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6342

Description

NCIC-PR.11 Form 1- Initial Evaluation Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=0EF80EFC-B7A8-1C24-E044-0003BA3F9857

Lien

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=0EF80EFC-B7A8-1C24-E044-0003BA3F9857

Mots-clés

Versions (4)
  1. 18/12/2014 18/12/2014 - Martin Dugas
  2. 09/01/2015 09/01/2015 - Martin Dugas
  3. 09/01/2015 09/01/2015 - Martin Dugas
  4. 17/09/2021 17/09/2021 -
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18 décembre 2014

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Creative Commons BY-NC 3.0 Legacy
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    Prostate Cancer NCT00499174 On-Study - NCIC-PR.11 Form 1- Initial Evaluation - 2457017v1.0

    Anglais

    These modules will be used on the majority of NCIC CTG case report forms submitted for CDE Review

    1 Formulaires  
    Patient Information
    Description

    Patient Information

    NCIC Patient ID (NCIC CTG Patient Serial Number issued at the time of randomization)
    Description

    PatientNationalCancerInstituteofCanadaIdentifierNumber

    Type de données

    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
    C25582
    UMLS 2011AA Property
    C1513884
    Patient Initials (first-middle-last)
    Description

    PatientInitialsName

    Type de données

    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 Medical Record Number (if permitted by IRB)
    Description

    PatientMedicalRecordNumber

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25261
    UMLS 2011AA Property
    C0205476
    NCI Thesaurus Property
    C25198
    UMLS 2011AA Property
    C0034869
    Intergroup Patient Serial No
    Description

    PatientMultipleClinicalTrialsCooperativeGroupIdentifierNumber

    Type de données

    text

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus Property
    C17648
    UMLS 2011AA Property
    C0439064
    NCI Thesaurus Property
    C18205
    UMLS 2011AA Property
    C1521808
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    Institution Name
    Description

    InstitutionName

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    NCI Thesaurus ObjectClass
    C21541
    UMLS 2011AA ObjectClass
    C0018704
    NCI Thesaurus ValueDomain
    C21541
    UMLS 2011AA ValueDomain
    C0018704
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Institution Number (CTEP assigned)
    Description

    NCIInstitutionIdentifierCode

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25162
    UMLS 2011AA ValueDomain
    C0805701
    NCI Thesaurus ObjectClass
    C21541
    UMLS 2011AA ObjectClass
    C0018704
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus ObjectClass
    C19202
    UMLS 2011AA ObjectClass
    C1513882
    Investigator First Name
    Description

    InvestigatorFirstName

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus Property
    C25509
    UMLS 2011AA Property
    C1279901
    NCI Thesaurus ObjectClass
    C17089
    UMLS 2011AA ObjectClass
    C0035173
    Investigator Last Name
    Description

    InvestigatorLastName

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus ObjectClass
    C17089
    UMLS 2011AA ObjectClass
    C0035173
    NCI Thesaurus Property
    C25551
    UMLS 2011AA Property
    C1517741
    Patient's Date of Birth (yyyy - mmm - dd)
    Description

    PatientBirthDate

    Type de données

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus ValueDomain
    C25367
    NCI Thesaurus Property
    C25155
    UMLS 2011AA Property
    C0005615
    Investigator Number (NCI Investigator Number)
    Description

    PhysicianInvestigatorIdentifierNumber

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus ObjectClass
    C25741
    UMLS 2011AA ObjectClass
    C0031831
    NCI Thesaurus ObjectClass
    C17089
    UMLS 2011AA ObjectClass
    C0035173
    Date of Randomization
    Description

    ProtocolRandomizationDate

    Type de données

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C25320
    UMLS 2011AA ObjectClass
    C1507394
    NCI Thesaurus Property
    C25196
    UMLS 2011AA Property
    C0034656
    Patient Ethnicity (check one only)
    Description

    PatientEthnicGroupCategory

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25372
    UMLS 2011AA ValueDomain
    C0683312
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C16564
    UMLS 2011AA Property
    C0015031
    Payment Method (check one USA only - )
    Description

    PatientPaymentType

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25371
    UMLS 2011AA Property
    C0680264
    ZIP Code
    Description

    AddressPostalCodeIdentifier

    Type de données

    text

    Alias
    NCI Thesaurus ObjectClass
    C25407
    UMLS 2011AA ObjectClass
    C1442065
    NCI Thesaurus Property
    C25621
    UMLS 2011AA Property
    C1514254
    NCI Thesaurus ValueDomain
    C25364
    UMLS 2011AA ValueDomain
    C0600091
    NCI Thesaurus ValueDomain
    C25407
    UMLS 2011AA ValueDomain
    C1442065
    NCI Thesaurus ValueDomain
    C25621
    UMLS 2011AA ValueDomain
    C1514254
    Race
    Description

    Race

    Race
    Description

    PatientRaceCategory

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25372
    UMLS 2011AA ValueDomain
    C0683312
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C17049
    UMLS 2011AA Property
    C0034510
    Physical Exam
    Description

    Physical Exam

    Date of Evaluation (yyyy - mmm - dd)
    Description

    LesionAssessmentDate

    Type de données

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C3824
    UMLS 2011AA ObjectClass
    C0221198
    NCI Thesaurus Property
    C20989
    UMLS 2011AA Property
    C0031809
    NCI Thesaurus ValueDomain
    C25367
    Performance Status (check one)
    Description

    PerformanceStatusAssessmentEasternCooperativeOncologyGroupScale

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25664
    UMLS 2011AA ValueDomain
    C0349674
    NCI Thesaurus Property
    C25367
    NCI Thesaurus ValueDomain
    C25491
    UMLS 2011AA ValueDomain
    C1512162
    NCI Thesaurus ObjectClass
    C20641
    UMLS 2011AA ObjectClass
    C1518965
    Disease History
    Description

    Disease History

    Date of Initial Diagnosis of Primary Tumor (yyyy mmm dd date of initial pathologic diagnosis submit a copy of the pathology report with the Form 1)
    Description

    FirstBiopsyPositiveDate

    Type de données

    date

    Alias
    NCI Thesaurus ObjectClass
    C15189
    UMLS 2011AA ObjectClass
    C0005558
    NCI Thesaurus ObjectClass
    C25509
    UMLS 2011AA ObjectClass
    C1279901
    NCI Thesaurus Property
    C25246
    UMLS 2011AA Property
    C1446409
    NCI Thesaurus Property
    C25275
    UMLS 2011AA Property
    C2745955
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ValueDomain
    C25367
    Histologic Type
    Description

    ProstateTumorHistologicCategory

    Type de données

    text

    Alias
    NCI Thesaurus ObjectClass
    C3262
    UMLS 2011AA ObjectClass
    C0027651
    NCI Thesaurus ObjectClass
    C12410
    UMLS 2011AA ObjectClass
    C0033572
    NCI Thesaurus Property
    C25526
    UMLS 2011AA Property
    C0205462
    NCI Thesaurus Property
    C25161
    UMLS 2011AA Property
    C0008902
    NCI Thesaurus ValueDomain
    C25372
    UMLS 2011AA ValueDomain
    C0683312
    NCI Thesaurus ValueDomain
    C25526
    UMLS 2011AA ValueDomain
    C0205462
    Other specify
    Description

    TumorHistologicCategorySpecify

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS 2011AA ValueDomain
    C1521902
    NCI Thesaurus ObjectClass
    C3262
    UMLS 2011AA ObjectClass
    C0027651
    NCI Thesaurus Property
    C25526
    UMLS 2011AA Property
    C0205462
    NCI Thesaurus Property
    C25161
    UMLS 2011AA Property
    C0008902
    Date Baseline Surgical Gleason Score Obtained (yyyy mmm dd)
    Description

    SpecimenBaselineGleasonScoreDate

    Type de données

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus Property
    C25213
    UMLS 2011AA Property
    C1442488
    NCI Thesaurus ObjectClass
    C19157
    UMLS 2011AA ObjectClass
    C0370003
    NCI Thesaurus Property
    C28084
    UMLS 2011AA Property
    C0332326
    Gleason Score Based on Specimen Type
    Description

    SpecimenGleasonScoreType

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C19157
    UMLS 2011AA ObjectClass
    C0370003
    NCI Thesaurus ObjectClass
    C28084
    UMLS 2011AA ObjectClass
    C0332326
    NCI Thesaurus Property
    C25365
    UMLS 2011AA Property
    C0678257
    Gleason Score, Primary Pattern (1-5)
    Description

    GleasonScorePrimaryPatternValue

    Type de données

    double

    Alias
    NCI Thesaurus Property
    C25251
    UMLS 2011AA Property
    C0205225
    NCI Thesaurus ObjectClass
    C28084
    UMLS 2011AA ObjectClass
    C0332326
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus Property
    C25336
    UMLS 2011AA Property
    C0449774
    Gleason Score, Secondary Pattern (1-5)
    Description

    GleasonScoreSecondaryPatternValue

    Type de données

    double

    Alias
    NCI Thesaurus Property
    C25667
    UMLS 2011AA Property
    C0175668
    NCI Thesaurus ObjectClass
    C28084
    UMLS 2011AA ObjectClass
    C0332326
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus Property
    C25336
    UMLS 2011AA Property
    C0449774
    Gleason Score, Combined (sum of the primary and secondary)
    Description

    GleasonScoreCombinedPatternValue

    Type de données

    double

    Alias
    NCI Thesaurus Property
    C25454
    UMLS 2011AA Property
    C0205195
    NCI Thesaurus ObjectClass
    C28084
    UMLS 2011AA ObjectClass
    C0332326
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    NCI Thesaurus Property
    C25336
    UMLS 2011AA Property
    C0449774
    Any tertiary elements of Gleason 4 or 5 pattern?
    Description

    SpecimenGleasonScoreIndicator

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25180
    UMLS 2011AA ValueDomain
    C1522602
    NCI Thesaurus ObjectClass
    C19157
    UMLS 2011AA ObjectClass
    C0370003
    NCI Thesaurus Property
    C28084
    UMLS 2011AA Property
    C0332326
    Percent (%) (If yes,)
    Description

    SpecimenGleasonScorePercentageValue

    Type de données

    double

    Alias
    NCI Thesaurus ValueDomain
    C25613
    UMLS 2011AA ValueDomain
    C0439165
    NCI Thesaurus ObjectClass
    C19157
    UMLS 2011AA ObjectClass
    C0370003
    NCI Thesaurus Property
    C28084
    UMLS 2011AA Property
    C0332326
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    Prostate intraepithelial neoplasia (PIN), High Grade
    Description

    SpecimenHighGradeProstaticIntraepithelialNeoplasiaInd-3

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ObjectClass
    C19157
    UMLS 2011AA ObjectClass
    C0370003
    NCI Thesaurus Property
    C5541
    UMLS 2011AA Property
    C1168327
    Atypical small acinar proliferation (ASAP)
    Description

    ProstatePathologyAtypicalSmallAcinarProliferationDiagnosisInd-2

    Type de données

    text

    Alias
    NCI Thesaurus ObjectClass
    C12410
    UMLS 2011AA ObjectClass
    C0033572
    NCI Thesaurus ObjectClass
    C18189
    UMLS 2011AA ObjectClass
    C0030664
    NCI Thesaurus Property
    C15220
    UMLS 2011AA Property
    C0011900
    NCI Thesaurus Property
    C37268
    UMLS 2011AA Property
    C1332353
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Total number cores (Left side)
    Description

    CoreBiopsyProstateGlandNeoplasmPerformedCount

    Type de données

    double

    Alias
    NCI Thesaurus ObjectClass
    C15680
    UMLS 2011AA ObjectClass
    C1318309
    NCI Thesaurus Property
    C3262
    UMLS 2011AA Property
    C0027651
    NCI Thesaurus Property
    C12410
    UMLS 2011AA Property
    C0033572
    NCI Thesaurus Property
    C38000
    UMLS 2011AA Property
    C0884358
    NCI Thesaurus ValueDomain
    C25463
    UMLS 2011AA ValueDomain
    C0750480
    Total number cores (Left side)
    Description

    CoreBiopsyProstateGlandNeoplasmPerformedCount

    Type de données

    double

    Alias
    NCI Thesaurus ObjectClass
    C15680
    UMLS 2011AA ObjectClass
    C1318309
    NCI Thesaurus Property
    C3262
    UMLS 2011AA Property
    C0027651
    NCI Thesaurus Property
    C12410
    UMLS 2011AA Property
    C0033572
    NCI Thesaurus Property
    C38000
    UMLS 2011AA Property
    C0884358
    NCI Thesaurus ValueDomain
    C25463
    UMLS 2011AA ValueDomain
    C0750480
    Number cores positive (Left side)
    Description

    CoreBiopsyProstateGlandMalignantNeoplasmPerformedCount

    Type de données

    double

    Alias
    NCI Thesaurus ObjectClass
    C15680
    UMLS 2011AA ObjectClass
    C1318309
    NCI Thesaurus Property
    C12410
    UMLS 2011AA Property
    C0033572
    NCI Thesaurus Property
    C38000
    UMLS 2011AA Property
    C0884358
    NCI Thesaurus Property
    C9305
    UMLS 2011AA Property
    C0006826
    NCI Thesaurus ValueDomain
    C25463
    UMLS 2011AA ValueDomain
    C0750480
    Number cores positive (Left side)
    Description

    CoreBiopsyProstateGlandMalignantNeoplasmPerformedCount

    Type de données

    double

    Alias
    NCI Thesaurus ObjectClass
    C15680
    UMLS 2011AA ObjectClass
    C1318309
    NCI Thesaurus Property
    C12410
    UMLS 2011AA Property
    C0033572
    NCI Thesaurus Property
    C38000
    UMLS 2011AA Property
    C0884358
    NCI Thesaurus Property
    C9305
    UMLS 2011AA Property
    C0006826
    NCI Thesaurus ValueDomain
    C25463
    UMLS 2011AA ValueDomain
    C0750480
    Specimen/Core No. (CRF text recommended - CRF only shows Specimen/Core #1, 2, 3, 4)
    Description

    PositiveMalignantNeoplasmProstateSpecimenNumber

    Type de données

    text

    Alias
    NCI Thesaurus ObjectClass
    C25246
    UMLS 2011AA ObjectClass
    C1446409
    NCI Thesaurus ObjectClass
    C9305
    UMLS 2011AA ObjectClass
    C0006826
    NCI Thesaurus Property
    C12410
    UMLS 2011AA Property
    C0033572
    NCI Thesaurus Property
    C19157
    UMLS 2011AA Property
    C0370003
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    Percent involved Right side
    Description

    PositiveMalignantNeoplasmRightProstateSpecimenPercentageValue

    Type de données

    double

    Alias
    NCI Thesaurus ObjectClass
    C25246
    UMLS 2011AA ObjectClass
    C1446409
    NCI Thesaurus ObjectClass
    C9305
    UMLS 2011AA ObjectClass
    C0006826
    NCI Thesaurus Property
    C25228
    UMLS 2011AA Property
    C0205090
    NCI Thesaurus Property
    C12410
    UMLS 2011AA Property
    C0033572
    NCI Thesaurus Property
    C19157
    UMLS 2011AA Property
    C0370003
    NCI Thesaurus ValueDomain
    C25613
    UMLS 2011AA ValueDomain
    C0439165
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    Percent involved Left side
    Description

    PositiveMalignantNeoplasmLeftProstateSpecimenPercentageValue

    Type de données

    double

    Unités de mesure
    • %
    Alias
    NCI Thesaurus ObjectClass
    C25246
    UMLS 2011AA ObjectClass
    C1446409
    NCI Thesaurus ObjectClass
    C9305
    UMLS 2011AA ObjectClass
    C0006826
    NCI Thesaurus Property
    C25229
    UMLS 2011AA Property
    C0205091
    NCI Thesaurus Property
    C12410
    UMLS 2011AA Property
    C0033572
    NCI Thesaurus Property
    C19157
    UMLS 2011AA Property
    C0370003
    NCI Thesaurus ValueDomain
    C25613
    UMLS 2011AA ValueDomain
    C0439165
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    %
    T Stage, Clinical
    Description

    ProstateTumorClinicalTStage

    Type de données

    text

    Alias
    NCI Thesaurus ObjectClass
    C3262
    UMLS 2011AA ObjectClass
    C0027651
    NCI Thesaurus ObjectClass
    C12410
    UMLS 2011AA ObjectClass
    C0033572
    NCI Thesaurus Property
    C25398
    UMLS 2011AA Property
    C0205210
    NCI Thesaurus Property
    C25728
    UMLS 2011AA Property
    C0475455
    NCI Thesaurus ValueDomain
    C16899
    UMLS 2011AA ValueDomain
    C1300072
    Untitled/disease History (continued)
    Description

    Untitled/disease History (continued)

    Date of Transrectal Ultrasound (yyyy mmm dd)
    Description

    TransrectalUltrasoundProstateAssessmentDate

    Type de données

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus Property
    C20989
    UMLS 2011AA Property
    C0031809
    NCI Thesaurus ObjectClass
    C18315
    UMLS 2011AA ObjectClass
    C0373345
    NCI Thesaurus Property
    C12410
    UMLS 2011AA Property
    C0033572
    Volume of gland/Prostate gland size (cubic centimetres)
    Description

    TransrectalUltrasoundProstateAssessmentVolumeMeasurement

    Type de données

    double

    Alias
    NCI Thesaurus ObjectClass
    C18315
    UMLS 2011AA ObjectClass
    C0373345
    NCI Thesaurus Property
    C20989
    UMLS 2011AA Property
    C0031809
    NCI Thesaurus Property
    C12410
    UMLS 2011AA Property
    C0033572
    NCI Thesaurus ValueDomain
    C25209
    UMLS 2011AA ValueDomain
    C0242485
    NCI Thesaurus ValueDomain
    C25335
    UMLS 2011AA ValueDomain
    C0449468
    Hypoechoic area
    Description

    TransrectalUltrasoundThickMidlineEchoProstateAreaInd-2

    Type de données

    text

    Alias
    NCI Thesaurus ObjectClass
    C18315
    UMLS 2011AA ObjectClass
    C0373345
    NCI Thesaurus Property
    C12410
    UMLS 2011AA Property
    C0033572
    NCI Thesaurus Property
    C25244
    UMLS 2011AA Property
    C0205146
    NCI Metathesaurus Property
    C0749762
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Size (cm) (If yes,)
    Description

    TransrectalUltrasoundThickMidlineEchoProstateAreaMeasurement

    Type de données

    double

    Alias
    NCI Thesaurus ObjectClass
    C18315
    UMLS 2011AA ObjectClass
    C0373345
    NCI Thesaurus Property
    C12410
    UMLS 2011AA Property
    C0033572
    NCI Thesaurus Property
    C25244
    UMLS 2011AA Property
    C0205146
    NCI Metathesaurus Property
    C0749762
    NCI Thesaurus ValueDomain
    C25209
    UMLS 2011AA ValueDomain
    C0242485
    NCI Thesaurus ValueDomain
    C25244
    UMLS 2011AA ValueDomain
    C0205146
    Date of exam (yyyy mmm dd)
    Description

    PatientMedicalExaminationDate

    Type de données

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25305
    UMLS 2011AA Property
    C0582103
    Was the nodule palpable (at baseline)
    Description

    ProstateMalignantNeoplasmPalpableNoduleInd-3

    Type de données

    text

    Alias
    NCI Thesaurus ObjectClass
    C12410
    UMLS 2011AA ObjectClass
    C0033572
    NCI Thesaurus ObjectClass
    C9305
    UMLS 2011AA ObjectClass
    C0006826
    NCI Thesaurus Property
    C25606
    UMLS 2011AA Property
    C0522499
    NCI Thesaurus Property
    C3280
    UMLS 2011AA Property
    C0028259
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    Nodule is (If yes, )
    Description

    ProstateMalignantNeoplasmPalpableNoduleType

    Type de données

    text

    Alias
    NCI Thesaurus ObjectClass
    C12410
    UMLS 2011AA ObjectClass
    C0033572
    NCI Thesaurus ObjectClass
    C9305
    UMLS 2011AA ObjectClass
    C0006826
    NCI Thesaurus Property
    C25606
    UMLS 2011AA Property
    C0522499
    NCI Thesaurus Property
    C3280
    UMLS 2011AA Property
    C0028259
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    Maximum Diameter (cm)
    Description

    TumorMaximumDiameterMeasurement

    Type de données

    double

    Alias
    NCI Thesaurus ValueDomain
    C25209
    UMLS 2011AA ValueDomain
    C0242485
    NCI Thesaurus Property
    C25285
    UMLS 2011AA Property
    C1301886
    NCI Thesaurus ObjectClass
    C3262
    UMLS 2011AA ObjectClass
    C0027651
    NCI Thesaurus Property
    C25564
    UMLS 2011AA Property
    C0806909
    Date of Baseline PSA (closest to randomization yyyy mmm dd)
    Description

    BaselinePSADate

    Type de données

    date

    Alias
    NCI Thesaurus ObjectClass
    C17525
    UMLS 2011AA ObjectClass
    C0138741
    NCI Thesaurus ObjectClass
    C25213
    UMLS 2011AA ObjectClass
    C1442488
    NCI Thesaurus Property
    C25275
    UMLS 2011AA Property
    C2745955
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ValueDomain
    C25367
    Baseline PSA Value
    Description

    LaboratoryProcedureBaselineProstate-SpecificAntigenOutcomeValue

    Type de données

    double

    Unités de mesure
    • ng/ml
    Alias
    NCI Thesaurus Property
    C17525
    UMLS 2011AA Property
    C0138741
    NCI Thesaurus Property
    C25213
    UMLS 2011AA Property
    C1442488
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    ng/ml
    Date of PSA prior to androgen deprivation therapy (if applicable yyyy mmm dd)
    Description

    LaboratoryProcedureBaselineProstate-SpecificAntigenPriorAntiandrogenTherapyOutcomeDate

    Type de données

    date

    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C17525
    UMLS 2011AA Property
    C0138741
    NCI Thesaurus Property
    C25213
    UMLS 2011AA Property
    C1442488
    NCI Thesaurus Property
    C25629
    UMLS 2011AA Property
    C0332152
    NCI Thesaurus Property
    C15481
    UMLS 2011AA Property
    C0279492
    NCI Metathesaurus Property
    CL025479
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    PSA Value prior to androgen deprivation therapy (if applicable)
    Description

    LaboratoryProcedureBaselineProstate-SpecificAntigenPriorAntiandrogenTherapyOutcomeValue

    Type de données

    double

    Unités de mesure
    • ng/ml
    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C17525
    UMLS 2011AA Property
    C0138741
    NCI Thesaurus Property
    C25213
    UMLS 2011AA Property
    C1442488
    NCI Thesaurus Property
    C25629
    UMLS 2011AA Property
    C0332152
    NCI Thesaurus Property
    C15481
    UMLS 2011AA Property
    C0279492
    NCI Metathesaurus Property
    CL025479
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    ng/ml
    PSA Value (total)
    Description

    LaboratoryProcedureProstate-SpecificAntigenTumorMarkerResultValue

    Type de données

    double

    Unités de mesure
    • ng/ml
    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C17525
    UMLS 2011AA Property
    C0138741
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property
    C17220
    UMLS 2011AA Property
    C0041365
    NCI Thesaurus ValueDomain
    C25712
    UMLS 2011AA ValueDomain
    C1522609
    ng/ml
    Units (* ng/ml, mg/L)
    Description

    AssessmentLabUOM

    Type de données

    text

    Alias
    NCI Thesaurus ObjectClass
    C20989
    UMLS 2011AA ObjectClass
    C0031809
    NCI Thesaurus Property
    C37984
    UMLS 2011AA Property
    C0022877
    NCI Thesaurus ValueDomain
    C25709
    UMLS 2011AA ValueDomain
    C1519795
    Units (* ng/ml, mg/L)
    Description

    AssessmentLabUOM

    Type de données

    text

    Alias
    NCI Thesaurus ObjectClass
    C20989
    UMLS 2011AA ObjectClass
    C0031809
    NCI Thesaurus Property
    C37984
    UMLS 2011AA Property
    C0022877
    NCI Thesaurus ValueDomain
    C25709
    UMLS 2011AA ValueDomain
    C1519795
    Units (* ng/ml, mg/L)
    Description

    AssessmentLabUOM

    Type de données

    text

    Alias
    NCI Thesaurus ObjectClass
    C20989
    UMLS 2011AA ObjectClass
    C0031809
    NCI Thesaurus Property
    C37984
    UMLS 2011AA Property
    C0022877
    NCI Thesaurus ValueDomain
    C25709
    UMLS 2011AA ValueDomain
    C1519795
    Date of PSA Assessment (yyyy mmm dd)
    Description

    LaboratoryProcedureProstate-SpecificAntigenTumorMarkerResultDate

    Type de données

    date

    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS 2011AA ObjectClass
    C0022885
    NCI Thesaurus Property
    C17525
    UMLS 2011AA Property
    C0138741
    NCI Thesaurus Property
    C20200
    UMLS 2011AA Property
    C1274040
    NCI Thesaurus Property
    C17220
    UMLS 2011AA Property
    C0041365
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ValueDomain
    C25367
    Therapy For Lower Urinary Tract Symptoms/prostate Cancer Prevention/prostate Cancer
    Description

    Therapy For Lower Urinary Tract Symptoms/prostate Cancer Prevention/prostate Cancer

    5 alpha-reductase inhibitor
    Description

    HormoneTherapy5Alpha-ReductaseInhibitorPriorAdministeredInd-2

    Type de données

    text

    Alias
    NCI Thesaurus ObjectClass
    C15445
    UMLS 2011AA ObjectClass
    C0279025
    NCI Thesaurus Property
    C25629
    UMLS 2011AA Property
    C0332152
    NCI Thesaurus Property
    C25382
    UMLS 2011AA Property
    C1521801
    NCI Thesaurus Property
    C2319
    UMLS 2011AA Property
    C1318898
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Reason for use
    Description

    Non-protocolTherapy5Alpha-ReductaseInhibitorAdministeredReason

    Type de données

    text

    Alias
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus ObjectClass
    C25590
    UMLS 2011AA ObjectClass
    C1518384
    NCI Thesaurus Property
    C25382
    UMLS 2011AA Property
    C1521801
    NCI Thesaurus Property
    C2319
    UMLS 2011AA Property
    C1318898
    NCI Thesaurus ValueDomain
    C25638
    UMLS 2011AA ValueDomain
    C0392360
    Agent (If yes,)
    Description

    Non-protocolTherapy5Alpha-ReductaseInhibitorAdministeredText

    Type de données

    text

    Alias
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus ObjectClass
    C25590
    UMLS 2011AA ObjectClass
    C1518384
    NCI Thesaurus Property
    C25382
    UMLS 2011AA Property
    C1521801
    NCI Thesaurus Property
    C2319
    UMLS 2011AA Property
    C1318898
    NCI Thesaurus ValueDomain
    C25704
    UMLS 2011AA ValueDomain
    C1527021
    Non-steroidal antiandrogen
    Description

    NonsteroidalAntiandrogenTherapyPriorAdministeredInd-2

    Type de données

    text

    Alias
    NCI Thesaurus ObjectClass
    C15368
    NCI Metathesaurus ObjectClass
    CL316360
    NCI Thesaurus Property
    C25629
    UMLS 2011AA Property
    C0332152
    NCI Thesaurus Property
    C25382
    UMLS 2011AA Property
    C1521801
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Agent (If yes,)
    Description

    Non-protocolTherapyNonsteroidalAntiandrogenAdministeredText

    Type de données

    text

    Alias
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus ObjectClass
    C25590
    UMLS 2011AA ObjectClass
    C1518384
    NCI Thesaurus Property
    C25382
    UMLS 2011AA Property
    C1521801
    NCI Metathesaurus Property
    CL316360
    NCI Thesaurus ValueDomain
    C25704
    UMLS 2011AA ValueDomain
    C1527021
    Date Agent Started (yyyy mmm dd)
    Description

    AgentBeginDate

    Type de données

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ValueDomain
    C25431
    UMLS 2011AA ValueDomain
    C0439659
    NCI Thesaurus ObjectClass
    C1708
    UMLS 2011AA ObjectClass
    C0450442
    NCI Thesaurus Property
    C25275
    UMLS 2011AA Property
    C2745955
    Date Agent Started (yyyy mmm dd)
    Description

    AgentBeginDate

    Type de données

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ValueDomain
    C25431
    UMLS 2011AA ValueDomain
    C0439659
    NCI Thesaurus ObjectClass
    C1708
    UMLS 2011AA ObjectClass
    C0450442
    NCI Thesaurus Property
    C25275
    UMLS 2011AA Property
    C2745955
    Date Agent Started (yyyy mmm dd)
    Description

    AgentBeginDate

    Type de données

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ValueDomain
    C25431
    UMLS 2011AA ValueDomain
    C0439659
    NCI Thesaurus ObjectClass
    C1708
    UMLS 2011AA ObjectClass
    C0450442
    NCI Thesaurus Property
    C25275
    UMLS 2011AA Property
    C2745955
    Date Agent Started (yyyy mmm dd)
    Description

    AgentBeginDate

    Type de données

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ValueDomain
    C25431
    UMLS 2011AA ValueDomain
    C0439659
    NCI Thesaurus ObjectClass
    C1708
    UMLS 2011AA ObjectClass
    C0450442
    NCI Thesaurus Property
    C25275
    UMLS 2011AA Property
    C2745955
    Date Agent Ended (yyyy mmm dd)
    Description

    AgentEndDate

    Type de données

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C1708
    UMLS 2011AA ObjectClass
    C0450442
    NCI Thesaurus Property
    C25275
    UMLS 2011AA Property
    C2745955
    Date Agent Ended (yyyy mmm dd)
    Description

    AgentEndDate

    Type de données

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C1708
    UMLS 2011AA ObjectClass
    C0450442
    NCI Thesaurus Property
    C25275
    UMLS 2011AA Property
    C2745955
    Date Agent Ended (yyyy mmm dd)
    Description

    AgentEndDate

    Type de données

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C1708
    UMLS 2011AA ObjectClass
    C0450442
    NCI Thesaurus Property
    C25275
    UMLS 2011AA Property
    C2745955
    Date Agent Ended (yyyy mmm dd)
    Description

    AgentEndDate

    Type de données

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C1708
    UMLS 2011AA ObjectClass
    C0450442
    NCI Thesaurus Property
    C25275
    UMLS 2011AA Property
    C2745955
    LHRH analogues
    Description

    HormoneTherapyNon-ProtocolGonadotropin-ReleasingHormoneAnalogAdministeredInd-2

    Type de données

    text

    Alias
    NCI Thesaurus ObjectClass
    C15445
    UMLS 2011AA ObjectClass
    C0279025
    NCI Thesaurus Property
    C25590
    UMLS 2011AA Property
    C1518384
    NCI Thesaurus Property
    C25382
    UMLS 2011AA Property
    C1521801
    NCI Thesaurus Property
    C2022
    UMLS 2011AA Property
    C1268900
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Agent (If yes,)
    Description

    HormoneTherapyNon-ProtocolGonadotropin-ReleasingHormoneAnalogAdministeredText

    Type de données

    text

    Alias
    NCI Thesaurus ObjectClass
    C15445
    UMLS 2011AA ObjectClass
    C0279025
    NCI Thesaurus Property
    C25590
    UMLS 2011AA Property
    C1518384
    NCI Thesaurus Property
    C25382
    UMLS 2011AA Property
    C1521801
    NCI Thesaurus Property
    C2022
    UMLS 2011AA Property
    C1268900
    NCI Thesaurus ValueDomain
    C25704
    UMLS 2011AA ValueDomain
    C1527021
    Prior Surgery (for prostate cancer other than biopsy or TURP?)
    Description

    PriorSurgeryPerformedInd-3

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus Property
    C38000
    UMLS 2011AA Property
    C0884358
    NCI Thesaurus ObjectClass
    C15329
    UMLS 2011AA ObjectClass
    C0543467
    NCI Thesaurus ObjectClass
    C25629
    UMLS 2011AA ObjectClass
    C0332152
    Radiation Therapy (for prostate cancer?)
    Description

    RTTreatmentInd-3

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ObjectClass
    C15313
    UMLS 2011AA ObjectClass
    C1522449
    NCI Thesaurus Property
    C15368
    Complementary and alternative medicines (*e.g. Saw palmetto, Vitamin B/E, Selenium, Lycopene)
    Description

    TherapyComplementaryandAlternativeMedicineAdministeredInd-2

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus Property
    C15178
    UMLS 2011AA Property
    C0002346
    NCI Thesaurus Property
    C25382
    UMLS 2011AA Property
    C1521801
    Agent (If yes, )
    Description

    TherapyComplementaryandAlternativeMedicineAdministeredText

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS 2011AA ValueDomain
    C1527021
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus Property
    C15178
    UMLS 2011AA Property
    C0002346
    NCI Thesaurus Property
    C25382
    UMLS 2011AA Property
    C1521801
    Adverse Event Status
    Description

    Adverse Event Status

    Has the patient experienced any symptoms in the 14 days prior to randomization
    Description

    AdverseEventSymptomInd-2

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus Property
    C4876
    UMLS 2011AA Property
    C1457887
    CTC Adverse Event Term
    Description

    AdverseEventCommonTerminologyforAdverseEventsVersion4TermName

    Type de données

    text

    Alias
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus Property
    C49704
    UMLS 2011AA Property
    C1516728
    NCI Thesaurus Property
    C45559
    UMLS 2011AA Property
    C1705313
    NCI Thesaurus ValueDomain
    C45255
    UMLS 2011AA ValueDomain
    C1708523
    NCI Thesaurus ValueDomain
    C49704
    UMLS 2011AA ValueDomain
    C1516728
    NCI Thesaurus ValueDomain
    C42614
    UMLS 2011AA ValueDomain
    C0027365
    NCI Thesaurus ValueDomain
    C45559
    UMLS 2011AA ValueDomain
    C1705313
    NCI Thesaurus ValueDomain
    C25714
    UMLS 2011AA ValueDomain
    C0333052
    Grade (Worst this time period - Consult grade definitions in CTCAE version 4.0 handbook and enter appropriate code below. - If event not present, leave event grade field blank.)
    Description

    AdverseEventSeverityGrade

    Type de données

    text

    Alias
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus Property
    C48309
    UMLS 2011AA Property
    C0441800
    NCI Thesaurus Property
    C49705
    UMLS 2011AA Property
    C1710065
    NCI Thesaurus Property
    C25676
    UMLS 2011AA Property
    C0439793
    NCI Thesaurus ValueDomain
    C41331
    UMLS 2011AA ValueDomain
    C0877248
    NCI Thesaurus ValueDomain
    C48309
    UMLS 2011AA ValueDomain
    C0441800
    NCI Thesaurus ValueDomain
    C25676
    UMLS 2011AA ValueDomain
    C0439793
    Other Major Medical Problems
    Description

    Other Major Medical Problems

    Have there been any major ongoing medical problems? (If yes, please enter details below:)
    Description

    PatientMedicalHistoryBaselineProblemInd-2

    Type de données

    text

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus ObjectClass
    C18772
    UMLS 2011AA ObjectClass
    C0262926
    NCI Thesaurus Property
    C25213
    UMLS 2011AA Property
    C1442488
    NCI Thesaurus Property
    C28020
    UMLS 2011AA Property
    C0033213
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Disease/Condition
    Description

    Disease/ConditionNameType

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Metathesaurus ObjectClass
    CL308231
    NCI Thesaurus Property
    C42614
    UMLS 2011AA Property
    C0027365
    Correlative Studies
    Description

    Correlative Studies

    Did the patient agree to allow tissue from tumor to be collected for tumor banking?
    Description

    PatientTissueBankingConsentStatus

    Type de données

    text

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus ValueDomain
    C25688
    UMLS 2011AA ValueDomain
    C0449438
    NCI Thesaurus Property
    C25460
    UMLS 2011AA Property
    C1511481
    NCI Metathesaurus Property
    C0087095
    Was tissue collected for tumor banking (If yes,)
    Description

    TissueSpecimenCollectedInd-2

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus ObjectClass
    C12801
    UMLS 2011AA ObjectClass
    C0040300
    NCI Thesaurus ObjectClass
    C19157
    UMLS 2011AA ObjectClass
    C0370003
    NCI Thesaurus Property
    C25452
    Reason
    Description

    TissueSampleNotCollectedReasonText

    Type de données

    text

    Alias
    NCI Thesaurus ObjectClass
    C19697
    UMLS 2011AA ObjectClass
    C1292533
    NCI Thesaurus Property
    C25594
    UMLS 2011AA Property
    C1518422
    NCI Thesaurus Property
    C25452
    NCI Thesaurus ValueDomain
    C25704
    UMLS 2011AA ValueDomain
    C1527021
    NCI Thesaurus ValueDomain
    C25638
    UMLS 2011AA ValueDomain
    C0392360
    Quality Of Life Questionnaire
    Description

    Quality Of Life Questionnaire

    Was QoL Questionnaire completed?
    Description

    QOLCompleteAssessmentIndicator

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25180
    UMLS 2011AA ValueDomain
    C1522602
    NCI Thesaurus ObjectClass
    C17047
    UMLS 2011AA ObjectClass
    C0518214
    NCI Thesaurus Property
    C20989
    UMLS 2011AA Property
    C0031809
    Date Questionnaire Completed (yyyy mmm dd Please submit quality of life questionnaires)
    Description

    QualityofLifeCompleteAssessmentDate

    Type de données

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C17047
    UMLS 2011AA ObjectClass
    C0518214
    NCI Thesaurus Property
    C25250
    UMLS 2011AA Property
    C0205197
    NCI Thesaurus Property
    C25367
    Reason Questionnaire was not Completed (check one)
    Description

    PatientIncompleteQuestionnaireReason

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25638
    UMLS 2011AA ValueDomain
    C0392360
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Metathesaurus Property
    C0034394
    Other reason, specify
    Description

    PatientIncompleteQuestionnaireOtherSpecify

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS 2011AA ValueDomain
    C1521902
    NCI Thesaurus ValueDomain
    C17649
    UMLS 2011AA ValueDomain
    C0205394
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Metathesaurus Property
    C0034394
    Planned Therapeutic Action
    Description

    Planned Therapeutic Action

    Planned Therapeutic Action for this patient (*Radical therapy must begin within 90 days of the date of the randomization)
    Description

    TreatmentPlannedProcedure

    Type de données

    text

    Alias
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus Property
    C25619
    UMLS 2011AA Property
    C1301732
    NCI Thesaurus ValueDomain
    C25218
    UMLS 2011AA ValueDomain
    C1948041
    Radiation Therapy Type
    Description

    RadiationTherapyProcedureType

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C15313
    UMLS 2011AA ObjectClass
    C1522449
    NCI Thesaurus Property
    C25218
    UMLS 2011AA Property
    C1948041
    Comments
    Description

    Comments

    Comments
    Description

    ResearchCommentsText

    Type de données

    text

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

    Supporting Documentation

    Investigator Signature
    Description

    Investigator Signature

    Person Completing Form, Last Name
    Description

    ResponsiblePersonLastName

    Type de données

    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
    Person Completing Form, First Name
    Description

    ResponsiblePersonFirstName

    Type de données

    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
    C25509
    UMLS 2011AA Property
    C1279901
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    Date Form Originally Completed (yyyy - mmm - dd)
    Description

    FormOriginalCompleteDate

    Type de données

    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
    Retour au début de la page

    Similar models

    These modules will be used on the majority of NCIC CTG case report forms submitted for CDE Review

    1 Formulaires
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    Patient Information
    PatientNationalCancerInstituteofCanadaIdentifierNumber
    Item
    NCIC Patient ID (NCIC CTG Patient Serial Number issued at the time of randomization)
    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)
    C25582 (NCI Thesaurus Property)
    C1513884 (UMLS 2011AA Property)
    PatientInitialsName
    Item
    Patient Initials (first-middle-last)
    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)
    PatientMedicalRecordNumber
    Item
    Patient Medical Record Number (if permitted by IRB)
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25261 (NCI Thesaurus Property)
    C0205476 (UMLS 2011AA Property)
    C25198 (NCI Thesaurus Property)
    C0034869 (UMLS 2011AA Property)
    PatientMultipleClinicalTrialsCooperativeGroupIdentifierNumber
    Item
    Intergroup Patient Serial No
    text
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C17648 (NCI Thesaurus Property)
    C0439064 (UMLS 2011AA Property)
    C18205 (NCI Thesaurus Property)
    C1521808 (UMLS 2011AA Property)
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    InstitutionName
    Item
    Institution Name
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    C21541 (NCI Thesaurus ObjectClass)
    C0018704 (UMLS 2011AA ObjectClass)
    C21541 (NCI Thesaurus ValueDomain)
    C0018704 (UMLS 2011AA ValueDomain)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    NCIInstitutionIdentifierCode
    Item
    NCI Institution Number (CTEP assigned)
    text
    C25162 (NCI Thesaurus ValueDomain)
    C0805701 (UMLS 2011AA ValueDomain)
    C21541 (NCI Thesaurus ObjectClass)
    C0018704 (UMLS 2011AA ObjectClass)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C19202 (NCI Thesaurus ObjectClass)
    C1513882 (UMLS 2011AA ObjectClass)
    InvestigatorFirstName
    Item
    Investigator First Name
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C25509 (NCI Thesaurus Property)
    C1279901 (UMLS 2011AA Property)
    C17089 (NCI Thesaurus ObjectClass)
    C0035173 (UMLS 2011AA ObjectClass)
    InvestigatorLastName
    Item
    Investigator Last Name
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C17089 (NCI Thesaurus ObjectClass)
    C0035173 (UMLS 2011AA ObjectClass)
    C25551 (NCI Thesaurus Property)
    C1517741 (UMLS 2011AA Property)
    PatientBirthDate
    Item
    Patient's Date of Birth (yyyy - mmm - dd)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25367 (NCI Thesaurus ValueDomain)
    C25155 (NCI Thesaurus Property)
    C0005615 (UMLS 2011AA Property)
    PhysicianInvestigatorIdentifierNumber
    Item
    Investigator Number (NCI Investigator Number)
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C25741 (NCI Thesaurus ObjectClass)
    C0031831 (UMLS 2011AA ObjectClass)
    C17089 (NCI Thesaurus ObjectClass)
    C0035173 (UMLS 2011AA ObjectClass)
    ProtocolRandomizationDate
    Item
    Date of Randomization
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25320 (NCI Thesaurus ObjectClass)
    C1507394 (UMLS 2011AA ObjectClass)
    C25196 (NCI Thesaurus Property)
    C0034656 (UMLS 2011AA Property)
    Item
    Patient Ethnicity (check one only)
    text
    C25372 (NCI Thesaurus ValueDomain)
    C0683312 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C16564 (NCI Thesaurus Property)
    C0015031 (UMLS 2011AA Property)
    CL.1
    Code List
    Patient Ethnicity (check one only)
    CL Item
    A Person Of Mexican, Puerto Rican, Cuban, Central Or South American Or Other Spanish Culture Or Origin, Regardless Of Race. (Hispanic or Latino)
    C17459 (NCI Thesaurus)
    C0086409 (UMLS 2011AA)
    CL Item
    A Person Not Meeting The Definition For Hispanic Or Latino. (Not Hispanic or Latino)
    C41222 (NCI Thesaurus)
    C1518424 (UMLS 2011AA)
    CL Item
    Not Provided Or Available (Not reported)
    C43234 (NCI Thesaurus)
    C1706613 (UMLS 2011AA)
    CL Item
    Could Not Be Determined Or Unsure (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    Item
    Payment Method (check one USA only - )
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25371 (NCI Thesaurus Property)
    C0680264 (UMLS 2011AA Property)
    CL.2
    Code List
    Payment Method (check one USA only - )
    CL Item
    Medicaid (Medicaid)
    C0025071 (NCI Metathesaurus)
    CL Item
    Medicaid And Medicare (Medicaid and Medicare)
    CL Item
    Medicare (Medicare)
    C16665 (NCI Thesaurus)
    C0018717 (UMLS 2011AA)
    CL Item
    Medicare And Private Insurance (Medicare and Private Insurance)
    CL Item
    Military Or Veterans Sponsored Nos (Military or Veterans Sponsored, Not Otherwise Specified (NOS))
    CL Item
    Military Sponsored (including Champus & Tricare) (Military Sponsored (including CHAMPUS & TRICARE))
    CL Item
    No Means Of Payment (no Insurance) (No means of payment (no insurance))
    CL Item
    Other (Other)
    C17649 (NCI Thesaurus)
    C0205394 (UMLS 2011AA)
    CL Item
    Private Insurance (Private Insurance)
    CL Item
    Self Pay (no Insurance) (Self Pay (No Insurance))
    CL Item
    Unknown (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    CL Item
    Veterans Sponsored (Veterans Sponsored)
    AddressPostalCodeIdentifier
    Item
    ZIP Code
    text
    C25407 (NCI Thesaurus ObjectClass)
    C1442065 (UMLS 2011AA ObjectClass)
    C25621 (NCI Thesaurus Property)
    C1514254 (UMLS 2011AA Property)
    C25364 (NCI Thesaurus ValueDomain)
    C0600091 (UMLS 2011AA ValueDomain)
    C25407 (NCI Thesaurus ValueDomain)
    C1442065 (UMLS 2011AA ValueDomain)
    C25621 (NCI Thesaurus ValueDomain)
    C1514254 (UMLS 2011AA ValueDomain)
    Item Group
    Race
    Item
    Race
    text
    C25372 (NCI Thesaurus ValueDomain)
    C0683312 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C17049 (NCI Thesaurus Property)
    C0034510 (UMLS 2011AA Property)
    CL.3
    Code List
    Race
    CL Item
    A Person Having Origins In Any Of The Original Peoples Of North And South America (including Central America), And Who Maintains Tribal Affiliation Or Community Attachment. (American Indian or Alaska Native)
    C41259 (NCI Thesaurus)
    C1515945 (UMLS 2011AA)
    CL Item
    A Person Having Origins In Any Of The Original Peoples Of The Far East, Southeast Asia, Or The Indian Subcontinent Including, For Example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, The Philippine Islands, Thailand, And Vietnam. (Asian)
    C41260 (NCI Thesaurus)
    C0078988 (UMLS 2011AA)
    CL Item
    A Person Having Origins In Any Of The Black Racial Groups Of Africa. Terms Such As "haitian" Or "negro" Can Be Used In Addition To "black Or African American." (Black or African American)
    C16352 (NCI Thesaurus)
    C0085756 (UMLS 2011AA)
    CL Item
    A Person Having Origins In Any Of The Original Peoples Of Hawaii, Guam, Samoa, Or Other Pacific Islands. (Native Hawaiian or other Pacific Islander)
    C41219 (NCI Thesaurus)
    C1513907 (UMLS 2011AA)
    CL Item
    Not Provided Or Available (Not Reported)
    C43234 (NCI Thesaurus)
    C1706613 (UMLS 2011AA)
    CL Item
    Could Not Be Determined Or Unsure (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    CL Item
    A Person Having Origins In Any Of The Original Peoples Of Europe, The Middle East, Or North Africa. (White)
    C41261 (NCI Thesaurus)
    C0007457 (UMLS 2011AA)
    Item Group
    Physical Exam
    LesionAssessmentDate
    Item
    Date of Evaluation (yyyy - mmm - dd)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C3824 (NCI Thesaurus ObjectClass)
    C0221198 (UMLS 2011AA ObjectClass)
    C20989 (NCI Thesaurus Property)
    C0031809 (UMLS 2011AA Property)
    C25367 (NCI Thesaurus ValueDomain)
    Item
    Performance Status (check one)
    text
    C25664 (NCI Thesaurus ValueDomain)
    C0349674 (UMLS 2011AA ValueDomain)
    C25367 (NCI Thesaurus Property)
    C25491 (NCI Thesaurus ValueDomain)
    C1512162 (UMLS 2011AA ValueDomain)
    C20641 (NCI Thesaurus ObjectClass)
    C1518965 (UMLS 2011AA ObjectClass)
    CL.4
    Code List
    Performance Status (check one)
    CL Item
    Fully Active, Able To Carry On All Pre-disease Performance Without Restriction. (0)
    CL Item
    Restricted In Physically Strenuous Activity But Ambulatory And Able To Carry Out Work Of A Light Or Sedentary Nature, E.g., Light Housework, Office Work. (1)
    CL Item
    Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities. Up And About More Than 50% Of Waking Hours. (2)
    CL Item
    Capable Of Only Limited Selfcare, Confined To Bed Or Chair More Than 50% Of Waking Hours. (3)
    CL Item
    Completely Disabled. Cannot Carry On Any Selfcare. Totally Confined To Bed Or Chair. (4)
    Item Group
    Disease History
    FirstBiopsyPositiveDate
    Item
    Date of Initial Diagnosis of Primary Tumor (yyyy mmm dd date of initial pathologic diagnosis submit a copy of the pathology report with the Form 1)
    date
    C15189 (NCI Thesaurus ObjectClass)
    C0005558 (UMLS 2011AA ObjectClass)
    C25509 (NCI Thesaurus ObjectClass)
    C1279901 (UMLS 2011AA ObjectClass)
    C25246 (NCI Thesaurus Property)
    C1446409 (UMLS 2011AA Property)
    C25275 (NCI Thesaurus Property)
    C2745955 (UMLS 2011AA Property)
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25367 (NCI Thesaurus ValueDomain)
    Item
    Histologic Type
    text
    C3262 (NCI Thesaurus ObjectClass)
    C0027651 (UMLS 2011AA ObjectClass)
    C12410 (NCI Thesaurus ObjectClass)
    C0033572 (UMLS 2011AA ObjectClass)
    C25526 (NCI Thesaurus Property)
    C0205462 (UMLS 2011AA Property)
    C25161 (NCI Thesaurus Property)
    C0008902 (UMLS 2011AA Property)
    C25372 (NCI Thesaurus ValueDomain)
    C0683312 (UMLS 2011AA ValueDomain)
    C25526 (NCI Thesaurus ValueDomain)
    C0205462 (UMLS 2011AA ValueDomain)
    CL.5
    Code List
    Histologic Type
    CL Item
    Adenocarcinoma (Adenocarcinoma)
    C2852 (NCI Thesaurus)
    C0001418 (UMLS 2011AA)
    CL Item
    Other Specify (Other)
    TumorHistologicCategorySpecify
    Item
    Other specify
    text
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
    C3262 (NCI Thesaurus ObjectClass)
    C0027651 (UMLS 2011AA ObjectClass)
    C25526 (NCI Thesaurus Property)
    C0205462 (UMLS 2011AA Property)
    C25161 (NCI Thesaurus Property)
    C0008902 (UMLS 2011AA Property)
    SpecimenBaselineGleasonScoreDate
    Item
    Date Baseline Surgical Gleason Score Obtained (yyyy mmm dd)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25213 (NCI Thesaurus Property)
    C1442488 (UMLS 2011AA Property)
    C19157 (NCI Thesaurus ObjectClass)
    C0370003 (UMLS 2011AA ObjectClass)
    C28084 (NCI Thesaurus Property)
    C0332326 (UMLS 2011AA Property)
    Item
    Gleason Score Based on Specimen Type
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C19157 (NCI Thesaurus ObjectClass)
    C0370003 (UMLS 2011AA ObjectClass)
    C28084 (NCI Thesaurus ObjectClass)
    C0332326 (UMLS 2011AA ObjectClass)
    C25365 (NCI Thesaurus Property)
    C0678257 (UMLS 2011AA Property)
    CL.6
    Code List
    Gleason Score Based on Specimen Type
    CL Item
    Fine Needle Aspiration Biopsy (Fine Needle Aspirate)
    CL Item
    Biopsy (Biopsy)
    C15189 (NCI Thesaurus)
    C0005558 (UMLS 2011AA)
    C15189 (NCI Thesaurus)
    C0005558 (UMLS 2011AA)
    CL Item
    Surgical Specimen (Surgical specimen)
    GleasonScorePrimaryPatternValue
    Item
    Gleason Score, Primary Pattern (1-5)
    double
    C25251 (NCI Thesaurus Property)
    C0205225 (UMLS 2011AA Property)
    C28084 (NCI Thesaurus ObjectClass)
    C0332326 (UMLS 2011AA ObjectClass)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C25336 (NCI Thesaurus Property)
    C0449774 (UMLS 2011AA Property)
    GleasonScoreSecondaryPatternValue
    Item
    Gleason Score, Secondary Pattern (1-5)
    double
    C25667 (NCI Thesaurus Property)
    C0175668 (UMLS 2011AA Property)
    C28084 (NCI Thesaurus ObjectClass)
    C0332326 (UMLS 2011AA ObjectClass)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C25336 (NCI Thesaurus Property)
    C0449774 (UMLS 2011AA Property)
    GleasonScoreCombinedPatternValue
    Item
    Gleason Score, Combined (sum of the primary and secondary)
    double
    C25454 (NCI Thesaurus Property)
    C0205195 (UMLS 2011AA Property)
    C28084 (NCI Thesaurus ObjectClass)
    C0332326 (UMLS 2011AA ObjectClass)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    C25336 (NCI Thesaurus Property)
    C0449774 (UMLS 2011AA Property)
    Item
    Any tertiary elements of Gleason 4 or 5 pattern?
    text
    C25180 (NCI Thesaurus ValueDomain)
    C1522602 (UMLS 2011AA ValueDomain)
    C19157 (NCI Thesaurus ObjectClass)
    C0370003 (UMLS 2011AA ObjectClass)
    C28084 (NCI Thesaurus Property)
    C0332326 (UMLS 2011AA Property)
    CL.7
    Code List
    Any tertiary elements of Gleason 4 or 5 pattern?
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    Unknown (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    SpecimenGleasonScorePercentageValue
    Item
    Percent (%) (If yes,)
    double
    C25613 (NCI Thesaurus ValueDomain)
    C0439165 (UMLS 2011AA ValueDomain)
    C19157 (NCI Thesaurus ObjectClass)
    C0370003 (UMLS 2011AA ObjectClass)
    C28084 (NCI Thesaurus Property)
    C0332326 (UMLS 2011AA Property)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    Item
    Prostate intraepithelial neoplasia (PIN), High Grade
    text
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C19157 (NCI Thesaurus ObjectClass)
    C0370003 (UMLS 2011AA ObjectClass)
    C5541 (NCI Thesaurus Property)
    C1168327 (UMLS 2011AA Property)
    CL.8
    Code List
    Prostate intraepithelial neoplasia (PIN), High Grade
    CL Item
    No (NO)
    CL Item
    Yes (YES)
    Item
    Atypical small acinar proliferation (ASAP)
    text
    C12410 (NCI Thesaurus ObjectClass)
    C0033572 (UMLS 2011AA ObjectClass)
    C18189 (NCI Thesaurus ObjectClass)
    C0030664 (UMLS 2011AA ObjectClass)
    C15220 (NCI Thesaurus Property)
    C0011900 (UMLS 2011AA Property)
    C37268 (NCI Thesaurus Property)
    C1332353 (UMLS 2011AA Property)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    CL.9
    Code List
    Atypical small acinar proliferation (ASAP)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CoreBiopsyProstateGlandNeoplasmPerformedCount
    Item
    Total number cores (Left side)
    double
    C15680 (NCI Thesaurus ObjectClass)
    C1318309 (UMLS 2011AA ObjectClass)
    C3262 (NCI Thesaurus Property)
    C0027651 (UMLS 2011AA Property)
    C12410 (NCI Thesaurus Property)
    C0033572 (UMLS 2011AA Property)
    C38000 (NCI Thesaurus Property)
    C0884358 (UMLS 2011AA Property)
    C25463 (NCI Thesaurus ValueDomain)
    C0750480 (UMLS 2011AA ValueDomain)
    CoreBiopsyProstateGlandNeoplasmPerformedCount
    Item
    Total number cores (Left side)
    double
    C15680 (NCI Thesaurus ObjectClass)
    C1318309 (UMLS 2011AA ObjectClass)
    C3262 (NCI Thesaurus Property)
    C0027651 (UMLS 2011AA Property)
    C12410 (NCI Thesaurus Property)
    C0033572 (UMLS 2011AA Property)
    C38000 (NCI Thesaurus Property)
    C0884358 (UMLS 2011AA Property)
    C25463 (NCI Thesaurus ValueDomain)
    C0750480 (UMLS 2011AA ValueDomain)
    CoreBiopsyProstateGlandMalignantNeoplasmPerformedCount
    Item
    Number cores positive (Left side)
    double
    C15680 (NCI Thesaurus ObjectClass)
    C1318309 (UMLS 2011AA ObjectClass)
    C12410 (NCI Thesaurus Property)
    C0033572 (UMLS 2011AA Property)
    C38000 (NCI Thesaurus Property)
    C0884358 (UMLS 2011AA Property)
    C9305 (NCI Thesaurus Property)
    C0006826 (UMLS 2011AA Property)
    C25463 (NCI Thesaurus ValueDomain)
    C0750480 (UMLS 2011AA ValueDomain)
    CoreBiopsyProstateGlandMalignantNeoplasmPerformedCount
    Item
    Number cores positive (Left side)
    double
    C15680 (NCI Thesaurus ObjectClass)
    C1318309 (UMLS 2011AA ObjectClass)
    C12410 (NCI Thesaurus Property)
    C0033572 (UMLS 2011AA Property)
    C38000 (NCI Thesaurus Property)
    C0884358 (UMLS 2011AA Property)
    C9305 (NCI Thesaurus Property)
    C0006826 (UMLS 2011AA Property)
    C25463 (NCI Thesaurus ValueDomain)
    C0750480 (UMLS 2011AA ValueDomain)
    PositiveMalignantNeoplasmProstateSpecimenNumber
    Item
    Specimen/Core No. (CRF text recommended - CRF only shows Specimen/Core #1, 2, 3, 4)
    text
    C25246 (NCI Thesaurus ObjectClass)
    C1446409 (UMLS 2011AA ObjectClass)
    C9305 (NCI Thesaurus ObjectClass)
    C0006826 (UMLS 2011AA ObjectClass)
    C12410 (NCI Thesaurus Property)
    C0033572 (UMLS 2011AA Property)
    C19157 (NCI Thesaurus Property)
    C0370003 (UMLS 2011AA Property)
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    PositiveMalignantNeoplasmRightProstateSpecimenPercentageValue
    Item
    Percent involved Right side
    double
    C25246 (NCI Thesaurus ObjectClass)
    C1446409 (UMLS 2011AA ObjectClass)
    C9305 (NCI Thesaurus ObjectClass)
    C0006826 (UMLS 2011AA ObjectClass)
    C25228 (NCI Thesaurus Property)
    C0205090 (UMLS 2011AA Property)
    C12410 (NCI Thesaurus Property)
    C0033572 (UMLS 2011AA Property)
    C19157 (NCI Thesaurus Property)
    C0370003 (UMLS 2011AA Property)
    C25613 (NCI Thesaurus ValueDomain)
    C0439165 (UMLS 2011AA ValueDomain)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    PositiveMalignantNeoplasmLeftProstateSpecimenPercentageValue
    Item
    Percent involved Left side
    double
    C25246 (NCI Thesaurus ObjectClass)
    C1446409 (UMLS 2011AA ObjectClass)
    C9305 (NCI Thesaurus ObjectClass)
    C0006826 (UMLS 2011AA ObjectClass)
    C25229 (NCI Thesaurus Property)
    C0205091 (UMLS 2011AA Property)
    C12410 (NCI Thesaurus Property)
    C0033572 (UMLS 2011AA Property)
    C19157 (NCI Thesaurus Property)
    C0370003 (UMLS 2011AA Property)
    C25613 (NCI Thesaurus ValueDomain)
    C0439165 (UMLS 2011AA ValueDomain)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    Item
    T Stage, Clinical
    text
    C3262 (NCI Thesaurus ObjectClass)
    C0027651 (UMLS 2011AA ObjectClass)
    C12410 (NCI Thesaurus ObjectClass)
    C0033572 (UMLS 2011AA ObjectClass)
    C25398 (NCI Thesaurus Property)
    C0205210 (UMLS 2011AA Property)
    C25728 (NCI Thesaurus Property)
    C0475455 (UMLS 2011AA Property)
    C16899 (NCI Thesaurus ValueDomain)
    C1300072 (UMLS 2011AA ValueDomain)
    CL.10
    Code List
    T Stage, Clinical
    CL Item
    Tumor Incidental Histologic Finding In 5% Or Less Of Tissue Resected (T1a)
    CL Item
    Tumor Incidental Histologic Finding In More Than 5% Of Tissue Resected (T1b)
    CL Item
    Tumor Identified By Needle Biopsy (eg, Because Of Elevated Psa) (T1c)
    CL Item
    Tumor Involves One Lobe (T2a)
    CL Item
    Tumor Involves Both Lobes (T2b)
    CL Item
    Tumor Involves Both Lobes (T2c)
    Item Group
    Untitled/disease History (continued)
    TransrectalUltrasoundProstateAssessmentDate
    Item
    Date of Transrectal Ultrasound (yyyy mmm dd)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C20989 (NCI Thesaurus Property)
    C0031809 (UMLS 2011AA Property)
    C18315 (NCI Thesaurus ObjectClass)
    C0373345 (UMLS 2011AA ObjectClass)
    C12410 (NCI Thesaurus Property)
    C0033572 (UMLS 2011AA Property)
    TransrectalUltrasoundProstateAssessmentVolumeMeasurement
    Item
    Volume of gland/Prostate gland size (cubic centimetres)
    double
    C18315 (NCI Thesaurus ObjectClass)
    C0373345 (UMLS 2011AA ObjectClass)
    C20989 (NCI Thesaurus Property)
    C0031809 (UMLS 2011AA Property)
    C12410 (NCI Thesaurus Property)
    C0033572 (UMLS 2011AA Property)
    C25209 (NCI Thesaurus ValueDomain)
    C0242485 (UMLS 2011AA ValueDomain)
    C25335 (NCI Thesaurus ValueDomain)
    C0449468 (UMLS 2011AA ValueDomain)
    Item
    Hypoechoic area
    text
    C18315 (NCI Thesaurus ObjectClass)
    C0373345 (UMLS 2011AA ObjectClass)
    C12410 (NCI Thesaurus Property)
    C0033572 (UMLS 2011AA Property)
    C25244 (NCI Thesaurus Property)
    C0205146 (UMLS 2011AA Property)
    C0749762 (NCI Metathesaurus Property)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    CL.11
    Code List
    Hypoechoic area
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    TransrectalUltrasoundThickMidlineEchoProstateAreaMeasurement
    Item
    Size (cm) (If yes,)
    double
    C18315 (NCI Thesaurus ObjectClass)
    C0373345 (UMLS 2011AA ObjectClass)
    C12410 (NCI Thesaurus Property)
    C0033572 (UMLS 2011AA Property)
    C25244 (NCI Thesaurus Property)
    C0205146 (UMLS 2011AA Property)
    C0749762 (NCI Metathesaurus Property)
    C25209 (NCI Thesaurus ValueDomain)
    C0242485 (UMLS 2011AA ValueDomain)
    C25244 (NCI Thesaurus ValueDomain)
    C0205146 (UMLS 2011AA ValueDomain)
    PatientMedicalExaminationDate
    Item
    Date of exam (yyyy mmm dd)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25305 (NCI Thesaurus Property)
    C0582103 (UMLS 2011AA Property)
    Item
    Was the nodule palpable (at baseline)
    text
    C12410 (NCI Thesaurus ObjectClass)
    C0033572 (UMLS 2011AA ObjectClass)
    C9305 (NCI Thesaurus ObjectClass)
    C0006826 (UMLS 2011AA ObjectClass)
    C25606 (NCI Thesaurus Property)
    C0522499 (UMLS 2011AA Property)
    C3280 (NCI Thesaurus Property)
    C0028259 (UMLS 2011AA Property)
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    CL.12
    Code List
    Was the nodule palpable (at baseline)
    CL Item
    No (NO)
    CL Item
    Yes (YES)
    Item
    Nodule is (If yes, )
    text
    C12410 (NCI Thesaurus ObjectClass)
    C0033572 (UMLS 2011AA ObjectClass)
    C9305 (NCI Thesaurus ObjectClass)
    C0006826 (UMLS 2011AA ObjectClass)
    C25606 (NCI Thesaurus Property)
    C0522499 (UMLS 2011AA Property)
    C3280 (NCI Thesaurus Property)
    C0028259 (UMLS 2011AA Property)
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    CL.13
    Code List
    Nodule is (If yes, )
    CL Item
    Mildly Suspicious For Cancer (Mildly suspicious for prostate cancer)
    CL Item
    Moderately Suspicious For Cancer (Moderately suspicious for prostate cancer)
    CL Item
    Highly Suspicious For Cancer (Highly suspicious for prostate cancer)
    TumorMaximumDiameterMeasurement
    Item
    Maximum Diameter (cm)
    double
    C25209 (NCI Thesaurus ValueDomain)
    C0242485 (UMLS 2011AA ValueDomain)
    C25285 (NCI Thesaurus Property)
    C1301886 (UMLS 2011AA Property)
    C3262 (NCI Thesaurus ObjectClass)
    C0027651 (UMLS 2011AA ObjectClass)
    C25564 (NCI Thesaurus Property)
    C0806909 (UMLS 2011AA Property)
    BaselinePSADate
    Item
    Date of Baseline PSA (closest to randomization yyyy mmm dd)
    date
    C17525 (NCI Thesaurus ObjectClass)
    C0138741 (UMLS 2011AA ObjectClass)
    C25213 (NCI Thesaurus ObjectClass)
    C1442488 (UMLS 2011AA ObjectClass)
    C25275 (NCI Thesaurus Property)
    C2745955 (UMLS 2011AA Property)
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25367 (NCI Thesaurus ValueDomain)
    LaboratoryProcedureBaselineProstate-SpecificAntigenOutcomeValue
    Item
    Baseline PSA Value
    double
    C17525 (NCI Thesaurus Property)
    C0138741 (UMLS 2011AA Property)
    C25213 (NCI Thesaurus Property)
    C1442488 (UMLS 2011AA Property)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    LaboratoryProcedureBaselineProstate-SpecificAntigenPriorAntiandrogenTherapyOutcomeDate
    Item
    Date of PSA prior to androgen deprivation therapy (if applicable yyyy mmm dd)
    date
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C17525 (NCI Thesaurus Property)
    C0138741 (UMLS 2011AA Property)
    C25213 (NCI Thesaurus Property)
    C1442488 (UMLS 2011AA Property)
    C25629 (NCI Thesaurus Property)
    C0332152 (UMLS 2011AA Property)
    C15481 (NCI Thesaurus Property)
    C0279492 (UMLS 2011AA Property)
    CL025479 (NCI Metathesaurus Property)
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    LaboratoryProcedureBaselineProstate-SpecificAntigenPriorAntiandrogenTherapyOutcomeValue
    Item
    PSA Value prior to androgen deprivation therapy (if applicable)
    double
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C17525 (NCI Thesaurus Property)
    C0138741 (UMLS 2011AA Property)
    C25213 (NCI Thesaurus Property)
    C1442488 (UMLS 2011AA Property)
    C25629 (NCI Thesaurus Property)
    C0332152 (UMLS 2011AA Property)
    C15481 (NCI Thesaurus Property)
    C0279492 (UMLS 2011AA Property)
    CL025479 (NCI Metathesaurus Property)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    LaboratoryProcedureProstate-SpecificAntigenTumorMarkerResultValue
    Item
    PSA Value (total)
    double
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C17525 (NCI Thesaurus Property)
    C0138741 (UMLS 2011AA Property)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C17220 (NCI Thesaurus Property)
    C0041365 (UMLS 2011AA Property)
    C25712 (NCI Thesaurus ValueDomain)
    C1522609 (UMLS 2011AA ValueDomain)
    Item
    Units (* ng/ml, mg/L)
    text
    C20989 (NCI Thesaurus ObjectClass)
    C0031809 (UMLS 2011AA ObjectClass)
    C37984 (NCI Thesaurus Property)
    C0022877 (UMLS 2011AA Property)
    C25709 (NCI Thesaurus ValueDomain)
    C1519795 (UMLS 2011AA ValueDomain)
    CL.16
    Code List
    Units (* ng/ml, mg/L)
    CL Item
    Micrograms Per Liter (mcg/L)
    CL Item
    Nanograms Per Milliliter (ng/mL)
    Item
    Units (* ng/ml, mg/L)
    text
    C20989 (NCI Thesaurus ObjectClass)
    C0031809 (UMLS 2011AA ObjectClass)
    C37984 (NCI Thesaurus Property)
    C0022877 (UMLS 2011AA Property)
    C25709 (NCI Thesaurus ValueDomain)
    C1519795 (UMLS 2011AA ValueDomain)
    CL.16
    Code List
    Units (* ng/ml, mg/L)
    CL Item
    Micrograms Per Liter (mcg/L)
    CL Item
    Nanograms Per Milliliter (ng/mL)
    Item
    Units (* ng/ml, mg/L)
    text
    C20989 (NCI Thesaurus ObjectClass)
    C0031809 (UMLS 2011AA ObjectClass)
    C37984 (NCI Thesaurus Property)
    C0022877 (UMLS 2011AA Property)
    C25709 (NCI Thesaurus ValueDomain)
    C1519795 (UMLS 2011AA ValueDomain)
    CL.16
    Code List
    Units (* ng/ml, mg/L)
    CL Item
    Micrograms Per Liter (mcg/L)
    CL Item
    Nanograms Per Milliliter (ng/mL)
    LaboratoryProcedureProstate-SpecificAntigenTumorMarkerResultDate
    Item
    Date of PSA Assessment (yyyy mmm dd)
    date
    C25294 (NCI Thesaurus ObjectClass)
    C0022885 (UMLS 2011AA ObjectClass)
    C17525 (NCI Thesaurus Property)
    C0138741 (UMLS 2011AA Property)
    C20200 (NCI Thesaurus Property)
    C1274040 (UMLS 2011AA Property)
    C17220 (NCI Thesaurus Property)
    C0041365 (UMLS 2011AA Property)
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25367 (NCI Thesaurus ValueDomain)
    Item Group
    Therapy For Lower Urinary Tract Symptoms/prostate Cancer Prevention/prostate Cancer
    Item
    5 alpha-reductase inhibitor
    text
    C15445 (NCI Thesaurus ObjectClass)
    C0279025 (UMLS 2011AA ObjectClass)
    C25629 (NCI Thesaurus Property)
    C0332152 (UMLS 2011AA Property)
    C25382 (NCI Thesaurus Property)
    C1521801 (UMLS 2011AA Property)
    C2319 (NCI Thesaurus Property)
    C1318898 (UMLS 2011AA Property)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    CL.17
    Code List
    5 alpha-reductase inhibitor
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Non-protocolTherapy5Alpha-ReductaseInhibitorAdministeredReason
    Item
    Reason for use
    text
    C15368 (NCI Thesaurus ObjectClass)
    C25590 (NCI Thesaurus ObjectClass)
    C1518384 (UMLS 2011AA ObjectClass)
    C25382 (NCI Thesaurus Property)
    C1521801 (UMLS 2011AA Property)
    C2319 (NCI Thesaurus Property)
    C1318898 (UMLS 2011AA Property)
    C25638 (NCI Thesaurus ValueDomain)
    C0392360 (UMLS 2011AA ValueDomain)
    Non-protocolTherapy5Alpha-ReductaseInhibitorAdministeredText
    Item
    Agent (If yes,)
    text
    C15368 (NCI Thesaurus ObjectClass)
    C25590 (NCI Thesaurus ObjectClass)
    C1518384 (UMLS 2011AA ObjectClass)
    C25382 (NCI Thesaurus Property)
    C1521801 (UMLS 2011AA Property)
    C2319 (NCI Thesaurus Property)
    C1318898 (UMLS 2011AA Property)
    C25704 (NCI Thesaurus ValueDomain)
    C1527021 (UMLS 2011AA ValueDomain)
    Item
    Non-steroidal antiandrogen
    text
    C15368 (NCI Thesaurus ObjectClass)
    CL316360 (NCI Metathesaurus ObjectClass)
    C25629 (NCI Thesaurus Property)
    C0332152 (UMLS 2011AA Property)
    C25382 (NCI Thesaurus Property)
    C1521801 (UMLS 2011AA Property)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    CL.18
    Code List
    Non-steroidal antiandrogen
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Non-protocolTherapyNonsteroidalAntiandrogenAdministeredText
    Item
    Agent (If yes,)
    text
    C15368 (NCI Thesaurus ObjectClass)
    C25590 (NCI Thesaurus ObjectClass)
    C1518384 (UMLS 2011AA ObjectClass)
    C25382 (NCI Thesaurus Property)
    C1521801 (UMLS 2011AA Property)
    CL316360 (NCI Metathesaurus Property)
    C25704 (NCI Thesaurus ValueDomain)
    C1527021 (UMLS 2011AA ValueDomain)
    AgentBeginDate
    Item
    Date Agent Started (yyyy mmm dd)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25431 (NCI Thesaurus ValueDomain)
    C0439659 (UMLS 2011AA ValueDomain)
    C1708 (NCI Thesaurus ObjectClass)
    C0450442 (UMLS 2011AA ObjectClass)
    C25275 (NCI Thesaurus Property)
    C2745955 (UMLS 2011AA Property)
    AgentBeginDate
    Item
    Date Agent Started (yyyy mmm dd)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25431 (NCI Thesaurus ValueDomain)
    C0439659 (UMLS 2011AA ValueDomain)
    C1708 (NCI Thesaurus ObjectClass)
    C0450442 (UMLS 2011AA ObjectClass)
    C25275 (NCI Thesaurus Property)
    C2745955 (UMLS 2011AA Property)
    AgentBeginDate
    Item
    Date Agent Started (yyyy mmm dd)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25431 (NCI Thesaurus ValueDomain)
    C0439659 (UMLS 2011AA ValueDomain)
    C1708 (NCI Thesaurus ObjectClass)
    C0450442 (UMLS 2011AA ObjectClass)
    C25275 (NCI Thesaurus Property)
    C2745955 (UMLS 2011AA Property)
    AgentBeginDate
    Item
    Date Agent Started (yyyy mmm dd)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25431 (NCI Thesaurus ValueDomain)
    C0439659 (UMLS 2011AA ValueDomain)
    C1708 (NCI Thesaurus ObjectClass)
    C0450442 (UMLS 2011AA ObjectClass)
    C25275 (NCI Thesaurus Property)
    C2745955 (UMLS 2011AA Property)
    AgentEndDate
    Item
    Date Agent Ended (yyyy mmm dd)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C1708 (NCI Thesaurus ObjectClass)
    C0450442 (UMLS 2011AA ObjectClass)
    C25275 (NCI Thesaurus Property)
    C2745955 (UMLS 2011AA Property)
    AgentEndDate
    Item
    Date Agent Ended (yyyy mmm dd)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C1708 (NCI Thesaurus ObjectClass)
    C0450442 (UMLS 2011AA ObjectClass)
    C25275 (NCI Thesaurus Property)
    C2745955 (UMLS 2011AA Property)
    AgentEndDate
    Item
    Date Agent Ended (yyyy mmm dd)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C1708 (NCI Thesaurus ObjectClass)
    C0450442 (UMLS 2011AA ObjectClass)
    C25275 (NCI Thesaurus Property)
    C2745955 (UMLS 2011AA Property)
    AgentEndDate
    Item
    Date Agent Ended (yyyy mmm dd)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C1708 (NCI Thesaurus ObjectClass)
    C0450442 (UMLS 2011AA ObjectClass)
    C25275 (NCI Thesaurus Property)
    C2745955 (UMLS 2011AA Property)
    Item
    LHRH analogues
    text
    C15445 (NCI Thesaurus ObjectClass)
    C0279025 (UMLS 2011AA ObjectClass)
    C25590 (NCI Thesaurus Property)
    C1518384 (UMLS 2011AA Property)
    C25382 (NCI Thesaurus Property)
    C1521801 (UMLS 2011AA Property)
    C2022 (NCI Thesaurus Property)
    C1268900 (UMLS 2011AA Property)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    CL.19
    Code List
    LHRH analogues
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    HormoneTherapyNon-ProtocolGonadotropin-ReleasingHormoneAnalogAdministeredText
    Item
    Agent (If yes,)
    text
    C15445 (NCI Thesaurus ObjectClass)
    C0279025 (UMLS 2011AA ObjectClass)
    C25590 (NCI Thesaurus Property)
    C1518384 (UMLS 2011AA Property)
    C25382 (NCI Thesaurus Property)
    C1521801 (UMLS 2011AA Property)
    C2022 (NCI Thesaurus Property)
    C1268900 (UMLS 2011AA Property)
    C25704 (NCI Thesaurus ValueDomain)
    C1527021 (UMLS 2011AA ValueDomain)
    Item
    Prior Surgery (for prostate cancer other than biopsy or TURP?)
    text
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C38000 (NCI Thesaurus Property)
    C0884358 (UMLS 2011AA Property)
    C15329 (NCI Thesaurus ObjectClass)
    C0543467 (UMLS 2011AA ObjectClass)
    C25629 (NCI Thesaurus ObjectClass)
    C0332152 (UMLS 2011AA ObjectClass)
    CL.20
    Code List
    Prior Surgery (for prostate cancer other than biopsy or TURP?)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item
    Radiation Therapy (for prostate cancer?)
    text
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C15313 (NCI Thesaurus ObjectClass)
    C1522449 (UMLS 2011AA ObjectClass)
    C15368 (NCI Thesaurus Property)
    CL.21
    Code List
    Radiation Therapy (for prostate cancer?)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item
    Complementary and alternative medicines (*e.g. Saw palmetto, Vitamin B/E, Selenium, Lycopene)
    text
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C15368 (NCI Thesaurus ObjectClass)
    C15178 (NCI Thesaurus Property)
    C0002346 (UMLS 2011AA Property)
    C25382 (NCI Thesaurus Property)
    C1521801 (UMLS 2011AA Property)
    CL.22
    Code List
    Complementary and alternative medicines (*e.g. Saw palmetto, Vitamin B/E, Selenium, Lycopene)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    TherapyComplementaryandAlternativeMedicineAdministeredText
    Item
    Agent (If yes, )
    text
    C25704 (NCI Thesaurus ValueDomain)
    C1527021 (UMLS 2011AA ValueDomain)
    C15368 (NCI Thesaurus ObjectClass)
    C15178 (NCI Thesaurus Property)
    C0002346 (UMLS 2011AA Property)
    C25382 (NCI Thesaurus Property)
    C1521801 (UMLS 2011AA Property)
    Item Group
    Adverse Event Status
    Item
    Has the patient experienced any symptoms in the 14 days prior to randomization
    text
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C4876 (NCI Thesaurus Property)
    C1457887 (UMLS 2011AA Property)
    CL.23
    Code List
    Has the patient experienced any symptoms in the 14 days prior to randomization
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item
    CTC Adverse Event Term
    text
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C49704 (NCI Thesaurus Property)
    C1516728 (UMLS 2011AA Property)
    C45559 (NCI Thesaurus Property)
    C1705313 (UMLS 2011AA Property)
    C45255 (NCI Thesaurus ValueDomain)
    C1708523 (UMLS 2011AA ValueDomain)
    C49704 (NCI Thesaurus ValueDomain)
    C1516728 (UMLS 2011AA ValueDomain)
    C42614 (NCI Thesaurus ValueDomain)
    C0027365 (UMLS 2011AA ValueDomain)
    C45559 (NCI Thesaurus ValueDomain)
    C1705313 (UMLS 2011AA ValueDomain)
    C25714 (NCI Thesaurus ValueDomain)
    C0333052 (UMLS 2011AA ValueDomain)
    CL.24
    Code List
    CTC Adverse Event Term
    CL Item
    Fatigue (Fatigue)
    CL Item
    Constipation (Constipation)
    CL Item
    Urinary Frequency (Urinary frequency)
    CL Item
    Impotence (Erectile dysfunction)
    Item
    Grade (Worst this time period - Consult grade definitions in CTCAE version 4.0 handbook and enter appropriate code below. - If event not present, leave event grade field blank.)
    text
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C48309 (NCI Thesaurus Property)
    C0441800 (UMLS 2011AA Property)
    C49705 (NCI Thesaurus Property)
    C1710065 (UMLS 2011AA Property)
    C25676 (NCI Thesaurus Property)
    C0439793 (UMLS 2011AA Property)
    C41331 (NCI Thesaurus ValueDomain)
    C0877248 (UMLS 2011AA ValueDomain)
    C48309 (NCI Thesaurus ValueDomain)
    C0441800 (UMLS 2011AA ValueDomain)
    C25676 (NCI Thesaurus ValueDomain)
    C0439793 (UMLS 2011AA ValueDomain)
    CL.25
    Code List
    Grade (Worst this time period - Consult grade definitions in CTCAE version 4.0 handbook and enter appropriate code below. - If event not present, leave event grade field blank.)
    CL Item
    Absent Adverse Event (0)
    C75533 (NCI Thesaurus)
    C2699517 (UMLS 2011AA)
    CL Item
    Mild Adverse Event (1)
    C84263 (NCI Thesaurus)
    C1513302 (UMLS 2011AA)
    CL Item
    Moderate Adverse Event (2)
    C84264 (NCI Thesaurus)
    C1513374 (UMLS 2011AA)
    CL Item
    Severe Adverse Event (3)
    C84265 (NCI Thesaurus)
    C2919019 (UMLS 2011AA)
    CL Item
    Life Threatening Adverse Event (4)
    C84266 (NCI Thesaurus)
    C1517874 (UMLS 2011AA)
    CL Item
    Death Related To Adverse Event (5)
    C48275 (NCI Thesaurus)
    C1705232 (UMLS 2011AA)
    Item Group
    Other Major Medical Problems
    Item
    Have there been any major ongoing medical problems? (If yes, please enter details below:)
    text
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C18772 (NCI Thesaurus ObjectClass)
    C0262926 (UMLS 2011AA ObjectClass)
    C25213 (NCI Thesaurus Property)
    C1442488 (UMLS 2011AA Property)
    C28020 (NCI Thesaurus Property)
    C0033213 (UMLS 2011AA Property)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    CL.26
    Code List
    Have there been any major ongoing medical problems? (If yes, please enter details below:)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Disease/ConditionNameType
    Item
    Disease/Condition
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    CL308231 (NCI Metathesaurus ObjectClass)
    C42614 (NCI Thesaurus Property)
    C0027365 (UMLS 2011AA Property)
    Item Group
    Correlative Studies
    Item
    Did the patient agree to allow tissue from tumor to be collected for tumor banking?
    text
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25688 (NCI Thesaurus ValueDomain)
    C0449438 (UMLS 2011AA ValueDomain)
    C25460 (NCI Thesaurus Property)
    C1511481 (UMLS 2011AA Property)
    C0087095 (NCI Metathesaurus Property)
    CL.27
    Code List
    Did the patient agree to allow tissue from tumor to be collected for tumor banking?
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item
    Was tissue collected for tumor banking (If yes,)
    text
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C12801 (NCI Thesaurus ObjectClass)
    C0040300 (UMLS 2011AA ObjectClass)
    C19157 (NCI Thesaurus ObjectClass)
    C0370003 (UMLS 2011AA ObjectClass)
    C25452 (NCI Thesaurus Property)
    CL.28
    Code List
    Was tissue collected for tumor banking (If yes,)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    TissueSampleNotCollectedReasonText
    Item
    Reason
    text
    C19697 (NCI Thesaurus ObjectClass)
    C1292533 (UMLS 2011AA ObjectClass)
    C25594 (NCI Thesaurus Property)
    C1518422 (UMLS 2011AA Property)
    C25452 (NCI Thesaurus Property)
    C25704 (NCI Thesaurus ValueDomain)
    C1527021 (UMLS 2011AA ValueDomain)
    C25638 (NCI Thesaurus ValueDomain)
    C0392360 (UMLS 2011AA ValueDomain)
    Item Group
    Quality Of Life Questionnaire
    Item
    Was QoL Questionnaire completed?
    text
    C25180 (NCI Thesaurus ValueDomain)
    C1522602 (UMLS 2011AA ValueDomain)
    C17047 (NCI Thesaurus ObjectClass)
    C0518214 (UMLS 2011AA ObjectClass)
    C20989 (NCI Thesaurus Property)
    C0031809 (UMLS 2011AA Property)
    CL.29
    Code List
    Was QoL Questionnaire completed?
    CL Item
    Yes: C49488 (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    No: C49487 (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Not Applicable (Not Applicable)
    C48660 (NCI Thesaurus)
    C1272460 (UMLS 2011AA)
    QualityofLifeCompleteAssessmentDate
    Item
    Date Questionnaire Completed (yyyy mmm dd Please submit quality of life questionnaires)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C17047 (NCI Thesaurus ObjectClass)
    C0518214 (UMLS 2011AA ObjectClass)
    C25250 (NCI Thesaurus Property)
    C0205197 (UMLS 2011AA Property)
    C25367 (NCI Thesaurus Property)
    Item
    Reason Questionnaire was not Completed (check one)
    text
    C25638 (NCI Thesaurus ValueDomain)
    C0392360 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C0034394 (NCI Metathesaurus Property)
    CL.30
    Code List
    Reason Questionnaire was not Completed (check one)
    CL Item
    Questionnaire Not Completed Due To Institutional Error (Questionnaire not completed due to institutional error)
    CL Item
    Other Reason (Other reason)
    PatientIncompleteQuestionnaireOtherSpecify
    Item
    Other reason, specify
    text
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
    C17649 (NCI Thesaurus ValueDomain)
    C0205394 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C0034394 (NCI Metathesaurus Property)
    Item Group
    Planned Therapeutic Action
    Item
    Planned Therapeutic Action for this patient (*Radical therapy must begin within 90 days of the date of the randomization)
    text
    C15368 (NCI Thesaurus ObjectClass)
    C25619 (NCI Thesaurus Property)
    C1301732 (UMLS 2011AA Property)
    C25218 (NCI Thesaurus ValueDomain)
    C1948041 (UMLS 2011AA ValueDomain)
    CL.31
    Code List
    Planned Therapeutic Action for this patient (*Radical therapy must begin within 90 days of the date of the randomization)
    CL Item
    Radical Prostatectomy (Radical prostatectomy)
    C15399 (NCI Thesaurus)
    C0194810 (UMLS 2011AA)
    CL Item
    Radical Radiation Therapy (Radical radiation therapy)
    Item
    Radiation Therapy Type
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C15313 (NCI Thesaurus ObjectClass)
    C1522449 (UMLS 2011AA ObjectClass)
    C25218 (NCI Thesaurus Property)
    C1948041 (UMLS 2011AA Property)
    CL.32
    Code List
    Radiation Therapy Type
    CL Item
    External Beam Radiation Therapy (External beam)
    C15751 (NCI Thesaurus)
    C1517033 (UMLS 2011AA)
    CL Item
    Prostate Implant Brachytherapy (Permanent prostate brachytherapy)
    CL044586 (NCI Metathesaurus)
    CL Item
    High-dose Rate Brachytherapy (High dose rate temporary brachytherapy)
    C15651 (NCI Thesaurus)
    C0454270 (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)
    Item Group
    Supporting Documentation
    Item Group
    Investigator Signature
    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)
    ResponsiblePersonFirstName
    Item
    Person Completing Form, First 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)
    C25509 (NCI Thesaurus Property)
    C1279901 (UMLS 2011AA Property)
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    FormOriginalCompleteDate
    Item
    Date Form Originally Completed (yyyy - mmm - dd)
    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)
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