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ID

3214

Beskrivning

Gynecologic Oncology Group Solid Tumor Evaluation Form (D2M version 3) Gemcitabine Hydrochloride and Docetaxel Followed by Doxorubicin Hydrochloride or Observation in Treating Patients With High-Risk Uterine Leiomyosarcoma Previously Removed by Surgery Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=8D1826DA-E799-F792-E040-BB89AD433BF7

Länk

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=8D1826DA-E799-F792-E040-BB89AD433BF7

Nyckelord

  1. 2012-09-19 2012-09-19 -
  2. 2015-01-09 2015-01-09 - Martin Dugas
Uppladdad den

19 september 2012

DOI

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Licens

Creative Commons BY-NC 3.0 Legacy

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    Sarcoma NCT01533207 On-Study - Gynecologic Oncology Group Solid Tumor Evaluation Form (D2M version 3) - 3127207v1.0

    No Instruction available.

    1. StudyEvent: Gynecologic Oncology Group Solid Tumor Evaluation Form (D2M version 3)
      1. No Instruction available.
    Header Module
    Beskrivning

    Header Module

    Date form originally completed (m d y)
    Beskrivning

    FormOriginalCompleteDate

    Datatyp

    date

    Alias
    NCI Thesaurus ObjectClass
    C19464
    UMLS 2011AA ObjectClass
    C0376315
    NCI Thesaurus Property
    C25250
    UMLS 2011AA Property
    C0205197
    NCI Thesaurus Property
    C25604
    UMLS 2011AA Property
    C0205313
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ValueDomain
    C25367
    Date form amended (m d y)
    Beskrivning

    FormAmendedCompleteDate

    Datatyp

    date

    Alias
    NCI Thesaurus ObjectClass
    C19464
    UMLS 2011AA ObjectClass
    C0376315
    NCI Thesaurus Property
    C25250
    UMLS 2011AA Property
    C0205197
    NCI Thesaurus Property
    C25416
    UMLS 2011AA Property
    C1691222
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ValueDomain
    C25367
    Person amending form, last name
    Beskrivning

    ResponsiblePersonReportingChangeLastName

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    NCI Thesaurus ObjectClass
    C25190
    UMLS 2011AA ObjectClass
    C0027361
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    Patient Initials (First, Middle, Last)
    Beskrivning

    PatientInitialsName

    Datatyp

    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
    Patient Study ID
    Beskrivning

    PatientGynecologicOncologyGroupIdentifierNumber

    Datatyp

    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
    C25521
    UMLS 2011AA Property
    C1512288
    Person completing form, last name
    Beskrivning

    ResponsiblePersonLastName

    Datatyp

    text

    Alias
    NCI Thesaurus ObjectClass
    C25190
    UMLS 2011AA ObjectClass
    C0027361
    NCI Thesaurus ObjectClass
    C25657
    UMLS 2011AA ObjectClass
    C1273518
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus Property
    C25551
    UMLS 2011AA Property
    C1517741
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    Target Lesion(s) Evaluation
    Beskrivning

    Target Lesion(s) Evaluation

    Did the patient have measurable disease at baseline
    Beskrivning

    MeasurableDiseaseBaselinePresentInd-3

    Datatyp

    text

    Alias
    NCI Thesaurus ObjectClass
    C2991
    UMLS 2011AA ObjectClass
    C0012634
    NCI Thesaurus ObjectClass
    C37894
    UMLS 2011AA ObjectClass
    C1513040
    NCI Thesaurus Property
    C25626
    UMLS 2011AA Property
    C0150312
    NCI Thesaurus Property
    C25213
    UMLS 2011AA Property
    C1442488
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ValueDomain
    C9305
    UMLS 2011AA ValueDomain
    C0006826
    Assessment
    Beskrivning

    AssessmentPeriodSpecify

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS 2011AA ValueDomain
    C1521902
    NCI Thesaurus ObjectClass
    C20989
    UMLS 2011AA ObjectClass
    C0031809
    NCI Thesaurus Property
    C25616
    UMLS 2011AA Property
    C1948053
    Site of Lesion
    Beskrivning

    LesionSite

    Datatyp

    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
    Method of Evaluation (Method of evaluation *)
    Beskrivning

    AssessmentMethodType

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C20989
    UMLS 2011AA ObjectClass
    C0031809
    NCI Thesaurus Property
    C16847
    UMLS 2011AA Property
    C0449851
    Lymph node
    Beskrivning

    LymphNodeInvolvementInd-3

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ObjectClass
    C12745
    UMLS 2011AA ObjectClass
    C0024204
    NCI Thesaurus Property
    C25547
    Date of evaluation (m d y)
    Beskrivning

    LesionAssessmentDate

    Datatyp

    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
    Tumor Size (cm) (Please report the longest diameter for non-nodal target lesions. The short axis should be reported for nodal target lesions)
    Beskrivning

    TumorSizeDiameterMeasurement

    Datatyp

    double

    Måttenheter
    • cm
    Alias
    NCI Thesaurus ValueDomain
    C25209
    UMLS 2011AA ValueDomain
    C0242485
    NCI Thesaurus ObjectClass
    C3262
    UMLS 2011AA ObjectClass
    C0027651
    NCI Thesaurus Property
    C25681
    UMLS 2011AA Property
    C0456389
    cm
    Sum of diameters (cm)
    Beskrivning

    SumLesionDiameterMeasurement

    Datatyp

    double

    Måttenheter
    • cm
    Alias
    NCI Thesaurus ObjectClass
    C3824
    UMLS 2011AA ObjectClass
    C0221198
    NCI Thesaurus ObjectClass
    C25697
    UMLS 2011AA ObjectClass
    C1515051
    NCI Thesaurus Property
    C25285
    UMLS 2011AA Property
    C1301886
    NCI Thesaurus ValueDomain
    C25209
    UMLS 2011AA ValueDomain
    C0242485
    NCI Thesaurus ValueDomain
    C25285
    UMLS 2011AA ValueDomain
    C1301886
    cm
    Non-target Lesion(s) Evaluation
    Beskrivning

    Non-target Lesion(s) Evaluation

    Were there any non-target lesions reported at baseline
    Beskrivning

    LesionNontargetBaselineLocationInd-3

    Datatyp

    text

    Alias
    NCI Thesaurus ObjectClass
    C3824
    UMLS 2011AA ObjectClass
    C0221198
    NCI Thesaurus Property
    C25592
    UMLS 2011AA Property
    C1518389
    NCI Thesaurus Property
    C25341
    UMLS 2011AA Property
    C0450429
    NCI Thesaurus Property
    C25213
    UMLS 2011AA Property
    C1442488
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ValueDomain
    C9305
    UMLS 2011AA ValueDomain
    C0006826
    Site of Lesion
    Beskrivning

    LesionSite

    Datatyp

    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
    Method of Evaluation (Method of evaluation *)
    Beskrivning

    AssessmentMethodType

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C20989
    UMLS 2011AA ObjectClass
    C0031809
    NCI Thesaurus Property
    C16847
    UMLS 2011AA Property
    C0449851
    Date of evaluation (m d y)
    Beskrivning

    LesionAssessmentDate

    Datatyp

    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
    Follow-up status of lesion
    Beskrivning

    Non-TargetLesionFollow-upStatus

    Datatyp

    text

    Alias
    NCI Thesaurus ObjectClass
    C3824
    UMLS 2011AA ObjectClass
    C0221198
    NCI Thesaurus ObjectClass
    C25592
    UMLS 2011AA ObjectClass
    C1518389
    NCI Thesaurus ValueDomain
    C25688
    UMLS 2011AA ValueDomain
    C0449438
    NCI Thesaurus Property
    C25365
    UMLS 2011AA Property
    C0678257
    New Target Lesion(s) At Follow-up Evaluation
    Beskrivning

    New Target Lesion(s) At Follow-up Evaluation

    Was the appearance of any new lesions documented (since the baseline evaluation)
    Beskrivning

    NewLesionAppearanceInd-2

    Datatyp

    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
    Site of Lesion
    Beskrivning

    LesionSite

    Datatyp

    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
    Method of Evaluation (Method of evaluation *)
    Beskrivning

    AssessmentMethodType

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C20989
    UMLS 2011AA ObjectClass
    C0031809
    NCI Thesaurus Property
    C16847
    UMLS 2011AA Property
    C0449851
    Date of evaluation (m d y)
    Beskrivning

    LesionAssessmentDate

    Datatyp

    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
    Overall Response
    Beskrivning

    Overall Response

    Time point response
    Beskrivning

    GynecologicMalignantNeoplasmResponseStatus

    Datatyp

    text

    Alias
    NCI Thesaurus ObjectClass
    C9305
    UMLS 2011AA ObjectClass
    C0006826
    NCI Thesaurus Property
    C50995
    UMLS 2011AA Property
    C1704632
    NCI Thesaurus ObjectClass
    C28016
    UMLS 2011AA ObjectClass
    C0205480
    NCI Thesaurus ValueDomain
    C25688
    UMLS 2011AA ValueDomain
    C0449438
    Overall best confirmed response
    Beskrivning

    GynecologicMalignantNeoplasmOverallConfirmationResponseStatus

    Datatyp

    text

    Alias
    NCI Thesaurus ObjectClass
    C9305
    UMLS 2011AA ObjectClass
    C0006826
    NCI Thesaurus ObjectClass
    C28016
    UMLS 2011AA ObjectClass
    C0205480
    NCI Thesaurus Property
    C25605
    UMLS 2011AA Property
    C1561607
    NCI Thesaurus Property
    C25458
    UMLS 2011AA Property
    C0750484
    NCI Thesaurus Property
    C50995
    UMLS 2011AA Property
    C1704632
    NCI Thesaurus ValueDomain
    C25688
    UMLS 2011AA ValueDomain
    C0449438
    Overall best response (unconfirmed)
    Beskrivning

    BestOverallNeoplasmResponseType

    Datatyp

    text

    Alias
    NCI Thesaurus ObjectClass
    C3262
    UMLS 2011AA ObjectClass
    C0027651
    NCI Thesaurus ObjectClass
    C25605
    UMLS 2011AA ObjectClass
    C1561607
    NCI Thesaurus ObjectClass
    C25432
    UMLS 2011AA ObjectClass
    C1522427
    NCI Thesaurus Property
    C25755
    UMLS 2011AA Property
    C0871261
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    PR First Observed Date (m d y)
    Beskrivning

    PartialResponseFirstObservedDate

    Datatyp

    date

    Alias
    NCI Thesaurus ObjectClass
    C25755
    UMLS 2011AA ObjectClass
    C0871261
    NCI Thesaurus ObjectClass
    C25378
    UMLS 2011AA ObjectClass
    C0728938
    NCI Thesaurus Property
    C25509
    UMLS 2011AA Property
    C1279901
    NCI Thesaurus Property
    C25599
    UMLS 2011AA Property
    C1441672
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ValueDomain
    C25367
    Response Confirmed Date, PR (m d y)
    Beskrivning

    PartialResponseConfirmedDate

    Datatyp

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C25755
    UMLS 2011AA ObjectClass
    C0871261
    NCI Thesaurus Property
    C25458
    UMLS 2011AA Property
    C0750484
    NCI Thesaurus ObjectClass
    C25378
    UMLS 2011AA ObjectClass
    C0728938
    CR First Observed Date (m d y)
    Beskrivning

    CompleteResponseFirstObservedDate

    Datatyp

    date

    Alias
    NCI Thesaurus ObjectClass
    C25755
    UMLS 2011AA ObjectClass
    C0871261
    NCI Thesaurus ObjectClass
    C25250
    UMLS 2011AA ObjectClass
    C0205197
    NCI Thesaurus Property
    C25509
    UMLS 2011AA Property
    C1279901
    NCI Thesaurus Property
    C25599
    UMLS 2011AA Property
    C1441672
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ValueDomain
    C25367
    Response Confirmed Date, CR (m d y)
    Beskrivning

    CompleteResponseConfirmedDate

    Datatyp

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C25755
    UMLS 2011AA ObjectClass
    C0871261
    NCI Thesaurus ObjectClass
    C25250
    UMLS 2011AA ObjectClass
    C0205197
    NCI Thesaurus Property
    C25458
    UMLS 2011AA Property
    C0750484
    Comments
    Beskrivning

    Comments

    Comments
    Beskrivning

    ResearchCommentsText

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS 2011AA ValueDomain
    C1527021
    NCI Thesaurus ObjectClass
    C15319
    NCI Thesaurus Property
    C25393
    UMLS 2011AA Property
    C0282411

    Similar models

    No Instruction available.

    1. StudyEvent: Gynecologic Oncology Group Solid Tumor Evaluation Form (D2M version 3)
      1. No Instruction available.
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Header Module
    FormOriginalCompleteDate
    Item
    Date form originally completed (m d y)
    date
    C19464 (NCI Thesaurus ObjectClass)
    C0376315 (UMLS 2011AA ObjectClass)
    C25250 (NCI Thesaurus Property)
    C0205197 (UMLS 2011AA Property)
    C25604 (NCI Thesaurus Property)
    C0205313 (UMLS 2011AA Property)
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25367 (NCI Thesaurus ValueDomain)
    FormAmendedCompleteDate
    Item
    Date form amended (m d y)
    date
    C19464 (NCI Thesaurus ObjectClass)
    C0376315 (UMLS 2011AA ObjectClass)
    C25250 (NCI Thesaurus Property)
    C0205197 (UMLS 2011AA Property)
    C25416 (NCI Thesaurus Property)
    C1691222 (UMLS 2011AA Property)
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25367 (NCI Thesaurus ValueDomain)
    ResponsiblePersonReportingChangeLastName
    Item
    Person amending form, last name
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    C25190 (NCI Thesaurus ObjectClass)
    C0027361 (UMLS 2011AA ObjectClass)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    PatientInitialsName
    Item
    Patient Initials (First, Middle, Last)
    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)
    PatientGynecologicOncologyGroupIdentifierNumber
    Item
    Patient Study 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)
    C25521 (NCI Thesaurus Property)
    C1512288 (UMLS 2011AA Property)
    ResponsiblePersonLastName
    Item
    Person completing form, last name
    text
    C25190 (NCI Thesaurus ObjectClass)
    C0027361 (UMLS 2011AA ObjectClass)
    C25657 (NCI Thesaurus ObjectClass)
    C1273518 (UMLS 2011AA ObjectClass)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C25551 (NCI Thesaurus Property)
    C1517741 (UMLS 2011AA Property)
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    Item Group
    Target Lesion(s) Evaluation
    Item
    Did the patient have measurable disease at baseline
    text
    C2991 (NCI Thesaurus ObjectClass)
    C0012634 (UMLS 2011AA ObjectClass)
    C37894 (NCI Thesaurus ObjectClass)
    C1513040 (UMLS 2011AA ObjectClass)
    C25626 (NCI Thesaurus Property)
    C0150312 (UMLS 2011AA Property)
    C25213 (NCI Thesaurus Property)
    C1442488 (UMLS 2011AA Property)
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C9305 (NCI Thesaurus ValueDomain)
    C0006826 (UMLS 2011AA ValueDomain)
    Code List
    Did the patient have measurable disease at baseline
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    AssessmentPeriodSpecify
    Item
    Assessment
    text
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
    C20989 (NCI Thesaurus ObjectClass)
    C0031809 (UMLS 2011AA ObjectClass)
    C25616 (NCI Thesaurus Property)
    C1948053 (UMLS 2011AA Property)
    LesionSite
    Item
    Site of Lesion
    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)
    Item
    Method of Evaluation (Method of evaluation *)
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C20989 (NCI Thesaurus ObjectClass)
    C0031809 (UMLS 2011AA ObjectClass)
    C16847 (NCI Thesaurus Property)
    C0449851 (UMLS 2011AA Property)
    Code List
    Method of Evaluation (Method of evaluation *)
    CL Item
    Clinical Examination (pe) (Clinical examination)
    CL Item
    Chest X-ray (Chest X-ray)
    CL Item
    Ct Scan (CT scan)
    CL Item
    Pet/ct Scan (PET/CT scan)
    CL Item
    Mri (MRI (NMR))
    CL Item
    Not Evaluated (Not evaluated)
    CL Item
    Positron Emission Tomography (FDG-PET)
    C17007 (NCI Thesaurus)
    C0032743 (UMLS 2011AA)
    CL Item
    Other (Other)
    C17649 (NCI Thesaurus)
    C0205394 (UMLS 2011AA)
    Item
    Lymph node
    text
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C12745 (NCI Thesaurus ObjectClass)
    C0024204 (UMLS 2011AA ObjectClass)
    C25547 (NCI Thesaurus Property)
    Code List
    Lymph node
    CL Item
    No (NO)
    CL Item
    Yes (YES)
    LesionAssessmentDate
    Item
    Date of evaluation (m d y)
    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)
    TumorSizeDiameterMeasurement
    Item
    Tumor Size (cm) (Please report the longest diameter for non-nodal target lesions. The short axis should be reported for nodal target lesions)
    double
    C25209 (NCI Thesaurus ValueDomain)
    C0242485 (UMLS 2011AA ValueDomain)
    C3262 (NCI Thesaurus ObjectClass)
    C0027651 (UMLS 2011AA ObjectClass)
    C25681 (NCI Thesaurus Property)
    C0456389 (UMLS 2011AA Property)
    SumLesionDiameterMeasurement
    Item
    Sum of diameters (cm)
    double
    C3824 (NCI Thesaurus ObjectClass)
    C0221198 (UMLS 2011AA ObjectClass)
    C25697 (NCI Thesaurus ObjectClass)
    C1515051 (UMLS 2011AA ObjectClass)
    C25285 (NCI Thesaurus Property)
    C1301886 (UMLS 2011AA Property)
    C25209 (NCI Thesaurus ValueDomain)
    C0242485 (UMLS 2011AA ValueDomain)
    C25285 (NCI Thesaurus ValueDomain)
    C1301886 (UMLS 2011AA ValueDomain)
    Item Group
    Non-target Lesion(s) Evaluation
    Item
    Were there any non-target lesions reported at baseline
    text
    C3824 (NCI Thesaurus ObjectClass)
    C0221198 (UMLS 2011AA ObjectClass)
    C25592 (NCI Thesaurus Property)
    C1518389 (UMLS 2011AA Property)
    C25341 (NCI Thesaurus Property)
    C0450429 (UMLS 2011AA Property)
    C25213 (NCI Thesaurus Property)
    C1442488 (UMLS 2011AA Property)
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C9305 (NCI Thesaurus ValueDomain)
    C0006826 (UMLS 2011AA ValueDomain)
    Code List
    Were there any non-target lesions reported at baseline
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    LesionSite
    Item
    Site of Lesion
    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)
    Item
    Method of Evaluation (Method of evaluation *)
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C20989 (NCI Thesaurus ObjectClass)
    C0031809 (UMLS 2011AA ObjectClass)
    C16847 (NCI Thesaurus Property)
    C0449851 (UMLS 2011AA Property)
    Code List
    Method of Evaluation (Method of evaluation *)
    CL Item
    Clinical Examination (pe) (Clinical examination)
    CL Item
    Chest X-ray (Chest X-ray)
    CL Item
    Ct Scan (CT scan)
    CL Item
    Pet/ct Scan (PET/CT scan)
    CL Item
    Mri (MRI (NMR))
    CL Item
    Not Evaluated (Not evaluated)
    CL Item
    Positron Emission Tomography (FDG-PET)
    C17007 (NCI Thesaurus)
    C0032743 (UMLS 2011AA)
    CL Item
    Other (Other)
    C17649 (NCI Thesaurus)
    C0205394 (UMLS 2011AA)
    LesionAssessmentDate
    Item
    Date of evaluation (m d y)
    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
    Follow-up status of lesion
    text
    C3824 (NCI Thesaurus ObjectClass)
    C0221198 (UMLS 2011AA ObjectClass)
    C25592 (NCI Thesaurus ObjectClass)
    C1518389 (UMLS 2011AA ObjectClass)
    C25688 (NCI Thesaurus ValueDomain)
    C0449438 (UMLS 2011AA ValueDomain)
    C25365 (NCI Thesaurus Property)
    C0678257 (UMLS 2011AA Property)
    Code List
    Follow-up status of lesion
    CL Item
    Complete Response (Complete response)
    CL Item
    Non Cr/ Non Pd (Non-CR/ Non-PD)
    CL Item
    Unequivocal Pd (Unequivocal PD)
    CL Item
    N/a - Baseline (N/A - Baseline)
    Item Group
    New Target Lesion(s) At Follow-up Evaluation
    Item
    Was the appearance of any new lesions documented (since the baseline evaluation)
    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)
    Code List
    Was the appearance of any new lesions documented (since the baseline evaluation)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    LesionSite
    Item
    Site of Lesion
    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)
    Item
    Method of Evaluation (Method of evaluation *)
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C20989 (NCI Thesaurus ObjectClass)
    C0031809 (UMLS 2011AA ObjectClass)
    C16847 (NCI Thesaurus Property)
    C0449851 (UMLS 2011AA Property)
    Code List
    Method of Evaluation (Method of evaluation *)
    CL Item
    Clinical Examination (pe) (Clinical examination)
    CL Item
    Chest X-ray (Chest X-ray)
    CL Item
    Ct Scan (CT scan)
    CL Item
    Pet/ct Scan (PET/CT scan)
    CL Item
    Mri (MRI (NMR))
    CL Item
    Not Evaluated (Not evaluated)
    CL Item
    Positron Emission Tomography (FDG-PET)
    C17007 (NCI Thesaurus)
    C0032743 (UMLS 2011AA)
    CL Item
    Other (Other)
    C17649 (NCI Thesaurus)
    C0205394 (UMLS 2011AA)
    LesionAssessmentDate
    Item
    Date of evaluation (m d y)
    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 Group
    Overall Response
    Item
    Time point response
    text
    C9305 (NCI Thesaurus ObjectClass)
    C0006826 (UMLS 2011AA ObjectClass)
    C50995 (NCI Thesaurus Property)
    C1704632 (UMLS 2011AA Property)
    C28016 (NCI Thesaurus ObjectClass)
    C0205480 (UMLS 2011AA ObjectClass)
    C25688 (NCI Thesaurus ValueDomain)
    C0449438 (UMLS 2011AA ValueDomain)
    Code List
    Time point response
    CL Item
    Complete Response (Complete response)
    C25250 (NCI Thesaurus)
    C0205197 (UMLS 2011AA)
    C50995 (NCI Thesaurus)
    C1704632 (UMLS 2011AA)
    CL Item
    Stable Disease (Stable Disease)
    C18213 (NCI Thesaurus)
    C0677946 (UMLS 2011AA)
    CL Item
    Partial Response (Partial Response)
    CL Item
    Pd (Progressive Disease)
    CL Item
    Not Evaluable (Not evaluable)
    C62222 (NCI Thesaurus)
    C1883425 (UMLS 2011AA)
    CL Item
    Not Applicable - Baseline (N/A - Baseline)
    CL Item
    Biologic Progression Only (Biologic progression only)
    Item
    Overall best confirmed response
    text
    C9305 (NCI Thesaurus ObjectClass)
    C0006826 (UMLS 2011AA ObjectClass)
    C28016 (NCI Thesaurus ObjectClass)
    C0205480 (UMLS 2011AA ObjectClass)
    C25605 (NCI Thesaurus Property)
    C1561607 (UMLS 2011AA Property)
    C25458 (NCI Thesaurus Property)
    C0750484 (UMLS 2011AA Property)
    C50995 (NCI Thesaurus Property)
    C1704632 (UMLS 2011AA Property)
    C25688 (NCI Thesaurus ValueDomain)
    C0449438 (UMLS 2011AA ValueDomain)
    Code List
    Overall best confirmed response
    CL Item
    Complete Response (Complete response)
    C25250 (NCI Thesaurus)
    C0205197 (UMLS 2011AA)
    C50995 (NCI Thesaurus)
    C1704632 (UMLS 2011AA)
    CL Item
    Stable Disease (Stable Disease)
    C18213 (NCI Thesaurus)
    C0677946 (UMLS 2011AA)
    CL Item
    Partial Response (Partial Response)
    CL Item
    Not Applicable - Baseline (N/A - Baseline)
    CL Item
    Not Evaluable (Not evaluable)
    C62222 (NCI Thesaurus)
    C1883425 (UMLS 2011AA)
    CL Item
    Non-measurable Disease At Baseline (Non-measurable disease at baseline)
    CL Item
    Pd (Progressive Disease)
    Item
    Overall best response (unconfirmed)
    text
    C3262 (NCI Thesaurus ObjectClass)
    C0027651 (UMLS 2011AA ObjectClass)
    C25605 (NCI Thesaurus ObjectClass)
    C1561607 (UMLS 2011AA ObjectClass)
    C25432 (NCI Thesaurus ObjectClass)
    C1522427 (UMLS 2011AA ObjectClass)
    C25755 (NCI Thesaurus Property)
    C0871261 (UMLS 2011AA Property)
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    Code List
    Overall best response (unconfirmed)
    CL Item
    Complete Response (CR)
    CL Item
    Stable Disease (SD)
    C18213 (NCI Thesaurus)
    C0677946 (UMLS 2011AA)
    CL Item
    Partial Response (PR)
    C18212 (NCI Thesaurus)
    CL Item
    N/a - Baseline (N/A - Baseline)
    CL Item
    Not Evaluable (ne) (NE)
    CL Item
    Non-measurable Disease At Baseline (Non-measurable disease at baseline)
    CL Item
    Progressive Disease (PD)
    C35571 (NCI Thesaurus)
    C1335499 (UMLS 2011AA)
    PartialResponseFirstObservedDate
    Item
    PR First Observed Date (m d y)
    date
    C25755 (NCI Thesaurus ObjectClass)
    C0871261 (UMLS 2011AA ObjectClass)
    C25378 (NCI Thesaurus ObjectClass)
    C0728938 (UMLS 2011AA ObjectClass)
    C25509 (NCI Thesaurus Property)
    C1279901 (UMLS 2011AA Property)
    C25599 (NCI Thesaurus Property)
    C1441672 (UMLS 2011AA Property)
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25367 (NCI Thesaurus ValueDomain)
    PartialResponseConfirmedDate
    Item
    Response Confirmed Date, PR (m d y)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25755 (NCI Thesaurus ObjectClass)
    C0871261 (UMLS 2011AA ObjectClass)
    C25458 (NCI Thesaurus Property)
    C0750484 (UMLS 2011AA Property)
    C25378 (NCI Thesaurus ObjectClass)
    C0728938 (UMLS 2011AA ObjectClass)
    CompleteResponseFirstObservedDate
    Item
    CR First Observed Date (m d y)
    date
    C25755 (NCI Thesaurus ObjectClass)
    C0871261 (UMLS 2011AA ObjectClass)
    C25250 (NCI Thesaurus ObjectClass)
    C0205197 (UMLS 2011AA ObjectClass)
    C25509 (NCI Thesaurus Property)
    C1279901 (UMLS 2011AA Property)
    C25599 (NCI Thesaurus Property)
    C1441672 (UMLS 2011AA Property)
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25367 (NCI Thesaurus ValueDomain)
    CompleteResponseConfirmedDate
    Item
    Response Confirmed Date, CR (m d y)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25755 (NCI Thesaurus ObjectClass)
    C0871261 (UMLS 2011AA ObjectClass)
    C25250 (NCI Thesaurus ObjectClass)
    C0205197 (UMLS 2011AA ObjectClass)
    C25458 (NCI Thesaurus Property)
    C0750484 (UMLS 2011AA Property)
    Item Group
    Comments
    ResearchCommentsText
    Item
    Comments
    text
    C25704 (NCI Thesaurus ValueDomain)
    C1527021 (UMLS 2011AA ValueDomain)
    C15319 (NCI Thesaurus ObjectClass)
    C25393 (NCI Thesaurus Property)
    C0282411 (UMLS 2011AA Property)

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