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6999

Description

North Central Cancer Treatment Group N0577 Nadir/Adverse Event Form Radiation Therapy or Radiation Therapy and Temozolomide or Temozolomide Alone in Treating Patients With Newly Diagnosed Anaplastic Glioma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=4C094A66-12E0-40DD-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=4C094A66-12E0-40DD-E044-0003BA3F9857

Keywords

Versions (5)
  1. 8/26/12 8/26/12 -
  2. 1/8/15 1/8/15 - Martin Dugas
  3. 1/9/15 1/9/15 - Martin Dugas
  4. 1/9/15 1/9/15 - Martin Dugas
  5. 1/10/15 1/10/15 - Martin Dugas
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January 8, 2015

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    Brain and Central Nervous System Tumors NCT00887146 Toxicity - North Central Cancer Treatment Group N0577 Nadir/Adverse Event Form - 2745613v1.0

    English

    No Instruction available.

    1 forms  
    1. StudyEvent: North Central Cancer Treatment Group N0577 Nadir/Adverse Event Form
      1. No Instruction available.
    Header
    Description

    Header

    Protocol Number
    Description

    Protocol ID NCCTG

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C3274381
    NCI Thesaurus ObjectClass
    C25320
    UMLS CUI-2
    C1518419
    NCI Thesaurus Property
    C25364
    NCI Thesaurus Property-2
    C25581
    Patient ID
    Description

    PatientNorthCentralCancerTreatmentGroupIdentifierNumber

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus Property-2
    C25581
    UMLS 2011AA Property-2
    C1518419
    Patient Initials (L F M)
    Description

    Patient Initials

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C2986440
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25536
    Institution Number
    Description

    Institution Number

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C1301943
    NCI Thesaurus ObjectClass
    C21541
    UMLS CUI-2
    C0805701
    NCI Thesaurus Property
    C25364
    Institution
    Description

    Institution Name

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C1301943
    NCI Thesaurus ObjectClass
    C21541
    NCI Thesaurus ValueDomain-2
    C21541
    NCI Thesaurus Property
    C25364
    Are data amended (If yes, highlight amended areas)
    Description

    Data amended

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS CUI-1
    C0680532
    NCI Thesaurus ObjectClass
    C25474
    NCI Thesaurus Property
    C25416
    Header
    Description

    Header

    Date of evaluation (mm/dd/yyyy)
    Description

    Assessment Date

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C2985720
    NCI Thesaurus ObjectClass
    C25367
    NCI Thesaurus ValueDomain-2
    C25367
    NCI Thesaurus Property
    C38000
    Platelets (PLT) (K/uL or 10^9/L)
    Description

    LaboratoryProcedurePlateletResultSpecifiedValue

    Data type

    float

    Measurement units
    • 1000/uL
    Alias
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property-2
    C12520
    UMLS 2011AA Property-2
    C0005821
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    1000/uL
    Leukocytes (WBC) (K/uL or 10^9/L)
    Description

    LaboratoryProcedureLeukocyteResultSpecifiedValue

    Data type

    float

    Measurement units
    • 1000/uL
    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C12529
    UMLS 2011AA Property
    C0023516
    NCI Thesaurus Property-2
    C20200
    UMLS 2011AA Property-2
    C1274040
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus ValueDomain-2
    C38024
    UMLS 2011AA ValueDomain-2
    C0205369
    1000/uL
    CTC AE Attribution Code (If Grade > 0)
    Description

    CTCAdverseEventAttributionScale

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25664
    UMLS 2011AA ValueDomain
    C0349674
    NCI Thesaurus ObjectClass
    C49704
    UMLS 2011AA ObjectClass
    C1516728
    NCI Thesaurus Property
    C25358
    UMLS 2011AA Property
    C0596130
    Hemoglobin (g/dL)
    Description

    LaboratoryProcedureHemoglobinResultSpecifiedValue

    Data type

    float

    Measurement units
    • g/dL
    Alias
    NCI Thesaurus Property
    C16676
    UMLS 2011AA Property
    C0019046
    NCI Thesaurus Property-2
    C20200
    UMLS 2011AA Property-2
    C1274040
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    g/dL
    Has an Adverse Event Expedited Report been submitted? (Enter 1 for Yes or 2 for No)
    Description

    AdverseEventReportInd-3

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus Property
    C25375
    UMLS 2011AA Property
    C0684224
    NCI Thesaurus ObjectClass-2
    C17648
    UMLS 2011AA ObjectClass-2
    C0439064
    Current Cycle Number
    Description

    Cycle Number Chemotherapeutics

    Data type

    integer

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C2045829
    NCI Thesaurus Property
    C25471
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus Property-2
    C25379
    Absolute Neutrophil Count (K/uL or 10^9/L)
    Description

    LaboratoryProcedureNeutrophilResultTotalValue

    Data type

    float

    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C12533
    UMLS 2011AA Property
    C0027950
    NCI Thesaurus Property-2
    C20200
    UMLS 2011AA Property-2
    C1274040
    NCI Thesaurus ValueDomain
    C25304
    UMLS 2011AA ValueDomain
    C0439810
    NCI Thesaurus ValueDomain-2
    C25712
    UMLS 2011AA ValueDomain-2
    C1522609
    Nadir/Worst Date (Date of lab test mm/dd/yyyy)
    Description

    AdverseEventWorstSymptomDate

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus Property
    C4876
    UMLS 2011AA Property
    C1457887
    NCI Thesaurus Property-2
    C25719
    UMLS 2011AA Property-2
    C1522166
    Nadir/Worst Value (The nadir is the lowest value of counts occurring between two treatments)
    Description

    AdverseEventWorstSymptomValue

    Data type

    float

    Alias
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus Property
    C4876
    UMLS 2011AA Property
    C1457887
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus Property-2
    C25719
    UMLS 2011AA Property-2
    C1522166
    Is nadir below LLN? (check one)
    Description

    AdverseEventWorstLaboratoryInd-3

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus Property
    C37984
    UMLS 2011AA Property
    C0022877
    NCI Thesaurus Property-2
    C25719
    UMLS 2011AA Property-2
    C1522166
    Description Of Primary Disease
    Description

    Description Of Primary Disease

    CTC Adverse Event Term
    Description

    CommonToxicityCriteriaAdverseEventTermType

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C49704
    UMLS 2011AA ObjectClass
    C1516728
    NCI Thesaurus Property
    C45559
    UMLS 2011AA Property
    C1705313
    MedDRA Code (primary tumor site: Metastases to brain parenchyma)
    Description

    MedDRACode

    Data type

    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 Grade (highest grade this cycle)
    Description

    CommonToxicityCriteriaAdverseEventGrade

    Data type

    float

    Alias
    NCI Thesaurus ObjectClass
    C49704
    UMLS 2011AA ObjectClass
    C1516728
    NCI Thesaurus ValueDomain
    C18000
    UMLS 2011AA ValueDomain
    C0919553
    NCI Thesaurus Property
    C25365
    UMLS 2011AA Property
    C0678257
    CTC AE Attribution Code (If Grade > 0)
    Description

    CTCAdverseEventAttributionScale

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25664
    UMLS 2011AA ValueDomain
    C0349674
    NCI Thesaurus ObjectClass
    C49704
    UMLS 2011AA ObjectClass
    C1516728
    NCI Thesaurus Property
    C25358
    UMLS 2011AA Property
    C0596130
    Has an Adverse Event Expedited Report been submitted? (Enter 1 for Yes or 2 for No)
    Description

    AdverseEventReportInd-3

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus Property
    C25375
    UMLS 2011AA Property
    C0684224
    NCI Thesaurus ObjectClass-2
    C17648
    UMLS 2011AA ObjectClass-2
    C0439064
    Current Cycle Number
    Description

    Cycle Number Chemotherapeutics

    Data type

    integer

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C2045829
    NCI Thesaurus Property
    C25471
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus Property-2
    C25379
    Were adverse events assessed during this report period (other)
    Description

    AdverseEventCurrentAssessmentInd

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25180
    UMLS 2011AA ValueDomain
    C1522602
    NCI Thesaurus Property
    C20989
    UMLS 2011AA Property
    C0031809
    NCI Thesaurus Property-2
    C25471
    UMLS 2011AA Property-2
    C0521116
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    Description Of Primary Disease
    Description

    Description Of Primary Disease

    Other CTC Adverse Event Term not listed
    Description

    CTCAdverseEventTermSpecify

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS 2011AA ValueDomain
    C1521902
    NCI Thesaurus ObjectClass
    C49704
    UMLS 2011AA ObjectClass
    C1516728
    NCI Thesaurus Property
    C45559
    UMLS 2011AA Property
    C1705313
    MedDRA Code (primary tumor site: Metastases to brain parenchyma)
    Description

    MedDRACode

    Data type

    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 Grade (highest grade this cycle)
    Description

    CommonToxicityCriteriaAdverseEventGrade

    Data type

    float

    Alias
    NCI Thesaurus ObjectClass
    C49704
    UMLS 2011AA ObjectClass
    C1516728
    NCI Thesaurus ValueDomain
    C18000
    UMLS 2011AA ValueDomain
    C0919553
    NCI Thesaurus Property
    C25365
    UMLS 2011AA Property
    C0678257
    CTC AE Attribution Code (If Grade > 0)
    Description

    CTCAdverseEventAttributionScale

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25664
    UMLS 2011AA ValueDomain
    C0349674
    NCI Thesaurus ObjectClass
    C49704
    UMLS 2011AA ObjectClass
    C1516728
    NCI Thesaurus Property
    C25358
    UMLS 2011AA Property
    C0596130
    Has an Adverse Event Expedited Report been submitted? (Enter 1 for Yes or 2 for No)
    Description

    AdverseEventReportInd-3

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus Property
    C25375
    UMLS 2011AA Property
    C0684224
    NCI Thesaurus ObjectClass-2
    C17648
    UMLS 2011AA ObjectClass-2
    C0439064
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    1 forms
    1. StudyEvent: North Central Cancer Treatment Group N0577 Nadir/Adverse Event Form
      1. No Instruction available.
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Header
    Protocol ID NCCTG
    Item
    Protocol Number
    text
    C25337 (NCI Thesaurus ValueDomain)
    C3274381 (UMLS CUI-1)
    C25320 (NCI Thesaurus ObjectClass)
    C1518419 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25581 (NCI Thesaurus Property-2)
    PatientNorthCentralCancerTreatmentGroupIdentifierNumber
    Item
    Patient ID
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C25581 (NCI Thesaurus Property-2)
    C1518419 (UMLS 2011AA Property-2)
    Patient Initials
    Item
    Patient Initials (L F M)
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2986440 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25536 (NCI Thesaurus Property)
    Institution Number
    Item
    Institution Number
    text
    C25337 (NCI Thesaurus ValueDomain)
    C1301943 (UMLS CUI-1)
    C21541 (NCI Thesaurus ObjectClass)
    C0805701 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    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)
    Data amended
    Item
    Are data amended (If yes, highlight amended areas)
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C0680532 (UMLS CUI-1)
    C25474 (NCI Thesaurus ObjectClass)
    C25416 (NCI Thesaurus Property)
    Item Group
    Header
    Assessment Date
    Item
    Date of evaluation (mm/dd/yyyy)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C2985720 (UMLS CUI-1)
    C25367 (NCI Thesaurus ObjectClass)
    C25367 (NCI Thesaurus ValueDomain-2)
    C38000 (NCI Thesaurus Property)
    LaboratoryProcedurePlateletResultSpecifiedValue
    Item
    Platelets (PLT) (K/uL or 10^9/L)
    float
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C12520 (NCI Thesaurus Property-2)
    C0005821 (UMLS 2011AA Property-2)
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    LaboratoryProcedureLeukocyteResultSpecifiedValue
    Item
    Leukocytes (WBC) (K/uL or 10^9/L)
    float
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C12529 (NCI Thesaurus Property)
    C0023516 (UMLS 2011AA Property)
    C20200 (NCI Thesaurus Property-2)
    C1274040 (UMLS 2011AA Property-2)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C38024 (NCI Thesaurus ValueDomain-2)
    C0205369 (UMLS 2011AA ValueDomain-2)
    Item
    CTC AE Attribution Code (If Grade > 0)
    text
    C25664 (NCI Thesaurus ValueDomain)
    C0349674 (UMLS 2011AA ValueDomain)
    C49704 (NCI Thesaurus ObjectClass)
    C1516728 (UMLS 2011AA ObjectClass)
    C25358 (NCI Thesaurus Property)
    C0596130 (UMLS 2011AA Property)
    CL.11
    Code List
    CTC AE Attribution Code (If Grade > 0)
    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)
    LaboratoryProcedureHemoglobinResultSpecifiedValue
    Item
    Hemoglobin (g/dL)
    float
    C16676 (NCI Thesaurus Property)
    C0019046 (UMLS 2011AA Property)
    C20200 (NCI Thesaurus Property-2)
    C1274040 (UMLS 2011AA Property-2)
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    AdverseEventReportInd-3
    Item
    Has an Adverse Event Expedited Report been submitted? (Enter 1 for Yes or 2 for No)
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C25375 (NCI Thesaurus Property)
    C0684224 (UMLS 2011AA Property)
    C17648 (NCI Thesaurus ObjectClass-2)
    C0439064 (UMLS 2011AA ObjectClass-2)
    Cycle Number Chemotherapeutics
    Item
    Current Cycle Number
    integer
    C25337 (NCI Thesaurus ValueDomain)
    C2045829 (UMLS CUI-1)
    C25471 (NCI Thesaurus Property)
    C15368 (NCI Thesaurus ObjectClass)
    C25379 (NCI Thesaurus Property-2)
    LaboratoryProcedureNeutrophilResultTotalValue
    Item
    Absolute Neutrophil Count (K/uL or 10^9/L)
    float
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C12533 (NCI Thesaurus Property)
    C0027950 (UMLS 2011AA Property)
    C20200 (NCI Thesaurus Property-2)
    C1274040 (UMLS 2011AA Property-2)
    C25304 (NCI Thesaurus ValueDomain)
    C0439810 (UMLS 2011AA ValueDomain)
    C25712 (NCI Thesaurus ValueDomain-2)
    C1522609 (UMLS 2011AA ValueDomain-2)
    AdverseEventWorstSymptomDate
    Item
    Nadir/Worst Date (Date of lab test mm/dd/yyyy)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C4876 (NCI Thesaurus Property)
    C1457887 (UMLS 2011AA Property)
    C25719 (NCI Thesaurus Property-2)
    C1522166 (UMLS 2011AA Property-2)
    AdverseEventWorstSymptomValue
    Item
    Nadir/Worst Value (The nadir is the lowest value of counts occurring between two treatments)
    float
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C4876 (NCI Thesaurus Property)
    C1457887 (UMLS 2011AA Property)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C25719 (NCI Thesaurus Property-2)
    C1522166 (UMLS 2011AA Property-2)
    AdverseEventWorstLaboratoryInd-3
    Item
    Is nadir below LLN? (check one)
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C37984 (NCI Thesaurus Property)
    C0022877 (UMLS 2011AA Property)
    C25719 (NCI Thesaurus Property-2)
    C1522166 (UMLS 2011AA Property-2)
    Item Group
    Description Of Primary Disease
    Item
    CTC Adverse Event Term
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C49704 (NCI Thesaurus ObjectClass)
    C1516728 (UMLS 2011AA ObjectClass)
    C45559 (NCI Thesaurus Property)
    C1705313 (UMLS 2011AA Property)
    CL.5
    Code List
    CTC Adverse Event Term
    CL Item
    Cough (Cough)
    C37935 (NCI Thesaurus)
    C0010200 (UMLS 2011AA)
    CL Item
    Dyspnoea Nos (Dyspnea (shortness of breath))
    CL Item
    Keratitis Nec (Keratitis (corneal inflammation/corneal ulceration))
    CL Item
    Diarrhoea Nos (Diarrhea)
    CL Item
    Nausea (Nausea)
    C3258 (NCI Thesaurus)
    C0027497 (UMLS 2011AA)
    CL Item
    Dermatitis Exfoliative Nos (Rash/desquamation)
    MedDRACode
    Item
    MedDRA Code (primary tumor site: Metastases to brain parenchyma)
    float
    C25162 (NCI Thesaurus ValueDomain)
    C0805701 (UMLS 2011AA ValueDomain)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    CL104089 (NCI Metathesaurus ObjectClass)
    CommonToxicityCriteriaAdverseEventGrade
    Item
    CTC Adverse Event Grade (highest grade this cycle)
    float
    C49704 (NCI Thesaurus ObjectClass)
    C1516728 (UMLS 2011AA ObjectClass)
    C18000 (NCI Thesaurus ValueDomain)
    C0919553 (UMLS 2011AA ValueDomain)
    C25365 (NCI Thesaurus Property)
    C0678257 (UMLS 2011AA Property)
    Item
    CTC AE Attribution Code (If Grade > 0)
    text
    C25664 (NCI Thesaurus ValueDomain)
    C0349674 (UMLS 2011AA ValueDomain)
    C49704 (NCI Thesaurus ObjectClass)
    C1516728 (UMLS 2011AA ObjectClass)
    C25358 (NCI Thesaurus Property)
    C0596130 (UMLS 2011AA Property)
    CL.11
    Code List
    CTC AE Attribution Code (If Grade > 0)
    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)
    AdverseEventReportInd-3
    Item
    Has an Adverse Event Expedited Report been submitted? (Enter 1 for Yes or 2 for No)
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C25375 (NCI Thesaurus Property)
    C0684224 (UMLS 2011AA Property)
    C17648 (NCI Thesaurus ObjectClass-2)
    C0439064 (UMLS 2011AA ObjectClass-2)
    Cycle Number Chemotherapeutics
    Item
    Current Cycle Number
    integer
    C25337 (NCI Thesaurus ValueDomain)
    C2045829 (UMLS CUI-1)
    C25471 (NCI Thesaurus Property)
    C15368 (NCI Thesaurus ObjectClass)
    C25379 (NCI Thesaurus Property-2)
    Item
    Were adverse events assessed during this report period (other)
    text
    C25180 (NCI Thesaurus ValueDomain)
    C1522602 (UMLS 2011AA ValueDomain)
    C20989 (NCI Thesaurus Property)
    C0031809 (UMLS 2011AA Property)
    C25471 (NCI Thesaurus Property-2)
    C0521116 (UMLS 2011AA Property-2)
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    CL.9
    Code List
    Were adverse events assessed during this report period (other)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes, And Reportable Adverse Events Occurred (Yes, and reportable adverse events occurred)
    CL Item
    Yes, But No Reportable Adverse Events Occurred (Yes, but no reportable adverse events occurred)
    CTCAdverseEventTermSpecify
    Item
    Other CTC Adverse Event Term not listed
    text
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
    C49704 (NCI Thesaurus ObjectClass)
    C1516728 (UMLS 2011AA ObjectClass)
    C45559 (NCI Thesaurus Property)
    C1705313 (UMLS 2011AA Property)
    MedDRACode
    Item
    MedDRA Code (primary tumor site: Metastases to brain parenchyma)
    float
    C25162 (NCI Thesaurus ValueDomain)
    C0805701 (UMLS 2011AA ValueDomain)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    CL104089 (NCI Metathesaurus ObjectClass)
    CommonToxicityCriteriaAdverseEventGrade
    Item
    CTC Adverse Event Grade (highest grade this cycle)
    float
    C49704 (NCI Thesaurus ObjectClass)
    C1516728 (UMLS 2011AA ObjectClass)
    C18000 (NCI Thesaurus ValueDomain)
    C0919553 (UMLS 2011AA ValueDomain)
    C25365 (NCI Thesaurus Property)
    C0678257 (UMLS 2011AA Property)
    Item
    CTC AE Attribution Code (If Grade > 0)
    text
    C25664 (NCI Thesaurus ValueDomain)
    C0349674 (UMLS 2011AA ValueDomain)
    C49704 (NCI Thesaurus ObjectClass)
    C1516728 (UMLS 2011AA ObjectClass)
    C25358 (NCI Thesaurus Property)
    C0596130 (UMLS 2011AA Property)
    CL.11
    Code List
    CTC AE Attribution Code (If Grade > 0)
    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)
    AdverseEventReportInd-3
    Item
    Has an Adverse Event Expedited Report been submitted? (Enter 1 for Yes or 2 for No)
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C25375 (NCI Thesaurus Property)
    C0684224 (UMLS 2011AA Property)
    C17648 (NCI Thesaurus ObjectClass-2)
    C0439064 (UMLS 2011AA ObjectClass-2)
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