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ID

10515

Descrizione

Adverse Event Form NCT00058149 A Phase III, Randomized Study of Gemcitabine (Fixed-Dose Rate Infusion) and Oxaliplatin (NSC 266046) Versus Gemcitabine (Fixed-Dose Rate Infusion) Versus Gemcitabine (30-Minute Infusion) in Pancreatic Carcinoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A6276505-5438-3D62-E034-0003BA0B1A09

collegamento

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A6276505-5438-3D62-E034-0003BA0B1A09

Keywords

versioni (3)
  1. 19/09/12 19/09/12 -
  2. 01/06/15 01/06/15 -
  3. 03/06/15 03/06/15 -
Caricato su

3 giugno 2015

DOI

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Licenza

Creative Commons BY-NC 3.0 Legacy
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    Adverse Event Form NCT00058149

    Inglese

    No Instruction available.

    1 moduli  
    1. StudyEvent: Adverse Event Form
      1. No Instruction available.
    ECOG clinical trial administrative data
    Descrizione

    ECOG clinical trial administrative data

    ECOG Protocol No.
    Descrizione

    ECOGProtocolNo.

    Tipo di dati

    text

    ECOG Patient ID
    Descrizione

    ECOGPatientID

    Tipo di dati

    text

    Registration Step
    Descrizione

    RegistrationStep

    Tipo di dati

    text

    Adverse Event Reporting From Date (M D Y)
    Descrizione

    CTCAdverseEventReportBeginDate

    Tipo di dati

    date

    Adverse Event Reporting To Date (M D Y)
    Descrizione

    CTCAdverseEventReportEndDate

    Tipo di dati

    date

    Cycle Number (For Arm A, first cycle is 8 weeks, subsequent cycles are 4 weeks. For Arm B, 1 cycle=4 weeks. For Arm C, 1 cycle=2 weeks.)
    Descrizione

    CycleNumber

    Tipo di dati

    text

    Patient?s Name
    Descrizione

    Patient'sName

    Tipo di dati

    text

    Participating Group Protocol No.
    Descrizione

    ParticipatingGroupProtocolNo.

    Tipo di dati

    text

    Participating Group Patient ID
    Descrizione

    ParticipatingGroupPatientID

    Tipo di dati

    text

    Institution/Affiliate
    Descrizione

    MainMemberInstitution/Affiliate

    Tipo di dati

    text

    Are data amended? (If yes, please circle amended items in red)
    Descrizione

    AmendedDataInd

    Tipo di dati

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C25474 (undefined)
    UMLS 2011AA ObjectClass
    C1511726 (Data)
    NCI Thesaurus Property
    C25416 (undefined)
    UMLS 2011AA Property
    C1691222 (Amended)
    Adverse event
    Descrizione

    Adverse event

    CTC Adverse Event Term
    Descrizione

    CTCAdverseEventTerm

    Tipo di dati

    text

    CTC Adverse Event Grade (this period)
    Descrizione

    CTCAdverseEventGrade

    Tipo di dati

    text

    CTC Adverse Event Attribution Code
    Descrizione

    CTCAdverseEventAttributionCode

    Tipo di dati

    text

    Other CTC Adverse Event Term(s) not listed (Use CTC terminology)
    Descrizione

    CTCAdverseEventTerm,Other

    Tipo di dati

    text

    Comments
    Descrizione

    Comments

    Comments
    Descrizione

    Comments

    Tipo di dati

    text

    Investigator Signature
    Descrizione

    InvestigatorSignature

    Tipo di dati

    text

    Alias
    NCI Thesaurus Property
    C25678 (undefined)
    UMLS 2011AA Property
    C1519316 (Signature)
    LOINC
    LP248948-4
    NCI Thesaurus ObjectClass
    C17089 (undefined)
    UMLS 2011AA ObjectClass
    C0035173 (Research Personnel)
    SNOMED
    769038007
    LOINC
    LA23773-7
    Date
    Descrizione

    InvestigatorSignatureDate

    Tipo di dati

    date

    Ccrr Module For Adverse Event Form
    Descrizione

    Ccrr Module For Adverse Event Form

    Ritorna all'inizio della pagina

    Similar models

    No Instruction available.

    1 moduli
    1. StudyEvent: Adverse Event Form
      1. No Instruction available.
    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    ECOG clinical trial administrative data
    ECOGProtocolNo.
    Item
    ECOG Protocol No.
    text
    ECOGPatientID
    Item
    ECOG Patient ID
    text
    RegistrationStep
    Item
    Registration Step
    text
    CTCAdverseEventReportBeginDate
    Item
    Adverse Event Reporting From Date (M D Y)
    date
    CTCAdverseEventReportEndDate
    Item
    Adverse Event Reporting To Date (M D Y)
    date
    CycleNumber
    Item
    Cycle Number (For Arm A, first cycle is 8 weeks, subsequent cycles are 4 weeks. For Arm B, 1 cycle=4 weeks. For Arm C, 1 cycle=2 weeks.)
    text
    Patient'sName
    Item
    Patient?s Name
    text
    ParticipatingGroupProtocolNo.
    Item
    Participating Group Protocol No.
    text
    ParticipatingGroupPatientID
    Item
    Participating Group Patient ID
    text
    MainMemberInstitution/Affiliate
    Item
    Institution/Affiliate
    text
    AmendedDataInd
    Item
    Are data amended? (If yes, please circle amended items in red)
    boolean
    C25474 (NCI Thesaurus ObjectClass)
    C1511726 (UMLS 2011AA ObjectClass)
    C25416 (NCI Thesaurus Property)
    C1691222 (UMLS 2011AA Property)
    Item Group
    Adverse event
    CTCAdverseEventTerm
    Item
    CTC Adverse Event Term
    text
    CTCAdverseEventGrade
    Item
    CTC Adverse Event Grade (this period)
    text
    CTCAdverseEventAttributionCode
    Item
    CTC Adverse Event Attribution Code
    text
    CTCAdverseEventTerm,Other
    Item
    Other CTC Adverse Event Term(s) not listed (Use CTC terminology)
    text
    Item Group
    Comments
    Comments
    Item
    Comments
    text
    InvestigatorSignature
    Item
    Investigator Signature
    text
    C25678 (NCI Thesaurus Property)
    C1519316 (UMLS 2011AA Property)
    C17089 (NCI Thesaurus ObjectClass)
    C0035173 (UMLS 2011AA ObjectClass)
    InvestigatorSignatureDate
    Item
    Date
    date
    Item Group
    Ccrr Module For Adverse Event Form
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