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9629

Beschreibung

North Central Cancer Treatment Group Adverse Events Log Stereotactic Radiation Therapy With or Without Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=10B44AAB-1A9A-0E7A-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=10B44AAB-1A9A-0E7A-E044-0003BA3F9857

Stichworte

  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
Hochgeladen am

9. Januar 2015

DOI

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Creative Commons BY-NC 3.0 Legacy

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    Breast Cancer NCT00377156 Toxicity - North Central Cancer Treatment Group Adverse Events Log - 2469808v1.0

    No Instruction available.

    1. StudyEvent: North Central Cancer Treatment Group Adverse Events Log
      1. No Instruction available.
    Header
    Beschreibung

    Header

    NCCTG Protocol Number
    Beschreibung

    Protocol ID NCCTG

    Datentyp

    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
    NCCTG Patient ID
    Beschreibung

    PatientNorthCentralCancerTreatmentGroupIdentifierNumber

    Datentyp

    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)
    Beschreibung

    Patient Initials

    Datentyp

    text

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

    Institution Name

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C1301943
    NCI Thesaurus ObjectClass
    C21541
    NCI Thesaurus ValueDomain-2
    C21541
    NCI Thesaurus Property
    C25364
    Institution Number
    Beschreibung

    Institution Number

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C1301943
    NCI Thesaurus ObjectClass
    C21541
    UMLS CUI-2
    C0805701
    NCI Thesaurus Property
    C25364
    Are data amended (If yes, highlight amended areas)
    Beschreibung

    Data amended

    Datentyp

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS CUI-1
    C0680532
    NCI Thesaurus ObjectClass
    C25474
    NCI Thesaurus Property
    C25416
    Description Of Primary Disease
    Beschreibung

    Description Of Primary Disease

    Cycle Number (Adverse events associated with)
    Beschreibung

    Cycle Number

    Datentyp

    integer

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C2045829
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus Property
    C25379
    Were adverse events assessed during this report period
    Beschreibung

    AdverseEventCurrentAssessmentInd

    Datentyp

    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
    Assessment Date
    Beschreibung

    AdverseEventAssessmentDate

    Datentyp

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus Property
    C20989
    UMLS 2011AA Property
    C0031809
    NCI Thesaurus ValueDomain-2
    C25367
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    CTC Adverse Event Term
    Beschreibung

    CTC Adverse Event Term

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS CUI-1
    C1516728
    NCI Thesaurus ObjectClass
    C49704
    UMLS CUI-2
    C2826934
    NCI Thesaurus Property
    C45559
    MedDRA Code (primary tumor site: Metastases to brain parenchyma)
    Beschreibung

    MedDRACode

    Datentyp

    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
    Beschreibung

    CTC Adverse Event Grade

    Datentyp

    float

    Alias
    NCI Thesaurus ObjectClass
    C49704
    UMLS CUI-1
    C2985911
    NCI Thesaurus ValueDomain
    C18000
    NCI Thesaurus Property
    C25365
    CTC AE Attribution Code
    Beschreibung

    CTC Adverse Event Attribution Category

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25664
    UMLS CUI-1
    C1706735
    NCI Thesaurus ObjectClass
    C49704
    NCI Thesaurus Property
    C25358
    Has an Adverse Event Expedited Report been submitted?
    Beschreibung

    AdverseEventReportInd-3

    Datentyp

    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
    Description Of Primary Disease
    Beschreibung

    Description Of Primary Disease

    Other CTC Adverse Event Term not listed
    Beschreibung

    CTC Adverse Event Term

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS CUI-1
    C1516728
    NCI Thesaurus ObjectClass
    C49704
    UMLS CUI-2
    C2826934
    NCI Thesaurus Property
    C45559
    MedDRA Code (primary tumor site: Metastases to brain parenchyma)
    Beschreibung

    MedDRACode

    Datentyp

    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
    Beschreibung

    CTC Adverse Event Grade

    Datentyp

    float

    Alias
    NCI Thesaurus ObjectClass
    C49704
    UMLS CUI-1
    C2985911
    NCI Thesaurus ValueDomain
    C18000
    NCI Thesaurus Property
    C25365
    CTC AE Attribution Code
    Beschreibung

    CTC Adverse Event Attribution Category

    Datentyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25664
    UMLS CUI-1
    C1706735
    NCI Thesaurus ObjectClass
    C49704
    NCI Thesaurus Property
    C25358
    Has an Adverse Event Expedited Report been submitted?
    Beschreibung

    AdverseEventReportInd-3

    Datentyp

    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

    Ähnliche Modelle

    No Instruction available.

    1. StudyEvent: North Central Cancer Treatment Group Adverse Events Log
      1. No Instruction available.
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Header
    Protocol ID NCCTG
    Item
    NCCTG 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
    NCCTG 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 Name
    Item
    Institution
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1301943 (UMLS CUI-1)
    C21541 (NCI Thesaurus ObjectClass)
    C21541 (NCI Thesaurus ValueDomain-2)
    C25364 (NCI Thesaurus Property)
    Institution Number
    Item
    Institution Number
    text
    C25337 (NCI Thesaurus ValueDomain)
    C1301943 (UMLS CUI-1)
    C21541 (NCI Thesaurus ObjectClass)
    C0805701 (UMLS CUI-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
    Description Of Primary Disease
    Cycle Number
    Item
    Cycle Number (Adverse events associated with)
    integer
    C25337 (NCI Thesaurus ValueDomain)
    C2045829 (UMLS CUI-1)
    C15368 (NCI Thesaurus ObjectClass)
    C25379 (NCI Thesaurus Property)
    Item
    Were adverse events assessed during this report period
    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)
    Code List
    Were adverse events assessed during this report period
    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)
    AdverseEventAssessmentDate
    Item
    Assessment Date
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C20989 (NCI Thesaurus Property)
    C0031809 (UMLS 2011AA Property)
    C25367 (NCI Thesaurus ValueDomain-2)
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    Item
    CTC Adverse Event Term
    text
    C25284 (NCI Thesaurus ValueDomain)
    C1516728 (UMLS CUI-1)
    C49704 (NCI Thesaurus ObjectClass)
    C2826934 (UMLS CUI-2)
    C45559 (NCI Thesaurus Property)
    Code List
    CTC Adverse Event Term
    CL Item
    Cns Necrosis/cystic Progression (CNS necrosis/cystic progression)
    CL Item
    Dermatitis Radiation Nos (Rash: dermatitis associated with radiation - Radiation)
    CL Item
    Vomiting Nos (Vomiting)
    CL Item
    Learning Disorder Nos (Cognitive disturbance)
    C0023186 (NCI Metathesaurus)
    CL Item
    Peripheral Motor Neuropathy (Neuropathy: motor)
    C3500 (NCI Thesaurus)
    C0018995 (UMLS 2011AA)
    CL Item
    Alopecia (Hair loss/Alopecia (scalp or body))
    C2865 (NCI Thesaurus)
    CL Item
    Otitis Externa (exc Boil Of Meatus) Nos (Otitis, external ear (non-infectious))
    CL Item
    Retinopathy (Retinopathy)
    CL Item
    Hearing: Patients With/without Baseline Audiogram And Enrolled In A Monitoring Program (Hearing: patients with/without baseline audiogram and enrolled in a monitoring program)
    CL Item
    Nausea (Nausea)
    C3258 (NCI Thesaurus)
    C0027497 (UMLS 2011AA)
    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)
    CTC Adverse Event Grade
    Item
    CTC Adverse Event Grade
    float
    C49704 (NCI Thesaurus ObjectClass)
    C2985911 (UMLS CUI-1)
    C18000 (NCI Thesaurus ValueDomain)
    C25365 (NCI Thesaurus Property)
    Item
    CTC AE Attribution Code
    text
    C25664 (NCI Thesaurus ValueDomain)
    C1706735 (UMLS CUI-1)
    C49704 (NCI Thesaurus ObjectClass)
    C25358 (NCI Thesaurus Property)
    Code List
    CTC AE Attribution Code
    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?
    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)
    CTC Adverse Event Term
    Item
    Other CTC Adverse Event Term not listed
    text
    C25685 (NCI Thesaurus ValueDomain)
    C1516728 (UMLS CUI-1)
    C49704 (NCI Thesaurus ObjectClass)
    C2826934 (UMLS CUI-2)
    C45559 (NCI Thesaurus 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)
    CTC Adverse Event Grade
    Item
    CTC Adverse Event Grade
    float
    C49704 (NCI Thesaurus ObjectClass)
    C2985911 (UMLS CUI-1)
    C18000 (NCI Thesaurus ValueDomain)
    C25365 (NCI Thesaurus Property)
    Item
    CTC AE Attribution Code
    text
    C25664 (NCI Thesaurus ValueDomain)
    C1706735 (UMLS CUI-1)
    C49704 (NCI Thesaurus ObjectClass)
    C25358 (NCI Thesaurus Property)
    Code List
    CTC AE Attribution Code
    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?
    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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