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North Central Cancer Treatment Group N0577 Notification Form NCT00887146 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=4C07CD25-652F-2417-E044-0003BA3F9857

Länk

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=4C07CD25-652F-2417-E044-0003BA3F9857

Nyckelord

Versioner (3)
  1. 26/08/2012 26/08/2012 -
  2. 08/01/2015 08/01/2015 - Martin Dugas
  3. 08/06/2015 08/06/2015 -
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8 de junho de 2015

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Creative Commons BY-NC 3.0 Legacy
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    North Central Cancer Treatment Group N0577 Notification Form NCT00887146

    Engelsk

    Grade 4 or 5 Non-AER Reportable Events/Hospitalization NCCTG Members Only

    1 Formulär  
    1. StudyEvent: North Central Cancer Treatment Group N0577 Notification Form
      1. Grade 4 or 5 Non-AER Reportable Events/Hospitalization NCCTG Members Only
    Header
    Beskrivning

    Header

    Protocol Number
    Beskrivning

    Protocol ID NCCTG

    Datatyp

    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
    Beskrivning

    PatientNorthCentralCancerTreatmentGroupIdentifierNumber

    Datatyp

    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)
    Beskrivning

    Patient Initials

    Datatyp

    text

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

    Institution Number

    Datatyp

    text

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

    Institution Name

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C1301943
    NCI Thesaurus ObjectClass
    C21541
    NCI Thesaurus ValueDomain-2
    C21541
    NCI Thesaurus Property
    C25364
    Patient status assessment
    Beskrivning

    Patient status assessment

    Date membership CRA aware of event(s) (mm/dd/yyyy)
    Beskrivning

    ClinicalResearchAssociateAssessmentDate

    Datatyp

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus Property
    C25367
    NCI Thesaurus ObjectClass
    C25465
    UMLS 2011AA ObjectClass
    C1516627
    Name of person completing form
    Beskrivning

    Person Completing Form

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C1550483
    NCI Thesaurus ObjectClass
    C25657
    NCI Thesaurus Property
    C25364
    Phone
    Beskrivning

    Person Completing Form Phone

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C1550483
    NCI Thesaurus ObjectClass
    C25190
    UMLS CUI-2
    C1515258
    NCI Thesaurus ObjectClass-2
    C25657
    NCI Thesaurus Property
    C25395
    Current Cycle Number
    Beskrivning

    Cycle Number Chemotherapeutics

    Datatyp

    integer

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C2045829
    NCI Thesaurus Property
    C25471
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus Property-2
    C25379
    Assigned Treatment Arm
    Beskrivning

    Protocol Treatment Arm

    Datatyp

    text

    Alias
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus ObjectClass-2
    C42651
    UMLS CUI-1
    C1522541
    NCI Thesaurus Property
    C32141
    NCI Thesaurus Property-2
    C25426
    NCI Thesaurus ValueDomain
    C25704
    Event => Grade 4 (check one)
    Beskrivning

    AdverseEventLife-ThreateningDisablingDeathGradeInd-2

    Datatyp

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus Property
    C48275
    UMLS 2011AA Property
    C1705232
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus Property-2
    C41337
    UMLS 2011AA Property-2
    C1517874
    NCI Thesaurus Property-3
    C48309
    UMLS 2011AA Property-3
    C0441800
    Date of First Occurrence of Adverse Event (mm/dd/yyyy)
    Beskrivning

    AdverseEventFirstOccurrenceDate

    Datatyp

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus Property
    C25509
    UMLS 2011AA Property
    C1279901
    NCI Thesaurus Property-2
    C25275
    UMLS 2011AA Property-2
    C2745955
    CTC Adverse Event Term (only one event per line)
    Beskrivning

    CommonToxicityCriteriaAdverseEventTermType

    Datatyp

    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
    CTC Adverse Event Grade
    Beskrivning

    CommonToxicityCriteriaAdverseEventGrade

    Datatyp

    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
    In your opinion, is this related to the study medication
    Beskrivning

    HospitalizationAdverseEventClinicalStudyAgentAttributionInd-3

    Datatyp

    text

    Alias
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus ObjectClass-2
    C25179
    UMLS 2011AA ObjectClass-2
    C0019993
    NCI Thesaurus Property
    C1708
    UMLS 2011AA Property
    C0450442
    NCI Thesaurus Property-2
    C15206
    UMLS 2011AA Property-2
    C0008972
    NCI Thesaurus Property-3
    C25358
    UMLS 2011AA Property-3
    C0596130
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    Hospitalization (check one)
    Beskrivning

    AdverseEventRequiredHospitalizationInd-2

    Datatyp

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus Property
    C25652
    UMLS 2011AA Property
    C1514873
    NCI Thesaurus Property-2
    C25179
    UMLS 2011AA Property-2
    C0019993
    Hospital Admission Date (mm/dd/yyyy)
    Beskrivning

    HospitalAdmissionDate

    Datatyp

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C16696
    UMLS 2011AA ObjectClass
    C0019994
    NCI Thesaurus Property
    C25385
    UMLS 2011AA Property
    C0809949
    Reason for Hospitalization (s)
    Beskrivning

    PatientHospitalizationReason

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25638
    UMLS 2011AA ValueDomain
    C0392360
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25179
    UMLS 2011AA Property
    C0019993
    Adverse event, specify type and grade
    Beskrivning

    PatientHospitalizationAdverseEventReasonSpecify

    Datatyp

    text

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus ObjectClass-2
    C25179
    UMLS 2011AA ObjectClass-2
    C0019993
    NCI Thesaurus Property
    C25638
    UMLS 2011AA Property
    C0392360
    NCI Thesaurus Property-2
    C41331
    UMLS 2011AA Property-2
    C0877248
    NCI Thesaurus ValueDomain
    C25685
    UMLS 2011AA ValueDomain
    C1521902
    Prophylactic, specify
    Beskrivning

    PatientHospitalizationPreventiveReasonSpecify

    Datatyp

    text

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus ObjectClass-2
    C25179
    UMLS 2011AA ObjectClass-2
    C0019993
    NCI Thesaurus Property
    C25638
    UMLS 2011AA Property
    C0392360
    NCI Thesaurus Property-2
    C28005
    UMLS 2011AA Property-2
    C1456501
    NCI Thesaurus ValueDomain
    C25685
    UMLS 2011AA ValueDomain
    C1521902
    Other reason, specify
    Beskrivning

    PatientHospitalizationOtherReasonSpecify

    Datatyp

    text

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus ObjectClass-2
    C25179
    UMLS 2011AA ObjectClass-2
    C0019993
    NCI Thesaurus Property
    C17649
    UMLS 2011AA Property
    C0205394
    NCI Thesaurus Property-2
    C25638
    UMLS 2011AA Property-2
    C0392360
    NCI Thesaurus ValueDomain
    C25685
    UMLS 2011AA ValueDomain
    C1521902
    Tillbaka till toppen

    Similar models

    Grade 4 or 5 Non-AER Reportable Events/Hospitalization NCCTG Members Only

    1 Formulär
    1. StudyEvent: North Central Cancer Treatment Group N0577 Notification Form
      1. Grade 4 or 5 Non-AER Reportable Events/Hospitalization NCCTG Members Only
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    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)
    Item Group
    Patient status assessment
    ClinicalResearchAssociateAssessmentDate
    Item
    Date membership CRA aware of event(s) (mm/dd/yyyy)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25367 (NCI Thesaurus Property)
    C25465 (NCI Thesaurus ObjectClass)
    C1516627 (UMLS 2011AA ObjectClass)
    Person Completing Form
    Item
    Name of person completing form
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1550483 (UMLS CUI-1)
    C25657 (NCI Thesaurus ObjectClass)
    C25364 (NCI Thesaurus Property)
    Person Completing Form Phone
    Item
    Phone
    text
    C25337 (NCI Thesaurus ValueDomain)
    C1550483 (UMLS CUI-1)
    C25190 (NCI Thesaurus ObjectClass)
    C1515258 (UMLS CUI-2)
    C25657 (NCI Thesaurus ObjectClass-2)
    C25395 (NCI Thesaurus Property)
    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)
    Protocol Treatment Arm
    Item
    Assigned Treatment Arm
    text
    C15368 (NCI Thesaurus ObjectClass)
    C42651 (NCI Thesaurus ObjectClass-2)
    C1522541 (UMLS CUI-1)
    C32141 (NCI Thesaurus Property)
    C25426 (NCI Thesaurus Property-2)
    C25704 (NCI Thesaurus ValueDomain)
    AdverseEventLife-ThreateningDisablingDeathGradeInd-2
    Item
    Event => Grade 4 (check one)
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C48275 (NCI Thesaurus Property)
    C1705232 (UMLS 2011AA Property)
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C41337 (NCI Thesaurus Property-2)
    C1517874 (UMLS 2011AA Property-2)
    C48309 (NCI Thesaurus Property-3)
    C0441800 (UMLS 2011AA Property-3)
    AdverseEventFirstOccurrenceDate
    Item
    Date of First Occurrence of Adverse Event (mm/dd/yyyy)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C25509 (NCI Thesaurus Property)
    C1279901 (UMLS 2011AA Property)
    C25275 (NCI Thesaurus Property-2)
    C2745955 (UMLS 2011AA Property-2)
    CommonToxicityCriteriaAdverseEventTermType
    Item
    CTC Adverse Event Term (only one event per line)
    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)
    CommonToxicityCriteriaAdverseEventGrade
    Item
    CTC Adverse Event Grade
    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
    In your opinion, is this related to the study medication
    text
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C25179 (NCI Thesaurus ObjectClass-2)
    C0019993 (UMLS 2011AA ObjectClass-2)
    C1708 (NCI Thesaurus Property)
    C0450442 (UMLS 2011AA Property)
    C15206 (NCI Thesaurus Property-2)
    C0008972 (UMLS 2011AA Property-2)
    C25358 (NCI Thesaurus Property-3)
    C0596130 (UMLS 2011AA Property-3)
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    CL.3
    Code List
    In your opinion, is this related to the study medication
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Unknown (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    AdverseEventRequiredHospitalizationInd-2
    Item
    Hospitalization (check one)
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C25652 (NCI Thesaurus Property)
    C1514873 (UMLS 2011AA Property)
    C25179 (NCI Thesaurus Property-2)
    C0019993 (UMLS 2011AA Property-2)
    HospitalAdmissionDate
    Item
    Hospital Admission Date (mm/dd/yyyy)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C16696 (NCI Thesaurus ObjectClass)
    C0019994 (UMLS 2011AA ObjectClass)
    C25385 (NCI Thesaurus Property)
    C0809949 (UMLS 2011AA Property)
    Item
    Reason for Hospitalization (s)
    text
    C25638 (NCI Thesaurus ValueDomain)
    C0392360 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25179 (NCI Thesaurus Property)
    C0019993 (UMLS 2011AA Property)
    CL.5
    Code List
    Reason for Hospitalization (s)
    CL Item
    Adverse Event (adverse event)
    C41331 (NCI Thesaurus)
    C0877248 (UMLS 2011AA)
    CL Item
    Prophylactic (Prophylactic)
    CL Item
    Other Reason (Other reason)
    PatientHospitalizationAdverseEventReasonSpecify
    Item
    Adverse event, specify type and grade
    text
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25179 (NCI Thesaurus ObjectClass-2)
    C0019993 (UMLS 2011AA ObjectClass-2)
    C25638 (NCI Thesaurus Property)
    C0392360 (UMLS 2011AA Property)
    C41331 (NCI Thesaurus Property-2)
    C0877248 (UMLS 2011AA Property-2)
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
    PatientHospitalizationPreventiveReasonSpecify
    Item
    Prophylactic, specify
    text
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25179 (NCI Thesaurus ObjectClass-2)
    C0019993 (UMLS 2011AA ObjectClass-2)
    C25638 (NCI Thesaurus Property)
    C0392360 (UMLS 2011AA Property)
    C28005 (NCI Thesaurus Property-2)
    C1456501 (UMLS 2011AA Property-2)
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
    PatientHospitalizationOtherReasonSpecify
    Item
    Other reason, specify
    text
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25179 (NCI Thesaurus ObjectClass-2)
    C0019993 (UMLS 2011AA ObjectClass-2)
    C17649 (NCI Thesaurus Property)
    C0205394 (UMLS 2011AA Property)
    C25638 (NCI Thesaurus Property-2)
    C0392360 (UMLS 2011AA Property-2)
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
    Tillbaka till toppen 

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