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ID

9555

Description

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

Lien

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

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
Téléchargé le

9 janvier 2015

DOI

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Licence

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
    Description

    Ccrr Module For Reported Adverse Events Form - Rf28b

    Patient Initials
    Description

    Patient Initials

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191 (undefined)
    UMLS CUI-1
    C2986440 (Person Initials)
    NCI Thesaurus ObjectClass
    C16960 (undefined)
    NCI Thesaurus Property
    C25536 (undefined)
    Cycle#
    Description

    Cycle Number Chemotherapeutics

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337 (undefined)
    UMLS CUI-1
    C2045829 (chemotherapeutics regimen status cycle number)
    NCI Thesaurus Property
    C25471 (undefined)
    NCI Thesaurus ObjectClass
    C15368 (undefined)
    NCI Thesaurus Property-2
    C25379 (undefined)
    Study#
    Description

    Protocol ID Coordinating Group

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337 (undefined)
    UMLS CUI-1
    C3274381 (Clinical Trial Registry Identifier)
    NCI Thesaurus ObjectClass
    C25320 (undefined)
    UMLS CUI-2
    C1711341 (Group Coordinator)
    NCI Thesaurus Property
    C25462 (undefined)
    NCI Thesaurus Property-2
    C25364 (undefined)
    Site#
    Description

    NCIInstitutionIdentifierCode

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25162 (undefined)
    UMLS 2011AA ValueDomain
    C0805701 (Code)
    NCI Thesaurus ObjectClass
    C21541 (undefined)
    UMLS 2011AA ObjectClass
    C0018704 (Health care facility)
    SNOMED
    257622000
    LOINC
    LA30302-6
    NCI Thesaurus Property
    C25364 (undefined)
    UMLS 2011AA Property
    C0600091 (Identifier)
    SNOMED
    118522005
    LOINC
    LP31795-5
    NCI Thesaurus ObjectClass-2
    C19202 (undefined)
    UMLS 2011AA ObjectClass-2
    C1513882 (National Cancer Institute)
    LOINC
    LA4524-0
    ID#
    Description

    Patient Study ID

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337 (undefined)
    UMLS CUI-1
    C2348585 (Clinical Trial Subject Unique Identifier)
    NCI Thesaurus ObjectClass
    C16960 (undefined)
    NCI Thesaurus Property
    C25462 (undefined)
    NCI Thesaurus Property-2
    C25364 (undefined)
    First Day of Cycle
    Description

    Chemotherapy Cycle Start Date

    Type de données

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164 (undefined)
    UMLS CUI-1
    C1302181 (Chemotherapy cycle)
    SNOMED
    399042005
    NCI Thesaurus ObjectClass
    C15368 (undefined)
    NCI Thesaurus ValueDomain-2
    C25431 (undefined)
    UMLS CUI-2
    C3173309 (Date treatment or therapy started)
    LOINC
    LP262646-5
    NCI Thesaurus Property
    C25379 (undefined)
    Has the patient experienced an adverse event during this cycle
    Description

    AdverseEventOccurrenceIndicator

    Type de données

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C25180 (undefined)
    UMLS 2011AA ValueDomain
    C1522602 (Indicator)
    NCI Thesaurus ObjectClass
    C41331 (undefined)
    UMLS 2011AA ObjectClass
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    NCI Metathesaurus Property
    CL209504 (undefined)
    MedDRA Code
    Description

    MedDRACode

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25162 (undefined)
    UMLS 2011AA ValueDomain
    C0805701 (Code)
    NCI Thesaurus Property
    C25364 (undefined)
    UMLS 2011AA Property
    C0600091 (Identifier)
    SNOMED
    118522005
    LOINC
    LP31795-5
    NCI Metathesaurus ObjectClass
    CL104089 (undefined)
    Description
    Description

    CTC Adverse Event Term

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284 (undefined)
    UMLS CUI-1
    C1516728 (National Cancer Institute common terminology criteria for adverse events)
    SNOMED
    446391000124101
    NCI Thesaurus ObjectClass
    C49704 (undefined)
    UMLS CUI-2
    C2826934 (Adverse Event Dictionary Derived Term)
    NCI Thesaurus Property
    C45559 (undefined)
    Date of onset
    Description

    Adverse Event Onset Date

    Type de données

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164 (undefined)
    UMLS CUI-1
    C2985916 (Adverse Event Onset Date)
    NCI Thesaurus ValueDomain-2
    C25367 (undefined)
    NCI Thesaurus ObjectClass
    C49704 (undefined)
    NCI Thesaurus Property
    C25279 (undefined)
    Date Ended
    Description

    Adverse Event Resolution Date

    Type de données

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164 (undefined)
    UMLS CUI-1
    C2985918 (Adverse Event Resolution Date)
    NCI Thesaurus ValueDomain-2
    C25367 (undefined)
    NCI Thesaurus ObjectClass
    C49704 (undefined)
    NCI Thesaurus Property
    C25655 (undefined)
    Ongoing
    Description

    CTCAdverseEventResolutionInd

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25180 (undefined)
    UMLS 2011AA ValueDomain
    C1522602 (Indicator)
    NCI Thesaurus ObjectClass
    C49704 (undefined)
    UMLS 2011AA ObjectClass
    C1516728 (National Cancer Institute common terminology criteria for adverse events)
    SNOMED
    446391000124101
    NCI Thesaurus Property
    C25655 (undefined)
    UMLS 2011AA Property
    C1514893 (physiologic resolution)
    Grade
    Description

    CTC Adverse Event Grade

    Type de données

    float

    Alias
    NCI Thesaurus ObjectClass
    C49704 (undefined)
    UMLS CUI-1
    C2985911 (Adverse Event Grade Code)
    NCI Thesaurus ValueDomain
    C18000 (undefined)
    NCI Thesaurus Property
    C25365 (undefined)
    Relationship to Therapy
    Description

    CTC Adverse Event Attribution Category

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25664 (undefined)
    UMLS CUI-1
    C1706735 (Adverse Event Attribution Category)
    NCI Thesaurus ObjectClass
    C49704 (undefined)
    NCI Thesaurus Property
    C25358 (undefined)
    Effect on Study
    Description

    AdverseEventActionType

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284 (undefined)
    UMLS 2011AA ValueDomain
    C0332307 (Type - attribute)
    SNOMED
    261664005
    NCI Thesaurus ObjectClass
    C41331 (undefined)
    UMLS 2011AA ObjectClass
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    NCI Thesaurus Property
    C25404 (undefined)
    UMLS 2011AA Property
    C0441472 (Clinical action)
    SNOMED
    129264002
    Indicate
    Description

    Reason for Therapy Modification

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25638 (undefined)
    UMLS CUI-1
    C1299575 (Treatment modification)
    SNOMED
    371133007
    NCI Thesaurus ObjectClass
    C15368 (undefined)
    NCI Thesaurus Property
    C25572 (undefined)
    UMLS CUI-2
    C0392360 (Indication of (contextual qualifier))
    SNOMED
    230165009
    LOINC
    MTHU008319
    Additional Action Taken
    Description

    InpatientHospitalizationInd

    Type de données

    text

    Has an AdEERs report been filed for this adverse event
    Description

    AdverseEventReportInd-3

    Type de données

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148 (undefined)
    UMLS 2011AA ValueDomain
    C1512699 (Yes, No, or Unknown Response)
    NCI Thesaurus ObjectClass
    C41331 (undefined)
    UMLS 2011AA ObjectClass
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    NCI Thesaurus Property
    C25375 (undefined)
    UMLS 2011AA Property
    C0684224 (Report (document))
    SNOMED
    229059009
    LOINC
    LP183761-8
    NCI Thesaurus ObjectClass-2
    C17648 (undefined)
    UMLS 2011AA ObjectClass-2
    C0439064 (Numerous)
    SNOMED
    255204007
    LOINC
    LP7748-9

    Similar models

    No Instruction available.

    1. StudyEvent: Reported Adverse Events Form - RF28B
      1. No Instruction available.
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    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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