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ID

607

Descrizione

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

collegamento

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

Keywords

  1. 26/08/12 26/08/12 -
  2. 08/01/15 08/01/15 - Martin Dugas
  3. 09/01/15 09/01/15 - Martin Dugas
  4. 09/01/15 09/01/15 - Martin Dugas
  5. 10/01/15 10/01/15 - Martin Dugas
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26 agosto 2012

DOI

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Licenza

Creative Commons BY-NC 3.0 Legacy

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

    No Instruction available.

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

    Header

    Protocol Number
    Descrizione

    ProtocolNorthCentralCancerTreatmentGroupIdentifierNumber

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus ObjectClass
    C25320
    UMLS 2011AA ObjectClass
    C1507394
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus Property
    C25581
    UMLS 2011AA Property
    C1518419
    Patient ID
    Descrizione

    PatientNorthCentralCancerTreatmentGroupIdentifierNumber

    Tipo di dati

    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
    C25581
    UMLS 2011AA Property
    C1518419
    Patient Initials (L F M)
    Descrizione

    PatientInitialsName

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25536
    UMLS 2011AA Property
    C1555582
    Institution Number
    Descrizione

    InstitutionIdentifierNumber

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus ObjectClass
    C21541
    UMLS 2011AA ObjectClass
    C0018704
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    Institution
    Descrizione

    InstitutionName

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    NCI Thesaurus ObjectClass
    C21541
    UMLS 2011AA ObjectClass
    C0018704
    NCI Thesaurus ValueDomain
    C21541
    UMLS 2011AA ValueDomain
    C0018704
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    Are data amended (If yes, highlight amended areas)
    Descrizione

    DataAmendedInd-3

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ObjectClass
    C25474
    UMLS 2011AA ObjectClass
    C1511726
    NCI Thesaurus Property
    C25416
    UMLS 2011AA Property
    C1691222
    Unnamed1
    Descrizione

    Unnamed1

    Date of evaluation (mm/dd/yyyy)
    Descrizione

    AssessmentPerformedDate

    Tipo di dati

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C25367
    NCI Thesaurus ValueDomain
    C25367
    NCI Thesaurus Property
    C38000
    UMLS 2011AA Property
    C0884358
    Platelets (PLT) (K/uL or 10^9/L)
    Descrizione

    LaboratoryProcedurePlateletResultSpecifiedValue

    Tipo di dati

    double

    Unità di misura
    • 1000/uL
    Alias
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property
    C12520
    UMLS 2011AA Property
    C0005821
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    1000/uL
    Leukocytes (WBC) (K/uL or 10^9/L)
    Descrizione

    LaboratoryProcedureLeukocyteResultSpecifiedValue

    Tipo di dati

    double

    Unità di misura
    • 1000/uL
    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C12529
    UMLS 2011AA Property
    C0023516
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus ValueDomain
    C38024
    UMLS 2011AA ValueDomain
    C0205369
    1000/uL
    CTC AE Attribution Code (If Grade > 0)
    Descrizione

    CTCAdverseEventAttributionScale

    Tipo di dati

    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)
    Descrizione

    LaboratoryProcedureHemoglobinResultSpecifiedValue

    Tipo di dati

    double

    Unità di misura
    • g/dL
    Alias
    NCI Thesaurus Property
    C16676
    UMLS 2011AA Property
    C0019046
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    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)
    Descrizione

    AdverseEventReportInd-3

    Tipo di dati

    text

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

    TreatmentCurrentCourseNumber

    Tipo di dati

    double

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus Property
    C25471
    UMLS 2011AA Property
    C0521116
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus Property
    C25379
    UMLS 2011AA Property
    C0750729
    Absolute Neutrophil Count (K/uL or 10^9/L)
    Descrizione

    LaboratoryProcedureNeutrophilResultTotalValue

    Tipo di dati

    double

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

    AdverseEventWorstSymptomDate

    Tipo di dati

    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
    C25719
    UMLS 2011AA Property
    C1522166
    Nadir/Worst Value (The nadir is the lowest value of counts occurring between two treatments)
    Descrizione

    AdverseEventWorstSymptomValue

    Tipo di dati

    double

    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
    C25719
    UMLS 2011AA Property
    C1522166
    Is nadir below LLN? (check one)
    Descrizione

    AdverseEventWorstLaboratoryInd-3

    Tipo di dati

    text

    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
    C25719
    UMLS 2011AA Property
    C1522166
    Description Of Primary Disease
    Descrizione

    Description Of Primary Disease

    CTC Adverse Event Term
    Descrizione

    CommonToxicityCriteriaAdverseEventTermType

    Tipo di dati

    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)
    Descrizione

    MedDRACode

    Tipo di dati

    double

    Alias
    NCI Thesaurus ValueDomain
    C25162
    UMLS 2011AA ValueDomain
    C0805701
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Metathesaurus ObjectClass
    CL104089
    CTC Adverse Event Grade (highest grade this cycle)
    Descrizione

    CommonToxicityCriteriaAdverseEventGrade

    Tipo di dati

    double

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

    CTCAdverseEventAttributionScale

    Tipo di dati

    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)
    Descrizione

    AdverseEventReportInd-3

    Tipo di dati

    text

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

    TreatmentCurrentCourseNumber

    Tipo di dati

    double

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus Property
    C25471
    UMLS 2011AA Property
    C0521116
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus Property
    C25379
    UMLS 2011AA Property
    C0750729
    Were adverse events assessed during this report period (other)
    Descrizione

    AdverseEventCurrentAssessmentInd

    Tipo di dati

    text

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

    Description Of Primary Disease

    Other CTC Adverse Event Term not listed
    Descrizione

    CTCAdverseEventTermSpecify

    Tipo di dati

    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)
    Descrizione

    MedDRACode

    Tipo di dati

    double

    Alias
    NCI Thesaurus ValueDomain
    C25162
    UMLS 2011AA ValueDomain
    C0805701
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Metathesaurus ObjectClass
    CL104089
    CTC Adverse Event Grade (highest grade this cycle)
    Descrizione

    CommonToxicityCriteriaAdverseEventGrade

    Tipo di dati

    double

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

    CTCAdverseEventAttributionScale

    Tipo di dati

    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)
    Descrizione

    AdverseEventReportInd-3

    Tipo di dati

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus Property
    C25375
    UMLS 2011AA Property
    C0684224
    NCI Thesaurus ObjectClass
    C17648
    UMLS 2011AA ObjectClass
    C0439064

    Similar models

    No Instruction available.

    1. StudyEvent: North Central Cancer Treatment Group N0577 Nadir/Adverse Event Form
      1. No Instruction available.
    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    Header
    ProtocolNorthCentralCancerTreatmentGroupIdentifierNumber
    Item
    Protocol Number
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C25320 (NCI Thesaurus ObjectClass)
    C1507394 (UMLS 2011AA ObjectClass)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C25581 (NCI Thesaurus Property)
    C1518419 (UMLS 2011AA Property)
    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)
    C1518419 (UMLS 2011AA Property)
    PatientInitialsName
    Item
    Patient Initials (L F M)
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25536 (NCI Thesaurus Property)
    C1555582 (UMLS 2011AA Property)
    InstitutionIdentifierNumber
    Item
    Institution Number
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C21541 (NCI Thesaurus ObjectClass)
    C0018704 (UMLS 2011AA ObjectClass)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    InstitutionName
    Item
    Institution
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    C21541 (NCI Thesaurus ObjectClass)
    C0018704 (UMLS 2011AA ObjectClass)
    C21541 (NCI Thesaurus ValueDomain)
    C0018704 (UMLS 2011AA ValueDomain)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    Item
    Are data amended (If yes, highlight amended areas)
    text
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C25474 (NCI Thesaurus ObjectClass)
    C1511726 (UMLS 2011AA ObjectClass)
    C25416 (NCI Thesaurus Property)
    C1691222 (UMLS 2011AA Property)
    Code List
    Are data amended (If yes, highlight amended areas)
    CL Item
    No (no)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item Group
    Unnamed1
    AssessmentPerformedDate
    Item
    Date of evaluation (mm/dd/yyyy)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25367 (NCI Thesaurus ObjectClass)
    C25367 (NCI Thesaurus ValueDomain)
    C38000 (NCI Thesaurus Property)
    C0884358 (UMLS 2011AA Property)
    LaboratoryProcedurePlateletResultSpecifiedValue
    Item
    Platelets (PLT) (K/uL or 10^9/L)
    double
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C12520 (NCI Thesaurus Property)
    C0005821 (UMLS 2011AA Property)
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    LaboratoryProcedureLeukocyteResultSpecifiedValue
    Item
    Leukocytes (WBC) (K/uL or 10^9/L)
    double
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C12529 (NCI Thesaurus Property)
    C0023516 (UMLS 2011AA Property)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C38024 (NCI Thesaurus ValueDomain)
    C0205369 (UMLS 2011AA ValueDomain)
    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)
    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)
    double
    C16676 (NCI Thesaurus Property)
    C0019046 (UMLS 2011AA Property)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    Item
    Has an Adverse Event Expedited Report been submitted? (Enter 1 for Yes or 2 for No)
    text
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C25375 (NCI Thesaurus Property)
    C0684224 (UMLS 2011AA Property)
    C17648 (NCI Thesaurus ObjectClass)
    C0439064 (UMLS 2011AA ObjectClass)
    Code List
    Has an Adverse Event Expedited Report been submitted? (Enter 1 for Yes or 2 for No)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    TreatmentCurrentCourseNumber
    Item
    Current Cycle Number
    double
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C25471 (NCI Thesaurus Property)
    C0521116 (UMLS 2011AA Property)
    C15368 (NCI Thesaurus ObjectClass)
    C25379 (NCI Thesaurus Property)
    C0750729 (UMLS 2011AA Property)
    LaboratoryProcedureNeutrophilResultTotalValue
    Item
    Absolute Neutrophil Count (K/uL or 10^9/L)
    double
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C12533 (NCI Thesaurus Property)
    C0027950 (UMLS 2011AA Property)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C25304 (NCI Thesaurus ValueDomain)
    C0439810 (UMLS 2011AA ValueDomain)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    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)
    C1522166 (UMLS 2011AA Property)
    AdverseEventWorstSymptomValue
    Item
    Nadir/Worst Value (The nadir is the lowest value of counts occurring between two treatments)
    double
    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)
    C1522166 (UMLS 2011AA Property)
    Item
    Is nadir below LLN? (check one)
    text
    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)
    C1522166 (UMLS 2011AA Property)
    Code List
    Is nadir below LLN? (check one)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    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)
    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)
    double
    C25162 (NCI Thesaurus ValueDomain)
    C0805701 (UMLS 2011AA ValueDomain)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    CL104089 (NCI Metathesaurus ObjectClass)
    Item
    CTC Adverse Event Grade (highest grade this cycle)
    double
    C49704 (NCI Thesaurus ObjectClass)
    C1516728 (UMLS 2011AA ObjectClass)
    C18000 (NCI Thesaurus ValueDomain)
    C0919553 (UMLS 2011AA ValueDomain)
    C25365 (NCI Thesaurus Property)
    C0678257 (UMLS 2011AA Property)
    Code List
    CTC Adverse Event Grade (highest grade this cycle)
    CL Item
    Moderate Adverse Event (2)
    C41339 (NCI Thesaurus)
    C1513374 (UMLS 2011AA)
    CL Item
    Severe Adverse Event (3)
    C41340 (NCI Thesaurus)
    C1519275 (UMLS 2011AA)
    CL Item
    Life-threatening Or Disabling Adverse Event (4)
    CL Item
    Death Related To Adverse Event (5)
    C48275 (NCI Thesaurus)
    C1705232 (UMLS 2011AA)
    Item
    CTC AE 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)
    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)
    Item
    Has an Adverse Event Expedited Report been submitted? (Enter 1 for Yes or 2 for No)
    text
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C25375 (NCI Thesaurus Property)
    C0684224 (UMLS 2011AA Property)
    C17648 (NCI Thesaurus ObjectClass)
    C0439064 (UMLS 2011AA ObjectClass)
    Code List
    Has an Adverse Event Expedited Report been submitted? (Enter 1 for Yes or 2 for No)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    TreatmentCurrentCourseNumber
    Item
    Current Cycle Number
    double
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C25471 (NCI Thesaurus Property)
    C0521116 (UMLS 2011AA Property)
    C15368 (NCI Thesaurus ObjectClass)
    C25379 (NCI Thesaurus Property)
    C0750729 (UMLS 2011AA Property)
    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)
    C0521116 (UMLS 2011AA Property)
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    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)
    double
    C25162 (NCI Thesaurus ValueDomain)
    C0805701 (UMLS 2011AA ValueDomain)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    CL104089 (NCI Metathesaurus ObjectClass)
    Item
    CTC Adverse Event Grade (highest grade this cycle)
    double
    C49704 (NCI Thesaurus ObjectClass)
    C1516728 (UMLS 2011AA ObjectClass)
    C18000 (NCI Thesaurus ValueDomain)
    C0919553 (UMLS 2011AA ValueDomain)
    C25365 (NCI Thesaurus Property)
    C0678257 (UMLS 2011AA Property)
    Code List
    CTC Adverse Event Grade (highest grade this cycle)
    CL Item
    Moderate Adverse Event (2)
    C41339 (NCI Thesaurus)
    C1513374 (UMLS 2011AA)
    CL Item
    Severe Adverse Event (3)
    C41340 (NCI Thesaurus)
    C1519275 (UMLS 2011AA)
    CL Item
    Life-threatening Or Disabling Adverse Event (4)
    CL Item
    Death Related To Adverse Event (5)
    C48275 (NCI Thesaurus)
    C1705232 (UMLS 2011AA)
    Item
    CTC AE 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)
    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)
    Item
    Has an Adverse Event Expedited Report been submitted? (Enter 1 for Yes or 2 for No)
    text
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C25375 (NCI Thesaurus Property)
    C0684224 (UMLS 2011AA Property)
    C17648 (NCI Thesaurus ObjectClass)
    C0439064 (UMLS 2011AA ObjectClass)
    Code List
    Has an Adverse Event Expedited Report been submitted? (Enter 1 for Yes or 2 for No)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)

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