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ID

8195

Description

Z4032 Adverse Events Form Surgery With or Without Internal Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=F20AB755-5BF4-19FB-E034-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=F20AB755-5BF4-19FB-E034-0003BA3F9857

Keywords

Versions (2)
  1. 9/19/12 9/19/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
Uploaded on

January 9, 2015

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Creative Commons BY-NC 3.0 Legacy
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    Lung Cancer NCT00107172 Toxicity - Z4032 Adverse Events Form - 2305695v3.0

    English

    No Instruction available.

    1 forms  
    1. StudyEvent: Z4032 Adverse Events Form
      1. No Instruction available.
    Header Module
    Description

    Header Module

    Visit
    Description

    AmericanCollegeofSurgeonsOncologyGroupVisitPeriodAmericanCollegeofSurgeonsOncologyGroupVisitPeriodType

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus Property
    C25616
    UMLS 2011AA Property
    C1948053
    NCI Thesaurus ObjectClass
    C19712
    UMLS 2011AA ObjectClass
    C1515944
    NCI Thesaurus ObjectClass-2
    C25716
    UMLS 2011AA ObjectClass-2
    C0545082
    Patient ID (Pt. ID issued during registration or previously issued Patient ID)
    Description

    Patient Study ID

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C2348585
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25462
    NCI Thesaurus Property-2
    C25364
    Patient Initials
    Description

    Patient Initials

    Data type

    text

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

    Instruction Module

    Date of Symptom/Event Assessment
    Description

    AdverseEventAssessmentDate

    Data type

    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
    Was patient hospitalized during this reporting interval?
    Description

    HospitalizationReportPeriodInd-2

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus Property
    C25616
    UMLS 2011AA Property
    C1948053
    NCI Thesaurus Property-2
    C25375
    UMLS 2011AA Property-2
    C0684224
    NCI Thesaurus ObjectClass
    C25179
    UMLS 2011AA ObjectClass
    C0019993
    Has an Adverse Event Expedited Report been submitted?
    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
    Ae Module
    Description

    Ae Module

    CTC Adverse Event Term
    Description

    CTC Adverse Event Term

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS CUI-1
    C1516728
    NCI Thesaurus ObjectClass
    C49704
    UMLS CUI-2
    C2826934
    NCI Thesaurus Property
    C45559
    Not Assessed (Also mark if Grade 1 or 2)
    Description

    AdverseEventNoAssessmentText

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS 2011AA ValueDomain
    C1527021
    NCI Thesaurus Property
    C49487
    UMLS 2011AA Property
    C1298908
    NCI Thesaurus Property-2
    C25217
    UMLS 2011AA Property-2
    C1516048
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    Not present
    Description

    AdverseEventAbsentText

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS 2011AA ValueDomain
    C1527021
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus Property
    C48190
    UMLS 2011AA Property
    C0332197
    CTCAE v3.0 Grade (1-5)
    Description

    CTC Adverse Event Grade

    Data type

    float

    Alias
    NCI Thesaurus ObjectClass
    C49704
    UMLS CUI-1
    C2985911
    NCI Thesaurus ValueDomain
    C18000
    NCI Thesaurus Property
    C25365
    Treatment Attribution (see above)
    Description

    CTC Adverse Event Attribution Category

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25664
    UMLS CUI-1
    C1706735
    NCI Thesaurus ObjectClass
    C49704
    NCI Thesaurus Property
    C25358
    Header
    Description

    Header

    Check box if no additional adverse events were experienced by the patient.
    Description

    AdverseEventNegativeAssessmentText

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS 2011AA ValueDomain
    C1527021
    NCI Thesaurus Property
    C20989
    UMLS 2011AA Property
    C0031809
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus Property-2
    C38757
    UMLS 2011AA Property-2
    C1513916
    Other Ae Module
    Description

    Other Ae Module

    CTC Adverse Event Term
    Description

    CTC Adverse Event Term

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS CUI-1
    C1516728
    NCI Thesaurus ObjectClass
    C49704
    UMLS CUI-2
    C2826934
    NCI Thesaurus Property
    C45559
    CTCAE v3.0 Grade (1-5)
    Description

    CTC Adverse Event Grade

    Data type

    float

    Alias
    NCI Thesaurus ObjectClass
    C49704
    UMLS CUI-1
    C2985911
    NCI Thesaurus ValueDomain
    C18000
    NCI Thesaurus Property
    C25365
    Completed by
    Description

    Person Completing Form

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C1550483
    NCI Thesaurus ObjectClass
    C25657
    NCI Thesaurus Property
    C25364
    Treatment Attribution (see above)
    Description

    CTC Adverse Event Attribution Category

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25664
    UMLS CUI-1
    C1706735
    NCI Thesaurus ObjectClass
    C49704
    NCI Thesaurus Property
    C25358
    Form Complete Date
    Description

    Date Form Completed

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C1115437
    NCI Thesaurus ObjectClass
    C40988
    NCI Thesaurus Property
    C25250
    NCI Thesaurus ValueDomain-2
    C25367
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    Similar models

    No Instruction available.

    1 forms
    1. StudyEvent: Z4032 Adverse Events Form
      1. No Instruction available.
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Header Module
    Item
    Visit
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C25616 (NCI Thesaurus Property)
    C1948053 (UMLS 2011AA Property)
    C19712 (NCI Thesaurus ObjectClass)
    C1515944 (UMLS 2011AA ObjectClass)
    C25716 (NCI Thesaurus ObjectClass-2)
    C0545082 (UMLS 2011AA ObjectClass-2)
    CL.1
    Code List
    Visit
    CL Item
    Day 0 (Day 0)
    CL Item
    Month 1 (Month 1)
    CL Item
    Month 12 (Month 12)
    CL Item
    Month 18 (Month 18)
    CL Item
    Month 24 (Month 24)
    CL Item
    Month 3 (Month 3)
    CL Item
    Month 6 (Month 6)
    Patient Study ID
    Item
    Patient ID (Pt. ID issued during registration or previously issued Patient ID)
    text
    C25337 (NCI Thesaurus ValueDomain)
    C2348585 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25462 (NCI Thesaurus Property)
    C25364 (NCI Thesaurus Property-2)
    Patient Initials
    Item
    Patient Initials
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2986440 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25536 (NCI Thesaurus Property)
    Institution Number
    Item
    Institution ID
    text
    C25337 (NCI Thesaurus ValueDomain)
    C1301943 (UMLS CUI-1)
    C21541 (NCI Thesaurus ObjectClass)
    C0805701 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    Institution Number
    Item
    Institution ID
    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
    Instruction Module
    AdverseEventAssessmentDate
    Item
    Date of Symptom/Event Assessment
    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)
    HospitalizationReportPeriodInd-2
    Item
    Was patient hospitalized during this reporting interval?
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C25616 (NCI Thesaurus Property)
    C1948053 (UMLS 2011AA Property)
    C25375 (NCI Thesaurus Property-2)
    C0684224 (UMLS 2011AA Property-2)
    C25179 (NCI Thesaurus ObjectClass)
    C0019993 (UMLS 2011AA ObjectClass)
    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)
    Item Group
    Ae Module
    CTC Adverse Event Term
    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)
    AdverseEventNoAssessmentText
    Item
    Not Assessed (Also mark if Grade 1 or 2)
    text
    C25704 (NCI Thesaurus ValueDomain)
    C1527021 (UMLS 2011AA ValueDomain)
    C49487 (NCI Thesaurus Property)
    C1298908 (UMLS 2011AA Property)
    C25217 (NCI Thesaurus Property-2)
    C1516048 (UMLS 2011AA Property-2)
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    AdverseEventAbsentText
    Item
    Not present
    text
    C25704 (NCI Thesaurus ValueDomain)
    C1527021 (UMLS 2011AA ValueDomain)
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C48190 (NCI Thesaurus Property)
    C0332197 (UMLS 2011AA Property)
    CTC Adverse Event Grade
    Item
    CTCAE v3.0 Grade (1-5)
    float
    C49704 (NCI Thesaurus ObjectClass)
    C2985911 (UMLS CUI-1)
    C18000 (NCI Thesaurus ValueDomain)
    C25365 (NCI Thesaurus Property)
    Item
    Treatment Attribution (see above)
    text
    C25664 (NCI Thesaurus ValueDomain)
    C1706735 (UMLS CUI-1)
    C49704 (NCI Thesaurus ObjectClass)
    C25358 (NCI Thesaurus Property)
    CL.8
    Code List
    Treatment Attribution (see above)
    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 Group
    Header
    AdverseEventNegativeAssessmentText
    Item
    Check box if no additional adverse events were experienced by the patient.
    text
    C25704 (NCI Thesaurus ValueDomain)
    C1527021 (UMLS 2011AA ValueDomain)
    C20989 (NCI Thesaurus Property)
    C0031809 (UMLS 2011AA Property)
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C38757 (NCI Thesaurus Property-2)
    C1513916 (UMLS 2011AA Property-2)
    Item Group
    Other Ae Module
    CTC Adverse Event Term
    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)
    CTC Adverse Event Grade
    Item
    CTCAE v3.0 Grade (1-5)
    float
    C49704 (NCI Thesaurus ObjectClass)
    C2985911 (UMLS CUI-1)
    C18000 (NCI Thesaurus ValueDomain)
    C25365 (NCI Thesaurus Property)
    Person Completing Form
    Item
    Completed by
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1550483 (UMLS CUI-1)
    C25657 (NCI Thesaurus ObjectClass)
    C25364 (NCI Thesaurus Property)
    Item
    Treatment Attribution (see above)
    text
    C25664 (NCI Thesaurus ValueDomain)
    C1706735 (UMLS CUI-1)
    C49704 (NCI Thesaurus ObjectClass)
    C25358 (NCI Thesaurus Property)
    CL.8
    Code List
    Treatment Attribution (see above)
    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)
    Date Form Completed
    Item
    Form Complete Date
    date
    C25164 (NCI Thesaurus ValueDomain)
    C1115437 (UMLS CUI-1)
    C40988 (NCI Thesaurus ObjectClass)
    C25250 (NCI Thesaurus Property)
    C25367 (NCI Thesaurus ValueDomain-2)
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