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653

Descrição

RTOG 0825 Phase III GBM Salvage Treatment Summary Form (SF) Temozolomide and Radiation Therapy With or Without Bevacizumab in Treating Patients With Newly Diagnosed Glioblastoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=5AE2A23C-8AF1-6A8B-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=5AE2A23C-8AF1-6A8B-E044-0003BA3F9857

Palavras-chave

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

26 de agosto de 2012

DOI

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Licença

Creative Commons BY-NC 3.0 Legacy
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    Brain and Central Nervous System Tumors NCT00884741 Treatment - RTOG 0825 Phase III GBM Salvage Treatment Summary Form (SF) - 2797440v1.0

    Inglês

    INSTRUCTIONS: Submit this form at the completion of each cycle of salvage treatment. Dates are to be recorded as mm-dd-yyyy unless otherwise specified

    1 Formulários  
    Module 1
    Descrição

    Module 1

    RTOG Study No.
    Descrição

    ProtocolRTOGIdentifierNumber

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus ObjectClass
    C25320
    UMLS 2011AA ObjectClass
    C1507394
    NCI Thesaurus Property
    C19778
    UMLS 2011AA Property
    C1514695
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    Case #
    Descrição

    RadiationTherapyOncologyGroupPatientCaseIdentifierNumber

    Tipo de dados

    text

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus ObjectClass
    C19778
    UMLS 2011AA ObjectClass
    C1514695
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus Property
    C49152
    UMLS 2011AA Property
    C1706256
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    Institution Name
    Descrição

    InstitutionName

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    NCI Thesaurus ObjectClass
    C21541
    UMLS 2011AA ObjectClass
    C0018704
    NCI Thesaurus ValueDomain
    C21541
    UMLS 2011AA ValueDomain
    C0018704
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    Institution No.
    Descrição

    InstitutionIdentifierNumber

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus ObjectClass
    C21541
    UMLS 2011AA ObjectClass
    C0018704
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    Patient Initials
    Descrição

    PatientInitialsName

    Tipo de dados

    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
    RTOG Patient ID
    Descrição

    PatientRadiationTherapyOncologyGroupIdentifierNumber

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C19778
    UMLS 2011AA Property
    C1514695
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    Amended Data (INSTRUCTIONS: Complete form on web to unblind the protocol treatment arm)
    Descrição

    DataAmendedInd-3

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ObjectClass
    C25474
    UMLS 2011AA ObjectClass
    C1511726
    NCI Thesaurus Property
    C25416
    UMLS 2011AA Property
    C1691222
    Assessment
    Descrição

    Assessment

    Height (CM)
    Descrição

    PatientHeightMeasurement

    Tipo de dados

    double

    Unidades de medida
    • cm
    Alias
    NCI Thesaurus ValueDomain
    C25209
    UMLS 2011AA ValueDomain
    C0242485
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25347
    UMLS 2011AA Property
    C0489786
    cm
    Weight (CM)
    Descrição

    PatientWeightMeasurement

    Tipo de dados

    double

    Unidades de medida
    • Kg
    Alias
    NCI Thesaurus ValueDomain
    C25209
    UMLS 2011AA ValueDomain
    C0242485
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25208
    UMLS 2011AA Property
    C0043100
    Kg
    BSA (M2)
    Descrição

    PersonBodySurfaceAreaValue

    Tipo de dados

    double

    Unidades de medida
    • m2
    Alias
    NCI Thesaurus ObjectClass
    C25190
    UMLS 2011AA ObjectClass
    C0027361
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus Property
    C25157
    UMLS 2011AA Property
    C0005902
    m2
    Karnofsky Performance Status (Use 9 if unknown)
    Descrição

    KarnofskyPerformanceStatusScore

    Tipo de dados

    text

    Alias
    NCI Thesaurus Property
    C25367
    NCI Thesaurus ObjectClass
    C20641
    UMLS 2011AA ObjectClass
    C1518965
    NCI Thesaurus ValueDomain
    C25338
    UMLS 2011AA ValueDomain
    C0449820
    Neurologic function
    Descrição

    NeurologicalFunctionStatus

    Tipo de dados

    text

    Alias
    NCI Thesaurus ObjectClass
    C25262
    UMLS 2011AA ObjectClass
    C0205494
    NCI Thesaurus ObjectClass
    C25518
    UMLS 2011AA ObjectClass
    C0542341
    NCI Thesaurus ValueDomain
    C25688
    UMLS 2011AA ValueDomain
    C0449438
    NCI Thesaurus Property
    C25365
    UMLS 2011AA Property
    C0678257
    Disease Progression
    Descrição

    Disease Progression

    Salvage treatment being reported
    Descrição

    ClinicalStudyProtocolSalvageTherapyAgentAdministeredType

    Tipo de dados

    text

    Alias
    NCI Thesaurus ObjectClass
    C25320
    UMLS 2011AA ObjectClass
    C1507394
    NCI Thesaurus ObjectClass
    C1708
    UMLS 2011AA ObjectClass
    C0450442
    NCI Thesaurus ObjectClass
    C15359
    UMLS 2011AA ObjectClass
    C0085405
    NCI Thesaurus Property
    C25382
    UMLS 2011AA Property
    C1521801
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    Is protocol chemotherapy continuing?
    Descrição

    ProtocolChemotherapyContinueAdministrationInd-2

    Tipo de dados

    text

    Alias
    NCI Thesaurus ObjectClass
    C15632
    UMLS 2011AA ObjectClass
    C0392920
    NCI Thesaurus ObjectClass
    C42651
    UMLS 2011AA ObjectClass
    C0442711
    NCI Thesaurus Property
    C53279
    UMLS 2011AA Property
    C0549178
    NCI Thesaurus Property
    C25409
    UMLS 2011AA Property
    C1533734
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Unnamed 3
    Descrição

    Unnamed 3

    Agent Name
    Descrição

    AgentName

    Tipo de dados

    text

    Alias
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus ObjectClass
    C1708
    UMLS 2011AA ObjectClass
    C0450442
    NCI Thesaurus ValueDomain
    C1708
    UMLS 2011AA ValueDomain
    C0450442
    NCI Thesaurus ValueDomain
    C42614
    UMLS 2011AA ValueDomain
    C0027365
    Agent Start Date (MM DD YYYY)
    Descrição

    AgentBeginDate

    Tipo de dados

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ValueDomain
    C25431
    UMLS 2011AA ValueDomain
    C0439659
    NCI Thesaurus ObjectClass
    C1708
    UMLS 2011AA ObjectClass
    C0450442
    NCI Thesaurus Property
    C25275
    UMLS 2011AA Property
    C2745955
    Agent End Date (MM DD YYYY)
    Descrição

    AgentEndDate

    Tipo de dados

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C1708
    UMLS 2011AA ObjectClass
    C0450442
    NCI Thesaurus Property
    C25275
    UMLS 2011AA Property
    C2745955
    Agent Total Dose (MG)
    Descrição

    AgentCourseTotalDose

    Tipo de dados

    double

    Alias
    NCI Thesaurus ValueDomain
    C25304
    UMLS 2011AA ValueDomain
    C0439810
    NCI Thesaurus Property
    C25379
    UMLS 2011AA Property
    C0750729
    NCI Thesaurus ValueDomain
    C25488
    UMLS 2011AA ValueDomain
    C0178602
    NCI Thesaurus ObjectClass
    C1708
    UMLS 2011AA ObjectClass
    C0450442
    Total number of doses
    Descrição

    AgentTotalDoseCount

    Tipo de dados

    double

    Alias
    NCI Thesaurus Property
    C25304
    UMLS 2011AA Property
    C0439810
    NCI Thesaurus ValueDomain
    C25463
    UMLS 2011AA ValueDomain
    C0750480
    NCI Thesaurus ObjectClass
    C1708
    UMLS 2011AA ObjectClass
    C0450442
    NCI Thesaurus Property
    C25256
    UMLS 2011AA Property
    C1265611
    Was dose reduced more than 20%
    Descrição

    AgentReducedPercentageQuantityInd-2

    Tipo de dados

    text

    Alias
    NCI Thesaurus ObjectClass
    C1708
    UMLS 2011AA ObjectClass
    C0450442
    NCI Thesaurus Property
    C25640
    UMLS 2011AA Property
    C0392756
    NCI Thesaurus Property
    C25613
    UMLS 2011AA Property
    C0439165
    NCI Thesaurus Property
    C25256
    UMLS 2011AA Property
    C1265611
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Reason for Treatment Modification
    Descrição

    TreatmentModifiedDoseReason

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25638
    UMLS 2011AA ValueDomain
    C0392360
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus Property
    C25256
    UMLS 2011AA Property
    C1265611
    NCI Thesaurus Property
    C25573
    Reason Treatment Ended
    Descrição

    Off-treatmentReason

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25638
    UMLS 2011AA ValueDomain
    C0392360
    NCI Thesaurus ObjectClass
    C25601
    UMLS 2011AA ObjectClass
    C1518544
    NCI Thesaurus Property
    C25365
    UMLS 2011AA Property
    C0678257
    Alternative therapy, specify
    Descrição

    AlternativeTherapyAdministeredSpecify

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS 2011AA ValueDomain
    C1521902
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus ObjectClass
    C25415
    UMLS 2011AA ObjectClass
    C1523987
    NCI Thesaurus Property
    C25382
    UMLS 2011AA Property
    C1521801
    Other specify
    Descrição

    Off-treatmentReasonSpecify

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS 2011AA ValueDomain
    C1521902
    NCI Thesaurus ObjectClass
    C25601
    UMLS 2011AA ObjectClass
    C1518544
    NCI Thesaurus Property
    C25365
    UMLS 2011AA Property
    C0678257
    Protocol Specific Adverse Event Evaluation
    Descrição

    Protocol Specific Adverse Event Evaluation

    Were there any hemorrhage events during this report period
    Descrição

    PatientHistoryHemorrhageEventInd-2

    Tipo de dados

    text

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25499
    UMLS 2011AA Property
    C0441471
    NCI Thesaurus Property
    C26791
    UMLS 2011AA Property
    C0019080
    NCI Metathesaurus Property
    C1321503
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    MedDRA Code
    Descrição

    MedDRACode

    Tipo de dados

    double

    Alias
    NCI Thesaurus ValueDomain
    C25162
    UMLS 2011AA ValueDomain
    C0805701
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Metathesaurus ObjectClass
    CL104089
    CTC Adverse Event Term
    Descrição

    CommonToxicityCriteriaAdverseEventTermType

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C49704
    UMLS 2011AA ObjectClass
    C1516728
    NCI Thesaurus Property
    C45559
    UMLS 2011AA Property
    C1705313
    CTC Adverse Event Term
    Descrição

    CommonToxicityCriteriaAdverseEventTermType

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C49704
    UMLS 2011AA ObjectClass
    C1516728
    NCI Thesaurus Property
    C45559
    UMLS 2011AA Property
    C1705313
    CTC AE Grade
    Descrição

    CommonToxicityCriteriaAdverseEventGrade

    Tipo de dados

    double

    Alias
    NCI Thesaurus ObjectClass
    C49704
    UMLS 2011AA ObjectClass
    C1516728
    NCI Thesaurus ValueDomain
    C18000
    UMLS 2011AA ValueDomain
    C0919553
    NCI Thesaurus Property
    C25365
    UMLS 2011AA Property
    C0678257
    CTC AE Grade
    Descrição

    CommonToxicityCriteriaAdverseEventGrade

    Tipo de dados

    double

    Alias
    NCI Thesaurus ObjectClass
    C49704
    UMLS 2011AA ObjectClass
    C1516728
    NCI Thesaurus ValueDomain
    C18000
    UMLS 2011AA ValueDomain
    C0919553
    NCI Thesaurus Property
    C25365
    UMLS 2011AA Property
    C0678257
    CTCAE Begin Date (MM DD YYYY)
    Descrição

    CTCAdverseEventReportBeginDate

    Tipo de dados

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus Property
    C25375
    UMLS 2011AA Property
    C0684224
    NCI Thesaurus ValueDomain
    C25431
    UMLS 2011AA ValueDomain
    C0439659
    NCI Thesaurus ObjectClass
    C49704
    UMLS 2011AA ObjectClass
    C1516728
    CTCAE Begin Date (MM DD YYYY)
    Descrição

    CTCAdverseEventReportBeginDate

    Tipo de dados

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus Property
    C25375
    UMLS 2011AA Property
    C0684224
    NCI Thesaurus ValueDomain
    C25431
    UMLS 2011AA ValueDomain
    C0439659
    NCI Thesaurus ObjectClass
    C49704
    UMLS 2011AA ObjectClass
    C1516728
    CTC AE Attribution Code
    Descrição

    CTCAdverseEventAttributionScale

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25664
    UMLS 2011AA ValueDomain
    C0349674
    NCI Thesaurus ObjectClass
    C49704
    UMLS 2011AA ObjectClass
    C1516728
    NCI Thesaurus Property
    C25358
    UMLS 2011AA Property
    C0596130
    CTC AE Attribution Code
    Descrição

    CTCAdverseEventAttributionScale

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25664
    UMLS 2011AA ValueDomain
    C0349674
    NCI Thesaurus ObjectClass
    C49704
    UMLS 2011AA ObjectClass
    C1516728
    NCI Thesaurus Property
    C25358
    UMLS 2011AA Property
    C0596130
    SAE report submitted
    Descrição

    SeriousAdverseEventReportInd-3

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus Property
    C25375
    UMLS 2011AA Property
    C0684224
    NCI Thesaurus ObjectClass
    C54035
    UMLS 2011AA ObjectClass
    C0205404
    SAE report submitted
    Descrição

    SeriousAdverseEventReportInd-3

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus Property
    C25375
    UMLS 2011AA Property
    C0684224
    NCI Thesaurus ObjectClass
    C54035
    UMLS 2011AA ObjectClass
    C0205404
    INR (International Normalized Ratio of prothrombin time Value)
    Descrição

    LaboratoryProcedureInternationalNormalizationRatioResultValue

    Tipo de dados

    double

    Alias
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C25352
    UMLS 2011AA Property
    C0525032
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    INR LLN (Institution)
    Descrição

    LaboratoryProcedureInternationalNormalizationRatioResultLowerLimitofNormalValue

    Tipo de dados

    double

    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property
    C25352
    UMLS 2011AA Property
    C0525032
    NCI Thesaurus ValueDomain
    C25555
    UMLS 2011AA ValueDomain
    C1518030
    NCI Thesaurus ValueDomain
    C49100
    UMLS 2011AA ValueDomain
    C1704610
    INR ULN (Institution)
    Descrição

    LaboratoryProcedureInternationalNormalizationRatioResultUpperLimitofNormalValue

    Tipo de dados

    double

    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property
    C25352
    UMLS 2011AA Property
    C0525032
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus ValueDomain
    C25706
    UMLS 2011AA ValueDomain
    C1519815
    PTT (sec) (Partial Thromboplastin Time Value)
    Descrição

    LaboratoryProcedurePartialThromboplastinTimeResultValue

    Tipo de dados

    double

    Alias
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus Property
    C38462
    UMLS 2011AA Property
    C0030605
    PTT LLN (Institution)
    Descrição

    LaboratoryProcedurePartialThromboplastinTimeResultLowerLimitofNormalValue

    Tipo de dados

    double

    Unidades de medida
    • seconds
    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property
    C38462
    UMLS 2011AA Property
    C0030605
    NCI Thesaurus ValueDomain
    C25555
    UMLS 2011AA ValueDomain
    C1518030
    NCI Thesaurus ValueDomain
    C49100
    UMLS 2011AA ValueDomain
    C1704610
    seconds
    PTT ULN (Institution)
    Descrição

    LaboratoryProcedurePartialThromboplastinTimeResultUpperLimitofNormalValue

    Tipo de dados

    double

    Unidades de medida
    • seconds
    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property
    C38462
    UMLS 2011AA Property
    C0030605
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus ValueDomain
    C25706
    UMLS 2011AA ValueDomain
    C1519815
    seconds
    PT (Prothrombin Time Value)
    Descrição

    LaboratoryProcedureProthrombinTimeResultValue

    Tipo de dados

    double

    Unidades de medida
    • seconds
    Alias
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property
    C62656
    UMLS 2011AA Property
    C0033707
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    seconds
    PT LLN (Institution)
    Descrição

    LaboratoryProcedureProthrombinTimeResultLowerLimitofNormalValue

    Tipo de dados

    double

    Unidades de medida
    • seconds
    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property
    C62656
    UMLS 2011AA Property
    C0033707
    NCI Thesaurus ValueDomain
    C25555
    UMLS 2011AA ValueDomain
    C1518030
    NCI Thesaurus ValueDomain
    C49100
    UMLS 2011AA ValueDomain
    C1704610
    seconds
    PT ULN (Institution)
    Descrição

    LaboratoryProcedureProthrombinTimeResultUpperLimitofNormalValue

    Tipo de dados

    double

    Unidades de medida
    • seconds
    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property
    C62656
    UMLS 2011AA Property
    C0033707
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus ValueDomain
    C25706
    UMLS 2011AA ValueDomain
    C1519815
    seconds
    Platelets (PLT) (Platelets x 1000 cmm Value)
    Descrição

    LaboratoryProcedurePlateletResultSpecifiedValue

    Tipo de dados

    double

    Unidades de medida
    • 1000/uL
    Alias
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property
    C12520
    UMLS 2011AA Property
    C0005821
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    1000/uL
    PLT LLN (Institution)
    Descrição

    LaboratoryProcedurePlateletResultLowerLimitofNormalValue

    Tipo de dados

    double

    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property
    C12520
    UMLS 2011AA Property
    C0005821
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus ValueDomain
    C25555
    UMLS 2011AA ValueDomain
    C1518030
    PLT ULN (Institution)
    Descrição

    LaboratoryProcedurePlateletResultUpperLimitofNormalValue

    Tipo de dados

    double

    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property
    C12520
    UMLS 2011AA Property
    C0005821
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus ValueDomain
    C25706
    UMLS 2011AA ValueDomain
    C1519815
    Date (MM DD YYYY)
    Descrição

    LaboratoryProcedureEvaluationPerformedDate

    Tipo de dados

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus Property
    C25214
    UMLS 2011AA Property
    C0220825
    NCI Thesaurus Property
    C38000
    UMLS 2011AA Property
    C0884358
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    Date (MM DD YYYY)
    Descrição

    LaboratoryProcedureEvaluationPerformedDate

    Tipo de dados

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus Property
    C25214
    UMLS 2011AA Property
    C0220825
    NCI Thesaurus Property
    C38000
    UMLS 2011AA Property
    C0884358
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    Date (MM DD YYYY)
    Descrição

    LaboratoryProcedureEvaluationPerformedDate

    Tipo de dados

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus Property
    C25214
    UMLS 2011AA Property
    C0220825
    NCI Thesaurus Property
    C38000
    UMLS 2011AA Property
    C0884358
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    Date (MM DD YYYY)
    Descrição

    LaboratoryProcedureEvaluationPerformedDate

    Tipo de dados

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus Property
    C25214
    UMLS 2011AA Property
    C0220825
    NCI Thesaurus Property
    C38000
    UMLS 2011AA Property
    C0884358
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    Protocol Specific Adverse Event Evaluation
    Descrição

    Protocol Specific Adverse Event Evaluation

    Were there any study-specific adverse events during this report period
    Descrição

    AdverseEventCancerTreatmentRelatedInd-3

    Tipo de dados

    text

    Alias
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus Property
    C3262
    UMLS 2011AA Property
    C0027651
    NCI Thesaurus Property
    C15368
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ValueDomain
    C25648
    UMLS 2011AA ValueDomain
    C0439849
    CTC Adverse Event Term
    Descrição

    CommonToxicityCriteriaAdverseEventTermType

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C49704
    UMLS 2011AA ObjectClass
    C1516728
    NCI Thesaurus Property
    C45559
    UMLS 2011AA Property
    C1705313
    CTC AE Grade
    Descrição

    CommonToxicityCriteriaAdverseEventGrade

    Tipo de dados

    double

    Alias
    NCI Thesaurus ObjectClass
    C49704
    UMLS 2011AA ObjectClass
    C1516728
    NCI Thesaurus ValueDomain
    C18000
    UMLS 2011AA ValueDomain
    C0919553
    NCI Thesaurus Property
    C25365
    UMLS 2011AA Property
    C0678257
    CTCAE Begin Date (MM DD YYYY)
    Descrição

    CTCAdverseEventReportBeginDate

    Tipo de dados

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus Property
    C25375
    UMLS 2011AA Property
    C0684224
    NCI Thesaurus ValueDomain
    C25431
    UMLS 2011AA ValueDomain
    C0439659
    NCI Thesaurus ObjectClass
    C49704
    UMLS 2011AA ObjectClass
    C1516728
    CTC AE Attribution Code
    Descrição

    CTCAdverseEventAttributionScale

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25664
    UMLS 2011AA ValueDomain
    C0349674
    NCI Thesaurus ObjectClass
    C49704
    UMLS 2011AA ObjectClass
    C1516728
    NCI Thesaurus Property
    C25358
    UMLS 2011AA Property
    C0596130
    SAE report submitted
    Descrição

    SeriousAdverseEventReportInd-3

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus Property
    C25375
    UMLS 2011AA Property
    C0684224
    NCI Thesaurus ObjectClass
    C54035
    UMLS 2011AA ObjectClass
    C0205404
    Protocol Specific Adverse Event Evaluation
    Descrição

    Protocol Specific Adverse Event Evaluation

    Any Treatment Related Adverse Events
    Descrição

    TreatmentRelatedAdverseEventReportInd-3

    Tipo de dados

    text

    Alias
    NCI Thesaurus ObjectClass
    C25648
    UMLS 2011AA ObjectClass
    C0439849
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus ObjectClass
    C15368
    NCI Metathesaurus Property
    C0684224
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    MedDRA Code
    Descrição

    MedDRACode

    Tipo de dados

    double

    Alias
    NCI Thesaurus ValueDomain
    C25162
    UMLS 2011AA ValueDomain
    C0805701
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Metathesaurus ObjectClass
    CL104089
    CTC Adverse Event Term
    Descrição

    CommonToxicityCriteriaAdverseEventTermType

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C49704
    UMLS 2011AA ObjectClass
    C1516728
    NCI Thesaurus Property
    C45559
    UMLS 2011AA Property
    C1705313
    CTC AE Grade
    Descrição

    CommonToxicityCriteriaAdverseEventGrade

    Tipo de dados

    double

    Alias
    NCI Thesaurus ObjectClass
    C49704
    UMLS 2011AA ObjectClass
    C1516728
    NCI Thesaurus ValueDomain
    C18000
    UMLS 2011AA ValueDomain
    C0919553
    NCI Thesaurus Property
    C25365
    UMLS 2011AA Property
    C0678257
    CTCAE Begin Date (MM DD YYYY)
    Descrição

    CTCAdverseEventReportBeginDate

    Tipo de dados

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus Property
    C25375
    UMLS 2011AA Property
    C0684224
    NCI Thesaurus ValueDomain
    C25431
    UMLS 2011AA ValueDomain
    C0439659
    NCI Thesaurus ObjectClass
    C49704
    UMLS 2011AA ObjectClass
    C1516728
    CTC AE Attribution Code
    Descrição

    CTCAdverseEventAttributionScale

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25664
    UMLS 2011AA ValueDomain
    C0349674
    NCI Thesaurus ObjectClass
    C49704
    UMLS 2011AA ObjectClass
    C1516728
    NCI Thesaurus Property
    C25358
    UMLS 2011AA Property
    C0596130
    SAE report submitted
    Descrição

    SeriousAdverseEventReportInd-3

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus Property
    C25375
    UMLS 2011AA Property
    C0684224
    NCI Thesaurus ObjectClass
    C54035
    UMLS 2011AA ObjectClass
    C0205404
    Footer Module
    Descrição

    Footer Module

    Comments
    Descrição

    ResearchCommentsText

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS 2011AA ValueDomain
    C1527021
    NCI Thesaurus ObjectClass
    C15319
    NCI Thesaurus Property
    C25393
    UMLS 2011AA Property
    C0282411
    Signature of Person Completing This Form
    Descrição

    ResponsiblePersonSignatureText

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS 2011AA ValueDomain
    C1527021
    NCI Thesaurus ObjectClass
    C25190
    UMLS 2011AA ObjectClass
    C0027361
    NCI Thesaurus ObjectClass
    C25657
    UMLS 2011AA ObjectClass
    C1273518
    NCI Thesaurus Property
    C25678
    UMLS 2011AA Property
    C1519316
    Form Completion Date, Original
    Descrição

    FormOriginalCompleteDate

    Tipo de dados

    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
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    Similar models

    INSTRUCTIONS: Submit this form at the completion of each cycle of salvage treatment. Dates are to be recorded as mm-dd-yyyy unless otherwise specified

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Module 1
    ProtocolRTOGIdentifierNumber
    Item
    RTOG Study No.
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C25320 (NCI Thesaurus ObjectClass)
    C1507394 (UMLS 2011AA ObjectClass)
    C19778 (NCI Thesaurus Property)
    C1514695 (UMLS 2011AA Property)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    RadiationTherapyOncologyGroupPatientCaseIdentifierNumber
    Item
    Case #
    text
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C19778 (NCI Thesaurus ObjectClass)
    C1514695 (UMLS 2011AA ObjectClass)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C49152 (NCI Thesaurus Property)
    C1706256 (UMLS 2011AA Property)
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    InstitutionName
    Item
    Institution Name
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    C21541 (NCI Thesaurus ObjectClass)
    C0018704 (UMLS 2011AA ObjectClass)
    C21541 (NCI Thesaurus ValueDomain)
    C0018704 (UMLS 2011AA ValueDomain)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    InstitutionIdentifierNumber
    Item
    Institution No.
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C21541 (NCI Thesaurus ObjectClass)
    C0018704 (UMLS 2011AA ObjectClass)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    PatientInitialsName
    Item
    Patient Initials
    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)
    PatientRadiationTherapyOncologyGroupIdentifierNumber
    Item
    RTOG Patient ID
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C19778 (NCI Thesaurus Property)
    C1514695 (UMLS 2011AA Property)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    Item
    Amended Data (INSTRUCTIONS: Complete form on web to unblind the protocol treatment arm)
    text
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C25474 (NCI Thesaurus ObjectClass)
    C1511726 (UMLS 2011AA ObjectClass)
    C25416 (NCI Thesaurus Property)
    C1691222 (UMLS 2011AA Property)
    CL.1
    Code List
    Amended Data (INSTRUCTIONS: Complete form on web to unblind the protocol treatment arm)
    CL Item
    Yes (yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item Group
    Assessment
    PatientHeightMeasurement
    Item
    Height (CM)
    double
    C25209 (NCI Thesaurus ValueDomain)
    C0242485 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25347 (NCI Thesaurus Property)
    C0489786 (UMLS 2011AA Property)
    PatientWeightMeasurement
    Item
    Weight (CM)
    double
    C25209 (NCI Thesaurus ValueDomain)
    C0242485 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25208 (NCI Thesaurus Property)
    C0043100 (UMLS 2011AA Property)
    PersonBodySurfaceAreaValue
    Item
    BSA (M2)
    double
    C25190 (NCI Thesaurus ObjectClass)
    C0027361 (UMLS 2011AA ObjectClass)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C25157 (NCI Thesaurus Property)
    C0005902 (UMLS 2011AA Property)
    Item
    Karnofsky Performance Status (Use 9 if unknown)
    text
    C25367 (NCI Thesaurus Property)
    C20641 (NCI Thesaurus ObjectClass)
    C1518965 (UMLS 2011AA ObjectClass)
    C25338 (NCI Thesaurus ValueDomain)
    C0449820 (UMLS 2011AA ValueDomain)
    CL.2
    Code List
    Karnofsky Performance Status (Use 9 if unknown)
    CL Item
    Dead (0)
    CL Item
    Moribund, Fatal Processes Progressing Rapidly (10)
    CL Item
    Normal, No Complaints, No Evidence Of Disease (100)
    CL Item
    Very Sick, Hospitalization Indicated. Death Not Imminent (20)
    CL Item
    Severely Disabled, Hospitalization Indicated. Death Not Imminent (30)
    CL Item
    Disabled, Requires Special Care And Assistance (40)
    CL Item
    Requires Considerable Assistance And Frequent Medical Care (50)
    CL Item
    Requires Occasional Assistance, But Is Able To Care For Most Of His/her Needs (60)
    CL Item
    Cares For Self, Unable To Carry On Normal Activity Or To Do Active Work (70)
    CL Item
    Normal Activity With Effort; Some Signs Or Symptoms Of Disease (80)
    CL Item
    Able To Carry On Normal Activity; Minor Signs Or Symptoms Of Disease (90)
    Item
    Neurologic function
    text
    C25262 (NCI Thesaurus ObjectClass)
    C0205494 (UMLS 2011AA ObjectClass)
    C25518 (NCI Thesaurus ObjectClass)
    C0542341 (UMLS 2011AA ObjectClass)
    C25688 (NCI Thesaurus ValueDomain)
    C0449438 (UMLS 2011AA ValueDomain)
    C25365 (NCI Thesaurus Property)
    C0678257 (UMLS 2011AA Property)
    CL.3
    Code List
    Neurologic function
    CL Item
    Minor Neurologic Symptoms, Fully Active At Home/work Without Assistance (Minor neurologic symptoms, fully active at home/work without assistance)
    CL Item
    Moderate Neurologic Symptoms, Fully Active At Home/work But Requires Assistance (Moderate neurologic symptoms, fully active at home/work but requires assistance)
    CL Item
    Moderate Neurologic Symptoms, Less Than Fully Active At Home/work And Requires Assitance (Moderate neurologic symptoms, less than fully active at home/work and requires assistance)
    CL Item
    No Neurologic Symptoms, Fully Active At Home/work Without Assistance (No neurologic symptoms, fully active at home/work without assistance)
    CL Item
    Severe Neurologic Symptoms, Totally Inactive Requiring Complete Assistance At Home Or Institution, Unable To Work (Severe neurologic symptoms, totally inactive requiring complete assistance at home or institution, unable to work)
    CL Item
    Unknown (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    Item Group
    Disease Progression
    Item
    Salvage treatment being reported
    text
    C25320 (NCI Thesaurus ObjectClass)
    C1507394 (UMLS 2011AA ObjectClass)
    C1708 (NCI Thesaurus ObjectClass)
    C0450442 (UMLS 2011AA ObjectClass)
    C15359 (NCI Thesaurus ObjectClass)
    C0085405 (UMLS 2011AA ObjectClass)
    C25382 (NCI Thesaurus Property)
    C1521801 (UMLS 2011AA Property)
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    CL.4
    Code List
    Salvage treatment being reported
    CL Item
    Bevacizumab Alone (Bevacizumab alone)
    CL Item
    Bevacizumab And Irinotecan (Bevacizumab and Irinotecan)
    CL Item
    Bevacizumab And Tmz Salvage (Bevacizumab and TMZ salvage)
    Item
    Is protocol chemotherapy continuing?
    text
    C15632 (NCI Thesaurus ObjectClass)
    C0392920 (UMLS 2011AA ObjectClass)
    C42651 (NCI Thesaurus ObjectClass)
    C0442711 (UMLS 2011AA ObjectClass)
    C53279 (NCI Thesaurus Property)
    C0549178 (UMLS 2011AA Property)
    C25409 (NCI Thesaurus Property)
    C1533734 (UMLS 2011AA Property)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    CL.5
    Code List
    Is protocol chemotherapy continuing?
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item Group
    Unnamed 3
    AgentName
    Item
    Agent Name
    text
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C1708 (NCI Thesaurus ObjectClass)
    C0450442 (UMLS 2011AA ObjectClass)
    C1708 (NCI Thesaurus ValueDomain)
    C0450442 (UMLS 2011AA ValueDomain)
    C42614 (NCI Thesaurus ValueDomain)
    C0027365 (UMLS 2011AA ValueDomain)
    AgentBeginDate
    Item
    Agent Start Date (MM DD YYYY)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25431 (NCI Thesaurus ValueDomain)
    C0439659 (UMLS 2011AA ValueDomain)
    C1708 (NCI Thesaurus ObjectClass)
    C0450442 (UMLS 2011AA ObjectClass)
    C25275 (NCI Thesaurus Property)
    C2745955 (UMLS 2011AA Property)
    AgentEndDate
    Item
    Agent End Date (MM DD YYYY)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C1708 (NCI Thesaurus ObjectClass)
    C0450442 (UMLS 2011AA ObjectClass)
    C25275 (NCI Thesaurus Property)
    C2745955 (UMLS 2011AA Property)
    AgentCourseTotalDose
    Item
    Agent Total Dose (MG)
    double
    C25304 (NCI Thesaurus ValueDomain)
    C0439810 (UMLS 2011AA ValueDomain)
    C25379 (NCI Thesaurus Property)
    C0750729 (UMLS 2011AA Property)
    C25488 (NCI Thesaurus ValueDomain)
    C0178602 (UMLS 2011AA ValueDomain)
    C1708 (NCI Thesaurus ObjectClass)
    C0450442 (UMLS 2011AA ObjectClass)
    AgentTotalDoseCount
    Item
    Total number of doses
    double
    C25304 (NCI Thesaurus Property)
    C0439810 (UMLS 2011AA Property)
    C25463 (NCI Thesaurus ValueDomain)
    C0750480 (UMLS 2011AA ValueDomain)
    C1708 (NCI Thesaurus ObjectClass)
    C0450442 (UMLS 2011AA ObjectClass)
    C25256 (NCI Thesaurus Property)
    C1265611 (UMLS 2011AA Property)
    Item
    Was dose reduced more than 20%
    text
    C1708 (NCI Thesaurus ObjectClass)
    C0450442 (UMLS 2011AA ObjectClass)
    C25640 (NCI Thesaurus Property)
    C0392756 (UMLS 2011AA Property)
    C25613 (NCI Thesaurus Property)
    C0439165 (UMLS 2011AA Property)
    C25256 (NCI Thesaurus Property)
    C1265611 (UMLS 2011AA Property)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    CL.6
    Code List
    Was dose reduced more than 20%
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item
    Reason for Treatment Modification
    text
    C25638 (NCI Thesaurus ValueDomain)
    C0392360 (UMLS 2011AA ValueDomain)
    C15368 (NCI Thesaurus ObjectClass)
    C25256 (NCI Thesaurus Property)
    C1265611 (UMLS 2011AA Property)
    C25573 (NCI Thesaurus Property)
    CL.7
    Code List
    Reason for Treatment Modification
    CL Item
    Adverse Event/side Effects/complications (Adverse event/side effects/complications)
    CL Item
    Alternative Therapy (Alternative therapy)
    CL Item
    Death On Study (Death on study)
    CL Item
    Disease Progression, Relapse During Active Treatment (Disease progression, relapse during active treatment)
    CL Item
    No Modification (No modification)
    CL Item
    Other (Other)
    C17649 (NCI Thesaurus)
    C0205394 (UMLS 2011AA)
    CL Item
    Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient withdrawal/refusal after beginning protocol therapy)
    CL Item
    Patient Withdrawal Or Refusal Prior To Beginning Protocol Therapy (Patient withdrawal/refusal prior to beginning protocol therapy)
    Item
    Reason Treatment Ended
    text
    C25638 (NCI Thesaurus ValueDomain)
    C0392360 (UMLS 2011AA ValueDomain)
    C25601 (NCI Thesaurus ObjectClass)
    C1518544 (UMLS 2011AA ObjectClass)
    C25365 (NCI Thesaurus Property)
    C0678257 (UMLS 2011AA Property)
    CL.8
    Code List
    Reason Treatment Ended
    CL Item
    Adverse Event/side Effects/complications (Adverse Event/Side Effects/Complications)
    CL Item
    Alternative Therapy (Alternative therapy)
    CL Item
    Death On Study (Death on study)
    CL Item
    Disease Progression, Relapse During Active Treatment (Disease progression, relapse during active treatment)
    CL Item
    Other (Other)
    C17649 (NCI Thesaurus)
    C0205394 (UMLS 2011AA)
    CL Item
    Patient Off-treatment For Other Complicating Disease (Patient off-treatment for other complicating disease)
    CL Item
    Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient withdrawal/refusal after beginning protocol therapy)
    CL Item
    Patient Withdrawal Or Refusal Before Beginning Protocol Therapy (Patient withdrawal/refusal prior to beginning protocol therapy)
    CL Item
    Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
    AlternativeTherapyAdministeredSpecify
    Item
    Alternative therapy, specify
    text
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
    C15368 (NCI Thesaurus ObjectClass)
    C25415 (NCI Thesaurus ObjectClass)
    C1523987 (UMLS 2011AA ObjectClass)
    C25382 (NCI Thesaurus Property)
    C1521801 (UMLS 2011AA Property)
    Off-treatmentReasonSpecify
    Item
    Other specify
    text
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
    C25601 (NCI Thesaurus ObjectClass)
    C1518544 (UMLS 2011AA ObjectClass)
    C25365 (NCI Thesaurus Property)
    C0678257 (UMLS 2011AA Property)
    Item Group
    Protocol Specific Adverse Event Evaluation
    Item
    Were there any hemorrhage events during this report period
    text
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25499 (NCI Thesaurus Property)
    C0441471 (UMLS 2011AA Property)
    C26791 (NCI Thesaurus Property)
    C0019080 (UMLS 2011AA Property)
    C1321503 (NCI Metathesaurus Property)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    CL.9
    Code List
    Were there any hemorrhage events during this report period
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    MedDRACode
    Item
    MedDRA Code
    double
    C25162 (NCI Thesaurus ValueDomain)
    C0805701 (UMLS 2011AA ValueDomain)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    CL104089 (NCI Metathesaurus ObjectClass)
    CommonToxicityCriteriaAdverseEventTermType
    Item
    CTC Adverse Event Term
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C49704 (NCI Thesaurus ObjectClass)
    C1516728 (UMLS 2011AA ObjectClass)
    C45559 (NCI Thesaurus Property)
    C1705313 (UMLS 2011AA Property)
    CommonToxicityCriteriaAdverseEventTermType
    Item
    CTC Adverse Event Term
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C49704 (NCI Thesaurus ObjectClass)
    C1516728 (UMLS 2011AA ObjectClass)
    C45559 (NCI Thesaurus Property)
    C1705313 (UMLS 2011AA Property)
    Item
    CTC AE Grade
    double
    C49704 (NCI Thesaurus ObjectClass)
    C1516728 (UMLS 2011AA ObjectClass)
    C18000 (NCI Thesaurus ValueDomain)
    C0919553 (UMLS 2011AA ValueDomain)
    C25365 (NCI Thesaurus Property)
    C0678257 (UMLS 2011AA Property)
    CL.23
    Code List
    CTC AE Grade
    CL Item
    No Adverse Event Or Within Normal Limits (0)
    CL Item
    Mild Adverse Event (1)
    C41338 (NCI Thesaurus)
    C1513302 (UMLS 2011AA)
    CL Item
    Moderate Adverse Event (2)
    C41339 (NCI Thesaurus)
    C1513374 (UMLS 2011AA)
    CL Item
    Severe Adverse Event (3)
    C41340 (NCI Thesaurus)
    C1519275 (UMLS 2011AA)
    CL Item
    Life-threatening Or Disabling Adverse Event (4)
    CL Item
    Death Related To Adverse Event (5)
    C48275 (NCI Thesaurus)
    C1705232 (UMLS 2011AA)
    Item
    CTC AE Grade
    double
    C49704 (NCI Thesaurus ObjectClass)
    C1516728 (UMLS 2011AA ObjectClass)
    C18000 (NCI Thesaurus ValueDomain)
    C0919553 (UMLS 2011AA ValueDomain)
    C25365 (NCI Thesaurus Property)
    C0678257 (UMLS 2011AA Property)
    CL.23
    Code List
    CTC AE Grade
    CL Item
    No Adverse Event Or Within Normal Limits (0)
    CL Item
    Mild Adverse Event (1)
    C41338 (NCI Thesaurus)
    C1513302 (UMLS 2011AA)
    CL Item
    Moderate Adverse Event (2)
    C41339 (NCI Thesaurus)
    C1513374 (UMLS 2011AA)
    CL Item
    Severe Adverse Event (3)
    C41340 (NCI Thesaurus)
    C1519275 (UMLS 2011AA)
    CL Item
    Life-threatening Or Disabling Adverse Event (4)
    CL Item
    Death Related To Adverse Event (5)
    C48275 (NCI Thesaurus)
    C1705232 (UMLS 2011AA)
    CTCAdverseEventReportBeginDate
    Item
    CTCAE Begin Date (MM DD YYYY)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25375 (NCI Thesaurus Property)
    C0684224 (UMLS 2011AA Property)
    C25431 (NCI Thesaurus ValueDomain)
    C0439659 (UMLS 2011AA ValueDomain)
    C49704 (NCI Thesaurus ObjectClass)
    C1516728 (UMLS 2011AA ObjectClass)
    CTCAdverseEventReportBeginDate
    Item
    CTCAE Begin Date (MM DD YYYY)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25375 (NCI Thesaurus Property)
    C0684224 (UMLS 2011AA Property)
    C25431 (NCI Thesaurus ValueDomain)
    C0439659 (UMLS 2011AA ValueDomain)
    C49704 (NCI Thesaurus ObjectClass)
    C1516728 (UMLS 2011AA ObjectClass)
    Item
    CTC AE Attribution Code
    text
    C25664 (NCI Thesaurus ValueDomain)
    C0349674 (UMLS 2011AA ValueDomain)
    C49704 (NCI Thesaurus ObjectClass)
    C1516728 (UMLS 2011AA ObjectClass)
    C25358 (NCI Thesaurus Property)
    C0596130 (UMLS 2011AA Property)
    CL.24
    Code List
    CTC AE Attribution Code
    CL Item
    Definite (Definite)
    CL209464 (NCI Metathesaurus)
    CL Item
    Possible (Possible)
    C0332149 (NCI Metathesaurus)
    CL Item
    Probable (Probable)
    C0332148 (NCI Metathesaurus)
    CL Item
    Unlikely (Unlikely)
    CL Item
    Unrelated (Unrelated)
    C25328 (NCI Thesaurus)
    C0445356 (UMLS 2011AA)
    Item
    CTC AE Attribution Code
    text
    C25664 (NCI Thesaurus ValueDomain)
    C0349674 (UMLS 2011AA ValueDomain)
    C49704 (NCI Thesaurus ObjectClass)
    C1516728 (UMLS 2011AA ObjectClass)
    C25358 (NCI Thesaurus Property)
    C0596130 (UMLS 2011AA Property)
    CL.24
    Code List
    CTC AE Attribution Code
    CL Item
    Definite (Definite)
    CL209464 (NCI Metathesaurus)
    CL Item
    Possible (Possible)
    C0332149 (NCI Metathesaurus)
    CL Item
    Probable (Probable)
    C0332148 (NCI Metathesaurus)
    CL Item
    Unlikely (Unlikely)
    CL Item
    Unrelated (Unrelated)
    C25328 (NCI Thesaurus)
    C0445356 (UMLS 2011AA)
    Item
    SAE report submitted
    text
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C25375 (NCI Thesaurus Property)
    C0684224 (UMLS 2011AA Property)
    C54035 (NCI Thesaurus ObjectClass)
    C0205404 (UMLS 2011AA ObjectClass)
    CL.25
    Code List
    SAE report submitted
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Unknown (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item
    SAE report submitted
    text
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C25375 (NCI Thesaurus Property)
    C0684224 (UMLS 2011AA Property)
    C54035 (NCI Thesaurus ObjectClass)
    C0205404 (UMLS 2011AA ObjectClass)
    CL.25
    Code List
    SAE report submitted
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Unknown (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    LaboratoryProcedureInternationalNormalizationRatioResultValue
    Item
    INR (International Normalized Ratio of prothrombin time Value)
    double
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C25352 (NCI Thesaurus Property)
    C0525032 (UMLS 2011AA Property)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    LaboratoryProcedureInternationalNormalizationRatioResultLowerLimitofNormalValue
    Item
    INR LLN (Institution)
    double
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C25352 (NCI Thesaurus Property)
    C0525032 (UMLS 2011AA Property)
    C25555 (NCI Thesaurus ValueDomain)
    C1518030 (UMLS 2011AA ValueDomain)
    C49100 (NCI Thesaurus ValueDomain)
    C1704610 (UMLS 2011AA ValueDomain)
    LaboratoryProcedureInternationalNormalizationRatioResultUpperLimitofNormalValue
    Item
    INR ULN (Institution)
    double
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C25352 (NCI Thesaurus Property)
    C0525032 (UMLS 2011AA Property)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C25706 (NCI Thesaurus ValueDomain)
    C1519815 (UMLS 2011AA ValueDomain)
    LaboratoryProcedurePartialThromboplastinTimeResultValue
    Item
    PTT (sec) (Partial Thromboplastin Time Value)
    double
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C38462 (NCI Thesaurus Property)
    C0030605 (UMLS 2011AA Property)
    LaboratoryProcedurePartialThromboplastinTimeResultLowerLimitofNormalValue
    Item
    PTT LLN (Institution)
    double
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C38462 (NCI Thesaurus Property)
    C0030605 (UMLS 2011AA Property)
    C25555 (NCI Thesaurus ValueDomain)
    C1518030 (UMLS 2011AA ValueDomain)
    C49100 (NCI Thesaurus ValueDomain)
    C1704610 (UMLS 2011AA ValueDomain)
    LaboratoryProcedurePartialThromboplastinTimeResultUpperLimitofNormalValue
    Item
    PTT ULN (Institution)
    double
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C38462 (NCI Thesaurus Property)
    C0030605 (UMLS 2011AA Property)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C25706 (NCI Thesaurus ValueDomain)
    C1519815 (UMLS 2011AA ValueDomain)
    LaboratoryProcedureProthrombinTimeResultValue
    Item
    PT (Prothrombin Time Value)
    double
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C62656 (NCI Thesaurus Property)
    C0033707 (UMLS 2011AA Property)
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    LaboratoryProcedureProthrombinTimeResultLowerLimitofNormalValue
    Item
    PT LLN (Institution)
    double
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C62656 (NCI Thesaurus Property)
    C0033707 (UMLS 2011AA Property)
    C25555 (NCI Thesaurus ValueDomain)
    C1518030 (UMLS 2011AA ValueDomain)
    C49100 (NCI Thesaurus ValueDomain)
    C1704610 (UMLS 2011AA ValueDomain)
    LaboratoryProcedureProthrombinTimeResultUpperLimitofNormalValue
    Item
    PT ULN (Institution)
    double
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C62656 (NCI Thesaurus Property)
    C0033707 (UMLS 2011AA Property)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C25706 (NCI Thesaurus ValueDomain)
    C1519815 (UMLS 2011AA ValueDomain)
    LaboratoryProcedurePlateletResultSpecifiedValue
    Item
    Platelets (PLT) (Platelets x 1000 cmm Value)
    double
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C12520 (NCI Thesaurus Property)
    C0005821 (UMLS 2011AA Property)
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    LaboratoryProcedurePlateletResultLowerLimitofNormalValue
    Item
    PLT LLN (Institution)
    double
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C12520 (NCI Thesaurus Property)
    C0005821 (UMLS 2011AA Property)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C25555 (NCI Thesaurus ValueDomain)
    C1518030 (UMLS 2011AA ValueDomain)
    LaboratoryProcedurePlateletResultUpperLimitofNormalValue
    Item
    PLT ULN (Institution)
    double
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C12520 (NCI Thesaurus Property)
    C0005821 (UMLS 2011AA Property)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C25706 (NCI Thesaurus ValueDomain)
    C1519815 (UMLS 2011AA ValueDomain)
    LaboratoryProcedureEvaluationPerformedDate
    Item
    Date (MM DD YYYY)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25214 (NCI Thesaurus Property)
    C0220825 (UMLS 2011AA Property)
    C38000 (NCI Thesaurus Property)
    C0884358 (UMLS 2011AA Property)
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    LaboratoryProcedureEvaluationPerformedDate
    Item
    Date (MM DD YYYY)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25214 (NCI Thesaurus Property)
    C0220825 (UMLS 2011AA Property)
    C38000 (NCI Thesaurus Property)
    C0884358 (UMLS 2011AA Property)
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    LaboratoryProcedureEvaluationPerformedDate
    Item
    Date (MM DD YYYY)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25214 (NCI Thesaurus Property)
    C0220825 (UMLS 2011AA Property)
    C38000 (NCI Thesaurus Property)
    C0884358 (UMLS 2011AA Property)
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    LaboratoryProcedureEvaluationPerformedDate
    Item
    Date (MM DD YYYY)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25214 (NCI Thesaurus Property)
    C0220825 (UMLS 2011AA Property)
    C38000 (NCI Thesaurus Property)
    C0884358 (UMLS 2011AA Property)
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    Item Group
    Protocol Specific Adverse Event Evaluation
    Item
    Were there any study-specific adverse events during this report period
    text
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C3262 (NCI Thesaurus Property)
    C0027651 (UMLS 2011AA Property)
    C15368 (NCI Thesaurus Property)
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C25648 (NCI Thesaurus ValueDomain)
    C0439849 (UMLS 2011AA ValueDomain)
    CL.17
    Code List
    Were there any study-specific adverse events during this report period
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    CommonToxicityCriteriaAdverseEventTermType
    Item
    CTC Adverse Event Term
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C49704 (NCI Thesaurus ObjectClass)
    C1516728 (UMLS 2011AA ObjectClass)
    C45559 (NCI Thesaurus Property)
    C1705313 (UMLS 2011AA Property)
    Item
    CTC AE Grade
    double
    C49704 (NCI Thesaurus ObjectClass)
    C1516728 (UMLS 2011AA ObjectClass)
    C18000 (NCI Thesaurus ValueDomain)
    C0919553 (UMLS 2011AA ValueDomain)
    C25365 (NCI Thesaurus Property)
    C0678257 (UMLS 2011AA Property)
    CL.23
    Code List
    CTC AE Grade
    CL Item
    No Adverse Event Or Within Normal Limits (0)
    CL Item
    Mild Adverse Event (1)
    C41338 (NCI Thesaurus)
    C1513302 (UMLS 2011AA)
    CL Item
    Moderate Adverse Event (2)
    C41339 (NCI Thesaurus)
    C1513374 (UMLS 2011AA)
    CL Item
    Severe Adverse Event (3)
    C41340 (NCI Thesaurus)
    C1519275 (UMLS 2011AA)
    CL Item
    Life-threatening Or Disabling Adverse Event (4)
    CL Item
    Death Related To Adverse Event (5)
    C48275 (NCI Thesaurus)
    C1705232 (UMLS 2011AA)
    CTCAdverseEventReportBeginDate
    Item
    CTCAE Begin Date (MM DD YYYY)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25375 (NCI Thesaurus Property)
    C0684224 (UMLS 2011AA Property)
    C25431 (NCI Thesaurus ValueDomain)
    C0439659 (UMLS 2011AA ValueDomain)
    C49704 (NCI Thesaurus ObjectClass)
    C1516728 (UMLS 2011AA ObjectClass)
    Item
    CTC AE Attribution Code
    text
    C25664 (NCI Thesaurus ValueDomain)
    C0349674 (UMLS 2011AA ValueDomain)
    C49704 (NCI Thesaurus ObjectClass)
    C1516728 (UMLS 2011AA ObjectClass)
    C25358 (NCI Thesaurus Property)
    C0596130 (UMLS 2011AA Property)
    CL.24
    Code List
    CTC AE Attribution Code
    CL Item
    Definite (Definite)
    CL209464 (NCI Metathesaurus)
    CL Item
    Possible (Possible)
    C0332149 (NCI Metathesaurus)
    CL Item
    Probable (Probable)
    C0332148 (NCI Metathesaurus)
    CL Item
    Unlikely (Unlikely)
    CL Item
    Unrelated (Unrelated)
    C25328 (NCI Thesaurus)
    C0445356 (UMLS 2011AA)
    Item
    SAE report submitted
    text
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C25375 (NCI Thesaurus Property)
    C0684224 (UMLS 2011AA Property)
    C54035 (NCI Thesaurus ObjectClass)
    C0205404 (UMLS 2011AA ObjectClass)
    CL.25
    Code List
    SAE report submitted
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Unknown (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item Group
    Protocol Specific Adverse Event Evaluation
    Item
    Any Treatment Related Adverse Events
    text
    C25648 (NCI Thesaurus ObjectClass)
    C0439849 (UMLS 2011AA ObjectClass)
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C15368 (NCI Thesaurus ObjectClass)
    C0684224 (NCI Metathesaurus Property)
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    CL.22
    Code List
    Any Treatment Related Adverse Events
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Unknown (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    MedDRACode
    Item
    MedDRA Code
    double
    C25162 (NCI Thesaurus ValueDomain)
    C0805701 (UMLS 2011AA ValueDomain)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    CL104089 (NCI Metathesaurus ObjectClass)
    CommonToxicityCriteriaAdverseEventTermType
    Item
    CTC Adverse Event Term
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C49704 (NCI Thesaurus ObjectClass)
    C1516728 (UMLS 2011AA ObjectClass)
    C45559 (NCI Thesaurus Property)
    C1705313 (UMLS 2011AA Property)
    Item
    CTC AE Grade
    double
    C49704 (NCI Thesaurus ObjectClass)
    C1516728 (UMLS 2011AA ObjectClass)
    C18000 (NCI Thesaurus ValueDomain)
    C0919553 (UMLS 2011AA ValueDomain)
    C25365 (NCI Thesaurus Property)
    C0678257 (UMLS 2011AA Property)
    CL.23
    Code List
    CTC AE Grade
    CL Item
    No Adverse Event Or Within Normal Limits (0)
    CL Item
    Mild Adverse Event (1)
    C41338 (NCI Thesaurus)
    C1513302 (UMLS 2011AA)
    CL Item
    Moderate Adverse Event (2)
    C41339 (NCI Thesaurus)
    C1513374 (UMLS 2011AA)
    CL Item
    Severe Adverse Event (3)
    C41340 (NCI Thesaurus)
    C1519275 (UMLS 2011AA)
    CL Item
    Life-threatening Or Disabling Adverse Event (4)
    CL Item
    Death Related To Adverse Event (5)
    C48275 (NCI Thesaurus)
    C1705232 (UMLS 2011AA)
    CTCAdverseEventReportBeginDate
    Item
    CTCAE Begin Date (MM DD YYYY)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25375 (NCI Thesaurus Property)
    C0684224 (UMLS 2011AA Property)
    C25431 (NCI Thesaurus ValueDomain)
    C0439659 (UMLS 2011AA ValueDomain)
    C49704 (NCI Thesaurus ObjectClass)
    C1516728 (UMLS 2011AA ObjectClass)
    Item
    CTC AE Attribution Code
    text
    C25664 (NCI Thesaurus ValueDomain)
    C0349674 (UMLS 2011AA ValueDomain)
    C49704 (NCI Thesaurus ObjectClass)
    C1516728 (UMLS 2011AA ObjectClass)
    C25358 (NCI Thesaurus Property)
    C0596130 (UMLS 2011AA Property)
    CL.24
    Code List
    CTC AE Attribution Code
    CL Item
    Definite (Definite)
    CL209464 (NCI Metathesaurus)
    CL Item
    Possible (Possible)
    C0332149 (NCI Metathesaurus)
    CL Item
    Probable (Probable)
    C0332148 (NCI Metathesaurus)
    CL Item
    Unlikely (Unlikely)
    CL Item
    Unrelated (Unrelated)
    C25328 (NCI Thesaurus)
    C0445356 (UMLS 2011AA)
    Item
    SAE report submitted
    text
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C25375 (NCI Thesaurus Property)
    C0684224 (UMLS 2011AA Property)
    C54035 (NCI Thesaurus ObjectClass)
    C0205404 (UMLS 2011AA ObjectClass)
    CL.25
    Code List
    SAE report submitted
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Unknown (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item Group
    Footer Module
    ResearchCommentsText
    Item
    Comments
    text
    C25704 (NCI Thesaurus ValueDomain)
    C1527021 (UMLS 2011AA ValueDomain)
    C15319 (NCI Thesaurus ObjectClass)
    C25393 (NCI Thesaurus Property)
    C0282411 (UMLS 2011AA Property)
    ResponsiblePersonSignatureText
    Item
    Signature of Person Completing This Form
    text
    C25704 (NCI Thesaurus ValueDomain)
    C1527021 (UMLS 2011AA ValueDomain)
    C25190 (NCI Thesaurus ObjectClass)
    C0027361 (UMLS 2011AA ObjectClass)
    C25657 (NCI Thesaurus ObjectClass)
    C1273518 (UMLS 2011AA ObjectClass)
    C25678 (NCI Thesaurus Property)
    C1519316 (UMLS 2011AA Property)
    FormOriginalCompleteDate
    Item
    Form Completion Date, Original
    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)
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