ID

11557

Beskrivning

RTOG-0421 AE: Adverse Event Evaluation Form NCT00113399 Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Recurrent Head and Neck Cancer That Cannot Be Removed By Surgery Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=EB6FBB34-B48C-4885-E034-0003BA3F9857

Länk

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=EB6FBB34-B48C-4885-E034-0003BA3F9857

Nyckelord

Versioner (4)
  1. 9/19/12 9/19/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 1/9/15 1/9/15 - Martin Dugas
  4. 7/8/15 7/8/15 -
Uppladdad den

July 8, 2015

DOI

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Creative Commons BY-NC 3.0 Legacy
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    RTOG-0421 AE: Adverse Event Evaluation Form NCT00113399

    Engelsk

    Radiation Therapy Oncology Group Phase III Lung Pre-Op Chemotherapy vs. Pre-Op Concurrent Chemoradiation for NSCLC

    1 Formulär  
    RTOG clinical trial administrative data
    Beskrivning

    RTOG clinical trial administrative data

    RTOG Study
    Beskrivning

    Protocol ID RTOG

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C3274381
    NCI Thesaurus ObjectClass
    C25320
    UMLS CUI-2
    C1514695
    NCI Thesaurus Property
    C19778
    NCI Thesaurus Property-2
    C25364
    Case #
    Beskrivning

    RadiationTherapyOncologyGroupPatientCaseIdentifierNumber

    Datatyp

    text

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus ObjectClass-2
    C19778
    UMLS 2011AA ObjectClass-2
    C1514695
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus Property-2
    C49152
    UMLS 2011AA Property-2
    C1706256
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    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
    Institution No.
    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
    Participant's Initials
    Beskrivning

    Patient Initials

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C2986440
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25536
    Participant's I.D. No.
    Beskrivning

    Trial subject ID RTOG

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C2348585
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-2
    C1514695
    NCI Thesaurus Property
    C19778
    NCI Thesaurus Property-2
    C25364
    AMENDED DATA
    Beskrivning

    Data amended

    Datatyp

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS CUI-1
    C0680532
    NCI Thesaurus ObjectClass
    C25474
    NCI Thesaurus Property
    C25416
    Report All Continuing Or New Adverse Events
    Beskrivning

    Report All Continuing Or New Adverse Events

    Date of assessment
    Beskrivning

    Assessment Date

    Datatyp

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C2985720
    NCI Thesaurus ObjectClass
    C25367
    NCI Thesaurus ValueDomain-2
    C25367
    NCI Thesaurus Property
    C38000
    Due date of corresponding form
    Beskrivning

    AssociatedFormSubmissionDate

    Datatyp

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C19464
    UMLS 2011AA ObjectClass
    C0376315
    NCI Thesaurus Property
    C25694
    UMLS 2011AA Property
    C1515022
    NCI Thesaurus ObjectClass-2
    C25281
    UMLS 2011AA ObjectClass-2
    C0332281
    Type of corresponding form (INSTRUCTIONS: the CTC AE Version 3.0 is used to score all adverse events)
    Beskrivning

    AssociatedFormSubmissionType

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C19464
    UMLS 2011AA ObjectClass
    C0376315
    NCI Thesaurus Property
    C25694
    UMLS 2011AA Property
    C1515022
    NCI Thesaurus ObjectClass-2
    C25281
    UMLS 2011AA ObjectClass-2
    C0332281
    MedDRA CODE ADVERSE EVENT BASED ON CTCAE TERM
    Beskrivning

    MedDRACode

    Datatyp

    float

    Alias
    NCI Thesaurus ValueDomain
    C25162
    UMLS 2011AA ValueDomain
    C0805701
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Metathesaurus ObjectClass
    CL104089
    CTCAE TERM
    Beskrivning

    CTC Adverse Event Term

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS CUI-1
    C1516728
    NCI Thesaurus ObjectClass
    C49704
    UMLS CUI-2
    C2826934
    NCI Thesaurus Property
    C45559
    CTCAE GRADE
    Beskrivning

    CTC Adverse Event Grade

    Datatyp

    float

    Alias
    NCI Thesaurus ObjectClass
    C49704
    UMLS CUI-1
    C2985911
    NCI Thesaurus ValueDomain
    C18000
    NCI Thesaurus Property
    C25365
    CTCAE BEGIN DATE
    Beskrivning

    Adverse Event Start Date

    Datatyp

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C2697888
    NCI Thesaurus Property
    C25375
    NCI Thesaurus ValueDomain-2
    C25431
    NCI Thesaurus ObjectClass
    C49704
    CTCAE ATTRIBUTION CODE (Attribution to Protocol Treatment See protocol sections 6 & 7 for definition of "protocol treatment")
    Beskrivning

    CTC Adverse Event Attribution Category

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25664
    UMLS CUI-1
    C1706735
    NCI Thesaurus ObjectClass
    C49704
    NCI Thesaurus Property
    C25358
    Serious Adverse Event Report Submitted
    Beskrivning

    SAE report

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS CUI-1
    C1519255
    NCI Thesaurus ObjectClass
    C41331
    UMLS CUI-2
    C0684224
    NCI Thesaurus Property
    C25375
    NCI Thesaurus ObjectClass-2
    C54035
    Other CTCAE Term
    Beskrivning

    CTC Adverse Event Term

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS CUI-1
    C1516728
    NCI Thesaurus ObjectClass
    C49704
    UMLS CUI-2
    C2826934
    NCI Thesaurus Property
    C45559
    AE Description
    Beskrivning

    Grade3AdverseEventDescriptionText

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS 2011AA ValueDomain
    C1527021
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus Property
    C25365
    UMLS 2011AA Property
    C0678257
    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
    Form completion date
    Beskrivning

    FormCompletionDate

    Datatyp

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    Tillbaka till toppen

    Similar models

    Radiation Therapy Oncology Group Phase III Lung Pre-Op Chemotherapy vs. Pre-Op Concurrent Chemoradiation for NSCLC

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    RTOG clinical trial administrative data
    Protocol ID RTOG
    Item
    RTOG Study
    text
    C25337 (NCI Thesaurus ValueDomain)
    C3274381 (UMLS CUI-1)
    C25320 (NCI Thesaurus ObjectClass)
    C1514695 (UMLS CUI-2)
    C19778 (NCI Thesaurus Property)
    C25364 (NCI Thesaurus Property-2)
    RadiationTherapyOncologyGroupPatientCaseIdentifierNumber
    Item
    Case #
    text
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C19778 (NCI Thesaurus ObjectClass-2)
    C1514695 (UMLS 2011AA ObjectClass-2)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C49152 (NCI Thesaurus Property-2)
    C1706256 (UMLS 2011AA Property-2)
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    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 No.
    text
    C25337 (NCI Thesaurus ValueDomain)
    C1301943 (UMLS CUI-1)
    C21541 (NCI Thesaurus ObjectClass)
    C0805701 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    Patient Initials
    Item
    Participant's Initials
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2986440 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25536 (NCI Thesaurus Property)
    Trial subject ID RTOG
    Item
    Participant's I.D. No.
    text
    C25337 (NCI Thesaurus ValueDomain)
    C2348585 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C1514695 (UMLS CUI-2)
    C19778 (NCI Thesaurus Property)
    C25364 (NCI Thesaurus Property-2)
    Data amended
    Item
    AMENDED DATA
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C0680532 (UMLS CUI-1)
    C25474 (NCI Thesaurus ObjectClass)
    C25416 (NCI Thesaurus Property)
    Item Group
    Report All Continuing Or New Adverse Events
    Assessment Date
    Item
    Date of assessment
    date
    C25164 (NCI Thesaurus ValueDomain)
    C2985720 (UMLS CUI-1)
    C25367 (NCI Thesaurus ObjectClass)
    C25367 (NCI Thesaurus ValueDomain-2)
    C38000 (NCI Thesaurus Property)
    AssociatedFormSubmissionDate
    Item
    Due date of corresponding form
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C19464 (NCI Thesaurus ObjectClass)
    C0376315 (UMLS 2011AA ObjectClass)
    C25694 (NCI Thesaurus Property)
    C1515022 (UMLS 2011AA Property)
    C25281 (NCI Thesaurus ObjectClass-2)
    C0332281 (UMLS 2011AA ObjectClass-2)
    Item
    Type of corresponding form (INSTRUCTIONS: the CTC AE Version 3.0 is used to score all adverse events)
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C19464 (NCI Thesaurus ObjectClass)
    C0376315 (UMLS 2011AA ObjectClass)
    C25694 (NCI Thesaurus Property)
    C1515022 (UMLS 2011AA Property)
    C25281 (NCI Thesaurus ObjectClass-2)
    C0332281 (UMLS 2011AA ObjectClass-2)
    CL.2
    Code List
    Type of corresponding form (INSTRUCTIONS: the CTC AE Version 3.0 is used to score all adverse events)
    CL Item
    Tf (TF)
    CL Item
    F1 (F1)
    MedDRACode
    Item
    MedDRA CODE ADVERSE EVENT BASED ON CTCAE TERM
    float
    C25162 (NCI Thesaurus ValueDomain)
    C0805701 (UMLS 2011AA ValueDomain)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    CL104089 (NCI Metathesaurus ObjectClass)
    CTC Adverse Event Term
    Item
    CTCAE 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 GRADE
    float
    C49704 (NCI Thesaurus ObjectClass)
    C2985911 (UMLS CUI-1)
    C18000 (NCI Thesaurus ValueDomain)
    C25365 (NCI Thesaurus Property)
    Adverse Event Start Date
    Item
    CTCAE BEGIN DATE
    date
    C25164 (NCI Thesaurus ValueDomain)
    C2697888 (UMLS CUI-1)
    C25375 (NCI Thesaurus Property)
    C25431 (NCI Thesaurus ValueDomain-2)
    C49704 (NCI Thesaurus ObjectClass)
    Item
    CTCAE ATTRIBUTION CODE (Attribution to Protocol Treatment See protocol sections 6 & 7 for definition of "protocol treatment")
    text
    C25664 (NCI Thesaurus ValueDomain)
    C1706735 (UMLS CUI-1)
    C49704 (NCI Thesaurus ObjectClass)
    C25358 (NCI Thesaurus Property)
    CL.4
    Code List
    CTCAE ATTRIBUTION CODE (Attribution to Protocol Treatment See protocol sections 6 & 7 for definition of "protocol treatment")
    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
    Serious Adverse Event Report Submitted
    text
    C38148 (NCI Thesaurus ValueDomain)
    C1519255 (UMLS CUI-1)
    C41331 (NCI Thesaurus ObjectClass)
    C0684224 (UMLS CUI-2)
    C25375 (NCI Thesaurus Property)
    C54035 (NCI Thesaurus ObjectClass-2)
    CL.5
    Code List
    Serious Adverse Event Report Submitted
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Unknown (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    CTC Adverse Event Term
    Item
    Other CTCAE Term
    text
    C25685 (NCI Thesaurus ValueDomain)
    C1516728 (UMLS CUI-1)
    C49704 (NCI Thesaurus ObjectClass)
    C2826934 (UMLS CUI-2)
    C45559 (NCI Thesaurus Property)
    Grade3AdverseEventDescriptionText
    Item
    AE Description
    text
    C25704 (NCI Thesaurus ValueDomain)
    C1527021 (UMLS 2011AA ValueDomain)
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C25365 (NCI Thesaurus Property)
    C0678257 (UMLS 2011AA Property)
    Person Completing Form
    Item
    Person completing form
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1550483 (UMLS CUI-1)
    C25657 (NCI Thesaurus ObjectClass)
    C25364 (NCI Thesaurus Property)
    FormCompletionDate
    Item
    Form completion date
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    Tillbaka till toppen 

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