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ID

11540

Descrição

CALGB: 30801 Adverse Event (AE) Form NCT01041781 Gemcitabine Hydrochloride or Pemetrexed Disodium and Carboplatin With or Without Celecoxib in Treating Patients With Advanced Non-Small Cell Lung Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=6AF26CA3-DF39-EEE0-E040-BB89AD436D54

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=6AF26CA3-DF39-EEE0-E040-BB89AD436D54

Palavras-chave

  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 -
Transferido a

8 de julho de 2015

DOI

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Licença

Creative Commons BY-NC 3.0 Legacy

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    CALGB: 30801 Adverse Event (AE) Form NCT01041781

    INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink.

    Header
    Descrição

    Header

    CALGB Form
    Descrição

    Form ID CALGB

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C3262252
    NCI Thesaurus ObjectClass
    C19464
    UMLS CUI-2
    C1516238
    NCI Thesaurus Property
    C25364
    NCI Thesaurus ObjectClass-2
    C25442
    CALGB Study No
    Descrição

    Protocol ID CALGB

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C3274381
    NCI Thesaurus ObjectClass
    C25320
    UMLS CUI-2
    C1516238
    NCI Thesaurus Property
    C25364
    NCI Thesaurus Property-2
    C25442
    CALGB Patient ID
    Descrição

    Trial subject ID CALGB

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C2348585
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-2
    C1516238
    NCI Thesaurus Property
    C25364
    NCI Thesaurus Property-2
    C25442
    CTC adverse event report begin date
    Descrição

    Adverse Event Start Date

    Tipo de dados

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C2697888
    NCI Thesaurus Property
    C25375
    NCI Thesaurus ValueDomain-2
    C25431
    NCI Thesaurus ObjectClass
    C49704
    CTC adverse event report end date
    Descrição

    Adverse Event End Date

    Tipo de dados

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C2697886
    NCI Thesaurus Property
    C25375
    NCI Thesaurus ObjectClass
    C49704
    Are data amended
    Descrição

    Data amended

    Tipo de dados

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS CUI-1
    C0680532
    NCI Thesaurus ObjectClass
    C25474
    NCI Thesaurus Property
    C25416
    Patient demographics
    Descrição

    Patient demographics

    Patient Initials
    Descrição

    Patient Initials

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C2986440
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25536
    Patient Hospital No.
    Descrição

    Medical Record Number

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C1301894
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25261
    NCI Thesaurus Property-2
    C25198
    Institution/Affiliate
    Descrição

    Institution Name

    Tipo de dados

    text

    Alias
    NCI Thesaurus ObjectClass
    C25454
    UMLS CUI-1
    C1301943
    NCI Thesaurus ObjectClass-2
    C21541
    NCI Thesaurus Property
    C25364
    NCI Thesaurus ValueDomain
    C25191
    NCI Thesaurus ValueDomain-2
    C21541
    Participating Group
    Descrição

    Participating Group

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C2347449
    NCI Thesaurus ObjectClass
    C25608
    NCI Thesaurus ObjectClass-2
    C17005
    NCI Thesaurus Property
    C25364
    Participating Group Study No.
    Descrição

    Study Number Participating Group

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C3274381
    NCI Thesaurus ObjectClass
    C25320
    UMLS CUI-2
    C2347449
    NCI Thesaurus Property
    C25608
    NCI Thesaurus Property-2
    C25364
    Participating Group Patient ID
    Descrição

    Trial subject ID Participating Group

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C2348585
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-2
    C2347449
    NCI Thesaurus Property
    C25608
    NCI Thesaurus Property-2
    C25364
    Adverse Event Expedited Reporting System filed?
    Descrição

    Adverse Event Expedited Reporting System filed?

    Has an AdEERS been filed (with Central Office based on an event reported below)
    Descrição

    AdverseEventReportInd-3

    Tipo de dados

    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
    Cycle Number
    Descrição

    Cycle Number

    Tipo de dados

    integer

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C2045829
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus Property
    C25379
    Expected Adverse Events
    Descrição

    Expected Adverse Events

    CTC Adverse Event Term
    Descrição

    CommonToxicityCriteriaAdverseEventShortNameType

    Tipo de dados

    text

    Alias
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus ObjectClass
    C49704
    UMLS 2011AA ObjectClass
    C1516728
    NCI Metathesaurus ValueDomain
    C0332307
    NCI Thesaurus Property-2
    C25249
    UMLS 2011AA Property-2
    C1806781
    CTC Select AE
    Descrição

    CTC Adverse Event Term

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS CUI-1
    C1516728
    NCI Thesaurus ObjectClass
    C49704
    UMLS CUI-2
    C2826934
    NCI Thesaurus Property
    C38024
    NCI Thesaurus Property-2
    C45559
    CTC AE Attribution Code (3^TREATMENT ATTRIBUTION CODES)
    Descrição

    CTC Adverse Event Attribution Category

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25664
    UMLS CUI-1
    C1706735
    NCI Thesaurus ObjectClass
    C49704
    NCI Thesaurus Property
    C25358
    CTC AE Attribution Code (3^TREATMENT ATTRIBUTION CODES)
    Descrição

    CTC Adverse Event Attribution Category

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25664
    UMLS CUI-1
    C1706735
    NCI Thesaurus ObjectClass
    C49704
    NCI Thesaurus Property
    C25358
    MedDRA Code
    Descrição

    MedDRACode

    Tipo de dados

    float

    Alias
    NCI Thesaurus ValueDomain
    C25162
    UMLS 2011AA ValueDomain
    C0805701
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Metathesaurus ObjectClass
    CL104089
    MedDRA Code
    Descrição

    MedDRACode

    Tipo de dados

    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 term
    Descrição

    CTC Adverse Event Term

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS CUI-1
    C1516728
    NCI Thesaurus ObjectClass
    C49704
    UMLS CUI-2
    C2826934
    NCI Thesaurus Property
    C45559
    CTC adverse event term
    Descrição

    CTC Adverse Event Term

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS CUI-1
    C1516728
    NCI Thesaurus ObjectClass
    C49704
    UMLS CUI-2
    C2826934
    NCI Thesaurus Property
    C45559
    CTC AE grade (1^Use NCI CTCAE v3.x or most current version with MedDRA codes posted at http://www.calgb.org to grade each adverse event.)
    Descrição

    CTC Adverse Event Grade

    Tipo de dados

    float

    Alias
    NCI Thesaurus ObjectClass
    C49704
    UMLS CUI-1
    C2985911
    NCI Thesaurus ValueDomain
    C18000
    NCI Thesaurus Property
    C25365
    CTC AE grade (1^Use NCI CTCAE v3.x or most current version with MedDRA codes posted at http://www.calgb.org to grade each adverse event.)
    Descrição

    CTC Adverse Event Grade

    Tipo de dados

    float

    Alias
    NCI Thesaurus ObjectClass
    C49704
    UMLS CUI-1
    C2985911
    NCI Thesaurus ValueDomain
    C18000
    NCI Thesaurus Property
    C25365
    Completed by (Last name, First name)
    Descrição

    Person Completing Form

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C1550483
    NCI Thesaurus ObjectClass
    C25657
    NCI Thesaurus Property
    C25364
    Date form completed (MM DD YYYY)
    Descrição

    Date Form Completed

    Tipo de dados

    date

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

    Similar models

    INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink.

    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Header
    Form ID CALGB
    Item
    CALGB Form
    text
    C25337 (NCI Thesaurus ValueDomain)
    C3262252 (UMLS CUI-1)
    C19464 (NCI Thesaurus ObjectClass)
    C1516238 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25442 (NCI Thesaurus ObjectClass-2)
    Protocol ID CALGB
    Item
    CALGB Study No
    text
    C25337 (NCI Thesaurus ValueDomain)
    C3274381 (UMLS CUI-1)
    C25320 (NCI Thesaurus ObjectClass)
    C1516238 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25442 (NCI Thesaurus Property-2)
    Trial subject ID CALGB
    Item
    CALGB Patient ID
    text
    C25337 (NCI Thesaurus ValueDomain)
    C2348585 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C1516238 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25442 (NCI Thesaurus Property-2)
    Adverse Event Start Date
    Item
    CTC adverse event report begin date
    date
    C25164 (NCI Thesaurus ValueDomain)
    C2697888 (UMLS CUI-1)
    C25375 (NCI Thesaurus Property)
    C25431 (NCI Thesaurus ValueDomain-2)
    C49704 (NCI Thesaurus ObjectClass)
    Adverse Event End Date
    Item
    CTC adverse event report end date
    date
    C25164 (NCI Thesaurus ValueDomain)
    C2697886 (UMLS CUI-1)
    C25375 (NCI Thesaurus Property)
    C49704 (NCI Thesaurus ObjectClass)
    Data amended
    Item
    Are data amended
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C0680532 (UMLS CUI-1)
    C25474 (NCI Thesaurus ObjectClass)
    C25416 (NCI Thesaurus Property)
    Item Group
    Patient demographics
    Patient Initials
    Item
    Patient Initials
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2986440 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25536 (NCI Thesaurus Property)
    Medical Record Number
    Item
    Patient Hospital No.
    text
    C25337 (NCI Thesaurus ValueDomain)
    C1301894 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25261 (NCI Thesaurus Property)
    C25198 (NCI Thesaurus Property-2)
    Institution Name
    Item
    Institution/Affiliate
    text
    C25454 (NCI Thesaurus ObjectClass)
    C1301943 (UMLS CUI-1)
    C21541 (NCI Thesaurus ObjectClass-2)
    C25364 (NCI Thesaurus Property)
    C25191 (NCI Thesaurus ValueDomain)
    C21541 (NCI Thesaurus ValueDomain-2)
    Participating Group
    Item
    Participating Group
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2347449 (UMLS CUI-1)
    C25608 (NCI Thesaurus ObjectClass)
    C17005 (NCI Thesaurus ObjectClass-2)
    C25364 (NCI Thesaurus Property)
    Study Number Participating Group
    Item
    Participating Group Study No.
    text
    C25337 (NCI Thesaurus ValueDomain)
    C3274381 (UMLS CUI-1)
    C25320 (NCI Thesaurus ObjectClass)
    C2347449 (UMLS CUI-2)
    C25608 (NCI Thesaurus Property)
    C25364 (NCI Thesaurus Property-2)
    Trial subject ID Participating Group
    Item
    Participating Group Patient ID
    text
    C25337 (NCI Thesaurus ValueDomain)
    C2348585 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C2347449 (UMLS CUI-2)
    C25608 (NCI Thesaurus Property)
    C25364 (NCI Thesaurus Property-2)
    Item Group
    Adverse Event Expedited Reporting System filed?
    AdverseEventReportInd-3
    Item
    Has an AdEERS been filed (with Central Office based on an event reported below)
    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)
    Cycle Number
    Item
    Cycle Number
    integer
    C25337 (NCI Thesaurus ValueDomain)
    C2045829 (UMLS CUI-1)
    C15368 (NCI Thesaurus ObjectClass)
    C25379 (NCI Thesaurus Property)
    Item Group
    Expected Adverse Events
    Item
    CTC Adverse Event Term
    text
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C49704 (NCI Thesaurus ObjectClass)
    C1516728 (UMLS 2011AA ObjectClass)
    C0332307 (NCI Metathesaurus ValueDomain)
    C25249 (NCI Thesaurus Property-2)
    C1806781 (UMLS 2011AA Property-2)
    Code List
    CTC Adverse Event Term
    CL Item
    Hemorrhage, Gi (Hemorrhage, GI - Select)
    CL Item
    Ulcer, Gi (Ulcer, GI - Select)
    CL Item
    Pain (Pain - Select)
    CTC Adverse Event Term
    Item
    CTC Select AE
    text
    C25284 (NCI Thesaurus ValueDomain)
    C1516728 (UMLS CUI-1)
    C49704 (NCI Thesaurus ObjectClass)
    C2826934 (UMLS CUI-2)
    C38024 (NCI Thesaurus Property)
    C45559 (NCI Thesaurus Property-2)
    Item
    CTC AE Attribution Code (3^TREATMENT ATTRIBUTION CODES)
    text
    C25664 (NCI Thesaurus ValueDomain)
    C1706735 (UMLS CUI-1)
    C49704 (NCI Thesaurus ObjectClass)
    C25358 (NCI Thesaurus Property)
    Code List
    CTC AE Attribution Code (3^TREATMENT ATTRIBUTION CODES)
    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
    CTC AE Attribution Code (3^TREATMENT ATTRIBUTION CODES)
    text
    C25664 (NCI Thesaurus ValueDomain)
    C1706735 (UMLS CUI-1)
    C49704 (NCI Thesaurus ObjectClass)
    C25358 (NCI Thesaurus Property)
    Code List
    CTC AE Attribution Code (3^TREATMENT ATTRIBUTION CODES)
    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)
    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)
    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
    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 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
    CTC AE grade (1^Use NCI CTCAE v3.x or most current version with MedDRA codes posted at http://www.calgb.org to grade each adverse event.)
    float
    C49704 (NCI Thesaurus ObjectClass)
    C2985911 (UMLS CUI-1)
    C18000 (NCI Thesaurus ValueDomain)
    C25365 (NCI Thesaurus Property)
    CTC Adverse Event Grade
    Item
    CTC AE grade (1^Use NCI CTCAE v3.x or most current version with MedDRA codes posted at http://www.calgb.org to grade each adverse event.)
    float
    C49704 (NCI Thesaurus ObjectClass)
    C2985911 (UMLS CUI-1)
    C18000 (NCI Thesaurus ValueDomain)
    C25365 (NCI Thesaurus Property)
    Person Completing Form
    Item
    Completed by (Last name, First name)
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1550483 (UMLS CUI-1)
    C25657 (NCI Thesaurus ObjectClass)
    C25364 (NCI Thesaurus Property)
    Date Form Completed
    Item
    Date form completed (MM DD YYYY)
    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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