0 Ratings
ID

10515

Description

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

Link

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

Keywords

Versions (3)
  1. 9/19/12 9/19/12 -
  2. 6/1/15 6/1/15 -
  3. 6/3/15 6/3/15 -
Uploaded on

June 3, 2015

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0 Legacy
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

  • Newest
  • Oldest
  • Popular
  • Newest
    • Newest
    • Oldest
    • Popular

    No comments

    In order to download data models you must be logged in. Please log in or register for free.

    Adverse Event Form NCT00058149

    English

    No Instruction available.

    1 forms  
    1. StudyEvent: Adverse Event Form
      1. No Instruction available.
    ECOG clinical trial administrative data
    Description

    ECOG clinical trial administrative data

    ECOG Protocol No.
    Description

    ECOGProtocolNo.

    Data type

    text

    ECOG Patient ID
    Description

    ECOGPatientID

    Data type

    text

    Registration Step
    Description

    RegistrationStep

    Data type

    text

    Adverse Event Reporting From Date (M D Y)
    Description

    CTCAdverseEventReportBeginDate

    Data type

    date

    Adverse Event Reporting To Date (M D Y)
    Description

    CTCAdverseEventReportEndDate

    Data type

    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.)
    Description

    CycleNumber

    Data type

    text

    Patient?s Name
    Description

    Patient'sName

    Data type

    text

    Participating Group Protocol No.
    Description

    ParticipatingGroupProtocolNo.

    Data type

    text

    Participating Group Patient ID
    Description

    ParticipatingGroupPatientID

    Data type

    text

    Institution/Affiliate
    Description

    MainMemberInstitution/Affiliate

    Data type

    text

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

    AmendedDataInd

    Data type

    boolean

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

    Adverse event

    CTC Adverse Event Term
    Description

    CTCAdverseEventTerm

    Data type

    text

    CTC Adverse Event Grade (this period)
    Description

    CTCAdverseEventGrade

    Data type

    text

    CTC Adverse Event Attribution Code
    Description

    CTCAdverseEventAttributionCode

    Data type

    text

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

    CTCAdverseEventTerm,Other

    Data type

    text

    Comments
    Description

    Comments

    Comments
    Description

    Comments

    Data type

    text

    Investigator Signature
    Description

    InvestigatorSignature

    Data type

    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
    Description

    InvestigatorSignatureDate

    Data type

    date

    Ccrr Module For Adverse Event Form
    Description

    Ccrr Module For Adverse Event Form

    Back to the top of the page

    Similar models

    No Instruction available.

    1 forms
    1. StudyEvent: Adverse Event Form
      1. No Instruction available.
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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
    Back to the top of the page 

    Help

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial