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ID

11589

Description

NCT00113386 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

Lien

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

Mots-clés

  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 -
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8 juillet 2015

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    NCT00113386 RTOG-0412 AE: Adverse Event Evaluation Form

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

    RTOG clinical trial administrative data
    Description

    RTOG clinical trial administrative data

    RTOG Study
    Description

    Protocol ID RTOG

    Type de données

    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 #
    Description

    Case#

    Type de données

    text

    Institution
    Description

    Institution Name

    Type de données

    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.
    Description

    Institution Number

    Type de données

    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
    Description

    Patient Initials

    Type de données

    text

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

    Patient Study ID

    Type de données

    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
    Description

    Data amended

    Type de données

    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
    Description

    Report All Continuing Or New Adverse Events

    Date of assessment
    Description

    Assessment Date

    Type de données

    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
    Description

    AssociatedFormSubmissionDate

    Type de données

    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)
    Description

    AssociatedFormSubmissionType

    Type de données

    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
    Description

    MedDRACode

    Type de données

    text

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

    CTC Adverse Event Term

    Type de données

    text

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

    CTC Adverse Event Grade

    Type de données

    float

    Alias
    NCI Thesaurus ObjectClass
    C49704
    UMLS CUI-1
    C2985911
    NCI Thesaurus ValueDomain
    C18000
    NCI Thesaurus Property
    C25365
    CTCAE BEGIN DATE
    Description

    Adverse Event Start Date

    Type de données

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C2697888
    NCI Thesaurus Property
    C25375
    NCI Thesaurus ValueDomain-2
    C25431
    NCI Thesaurus ObjectClass
    C49704
    CTCAE ATTRIBUTION CODE (Attribution to Protocol Treatment See protocol sections 6 & 7 for definition of "protocol treatment")
    Description

    CTC Adverse Event Attribution Category

    Type de données

    text

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

    SAE report

    Type de données

    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
    Description

    Non-ProtocolAdverseEventAssessmentSpecify

    Type de données

    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
    Description

    Research Comments

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS CUI-1
    C0947611
    NCI Thesaurus ObjectClass
    C15319
    NCI Thesaurus Property
    C25393
    Laboratory Procedure Date
    Description

    Laboratory Procedure Date

    Date (mm/dd Year)
    Description

    Laboratory Procedure Date

    Type de données

    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
    Description

    TreatmentReportingPeriodWeekNumber

    Type de données

    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
    Description

    Blood

    Hgb (gms)
    Description

    Hemoglobin

    Type de données

    float

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

    HematologyLabHematocritCount

    Type de données

    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)
    Description

    Leukocytes (WBC)

    Type de données

    float

    Unités de mesure
    • 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)
    Description

    Platelets

    Type de données

    float

    Unités de mesure
    • 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 (%)
    Description

    Neutrophil percentage

    Type de données

    float

    Unités de mesure
    • %
    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
    Description

    Neutrophil count

    Type de données

    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
    Description

    Chemistries

    BUN
    Description

    Blood Urea Nitrogen

    Type de données

    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%)
    Description

    RenalCreatinineLabSpecifiedValue

    Type de données

    float

    Unités de mesure
    • 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
    Description

    Creatinine Clearance

    Type de données

    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%)
    Description

    TotalBilirubinHepaticLabUnspecifiedValue

    Type de données

    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
    Description

    HepaticAlkalinePhosphataseLabValue

    Type de données

    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
    Description

    LDH

    Type de données

    float

    Unités de mesure
    • 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
    Description

    HepaticSGOT(AST)LabUnspecifiedValue

    Type de données

    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
    Description

    HepaticSGPT(ALT)LabUnspecifiedValue

    Type de données

    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%)
    Description

    LaboratoryProcedureUricAcidResultSpecifiedValue

    Type de données

    float

    Unités de mesure
    • 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%)
    Description

    Albumin

    Type de données

    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)
    Description

    LaboratoryProcedurePotassiumElectrolytesOutcomeSpecifiedValue

    Type de données

    float

    Unités de mesure
    • 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)
    Description

    ElectrolytesCalciumLabSpecifiedValue

    Type de données

    float

    Unités de mesure
    • 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
    Description

    LaboratoryProcedureGlucoseElectrolytesOutcomeUnspecifiedValue

    Type de données

    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)
    Description

    LaboratoryProcedureSodiumElectrolytesOutcomeSpecifiedValue

    Type de données

    float

    Unités de mesure
    • 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
    Description

    TotalProtein

    Type de données

    text

    Other Studies
    Description

    Other Studies

    Other
    Description

    LaboratoryProcedurePerformedSpecify

    Type de données

    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.)
    Description

    InstitutionNormalLabValue

    Type de données

    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
    Description

    Person Completing Form

    Type de données

    text

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

    Form Completion Date

    Type de données

    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
    Description

    Research Comments

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS CUI-1
    C0947611
    NCI Thesaurus ObjectClass
    C15319
    NCI Thesaurus Property
    C25393

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    Item Group
    RTOG clinical trial administrative data
    Protocol ID RTOG
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    RTOG Study
    text
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    C3274381 (UMLS CUI-1)
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    Item
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    text
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    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)
    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)
    Adverse Event Start Date
    Item
    CTCAE BEGIN DATE
    date
    C25164 (NCI Thesaurus ValueDomain)
    C2697888 (UMLS CUI-1)
    C25375 (NCI Thesaurus Property)
    C25431 (NCI Thesaurus ValueDomain-2)
    C49704 (NCI Thesaurus 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)
    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)
    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
    Laboratory Procedure Date
    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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