (UMLS 2011AA Property)
    C25702 (NCI Thesaurus ObjectClass-2)
    C1521840 (UMLS 2011AA ObjectClass-2)
    LesionTargetSite
    Item
    Target Lesion Site
    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)
    Item
    Method of Evaluation (Mark one with an X.)
    text
    C25284 (NCI Thesaurus ValueDomain)
    C2911685 (UMLS CUI-1)
    C20989 (NCI Thesaurus ObjectClass)
    C16847 (NCI Thesaurus Property)
    CL.8
    Code List
    Method of Evaluation (Mark one with an X.)
    CL Item
    Ct Scan (CT scan)
    CL Item
    X-ray (X-ray)
    CL Item
    Mri (MRI (NMR))
    CL Item
    Other (Other)
    C17649 (NCI Thesaurus)
    C0205394 (UMLS 2011AA)
    LesionSizeNumber
    Item
    Lesion size (mm)
    float
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C3824 (NCI Thesaurus ObjectClass)
    C0221198 (UMLS 2011AA ObjectClass)
    C25681 (NCI Thesaurus Property)
    C0456389 (UMLS 2011AA Property)
    Item
    Lesion type (Mark one with an X.)
    text
    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)
    C37901 (NCI Thesaurus ValueDomain)
    C0205145 (UMLS 2011AA ValueDomain)
    CL.5
    Code List
    Lesion type (Mark one with an X.)
    CL Item
    Non-nodal (Non-nodal)
    CL Item
    Lymph Node (Lymph node)
    C12745 (NCI Thesaurus)
    C0024204 (UMLS 2011AA)
    Item
    Lesion status (Mark one with an X.)
    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.9
    Code List
    Lesion status (Mark one with an X.)
    CL Item
    Absent (Absent)
    C48190 (NCI Thesaurus)
    C0332197 (UMLS 2011AA)
    CL Item
    Present (Present)
    C25626 (NCI Thesaurus)
    C0150312 (UMLS 2011AA)
    CL Item
    Progression (Unequivocal progression)
    C25331 (NCI Thesaurus)
    CL Item
    New Lesion (New lesion)
    CL Item
    Not Evaluable (Not evaluable)
    BaselineMalignantNeoplasmLongestDiameterSumMeasurement
    Item
    Baseline Sum (mm)
    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)
    MalignantNeoplasmLesserPreviousLongestDiameterSumMeasurement
    Item
    Smallest sum since baseline (mm)
    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)
    PersonLesionLongestMeasurementSumMeasurement
    Item
    Total tumor size (mm)
    float
    C25190 (NCI Thesaurus ObjectClass)
    C0027361 (UMLS 2011AA ObjectClass)
    C3824 (NCI Thesaurus ObjectClass-2)
    C0221198 (UMLS 2011AA ObjectClass-2)
    C25209 (NCI Thesaurus Property)
    C0242485 (UMLS 2011AA Property)
    C25558 (NCI Thesaurus Property-2)
    C1522425 (UMLS 2011AA Property-2)
    C25697 (NCI Thesaurus Property-3)
    C1515051 (UMLS 2011AA Property-3)
    C25209 (NCI Thesaurus ValueDomain)
    C0242485 (UMLS 2011AA ValueDomain)
    BaselineMalignantNeoplasmChangeLongestDiameterPercentageValue
    Item
    Percent change from baseline (%)
    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)
    MalignantNeoplasmChangeLesserPreviousLongestDiameterPercentageValue
    Item
    Percent change from smallest sum (%)
    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 Group
    Comments
    Research Comments
    Item
    Comments
    text
    C25704 (NCI Thesaurus ValueDomain)
    C0947611 (UMLS CUI-1)
    C15319 (NCI Thesaurus ObjectClass)
    C25393 (NCI Thesaurus Property)
    Item Group
    Non-target Lesion(s) Follow-up Evaluation
    NontargetLesionPresentInd-2
    Item
    Are there any non-target 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)
    LesionNontargetSite
    Item
    Nontarget Lesion Site
    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 (Mark one with an X.)
    text
    C25284 (NCI Thesaurus ValueDomain)
    C2911685 (UMLS CUI-1)
    C20989 (NCI Thesaurus ObjectClass)
    C16847 (NCI Thesaurus Property)
    CL.8
    Code List
    Method of Evaluation (Mark one with an X.)
    CL Item
    Ct Scan (CT scan)
    CL Item
    X-ray (X-ray)
    CL Item
    Mri (MRI (NMR))
    CL Item
    Other (Other)
    C17649 (NCI Thesaurus)
    C0205394 (UMLS 2011AA)
    Item
    Overall response at this assessment (tumor Mark one with an X.)
    text
    C3824 (NCI Thesaurus ObjectClass)
    C0221198 (UMLS 2011AA ObjectClass)
    C25605 (NCI Thesaurus ObjectClass-2)
    C1561607 (UMLS 2011AA ObjectClass-2)
    C25755 (NCI Thesaurus Property)
    C0871261 (UMLS 2011AA Property)
    C25688 (NCI Thesaurus ValueDomain)
    C0449438 (UMLS 2011AA ValueDomain)
    CL.10
    Code List
    Overall response at this assessment (tumor Mark one with an X.)
    CL Item
    Complete Response (Complete Response)
    CL Item
    Partial Response (Partial Response)
    CL Item
    Stable Disease (Stable disease)
    C18213 (NCI Thesaurus)
    C0677946 (UMLS 2011AA)
    CL Item
    Progressive Disease (Progressive Disease)
    C35571 (NCI Thesaurus)
    C1335499 (UMLS 2011AA)
    CL Item
    Not Evaluable (Not evaluable)
    Item
    Lesion status (Mark one with an X.)
    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.9
    Code List
    Lesion status (Mark one with an X.)
    CL Item
    Absent (Absent)
    C48190 (NCI Thesaurus)
    C0332197 (UMLS 2011AA)
    CL Item
    Present (Present)
    C25626 (NCI Thesaurus)
    C0150312 (UMLS 2011AA)
    CL Item
    Progression (Unequivocal progression)
    C25331 (NCI Thesaurus)
    CL Item
    New Lesion (New lesion)
    CL Item
    Not Evaluable (Not evaluable)
    NewLesionAppearanceInd-2
    Item
    Was the appearance of any new lesions documented
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C3824 (NCI Thesaurus ObjectClass)
    C0221198 (UMLS 2011AA ObjectClass)
    C25586 (NCI Thesaurus ObjectClass-2)
    C0205314 (UMLS 2011AA ObjectClass-2)
    C25377 (NCI Thesaurus Property)
    C0700364 (UMLS 2011AA Property)
    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-2)
    C0450429 (UMLS 2011AA Property-2)
    ResponseSymptomaticDeteriorationInd-3
    Item
    Is there symptomatic deterioration of the patient's health status
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C25755 (NCI Thesaurus ObjectClass)
    C0871261 (UMLS 2011AA ObjectClass)
    C25269 (NCI Thesaurus Property)
    C0231220 (UMLS 2011AA Property)
    C25751 (NCI Thesaurus Property-2)
    C0868945 (UMLS 2011AA Property-2)
    Item Group
    Overall Response
    Person Completing Form
    Item
    Completed by (Last name, First name)
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1550483 (UMLS CUI-1)
    C25657 (NCI Thesaurus ObjectClass)
    C25364 (NCI Thesaurus Property)
    Form Completion Date
    Item
    Date Form Originally Completed (MM DD YYYY)
    date
    C19464 (NCI Thesaurus ObjectClass)
    C1549507 (UMLS CUI-1)
    C25250 (NCI Thesaurus Property)
    C25604 (NCI Thesaurus Property-2)
    C25164 (NCI Thesaurus ValueDomain)
    C25367 (NCI Thesaurus ValueDomain-2)
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