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8189

Description

GOG-0249 Follow-Up Period Adverse Event Reporting Form Pelvic Radiation Therapy or Vaginal Implant Radiation Therapy, Paclitaxel, and Carboplatin in Treating Patients With High-Risk Stage I or Stage II Endometrial Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=4FF32E53-FBDD-394B-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=4FF32E53-FBDD-394B-E044-0003BA3F9857

Keywords

Versions (2)
  1. 9/19/12 9/19/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
Uploaded on

January 9, 2015

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Creative Commons BY-NC 3.0 Legacy
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    Endometrial Cancer NCT00807768 Toxicity - GOG-0249 Follow-Up Period Adverse Event Reporting Form - 2760083v1.0

    English

    No Instruction available.

    1 forms  
    1. StudyEvent: GOG-0249 Follow-Up Period Adverse Event Reporting Form
      1. No Instruction available.
    Header Module
    Description

    Header Module

    Date form originally completed (m d y)
    Description

    Form Completion Date

    Data type

    date

    Alias
    NCI Thesaurus ObjectClass
    C19464
    UMLS CUI-1
    C1549507
    NCI Thesaurus Property
    C25250
    NCI Thesaurus Property-2
    C25604
    NCI Thesaurus ValueDomain
    C25164
    NCI Thesaurus ValueDomain-2
    C25367
    Date form amended (m d y)
    Description

    Amendment date

    Data type

    date

    Alias
    NCI Thesaurus ObjectClass
    C19464
    UMLS CUI-1
    C0680532
    NCI Thesaurus Property
    C25250
    UMLS CUI-2
    C0011008
    NCI Thesaurus Property-2
    C25416
    NCI Thesaurus ValueDomain
    C25164
    NCI Thesaurus ValueDomain-2
    C25367
    Person amending form, last name
    Description

    Person Amending Form

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C0680532
    NCI Thesaurus ObjectClass
    C25190
    UMLS CUI-2
    C1547383
    NCI Thesaurus Property
    C25364
    Patient Initials
    Description

    Patient Initials

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C2986440
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25536
    Patient Study ID
    Description

    Patient ID GOG

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C2348585
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-2
    C1512288
    NCI Thesaurus Property
    C25364
    NCI Thesaurus Property-2
    C25521
    Person Completing Form, Last Name
    Description

    Person Completing Form Last Name

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C25190
    UMLS CUI-1
    C1550483
    NCI Thesaurus ObjectClass-2
    C25657
    UMLS CUI-2
    C1301584
    NCI Thesaurus Property
    C25364
    NCI Thesaurus Property-2
    C25551
    NCI Thesaurus ValueDomain
    C25191
    Adverse Events - Section 1
    Description

    Adverse Events - Section 1

    Reporting Period
    Description

    Clinical Trial Period

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS CUI-1
    C2347804
    NCI Thesaurus ObjectClass
    C25214
    NCI Thesaurus Property
    C25616
    NCI Thesaurus ObjectClass-2
    C25651
    Are there any adverse events to report
    Description

    AdverseEventNewPeriodicReportInd-3

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus Property
    C25586
    UMLS 2011AA Property
    C0205314
    NCI Thesaurus Property-2
    C25375
    UMLS 2011AA Property-2
    C0684224
    NCI Metathesaurus Property
    CL158136
    NCI Thesaurus ValueDomain
    C25180
    UMLS 2011AA ValueDomain
    C1522602
    Were adverse events assessed during most recent period
    Description

    AdverseEventMostRecentAssessmentInd-3

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus Property
    C20989
    UMLS 2011AA Property
    C0031809
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus Property-2
    C25577
    UMLS 2011AA Property-2
    C1513491
    Date of Most Recent Adverse Event Assessment (m d y)
    Description

    AdverseEventMostRecentAssessmentDate

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus Property
    C20989
    UMLS 2011AA Property
    C0031809
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus Property-2
    C25577
    UMLS 2011AA Property-2
    C1513491
    Was patient hospitalized as a result of reported adverse events? (during this reporting period)
    Description

    Hospitalization

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS CUI-1
    C0019993
    NCI Thesaurus ObjectClass
    C16696
    NCI Thesaurus ObjectClass-2
    C25182
    NCI Thesaurus Property
    C25385
    Adverse Events - Section 3
    Description

    Adverse Events - Section 3

    CTC Adverse Event Term
    Description

    CTC Adverse Event Term

    Data type

    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 Grade
    Description

    CTC Adverse Event Grade

    Data type

    float

    Alias
    NCI Thesaurus ObjectClass
    C49704
    UMLS CUI-1
    C2985911
    NCI Thesaurus ValueDomain
    C18000
    NCI Thesaurus Property
    C25365
    CTC Adverse Event Attribution Code (Attribution Codes for Relationship of Event to Treatment: 1=Unrelated, 2=Unlikely, 3=Possibly, 4=Probably, 5=Definitely)
    Description

    CTC Adverse Event Attribution Category

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25664
    UMLS CUI-1
    C1706735
    NCI Thesaurus ObjectClass
    C49704
    NCI Thesaurus Property
    C25358
    SAE report submitted
    Description

    SAE report

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS CUI-1
    C1519255
    NCI Thesaurus ObjectClass
    C41331
    UMLS CUI-2
    C0684224
    NCI Thesaurus Property
    C25375
    NCI Thesaurus ObjectClass-2
    C54035
    AE Onset Date
    Description

    Adverse Event Onset Date

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C2985916
    NCI Thesaurus ValueDomain-2
    C25367
    NCI Thesaurus ObjectClass
    C49704
    NCI Thesaurus Property
    C25279
    Present Status
    Description

    AdverseEventContinueStatus

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus Property
    C53279
    UMLS 2011AA Property
    C0549178
    NCI Thesaurus ValueDomain
    C25688
    UMLS 2011AA ValueDomain
    C0449438
    Comments
    Description

    Comments

    COMMENTS
    Description

    Research Comments

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS CUI-1
    C0947611
    NCI Thesaurus ObjectClass
    C15319
    NCI Thesaurus Property
    C25393
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    Similar models

    No Instruction available.

    1 forms
    1. StudyEvent: GOG-0249 Follow-Up Period Adverse Event Reporting Form
      1. No Instruction available.
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Header Module
    Form Completion Date
    Item
    Date form originally completed (m d y)
    date
    C19464 (NCI Thesaurus ObjectClass)
    C1549507 (UMLS CUI-1)
    C25250 (NCI Thesaurus Property)
    C25604 (NCI Thesaurus Property-2)
    C25164 (NCI Thesaurus ValueDomain)
    C25367 (NCI Thesaurus ValueDomain-2)
    Amendment date
    Item
    Date form amended (m d y)
    date
    C19464 (NCI Thesaurus ObjectClass)
    C0680532 (UMLS CUI-1)
    C25250 (NCI Thesaurus Property)
    C0011008 (UMLS CUI-2)
    C25416 (NCI Thesaurus Property-2)
    C25164 (NCI Thesaurus ValueDomain)
    C25367 (NCI Thesaurus ValueDomain-2)
    Person Amending Form
    Item
    Person amending form, last name
    text
    C25191 (NCI Thesaurus ValueDomain)
    C0680532 (UMLS CUI-1)
    C25190 (NCI Thesaurus ObjectClass)
    C1547383 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    Patient Initials
    Item
    Patient Initials
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2986440 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25536 (NCI Thesaurus Property)
    Patient ID GOG
    Item
    Patient Study ID
    text
    C25337 (NCI Thesaurus ValueDomain)
    C2348585 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C1512288 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25521 (NCI Thesaurus Property-2)
    Person Completing Form Last Name
    Item
    Person Completing Form, Last Name
    text
    C25190 (NCI Thesaurus ObjectClass)
    C1550483 (UMLS CUI-1)
    C25657 (NCI Thesaurus ObjectClass-2)
    C1301584 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25551 (NCI Thesaurus Property-2)
    C25191 (NCI Thesaurus ValueDomain)
    Item Group
    Adverse Events - Section 1
    Clinical Trial Period
    Item
    Reporting Period
    text
    C25284 (NCI Thesaurus ValueDomain)
    C2347804 (UMLS CUI-1)
    C25214 (NCI Thesaurus ObjectClass)
    C25616 (NCI Thesaurus Property)
    C25651 (NCI Thesaurus ObjectClass-2)
    Item
    Are there any adverse events to report
    text
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C25586 (NCI Thesaurus Property)
    C0205314 (UMLS 2011AA Property)
    C25375 (NCI Thesaurus Property-2)
    C0684224 (UMLS 2011AA Property-2)
    CL158136 (NCI Metathesaurus Property)
    C25180 (NCI Thesaurus ValueDomain)
    C1522602 (UMLS 2011AA ValueDomain)
    CL.1
    Code List
    Are there any adverse events to report
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Patient Not Evaluated (Patient not evaluated)
    AdverseEventMostRecentAssessmentInd-3
    Item
    Were adverse events assessed during most recent period
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C20989 (NCI Thesaurus Property)
    C0031809 (UMLS 2011AA Property)
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C25577 (NCI Thesaurus Property-2)
    C1513491 (UMLS 2011AA Property-2)
    AdverseEventMostRecentAssessmentDate
    Item
    Date of Most Recent Adverse Event Assessment (m d y)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C20989 (NCI Thesaurus Property)
    C0031809 (UMLS 2011AA Property)
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C25577 (NCI Thesaurus Property-2)
    C1513491 (UMLS 2011AA Property-2)
    Hospitalization
    Item
    Was patient hospitalized as a result of reported adverse events? (during this reporting period)
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C0019993 (UMLS CUI-1)
    C16696 (NCI Thesaurus ObjectClass)
    C25182 (NCI Thesaurus ObjectClass-2)
    C25385 (NCI Thesaurus Property)
    Item Group
    Adverse Events - Section 3
    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 Adverse Event Grade
    float
    C49704 (NCI Thesaurus ObjectClass)
    C2985911 (UMLS CUI-1)
    C18000 (NCI Thesaurus ValueDomain)
    C25365 (NCI Thesaurus Property)
    Item
    CTC Adverse Event Attribution Code (Attribution Codes for Relationship of Event to Treatment: 1=Unrelated, 2=Unlikely, 3=Possibly, 4=Probably, 5=Definitely)
    text
    C25664 (NCI Thesaurus ValueDomain)
    C1706735 (UMLS CUI-1)
    C49704 (NCI Thesaurus ObjectClass)
    C25358 (NCI Thesaurus Property)
    CL.4
    Code List
    CTC Adverse Event Attribution Code (Attribution Codes for Relationship of Event to Treatment: 1=Unrelated, 2=Unlikely, 3=Possibly, 4=Probably, 5=Definitely)
    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
    SAE report submitted
    text
    C38148 (NCI Thesaurus ValueDomain)
    C1519255 (UMLS CUI-1)
    C41331 (NCI Thesaurus ObjectClass)
    C0684224 (UMLS CUI-2)
    C25375 (NCI Thesaurus Property)
    C54035 (NCI Thesaurus ObjectClass-2)
    CL.5
    Code List
    SAE report submitted
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Unknown (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Adverse Event Onset Date
    Item
    AE Onset Date
    date
    C25164 (NCI Thesaurus ValueDomain)
    C2985916 (UMLS CUI-1)
    C25367 (NCI Thesaurus ValueDomain-2)
    C49704 (NCI Thesaurus ObjectClass)
    C25279 (NCI Thesaurus Property)
    Item
    Present Status
    text
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C53279 (NCI Thesaurus Property)
    C0549178 (UMLS 2011AA Property)
    C25688 (NCI Thesaurus ValueDomain)
    C0449438 (UMLS 2011AA ValueDomain)
    CL.6
    Code List
    Present Status
    CL Item
    Fatal Or Died (Fatal/Died)
    CL Item
    Ae Status Not Evaluated (AE status not evaluated)
    CL Item
    Intervention For Adverse Event Continues (Intervention for AE Continues)
    CL Item
    Not Recovered Or Not Resolved (Not recovered/Not resolved)
    C49494 (NCI Thesaurus)
    C1709277 (UMLS 2011AA)
    CL Item
    Recovered Or Resolved With Sequelae (Recovered/Resolved with Sequelae)
    C49495 (NCI Thesaurus)
    C1709862 (UMLS 2011AA)
    CL Item
    Recovered Or Resolved Without Sequelae (Recovered/Resolved without Sequelae)
    C85257 (NCI Thesaurus)
    C2827606 (UMLS 2011AA)
    CL Item
    Recovering Or Resolving (Recovering/Resolving)
    C49496 (NCI Thesaurus)
    C1709864 (UMLS 2011AA)
    Item Group
    Comments
    Research Comments
    Item
    COMMENTS
    text
    C25704 (NCI Thesaurus ValueDomain)
    C0947611 (UMLS CUI-1)
    C15319 (NCI Thesaurus ObjectClass)
    C25393 (NCI Thesaurus Property)
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