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ID

9555

Descrição

Reported Adverse Events Form - RF28B Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=CCE3B728-C8B8-5047-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=CCE3B728-C8B8-5047-E034-0003BA12F5E7

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
Transferido a

9 de janeiro de 2015

DOI

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Licença

Creative Commons BY-NC 3.0 Legacy

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    Sarcoma, Kaposi xxx On-Study - Reported Adverse Events Form - RF28B - 2267256v3.0

    No Instruction available.

    1. StudyEvent: Reported Adverse Events Form - RF28B
      1. No Instruction available.
    Ccrr Module For Reported Adverse Events Form - Rf28b
    Descrição

    Ccrr Module For Reported Adverse Events Form - Rf28b

    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
    Cycle#
    Descrição

    Cycle Number Chemotherapeutics

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C2045829
    NCI Thesaurus Property
    C25471
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus Property-2
    C25379
    Study#
    Descrição

    Protocol ID Coordinating Group

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C3274381
    NCI Thesaurus ObjectClass
    C25320
    UMLS CUI-2
    C1711341
    NCI Thesaurus Property
    C25462
    NCI Thesaurus Property-2
    C25364
    Site#
    Descrição

    NCIInstitutionIdentifierCode

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25162
    UMLS 2011AA ValueDomain
    C0805701
    NCI Thesaurus ObjectClass
    C21541
    UMLS 2011AA ObjectClass
    C0018704
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus ObjectClass-2
    C19202
    UMLS 2011AA ObjectClass-2
    C1513882
    ID#
    Descrição

    Patient Study ID

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C2348585
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25462
    NCI Thesaurus Property-2
    C25364
    First Day of Cycle
    Descrição

    Chemotherapy Cycle Start Date

    Tipo de dados

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C1302181
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus ValueDomain-2
    C25431
    UMLS CUI-2
    C3173309
    NCI Thesaurus Property
    C25379
    Has the patient experienced an adverse event during this cycle
    Descrição

    AdverseEventOccurrenceIndicator

    Tipo de dados

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C25180
    UMLS 2011AA ValueDomain
    C1522602
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Metathesaurus Property
    CL209504
    MedDRA Code
    Descrição

    MedDRACode

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25162
    UMLS 2011AA ValueDomain
    C0805701
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Metathesaurus ObjectClass
    CL104089
    Description
    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
    Date of onset
    Descrição

    Adverse Event Onset Date

    Tipo de dados

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C2985916
    NCI Thesaurus ValueDomain-2
    C25367
    NCI Thesaurus ObjectClass
    C49704
    NCI Thesaurus Property
    C25279
    Date Ended
    Descrição

    Adverse Event Resolution Date

    Tipo de dados

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C2985918
    NCI Thesaurus ValueDomain-2
    C25367
    NCI Thesaurus ObjectClass
    C49704
    NCI Thesaurus Property
    C25655
    Ongoing
    Descrição

    CTCAdverseEventResolutionInd

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25180
    UMLS 2011AA ValueDomain
    C1522602
    NCI Thesaurus ObjectClass
    C49704
    UMLS 2011AA ObjectClass
    C1516728
    NCI Thesaurus Property
    C25655
    UMLS 2011AA Property
    C1514893
    Grade
    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
    Relationship to Therapy
    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
    Effect on Study
    Descrição

    AdverseEventActionType

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus Property
    C25404
    UMLS 2011AA Property
    C0441472
    Indicate
    Descrição

    Reason for Therapy Modification

    Tipo de dados

    text

    Alias
    NCI Thesaurus ValueDomain
    C25638
    UMLS CUI-1
    C1299575
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus Property
    C25572
    UMLS CUI-2
    C0392360
    Additional Action Taken
    Descrição

    InpatientHospitalizationInd

    Tipo de dados

    text

    Has an AdEERs report been filed for this adverse event
    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

    Similar models

    No Instruction available.

    1. StudyEvent: Reported Adverse Events Form - RF28B
      1. No Instruction available.
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Ccrr Module For Reported Adverse Events Form - Rf28b
    Patient Initials
    Item
    Patient Initials
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2986440 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25536 (NCI Thesaurus Property)
    Cycle Number Chemotherapeutics
    Item
    Cycle#
    text
    C25337 (NCI Thesaurus ValueDomain)
    C2045829 (UMLS CUI-1)
    C25471 (NCI Thesaurus Property)
    C15368 (NCI Thesaurus ObjectClass)
    C25379 (NCI Thesaurus Property-2)
    Protocol ID Coordinating Group
    Item
    Study#
    text
    C25337 (NCI Thesaurus ValueDomain)
    C3274381 (UMLS CUI-1)
    C25320 (NCI Thesaurus ObjectClass)
    C1711341 (UMLS CUI-2)
    C25462 (NCI Thesaurus Property)
    C25364 (NCI Thesaurus Property-2)
    NCIInstitutionIdentifierCode
    Item
    Site#
    text
    C25162 (NCI Thesaurus ValueDomain)
    C0805701 (UMLS 2011AA ValueDomain)
    C21541 (NCI Thesaurus ObjectClass)
    C0018704 (UMLS 2011AA ObjectClass)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C19202 (NCI Thesaurus ObjectClass-2)
    C1513882 (UMLS 2011AA ObjectClass-2)
    Patient Study ID
    Item
    ID#
    text
    C25337 (NCI Thesaurus ValueDomain)
    C2348585 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25462 (NCI Thesaurus Property)
    C25364 (NCI Thesaurus Property-2)
    Chemotherapy Cycle Start Date
    Item
    First Day of Cycle
    date
    C25164 (NCI Thesaurus ValueDomain)
    C1302181 (UMLS CUI-1)
    C15368 (NCI Thesaurus ObjectClass)
    C25431 (NCI Thesaurus ValueDomain-2)
    C3173309 (UMLS CUI-2)
    C25379 (NCI Thesaurus Property)
    AdverseEventOccurrenceIndicator
    Item
    Has the patient experienced an adverse event during this cycle
    boolean
    C25180 (NCI Thesaurus ValueDomain)
    C1522602 (UMLS 2011AA ValueDomain)
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    CL209504 (NCI Metathesaurus Property)
    MedDRACode
    Item
    MedDRA Code
    text
    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
    Description
    text
    C25284 (NCI Thesaurus ValueDomain)
    C1516728 (UMLS CUI-1)
    C49704 (NCI Thesaurus ObjectClass)
    C2826934 (UMLS CUI-2)
    C45559 (NCI Thesaurus Property)
    Adverse Event Onset Date
    Item
    Date of onset
    date
    C25164 (NCI Thesaurus ValueDomain)
    C2985916 (UMLS CUI-1)
    C25367 (NCI Thesaurus ValueDomain-2)
    C49704 (NCI Thesaurus ObjectClass)
    C25279 (NCI Thesaurus Property)
    Adverse Event Resolution Date
    Item
    Date Ended
    date
    C25164 (NCI Thesaurus ValueDomain)
    C2985918 (UMLS CUI-1)
    C25367 (NCI Thesaurus ValueDomain-2)
    C49704 (NCI Thesaurus ObjectClass)
    C25655 (NCI Thesaurus Property)
    Item
    Ongoing
    text
    C25180 (NCI Thesaurus ValueDomain)
    C1522602 (UMLS 2011AA ValueDomain)
    C49704 (NCI Thesaurus ObjectClass)
    C1516728 (UMLS 2011AA ObjectClass)
    C25655 (NCI Thesaurus Property)
    C1514893 (UMLS 2011AA Property)
    Code List
    Ongoing
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    Not Applicable (Not applicable)
    C48660 (NCI Thesaurus)
    C1272460 (UMLS 2011AA)
    CTC Adverse Event Grade
    Item
    Grade
    float
    C49704 (NCI Thesaurus ObjectClass)
    C2985911 (UMLS CUI-1)
    C18000 (NCI Thesaurus ValueDomain)
    C25365 (NCI Thesaurus Property)
    Item
    Relationship to Therapy
    text
    C25664 (NCI Thesaurus ValueDomain)
    C1706735 (UMLS CUI-1)
    C49704 (NCI Thesaurus ObjectClass)
    C25358 (NCI Thesaurus Property)
    Code List
    Relationship to Therapy
    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 (Definate)
    CL209464 (NCI Metathesaurus)
    Item
    Effect on Study
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C25404 (NCI Thesaurus Property)
    C0441472 (UMLS 2011AA Property)
    Code List
    Effect on Study
    CL Item
    There Was No Action Taken Based On The Adverse Event (None)
    CL Item
    Study Dose Was Reduced As A Result Of The Adverse Event (Reduced)
    CL Item
    Protocol Treatment Was Delayed As A Result Of The Adverse Event (Interrupted)
    CL Item
    Protocol Treatment Was Discontinued As A Result Of The Adverse Event (Discontinued)
    CL Item
    Other Treatment Was Required As A Result Of The Adverse Event (other treatment required)
    Item
    Indicate
    text
    C25638 (NCI Thesaurus ValueDomain)
    C1299575 (UMLS CUI-1)
    C15368 (NCI Thesaurus ObjectClass)
    C25572 (NCI Thesaurus Property)
    C0392360 (UMLS CUI-2)
    Code List
    Indicate
    CL Item
    Pt. Initiated (Pt. Initiated)
    CL Item
    Phys. Initiated (Phys. Initiated)
    Item
    Additional Action Taken
    text
    Code List
    Additional Action Taken
    CL Item
    No (None)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    OTC/non-RX (OTC/non-RX)
    CL Item
    Prescription (Prescription)
    CL Item
    Yes (Hospitalization)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    AdverseEventReportInd-3
    Item
    Has an AdEERs report been filed for this adverse event
    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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