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1598

Beskrivning

Gynecologic Oncology Group Follow-Up Period Adverse Event Reporting Form (TLC) Carboplatin and Paclitaxel With or Without Cisplatin and Radiation Therapy in Treating Patients With Stage I, Stage II, Stage III, or Stage IVA Endometrial Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=644E86D7-E1C5-D7C8-E040-BB89AD4321CC

Länk

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=644E86D7-E1C5-D7C8-E040-BB89AD4321CC

Nyckelord

  1. 2012-09-19 2012-09-19 -
  2. 2015-01-09 2015-01-09 - Martin Dugas
Uppladdad den

19 september 2012

DOI

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Creative Commons BY-NC 3.0 Legacy

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    Endometrial Cancer NCT00942357 Toxicity - Gynecologic Oncology Group Follow-Up Period Adverse Event Reporting Form (TLC) - 2845009v1.0

    No Instruction available.

    1. StudyEvent: Gynecologic Oncology Group Follow-Up Period Adverse Event Reporting Form (TLC)
      1. No Instruction available.
    Header Module
    Beskrivning

    Header Module

    Date form originally completed (m d y)
    Beskrivning

    FormOriginalCompleteDate

    Datatyp

    date

    Alias
    NCI Thesaurus ObjectClass
    C19464
    UMLS 2011AA ObjectClass
    C0376315
    NCI Thesaurus Property
    C25250
    UMLS 2011AA Property
    C0205197
    NCI Thesaurus Property
    C25604
    UMLS 2011AA Property
    C0205313
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ValueDomain
    C25367
    Date form amended (m d y)
    Beskrivning

    FormAmendedCompleteDate

    Datatyp

    date

    Alias
    NCI Thesaurus ObjectClass
    C19464
    UMLS 2011AA ObjectClass
    C0376315
    NCI Thesaurus Property
    C25250
    UMLS 2011AA Property
    C0205197
    NCI Thesaurus Property
    C25416
    UMLS 2011AA Property
    C1691222
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ValueDomain
    C25367
    Person amending form, last name
    Beskrivning

    ResponsiblePersonReportingChangeLastName

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    NCI Thesaurus ObjectClass
    C25190
    UMLS 2011AA ObjectClass
    C0027361
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    Patient Initials
    Beskrivning

    PatientInitialsName

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25536
    UMLS 2011AA Property
    C1555582
    Patient Study ID
    Beskrivning

    PatientGynecologicOncologyGroupIdentifierNumber

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus Property
    C25521
    UMLS 2011AA Property
    C1512288
    Person Completing Form, Last Name
    Beskrivning

    ResponsiblePersonLastName

    Datatyp

    text

    Alias
    NCI Thesaurus ObjectClass
    C25190
    UMLS 2011AA ObjectClass
    C0027361
    NCI Thesaurus ObjectClass
    C25657
    UMLS 2011AA ObjectClass
    C1273518
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus Property
    C25551
    UMLS 2011AA Property
    C1517741
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    Adverse Events - Section 1
    Beskrivning

    Adverse Events - Section 1

    Reporting Period
    Beskrivning

    ReportingEvaluationPeriodType

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C25214
    UMLS 2011AA ObjectClass
    C0220825
    NCI Thesaurus Property
    C25616
    UMLS 2011AA Property
    C1948053
    NCI Thesaurus ObjectClass
    C25651
    UMLS 2011AA ObjectClass
    C0700287
    Are there any adverse events to report
    Beskrivning

    AdverseEventNewPeriodicReportInd-3

    Datatyp

    text

    Alias
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus Property
    C25586
    UMLS 2011AA Property
    C0205314
    NCI Thesaurus Property
    C25375
    UMLS 2011AA Property
    C0684224
    NCI Metathesaurus Property
    CL158136
    NCI Thesaurus ValueDomain
    C25180
    UMLS 2011AA ValueDomain
    C1522602
    Date of Most Recent Adverse Event Assessment (m d y)
    Beskrivning

    AdverseEventMostRecentAssessmentDate

    Datatyp

    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
    C25577
    UMLS 2011AA Property
    C1513491
    Was patient hospitalized as a result of reported adverse events? (during this reporting period)
    Beskrivning

    InpatientHospitalAdmissionInd-3

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ObjectClass
    C16696
    UMLS 2011AA ObjectClass
    C0019994
    NCI Thesaurus ObjectClass
    C25182
    UMLS 2011AA ObjectClass
    C0021562
    NCI Thesaurus Property
    C25385
    UMLS 2011AA Property
    C0809949
    Adverse Events - Section 3
    Beskrivning

    Adverse Events - Section 3

    CTC Adverse Event Term
    Beskrivning

    CommonToxicityCriteriaAdverseEventTermType

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C49704
    UMLS 2011AA ObjectClass
    C1516728
    NCI Thesaurus Property
    C45559
    UMLS 2011AA Property
    C1705313
    CTC Adverse Event Grade
    Beskrivning

    CommonToxicityCriteriaAdverseEventGrade

    Datatyp

    double

    Alias
    NCI Thesaurus ObjectClass
    C49704
    UMLS 2011AA ObjectClass
    C1516728
    NCI Thesaurus ValueDomain
    C18000
    UMLS 2011AA ValueDomain
    C0919553
    NCI Thesaurus Property
    C25365
    UMLS 2011AA Property
    C0678257
    CTC Adverse Event Attribution Code (Attribution Codes for Relationship of Event to Treatment: 1=Unrelated, 2=Unlikely, 3=Possibly, 4=Probably, 5=Definitely)
    Beskrivning

    CTCAdverseEventAttributionScale

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25664
    UMLS 2011AA ValueDomain
    C0349674
    NCI Thesaurus ObjectClass
    C49704
    UMLS 2011AA ObjectClass
    C1516728
    NCI Thesaurus Property
    C25358
    UMLS 2011AA Property
    C0596130
    SAE report submitted
    Beskrivning

    SeriousAdverseEventReportInd-3

    Datatyp

    text

    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
    C54035
    UMLS 2011AA ObjectClass
    C0205404
    AE Onset Date
    Beskrivning

    CTCAdverseEventOnsetDate

    Datatyp

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ValueDomain
    C25367
    NCI Thesaurus ObjectClass
    C49704
    UMLS 2011AA ObjectClass
    C1516728
    NCI Thesaurus Property
    C25279
    UMLS 2011AA Property
    C0332162
    Present Status
    Beskrivning

    AdverseEventContinueStatus

    Datatyp

    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
    Beskrivning

    Comments

    COMMENTS
    Beskrivning

    ResearchCommentsText

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS 2011AA ValueDomain
    C1527021
    NCI Thesaurus ObjectClass
    C15319
    NCI Thesaurus Property
    C25393
    UMLS 2011AA Property
    C0282411

    Similar models

    No Instruction available.

    1. StudyEvent: Gynecologic Oncology Group Follow-Up Period Adverse Event Reporting Form (TLC)
      1. No Instruction available.
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Header Module
    FormOriginalCompleteDate
    Item
    Date form originally completed (m d y)
    date
    C19464 (NCI Thesaurus ObjectClass)
    C0376315 (UMLS 2011AA ObjectClass)
    C25250 (NCI Thesaurus Property)
    C0205197 (UMLS 2011AA Property)
    C25604 (NCI Thesaurus Property)
    C0205313 (UMLS 2011AA Property)
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25367 (NCI Thesaurus ValueDomain)
    FormAmendedCompleteDate
    Item
    Date form amended (m d y)
    date
    C19464 (NCI Thesaurus ObjectClass)
    C0376315 (UMLS 2011AA ObjectClass)
    C25250 (NCI Thesaurus Property)
    C0205197 (UMLS 2011AA Property)
    C25416 (NCI Thesaurus Property)
    C1691222 (UMLS 2011AA Property)
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25367 (NCI Thesaurus ValueDomain)
    ResponsiblePersonReportingChangeLastName
    Item
    Person amending form, last name
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    C25190 (NCI Thesaurus ObjectClass)
    C0027361 (UMLS 2011AA ObjectClass)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    PatientInitialsName
    Item
    Patient Initials
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25536 (NCI Thesaurus Property)
    C1555582 (UMLS 2011AA Property)
    PatientGynecologicOncologyGroupIdentifierNumber
    Item
    Patient Study ID
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C25521 (NCI Thesaurus Property)
    C1512288 (UMLS 2011AA Property)
    ResponsiblePersonLastName
    Item
    Person Completing Form, Last Name
    text
    C25190 (NCI Thesaurus ObjectClass)
    C0027361 (UMLS 2011AA ObjectClass)
    C25657 (NCI Thesaurus ObjectClass)
    C1273518 (UMLS 2011AA ObjectClass)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C25551 (NCI Thesaurus Property)
    C1517741 (UMLS 2011AA Property)
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    Item Group
    Adverse Events - Section 1
    ReportingEvaluationPeriodType
    Item
    Reporting Period
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C25214 (NCI Thesaurus ObjectClass)
    C0220825 (UMLS 2011AA ObjectClass)
    C25616 (NCI Thesaurus Property)
    C1948053 (UMLS 2011AA Property)
    C25651 (NCI Thesaurus ObjectClass)
    C0700287 (UMLS 2011AA ObjectClass)
    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)
    C0684224 (UMLS 2011AA Property)
    CL158136 (NCI Metathesaurus Property)
    C25180 (NCI Thesaurus ValueDomain)
    C1522602 (UMLS 2011AA ValueDomain)
    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)
    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)
    C1513491 (UMLS 2011AA Property)
    Item
    Was patient hospitalized as a result of reported adverse events? (during this reporting period)
    text
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C16696 (NCI Thesaurus ObjectClass)
    C0019994 (UMLS 2011AA ObjectClass)
    C25182 (NCI Thesaurus ObjectClass)
    C0021562 (UMLS 2011AA ObjectClass)
    C25385 (NCI Thesaurus Property)
    C0809949 (UMLS 2011AA Property)
    Code List
    Was patient hospitalized as a result of reported adverse events? (during this reporting period)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item Group
    Adverse Events - Section 3
    CommonToxicityCriteriaAdverseEventTermType
    Item
    CTC Adverse Event Term
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C49704 (NCI Thesaurus ObjectClass)
    C1516728 (UMLS 2011AA ObjectClass)
    C45559 (NCI Thesaurus Property)
    C1705313 (UMLS 2011AA Property)
    CommonToxicityCriteriaAdverseEventGrade
    Item
    CTC Adverse Event Grade
    double
    C49704 (NCI Thesaurus ObjectClass)
    C1516728 (UMLS 2011AA ObjectClass)
    C18000 (NCI Thesaurus ValueDomain)
    C0919553 (UMLS 2011AA ValueDomain)
    C25365 (NCI Thesaurus Property)
    C0678257 (UMLS 2011AA 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)
    C0349674 (UMLS 2011AA ValueDomain)
    C49704 (NCI Thesaurus ObjectClass)
    C1516728 (UMLS 2011AA ObjectClass)
    C25358 (NCI Thesaurus Property)
    C0596130 (UMLS 2011AA Property)
    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)
    C1512699 (UMLS 2011AA ValueDomain)
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C25375 (NCI Thesaurus Property)
    C0684224 (UMLS 2011AA Property)
    C54035 (NCI Thesaurus ObjectClass)
    C0205404 (UMLS 2011AA ObjectClass)
    Code List
    SAE report submitted
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CTCAdverseEventOnsetDate
    Item
    AE Onset Date
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25367 (NCI Thesaurus ValueDomain)
    C49704 (NCI Thesaurus ObjectClass)
    C1516728 (UMLS 2011AA ObjectClass)
    C25279 (NCI Thesaurus Property)
    C0332162 (UMLS 2011AA 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)
    Code List
    Present Status
    CL Item
    Fatal Or Died (Fatal/Died)
    CL Item
    Intervention For Adverse Event Continues (Intervention for AE Continues)
    CL Item
    Ae Status Not Evaluated (AE status not evaluated)
    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
    ResearchCommentsText
    Item
    COMMENTS
    text
    C25704 (NCI Thesaurus ValueDomain)
    C1527021 (UMLS 2011AA ValueDomain)
    C15319 (NCI Thesaurus ObjectClass)
    C25393 (NCI Thesaurus Property)
    C0282411 (UMLS 2011AA Property)

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