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ID

8671

Descrição

RTOG-0412 AE: Adverse Event Evaluation Form Cisplatin and Docetaxel With or Without Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Newly Diagnosed Stage III Non-Small Cell Lung Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=E488DFC2-2D0B-654D-E034-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=E488DFC2-2D0B-654D-E034-0003BA3F9857

Palavras-chave

Versões (5)
  1. 19/09/2012 19/09/2012 -
  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
  5. 08/07/2015 08/07/2015 -
Transferido a

9 de janeiro de 2015

DOI

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Licença

Creative Commons BY-NC 3.0 Legacy
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    Lung Cancer NCT00113386 Toxicity - RTOG-0412 AE: Adverse Event Evaluation Form - 2292423v3.0

    Inglês

    Radiation Therapy Oncology Group Phase III Lung Pre-Op Chemotherapy vs. Pre-Op Concurrent Chemoradiation for NSCLC

    1 Formulários  
    Unnamed Module 1
    Descrição

    Unnamed Module 1

    RTOG Study
    Descrição

    Protocol ID RTOG

    Tipo de dados

    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 #
    Descrição

    Case#

    Tipo de dados

    text

    Institution
    Descrição

    Institution Name

    Tipo de dados

    text

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

    Institution Number

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C1301943
    NCI Thesaurus ObjectClass
    C21541
    UMLS CUI-2
    C0805701
    NCI Thesaurus Property
    C25364
    Participant's Initials
    Descrição

    Patient Initials

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C2986440
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25536
    Participant's I.D. No.
    Descrição

    Patient Study ID

    Tipo de dados

    text

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

    Data amended

    Tipo de dados

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS CUI-1
    C0680532
    NCI Thesaurus ObjectClass
    C25474
    NCI Thesaurus Property
    C25416
    Report All Continuing Or New Adverse Events
    Descrição

    Report All Continuing Or New Adverse Events

    Date of assessment
    Descrição

    Assessment Date

    Tipo de dados

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C2985720
    NCI Thesaurus ObjectClass
    C25367
    NCI Thesaurus ValueDomain-2
    C25367
    NCI Thesaurus Property
    C38000
    Due date of corresponding form
    Descrição

    AssociatedFormSubmissionDate

    Tipo de dados

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C19464
    UMLS 2011AA ObjectClass
    C0376315
    NCI Thesaurus Property
    C25694
    UMLS 2011AA Property
    C1515022
    NCI Thesaurus ObjectClass-2
    C25281
    UMLS 2011AA ObjectClass-2
    C0332281
    Type of corresponding form (INSTRUCTIONS: the CTC AE Version 3.0 is used to score all adverse events)
    Descrição

    AssociatedFormSubmissionType

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C19464
    UMLS 2011AA ObjectClass
    C0376315
    NCI Thesaurus Property
    C25694
    UMLS 2011AA Property
    C1515022
    NCI Thesaurus ObjectClass-2
    C25281
    UMLS 2011AA ObjectClass-2
    C0332281
    MedDRA CODE ADVERSE EVENT BASED ON CTCAE TERM
    Descrição

    MedDRACode

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25162
    UMLS 2011AA ValueDomain
    C0805701
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Metathesaurus ObjectClass
    CL104089
    CTCAE TERM
    Descrição

    CTC Adverse Event Term

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS CUI-1
    C1516728
    NCI Thesaurus ObjectClass
    C49704
    UMLS CUI-2
    C2826934
    NCI Thesaurus Property
    C45559
    CTCAE GRADE
    Descrição

    CTC Adverse Event Grade

    Tipo de dados

    float

    Alias
    NCI Thesaurus ObjectClass
    C49704
    UMLS CUI-1
    C2985911
    NCI Thesaurus ValueDomain
    C18000
    NCI Thesaurus Property
    C25365
    CTCAE BEGIN DATE
    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-2
    C25431
    UMLS 2011AA ValueDomain-2
    C0439659
    NCI Thesaurus ObjectClass
    C49704
    UMLS 2011AA ObjectClass
    C1516728
    CTCAE ATTRIBUTION CODE (Attribution to Protocol Treatment See protocol sections 6 & 7 for definition of "protocol treatment")
    Descrição

    CTC Adverse Event Attribution Category

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25664
    UMLS CUI-1
    C1706735
    NCI Thesaurus ObjectClass
    C49704
    NCI Thesaurus Property
    C25358
    Serious Adverse Event Report Submitted
    Descrição

    SAE report

    Tipo de dados

    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
    IF UNRELATED TO PROTOCOL TREATMENTS SPECIFY CAUSE
    Descrição

    Non-ProtocolAdverseEventAssessmentSpecify

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS 2011AA ValueDomain
    C1521902
    NCI Thesaurus Property
    C20989
    UMLS 2011AA Property
    C0031809
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus ObjectClass-2
    C25590
    UMLS 2011AA ObjectClass-2
    C1518384
    Comments
    Descrição

    Research Comments

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS CUI-1
    C0947611
    NCI Thesaurus ObjectClass
    C15319
    NCI Thesaurus Property
    C25393
    Unnamed Module 2
    Descrição

    Unnamed Module 2

    Date (mm/dd Year)
    Descrição

    Laboratory Procedure Date

    Tipo de dados

    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
    Treatment Week
    Descrição

    TreatmentReportingPeriodWeekNumber

    Tipo de dados

    float

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus Property
    C25616
    UMLS 2011AA Property
    C1948053
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus Property-2
    C25651
    UMLS 2011AA Property-2
    C0700287
    Blood
    Descrição

    Blood

    Hgb (gms)
    Descrição

    Hemoglobin

    Tipo de dados

    float

    Alias
    NCI Thesaurus Property
    C16676
    UMLS CUI-1
    C0019046
    NCI Thesaurus Property-2
    C20200
    NCI Thesaurus ObjectClass
    C25294
    NCI Thesaurus ValueDomain
    C25712
    Hct (%)
    Descrição

    HematologyLabHematocritCount

    Tipo de dados

    float

    Alias
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus ValueDomain
    C25463
    UMLS 2011AA ValueDomain
    C0750480
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    WBC (x1000)
    Descrição

    Leukocytes (WBC)

    Tipo de dados

    float

    Unidades de medida
    • 1000/uL
    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS CUI-1
    C0023508
    NCI Thesaurus Property
    C12529
    NCI Thesaurus Property-2
    C20200
    NCI Thesaurus ValueDomain
    C25712
    NCI Thesaurus ValueDomain-2
    C38024
    1000/uL
    Platelets (x1000)
    Descrição

    Platelets

    Tipo de dados

    float

    Unidades de medida
    • 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
    Neutrophils/gran (%)
    Descrição

    Neutrophil percentage

    Tipo de dados

    float

    Unidades de medida
    • %
    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS CUI-1
    C1171400
    NCI Thesaurus Property
    C12533
    NCI Thesaurus Property-2
    C20200
    NCI Thesaurus ValueDomain
    C25613
    NCI Thesaurus ValueDomain-2
    C25712
    %
    ANC
    Descrição

    Neutrophil count

    Tipo de dados

    float

    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS CUI-1
    C0200633
    NCI Thesaurus Property
    C12533
    NCI Thesaurus Property-2
    C20200
    NCI Thesaurus ValueDomain
    C25304
    NCI Thesaurus ValueDomain-2
    C25712
    Chemistries
    Descrição

    Chemistries

    BUN
    Descrição

    Blood Urea Nitrogen

    Tipo de dados

    float

    Alias
    NCI Thesaurus Property
    C20200
    UMLS CUI-1
    C0005845
    NCI Thesaurus ObjectClass
    C25294
    NCI Thesaurus Property-2
    C61019
    NCI Thesaurus ValueDomain
    C25712
    Creatinine (mg%)
    Descrição

    RenalCreatinineLabSpecifiedValue

    Tipo de dados

    float

    Unidades de medida
    • mg/dL
    Alias
    NCI Thesaurus ObjectClass
    C25225
    UMLS 2011AA ObjectClass
    C0022646
    NCI Thesaurus Property
    C399
    UMLS 2011AA Property
    C0010294
    NCI Thesaurus Property-2
    C25294
    UMLS 2011AA Property-2
    C0022885
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    mg/dL
    Calc. Creatinine Clearance
    Descrição

    Creatinine Clearance

    Tipo de dados

    float

    Alias
    NCI Thesaurus Property
    C20200
    UMLS CUI-1
    C0373595
    NCI Thesaurus Property-2
    C25747
    NCI Thesaurus ObjectClass
    C25294
    NCI Thesaurus ValueDomain
    C25712
    Bilirubin (total mg%)
    Descrição

    TotalBilirubinHepaticLabUnspecifiedValue

    Tipo de dados

    float

    Alias
    NCI Thesaurus ObjectClass
    C25304
    UMLS 2011AA ObjectClass
    C0439810
    NCI Thesaurus ObjectClass-2
    C305
    UMLS 2011AA ObjectClass-2
    C0005437
    NCI Thesaurus Property
    C13308
    UMLS 2011AA Property
    C0205054
    NCI Thesaurus Property-2
    C37984
    UMLS 2011AA Property-2
    C0022877
    NCI Thesaurus ValueDomain
    C38046
    UMLS 2011AA ValueDomain
    C0205370
    NCI Thesaurus ValueDomain-2
    C25712
    UMLS 2011AA ValueDomain-2
    C1522609
    Alkaline Phosphatase
    Descrição

    HepaticAlkalinePhosphataseLabValue

    Tipo de dados

    float

    Alias
    NCI Thesaurus ObjectClass
    C13308
    UMLS 2011AA ObjectClass
    C0205054
    NCI Thesaurus Property
    C37984
    UMLS 2011AA Property
    C0022877
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus Property-2
    C16276
    UMLS 2011AA Property-2
    C0002059
    LDH
    Descrição

    LDH

    Tipo de dados

    float

    Unidades de medida
    • U/L
    Alias
    NCI Thesaurus Property
    C20200
    UMLS CUI-1
    C0202113
    NCI Thesaurus ObjectClass
    C25294
    NCI Thesaurus ValueDomain
    C25712
    NCI Thesaurus Property-2
    C25184
    U/L
    SGOT
    Descrição

    HepaticSGOT(AST)LabUnspecifiedValue

    Tipo de dados

    float

    Alias
    NCI Thesaurus ObjectClass
    C13308
    UMLS 2011AA ObjectClass
    C0205054
    NCI Thesaurus Property
    C25202
    UMLS 2011AA Property
    C0242192
    NCI Thesaurus Property-2
    C37984
    UMLS 2011AA Property-2
    C0022877
    NCI Thesaurus ValueDomain
    C38046
    UMLS 2011AA ValueDomain
    C0205370
    NCI Thesaurus ValueDomain-2
    C25712
    UMLS 2011AA ValueDomain-2
    C1522609
    SGPT
    Descrição

    HepaticSGPT(ALT)LabUnspecifiedValue

    Tipo de dados

    float

    Alias
    NCI Thesaurus ObjectClass
    C13308
    UMLS 2011AA ObjectClass
    C0205054
    NCI Thesaurus Property
    C37984
    UMLS 2011AA Property
    C0022877
    NCI Thesaurus Property-2
    C25293
    UMLS 2011AA Property-2
    C0376147
    NCI Thesaurus ValueDomain
    C38046
    UMLS 2011AA ValueDomain
    C0205370
    NCI Thesaurus ValueDomain-2
    C25712
    UMLS 2011AA ValueDomain-2
    C1522609
    Uric Acid (mg%)
    Descrição

    LaboratoryProcedureUricAcidResultSpecifiedValue

    Tipo de dados

    float

    Unidades de medida
    • mg/dL
    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
    C62652
    UMLS 2011AA Property-2
    C0041980
    mg/dL
    Albumin (gm%)
    Descrição

    Albumin

    Tipo de dados

    float

    Alias
    NCI Thesaurus Property
    C20200
    UMLS CUI-1
    C0201838
    NCI Thesaurus Property-2
    C214
    NCI Thesaurus ObjectClass
    C25294
    NCI Thesaurus ValueDomain
    C25712
    Potassium (mg/L)
    Descrição

    LaboratoryProcedurePotassiumElectrolytesOutcomeSpecifiedValue

    Tipo de dados

    float

    Unidades de medida
    • mmol/L
    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property-2
    C464
    UMLS 2011AA Property-2
    C0013832
    NCI Thesaurus Property-3
    C765
    UMLS 2011AA Property-3
    C0032821
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    mmol/L
    Calcium (mg/d)
    Descrição

    ElectrolytesCalciumLabSpecifiedValue

    Tipo de dados

    float

    Unidades de medida
    • mg/dL
    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C331
    UMLS 2011AA Property
    C0006675
    NCI Thesaurus Property-2
    C20200
    UMLS 2011AA Property-2
    C1274040
    NCI Thesaurus Property-3
    C464
    UMLS 2011AA Property-3
    C0013832
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    mg/dL
    Glucose
    Descrição

    LaboratoryProcedureGlucoseElectrolytesOutcomeUnspecifiedValue

    Tipo de dados

    float

    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property-2
    C2831
    UMLS 2011AA Property-2
    C0017725
    NCI Thesaurus Property-3
    C464
    UMLS 2011AA Property-3
    C0013832
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    Sodium (meq/L)
    Descrição

    LaboratoryProcedureSodiumElectrolytesOutcomeSpecifiedValue

    Tipo de dados

    float

    Unidades de medida
    • mmol/L
    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property-2
    C830
    UMLS 2011AA Property-2
    C0037473
    NCI Thesaurus Property-3
    C464
    UMLS 2011AA Property-3
    C0013832
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    mmol/L
    Total Protein
    Descrição

    TotalProtein

    Tipo de dados

    text

    Other Studies
    Descrição

    Other Studies

    Other
    Descrição

    LaboratoryProcedurePerformedSpecify

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS 2011AA ValueDomain
    C1521902
    NCI Thesaurus Property
    C38000
    UMLS 2011AA Property
    C0884358
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    Normal Range (Remarks use R1, R2, R3, etc.)
    Descrição

    InstitutionNormalLabValue

    Tipo de dados

    text

    Alias
    NCI Thesaurus ObjectClass
    C21541
    UMLS 2011AA ObjectClass
    C0018704
    NCI Thesaurus Property
    C14165
    UMLS 2011AA Property
    C0205307
    NCI Thesaurus Property-2
    C37984
    UMLS 2011AA Property-2
    C0022877
    NCI Thesaurus ValueDomain
    C37984
    UMLS 2011AA ValueDomain
    C0022877
    NCI Thesaurus ValueDomain-2
    C25712
    UMLS 2011AA ValueDomain-2
    C1522609
    Name of person completing this form
    Descrição

    Person Completing Form

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C1550483
    NCI Thesaurus ObjectClass
    C25657
    NCI Thesaurus Property
    C25364
    Form completion date, original
    Descrição

    Form Completion Date

    Tipo de dados

    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
    Comments
    Descrição

    Research Comments

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS CUI-1
    C0947611
    NCI Thesaurus ObjectClass
    C15319
    NCI Thesaurus Property
    C25393
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    Radiation Therapy Oncology Group Phase III Lung Pre-Op Chemotherapy vs. Pre-Op Concurrent Chemoradiation for NSCLC

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Unnamed Module 1
    Protocol ID RTOG
    Item
    RTOG Study
    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)
    Case#
    Item
    Case #
    text
    Institution Name
    Item
    Institution
    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
    Participant's Initials
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2986440 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25536 (NCI Thesaurus Property)
    Patient Study ID
    Item
    Participant's I.D. No.
    text
    C25337 (NCI Thesaurus ValueDomain)
    C2348585 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25462 (NCI Thesaurus Property)
    C25364 (NCI Thesaurus Property-2)
    Data amended
    Item
    AMENDED DATA
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C0680532 (UMLS CUI-1)
    C25474 (NCI Thesaurus ObjectClass)
    C25416 (NCI Thesaurus Property)
    Item Group
    Report All Continuing Or New Adverse Events
    Assessment Date
    Item
    Date of assessment
    date
    C25164 (NCI Thesaurus ValueDomain)
    C2985720 (UMLS CUI-1)
    C25367 (NCI Thesaurus ObjectClass)
    C25367 (NCI Thesaurus ValueDomain-2)
    C38000 (NCI Thesaurus Property)
    AssociatedFormSubmissionDate
    Item
    Due date of corresponding form
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C19464 (NCI Thesaurus ObjectClass)
    C0376315 (UMLS 2011AA ObjectClass)
    C25694 (NCI Thesaurus Property)
    C1515022 (UMLS 2011AA Property)
    C25281 (NCI Thesaurus ObjectClass-2)
    C0332281 (UMLS 2011AA ObjectClass-2)
    Item
    Type of corresponding form (INSTRUCTIONS: the CTC AE Version 3.0 is used to score all adverse events)
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C19464 (NCI Thesaurus ObjectClass)
    C0376315 (UMLS 2011AA ObjectClass)
    C25694 (NCI Thesaurus Property)
    C1515022 (UMLS 2011AA Property)
    C25281 (NCI Thesaurus ObjectClass-2)
    C0332281 (UMLS 2011AA ObjectClass-2)
    CL.2
    Code List
    Type of corresponding form (INSTRUCTIONS: the CTC AE Version 3.0 is used to score all adverse events)
    CL Item
    Tf (TF)
    CL Item
    F1 (F1)
    MedDRACode
    Item
    MedDRA CODE ADVERSE EVENT BASED ON CTCAE TERM
    text
    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
    CTCAE 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
    CTCAE GRADE
    float
    C49704 (NCI Thesaurus ObjectClass)
    C2985911 (UMLS CUI-1)
    C18000 (NCI Thesaurus ValueDomain)
    C25365 (NCI Thesaurus Property)
    CTCAdverseEventReportBeginDate
    Item
    CTCAE BEGIN DATE
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25375 (NCI Thesaurus Property)
    C0684224 (UMLS 2011AA Property)
    C25431 (NCI Thesaurus ValueDomain-2)
    C0439659 (UMLS 2011AA ValueDomain-2)
    C49704 (NCI Thesaurus ObjectClass)
    C1516728 (UMLS 2011AA ObjectClass)
    Item
    CTCAE ATTRIBUTION CODE (Attribution to Protocol Treatment See protocol sections 6 & 7 for definition of "protocol treatment")
    text
    C25664 (NCI Thesaurus ValueDomain)
    C1706735 (UMLS CUI-1)
    C49704 (NCI Thesaurus ObjectClass)
    C25358 (NCI Thesaurus Property)
    CL.3
    Code List
    CTCAE ATTRIBUTION CODE (Attribution to Protocol Treatment See protocol sections 6 & 7 for definition of "protocol treatment")
    CL Item
    Unrelated (Unrelated)
    C25328 (NCI Thesaurus)
    C0445356 (UMLS 2011AA)
    CL Item
    Unlikely (Unlikely)
    CL Item
    Possible (Possible)
    C0332149 (NCI Metathesaurus)
    CL Item
    Probable (Probable)
    C0332148 (NCI Metathesaurus)
    CL Item
    Definite (Definite)
    CL209464 (NCI Metathesaurus)
    Item
    Serious Adverse Event 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.4
    Code List
    Serious Adverse Event Report Submitted
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Unknown (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    Non-ProtocolAdverseEventAssessmentSpecify
    Item
    IF UNRELATED TO PROTOCOL TREATMENTS SPECIFY CAUSE
    text
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
    C20989 (NCI Thesaurus Property)
    C0031809 (UMLS 2011AA Property)
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C25590 (NCI Thesaurus ObjectClass-2)
    C1518384 (UMLS 2011AA ObjectClass-2)
    Research Comments
    Item
    Comments
    text
    C25704 (NCI Thesaurus ValueDomain)
    C0947611 (UMLS CUI-1)
    C15319 (NCI Thesaurus ObjectClass)
    C25393 (NCI Thesaurus Property)
    Item Group
    Unnamed Module 2
    Laboratory Procedure Date
    Item
    Date (mm/dd Year)
    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)
    TreatmentReportingPeriodWeekNumber
    Item
    Treatment Week
    float
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C25616 (NCI Thesaurus Property)
    C1948053 (UMLS 2011AA Property)
    C15368 (NCI Thesaurus ObjectClass)
    C25651 (NCI Thesaurus Property-2)
    C0700287 (UMLS 2011AA Property-2)
    Item Group
    Blood
    Hemoglobin
    Item
    Hgb (gms)
    float
    C16676 (NCI Thesaurus Property)
    C0019046 (UMLS CUI-1)
    C20200 (NCI Thesaurus Property-2)
    C25294 (NCI Thesaurus ObjectClass)
    C25712 (NCI Thesaurus ValueDomain)
    HematologyLabHematocritCount
    Item
    Hct (%)
    float
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C25463 (NCI Thesaurus ValueDomain)
    C0750480 (UMLS 2011AA ValueDomain)
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    Leukocytes (WBC)
    Item
    WBC (x1000)
    float
    C25294 (NCI Thesaurus ObjectClass)
    C0023508 (UMLS CUI-1)
    C12529 (NCI Thesaurus Property)
    C20200 (NCI Thesaurus Property-2)
    C25712 (NCI Thesaurus ValueDomain)
    C38024 (NCI Thesaurus ValueDomain-2)
    Platelets
    Item
    Platelets (x1000)
    float
    C20200 (NCI Thesaurus Property)
    C0005821 (UMLS CUI-1)
    C12520 (NCI Thesaurus Property-2)
    C25294 (NCI Thesaurus ObjectClass)
    C25712 (NCI Thesaurus ValueDomain)
    Neutrophil percentage
    Item
    Neutrophils/gran (%)
    float
    C25294 (NCI Thesaurus ObjectClass)
    C1171400 (UMLS CUI-1)
    C12533 (NCI Thesaurus Property)
    C20200 (NCI Thesaurus Property-2)
    C25613 (NCI Thesaurus ValueDomain)
    C25712 (NCI Thesaurus ValueDomain-2)
    Neutrophil count
    Item
    ANC
    float
    C25294 (NCI Thesaurus ObjectClass)
    C0200633 (UMLS CUI-1)
    C12533 (NCI Thesaurus Property)
    C20200 (NCI Thesaurus Property-2)
    C25304 (NCI Thesaurus ValueDomain)
    C25712 (NCI Thesaurus ValueDomain-2)
    Item Group
    Chemistries
    Blood Urea Nitrogen
    Item
    BUN
    float
    C20200 (NCI Thesaurus Property)
    C0005845 (UMLS CUI-1)
    C25294 (NCI Thesaurus ObjectClass)
    C61019 (NCI Thesaurus Property-2)
    C25712 (NCI Thesaurus ValueDomain)
    RenalCreatinineLabSpecifiedValue
    Item
    Creatinine (mg%)
    float
    C25225 (NCI Thesaurus ObjectClass)
    C0022646 (UMLS 2011AA ObjectClass)
    C399 (NCI Thesaurus Property)
    C0010294 (UMLS 2011AA Property)
    C25294 (NCI Thesaurus Property-2)
    C0022885 (UMLS 2011AA Property-2)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    Creatinine Clearance
    Item
    Calc. Creatinine Clearance
    float
    C20200 (NCI Thesaurus Property)
    C0373595 (UMLS CUI-1)
    C25747 (NCI Thesaurus Property-2)
    C25294 (NCI Thesaurus ObjectClass)
    C25712 (NCI Thesaurus ValueDomain)
    TotalBilirubinHepaticLabUnspecifiedValue
    Item
    Bilirubin (total mg%)
    float
    C25304 (NCI Thesaurus ObjectClass)
    C0439810 (UMLS 2011AA ObjectClass)
    C305 (NCI Thesaurus ObjectClass-2)
    C0005437 (UMLS 2011AA ObjectClass-2)
    C13308 (NCI Thesaurus Property)
    C0205054 (UMLS 2011AA Property)
    C37984 (NCI Thesaurus Property-2)
    C0022877 (UMLS 2011AA Property-2)
    C38046 (NCI Thesaurus ValueDomain)
    C0205370 (UMLS 2011AA ValueDomain)
    C25712 (NCI Thesaurus ValueDomain-2)
    C1522609 (UMLS 2011AA ValueDomain-2)
    HepaticAlkalinePhosphataseLabValue
    Item
    Alkaline Phosphatase
    float
    C13308 (NCI Thesaurus ObjectClass)
    C0205054 (UMLS 2011AA ObjectClass)
    C37984 (NCI Thesaurus Property)
    C0022877 (UMLS 2011AA Property)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C16276 (NCI Thesaurus Property-2)
    C0002059 (UMLS 2011AA Property-2)
    LDH
    Item
    LDH
    float
    C20200 (NCI Thesaurus Property)
    C0202113 (UMLS CUI-1)
    C25294 (NCI Thesaurus ObjectClass)
    C25712 (NCI Thesaurus ValueDomain)
    C25184 (NCI Thesaurus Property-2)
    HepaticSGOT(AST)LabUnspecifiedValue
    Item
    SGOT
    float
    C13308 (NCI Thesaurus ObjectClass)
    C0205054 (UMLS 2011AA ObjectClass)
    C25202 (NCI Thesaurus Property)
    C0242192 (UMLS 2011AA Property)
    C37984 (NCI Thesaurus Property-2)
    C0022877 (UMLS 2011AA Property-2)
    C38046 (NCI Thesaurus ValueDomain)
    C0205370 (UMLS 2011AA ValueDomain)
    C25712 (NCI Thesaurus ValueDomain-2)
    C1522609 (UMLS 2011AA ValueDomain-2)
    HepaticSGPT(ALT)LabUnspecifiedValue
    Item
    SGPT
    float
    C13308 (NCI Thesaurus ObjectClass)
    C0205054 (UMLS 2011AA ObjectClass)
    C37984 (NCI Thesaurus Property)
    C0022877 (UMLS 2011AA Property)
    C25293 (NCI Thesaurus Property-2)
    C0376147 (UMLS 2011AA Property-2)
    C38046 (NCI Thesaurus ValueDomain)
    C0205370 (UMLS 2011AA ValueDomain)
    C25712 (NCI Thesaurus ValueDomain-2)
    C1522609 (UMLS 2011AA ValueDomain-2)
    LaboratoryProcedureUricAcidResultSpecifiedValue
    Item
    Uric Acid (mg%)
    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)
    C62652 (NCI Thesaurus Property-2)
    C0041980 (UMLS 2011AA Property-2)
    Albumin
    Item
    Albumin (gm%)
    float
    C20200 (NCI Thesaurus Property)
    C0201838 (UMLS CUI-1)
    C214 (NCI Thesaurus Property-2)
    C25294 (NCI Thesaurus ObjectClass)
    C25712 (NCI Thesaurus ValueDomain)
    LaboratoryProcedurePotassiumElectrolytesOutcomeSpecifiedValue
    Item
    Potassium (mg/L)
    float
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C464 (NCI Thesaurus Property-2)
    C0013832 (UMLS 2011AA Property-2)
    C765 (NCI Thesaurus Property-3)
    C0032821 (UMLS 2011AA Property-3)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    ElectrolytesCalciumLabSpecifiedValue
    Item
    Calcium (mg/d)
    float
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C331 (NCI Thesaurus Property)
    C0006675 (UMLS 2011AA Property)
    C20200 (NCI Thesaurus Property-2)
    C1274040 (UMLS 2011AA Property-2)
    C464 (NCI Thesaurus Property-3)
    C0013832 (UMLS 2011AA Property-3)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    LaboratoryProcedureGlucoseElectrolytesOutcomeUnspecifiedValue
    Item
    Glucose
    float
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C2831 (NCI Thesaurus Property-2)
    C0017725 (UMLS 2011AA Property-2)
    C464 (NCI Thesaurus Property-3)
    C0013832 (UMLS 2011AA Property-3)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    LaboratoryProcedureSodiumElectrolytesOutcomeSpecifiedValue
    Item
    Sodium (meq/L)
    float
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C830 (NCI Thesaurus Property-2)
    C0037473 (UMLS 2011AA Property-2)
    C464 (NCI Thesaurus Property-3)
    C0013832 (UMLS 2011AA Property-3)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    TotalProtein
    Item
    Total Protein
    text
    Item Group
    Other Studies
    LaboratoryProcedurePerformedSpecify
    Item
    Other
    text
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
    C38000 (NCI Thesaurus Property)
    C0884358 (UMLS 2011AA Property)
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    InstitutionNormalLabValue
    Item
    Normal Range (Remarks use R1, R2, R3, etc.)
    text
    C21541 (NCI Thesaurus ObjectClass)
    C0018704 (UMLS 2011AA ObjectClass)
    C14165 (NCI Thesaurus Property)
    C0205307 (UMLS 2011AA Property)
    C37984 (NCI Thesaurus Property-2)
    C0022877 (UMLS 2011AA Property-2)
    C37984 (NCI Thesaurus ValueDomain)
    C0022877 (UMLS 2011AA ValueDomain)
    C25712 (NCI Thesaurus ValueDomain-2)
    C1522609 (UMLS 2011AA ValueDomain-2)
    Person Completing Form
    Item
    Name of person completing this form
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1550483 (UMLS CUI-1)
    C25657 (NCI Thesaurus ObjectClass)
    C25364 (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)
    Research Comments
    Item
    Comments
    text
    C25704 (NCI Thesaurus ValueDomain)
    C0947611 (UMLS CUI-1)
    C15319 (NCI Thesaurus ObjectClass)
    C25393 (NCI Thesaurus Property)
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