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ID

11556

Description

RTOG-0522 AE: Adverse Event Evaluation Form NCT00265941 Radiation Therapy and Cisplatin With or Without Cetuximab in Treating Patients With Stage III or Stage IV Head and Neck Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=F5E8260F-4A36-157F-E034-0003BA3F9857

Lien

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=F5E8260F-4A36-157F-E034-0003BA3F9857

Mots-clés

  1. 19/09/2012 19/09/2012 -
  2. 09/01/2015 09/01/2015 - Martin Dugas
  3. 09/01/2015 09/01/2015 - Martin Dugas
  4. 08/07/2015 08/07/2015 -
Téléchargé le

8 juillet 2015

DOI

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Licence

Creative Commons BY-NC 3.0 Legacy

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    RTOG-0522 AE: Adverse Event Evaluation Form NCT00265941

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

    RTOG clinical trial administrative data
    Description

    RTOG clinical trial administrative data

    RTOG Study No.
    Description

    Protocol ID RTOG

    Type de données

    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 #
    Description

    RadiationTherapyOncologyGroupPatientCaseIdentifierNumber

    Type de données

    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 Name
    Description

    Institution Name

    Type de données

    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.
    Description

    Institution Number

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C1301943
    NCI Thesaurus ObjectClass
    C21541
    UMLS CUI-2
    C0805701
    NCI Thesaurus Property
    C25364
    Patient Initials
    Description

    Patient Initials

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C2986440
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25536
    RTOG Patient ID
    Description

    Trial subject ID RTOG

    Type de données

    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
    Description

    Data amended

    Type de données

    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
    Description

    Report All Continuing Or New Adverse Events

    Date of Last Clinical Assessment
    Description

    Follow-Up Date

    Type de données

    date

    Alias
    NCI Thesaurus ObjectClass
    C9305
    UMLS CUI-1
    C3694716
    NCI Thesaurus Property
    C16033
    NCI Thesaurus Property-2
    C25365
    NCI Thesaurus ValueDomain
    C25164
    NCI Thesaurus ValueDomain-2
    C25367
    Due date of corresponding form
    Description

    AssociatedFormSubmissionDate

    Type de données

    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 (Score most severe grade observed during report period Grade 1-5.)
    Description

    AssociatedFormSubmissionType

    Type de données

    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
    Description

    MedDRACode

    Type de données

    float

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

    CTC Adverse Event Term

    Type de données

    text

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

    CTC Adverse Event Grade

    Type de données

    float

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

    Adverse Event Start Date

    Type de données

    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")
    Description

    CTC Adverse Event Attribution Category

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25664
    UMLS CUI-1
    C1706735
    NCI Thesaurus ObjectClass
    C49704
    NCI Thesaurus Property
    C25358
    Serious adverse event report submitted
    Description

    SAE report

    Type de données

    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
    CTC Adverse Event Term Specify
    Description

    CTC Adverse Event Term

    Type de données

    text

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

    Grade3AdverseEventDescriptionText

    Type de données

    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
    Description

    Person Completing Form

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C1550483
    NCI Thesaurus ObjectClass
    C25657
    NCI Thesaurus Property
    C25364
    Form Completion Date
    Description

    FormCompletionDate

    Type de données

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C40988
    UMLS 2011AA ObjectClass
    C1516308
    NCI Thesaurus Property
    C25250
    UMLS 2011AA Property
    C0205197

    Similar models

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

    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    RTOG clinical trial administrative data
    Protocol ID RTOG
    Item
    RTOG Study No.
    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 Name
    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
    Patient Initials
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2986440 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25536 (NCI Thesaurus Property)
    Trial subject ID RTOG
    Item
    RTOG Patient ID
    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
    Follow-Up Date
    Item
    Date of Last Clinical Assessment
    date
    C9305 (NCI Thesaurus ObjectClass)
    C3694716 (UMLS CUI-1)
    C16033 (NCI Thesaurus Property)
    C25365 (NCI Thesaurus Property-2)
    C25164 (NCI Thesaurus ValueDomain)
    C25367 (NCI Thesaurus ValueDomain-2)
    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 (Score most severe grade observed during report period Grade 1-5.)
    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)
    Code List
    Type of corresponding form (Score most severe grade observed during report period Grade 1-5.)
    CL Item
    Tf (TF)
    CL Item
    F1 (F1)
    MedDRACode
    Item
    MedDRA Code
    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)
    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)
    Code List
    Serious adverse event report submitted
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    Unknown (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    CTC Adverse Event Term
    Item
    CTC Adverse Event Term Specify
    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)
    C40988 (NCI Thesaurus ObjectClass)
    C1516308 (UMLS 2011AA ObjectClass)
    C25250 (NCI Thesaurus Property)
    C0205197 (UMLS 2011AA Property)

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