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691

Description

E3F05 Off-Treatment Form Radiation Therapy With or Without Temozolomide in Treating Patients With Low-Grade Glioma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=6C1889F9-CF7D-5474-E040-BB89AD431A23

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=6C1889F9-CF7D-5474-E040-BB89AD431A23

Keywords

Versions (3)
  1. 8/26/12 8/26/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 6/12/15 6/12/15 -
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August 26, 2012

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Creative Commons BY-NC 3.0 Legacy
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    Brain and Central Nervous System Tumors NCT00978458 Off Treatment - E3F05 Off-Treatment Form - 2900740v1.0

    English

    INSTRUCTIONS : Complete one Off-Treatment Form. After patient has completed protocol treatment, complete this form and submit original to the ECOG Coordinating Center. Keep a copy for your files

    1 forms  
    Unnamed1
    Description

    Unnamed1

    ECOG Protocol Number
    Description

    ProtocolECOGIdentifierNumber

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus ObjectClass
    C25320
    UMLS 2011AA ObjectClass
    C1507394
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus Property
    C25491
    UMLS 2011AA Property
    C1512162
    ECOG Patient ID
    Description

    PatientECOGIdentifierNumber

    Data type

    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
    C25491
    UMLS 2011AA Property
    C1512162
    DCI Name
    Description

    CollectedDataFormName

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    NCI Thesaurus Property
    C19464
    UMLS 2011AA Property
    C0376315
    NCI Thesaurus ObjectClass
    C25474
    UMLS 2011AA ObjectClass
    C1511726
    NCI Thesaurus ObjectClass
    C25452
    Registration Step
    Description

    RegistrationStepNumber

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus ObjectClass
    C25646
    UMLS 2011AA ObjectClass
    C1514821
    NCI Thesaurus Property
    C16154
    UMLS 2011AA Property
    C1704379
    NCI Thesaurus ValueDomain
    C16154
    UMLS 2011AA ValueDomain
    C1704379
    Reporting Period
    Description

    ReportingEvaluationPeriodType

    Data type

    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
    Unnamed2
    Description

    Unnamed2

    Patient Initials (Last, First)
    Description

    PatientInitialsName

    Data type

    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
    Participating Group Protocol Number
    Description

    ProtocolParticipatingIdentifierNumber

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus ObjectClass
    C25320
    UMLS 2011AA ObjectClass
    C1507394
    NCI Thesaurus Property
    C25608
    UMLS 2011AA Property
    C0679823
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    ECOG Protocol Number
    Description

    ProtocolECOGIdentifierNumber

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus ObjectClass
    C25320
    UMLS 2011AA ObjectClass
    C1507394
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus Property
    C25491
    UMLS 2011AA Property
    C1512162
    Institution/Affiliate
    Description

    CombinedInstitutionName

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C25454
    UMLS 2011AA ObjectClass
    C0205195
    NCI Thesaurus ObjectClass
    C21541
    UMLS 2011AA ObjectClass
    C0018704
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    NCI Thesaurus ValueDomain
    C21541
    UMLS 2011AA ValueDomain
    C0018704
    ECOG Patient ID
    Description

    PatientECOGIdentifierNumber

    Data type

    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
    C25491
    UMLS 2011AA Property
    C1512162
    Participating Group Patient ID
    Description

    PatientParticipatingIdentifierNumber

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25608
    UMLS 2011AA Property
    C0679823
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    Unnamed3
    Description

    Unnamed3

    Please mark an 'X' if data have been amended. (Please circle amended items in red)
    Description

    DataAmendedText

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS 2011AA ValueDomain
    C1527021
    NCI Thesaurus ObjectClass
    C25474
    UMLS 2011AA ObjectClass
    C1511726
    NCI Thesaurus Property
    C25416
    UMLS 2011AA Property
    C1691222
    Date data amended (s m d y)
    Description

    DataAmendedDate

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C25474
    UMLS 2011AA ObjectClass
    C1511726
    NCI Thesaurus Property
    C25416
    UMLS 2011AA Property
    C1691222
    NCI Thesaurus ValueDomain
    C25367
    Vital Status
    Description

    Vital Status

    Patient's Vital Status
    Description

    PatientVitalStatus

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus ValueDomain
    C18003
    UMLS 2011AA ValueDomain
    C0442732
    NCI Thesaurus ValueDomain
    C25688
    UMLS 2011AA ValueDomain
    C0449438
    NCI Thesaurus Property
    C25717
    UMLS 2011AA Property
    C1148433
    Date of Last Contact or Death (m d y)
    Description

    PatientLastContactDate

    Data type

    date

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25461
    UMLS 2011AA Property
    C0337611
    NCI Thesaurus Property
    C25551
    UMLS 2011AA Property
    C1517741
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ValueDomain
    C25367
    Primary Cause of Death (if applicable)
    Description

    PatientDeathPatientDeathPrimaryReason

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25638
    UMLS 2011AA ValueDomain
    C0392360
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C28554
    UMLS 2011AA Property
    C0011065
    NCI Thesaurus ValueDomain
    C25251
    UMLS 2011AA ValueDomain
    C0205225
    Describe cause of death
    Description

    PatientDeathSpecify

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS 2011AA ValueDomain
    C1521902
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C28554
    UMLS 2011AA Property
    C0011065
    Unnamed4
    Description

    Unnamed4

    Did patient receive protocol therapy
    Description

    ProtocolTreatmentAdministeredInd-3

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus ObjectClass
    C42651
    UMLS 2011AA ObjectClass
    C0442711
    NCI Thesaurus Property
    C25382
    UMLS 2011AA Property
    C1521801
    Section I
    Description

    Section I

    Reason Treatment Ended
    Description

    Off-treatmentReason

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25638
    UMLS 2011AA ValueDomain
    C0392360
    NCI Thesaurus ObjectClass
    C25601
    UMLS 2011AA ObjectClass
    C1518544
    NCI Thesaurus Property
    C25365
    UMLS 2011AA Property
    C0678257
    Other Complicating Disease specify (specify)
    Description

    Off-treatmentComplicatingReasonSpecify

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS 2011AA ValueDomain
    C1521902
    NCI Thesaurus ObjectClass
    C25601
    UMLS 2011AA ObjectClass
    C1518544
    NCI Thesaurus Property
    C25365
    UMLS 2011AA Property
    C0678257
    NCI Thesaurus Property
    C25455
    UMLS 2011AA Property
    C1522701
    Other specify
    Description

    Off-treatmentReasonSpecify

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS 2011AA ValueDomain
    C1521902
    NCI Thesaurus ObjectClass
    C25601
    UMLS 2011AA ObjectClass
    C1518544
    NCI Thesaurus Property
    C25365
    UMLS 2011AA Property
    C0678257
    Last date protocol therapy was given (m d y)
    Description

    ProtocolTreatmentAdministeredEndDate

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus ObjectClass
    C42651
    UMLS 2011AA ObjectClass
    C0442711
    NCI Thesaurus Property
    C25382
    UMLS 2011AA Property
    C1521801
    Section Ii
    Description

    Section Ii

    Reason treatment never started
    Description

    TreatmentNotBeginReason

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus Property
    C25594
    UMLS 2011AA Property
    C1518422
    NCI Thesaurus Property
    C25431
    UMLS 2011AA Property
    C0439659
    NCI Thesaurus Property
    C25365
    UMLS 2011AA Property
    C0678257
    NCI Thesaurus ValueDomain
    C25638
    UMLS 2011AA ValueDomain
    C0392360
    Other specify
    Description

    Off-treatmentReasonSpecify

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS 2011AA ValueDomain
    C1521902
    NCI Thesaurus ObjectClass
    C25601
    UMLS 2011AA ObjectClass
    C1518544
    NCI Thesaurus Property
    C25365
    UMLS 2011AA Property
    C0678257
    Comments
    Description

    Comments

    Investigator Signature
    Description

    InvestigatorSignatureText

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS 2011AA ValueDomain
    C1527021
    NCI Thesaurus Property
    C25678
    UMLS 2011AA Property
    C1519316
    NCI Thesaurus ObjectClass
    C17089
    UMLS 2011AA ObjectClass
    C0035173
    Investigator Signature Date (MM DD YYYY)
    Description

    InvestigatorSignatureDate

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus Property
    C25678
    UMLS 2011AA Property
    C1519316
    NCI Thesaurus ValueDomain
    C25367
    NCI Thesaurus ObjectClass
    C17089
    UMLS 2011AA ObjectClass
    C0035173
    Back to the top of the page

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    INSTRUCTIONS : Complete one Off-Treatment Form. After patient has completed protocol treatment, complete this form and submit original to the ECOG Coordinating Center. Keep a copy for your files

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Unnamed1
    ProtocolECOGIdentifierNumber
    Item
    ECOG Protocol Number
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C25320 (NCI Thesaurus ObjectClass)
    C1507394 (UMLS 2011AA ObjectClass)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C25491 (NCI Thesaurus Property)
    C1512162 (UMLS 2011AA Property)
    PatientECOGIdentifierNumber
    Item
    ECOG Patient 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)
    C25491 (NCI Thesaurus Property)
    C1512162 (UMLS 2011AA Property)
    CollectedDataFormName
    Item
    DCI Name
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    C19464 (NCI Thesaurus Property)
    C0376315 (UMLS 2011AA Property)
    C25474 (NCI Thesaurus ObjectClass)
    C1511726 (UMLS 2011AA ObjectClass)
    C25452 (NCI Thesaurus ObjectClass)
    RegistrationStepNumber
    Item
    Registration Step
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C25646 (NCI Thesaurus ObjectClass)
    C1514821 (UMLS 2011AA ObjectClass)
    C16154 (NCI Thesaurus Property)
    C1704379 (UMLS 2011AA Property)
    C16154 (NCI Thesaurus ValueDomain)
    C1704379 (UMLS 2011AA ValueDomain)
    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)
    CL.1
    Code List
    Reporting Period
    CL Item
    End Of Treatment (End of treatment)
    Item Group
    Unnamed2
    PatientInitialsName
    Item
    Patient Initials (Last, First)
    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)
    ProtocolParticipatingIdentifierNumber
    Item
    Participating Group Protocol Number
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C25320 (NCI Thesaurus ObjectClass)
    C1507394 (UMLS 2011AA ObjectClass)
    C25608 (NCI Thesaurus Property)
    C0679823 (UMLS 2011AA Property)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    ProtocolECOGIdentifierNumber
    Item
    ECOG Protocol Number
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C25320 (NCI Thesaurus ObjectClass)
    C1507394 (UMLS 2011AA ObjectClass)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C25491 (NCI Thesaurus Property)
    C1512162 (UMLS 2011AA Property)
    CombinedInstitutionName
    Item
    Institution/Affiliate
    text
    C25454 (NCI Thesaurus ObjectClass)
    C0205195 (UMLS 2011AA ObjectClass)
    C21541 (NCI Thesaurus ObjectClass)
    C0018704 (UMLS 2011AA ObjectClass)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    C21541 (NCI Thesaurus ValueDomain)
    C0018704 (UMLS 2011AA ValueDomain)
    PatientECOGIdentifierNumber
    Item
    ECOG Patient 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)
    C25491 (NCI Thesaurus Property)
    C1512162 (UMLS 2011AA Property)
    PatientParticipatingIdentifierNumber
    Item
    Participating Group Patient ID
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25608 (NCI Thesaurus Property)
    C0679823 (UMLS 2011AA Property)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    Item Group
    Unnamed3
    DataAmendedText
    Item
    Please mark an 'X' if data have been amended. (Please circle amended items in red)
    text
    C25704 (NCI Thesaurus ValueDomain)
    C1527021 (UMLS 2011AA ValueDomain)
    C25474 (NCI Thesaurus ObjectClass)
    C1511726 (UMLS 2011AA ObjectClass)
    C25416 (NCI Thesaurus Property)
    C1691222 (UMLS 2011AA Property)
    DataAmendedDate
    Item
    Date data amended (s m d y)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25474 (NCI Thesaurus ObjectClass)
    C1511726 (UMLS 2011AA ObjectClass)
    C25416 (NCI Thesaurus Property)
    C1691222 (UMLS 2011AA Property)
    C25367 (NCI Thesaurus ValueDomain)
    Item Group
    Vital Status
    Item
    Patient's Vital Status
    text
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C18003 (NCI Thesaurus ValueDomain)
    C0442732 (UMLS 2011AA ValueDomain)
    C25688 (NCI Thesaurus ValueDomain)
    C0449438 (UMLS 2011AA ValueDomain)
    C25717 (NCI Thesaurus Property)
    C1148433 (UMLS 2011AA Property)
    CL.2
    Code List
    Patient's Vital Status
    CL Item
    Alive (Alive)
    CL Item
    Dead (Dead)
    PatientLastContactDate
    Item
    Date of Last Contact or Death (m d y)
    date
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25461 (NCI Thesaurus Property)
    C0337611 (UMLS 2011AA Property)
    C25551 (NCI Thesaurus Property)
    C1517741 (UMLS 2011AA Property)
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25367 (NCI Thesaurus ValueDomain)
    Item
    Primary Cause of Death (if applicable)
    text
    C25638 (NCI Thesaurus ValueDomain)
    C0392360 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C28554 (NCI Thesaurus Property)
    C0011065 (UMLS 2011AA Property)
    C25251 (NCI Thesaurus ValueDomain)
    C0205225 (UMLS 2011AA ValueDomain)
    CL.3
    Code List
    Primary Cause of Death (if applicable)
    CL Item
    Due To Protocol Treatment (Due to protocol treatment)
    CL Item
    Due To This Disease (Due to this disease)
    CL Item
    Due To Other Cause (Due to other cause)
    CL Item
    Unknown (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    PatientDeathSpecify
    Item
    Describe cause of death
    text
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C28554 (NCI Thesaurus Property)
    C0011065 (UMLS 2011AA Property)
    Item Group
    Unnamed4
    Item
    Did patient receive protocol therapy
    text
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C15368 (NCI Thesaurus ObjectClass)
    C42651 (NCI Thesaurus ObjectClass)
    C0442711 (UMLS 2011AA ObjectClass)
    C25382 (NCI Thesaurus Property)
    C1521801 (UMLS 2011AA Property)
    CL.4
    Code List
    Did patient receive protocol therapy
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item Group
    Section I
    Item
    Reason Treatment Ended
    text
    C25638 (NCI Thesaurus ValueDomain)
    C0392360 (UMLS 2011AA ValueDomain)
    C25601 (NCI Thesaurus ObjectClass)
    C1518544 (UMLS 2011AA ObjectClass)
    C25365 (NCI Thesaurus Property)
    C0678257 (UMLS 2011AA Property)
    CL.5
    Code List
    Reason Treatment Ended
    CL Item
    Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
    CL Item
    Disease Progression, Relapse During Active Treatment (Disease progression, relapse during active treatment)
    CL Item
    Adverse Event/side Effects/complications (Adverse Event/Side Effects/Complications)
    CL Item
    Death On Study (Death on study)
    CL Item
    Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient withdrawal/refusal after beginning protocol therapy)
    CL Item
    Alternative Therapy (Alternative therapy)
    CL Item
    Patient Off-treatment For Other Complicating Disease (Patient off-treatment for other complicating disease)
    CL Item
    Other (Other)
    C17649 (NCI Thesaurus)
    C0205394 (UMLS 2011AA)
    Off-treatmentComplicatingReasonSpecify
    Item
    Other Complicating Disease specify (specify)
    text
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
    C25601 (NCI Thesaurus ObjectClass)
    C1518544 (UMLS 2011AA ObjectClass)
    C25365 (NCI Thesaurus Property)
    C0678257 (UMLS 2011AA Property)
    C25455 (NCI Thesaurus Property)
    C1522701 (UMLS 2011AA Property)
    Off-treatmentReasonSpecify
    Item
    Other specify
    text
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
    C25601 (NCI Thesaurus ObjectClass)
    C1518544 (UMLS 2011AA ObjectClass)
    C25365 (NCI Thesaurus Property)
    C0678257 (UMLS 2011AA Property)
    ProtocolTreatmentAdministeredEndDate
    Item
    Last date protocol therapy was given (m d y)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C15368 (NCI Thesaurus ObjectClass)
    C42651 (NCI Thesaurus ObjectClass)
    C0442711 (UMLS 2011AA ObjectClass)
    C25382 (NCI Thesaurus Property)
    C1521801 (UMLS 2011AA Property)
    Item Group
    Section Ii
    Item
    Reason treatment never started
    text
    C15368 (NCI Thesaurus ObjectClass)
    C25594 (NCI Thesaurus Property)
    C1518422 (UMLS 2011AA Property)
    C25431 (NCI Thesaurus Property)
    C0439659 (UMLS 2011AA Property)
    C25365 (NCI Thesaurus Property)
    C0678257 (UMLS 2011AA Property)
    C25638 (NCI Thesaurus ValueDomain)
    C0392360 (UMLS 2011AA ValueDomain)
    CL.6
    Code List
    Reason treatment never started
    CL Item
    Adverse Event/side Effects/complications (Adverse events/side effects/complications)
    CL Item
    Death Before Beginning Protocol Therapy (Death before beginning protocol therapy)
    CL Item
    Disease Progression, Relapse Prior To Beginning Protocol Therapy (Disease progression, relapse before protocol treatment)
    CL Item
    Medical Decision (Medical decision)
    CL Item
    No Treatment, Per Protocol Criteria (No treatment assigned per protocol)
    CL Item
    Patient Withdrawal/refusal Before Beginning Protocol Therapy (Patient withdrawal/refusal before beginning protocol therapy)
    CL Item
    Other (Other)
    C17649 (NCI Thesaurus)
    C0205394 (UMLS 2011AA)
    CL Item
    Patient_ineligible (Patient ineligible)
    Off-treatmentReasonSpecify
    Item
    Other specify
    text
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
    C25601 (NCI Thesaurus ObjectClass)
    C1518544 (UMLS 2011AA ObjectClass)
    C25365 (NCI Thesaurus Property)
    C0678257 (UMLS 2011AA Property)
    Item Group
    Comments
    InvestigatorSignatureText
    Item
    Investigator Signature
    text
    C25704 (NCI Thesaurus ValueDomain)
    C1527021 (UMLS 2011AA ValueDomain)
    C25678 (NCI Thesaurus Property)
    C1519316 (UMLS 2011AA Property)
    C17089 (NCI Thesaurus ObjectClass)
    C0035173 (UMLS 2011AA ObjectClass)
    InvestigatorSignatureDate
    Item
    Investigator Signature Date (MM DD YYYY)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25678 (NCI Thesaurus Property)
    C1519316 (UMLS 2011AA Property)
    C25367 (NCI Thesaurus ValueDomain)
    C17089 (NCI Thesaurus ObjectClass)
    C0035173 (UMLS 2011AA ObjectClass)
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