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9672

Descrizione

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

collegamento

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

Keywords

versioni (4)
  1. 26/08/12 26/08/12 -
  2. 09/01/15 09/01/15 - Martin Dugas
  3. 09/01/15 09/01/15 - Martin Dugas
  4. 09/01/15 09/01/15 - Martin Dugas
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9 gennaio 2015

DOI

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Licenza

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

    Inglese

    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 moduli  
    Module 1
    Descrizione

    Module 1

    RTOG Study No.
    Descrizione

    Protocol ID RTOG

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C3274381
    NCI Thesaurus ObjectClass
    C25320
    UMLS CUI-2
    C1514695
    NCI Thesaurus Property
    C19778
    NCI Thesaurus Property-2
    C25364
    Case #
    Descrizione

    RadiationTherapyOncologyGroupPatientCaseIdentifierNumber

    Tipo di dati

    text

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus ObjectClass-2
    C19778
    UMLS 2011AA ObjectClass-2
    C1514695
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus Property-2
    C49152
    UMLS 2011AA Property-2
    C1706256
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    Institution Name
    Descrizione

    Institution Name

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C1301943
    NCI Thesaurus ObjectClass
    C21541
    NCI Thesaurus ValueDomain-2
    C21541
    NCI Thesaurus Property
    C25364
    Institution No.
    Descrizione

    Institution Number

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C1301943
    NCI Thesaurus ObjectClass
    C21541
    UMLS CUI-2
    C0805701
    NCI Thesaurus Property
    C25364
    Patient Initials
    Descrizione

    Patient Initials

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C2986440
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25536
    RTOG Patient ID
    Descrizione

    Trial subject ID RTOG

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C2348585
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-2
    C1514695
    NCI Thesaurus Property
    C19778
    NCI Thesaurus Property-2
    C25364
    Amended Data (INSTRUCTIONS: Complete form on web to unblind the protocol treatment arm)
    Descrizione

    Data amended

    Tipo di dati

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS CUI-1
    C0680532
    NCI Thesaurus ObjectClass
    C25474
    NCI Thesaurus Property
    C25416
    Assessment
    Descrizione

    Assessment

    Height (CM)
    Descrizione

    Patient Height

    Tipo di dati

    float

    Unità di misura
    • cm
    Alias
    NCI Thesaurus ValueDomain
    C25209
    UMLS CUI-1
    C0489786
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25347
    cm
    Weight (CM)
    Descrizione

    Patient Weight

    Tipo di dati

    float

    Unità di misura
    • Kg
    Alias
    NCI Thesaurus ValueDomain
    C25209
    UMLS CUI-1
    C0005910
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25208
    Kg
    BSA (M2)
    Descrizione

    Body Surface Area

    Tipo di dati

    float

    Unità di misura
    • m2
    Alias
    NCI Thesaurus ObjectClass
    C25190
    UMLS CUI-1
    C0005902
    NCI Thesaurus ValueDomain
    C25712
    NCI Thesaurus Property
    C25157
    m2
    Karnofsky Performance Status (Use 9 if unknown)
    Descrizione

    KarnofskyPerformanceStatusScore

    Tipo di dati

    text

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

    NeurologicalFunctionStatus

    Tipo di dati

    text

    Alias
    NCI Thesaurus ObjectClass
    C25262
    UMLS 2011AA ObjectClass
    C0205494
    NCI Thesaurus ObjectClass-2
    C25518
    UMLS 2011AA ObjectClass-2
    C0542341
    NCI Thesaurus ValueDomain
    C25688
    UMLS 2011AA ValueDomain
    C0449438
    NCI Thesaurus Property
    C25365
    UMLS 2011AA Property
    C0678257
    Disease Progression
    Descrizione

    Disease Progression

    Salvage treatment being reported
    Descrizione

    ClinicalStudyProtocolSalvageTherapyAgentAdministeredType

    Tipo di dati

    text

    Alias
    NCI Thesaurus ObjectClass
    C25320
    UMLS 2011AA ObjectClass
    C1507394
    NCI Thesaurus ObjectClass-2
    C1708
    UMLS 2011AA ObjectClass-2
    C0450442
    NCI Thesaurus ObjectClass-3
    C15359
    UMLS 2011AA ObjectClass-3
    C0085405
    NCI Thesaurus Property
    C25382
    UMLS 2011AA Property
    C1521801
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    Is protocol chemotherapy continuing?
    Descrizione

    ProtocolChemotherapyContinueAdministrationInd-2

    Tipo di dati

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C15632
    UMLS 2011AA ObjectClass
    C0392920
    NCI Thesaurus ObjectClass-2
    C42651
    UMLS 2011AA ObjectClass-2
    C0442711
    NCI Thesaurus Property
    C53279
    UMLS 2011AA Property
    C0549178
    NCI Thesaurus Property-2
    C25409
    UMLS 2011AA Property-2
    C1533734
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Unnamed 3
    Descrizione

    Unnamed 3

    Agent Name
    Descrizione

    Agent

    Tipo di dati

    text

    Alias
    NCI Thesaurus Property
    C25364
    UMLS CUI-1
    C1521826
    NCI Thesaurus ObjectClass
    C1708
    NCI Thesaurus ValueDomain
    C1708
    NCI Thesaurus ValueDomain-2
    C42614
    Agent Start Date (MM DD YYYY)
    Descrizione

    Medication Start Date

    Tipo di dati

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C1521826
    NCI Thesaurus ValueDomain-2
    C25431
    UMLS CUI-2
    C0808070
    NCI Thesaurus ObjectClass
    C1708
    NCI Thesaurus Property
    C25275
    Agent End Date (MM DD YYYY)
    Descrizione

    Medication End Date

    Tipo di dati

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C1521826
    NCI Thesaurus ObjectClass
    C1708
    UMLS CUI-2
    C0806020
    NCI Thesaurus Property
    C25275
    Agent Total Dose (MG)
    Descrizione

    Agent Total Dose

    Tipo di dati

    float

    Alias
    NCI Thesaurus ValueDomain
    C25304
    UMLS CUI-1
    C2986497
    NCI Thesaurus Property
    C25379
    NCI Thesaurus ValueDomain-2
    C25488
    NCI Thesaurus ObjectClass
    C1708
    Total number of doses
    Descrizione

    Number of Doses, Total

    Tipo di dati

    float

    Alias
    NCI Thesaurus Property
    C25304
    UMLS CUI-1
    C0178602
    NCI Thesaurus ValueDomain
    C25463
    UMLS CUI-2
    C0750480
    NCI Thesaurus ObjectClass
    C1708
    NCI Thesaurus Property-2
    C25256
    Was dose reduced more than 20%
    Descrizione

    AgentReducedPercentageQuantityInd-2

    Tipo di dati

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C1708
    UMLS 2011AA ObjectClass
    C0450442
    NCI Thesaurus Property
    C25640
    UMLS 2011AA Property
    C0392756
    NCI Thesaurus Property-2
    C25613
    UMLS 2011AA Property-2
    C0439165
    NCI Thesaurus Property-3
    C25256
    UMLS 2011AA Property-3
    C1265611
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Reason for Treatment Modification
    Descrizione

    Dose Modification Reason

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25638
    UMLS CUI-1
    C1707811
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus Property
    C25256
    UMLS CUI-2
    C0392360
    NCI Thesaurus Property-2
    C25573
    Reason Treatment Ended
    Descrizione

    Off Treatment Reason

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25638
    UMLS CUI-1
    C1518544
    NCI Thesaurus ObjectClass
    C25601
    UMLS CUI-2
    C0566251
    NCI Thesaurus Property
    C25365
    Alternative therapy, specify
    Descrizione

    Alternative therapy, specify

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS CUI-1
    C0949216
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus ObjectClass-2
    C25415
    NCI Thesaurus Property
    C25382
    Other specify
    Descrizione

    Off Treatment Reason, specify

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS CUI-1
    C1518544
    NCI Thesaurus ObjectClass
    C25601
    UMLS CUI-2
    C0566251
    NCI Thesaurus Property
    C25365
    UMLS CUI-3
    C1521902
    Protocol Specific Adverse Event Evaluation
    Descrizione

    Protocol Specific Adverse Event Evaluation

    Were there any hemorrhage events during this report period
    Descrizione

    PatientHistoryHemorrhageEventInd-2

    Tipo di dati

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25499
    UMLS 2011AA Property
    C0441471
    NCI Thesaurus Property-2
    C26791
    UMLS 2011AA Property-2
    C0019080
    NCI Metathesaurus Property
    C1321503
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    MedDRA Code
    Descrizione

    MedDRACode

    Tipo di dati

    float

    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
    Descrizione

    CTC Adverse Event Term

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS CUI-1
    C1516728
    NCI Thesaurus ObjectClass
    C49704
    UMLS CUI-2
    C2826934
    NCI Thesaurus Property
    C45559
    CTC Adverse Event Term
    Descrizione

    CTC Adverse Event Term

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS CUI-1
    C1516728
    NCI Thesaurus ObjectClass
    C49704
    UMLS CUI-2
    C2826934
    NCI Thesaurus Property
    C45559
    CTC AE Grade
    Descrizione

    CTC Adverse Event Grade

    Tipo di dati

    float

    Alias
    NCI Thesaurus ObjectClass
    C49704
    UMLS CUI-1
    C2985911
    NCI Thesaurus ValueDomain
    C18000
    NCI Thesaurus Property
    C25365
    CTC AE Grade
    Descrizione

    CTC Adverse Event Grade

    Tipo di dati

    float

    Alias
    NCI Thesaurus ObjectClass
    C49704
    UMLS CUI-1
    C2985911
    NCI Thesaurus ValueDomain
    C18000
    NCI Thesaurus Property
    C25365
    CTCAE Begin Date (MM DD YYYY)
    Descrizione

    Adverse Event Start Date

    Tipo di dati

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C2697888
    NCI Thesaurus Property
    C25375
    NCI Thesaurus ValueDomain-2
    C25431
    NCI Thesaurus ObjectClass
    C49704
    CTCAE Begin Date (MM DD YYYY)
    Descrizione

    Adverse Event Start Date

    Tipo di dati

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C2697888
    NCI Thesaurus Property
    C25375
    NCI Thesaurus ValueDomain-2
    C25431
    NCI Thesaurus ObjectClass
    C49704
    CTC AE Attribution Code
    Descrizione

    CTC Adverse Event Attribution Category

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25664
    UMLS CUI-1
    C1706735
    NCI Thesaurus ObjectClass
    C49704
    NCI Thesaurus Property
    C25358
    CTC AE Attribution Code
    Descrizione

    CTC Adverse Event Attribution Category

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25664
    UMLS CUI-1
    C1706735
    NCI Thesaurus ObjectClass
    C49704
    NCI Thesaurus Property
    C25358
    SAE report submitted
    Descrizione

    SAE report

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS CUI-1
    C1519255
    NCI Thesaurus ObjectClass
    C41331
    UMLS CUI-2
    C0684224
    NCI Thesaurus Property
    C25375
    NCI Thesaurus ObjectClass-2
    C54035
    SAE report submitted
    Descrizione

    SAE report

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS CUI-1
    C1519255
    NCI Thesaurus ObjectClass
    C41331
    UMLS CUI-2
    C0684224
    NCI Thesaurus Property
    C25375
    NCI Thesaurus ObjectClass-2
    C54035
    INR (International Normalized Ratio of prothrombin time Value)
    Descrizione

    INR

    Tipo di dati

    float

    Alias
    NCI Thesaurus Property
    C20200
    UMLS CUI-1
    C0525032
    NCI Thesaurus ObjectClass
    C25294
    NCI Thesaurus Property-2
    C25352
    NCI Thesaurus ValueDomain
    C25712
    INR LLN (Institution)
    Descrizione

    LaboratoryProcedureInternationalNormalizationRatioResultLowerLimitofNormalValue

    Tipo di dati

    float

    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property-2
    C25352
    UMLS 2011AA Property-2
    C0525032
    NCI Thesaurus ValueDomain
    C25555
    UMLS 2011AA ValueDomain
    C1518030
    NCI Thesaurus ValueDomain-2
    C49100
    UMLS 2011AA ValueDomain-2
    C1704610
    INR ULN (Institution)
    Descrizione

    LaboratoryProcedureInternationalNormalizationRatioResultUpperLimitofNormalValue

    Tipo di dati

    float

    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property-2
    C25352
    UMLS 2011AA Property-2
    C0525032
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus ValueDomain-2
    C25706
    UMLS 2011AA ValueDomain-2
    C1519815
    PTT (sec) (Partial Thromboplastin Time Value)
    Descrizione

    LaboratoryProcedurePartialThromboplastinTimeResultValue

    Tipo di dati

    float

    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-2
    C38462
    UMLS 2011AA Property-2
    C0030605
    PTT LLN (Institution)
    Descrizione

    LaboratoryProcedurePartialThromboplastinTimeResultLowerLimitofNormalValue

    Tipo di dati

    float

    Unità di misura
    • seconds
    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property-2
    C38462
    UMLS 2011AA Property-2
    C0030605
    NCI Thesaurus ValueDomain
    C25555
    UMLS 2011AA ValueDomain
    C1518030
    NCI Thesaurus ValueDomain-2
    C49100
    UMLS 2011AA ValueDomain-2
    C1704610
    seconds
    PTT ULN (Institution)
    Descrizione

    LaboratoryProcedurePartialThromboplastinTimeResultUpperLimitofNormalValue

    Tipo di dati

    float

    Unità di misura
    • seconds
    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property-2
    C38462
    UMLS 2011AA Property-2
    C0030605
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus ValueDomain-2
    C25706
    UMLS 2011AA ValueDomain-2
    C1519815
    seconds
    PT (Prothrombin Time Value)
    Descrizione

    LaboratoryProcedureProthrombinTimeResultValue

    Tipo di dati

    float

    Unità di misura
    • seconds
    Alias
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property-2
    C62656
    UMLS 2011AA Property-2
    C0033707
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    seconds
    PT LLN (Institution)
    Descrizione

    LaboratoryProcedureProthrombinTimeResultLowerLimitofNormalValue

    Tipo di dati

    float

    Unità di misura
    • seconds
    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property-2
    C62656
    UMLS 2011AA Property-2
    C0033707
    NCI Thesaurus ValueDomain
    C25555
    UMLS 2011AA ValueDomain
    C1518030
    NCI Thesaurus ValueDomain-2
    C49100
    UMLS 2011AA ValueDomain-2
    C1704610
    seconds
    PT ULN (Institution)
    Descrizione

    LaboratoryProcedureProthrombinTimeResultUpperLimitofNormalValue

    Tipo di dati

    float

    Unità di misura
    • seconds
    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property-2
    C62656
    UMLS 2011AA Property-2
    C0033707
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus ValueDomain-2
    C25706
    UMLS 2011AA ValueDomain-2
    C1519815
    seconds
    Platelets (PLT) (Platelets x 1000 cmm Value)
    Descrizione

    Platelets

    Tipo di dati

    float

    Unità di misura
    • 1000/uL
    Alias
    NCI Thesaurus Property
    C20200
    UMLS CUI-1
    C0005821
    NCI Thesaurus Property-2
    C12520
    NCI Thesaurus ObjectClass
    C25294
    NCI Thesaurus ValueDomain
    C25712
    1000/uL
    PLT LLN (Institution)
    Descrizione

    Platelets LLN

    Tipo di dati

    float

    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS CUI-1
    C0005821
    NCI Thesaurus Property
    C20200
    UMLS CUI-2
    C1518030
    NCI Thesaurus Property-2
    C12520
    NCI Thesaurus ValueDomain
    C25712
    NCI Thesaurus ValueDomain-2
    C25555
    PLT ULN (Institution)
    Descrizione

    LaboratoryProcedurePlateletResultUpperLimitofNormalValue

    Tipo di dati

    float

    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property-2
    C12520
    UMLS 2011AA Property-2
    C0005821
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus ValueDomain-2
    C25706
    UMLS 2011AA ValueDomain-2
    C1519815
    Date (MM DD YYYY)
    Descrizione

    Laboratory Procedure Date

    Tipo di dati

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C0022885
    NCI Thesaurus Property
    C25214
    UMLS CUI-2
    C0011008
    NCI Thesaurus Property-2
    C38000
    NCI Thesaurus ObjectClass
    C25294
    Date (MM DD YYYY)
    Descrizione

    Laboratory Procedure Date

    Tipo di dati

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C0022885
    NCI Thesaurus Property
    C25214
    UMLS CUI-2
    C0011008
    NCI Thesaurus Property-2
    C38000
    NCI Thesaurus ObjectClass
    C25294
    Date (MM DD YYYY)
    Descrizione

    Laboratory Procedure Date

    Tipo di dati

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C0022885
    NCI Thesaurus Property
    C25214
    UMLS CUI-2
    C0011008
    NCI Thesaurus Property-2
    C38000
    NCI Thesaurus ObjectClass
    C25294
    Date (MM DD YYYY)
    Descrizione

    Laboratory Procedure Date

    Tipo di dati

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C0022885
    NCI Thesaurus Property
    C25214
    UMLS CUI-2
    C0011008
    NCI Thesaurus Property-2
    C38000
    NCI Thesaurus ObjectClass
    C25294
    Protocol Specific Adverse Event Evaluation
    Descrizione

    Protocol Specific Adverse Event Evaluation

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

    AdverseEventCancerTreatmentRelatedInd-3

    Tipo di dati

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus Property
    C3262
    UMLS 2011AA Property
    C0027651
    NCI Thesaurus Property-2
    C15368
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ValueDomain-2
    C25648
    UMLS 2011AA ValueDomain-2
    C0439849
    CTC Adverse Event Term
    Descrizione

    CTC Adverse Event Term

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS CUI-1
    C1516728
    NCI Thesaurus ObjectClass
    C49704
    UMLS CUI-2
    C2826934
    NCI Thesaurus Property
    C45559
    CTC AE Grade
    Descrizione

    CTC Adverse Event Grade

    Tipo di dati

    float

    Alias
    NCI Thesaurus ObjectClass
    C49704
    UMLS CUI-1
    C2985911
    NCI Thesaurus ValueDomain
    C18000
    NCI Thesaurus Property
    C25365
    CTCAE Begin Date (MM DD YYYY)
    Descrizione

    Adverse Event Start Date

    Tipo di dati

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C2697888
    NCI Thesaurus Property
    C25375
    NCI Thesaurus ValueDomain-2
    C25431
    NCI Thesaurus ObjectClass
    C49704
    CTC AE Attribution Code
    Descrizione

    CTC Adverse Event Attribution Category

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25664
    UMLS CUI-1
    C1706735
    NCI Thesaurus ObjectClass
    C49704
    NCI Thesaurus Property
    C25358
    SAE report submitted
    Descrizione

    SAE report

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS CUI-1
    C1519255
    NCI Thesaurus ObjectClass
    C41331
    UMLS CUI-2
    C0684224
    NCI Thesaurus Property
    C25375
    NCI Thesaurus ObjectClass-2
    C54035
    Protocol Specific Adverse Event Evaluation
    Descrizione

    Protocol Specific Adverse Event Evaluation

    Any Treatment Related Adverse Events
    Descrizione

    Adverse Event

    Tipo di dati

    text

    Alias
    NCI Thesaurus ObjectClass
    C25648
    UMLS CUI-1
    C0877248
    NCI Thesaurus ObjectClass-2
    C41331
    NCI Thesaurus ObjectClass-3
    C15368
    NCI Metathesaurus Property
    C0684224
    NCI Thesaurus ValueDomain
    C38148
    MedDRA Code
    Descrizione

    MedDRACode

    Tipo di dati

    float

    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
    Descrizione

    CTC Adverse Event Term

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS CUI-1
    C1516728
    NCI Thesaurus ObjectClass
    C49704
    UMLS CUI-2
    C2826934
    NCI Thesaurus Property
    C45559
    CTC AE Grade
    Descrizione

    CTC Adverse Event Grade

    Tipo di dati

    float

    Alias
    NCI Thesaurus ObjectClass
    C49704
    UMLS CUI-1
    C2985911
    NCI Thesaurus ValueDomain
    C18000
    NCI Thesaurus Property
    C25365
    CTCAE Begin Date (MM DD YYYY)
    Descrizione

    Adverse Event Start Date

    Tipo di dati

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C2697888
    NCI Thesaurus Property
    C25375
    NCI Thesaurus ValueDomain-2
    C25431
    NCI Thesaurus ObjectClass
    C49704
    CTC AE Attribution Code
    Descrizione

    CTC Adverse Event Attribution Category

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25664
    UMLS CUI-1
    C1706735
    NCI Thesaurus ObjectClass
    C49704
    NCI Thesaurus Property
    C25358
    SAE report submitted
    Descrizione

    SAE report

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS CUI-1
    C1519255
    NCI Thesaurus ObjectClass
    C41331
    UMLS CUI-2
    C0684224
    NCI Thesaurus Property
    C25375
    NCI Thesaurus ObjectClass-2
    C54035
    Footer Module
    Descrizione

    Footer Module

    Comments
    Descrizione

    Research Comments

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS CUI-1
    C0947611
    NCI Thesaurus ObjectClass
    C15319
    NCI Thesaurus Property
    C25393
    Signature of Person Completing This Form
    Descrizione

    Responsible Person Signature

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS CUI-1
    C1550483
    NCI Thesaurus ObjectClass
    C25190
    NCI Thesaurus ObjectClass-2
    C25657
    NCI Thesaurus Property
    C25678
    Form Completion Date, Original
    Descrizione

    Form Completion Date

    Tipo di dati

    date

    Alias
    NCI Thesaurus ObjectClass
    C19464
    UMLS CUI-1
    C1549507
    NCI Thesaurus Property
    C25250
    NCI Thesaurus Property-2
    C25604
    NCI Thesaurus ValueDomain
    C25164
    NCI Thesaurus ValueDomain-2
    C25367
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    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 moduli
    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    Module 1
    Protocol ID RTOG
    Item
    RTOG Study No.
    text
    C25337 (NCI Thesaurus ValueDomain)
    C3274381 (UMLS CUI-1)
    C25320 (NCI Thesaurus ObjectClass)
    C1514695 (UMLS CUI-2)
    C19778 (NCI Thesaurus Property)
    C25364 (NCI Thesaurus Property-2)
    RadiationTherapyOncologyGroupPatientCaseIdentifierNumber
    Item
    Case #
    text
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C19778 (NCI Thesaurus ObjectClass-2)
    C1514695 (UMLS 2011AA ObjectClass-2)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C49152 (NCI Thesaurus Property-2)
    C1706256 (UMLS 2011AA Property-2)
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    Institution Name
    Item
    Institution Name
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1301943 (UMLS CUI-1)
    C21541 (NCI Thesaurus ObjectClass)
    C21541 (NCI Thesaurus ValueDomain-2)
    C25364 (NCI Thesaurus Property)
    Institution Number
    Item
    Institution No.
    text
    C25337 (NCI Thesaurus ValueDomain)
    C1301943 (UMLS CUI-1)
    C21541 (NCI Thesaurus ObjectClass)
    C0805701 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    Patient Initials
    Item
    Patient Initials
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2986440 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25536 (NCI Thesaurus Property)
    Trial subject ID RTOG
    Item
    RTOG Patient ID
    text
    C25337 (NCI Thesaurus ValueDomain)
    C2348585 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C1514695 (UMLS CUI-2)
    C19778 (NCI Thesaurus Property)
    C25364 (NCI Thesaurus Property-2)
    Data amended
    Item
    Amended Data (INSTRUCTIONS: Complete form on web to unblind the protocol treatment arm)
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C0680532 (UMLS CUI-1)
    C25474 (NCI Thesaurus ObjectClass)
    C25416 (NCI Thesaurus Property)
    Item Group
    Assessment
    Patient Height
    Item
    Height (CM)
    float
    C25209 (NCI Thesaurus ValueDomain)
    C0489786 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25347 (NCI Thesaurus Property)
    Patient Weight
    Item
    Weight (CM)
    float
    C25209 (NCI Thesaurus ValueDomain)
    C0005910 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25208 (NCI Thesaurus Property)
    Body Surface Area
    Item
    BSA (M2)
    float
    C25190 (NCI Thesaurus ObjectClass)
    C0005902 (UMLS CUI-1)
    C25712 (NCI Thesaurus ValueDomain)
    C25157 (NCI Thesaurus 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-2)
    C0542341 (UMLS 2011AA ObjectClass-2)
    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-2)
    C0450442 (UMLS 2011AA ObjectClass-2)
    C15359 (NCI Thesaurus ObjectClass-3)
    C0085405 (UMLS 2011AA ObjectClass-3)
    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)
    ProtocolChemotherapyContinueAdministrationInd-2
    Item
    Is protocol chemotherapy continuing?
    boolean
    C15632 (NCI Thesaurus ObjectClass)
    C0392920 (UMLS 2011AA ObjectClass)
    C42651 (NCI Thesaurus ObjectClass-2)
    C0442711 (UMLS 2011AA ObjectClass-2)
    C53279 (NCI Thesaurus Property)
    C0549178 (UMLS 2011AA Property)
    C25409 (NCI Thesaurus Property-2)
    C1533734 (UMLS 2011AA Property-2)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    Item Group
    Unnamed 3
    Agent
    Item
    Agent Name
    text
    C25364 (NCI Thesaurus Property)
    C1521826 (UMLS CUI-1)
    C1708 (NCI Thesaurus ObjectClass)
    C1708 (NCI Thesaurus ValueDomain)
    C42614 (NCI Thesaurus ValueDomain-2)
    Medication Start Date
    Item
    Agent Start Date (MM DD YYYY)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C1521826 (UMLS CUI-1)
    C25431 (NCI Thesaurus ValueDomain-2)
    C0808070 (UMLS CUI-2)
    C1708 (NCI Thesaurus ObjectClass)
    C25275 (NCI Thesaurus Property)
    Medication End Date
    Item
    Agent End Date (MM DD YYYY)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C1521826 (UMLS CUI-1)
    C1708 (NCI Thesaurus ObjectClass)
    C0806020 (UMLS CUI-2)
    C25275 (NCI Thesaurus Property)
    Agent Total Dose
    Item
    Agent Total Dose (MG)
    float
    C25304 (NCI Thesaurus ValueDomain)
    C2986497 (UMLS CUI-1)
    C25379 (NCI Thesaurus Property)
    C25488 (NCI Thesaurus ValueDomain-2)
    C1708 (NCI Thesaurus ObjectClass)
    Number of Doses, Total
    Item
    Total number of doses
    float
    C25304 (NCI Thesaurus Property)
    C0178602 (UMLS CUI-1)
    C25463 (NCI Thesaurus ValueDomain)
    C0750480 (UMLS CUI-2)
    C1708 (NCI Thesaurus ObjectClass)
    C25256 (NCI Thesaurus Property-2)
    AgentReducedPercentageQuantityInd-2
    Item
    Was dose reduced more than 20%
    boolean
    C1708 (NCI Thesaurus ObjectClass)
    C0450442 (UMLS 2011AA ObjectClass)
    C25640 (NCI Thesaurus Property)
    C0392756 (UMLS 2011AA Property)
    C25613 (NCI Thesaurus Property-2)
    C0439165 (UMLS 2011AA Property-2)
    C25256 (NCI Thesaurus Property-3)
    C1265611 (UMLS 2011AA Property-3)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    Item
    Reason for Treatment Modification
    text
    C25638 (NCI Thesaurus ValueDomain)
    C1707811 (UMLS CUI-1)
    C15368 (NCI Thesaurus ObjectClass)
    C25256 (NCI Thesaurus Property)
    C0392360 (UMLS CUI-2)
    C25573 (NCI Thesaurus Property-2)
    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)
    C1518544 (UMLS CUI-1)
    C25601 (NCI Thesaurus ObjectClass)
    C0566251 (UMLS CUI-2)
    C25365 (NCI Thesaurus 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)
    Alternative therapy, specify
    Item
    Alternative therapy, specify
    text
    C25685 (NCI Thesaurus ValueDomain)
    C0949216 (UMLS CUI-1)
    C15368 (NCI Thesaurus ObjectClass)
    C25415 (NCI Thesaurus ObjectClass-2)
    C25382 (NCI Thesaurus Property)
    Off Treatment Reason, specify
    Item
    Other specify
    text
    C25685 (NCI Thesaurus ValueDomain)
    C1518544 (UMLS CUI-1)
    C25601 (NCI Thesaurus ObjectClass)
    C0566251 (UMLS CUI-2)
    C25365 (NCI Thesaurus Property)
    C1521902 (UMLS CUI-3)
    Item Group
    Protocol Specific Adverse Event Evaluation
    PatientHistoryHemorrhageEventInd-2
    Item
    Were there any hemorrhage events during this report period
    boolean
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25499 (NCI Thesaurus Property)
    C0441471 (UMLS 2011AA Property)
    C26791 (NCI Thesaurus Property-2)
    C0019080 (UMLS 2011AA Property-2)
    C1321503 (NCI Metathesaurus Property)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    MedDRACode
    Item
    MedDRA Code
    float
    C25162 (NCI Thesaurus ValueDomain)
    C0805701 (UMLS 2011AA ValueDomain)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    CL104089 (NCI Metathesaurus ObjectClass)
    CTC Adverse Event Term
    Item
    CTC Adverse Event Term
    text
    C25284 (NCI Thesaurus ValueDomain)
    C1516728 (UMLS CUI-1)
    C49704 (NCI Thesaurus ObjectClass)
    C2826934 (UMLS CUI-2)
    C45559 (NCI Thesaurus Property)
    CTC Adverse Event Term
    Item
    CTC Adverse Event Term
    text
    C25284 (NCI Thesaurus ValueDomain)
    C1516728 (UMLS CUI-1)
    C49704 (NCI Thesaurus ObjectClass)
    C2826934 (UMLS CUI-2)
    C45559 (NCI Thesaurus Property)
    CTC Adverse Event Grade
    Item
    CTC AE Grade
    float
    C49704 (NCI Thesaurus ObjectClass)
    C2985911 (UMLS CUI-1)
    C18000 (NCI Thesaurus ValueDomain)
    C25365 (NCI Thesaurus Property)
    CTC Adverse Event Grade
    Item
    CTC AE Grade
    float
    C49704 (NCI Thesaurus ObjectClass)
    C2985911 (UMLS CUI-1)
    C18000 (NCI Thesaurus ValueDomain)
    C25365 (NCI Thesaurus Property)
    Adverse Event Start Date
    Item
    CTCAE Begin Date (MM DD YYYY)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C2697888 (UMLS CUI-1)
    C25375 (NCI Thesaurus Property)
    C25431 (NCI Thesaurus ValueDomain-2)
    C49704 (NCI Thesaurus ObjectClass)
    Adverse Event Start Date
    Item
    CTCAE Begin Date (MM DD YYYY)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C2697888 (UMLS CUI-1)
    C25375 (NCI Thesaurus Property)
    C25431 (NCI Thesaurus ValueDomain-2)
    C49704 (NCI Thesaurus ObjectClass)
    Item
    CTC AE Attribution Code
    text
    C25664 (NCI Thesaurus ValueDomain)
    C1706735 (UMLS CUI-1)
    C49704 (NCI Thesaurus ObjectClass)
    C25358 (NCI Thesaurus 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)
    C1706735 (UMLS CUI-1)
    C49704 (NCI Thesaurus ObjectClass)
    C25358 (NCI Thesaurus 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)
    C1519255 (UMLS CUI-1)
    C41331 (NCI Thesaurus ObjectClass)
    C0684224 (UMLS CUI-2)
    C25375 (NCI Thesaurus Property)
    C54035 (NCI Thesaurus ObjectClass-2)
    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)
    C1519255 (UMLS CUI-1)
    C41331 (NCI Thesaurus ObjectClass)
    C0684224 (UMLS CUI-2)
    C25375 (NCI Thesaurus Property)
    C54035 (NCI Thesaurus ObjectClass-2)
    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)
    INR
    Item
    INR (International Normalized Ratio of prothrombin time Value)
    float
    C20200 (NCI Thesaurus Property)
    C0525032 (UMLS CUI-1)
    C25294 (NCI Thesaurus ObjectClass)
    C25352 (NCI Thesaurus Property-2)
    C25712 (NCI Thesaurus ValueDomain)
    LaboratoryProcedureInternationalNormalizationRatioResultLowerLimitofNormalValue
    Item
    INR LLN (Institution)
    float
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C25352 (NCI Thesaurus Property-2)
    C0525032 (UMLS 2011AA Property-2)
    C25555 (NCI Thesaurus ValueDomain)
    C1518030 (UMLS 2011AA ValueDomain)
    C49100 (NCI Thesaurus ValueDomain-2)
    C1704610 (UMLS 2011AA ValueDomain-2)
    LaboratoryProcedureInternationalNormalizationRatioResultUpperLimitofNormalValue
    Item
    INR ULN (Institution)
    float
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C25352 (NCI Thesaurus Property-2)
    C0525032 (UMLS 2011AA Property-2)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C25706 (NCI Thesaurus ValueDomain-2)
    C1519815 (UMLS 2011AA ValueDomain-2)
    LaboratoryProcedurePartialThromboplastinTimeResultValue
    Item
    PTT (sec) (Partial Thromboplastin Time Value)
    float
    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-2)
    C0030605 (UMLS 2011AA Property-2)
    LaboratoryProcedurePartialThromboplastinTimeResultLowerLimitofNormalValue
    Item
    PTT LLN (Institution)
    float
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C38462 (NCI Thesaurus Property-2)
    C0030605 (UMLS 2011AA Property-2)
    C25555 (NCI Thesaurus ValueDomain)
    C1518030 (UMLS 2011AA ValueDomain)
    C49100 (NCI Thesaurus ValueDomain-2)
    C1704610 (UMLS 2011AA ValueDomain-2)
    LaboratoryProcedurePartialThromboplastinTimeResultUpperLimitofNormalValue
    Item
    PTT ULN (Institution)
    float
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C38462 (NCI Thesaurus Property-2)
    C0030605 (UMLS 2011AA Property-2)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C25706 (NCI Thesaurus ValueDomain-2)
    C1519815 (UMLS 2011AA ValueDomain-2)
    LaboratoryProcedureProthrombinTimeResultValue
    Item
    PT (Prothrombin Time Value)
    float
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C62656 (NCI Thesaurus Property-2)
    C0033707 (UMLS 2011AA Property-2)
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    LaboratoryProcedureProthrombinTimeResultLowerLimitofNormalValue
    Item
    PT LLN (Institution)
    float
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C62656 (NCI Thesaurus Property-2)
    C0033707 (UMLS 2011AA Property-2)
    C25555 (NCI Thesaurus ValueDomain)
    C1518030 (UMLS 2011AA ValueDomain)
    C49100 (NCI Thesaurus ValueDomain-2)
    C1704610 (UMLS 2011AA ValueDomain-2)
    LaboratoryProcedureProthrombinTimeResultUpperLimitofNormalValue
    Item
    PT ULN (Institution)
    float
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C62656 (NCI Thesaurus Property-2)
    C0033707 (UMLS 2011AA Property-2)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C25706 (NCI Thesaurus ValueDomain-2)
    C1519815 (UMLS 2011AA ValueDomain-2)
    Platelets
    Item
    Platelets (PLT) (Platelets x 1000 cmm Value)
    float
    C20200 (NCI Thesaurus Property)
    C0005821 (UMLS CUI-1)
    C12520 (NCI Thesaurus Property-2)
    C25294 (NCI Thesaurus ObjectClass)
    C25712 (NCI Thesaurus ValueDomain)
    Platelets LLN
    Item
    PLT LLN (Institution)
    float
    C25294 (NCI Thesaurus ObjectClass)
    C0005821 (UMLS CUI-1)
    C20200 (NCI Thesaurus Property)
    C1518030 (UMLS CUI-2)
    C12520 (NCI Thesaurus Property-2)
    C25712 (NCI Thesaurus ValueDomain)
    C25555 (NCI Thesaurus ValueDomain-2)
    LaboratoryProcedurePlateletResultUpperLimitofNormalValue
    Item
    PLT ULN (Institution)
    float
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C12520 (NCI Thesaurus Property-2)
    C0005821 (UMLS 2011AA Property-2)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C25706 (NCI Thesaurus ValueDomain-2)
    C1519815 (UMLS 2011AA ValueDomain-2)
    Laboratory Procedure Date
    Item
    Date (MM DD YYYY)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0022885 (UMLS CUI-1)
    C25214 (NCI Thesaurus Property)
    C0011008 (UMLS CUI-2)
    C38000 (NCI Thesaurus Property-2)
    C25294 (NCI Thesaurus ObjectClass)
    Laboratory Procedure Date
    Item
    Date (MM DD YYYY)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0022885 (UMLS CUI-1)
    C25214 (NCI Thesaurus Property)
    C0011008 (UMLS CUI-2)
    C38000 (NCI Thesaurus Property-2)
    C25294 (NCI Thesaurus ObjectClass)
    Laboratory Procedure Date
    Item
    Date (MM DD YYYY)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0022885 (UMLS CUI-1)
    C25214 (NCI Thesaurus Property)
    C0011008 (UMLS CUI-2)
    C38000 (NCI Thesaurus Property-2)
    C25294 (NCI Thesaurus ObjectClass)
    Laboratory Procedure Date
    Item
    Date (MM DD YYYY)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0022885 (UMLS CUI-1)
    C25214 (NCI Thesaurus Property)
    C0011008 (UMLS CUI-2)
    C38000 (NCI Thesaurus Property-2)
    C25294 (NCI Thesaurus ObjectClass)
    Item Group
    Protocol Specific Adverse Event Evaluation
    AdverseEventCancerTreatmentRelatedInd-3
    Item
    Were there any study-specific adverse events during this report period
    boolean
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C3262 (NCI Thesaurus Property)
    C0027651 (UMLS 2011AA Property)
    C15368 (NCI Thesaurus Property-2)
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C25648 (NCI Thesaurus ValueDomain-2)
    C0439849 (UMLS 2011AA ValueDomain-2)
    CTC Adverse Event Term
    Item
    CTC Adverse Event Term
    text
    C25284 (NCI Thesaurus ValueDomain)
    C1516728 (UMLS CUI-1)
    C49704 (NCI Thesaurus ObjectClass)
    C2826934 (UMLS CUI-2)
    C45559 (NCI Thesaurus Property)
    CTC Adverse Event Grade
    Item
    CTC AE Grade
    float
    C49704 (NCI Thesaurus ObjectClass)
    C2985911 (UMLS CUI-1)
    C18000 (NCI Thesaurus ValueDomain)
    C25365 (NCI Thesaurus Property)
    Adverse Event Start Date
    Item
    CTCAE Begin Date (MM DD YYYY)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C2697888 (UMLS CUI-1)
    C25375 (NCI Thesaurus Property)
    C25431 (NCI Thesaurus ValueDomain-2)
    C49704 (NCI Thesaurus ObjectClass)
    Item
    CTC AE Attribution Code
    text
    C25664 (NCI Thesaurus ValueDomain)
    C1706735 (UMLS CUI-1)
    C49704 (NCI Thesaurus ObjectClass)
    C25358 (NCI Thesaurus 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)
    C1519255 (UMLS CUI-1)
    C41331 (NCI Thesaurus ObjectClass)
    C0684224 (UMLS CUI-2)
    C25375 (NCI Thesaurus Property)
    C54035 (NCI Thesaurus ObjectClass-2)
    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)
    C0877248 (UMLS CUI-1)
    C41331 (NCI Thesaurus ObjectClass-2)
    C15368 (NCI Thesaurus ObjectClass-3)
    C0684224 (NCI Metathesaurus Property)
    C38148 (NCI Thesaurus 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
    float
    C25162 (NCI Thesaurus ValueDomain)
    C0805701 (UMLS 2011AA ValueDomain)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    CL104089 (NCI Metathesaurus ObjectClass)
    CTC Adverse Event Term
    Item
    CTC Adverse Event Term
    text
    C25284 (NCI Thesaurus ValueDomain)
    C1516728 (UMLS CUI-1)
    C49704 (NCI Thesaurus ObjectClass)
    C2826934 (UMLS CUI-2)
    C45559 (NCI Thesaurus Property)
    CTC Adverse Event Grade
    Item
    CTC AE Grade
    float
    C49704 (NCI Thesaurus ObjectClass)
    C2985911 (UMLS CUI-1)
    C18000 (NCI Thesaurus ValueDomain)
    C25365 (NCI Thesaurus Property)
    Adverse Event Start Date
    Item
    CTCAE Begin Date (MM DD YYYY)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C2697888 (UMLS CUI-1)
    C25375 (NCI Thesaurus Property)
    C25431 (NCI Thesaurus ValueDomain-2)
    C49704 (NCI Thesaurus ObjectClass)
    Item
    CTC AE Attribution Code
    text
    C25664 (NCI Thesaurus ValueDomain)
    C1706735 (UMLS CUI-1)
    C49704 (NCI Thesaurus ObjectClass)
    C25358 (NCI Thesaurus 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)
    C1519255 (UMLS CUI-1)
    C41331 (NCI Thesaurus ObjectClass)
    C0684224 (UMLS CUI-2)
    C25375 (NCI Thesaurus Property)
    C54035 (NCI Thesaurus ObjectClass-2)
    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
    Research Comments
    Item
    Comments
    text
    C25704 (NCI Thesaurus ValueDomain)
    C0947611 (UMLS CUI-1)
    C15319 (NCI Thesaurus ObjectClass)
    C25393 (NCI Thesaurus Property)
    Responsible Person Signature
    Item
    Signature of Person Completing This Form
    text
    C25704 (NCI Thesaurus ValueDomain)
    C1550483 (UMLS CUI-1)
    C25190 (NCI Thesaurus ObjectClass)
    C25657 (NCI Thesaurus ObjectClass-2)
    C25678 (NCI Thesaurus Property)
    Form Completion Date
    Item
    Form Completion Date, Original
    date
    C19464 (NCI Thesaurus ObjectClass)
    C1549507 (UMLS CUI-1)
    C25250 (NCI Thesaurus Property)
    C25604 (NCI Thesaurus Property-2)
    C25164 (NCI Thesaurus ValueDomain)
    C25367 (NCI Thesaurus ValueDomain-2)
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