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6050

Description

NCIC MA.32 Baseline Report A Phase III Randomized Trial of Metformin vs Placebo in Early Stage Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=81E21D11-128C-1198-E040-BB89AD434372

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=81E21D11-128C-1198-E040-BB89AD434372

Keywords

  1. 8/27/12 8/27/12 -
  2. 8/11/14 8/11/14 - Martin Dugas
  3. 8/11/14 8/11/14 - Martin Dugas
  4. 8/11/14 8/11/14 - Martin Dugas
  5. 11/26/14 11/26/14 - Martin Dugas
  6. 1/9/15 1/9/15 - Martin Dugas
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November 26, 2014

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Creative Commons BY-NC 3.0 Legacy

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    Breast Cancer NCT01101438 Pre-Study - NCIC MA.32 Baseline Report - 3027459v1.0

    Aim - The aim of the Baseline Folder is to collect information about patient status at the time of randomization. Completion - The Baseline Report Folder must be completed within 6 weeks after randomization Timing of Investigations - The timing of protocol-required pre-treatment investigations covered by the Baseline Report is as follows: (Please note: Some protocol required pre-treatment investigations are collected on the Eligibility Checklist, so they are not repeated on this Report. Please refer to the protocol (section 6.0) for a complete list of required pre-treatment investigations.) ¿ Adverse Events (AEs) ¿ within 14 days before first treatment Note: Correlative Studies details will be reported in the separate correlative studies folder.

    Tobacco Smoking History - Baseline
    Description

    Tobacco Smoking History - Baseline

    Has the patient previously been a smoker?
    Description

    Smoking use

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS CUI-1
    C3241966
    NCI Thesaurus ObjectClass
    C17934
    NCI Thesaurus Property
    C25340
    Does the patient currently smoke
    Description

    Current Smoker

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS CUI-1
    C3241966
    NCI Thesaurus Property
    C25471
    NCI Thesaurus ObjectClass
    C17934
    NCI Metathesaurus Property
    C0449865
    Average number of cigarettes smoked per day
    Description

    Smoker amount smoked

    Data type

    double

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C1608325
    NCI Thesaurus ObjectClass
    C17934
    NCI Thesaurus Property
    C25340
    Date of quitting smoking
    Description

    SmokingDiscontinuedDate

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus Property
    C25484
    UMLS 2011AA Property
    C1444662
    NCI Thesaurus ObjectClass
    C17934
    UMLS 2011AA ObjectClass
    C0453996
    Smoking history
    Description

    CurrentSmokingHistoryType

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C25471
    UMLS 2011AA ObjectClass
    C0521116
    NCI Thesaurus ObjectClass
    C17934
    UMLS 2011AA ObjectClass
    C0453996
    NCI Thesaurus Property
    C18772
    UMLS 2011AA Property
    C0262926
    Date started smoking
    Description

    SmokingUseBeginDate

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ValueDomain
    C25431
    UMLS 2011AA ValueDomain
    C0439659
    NCI Thesaurus ObjectClass
    C17934
    UMLS 2011AA ObjectClass
    C0453996
    NCI Thesaurus Property
    C25340
    UMLS 2011AA Property
    C0457083
    Number of years smoked cigarettes
    Description

    CigarettesSmokingYearNumber

    Data type

    double

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus ObjectClass
    C1802
    UMLS 2011AA ObjectClass
    C0677453
    NCI Thesaurus ValueDomain
    C29848
    UMLS 2011AA ValueDomain
    C0439234
    NCI Thesaurus Property
    C17934
    UMLS 2011AA Property
    C0453996
    Average per day over lifetime of smoking
    Description

    CigaretteSmokingLifetimeUseAverageNumber

    Data type

    double

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus ObjectClass
    C18270
    UMLS 2011AA ObjectClass
    C0700219
    NCI Thesaurus Property
    C25340
    UMLS 2011AA Property
    C0457083
    NCI Thesaurus Property
    C19662
    UMLS 2011AA Property
    C1517878
    Number pack years smoked
    Description

    CigaretteSmokingHistoryPackYearAmount

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C17934
    UMLS 2011AA ObjectClass
    C0453996
    NCI Thesaurus Property
    C18772
    UMLS 2011AA Property
    C0262926
    NCI Thesaurus ValueDomain
    C25417
    Alcohol Consumption - Question
    Description

    Alcohol Consumption - Question

    Alcohol Use in the Past Year
    Description

    AlcoholConsumptionPastYearIndicator

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C2190
    UMLS 2011AA ObjectClass
    C0001962
    NCI Thesaurus Property
    C29848
    UMLS 2011AA Property
    C0439234
    NCI Thesaurus Property
    C25340
    UMLS 2011AA Property
    C0457083
    NCI Thesaurus Property
    C25609
    UMLS 2011AA Property
    C1444637
    NCI Thesaurus ValueDomain
    C25180
    UMLS 2011AA ValueDomain
    C1522602
    Average Alcohol Consumption
    Description

    AlcoholCurrentUseRangeType

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus Property
    C25471
    UMLS 2011AA Property
    C0521116
    NCI Thesaurus ObjectClass
    C2190
    UMLS 2011AA ObjectClass
    C0001962
    NCI Thesaurus Property
    C25340
    UMLS 2011AA Property
    C0457083
    Bilateral Breast Carcinoma - Question
    Description

    Bilateral Breast Carcinoma - Question

    Was this subject enrolled as having bilateral breast carcinoma
    Description

    BilateralBreastCarcinomaPatientClinicalTrialEnrollmentInd-2

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus ObjectClass
    C13332
    UMLS 2011AA ObjectClass
    C0238767
    NCI Thesaurus ObjectClass
    C4872
    UMLS 2011AA ObjectClass
    C0678222
    NCI Thesaurus Property
    C71104
    UMLS 2011AA Property
    C0008976
    NCI Thesaurus Property
    C37948
    UMLS 2011AA Property
    C1516879
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Bilateral Breast Carcinoma
    Description

    Bilateral Breast Carcinoma

    Pathologic T Stage
    Description

    BreastTumorPathologicTStage

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C3262
    UMLS 2011AA ObjectClass
    C0027651
    NCI Thesaurus ObjectClass
    C12971
    UMLS 2011AA ObjectClass
    C0006141
    NCI Thesaurus Property
    C25610
    UMLS 2011AA Property
    C1521733
    NCI Thesaurus Property
    C25728
    UMLS 2011AA Property
    C0475455
    NCI Thesaurus ValueDomain
    C16899
    UMLS 2011AA ValueDomain
    C1300072
    Pathologic N Stage
    Description

    BreastTumorPathologicNStage

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C3262
    UMLS 2011AA ObjectClass
    C0027651
    NCI Thesaurus ObjectClass
    C12971
    UMLS 2011AA ObjectClass
    C0006141
    NCI Thesaurus Property
    C25610
    UMLS 2011AA Property
    C1521733
    NCI Thesaurus Property
    C25580
    UMLS 2011AA Property
    C0456532
    NCI Thesaurus ValueDomain
    C16899
    UMLS 2011AA ValueDomain
    C1300072
    Pathologic M Stage
    Description

    BreastTumorPathologicMStage

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C3262
    UMLS 2011AA ObjectClass
    C0027651
    NCI Thesaurus ObjectClass
    C12971
    UMLS 2011AA ObjectClass
    C0006141
    NCI Thesaurus Property
    C25610
    UMLS 2011AA Property
    C1521733
    NCI Thesaurus Property
    C25727
    UMLS 2011AA Property
    C0456533
    NCI Thesaurus ValueDomain
    C16899
    UMLS 2011AA ValueDomain
    C1300072
    Was sentinel node sampling performed
    Description

    SentinelNodeBiopsyInd-3

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus Property
    C15189
    UMLS 2011AA Property
    C0005558
    NCI Thesaurus ObjectClass
    C12947
    UMLS 2011AA ObjectClass
    C1522495
    Sentinel Node Biopsy Date
    Description

    SentinelNodeBiopsyDate

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ValueDomain
    C25367
    NCI Thesaurus Property
    C15189
    UMLS 2011AA Property
    C0005558
    NCI Thesaurus ObjectClass
    C12947
    UMLS 2011AA ObjectClass
    C1522495
    Number of Sentinel Nodes Examined
    Description

    SentinelNodeExaminedCount

    Data type

    double

    Alias
    NCI Thesaurus Property
    C25500
    UMLS 2011AA Property
    C0332128
    NCI Thesaurus ValueDomain
    C25463
    UMLS 2011AA ValueDomain
    C0750480
    NCI Thesaurus ObjectClass
    C12947
    UMLS 2011AA ObjectClass
    C1522495
    Number of Positive Sentinel Nodes
    Description

    SentinelNodePositiveAssessmentCount

    Data type

    double

    Alias
    NCI Thesaurus Property
    C20989
    UMLS 2011AA Property
    C0031809
    NCI Metathesaurus Property
    C0205159
    NCI Thesaurus ValueDomain
    C25463
    UMLS 2011AA ValueDomain
    C0750480
    NCI Thesaurus ObjectClass
    C12947
    UMLS 2011AA ObjectClass
    C1522495
    Was axillary dissection performed?
    Description

    AxillaryNodeDissectionInd-3

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus Property
    C15227
    UMLS 2011AA Property
    C0012737
    NCI Thesaurus ObjectClass
    C12904
    UMLS 2011AA ObjectClass
    C0729594
    Date of Axillary Node Biopsy
    Description

    AxillaryLymphNodeCoreBiopsyFine-NeedleAspirationLymphNodeBiopsyPriorClinicalStudyPerformedDate

    Data type

    date

    Alias
    NCI Thesaurus ObjectClass
    C15680
    UMLS 2011AA ObjectClass
    C1318309
    NCI Thesaurus ObjectClass
    C15361
    UMLS 2011AA ObjectClass
    C1510483
    NCI Thesaurus ObjectClass
    C51900
    UMLS 2011AA ObjectClass
    C0193842
    NCI Thesaurus ObjectClass
    C12904
    UMLS 2011AA ObjectClass
    C0729594
    NCI Thesaurus Property
    C38000
    UMLS 2011AA Property
    C0884358
    NCI Thesaurus Property
    C25629
    UMLS 2011AA Property
    C0332152
    NCI Thesaurus Property
    C15206
    UMLS 2011AA Property
    C0008972
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    Number of axillary nodes examined
    Description

    AxillaryNodeExaminedTotalCount

    Data type

    double

    Alias
    NCI Thesaurus ValueDomain
    C25304
    UMLS 2011AA ValueDomain
    C0439810
    NCI Thesaurus Property
    C25500
    UMLS 2011AA Property
    C0332128
    NCI Thesaurus ValueDomain
    C25463
    UMLS 2011AA ValueDomain
    C0750480
    NCI Thesaurus ObjectClass
    C12904
    UMLS 2011AA ObjectClass
    C0729594
    Number of positive axillary nodes
    Description

    PositiveAxillaryNodeExaminedTotalCount

    Data type

    double

    Alias
    NCI Thesaurus ObjectClass
    C25246
    UMLS 2011AA ObjectClass
    C1446409
    NCI Thesaurus ObjectClass
    C12904
    UMLS 2011AA ObjectClass
    C0729594
    NCI Thesaurus Property
    C25500
    UMLS 2011AA Property
    C0332128
    NCI Thesaurus ValueDomain
    C25304
    UMLS 2011AA ValueDomain
    C0439810
    NCI Thesaurus ValueDomain
    C25463
    UMLS 2011AA ValueDomain
    C0750480
    Number of Lymph Nodes Examined
    Description

    LymphNodeExaminedCount

    Data type

    double

    Alias
    NCI Thesaurus Property
    C25500
    UMLS 2011AA Property
    C0332128
    NCI Thesaurus ObjectClass
    C12745
    UMLS 2011AA ObjectClass
    C0024204
    NCI Thesaurus ValueDomain
    C25463
    UMLS 2011AA ValueDomain
    C0750480
    Number of Positive Lymph Nodes
    Description

    LymphNodePositiveCount

    Data type

    double

    Alias
    NCI Thesaurus Property
    C25246
    UMLS 2011AA Property
    C1446409
    NCI Thesaurus ObjectClass
    C12745
    UMLS 2011AA ObjectClass
    C0024204
    NCI Thesaurus ValueDomain
    C25463
    UMLS 2011AA ValueDomain
    C0750480
    Baseline Adverse Events - Question
    Description

    Baseline Adverse Events - Question

    Did the participant report any symptoms or adverse events?
    Description

    SymptomorAdverseEventOccurrenceInd

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25180
    UMLS 2011AA ValueDomain
    C1522602
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Metathesaurus Property
    CL209504
    Baseline Advers Events
    Description

    Baseline Advers Events

    CTCAE Term
    Description

    AdverseEventCommonTerminologyforAdverseEventsVersion4TermName

    Data type

    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
    Description

    CommonToxicityCriteriaAdverseEventReportingGrade

    Data type

    double

    Alias
    NCI Thesaurus ObjectClass
    C49704
    UMLS 2011AA ObjectClass
    C1516728
    NCI Thesaurus Property
    C25651
    UMLS 2011AA Property
    C0700287
    NCI Thesaurus ValueDomain
    C18000
    UMLS 2011AA ValueDomain
    C0919553
    NCI Thesaurus Property
    C25365
    UMLS 2011AA Property
    C0678257
    AE Ongoing
    Description

    AdverseEventContinueIndicator

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25180
    UMLS 2011AA ValueDomain
    C1522602
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus Property
    C53279
    UMLS 2011AA Property
    C0549178
    Cardiovascular History - Question
    Description

    Cardiovascular History - Question

    Has the patient suffered cardiovascular disease?
    Description

    CardiovascularDiseasePresentInd-2

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus Property
    C25626
    UMLS 2011AA Property
    C0150312
    NCI Thesaurus ObjectClass
    C25292
    UMLS 2011AA ObjectClass
    C0007226
    NCI Thesaurus ObjectClass
    C2991
    UMLS 2011AA ObjectClass
    C0012634
    Cardiovascular History
    Description

    Cardiovascular History

    Problem, cardiovascular
    Description

    CardiacDiseaseAssessmentType

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus Property
    C20989
    UMLS 2011AA Property
    C0031809
    NCI Thesaurus ObjectClass
    C13306
    UMLS 2011AA ObjectClass
    C1522601
    NCI Thesaurus ObjectClass
    C2991
    UMLS 2011AA ObjectClass
    C0012634
    Specify
    Description

    CardiacDiseaseAssessmentSpecify

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS 2011AA ValueDomain
    C1521902
    NCI Thesaurus Property
    C20989
    UMLS 2011AA Property
    C0031809
    NCI Thesaurus ObjectClass
    C13306
    UMLS 2011AA ObjectClass
    C1522601
    NCI Thesaurus ObjectClass
    C2991
    UMLS 2011AA ObjectClass
    C0012634
    Baseline Concomitant Medications
    Description

    Baseline Concomitant Medications

    Did the participant report taking any concomitant medication
    Description

    ConcomitantMedicationUseInd-3

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ObjectClass
    C459
    UMLS 2011AA ObjectClass
    C0013227
    NCI Thesaurus ObjectClass
    C25730
    UMLS 2011AA ObjectClass
    C0521115
    NCI Thesaurus Property
    C25340
    UMLS 2011AA Property
    C0457083
    Concomitant Medication
    Description

    ConcomitantMedicationReceivedText

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS 2011AA ValueDomain
    C1527021
    NCI Thesaurus ObjectClass
    C459
    UMLS 2011AA ObjectClass
    C0013227
    NCI Thesaurus Property
    C25639
    UMLS 2011AA Property
    C1514756
    NCI Thesaurus ObjectClass
    C25730
    UMLS 2011AA ObjectClass
    C0521115
    Reason for Administration
    Description

    ConcomitantMedicationAdministeredReasonText

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C459
    UMLS 2011AA ObjectClass
    C0013227
    NCI Thesaurus ObjectClass
    C25730
    UMLS 2011AA ObjectClass
    C0521115
    NCI Thesaurus Property
    C25382
    UMLS 2011AA Property
    C1521801
    NCI Thesaurus ValueDomain
    C25704
    UMLS 2011AA ValueDomain
    C1527021
    NCI Thesaurus ValueDomain
    C25638
    UMLS 2011AA ValueDomain
    C0392360
    Is this medication continuing?
    Description

    Medication continued

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS CUI-1
    C0013227
    NCI Thesaurus ObjectClass
    C459
    UMLS CUI-2
    C0549178
    NCI Thesaurus Property
    C25409
    NCI Metathesaurus Property
    C0750536
    Adjuvant Radiation Therapy
    Description

    Adjuvant Radiation Therapy

    Has the patient received adjuvant RT
    Description

    AdjuvantRadiationTherapyAdministeredInd-3

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ObjectClass
    C15313
    UMLS 2011AA ObjectClass
    C1522449
    NCI Thesaurus ObjectClass
    C2140
    UMLS 2011AA ObjectClass
    C0001552
    NCI Thesaurus Property
    C25382
    UMLS 2011AA Property
    C1521801
    Date Adjuvant Radiation Therapy Started
    Description

    AdjuvantRadiationTherapyBeginDate

    Data type

    date

    Alias
    NCI Thesaurus ObjectClass
    C15313
    UMLS 2011AA ObjectClass
    C1522449
    NCI Thesaurus ObjectClass
    C2140
    UMLS 2011AA ObjectClass
    C0001552
    NCI Thesaurus Property
    C25431
    UMLS 2011AA Property
    C0439659
    NCI Thesaurus Property
    C25275
    UMLS 2011AA Property
    C2745955
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ValueDomain
    C25431
    UMLS 2011AA ValueDomain
    C0439659
    Date Adjuvant Radiation Therapy Ended
    Description

    AdjuvantRadiationTherapyEndDate

    Data type

    date

    Alias
    NCI Thesaurus ObjectClass
    C15313
    UMLS 2011AA ObjectClass
    C1522449
    NCI Thesaurus ObjectClass
    C2140
    UMLS 2011AA ObjectClass
    C0001552
    NCI Thesaurus Property
    C25275
    UMLS 2011AA Property
    C2745955
    NCI Thesaurus Property
    C25496
    UMLS 2011AA Property
    C2746065
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    Total Dose of Radiation Therapy (cGy)
    Description

    RTAdministeredTotalDose

    Data type

    double

    Alias
    NCI Thesaurus ValueDomain
    C25304
    UMLS 2011AA ValueDomain
    C0439810
    NCI Thesaurus ObjectClass
    C15313
    UMLS 2011AA ObjectClass
    C1522449
    NCI Thesaurus ValueDomain
    C25488
    UMLS 2011AA ValueDomain
    C0178602
    NCI Thesaurus Property
    C25382
    UMLS 2011AA Property
    C1521801
    Systemic Therapy
    Description

    Systemic Therapy

    Has the patient received systemic therapy?
    Description

    SystemicTherapyAdministeredInd-3

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ObjectClass
    C15698
    UMLS 2011AA ObjectClass
    C1515119
    NCI Thesaurus Property
    C25382
    UMLS 2011AA Property
    C1521801
    Agent Name
    Description

    AgentName

    Data type

    text

    Alias
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus ObjectClass
    C1708
    UMLS 2011AA ObjectClass
    C0450442
    NCI Thesaurus ValueDomain
    C1708
    UMLS 2011AA ValueDomain
    C0450442
    NCI Thesaurus ValueDomain
    C42614
    UMLS 2011AA ValueDomain
    C0027365
    Non-protocol Therapy Start Date
    Description

    Non-protocolTherapyAdministeredBeginDate

    Data type

    date

    Alias
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus ObjectClass
    C25590
    UMLS 2011AA ObjectClass
    C1518384
    NCI Thesaurus Property
    C25382
    UMLS 2011AA Property
    C1521801
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ValueDomain
    C25431
    UMLS 2011AA ValueDomain
    C0439659
    Continuing
    Description

    Non-ProtocolTherapyContinueInd-2

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus ObjectClass
    C25590
    UMLS 2011AA ObjectClass
    C1518384
    NCI Thesaurus Property
    C54064
    Non-protocol Therapy End Date
    Description

    Non-protocolTherapyAdministeredEndDate

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus ObjectClass
    C25590
    UMLS 2011AA ObjectClass
    C1518384
    NCI Thesaurus Property
    C25382
    UMLS 2011AA Property
    C1521801
    Therapy Intent
    Description

    TreatmentRegimenType

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus Property
    C15697
    UMLS 2011AA Property
    C0040808
    Specify
    Description

    TherapyRegimenSpecify

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS 2011AA ValueDomain
    C1521902
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus Property
    C15697
    UMLS 2011AA Property
    C0040808
    Major Medical Problems At Baseline
    Description

    Major Medical Problems At Baseline

    Concomitant Diseases and/or Relevant Medical Conditions
    Description

    PatientHistoryText

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS 2011AA ValueDomain
    C1527021
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C18772
    UMLS 2011AA Property
    C0262926
    Ongoing
    Description

    PatientMedicalHistoryBaselineProblemInd-2

    Data type

    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
    Ongoing
    Description

    PatientMedicalHistoryBaselineProblemInd-2

    Data type

    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
    Other Clinical Trial Participation
    Description

    Other Clinical Trial Participation

    Is the subject participating in another clinical trial of Breast Cancer treatment
    Description

    PatientBreastMalignantNeoplasmOtherClinicalTrialParticipantInd-2

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C17649
    UMLS 2011AA Property
    C0205394
    NCI Thesaurus Property
    C12971
    UMLS 2011AA Property
    C0006141
    NCI Thesaurus Property
    C9305
    UMLS 2011AA Property
    C0006826
    NCI Thesaurus Property
    C29867
    UMLS 2011AA Property
    C0679646
    NCI Thesaurus Property
    C71104
    UMLS 2011AA Property
    C0008976
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Clinical Trial Protocol ID
    Description

    ClinicalTrialProtocolIdentifier64CharacterText

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS 2011AA ValueDomain
    C1527021
    NCI Thesaurus ObjectClass
    C25320
    UMLS 2011AA ObjectClass
    C1507394
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus ValueDomain
    C45253
    UMLS 2011AA ValueDomain
    C1547402
    Clinical Trial Sponsor Name
    Description

    ClinicalTrialSponsorName64CharacterText

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C48355
    UMLS 2011AA ObjectClass
    C1711305
    NCI Thesaurus ObjectClass
    C71104
    UMLS 2011AA ObjectClass
    C0008976
    NCI Thesaurus Property
    C42614
    UMLS 2011AA Property
    C0027365
    NCI Thesaurus ValueDomain
    C25704
    UMLS 2011AA ValueDomain
    C1527021
    NCI Thesaurus ValueDomain
    C45253
    UMLS 2011AA ValueDomain
    C1547402
    Patient Entry Date
    Description

    PatientEnrollmentDate

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25171
    UMLS 2011AA Property
    C0013893

    Similar models

    Aim - The aim of the Baseline Folder is to collect information about patient status at the time of randomization. Completion - The Baseline Report Folder must be completed within 6 weeks after randomization Timing of Investigations - The timing of protocol-required pre-treatment investigations covered by the Baseline Report is as follows: (Please note: Some protocol required pre-treatment investigations are collected on the Eligibility Checklist, so they are not repeated on this Report. Please refer to the protocol (section 6.0) for a complete list of required pre-treatment investigations.) ¿ Adverse Events (AEs) ¿ within 14 days before first treatment Note: Correlative Studies details will be reported in the separate correlative studies folder.

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Tobacco Smoking History - Baseline
    Item
    Has the patient previously been a smoker?
    text
    C38148 (NCI Thesaurus ValueDomain)
    C3241966 (UMLS CUI-1)
    C17934 (NCI Thesaurus ObjectClass)
    C25340 (NCI Thesaurus Property)
    Code List
    Has the patient previously been a smoker?
    CL Item
    Yes (yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    No (no)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Unknown (unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    Item
    Does the patient currently smoke
    text
    C38148 (NCI Thesaurus ValueDomain)
    C3241966 (UMLS CUI-1)
    C25471 (NCI Thesaurus Property)
    C17934 (NCI Thesaurus ObjectClass)
    C0449865 (NCI Metathesaurus Property)
    Code List
    Does the patient currently smoke
    CL Item
    Yes (yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    No (no)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    Smoker amount smoked
    Item
    Average number of cigarettes smoked per day
    double
    C25337 (NCI Thesaurus ValueDomain)
    C1608325 (UMLS CUI-1)
    C17934 (NCI Thesaurus ObjectClass)
    C25340 (NCI Thesaurus Property)
    SmokingDiscontinuedDate
    Item
    Date of quitting smoking
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25484 (NCI Thesaurus Property)
    C1444662 (UMLS 2011AA Property)
    C17934 (NCI Thesaurus ObjectClass)
    C0453996 (UMLS 2011AA ObjectClass)
    Item
    Smoking history
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C25471 (NCI Thesaurus ObjectClass)
    C0521116 (UMLS 2011AA ObjectClass)
    C17934 (NCI Thesaurus ObjectClass)
    C0453996 (UMLS 2011AA ObjectClass)
    C18772 (NCI Thesaurus Property)
    C0262926 (UMLS 2011AA Property)
    Code List
    Smoking history
    CL Item
    Pipe Or Cigar Smoker Only (Pipe or cigar smoker only)
    CL Item
    100 Or Fewer Cigarettes During Lifetime (100 or fewer cigarettes during lifetime)
    CL Item
    Greater Than 100 Cigarettes During Lifetime (greater than 100 cigarettes during lifetime)
    SmokingUseBeginDate
    Item
    Date started smoking
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25431 (NCI Thesaurus ValueDomain)
    C0439659 (UMLS 2011AA ValueDomain)
    C17934 (NCI Thesaurus ObjectClass)
    C0453996 (UMLS 2011AA ObjectClass)
    C25340 (NCI Thesaurus Property)
    C0457083 (UMLS 2011AA Property)
    CigarettesSmokingYearNumber
    Item
    Number of years smoked cigarettes
    double
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C1802 (NCI Thesaurus ObjectClass)
    C0677453 (UMLS 2011AA ObjectClass)
    C29848 (NCI Thesaurus ValueDomain)
    C0439234 (UMLS 2011AA ValueDomain)
    C17934 (NCI Thesaurus Property)
    C0453996 (UMLS 2011AA Property)
    CigaretteSmokingLifetimeUseAverageNumber
    Item
    Average per day over lifetime of smoking
    double
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C18270 (NCI Thesaurus ObjectClass)
    C0700219 (UMLS 2011AA ObjectClass)
    C25340 (NCI Thesaurus Property)
    C0457083 (UMLS 2011AA Property)
    C19662 (NCI Thesaurus Property)
    C1517878 (UMLS 2011AA Property)
    CigaretteSmokingHistoryPackYearAmount
    Item
    Number pack years smoked
    text
    C17934 (NCI Thesaurus ObjectClass)
    C0453996 (UMLS 2011AA ObjectClass)
    C18772 (NCI Thesaurus Property)
    C0262926 (UMLS 2011AA Property)
    C25417 (NCI Thesaurus ValueDomain)
    Item Group
    Alcohol Consumption - Question
    Item
    Alcohol Use in the Past Year
    text
    C2190 (NCI Thesaurus ObjectClass)
    C0001962 (UMLS 2011AA ObjectClass)
    C29848 (NCI Thesaurus Property)
    C0439234 (UMLS 2011AA Property)
    C25340 (NCI Thesaurus Property)
    C0457083 (UMLS 2011AA Property)
    C25609 (NCI Thesaurus Property)
    C1444637 (UMLS 2011AA Property)
    C25180 (NCI Thesaurus ValueDomain)
    C1522602 (UMLS 2011AA ValueDomain)
    Code List
    Alcohol Use in the Past Year
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    Item
    Average Alcohol Consumption
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C25471 (NCI Thesaurus Property)
    C0521116 (UMLS 2011AA Property)
    C2190 (NCI Thesaurus ObjectClass)
    C0001962 (UMLS 2011AA ObjectClass)
    C25340 (NCI Thesaurus Property)
    C0457083 (UMLS 2011AA Property)
    Code List
    Average Alcohol Consumption
    CL Item
    Less Than 1 Drink Per Month (Less than 1 drink per month)
    CL Item
    1 To 5 Drinks Per Month (1 to 5 drinks per month)
    CL Item
    1 To 10 Drinks Per Week (1 to 10 drinks per week)
    CL Item
    11 To 30 Drinks Per Week (11 to 30 drinks per week)
    CL Item
    More Than 30 Drinks Per Week (More than 30 drinks per week)
    CL Item
    Unknown (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    Item Group
    Bilateral Breast Carcinoma - Question
    Item
    Was this subject enrolled as having bilateral breast carcinoma
    text
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C13332 (NCI Thesaurus ObjectClass)
    C0238767 (UMLS 2011AA ObjectClass)
    C4872 (NCI Thesaurus ObjectClass)
    C0678222 (UMLS 2011AA ObjectClass)
    C71104 (NCI Thesaurus Property)
    C0008976 (UMLS 2011AA Property)
    C37948 (NCI Thesaurus Property)
    C1516879 (UMLS 2011AA Property)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    Code List
    Was this subject enrolled as having bilateral breast carcinoma
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    Item Group
    Bilateral Breast Carcinoma
    Item
    Pathologic T Stage
    text
    C3262 (NCI Thesaurus ObjectClass)
    C0027651 (UMLS 2011AA ObjectClass)
    C12971 (NCI Thesaurus ObjectClass)
    C0006141 (UMLS 2011AA ObjectClass)
    C25610 (NCI Thesaurus Property)
    C1521733 (UMLS 2011AA Property)
    C25728 (NCI Thesaurus Property)
    C0475455 (UMLS 2011AA Property)
    C16899 (NCI Thesaurus ValueDomain)
    C1300072 (UMLS 2011AA ValueDomain)
    Code List
    Pathologic T Stage
    CL Item
    No Evidence Of Primary Tumor (T0)
    CL Item
    Tumor 2 Cm Or Less In Greatest Dimension (T1)
    CL Item
    Tumor More Than 0.1 Cm But Not More Than 0.5 Cm In Greatest Dimension (T1a)
    CL Item
    Tumor More Than 0.5 Cm But Not More Than 1 Cm In Greatest Dimension (T1b)
    CL Item
    Tumor More Than 1 Cm But Not More Than 2 Cm In Greatest Dimension (T1c)
    CL Item
    Microinvasion 0.1 Cm Or Less In Greatest Dimension (T1mic)
    CL Item
    Tumor More Than 2 Cm But Not More Than 5 Cm In Greatest Dimension (T2)
    CL Item
    Tumor More Than 5 Cm In Greatest Dimension (T3)
    CL Item
    Tumor Of Any Size With Direct (T4)
    CL Item
    Extension To Chest Wall (T4a)
    CL Item
    Edema (including Peau D'orange) Or Ulceration Of The Skin Of The Breast Or Satellite Skin Nodules Confined To The Same Breast (T4b)
    CL Item
    Both T4a And T4b (T4c)
    CL Item
    Inflammatory Carcinoma (T4d)
    C0334385 (NCI Metathesaurus)
    CL Item
    Carcinoma In Situ: Intraductal Carcinoma, Lobular Carcinoma In Situ, Or Paget's Disease Of The Nipple With No Tumor (Tis)
    CL Item
    Ductal Carcinoma In Situ (Tis (DCIS))
    CL Item
    Lobular Carcinoma In Situ (Tis (LCIS))
    CL Item
    Paget's Disease Of The Nipple With No Tumor. [note: Paget's Disease Associated With A Tumor Is Classified According To The Size Of The Tumor.] (Tis (Paget's))
    CL Item
    Primary Tumor Cannot Be Assessed (TX)
    Item
    Pathologic N Stage
    text
    C3262 (NCI Thesaurus ObjectClass)
    C0027651 (UMLS 2011AA ObjectClass)
    C12971 (NCI Thesaurus ObjectClass)
    C0006141 (UMLS 2011AA ObjectClass)
    C25610 (NCI Thesaurus Property)
    C1521733 (UMLS 2011AA Property)
    C25580 (NCI Thesaurus Property)
    C0456532 (UMLS 2011AA Property)
    C16899 (NCI Thesaurus ValueDomain)
    C1300072 (UMLS 2011AA ValueDomain)
    Code List
    Pathologic N Stage
    CL Item
    No Regional Lymph Node Metastasis Histologically, No Additional Examination For Isolated Tumor Cells (itc) (pN0)
    CL Item
    No Regional Lymph Node Metastasis Histologically, Positive Ihc, No Ihc Cluster >0.2 Mm (pN0(i+))
    CL Item
    No Regional Lymph Node Metastasis Histologically, Negative Ihc (pN0(i-))
    CL Item
    No Regionally Lymph Node Metastasis Histologically, Positive Molecular Findings (rt-pcr) (pN0(mol+))
    CL Item
    No Regional Lymph Node Metastasis Histologically, Negative Molecular Findings (rt-pcr) (pN0(mol-))
    CL Item
    Metastasis In 1 To 3 Axillary Lymph Nodes, And/or In Internal Mammary Nodes With Microscopic Disease Detected By Sln Dissection But Not Clinically Apparent (pN1)
    CL Item
    Metastasis In 1 To 3 Axillary Lymph Nodes (pN1a)
    CL Item
    Metastasis In Internal Mammary Nodes With Microscopic Disease Detected By Sln Dissection But Not Clinically Apparent (pN1b)
    CL Item
    Metastasis In 1 To 3 Axillary Lymph Nodes And In Internal Mammary Lymph Nodes With Microscopic Disease Detected By Sln Dissection But Not Clinically Apparent. (pN1c)
    CL Item
    Micrometastasis (>0.2 Mm But <=2.0 Mm) (pN1mi)
    CL Item
    Metastasis In 4 To 9 Axillary Lymph Nodes, Or In Clinically Apparent ** Internal Mammary Lymph Nodes In The Absence Of Axillary Lymph Node Metastasis To Ipsilateral Axillary Lymph Node(s) Fixed To Each Other Or To Other Structures (pN2)
    CL Item
    Metastasis In 4 To 9 Axillary Lymph Nodes (at Least 1 Tumor Deposit >2.0 Mm) (pN2a)
    CL Item
    Metastasis In Clinically Apparent* Internal Mammary Lymph Nodes In The Absence Of Axillary Lymph Node Metastasis (pN2b)
    CL Item
    Metastasis In >= Axillary Lymph Nodes, Or In Infraclavicular Lymph Nodes, Or In Clinically Apparent* Ipsilateral Internal Mammary Lymph Node(s) In The Presence Of 1 Or More Positive Axillary Lymph Node(s); Or, In >3 Axillary Lymph Nodes With Clinically N (pN3)
    CL Item
    Metastasis In >=10 Axillary Lymph Nodes (at Least 1 Tumor Deposit >2.0 Mm); Or, Metastasis To The Infraclavicular Lymph Nodes (pN3a)
    CL Item
    Metastasis In Clinically Apparent* Ipsilateral Internal Mammary Lymph Nodes In The Presence Of >=1 Positive Axillary Lymph Node(s); Or, In >3 Axillary Lymph Nodes And In Internal Mammary Lymph Nodes With Microscopic Disease Detected By Sentinel Lymph Node (pN3b)
    CL Item
    Metastasis In Ipsilateral Supraclavicular Lymph Nodes (pN3c)
    CL Item
    Regional Lymph Nodes Cannot Be Assessed (e.g., Not Removed For Pathologic Study Or Previously Removed) (pNX)
    Item
    Pathologic M Stage
    text
    C3262 (NCI Thesaurus ObjectClass)
    C0027651 (UMLS 2011AA ObjectClass)
    C12971 (NCI Thesaurus ObjectClass)
    C0006141 (UMLS 2011AA ObjectClass)
    C25610 (NCI Thesaurus Property)
    C1521733 (UMLS 2011AA Property)
    C25727 (NCI Thesaurus Property)
    C0456533 (UMLS 2011AA Property)
    C16899 (NCI Thesaurus ValueDomain)
    C1300072 (UMLS 2011AA ValueDomain)
    Code List
    Pathologic M Stage
    CL Item
    No Distant Metastasis (M0)
    CL Item
    Distant Metastasis (M1)
    C18206 (NCI Thesaurus)
    C1269798 (UMLS 2011AA)
    CL Item
    Distant Metastasis Cannot Be Assessed (MX)
    Item
    Was sentinel node sampling performed
    text
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C15189 (NCI Thesaurus Property)
    C0005558 (UMLS 2011AA Property)
    C12947 (NCI Thesaurus ObjectClass)
    C1522495 (UMLS 2011AA ObjectClass)
    Code List
    Was sentinel node sampling performed
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    SentinelNodeBiopsyDate
    Item
    Sentinel Node Biopsy Date
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25367 (NCI Thesaurus ValueDomain)
    C15189 (NCI Thesaurus Property)
    C0005558 (UMLS 2011AA Property)
    C12947 (NCI Thesaurus ObjectClass)
    C1522495 (UMLS 2011AA ObjectClass)
    SentinelNodeExaminedCount
    Item
    Number of Sentinel Nodes Examined
    double
    C25500 (NCI Thesaurus Property)
    C0332128 (UMLS 2011AA Property)
    C25463 (NCI Thesaurus ValueDomain)
    C0750480 (UMLS 2011AA ValueDomain)
    C12947 (NCI Thesaurus ObjectClass)
    C1522495 (UMLS 2011AA ObjectClass)
    SentinelNodePositiveAssessmentCount
    Item
    Number of Positive Sentinel Nodes
    double
    C20989 (NCI Thesaurus Property)
    C0031809 (UMLS 2011AA Property)
    C0205159 (NCI Metathesaurus Property)
    C25463 (NCI Thesaurus ValueDomain)
    C0750480 (UMLS 2011AA ValueDomain)
    C12947 (NCI Thesaurus ObjectClass)
    C1522495 (UMLS 2011AA ObjectClass)
    Item
    Was axillary dissection performed?
    text
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C15227 (NCI Thesaurus Property)
    C0012737 (UMLS 2011AA Property)
    C12904 (NCI Thesaurus ObjectClass)
    C0729594 (UMLS 2011AA ObjectClass)
    Code List
    Was axillary dissection performed?
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    AxillaryLymphNodeCoreBiopsyFine-NeedleAspirationLymphNodeBiopsyPriorClinicalStudyPerformedDate
    Item
    Date of Axillary Node Biopsy
    date
    C15680 (NCI Thesaurus ObjectClass)
    C1318309 (UMLS 2011AA ObjectClass)
    C15361 (NCI Thesaurus ObjectClass)
    C1510483 (UMLS 2011AA ObjectClass)
    C51900 (NCI Thesaurus ObjectClass)
    C0193842 (UMLS 2011AA ObjectClass)
    C12904 (NCI Thesaurus ObjectClass)
    C0729594 (UMLS 2011AA ObjectClass)
    C38000 (NCI Thesaurus Property)
    C0884358 (UMLS 2011AA Property)
    C25629 (NCI Thesaurus Property)
    C0332152 (UMLS 2011AA Property)
    C15206 (NCI Thesaurus Property)
    C0008972 (UMLS 2011AA Property)
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    AxillaryNodeExaminedTotalCount
    Item
    Number of axillary nodes examined
    double
    C25304 (NCI Thesaurus ValueDomain)
    C0439810 (UMLS 2011AA ValueDomain)
    C25500 (NCI Thesaurus Property)
    C0332128 (UMLS 2011AA Property)
    C25463 (NCI Thesaurus ValueDomain)
    C0750480 (UMLS 2011AA ValueDomain)
    C12904 (NCI Thesaurus ObjectClass)
    C0729594 (UMLS 2011AA ObjectClass)
    PositiveAxillaryNodeExaminedTotalCount
    Item
    Number of positive axillary nodes
    double
    C25246 (NCI Thesaurus ObjectClass)
    C1446409 (UMLS 2011AA ObjectClass)
    C12904 (NCI Thesaurus ObjectClass)
    C0729594 (UMLS 2011AA ObjectClass)
    C25500 (NCI Thesaurus Property)
    C0332128 (UMLS 2011AA Property)
    C25304 (NCI Thesaurus ValueDomain)
    C0439810 (UMLS 2011AA ValueDomain)
    C25463 (NCI Thesaurus ValueDomain)
    C0750480 (UMLS 2011AA ValueDomain)
    LymphNodeExaminedCount
    Item
    Number of Lymph Nodes Examined
    double
    C25500 (NCI Thesaurus Property)
    C0332128 (UMLS 2011AA Property)
    C12745 (NCI Thesaurus ObjectClass)
    C0024204 (UMLS 2011AA ObjectClass)
    C25463 (NCI Thesaurus ValueDomain)
    C0750480 (UMLS 2011AA ValueDomain)
    LymphNodePositiveCount
    Item
    Number of Positive Lymph Nodes
    double
    C25246 (NCI Thesaurus Property)
    C1446409 (UMLS 2011AA Property)
    C12745 (NCI Thesaurus ObjectClass)
    C0024204 (UMLS 2011AA ObjectClass)
    C25463 (NCI Thesaurus ValueDomain)
    C0750480 (UMLS 2011AA ValueDomain)
    Item Group
    Baseline Adverse Events - Question
    Item
    Did the participant report any symptoms or adverse events?
    text
    C25180 (NCI Thesaurus ValueDomain)
    C1522602 (UMLS 2011AA ValueDomain)
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    CL209504 (NCI Metathesaurus Property)
    Code List
    Did the participant report any symptoms or adverse events?
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    Item Group
    Baseline Advers Events
    AdverseEventCommonTerminologyforAdverseEventsVersion4TermName
    Item
    CTCAE 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)
    Item
    Grade
    double
    C49704 (NCI Thesaurus ObjectClass)
    C1516728 (UMLS 2011AA ObjectClass)
    C25651 (NCI Thesaurus Property)
    C0700287 (UMLS 2011AA Property)
    C18000 (NCI Thesaurus ValueDomain)
    C0919553 (UMLS 2011AA ValueDomain)
    C25365 (NCI Thesaurus Property)
    C0678257 (UMLS 2011AA Property)
    Code List
    Grade
    CL Item
    No Adverse Event Or Within Normal Limits (0)
    CL Item
    Mild Adverse Event (1)
    C41338 (NCI Thesaurus)
    C1513302 (UMLS 2011AA)
    CL Item
    Moderate Adverse Event (2)
    C41339 (NCI Thesaurus)
    C1513374 (UMLS 2011AA)
    CL Item
    Severe Adverse Event (3)
    C41340 (NCI Thesaurus)
    C1519275 (UMLS 2011AA)
    CL Item
    Life-threatening Or Disabling Adverse Event (4)
    CL Item
    Death Related To Adverse Event (5)
    C48275 (NCI Thesaurus)
    C1705232 (UMLS 2011AA)
    Item
    AE Ongoing
    text
    C25180 (NCI Thesaurus ValueDomain)
    C1522602 (UMLS 2011AA ValueDomain)
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C53279 (NCI Thesaurus Property)
    C0549178 (UMLS 2011AA Property)
    Code List
    AE Ongoing
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    Item Group
    Cardiovascular History - Question
    Item
    Has the patient suffered cardiovascular disease?
    text
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C25626 (NCI Thesaurus Property)
    C0150312 (UMLS 2011AA Property)
    C25292 (NCI Thesaurus ObjectClass)
    C0007226 (UMLS 2011AA ObjectClass)
    C2991 (NCI Thesaurus ObjectClass)
    C0012634 (UMLS 2011AA ObjectClass)
    Code List
    Has the patient suffered cardiovascular disease?
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item Group
    Cardiovascular History
    Item
    Problem, cardiovascular
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C20989 (NCI Thesaurus Property)
    C0031809 (UMLS 2011AA Property)
    C13306 (NCI Thesaurus ObjectClass)
    C1522601 (UMLS 2011AA ObjectClass)
    C2991 (NCI Thesaurus ObjectClass)
    C0012634 (UMLS 2011AA ObjectClass)
    Code List
    Problem, cardiovascular
    CL Item
    Myocardial Infarction (Myocardial Infarction)
    C27996 (NCI Thesaurus)
    C0027051 (UMLS 2011AA)
    CL Item
    Transient Ischemic Attack Cerebrovascular Accident (Stroke / transient inschemic attack TIA)
    C50781 (NCI Thesaurus)
    C0007787 (UMLS 2011AA)
    C3390 (NCI Thesaurus)
    C0038454 (UMLS 2011AA)
    CL Item
    New Or Worsening Angina (New or worsening angina)
    CL Item
    Angina Requiring Transluminal Coronary Angioplasty (Angina requiring transluminal coronary angioplasty)
    CL Item
    Angina Requiring Coronary Artery Bypass Graft (Angina requiring coronary artery bypass graft)
    CL Item
    Thromboembolism (Thromboembolic Event)
    C28195 (NCI Thesaurus)
    C0040038 (UMLS 2011AA)
    CL Item
    Other (Other)
    CardiacDiseaseAssessmentSpecify
    Item
    Specify
    text
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
    C20989 (NCI Thesaurus Property)
    C0031809 (UMLS 2011AA Property)
    C13306 (NCI Thesaurus ObjectClass)
    C1522601 (UMLS 2011AA ObjectClass)
    C2991 (NCI Thesaurus ObjectClass)
    C0012634 (UMLS 2011AA ObjectClass)
    Item Group
    Baseline Concomitant Medications
    Item
    Did the participant report taking any concomitant medication
    text
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C459 (NCI Thesaurus ObjectClass)
    C0013227 (UMLS 2011AA ObjectClass)
    C25730 (NCI Thesaurus ObjectClass)
    C0521115 (UMLS 2011AA ObjectClass)
    C25340 (NCI Thesaurus Property)
    C0457083 (UMLS 2011AA Property)
    Code List
    Did the participant report taking any concomitant medication
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    ConcomitantMedicationReceivedText
    Item
    Concomitant Medication
    text
    C25704 (NCI Thesaurus ValueDomain)
    C1527021 (UMLS 2011AA ValueDomain)
    C459 (NCI Thesaurus ObjectClass)
    C0013227 (UMLS 2011AA ObjectClass)
    C25639 (NCI Thesaurus Property)
    C1514756 (UMLS 2011AA Property)
    C25730 (NCI Thesaurus ObjectClass)
    C0521115 (UMLS 2011AA ObjectClass)
    ConcomitantMedicationAdministeredReasonText
    Item
    Reason for Administration
    text
    C459 (NCI Thesaurus ObjectClass)
    C0013227 (UMLS 2011AA ObjectClass)
    C25730 (NCI Thesaurus ObjectClass)
    C0521115 (UMLS 2011AA ObjectClass)
    C25382 (NCI Thesaurus Property)
    C1521801 (UMLS 2011AA Property)
    C25704 (NCI Thesaurus ValueDomain)
    C1527021 (UMLS 2011AA ValueDomain)
    C25638 (NCI Thesaurus ValueDomain)
    C0392360 (UMLS 2011AA ValueDomain)
    Item
    Is this medication continuing?
    text
    C38147 (NCI Thesaurus ValueDomain)
    C0013227 (UMLS CUI-1)
    C459 (NCI Thesaurus ObjectClass)
    C0549178 (UMLS CUI-2)
    C25409 (NCI Thesaurus Property)
    C0750536 (NCI Metathesaurus Property)
    Code List
    Is this medication continuing?
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item Group
    Adjuvant Radiation Therapy
    Item
    Has the patient received adjuvant RT
    text
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C15313 (NCI Thesaurus ObjectClass)
    C1522449 (UMLS 2011AA ObjectClass)
    C2140 (NCI Thesaurus ObjectClass)
    C0001552 (UMLS 2011AA ObjectClass)
    C25382 (NCI Thesaurus Property)
    C1521801 (UMLS 2011AA Property)
    Code List
    Has the patient received adjuvant RT
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    AdjuvantRadiationTherapyBeginDate
    Item
    Date Adjuvant Radiation Therapy Started
    date
    C15313 (NCI Thesaurus ObjectClass)
    C1522449 (UMLS 2011AA ObjectClass)
    C2140 (NCI Thesaurus ObjectClass)
    C0001552 (UMLS 2011AA ObjectClass)
    C25431 (NCI Thesaurus Property)
    C0439659 (UMLS 2011AA Property)
    C25275 (NCI Thesaurus Property)
    C2745955 (UMLS 2011AA Property)
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25431 (NCI Thesaurus ValueDomain)
    C0439659 (UMLS 2011AA ValueDomain)
    AdjuvantRadiationTherapyEndDate
    Item
    Date Adjuvant Radiation Therapy Ended
    date
    C15313 (NCI Thesaurus ObjectClass)
    C1522449 (UMLS 2011AA ObjectClass)
    C2140 (NCI Thesaurus ObjectClass)
    C0001552 (UMLS 2011AA ObjectClass)
    C25275 (NCI Thesaurus Property)
    C2745955 (UMLS 2011AA Property)
    C25496 (NCI Thesaurus Property)
    C2746065 (UMLS 2011AA Property)
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    RTAdministeredTotalDose
    Item
    Total Dose of Radiation Therapy (cGy)
    double
    C25304 (NCI Thesaurus ValueDomain)
    C0439810 (UMLS 2011AA ValueDomain)
    C15313 (NCI Thesaurus ObjectClass)
    C1522449 (UMLS 2011AA ObjectClass)
    C25488 (NCI Thesaurus ValueDomain)
    C0178602 (UMLS 2011AA ValueDomain)
    C25382 (NCI Thesaurus Property)
    C1521801 (UMLS 2011AA Property)
    Item Group
    Systemic Therapy
    Item
    Has the patient received systemic therapy?
    text
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C15698 (NCI Thesaurus ObjectClass)
    C1515119 (UMLS 2011AA ObjectClass)
    C25382 (NCI Thesaurus Property)
    C1521801 (UMLS 2011AA Property)
    Code List
    Has the patient received systemic therapy?
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Unknown (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    AgentName
    Item
    Agent Name
    text
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C1708 (NCI Thesaurus ObjectClass)
    C0450442 (UMLS 2011AA ObjectClass)
    C1708 (NCI Thesaurus ValueDomain)
    C0450442 (UMLS 2011AA ValueDomain)
    C42614 (NCI Thesaurus ValueDomain)
    C0027365 (UMLS 2011AA ValueDomain)
    Non-protocolTherapyAdministeredBeginDate
    Item
    Non-protocol Therapy Start Date
    date
    C15368 (NCI Thesaurus ObjectClass)
    C25590 (NCI Thesaurus ObjectClass)
    C1518384 (UMLS 2011AA ObjectClass)
    C25382 (NCI Thesaurus Property)
    C1521801 (UMLS 2011AA Property)
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25431 (NCI Thesaurus ValueDomain)
    C0439659 (UMLS 2011AA ValueDomain)
    Item
    Continuing
    text
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C15368 (NCI Thesaurus ObjectClass)
    C25590 (NCI Thesaurus ObjectClass)
    C1518384 (UMLS 2011AA ObjectClass)
    C54064 (NCI Thesaurus Property)
    Code List
    Continuing
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Non-protocolTherapyAdministeredEndDate
    Item
    Non-protocol Therapy End Date
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C15368 (NCI Thesaurus ObjectClass)
    C25590 (NCI Thesaurus ObjectClass)
    C1518384 (UMLS 2011AA ObjectClass)
    C25382 (NCI Thesaurus Property)
    C1521801 (UMLS 2011AA Property)
    Item
    Therapy Intent
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C15368 (NCI Thesaurus ObjectClass)
    C15697 (NCI Thesaurus Property)
    C0040808 (UMLS 2011AA Property)
    Code List
    Therapy Intent
    CL Item
    Adjuvant (Adjuvant)
    C25722 (NCI Thesaurus)
    C1522673 (UMLS 2011AA)
    CL Item
    Neoadjuvant Therapy (Neoadjuvant)
    C15665 (NCI Thesaurus)
    C0600558 (UMLS 2011AA)
    CL Item
    Advanced/recurrent/metastatic Disease (Advanced/recurrent/metastatic disease)
    CL Item
    Other Specify (Other)
    TherapyRegimenSpecify
    Item
    Specify
    text
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
    C15368 (NCI Thesaurus ObjectClass)
    C15697 (NCI Thesaurus Property)
    C0040808 (UMLS 2011AA Property)
    Item Group
    Major Medical Problems At Baseline
    PatientHistoryText
    Item
    Concomitant Diseases and/or Relevant Medical Conditions
    text
    C25704 (NCI Thesaurus ValueDomain)
    C1527021 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C18772 (NCI Thesaurus Property)
    C0262926 (UMLS 2011AA Property)
    Item
    Ongoing
    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)
    Code List
    Ongoing
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    Item
    Ongoing
    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)
    Code List
    Ongoing
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    Item Group
    Other Clinical Trial Participation
    Item
    Is the subject participating in another clinical trial of Breast Cancer treatment
    text
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C17649 (NCI Thesaurus Property)
    C0205394 (UMLS 2011AA Property)
    C12971 (NCI Thesaurus Property)
    C0006141 (UMLS 2011AA Property)
    C9305 (NCI Thesaurus Property)
    C0006826 (UMLS 2011AA Property)
    C29867 (NCI Thesaurus Property)
    C0679646 (UMLS 2011AA Property)
    C71104 (NCI Thesaurus Property)
    C0008976 (UMLS 2011AA Property)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    Code List
    Is the subject participating in another clinical trial of Breast Cancer treatment
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    ClinicalTrialProtocolIdentifier64CharacterText
    Item
    Clinical Trial Protocol ID
    text
    C25704 (NCI Thesaurus ValueDomain)
    C1527021 (UMLS 2011AA ValueDomain)
    C25320 (NCI Thesaurus ObjectClass)
    C1507394 (UMLS 2011AA ObjectClass)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C45253 (NCI Thesaurus ValueDomain)
    C1547402 (UMLS 2011AA ValueDomain)
    ClinicalTrialSponsorName64CharacterText
    Item
    Clinical Trial Sponsor Name
    text
    C48355 (NCI Thesaurus ObjectClass)
    C1711305 (UMLS 2011AA ObjectClass)
    C71104 (NCI Thesaurus ObjectClass)
    C0008976 (UMLS 2011AA ObjectClass)
    C42614 (NCI Thesaurus Property)
    C0027365 (UMLS 2011AA Property)
    C25704 (NCI Thesaurus ValueDomain)
    C1527021 (UMLS 2011AA ValueDomain)
    C45253 (NCI Thesaurus ValueDomain)
    C1547402 (UMLS 2011AA ValueDomain)
    PatientEnrollmentDate
    Item
    Patient Entry Date
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25171 (NCI Thesaurus Property)
    C0013893 (UMLS 2011AA Property)

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