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11842

Description

NCIC MA.32 Treatment Report Form 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=80FC65BF-C111-5459-E040-BB89AD430BEC

Lien

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=80FC65BF-C111-5459-E040-BB89AD430BEC

Mots-clés

  1. 08/08/2014 08/08/2014 - Martin Dugas
  2. 08/01/2015 08/01/2015 - Martin Dugas
  3. 09/01/2015 09/01/2015 - Martin Dugas
  4. 07/08/2015 07/08/2015 - Martin Dugas
  5. 20/09/2021 20/09/2021 -
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7 août 2015

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    Treatment Form Breast Cancer Early Stage NCIC MA.32 NCT01101438

    The purpose of the "Treatment Report" is to document drug administration, adverse events and response for one reporting period. For this study a reporting period is defined as one cycle (i.e. 1 cycle = 3 weeks or 21 days). Cycle length will be increased in cases where the start of the next cycle of treatment is delayed and will be decreased if the patient goes off protocol treatment before the end of the cycle. The "Treatment Report" should be completed within 2 weeks of the end of each reporting period.

    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-2
    C25582
    UMLS 2011AA Property-2
    C1513884
    Patient Initials (first-middle-last)
    Description

    Patient Initials

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C2986440
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25536
    Patient Hospital No. (if permitted by REB)
    Description

    Medical Record Number

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C1301894
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25261
    NCI Thesaurus Property-2
    C25198
    Investigator No.
    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-2
    C17089
    UMLS 2011AA ObjectClass-2
    C0035173
    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-2
    C25509
    UMLS 2011AA Property-2
    C1279901
    NCI Thesaurus ObjectClass
    C17089
    UMLS 2011AA ObjectClass
    C0035173
    Investigator Middle Name
    Description

    TreatingPhysicianMiddleName

    Type de données

    text

    Alias
    NCI Thesaurus ObjectClass
    C25741
    UMLS 2011AA ObjectClass
    C0031831
    NCI Thesaurus ObjectClass-2
    C25705
    UMLS 2011AA ObjectClass-2
    C1522326
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus Property-2
    C25569
    UMLS 2011AA Property-2
    C0444598
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    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-2
    C25551
    UMLS 2011AA Property-2
    C1517741
    Timing Of Report
    Description

    Timing Of Report

    Date
    Description

    Assessment Date

    Type de données

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C2985720
    NCI Thesaurus ObjectClass
    C25367
    NCI Thesaurus ValueDomain-2
    C25367
    NCI Thesaurus Property
    C38000
    On Treatment Reporting Period
    Description

    Cycle number

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS CUI-1
    C2045829
    NCI Thesaurus Property
    C25214
    NCI Thesaurus Property-2
    C25616
    NCI Thesaurus ObjectClass
    C15368
    Physical Exam
    Description

    Physical Exam

    Date of Physical Exam (yyyy-mmm-dd)
    Description

    PatientPhysicalExaminationDate

    Type de données

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C20989
    UMLS 2011AA Property
    C0031809
    Body weight
    Description

    Body weight

    Type de données

    float

    Unités de mesure
    • kg
    Alias
    NCI Thesaurus ValueDomain
    C25209
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25208
    UMLS CUI [1]
    C0005910
    kg
    Body Mass Index
    Description

    Body Mass Index

    Type de données

    float

    Unités de mesure
    • kg/m2
    Alias
    NCI Thesaurus ObjectClass
    C25190
    NCI Thesaurus ValueDomain
    C25712
    NCI Thesaurus Property
    C16358
    NCI Thesaurus ValueDomain-2
    C16358
    UMLS CUI [1]
    C1305855
    kg/m2
    Waist Circumference
    Description

    Waist Circumference

    Type de données

    float

    Unités de mesure
    • cm
    Alias
    NCI Thesaurus ValueDomain
    C25337
    NCI Thesaurus Property
    C25209
    NCI Metathesaurus ObjectClass
    C0332520
    NCI Thesaurus ObjectClass
    C64192
    UMLS CUI [1]
    C0455829
    cm
    Hip Circumference
    Description

    HipCircumferenceMeasurementNumbers3NoDecimal

    Type de données

    float

    Unités de mesure
    • cm
    Alias
    NCI Thesaurus ValueDomain
    C25337
    NCI Thesaurus Property
    C25209
    NCI Metathesaurus ObjectClass
    C0019552
    NCI Metathesaurus ObjectClass-2
    C0332520
    UMLS CUI [1]
    C0562350
    cm
    Systolic
    Description

    Systolic

    Type de données

    integer

    Unités de mesure
    • mmHg
    Alias
    NCI Thesaurus ValueDomain
    C25209
    NCI Thesaurus Property
    C25214
    NCI Thesaurus ObjectClass
    C25298
    UMLS CUI [1]
    C0871470
    mmHg
    Diastolic
    Description

    Diastolic

    Type de données

    integer

    Unités de mesure
    • mmHg
    Alias
    NCI Thesaurus ValueDomain
    C25209
    NCI Thesaurus Property
    C25214
    NCI Thesaurus ObjectClass
    C25299
    UMLS CUI [1]
    C0428883
    mmHg
    Disease Status
    Description

    Disease Status

    Alias
    UMLS CUI-1
    C0012634
    Status of Most Recent Clinical Assessment
    Description

    CancerFollow-UpMostRecentStatus

    Type de données

    text

    Alias
    NCI Thesaurus Property
    C16033
    UMLS 2011AA Property
    C1522577
    NCI Thesaurus ObjectClass
    C9305
    UMLS 2011AA ObjectClass
    C0006826
    NCI Thesaurus ValueDomain
    C25688
    UMLS 2011AA ValueDomain
    C0449438
    NCI Thesaurus ValueDomain-2
    C25577
    UMLS 2011AA ValueDomain-2
    C1513491
    In Situ Disease Follow-up
    Description

    In Situ Disease Follow-up

    Since the last report has there been a biopsy proven diagnosis of DCIS
    Description

    DuctalBreastCarcinomainSituHistologicallyConfirmedInd-2

    Type de données

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus Property
    C25458
    UMLS 2011AA Property
    C0750484
    NCI Thesaurus ObjectClass
    C2924
    UMLS 2011AA ObjectClass
    C0007124
    NCI Thesaurus Property-2
    C25527
    UMLS 2011AA Property-2
    C0205462
    Tumor Laterality
    Description

    Tumor Laterality

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    NCI Thesaurus ObjectClass
    C3262
    NCI Thesaurus ObjectClass-2
    C25251
    NCI Thesaurus Property
    C25185
    UMLS CUI [1,1]
    C0441987
    UMLS CUI [1,2]
    C0475445
    Date of radiologic detection of DCIS (If yes,)
    Description

    DuctalBreastCarcinomainSituHistologicallyRadiologicFindingConfirmedDate

    Type de données

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus Property
    C25458
    UMLS 2011AA Property
    C0750484
    NCI Thesaurus ObjectClass
    C2924
    UMLS 2011AA ObjectClass
    C0007124
    NCI Thesaurus Property-2
    C35869
    UMLS 2011AA Property-2
    C1290916
    Date of histologic DCIS diagnosis (If yes,)
    Description

    DuctalBreastCarcinomainSituHistologicallyConfirmedDate

    Type de données

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus Property
    C25458
    UMLS 2011AA Property
    C0750484
    NCI Thesaurus ObjectClass
    C2924
    UMLS 2011AA ObjectClass
    C0007124
    NCI Thesaurus Property-2
    C25527
    UMLS 2011AA Property-2
    C0205462
    Kit Return - Question
    Description

    Kit Return - Question

    Have any treatment kits been returned this reporting period
    Description

    TreatmentKitReturnInd-2

    Type de données

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus ObjectClass-2
    C42793
    UMLS 2011AA ObjectClass
    C0812225
    NCI Thesaurus Property
    C71900
    UMLS 2011AA Property
    C0332156
    Kit Return
    Description

    Kit Return

    Kit number
    Description

    BlindedProtocolAgentIdentifierNumber

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus ObjectClass
    C41161
    UMLS 2011AA ObjectClass
    C1521826
    NCI Thesaurus ObjectClass-2
    C49068
    UMLS 2011AA ObjectClass-2
    C0150108
    Number of pills returned
    Description

    PillsRemainingCount

    Type de données

    float

    Alias
    NCI Thesaurus ValueDomain
    C25463
    UMLS 2011AA ValueDomain
    C0750480
    NCI Thesaurus ObjectClass
    C25394
    UMLS 2011AA ObjectClass
    C0994475
    NCI Thesaurus Property
    C25649
    UMLS 2011AA Property
    C1527428
    Kit Dispension - Question
    Description

    Kit Dispension - Question

    Have any treatment kits been dispensed this reporting period
    Description

    TreatmentKitDispenseInd-2

    Type de données

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus ObjectClass-2
    C42793
    UMLS 2011AA ObjectClass
    C0812225
    NCI Thesaurus Property
    C64658
    UMLS 2011AA Property
    C1880359
    Kit Dispensation
    Description

    Kit Dispensation

    Date dispensed
    Description

    TreatmentKitDispenseDate

    Type de données

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus ObjectClass-2
    C42793
    UMLS 2011AA ObjectClass
    C0812225
    NCI Thesaurus Property
    C64658
    UMLS 2011AA Property
    C1880359
    Metformin/placebo Administration - Ramp-up
    Description

    Metformin/placebo Administration - Ramp-up

    Date of Initial Dose
    Description

    Treatment Start Date

    Type de données

    date

    Alias
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus Property
    C25509
    UMLS CUI-1
    C3173309
    NCI Thesaurus Property-2
    C25256
    NCI Thesaurus ValueDomain
    C25164
    NCI Thesaurus ValueDomain-2
    C25431
    Date subject scheduled to begin full dose
    Description

    TherapyFullDoseScheduleDate

    Type de données

    date

    Alias
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus Property
    C25488
    UMLS 2011AA Property
    C0178602
    NCI Thesaurus Property-2
    C25211
    UMLS 2011AA Property-2
    C0086960
    NCI Thesaurus Property-3
    C25517
    UMLS 2011AA Property-3
    C0443225
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    Date subject reports full dose begun
    Description

    TherapyFullDoseAdministrationDate

    Type de données

    date

    Alias
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus Property
    C25488
    UMLS 2011AA Property
    C0178602
    NCI Thesaurus Property-2
    C25409
    UMLS 2011AA Property-2
    C1533734
    NCI Thesaurus Property-3
    C25517
    UMLS 2011AA Property-3
    C0443225
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    Metformin/placebo Administration
    Description

    Metformin/placebo Administration

    Has subject taken protocol medication every day
    Description

    ClinicalStudyProtocolMedicationDailySelf-AdministeredInd-2

    Type de données

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C25320
    UMLS 2011AA ObjectClass
    C1507394
    NCI Thesaurus ObjectClass-2
    C459
    UMLS 2011AA ObjectClass-2
    C0013227
    NCI Thesaurus Property
    C25473
    UMLS 2011AA Property
    C0332173
    NCI Thesaurus Property-2
    C25670
    UMLS 2011AA Property-2
    C1519231
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    How many pills does the subject report having missed (If no,)
    Description

    PillsNegationTakenCount

    Type de données

    float

    Alias
    NCI Thesaurus Property
    C25594
    UMLS 2011AA Property
    C1518422
    NCI Thesaurus ValueDomain
    C25463
    UMLS 2011AA ValueDomain
    C0750480
    NCI Thesaurus ObjectClass
    C25394
    UMLS 2011AA ObjectClass
    C0994475
    NCI Thesaurus Property-2
    C25701
    UMLS 2011AA Property-2
    C1883727
    Dose Modification Reason (If no, please enter the reasons for dose modifications in the table below:)
    Description

    Dose Modification Reason

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25638
    UMLS CUI-1
    C1707811
    NCI Thesaurus ObjectClass
    C25488
    UMLS CUI-2
    C0392360
    NCI Thesaurus Property
    C25572
    Specify
    Description

    Dose Modification Reason, other

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS CUI-1
    C1707811
    NCI Thesaurus ObjectClass
    C25488
    UMLS CUI-2
    C3840932
    NCI Thesaurus Property
    C25572
    Was this dose modification or addition/omission as per protocol guidelines
    Description

    Dose Increased

    Type de données

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS CUI-1
    C1707810
    NCI Thesaurus ObjectClass
    C25488
    NCI Thesaurus Property
    C25572
    Radiology Investigations - Question
    Description

    Radiology Investigations - Question

    Was a mammogram performed
    Description

    MammogramPerformedInd-3b

    Type de données

    text

    Alias
    NCI Thesaurus ObjectClass
    C20178
    UMLS 2011AA ObjectClass
    C0024671
    NCI Thesaurus Property
    C38000
    UMLS 2011AA Property
    C0884358
    NCI Thesaurus ValueDomain
    C49797
    UMLS 2011AA ValueDomain
    C1708496
    Mammogram laterality
    Description

    MammogramPerformedAnatomicSite

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C13717
    UMLS 2011AA ValueDomain
    C1515974
    NCI Thesaurus ObjectClass
    C20178
    UMLS 2011AA ObjectClass
    C0024671
    NCI Thesaurus Property
    C38000
    UMLS 2011AA Property
    C0884358
    Specify side
    Description

    MammogramUnilateralPerformedAnatomicSite

    Type de données

    text

    Alias
    NCI Thesaurus ObjectClass
    C20178
    UMLS 2011AA ObjectClass
    C0024671
    NCI Thesaurus Property
    C28012
    UMLS 2011AA Property
    C0205092
    NCI Thesaurus Property-2
    C38000
    UMLS 2011AA Property-2
    C0884358
    NCI Thesaurus ValueDomain
    C13717
    UMLS 2011AA ValueDomain
    C1515974
    NCI Thesaurus ValueDomain-2
    C25306
    UMLS 2011AA ValueDomain-2
    C0441987
    Was imaging done to assess for recurrence (other than mammogram)
    Description

    DiagnosticImagingRecurrentDiseasePerformedInd-3

    Type de données

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ObjectClass
    C16502
    UMLS 2011AA ObjectClass
    C0011923
    NCI Thesaurus Property
    C38000
    UMLS 2011AA Property
    C0884358
    NCI Thesaurus Property-2
    C38155
    UMLS 2011AA Property-2
    C0277556
    Radiology Investigations
    Description

    Radiology Investigations

    Type of imaging
    Description

    ImagingMethodType

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus Property
    C16847
    UMLS 2011AA Property
    C0449851
    NCI Thesaurus ObjectClass
    C16502
    UMLS 2011AA ObjectClass
    C0011923
    Specify
    Description

    ImagingMethodSpecify

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS 2011AA ValueDomain
    C1521902
    NCI Thesaurus Property
    C16847
    UMLS 2011AA Property
    C0449851
    NCI Thesaurus ObjectClass
    C16502
    UMLS 2011AA ObjectClass
    C0011923
    Date of test
    Description

    DiagnosticImagingProcedureDate

    Type de données

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ValueDomain-2
    C25367
    NCI Thesaurus ObjectClass
    C16502
    UMLS 2011AA ObjectClass
    C0011923
    NCI Thesaurus Property
    C25218
    UMLS 2011AA Property
    C1948041
    Result
    Description

    AssessmentImageReportingType

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C20989
    UMLS 2011AA ObjectClass
    C0031809
    NCI Thesaurus ValueDomain-2
    C25651
    UMLS 2011AA ValueDomain-2
    C0700287
    NCI Thesaurus Property
    C19477
    UMLS 2011AA Property
    C1704254
    Hematology
    Description

    Hematology

    Lab, Hematology, Sample Collection Date
    Description

    HematologySpecimenCollectedDate

    Type de données

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C16673
    UMLS 2011AA ObjectClass
    C0018943
    NCI Thesaurus ObjectClass-2
    C19157
    UMLS 2011AA ObjectClass-2
    C0370003
    NCI Thesaurus Property
    C25452
    Date
    Description

    Laboratory Procedure Date

    Type de données

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C0022885
    NCI Thesaurus Property
    C25214
    UMLS CUI-2
    C0011008
    NCI Thesaurus Property-2
    C38000
    NCI Thesaurus ObjectClass
    C25294
    Was sample obtained
    Description

    BloodSpecimenCollectedInd-3

    Type de données

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ObjectClass
    C12434
    UMLS 2011AA ObjectClass
    C0229664
    NCI Thesaurus ObjectClass-2
    C19157
    UMLS 2011AA ObjectClass-2
    C0370003
    NCI Thesaurus Property
    C25452
    Hemoglobin
    Description

    Hemoglobin

    Type de données

    float

    Unités de mesure
    • g/dL
    Alias
    NCI Thesaurus Property
    C16676
    NCI Thesaurus Property-2
    C20200
    NCI Thesaurus ObjectClass
    C25294
    NCI Thesaurus ValueDomain
    C25712
    UMLS CUI [1]
    C0019046
    g/dL
    Hemoglobin LLN
    Description

    Hemoglobin LLN

    Type de données

    float

    Unités de mesure
    • g/dL
    Alias
    NCI Thesaurus ObjectClass
    C25294
    NCI Thesaurus Property
    C16676
    NCI Thesaurus Property-2
    C20200
    NCI Thesaurus ValueDomain
    C25712
    NCI Thesaurus ValueDomain-2
    C38024
    NCI Thesaurus ValueDomain-3
    C25555
    UMLS CUI [1,1]
    C0019046
    UMLS CUI [1,2]
    C1518030
    g/dL
    Hemoglobin ULN
    Description

    Hemoglobin ULN

    Type de données

    float

    Unités de mesure
    • g/dL
    Alias
    NCI Thesaurus ObjectClass
    C25294
    NCI Thesaurus Property
    C16676
    NCI Thesaurus Property-2
    C20200
    NCI Thesaurus ValueDomain
    C25712
    NCI Thesaurus ValueDomain-2
    C25706
    UMLS CUI [1,1]
    C0019046
    UMLS CUI [1,2]
    C1519815
    g/dL
    Peripheral Platelet Count
    Description

    Peripheral Platelet Count

    Type de données

    float

    Unités de mesure
    • 1000/uL
    Alias
    NCI Thesaurus ObjectClass
    C25294
    NCI Thesaurus Property
    C20200
    NCI Thesaurus Property-2
    C12520
    NCI Thesaurus ValueDomain
    C38046
    NCI Thesaurus ValueDomain-2
    C25712
    UMLS CUI [1]
    C0005821
    1000/uL
    Platelets LLN
    Description

    Platelets LLN

    Type de données

    float

    Unités de mesure
    • 1000/ul
    Alias
    NCI Thesaurus ObjectClass
    C25294
    NCI Thesaurus Property
    C20200
    NCI Thesaurus Property-2
    C12520
    NCI Thesaurus ValueDomain
    C25712
    NCI Thesaurus ValueDomain-2
    C25555
    UMLS CUI [1,1]
    C0005821
    UMLS CUI [1,2]
    C1518030
    1000/ul
    Platelets ULN
    Description

    Platelets ULN

    Type de données

    float

    Unités de mesure
    • 1000/ul
    Alias
    NCI Thesaurus ObjectClass
    C25294
    NCI Thesaurus Property
    C20200
    NCI Thesaurus Property-2
    C12520
    NCI Thesaurus ValueDomain
    C25712
    NCI Thesaurus ValueDomain-2
    C25706
    UMLS CUI [1,1]
    C0005821
    UMLS CUI [1,2]
    C1519815
    1000/ul
    WBC
    Description

    WBC

    Type de données

    float

    Unités de mesure
    • /ul
    Alias
    NCI Thesaurus ObjectClass
    C25294
    NCI Thesaurus Property
    C12529
    NCI Thesaurus Property-2
    C20200
    NCI Thesaurus ValueDomain
    C38046
    NCI Thesaurus ValueDomain-2
    C25712
    UMLS CUI [1]
    C0023508
    /ul
    WBC LLN
    Description

    WBC LLN

    Type de données

    float

    Unités de mesure
    • /ul
    Alias
    NCI Thesaurus ObjectClass
    C25294
    NCI Thesaurus Property
    C12529
    NCI Thesaurus Property-2
    C20200
    NCI Thesaurus ValueDomain
    C25712
    NCI Thesaurus ValueDomain-2
    C25555
    UMLS CUI [1,1]
    C0023508
    UMLS CUI [1,2]
    C1518030
    /ul
    WBC ULN
    Description

    WBC ULN

    Type de données

    float

    Unités de mesure
    • /ul
    Alias
    NCI Thesaurus ObjectClass
    C25294
    NCI Thesaurus Property
    C12529
    NCI Thesaurus Property-2
    C20200
    NCI Thesaurus ValueDomain
    C25712
    NCI Thesaurus ValueDomain-2
    C25706
    UMLS CUI [1,1]
    C0023508
    UMLS CUI [1,2]
    C1519815
    /ul
    Peripheral Granulocytes Count
    Description

    Granulocyte count

    Type de données

    float

    Unités de mesure
    • 1000/uL
    Alias
    NCI Thesaurus Property
    C20200
    UMLS CUI-1
    C0857490
    NCI Thesaurus Property-2
    C12530
    NCI Thesaurus ValueDomain
    C25463
    NCI Thesaurus ObjectClass
    C25294
    1000/uL
    Peripheral Granulocytes Count LLN
    Description

    Peripheral Granulocytes Count LLN

    Type de données

    float

    Unités de mesure
    • 1000/ul
    Alias
    NCI Thesaurus ObjectClass
    C25294
    NCI Thesaurus Property
    C20200
    NCI Thesaurus Property-2
    C12530
    NCI Thesaurus ValueDomain
    C25463
    NCI Thesaurus ValueDomain-2
    C25555
    UMLS CUI [1,1]
    C0857490
    UMLS CUI [1,2]
    C1518030
    1000/ul
    Peripheral Granulocytes Count ULN
    Description

    Peripheral Granulocytes Count ULN

    Type de données

    float

    Unités de mesure
    • 1000/ul
    Alias
    NCI Thesaurus ObjectClass
    C25294
    NCI Thesaurus Property
    C20200
    NCI Thesaurus Property-2
    C12530
    NCI Thesaurus ValueDomain
    C25463
    NCI Thesaurus ValueDomain-2
    C25706
    UMLS CUI [1,1]
    C0857490
    UMLS CUI [1,2]
    C1519815
    1000/ul
    Mean Corpuscular Volume
    Description

    Mean Corpuscular Volume

    Type de données

    float

    Unités de mesure
    • fl
    Alias
    NCI Thesaurus ObjectClass
    C16673
    NCI Thesaurus Property
    C37984
    NCI Thesaurus ValueDomain
    C25712
    NCI Thesaurus Property-2
    C64799
    UMLS CUI [1]
    C1948043
    fl
    Mean Corpuscular Volume LLN
    Description

    Mean Corpuscular Volume LLN

    Type de données

    float

    Unités de mesure
    • fl
    Alias
    NCI Thesaurus ObjectClass
    C25294
    NCI Thesaurus Property
    C20200
    NCI Thesaurus Property-2
    C64799
    NCI Thesaurus ValueDomain
    C25712
    NCI Thesaurus ValueDomain-2
    C25555
    UMLS CUI [1,1]
    C1948043
    UMLS CUI [1,2]
    C1518030
    fl
    Mean Corpuscular Volume ULN
    Description

    Mean Corpuscular Volume ULN

    Type de données

    float

    Unités de mesure
    • fl
    Alias
    NCI Thesaurus ObjectClass
    C25294
    NCI Thesaurus Property
    C20200
    NCI Thesaurus Property-2
    C64799
    NCI Thesaurus ValueDomain
    C25712
    NCI Thesaurus ValueDomain-2
    C25706
    UMLS CUI [1,1]
    C1948043
    UMLS CUI [1,2]
    C1519815
    fl
    Biochemistry
    Description

    Biochemistry

    Date Specimen collected (biochemical investigations)
    Description

    SpecimenCollectedDate

    Type de données

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C19157
    UMLS 2011AA ObjectClass
    C0370003
    NCI Thesaurus Property
    C25452
    NCI Thesaurus Property-2
    C25275
    UMLS 2011AA Property
    C2745955
    Was sample obtained
    Description

    SpecimenObtainInd-2

    Type de données

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus ObjectClass
    C19157
    UMLS 2011AA ObjectClass
    C0370003
    NCI Thesaurus Property
    C52349
    UMLS 2011AA Property
    C1301820
    Alkaline Phosphatase
    Description

    Alkaline Phosphatase

    Type de données

    float

    Unités de mesure
    • U/L
    Alias
    NCI Thesaurus Property
    C20200
    NCI Thesaurus ObjectClass
    C25294
    NCI Thesaurus ValueDomain
    C25712
    NCI Thesaurus Property-2
    C16276
    UMLS CUI [1]
    C0201850
    U/L
    Alkaline Phosphatase LLN
    Description

    Alkaline Phosphatase LLN

    Type de données

    float

    Unités de mesure
    • U/L
    Alias
    NCI Thesaurus ObjectClass
    C25294
    NCI Thesaurus Property
    C20200
    NCI Thesaurus Property-2
    C16276
    NCI Thesaurus ValueDomain
    C25712
    NCI Thesaurus ValueDomain-2
    C25555
    UMLS CUI [1,1]
    C0002059
    UMLS CUI [1,2]
    C1518030
    U/L
    Alkaline Phosphatase ULN
    Description

    Alkaline Phosphatase ULN

    Type de données

    float

    Unités de mesure
    • U/L
    Alias
    NCI Thesaurus ObjectClass
    C25294
    NCI Thesaurus Property
    C20200
    NCI Thesaurus Property-2
    C16276
    NCI Thesaurus ValueDomain
    C25712
    NCI Thesaurus ValueDomain-2
    C25706
    UMLS CUI [1,1]
    C0151420
    UMLS CUI [1,2]
    C1519815
    U/L
    ALT (SGPT)
    Description

    ALT (SGPT)

    Type de données

    float

    Unités de mesure
    • U/L
    Alias
    NCI Thesaurus ObjectClass
    C25294
    NCI Thesaurus Property
    C20200
    NCI Thesaurus Property-2
    C25293
    NCI Thesaurus ValueDomain
    C38046
    NCI Thesaurus ValueDomain-2
    C25712
    UMLS CUI [1]
    C0201836
    U/L
    ALT LLN
    Description

    ALT LLN

    Type de données

    float

    Unités de mesure
    • U/L
    Alias
    NCI Thesaurus ObjectClass
    C25294
    NCI Thesaurus Property
    C20200
    NCI Thesaurus Property-2
    C25293
    NCI Thesaurus ValueDomain
    C38046
    NCI Thesaurus ValueDomain-2
    C25712
    NCI Thesaurus ValueDomain-3
    C25555
    UMLS CUI [1,1]
    C0201836
    UMLS CUI [1,2]
    C1518030
    U/L
    ALT (SGPT) ULN
    Description

    ALT (SGPT) ULN

    Type de données

    float

    Unités de mesure
    • U/L
    Alias
    NCI Thesaurus ObjectClass
    C25294
    NCI Thesaurus Property
    C20200
    NCI Thesaurus Property-2
    C25293
    NCI Thesaurus ValueDomain
    C25712
    NCI Thesaurus ValueDomain-2
    C25706
    UMLS CUI [1,1]
    C0376147
    UMLS CUI [1,2]
    C1519815
    U/L
    AST (SGOT)
    Description

    AST (SGOT)

    Type de données

    float

    Unités de mesure
    • U/L
    Alias
    NCI Thesaurus ObjectClass
    C25294
    NCI Thesaurus Property
    C25202
    NCI Thesaurus Property-2
    C20200
    NCI Thesaurus ValueDomain
    C38046
    NCI Thesaurus ValueDomain-2
    C25712
    UMLS CUI [1]
    C0201899
    U/L
    AST LLN
    Description

    AST LLN

    Type de données

    float

    Unités de mesure
    • U/L
    Alias
    NCI Thesaurus ObjectClass
    C25294
    NCI Thesaurus Property
    C25202
    NCI Thesaurus Property-2
    C20200
    NCI Thesaurus ValueDomain
    C38046
    NCI Thesaurus ValueDomain-2
    C25712
    NCI Thesaurus ValueDomain-3
    C25555
    UMLS CUI [1,1]
    C0242192
    UMLS CUI [1,2]
    C1518030
    U/L
    AST (SGOT) ULN
    Description

    AST (SGOT) ULN

    Type de données

    float

    Unités de mesure
    • U/L
    Alias
    NCI Thesaurus ObjectClass
    C25294
    NCI Thesaurus Property
    C25202
    NCI Thesaurus Property-2
    C20200
    NCI Thesaurus ValueDomain
    C25712
    NCI Thesaurus ValueDomain-2
    C25706
    UMLS CUI [1,1]
    C0242192
    UMLS CUI [1,2]
    C1519815
    U/L
    Total Bilirubin
    Description

    Total Bilirubin

    Type de données

    float

    Unités de mesure
    • mg/dL
    Alias
    NCI Thesaurus ObjectClass
    C25294
    NCI Thesaurus Property
    C20200
    NCI Thesaurus Property-2
    C38037
    NCI Thesaurus ValueDomain
    C38046
    NCI Thesaurus ValueDomain-2
    C25712
    UMLS CUI [1]
    C0201913
    mg/dL
    Total bilirubin LLN
    Description

    Total bilirubin LLN

    Type de données

    float

    Unités de mesure
    • mg/dL
    Alias
    NCI Thesaurus ObjectClass
    C25294
    NCI Thesaurus Property
    C20200
    NCI Thesaurus Property-2
    C38037
    NCI Thesaurus ValueDomain
    C25555
    NCI Thesaurus ValueDomain-2
    C49100
    UMLS CUI [1,1]
    C0201913
    UMLS CUI [1,2]
    C1518030
    mg/dL
    Total bilirubin ULN
    Description

    Total bilirubin ULN

    Type de données

    float

    Unités de mesure
    • mg/dL
    Alias
    NCI Thesaurus ObjectClass
    C25294
    NCI Thesaurus Property
    C20200
    NCI Thesaurus Property-2
    C38037
    NCI Thesaurus ValueDomain
    C25712
    NCI Thesaurus ValueDomain-2
    C25706
    UMLS CUI [1,1]
    C0201913
    UMLS CUI [1,2]
    C1519815
    mg/dL
    Creatinine
    Description

    Creatinine

    Type de données

    float

    Unités de mesure
    • mg/dL
    Alias
    NCI Thesaurus ObjectClass
    C25294
    NCI Thesaurus Property
    C20200
    NCI Thesaurus Property-2
    C399
    NCI Thesaurus ValueDomain
    C38046
    NCI Thesaurus ValueDomain-2
    C25712
    UMLS CUI [1]
    C0201976
    mg/dL
    Creatinine LLN
    Description

    Creatinine LLN

    Type de données

    float

    Unités de mesure
    • mg/dL
    Alias
    NCI Thesaurus ObjectClass
    C25294
    NCI Thesaurus Property
    C20200
    NCI Thesaurus Property-2
    C399
    NCI Thesaurus ValueDomain
    C25712
    NCI Thesaurus ValueDomain-2
    C25555
    UMLS CUI [1,1]
    C0201976
    UMLS CUI [1,2]
    C1518030
    mg/dL
    Serum Creatinine ULN
    Description

    Creatinine, serum ULN

    Type de données

    float

    Unités de mesure
    • mg/dL
    Alias
    NCI Thesaurus ObjectClass
    C25294
    UMLS CUI-1
    C0201976
    NCI Thesaurus Property
    C20200
    UMLS CUI-2
    C1519815
    NCI Thesaurus Property-2
    C399
    NCI Thesaurus ValueDomain
    C25712
    NCI Thesaurus ValueDomain-2
    C25706
    mg/dL
    Serum Vitamin B12
    Description

    Vitamin B12

    Type de données

    float

    Unités de mesure
    • pg/ml
    Alias
    NCI Thesaurus Property
    C20200
    NCI Thesaurus ObjectClass
    C25294
    NCI Thesaurus ValueDomain
    C25712
    NCI Thesaurus Property-2
    C939
    UMLS CUI [1]
    C0202252
    pg/ml
    Serum Vitamin B12 LLN
    Description

    Serum Vitamin B12 LLN

    Type de données

    float

    Unités de mesure
    • pg/ml
    Alias
    NCI Thesaurus ObjectClass
    C25294
    NCI Thesaurus Property
    C20200
    NCI Thesaurus Property-2
    C939
    NCI Thesaurus ValueDomain
    C25712
    NCI Thesaurus ValueDomain-2
    C25555
    UMLS CUI [1,1]
    C0202252
    UMLS CUI [1,2]
    C1518030
    pg/ml
    Serum Vitamin B12 ULN
    Description

    Serum Vitamin B12 ULN

    Type de données

    float

    Unités de mesure
    • pg/ml
    Alias
    NCI Thesaurus ObjectClass
    C25294
    NCI Thesaurus Property
    C20200
    NCI Thesaurus Property-2
    C939
    NCI Thesaurus ValueDomain
    C25712
    NCI Thesaurus ValueDomain-2
    C25706
    UMLS CUI [1,1]
    C0202252
    UMLS CUI [1,2]
    C1519815
    pg/ml
    Fasting glucose
    Description

    Fasting glucose

    Type de données

    float

    Unités de mesure
    • mg/dL
    Alias
    NCI Thesaurus ObjectClass
    C25294
    NCI Thesaurus Property
    C20200
    NCI Thesaurus Property-2
    C41376
    NCI Thesaurus Property-3
    C63663
    NCI Thesaurus ValueDomain
    C25712
    UMLS CUI [1]
    C0202045
    mg/dL
    Fasting glucose, LLN
    Description

    Fasting glucose, LLN

    Type de données

    float

    Unités de mesure
    • mg/dL
    Alias
    NCI Thesaurus ObjectClass
    C25294
    NCI Thesaurus Property
    C20200
    NCI Thesaurus Property-2
    C41376
    NCI Thesaurus Property-3
    C63663
    NCI Thesaurus ValueDomain
    C25712
    NCI Thesaurus ValueDomain-2
    C25555
    UMLS CUI [1,1]
    C0202045
    UMLS CUI [1,2]
    C1518030
    mg/dL
    Fasting glucose, ULN
    Description

    Fasting glucose, ULN

    Type de données

    float

    Unités de mesure
    • mg/dL
    Alias
    NCI Thesaurus ObjectClass
    C25294
    NCI Thesaurus Property
    C20200
    NCI Thesaurus Property-2
    C41376
    NCI Thesaurus Property-3
    C63663
    NCI Thesaurus ValueDomain
    C25712
    NCI Thesaurus ValueDomain-2
    C25706
    UMLS CUI [1,1]
    C0202045
    UMLS CUI [1,2]
    C1519815
    mg/dL
    Serious Adverse Event - Question
    Description

    Serious Adverse Event - Question

    Did the patient experience a Serious Adverse Event, as defined in protocol section 11, during this reporting period
    Description

    Did the patient experience a Serious Adverse Event, as defined in protocol section 11, during this reporting period

    Type de données

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    NCI Thesaurus ObjectClass
    C41331
    NCI Thesaurus Property
    C25375
    NCI Thesaurus ObjectClass-2
    C54035
    UMLS CUI [1]
    C1519255
    Adverse Events On Treatment - Question
    Description

    Adverse Events On Treatment - Question

    Were any additional adverse events experienced by the patient
    Description

    OtherAdverseEventPresentIndicator

    Type de données

    text

    Alias
    NCI Thesaurus ObjectClass
    C17649
    NCI Thesaurus ValueDomain
    C25180
    NCI Thesaurus Property
    C25626
    NCI Thesaurus ObjectClass-2
    C41331
    UMLS CUI [1]
    C0877248
    Has a new primary cancer or MDS been diagnosed that has not been previously reported?
    Description

    NewCancerDiagnosisInd-3

    Type de données

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ObjectClass
    C25586
    UMLS 2011AA ObjectClass
    C0205314
    NCI Thesaurus ObjectClass-2
    C9305
    UMLS 2011AA ObjectClass-2
    C0006826
    NCI Thesaurus Property
    C15220
    UMLS 2011AA Property
    C0011900
    Has there been a new diagnosis of diabetes since the last report
    Description

    DiabetesMellitusNewInd-3

    Type de données

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus Property
    C25586
    UMLS 2011AA Property
    C0205314
    NCI Thesaurus ObjectClass
    C2985
    UMLS 2011AA ObjectClass
    C0011849
    NCI Thesaurus Property-2
    C15220
    UMLS 2011AA Property-2
    C0011900
    Adverse Events
    Description

    Adverse Events

    Would you like to carry forward the adverse events (indicated as continuing) from the previous reporting period
    Description

    AdverseEventContinueReportInd-2

    Type de données

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus Property
    C53279
    UMLS 2011AA Property
    C0549178
    NCI Thesaurus Property-2
    C25375
    UMLS 2011AA Property-2
    C0684224
    CTCAE 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-2
    C45559
    UMLS 2011AA Property-2
    C1705313
    NCI Thesaurus ValueDomain
    C45255
    UMLS 2011AA ValueDomain
    C1708523
    NCI Thesaurus ValueDomain-2
    C49704
    UMLS 2011AA ValueDomain-2
    C1516728
    NCI Thesaurus ValueDomain-3
    C42614
    UMLS 2011AA ValueDomain-3
    C0027365
    NCI Thesaurus ValueDomain-4
    C45559
    UMLS 2011AA ValueDomain-4
    C1705313
    NCI Thesaurus ValueDomain-5
    C25714
    UMLS 2011AA ValueDomain-5
    C0333052
    AE Ongoing
    Description

    AdverseEventContinueIndicator

    Type de données

    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
    Grade
    Description

    CommonToxicityCriteriaAdverseEventReportingGrade

    Type de données

    float

    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-2
    C25365
    UMLS 2011AA Property-2
    C0678257
    Seriousness Attributed to Adverse Event
    Description

    AdverseEventSeriousnessAttributionScale

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25664
    UMLS 2011AA ValueDomain
    C0349674
    NCI Thesaurus ObjectClass
    C41331
    UMLS 2011AA ObjectClass
    C0877248
    NCI Thesaurus Property
    C25358
    UMLS 2011AA Property
    C0596130
    Attribution
    Description

    CTC Adverse Event Attribution Category

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25664
    UMLS CUI-1
    C1706735
    NCI Thesaurus ObjectClass
    C49704
    NCI Thesaurus Property
    C25358
    Cardiovascular Morbidity - Question
    Description

    Cardiovascular Morbidity - Question

    Has there been a hospitalization for a cardiovascular event since the last report
    Description

    HospitalizationCardiovascularDisorderAttributionInd-2

    Type de données

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus ObjectClass
    C25179
    UMLS 2011AA ObjectClass
    C0019993
    NCI Thesaurus Property
    C2931
    UMLS 2011AA Property
    C0007222
    NCI Thesaurus Property-2
    C25358
    UMLS 2011AA Property-2
    C0596130
    Cardiovascular Mobidity
    Description

    Cardiovascular Mobidity

    Problem, cardiovascular
    Description

    CardiacDiseaseAssessmentType

    Type de données

    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-2
    C2991
    UMLS 2011AA ObjectClass-2
    C0012634
    Specify
    Description

    CardiacDiseaseAssessmentSpecify

    Type de données

    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-2
    C2991
    UMLS 2011AA ObjectClass-2
    C0012634
    Date of hospital admission
    Description

    HospitalAdmissionDate

    Type de données

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C16696
    UMLS 2011AA ObjectClass
    C0019994
    NCI Thesaurus Property
    C25385
    UMLS 2011AA Property
    C0809949
    Cancer Treatment Since Last Report ¿ Question
    Description

    Cancer Treatment Since Last Report ¿ Question

    Has patient received any new treatment for breast cancer since the last report
    Description

    BreastCarcinomaTherapyNewAdministeredInd-3

    Type de données

    text

    Alias
    NCI Thesaurus ObjectClass
    C4872
    UMLS 2011AA ObjectClass
    C0678222
    NCI Thesaurus ObjectClass-2
    C15368
    NCI Thesaurus Property
    C25586
    UMLS 2011AA Property
    C0205314
    NCI Thesaurus Property-2
    C25382
    UMLS 2011AA Property-2
    C1521801
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    Cancer Treatment Since Last Report
    Description

    Cancer Treatment Since Last Report

    Non-Protocol Therapy Type
    Description

    Non-ProtocolTherapyAdministeredType

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus ObjectClass-2
    C25590
    UMLS 2011AA ObjectClass
    C1518384
    NCI Thesaurus Property
    C25382
    UMLS 2011AA Property
    C1521801
    Specify
    Description

    Non-ProtocolTherapyAdministeredSpecify

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS 2011AA ValueDomain
    C1521902
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus ObjectClass-2
    C25590
    UMLS 2011AA ObjectClass
    C1518384
    NCI Thesaurus Property
    C25382
    UMLS 2011AA Property
    C1521801
    Name of Other Non-Protocol Therapy
    Description

    Non-protocolTherapyOtherAdministeredName

    Type de données

    text

    Alias
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus ObjectClass-2
    C25590
    UMLS 2011AA ObjectClass
    C1518384
    NCI Thesaurus Property
    C17649
    UMLS 2011AA Property
    C0205394
    NCI Thesaurus Property-2
    C25382
    UMLS 2011AA Property-2
    C1521801
    NCI Thesaurus ValueDomain
    C42614
    UMLS 2011AA ValueDomain
    C0027365
    Non protocol surgery
    Description

    Non-protocolSurgeryPerformedType

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus Property
    C38000
    UMLS 2011AA Property
    C0884358
    NCI Thesaurus ObjectClass
    C15329
    UMLS 2011AA ObjectClass
    C0543467
    NCI Thesaurus ObjectClass-2
    C25590
    UMLS 2011AA ObjectClass-2
    C1518384
    Non-protocol Therapy Start Date
    Description

    Non-protocolTherapyAdministeredBeginDate

    Type de données

    date

    Alias
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus ObjectClass-2
    C25590
    UMLS 2011AA ObjectClass
    C1518384
    NCI Thesaurus Property
    C25382
    UMLS 2011AA Property
    C1521801
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ValueDomain-2
    C25431
    UMLS 2011AA ValueDomain-2
    C0439659
    Major Medical Problems
    Description

    Major Medical Problems

    Concomitant Diseases and/or Relevant Medical Conditions
    Description

    PatientHistoryText

    Type de données

    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
    Quality Of Life Questionnaire
    Description

    Quality Of Life Questionnaire

    Was this subject one of the sub-set of subjects who completed questionnaires at baseline
    Description

    PatientQuestionnaireCompleteInd-2

    Type de données

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25250
    UMLS 2011AA Property
    C0205197
    NCI Thesaurus Property-2
    C17048
    UMLS 2011AA Property-2
    C0034394
    Date patient filled out questionnaire
    Description

    PatientQuestionnaireCompleteDate

    Type de données

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25250
    UMLS 2011AA Property
    C0205197
    NCI Thesaurus Property-2
    C17048
    UMLS 2011AA Property-2
    C0034394
    Questionnaire
    Description

    QuestionnaireRequestType

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C17048
    UMLS 2011AA ObjectClass
    C0034394
    NCI Thesaurus Property
    C48312
    UMLS 2011AA Property
    C1272683
    Done
    Description

    QuestionnaireRequestInd-2

    Type de données

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    NCI Thesaurus ObjectClass
    C17048
    UMLS 2011AA ObjectClass
    C0034394
    NCI Thesaurus Property
    C48312
    UMLS 2011AA Property
    C1272683
    Reason questionnaire was not completed
    Description

    PatientQuestionnaireCompleteNotAdministeredReason

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25638
    UMLS 2011AA ValueDomain
    C0392360
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C25250
    UMLS 2011AA Property
    C0205197
    NCI Thesaurus Property-2
    C17048
    UMLS 2011AA Property-2
    C0034394
    Specify
    Description

    Quality-of-LifeAssessmentOtherIncompleteSpecify

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS 2011AA ValueDomain
    C1521902
    NCI Thesaurus Property
    C17649
    UMLS 2011AA Property
    C0205394
    NCI Thesaurus Property-2
    C49160
    UMLS 2011AA Property-2
    C0205257
    NCI Thesaurus ObjectClass
    C15584
    UMLS 2011AA ObjectClass
    C0281588
    Comments
    Description

    Comments

    Comments
    Description

    Research Comments

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS CUI-1
    C0947611
    NCI Thesaurus ObjectClass
    C15319
    NCI Thesaurus Property
    C25393
    Contact Information
    Description

    Contact Information

    CRA Name
    Description

    CRAName

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus ObjectClass
    C25465
    UMLS 2011AA ObjectClass
    C1516627
    Phone number
    Description

    ClinicalResearchAssociatePersonTelephoneNumber

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus ObjectClass
    C25190
    UMLS 2011AA ObjectClass
    C0027361
    NCI Thesaurus Property
    C25395
    UMLS 2011AA Property
    C0039457
    NCI Thesaurus ObjectClass-2
    C25465
    UMLS 2011AA ObjectClass-2
    C1516627
    Fax Number
    Description

    ClinicalResearchAssociatePersonFaxNumber

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS 2011AA ValueDomain
    C0237753
    NCI Thesaurus ObjectClass
    C25190
    UMLS 2011AA ObjectClass
    C0027361
    NCI Thesaurus ObjectClass-2
    C25465
    UMLS 2011AA ObjectClass-2
    C1516627
    NCI Thesaurus Property
    C25210
    UMLS 2011AA Property
    C0085205
    Institution Name
    Description

    Institution Name

    Type de données

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C1301943
    NCI Thesaurus ObjectClass
    C21541
    NCI Thesaurus ValueDomain-2
    C21541
    NCI Thesaurus Property
    C25364

    Similar models

    The purpose of the "Treatment Report" is to document drug administration, adverse events and response for one reporting period. For this study a reporting period is defined as one cycle (i.e. 1 cycle = 3 weeks or 21 days). Cycle length will be increased in cases where the start of the next cycle of treatment is delayed and will be decreased if the patient goes off protocol treatment before the end of the cycle. The "Treatment Report" should be completed within 2 weeks of the end of each reporting period.

    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-2)
    C1513884 (UMLS 2011AA Property-2)
    Patient Initials
    Item
    Patient Initials (first-middle-last)
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2986440 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25536 (NCI Thesaurus Property)
    Medical Record Number
    Item
    Patient Hospital No. (if permitted by REB)
    text
    C25337 (NCI Thesaurus ValueDomain)
    C1301894 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25261 (NCI Thesaurus Property)
    C25198 (NCI Thesaurus Property-2)
    PhysicianInvestigatorIdentifierNumber
    Item
    Investigator No.
    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-2)
    C0035173 (UMLS 2011AA ObjectClass-2)
    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-2)
    C1279901 (UMLS 2011AA Property-2)
    C17089 (NCI Thesaurus ObjectClass)
    C0035173 (UMLS 2011AA ObjectClass)
    TreatingPhysicianMiddleName
    Item
    Investigator Middle Name
    text
    C25741 (NCI Thesaurus ObjectClass)
    C0031831 (UMLS 2011AA ObjectClass)
    C25705 (NCI Thesaurus ObjectClass-2)
    C1522326 (UMLS 2011AA ObjectClass-2)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C25569 (NCI Thesaurus Property-2)
    C0444598 (UMLS 2011AA Property-2)
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    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-2)
    C1517741 (UMLS 2011AA Property-2)
    Item Group
    Timing Of Report
    Assessment Date
    Item
    Date
    date
    C25164 (NCI Thesaurus ValueDomain)
    C2985720 (UMLS CUI-1)
    C25367 (NCI Thesaurus ObjectClass)
    C25367 (NCI Thesaurus ValueDomain-2)
    C38000 (NCI Thesaurus Property)
    Item
    On Treatment Reporting Period
    text
    C25284 (NCI Thesaurus ValueDomain)
    C2045829 (UMLS CUI-1)
    C25214 (NCI Thesaurus Property)
    C25616 (NCI Thesaurus Property-2)
    C15368 (NCI Thesaurus ObjectClass)
    Code List
    On Treatment Reporting Period
    CL Item
    6 Months (6 months)
    CL Item
    12 Months (12 months)
    CL Item
    24 Months (24 months)
    CL Item
    36 Months (36 months)
    CL Item
    48 Months (48 months)
    Item Group
    Physical Exam
    PatientPhysicalExaminationDate
    Item
    Date of Physical Exam (yyyy-mmm-dd)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C20989 (NCI Thesaurus Property)
    C0031809 (UMLS 2011AA Property)
    Weight
    Item
    Body weight
    float
    C25209 (NCI Thesaurus ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C25208 (NCI Thesaurus Property)
    C0005910 (UMLS CUI [1])
    BMI
    Item
    Body Mass Index
    float
    C25190 (NCI Thesaurus ObjectClass)
    C25712 (NCI Thesaurus ValueDomain)
    C16358 (NCI Thesaurus Property)
    C16358 (NCI Thesaurus ValueDomain-2)
    C1305855 (UMLS CUI [1])
    Waist Circumference
    Item
    Waist Circumference
    float
    C25337 (NCI Thesaurus ValueDomain)
    C25209 (NCI Thesaurus Property)
    C0332520 (NCI Metathesaurus ObjectClass)
    C64192 (NCI Thesaurus ObjectClass)
    C0455829 (UMLS CUI [1])
    Hip Circumference
    Item
    Hip Circumference
    float
    C25337 (NCI Thesaurus ValueDomain)
    C25209 (NCI Thesaurus Property)
    C0019552 (NCI Metathesaurus ObjectClass)
    C0332520 (NCI Metathesaurus ObjectClass-2)
    C0562350 (UMLS CUI [1])
    Systolic blood pressure
    Item
    Systolic
    integer
    C25209 (NCI Thesaurus ValueDomain)
    C25214 (NCI Thesaurus Property)
    C25298 (NCI Thesaurus ObjectClass)
    C0871470 (UMLS CUI [1])
    Diastolic blood pressure
    Item
    Diastolic
    integer
    C25209 (NCI Thesaurus ValueDomain)
    C25214 (NCI Thesaurus Property)
    C25299 (NCI Thesaurus ObjectClass)
    C0428883 (UMLS CUI [1])
    Item Group
    Disease Status
    C0012634 (UMLS CUI-1)
    Item
    Status of Most Recent Clinical Assessment
    text
    C16033 (NCI Thesaurus Property)
    C1522577 (UMLS 2011AA Property)
    C9305 (NCI Thesaurus ObjectClass)
    C0006826 (UMLS 2011AA ObjectClass)
    C25688 (NCI Thesaurus ValueDomain)
    C0449438 (UMLS 2011AA ValueDomain)
    C25577 (NCI Thesaurus ValueDomain-2)
    C1513491 (UMLS 2011AA ValueDomain-2)
    Code List
    Status of Most Recent Clinical Assessment
    CL Item
    No Evidence Of Disease (No evidence of disease)
    CL Item
    Cancer Present (Cancer present)
    Item Group
    In Situ Disease Follow-up
    DuctalBreastCarcinomainSituHistologicallyConfirmedInd-2
    Item
    Since the last report has there been a biopsy proven diagnosis of DCIS
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C25458 (NCI Thesaurus Property)
    C0750484 (UMLS 2011AA Property)
    C2924 (NCI Thesaurus ObjectClass)
    C0007124 (UMLS 2011AA ObjectClass)
    C25527 (NCI Thesaurus Property-2)
    C0205462 (UMLS 2011AA Property-2)
    Item
    Tumor Laterality
    text
    C25284 (NCI Thesaurus ValueDomain)
    C3262 (NCI Thesaurus ObjectClass)
    C25251 (NCI Thesaurus ObjectClass-2)
    C25185 (NCI Thesaurus Property)
    C0441987 (UMLS CUI [1,1])
    C0475445 (UMLS CUI [1,2])
    Code List
    Tumor Laterality
    CL Item
    Left (L)
    CL Item
    Right (R)
    DuctalBreastCarcinomainSituHistologicallyRadiologicFindingConfirmedDate
    Item
    Date of radiologic detection of DCIS (If yes,)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25458 (NCI Thesaurus Property)
    C0750484 (UMLS 2011AA Property)
    C2924 (NCI Thesaurus ObjectClass)
    C0007124 (UMLS 2011AA ObjectClass)
    C35869 (NCI Thesaurus Property-2)
    C1290916 (UMLS 2011AA Property-2)
    DuctalBreastCarcinomainSituHistologicallyConfirmedDate
    Item
    Date of histologic DCIS diagnosis (If yes,)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25458 (NCI Thesaurus Property)
    C0750484 (UMLS 2011AA Property)
    C2924 (NCI Thesaurus ObjectClass)
    C0007124 (UMLS 2011AA ObjectClass)
    C25527 (NCI Thesaurus Property-2)
    C0205462 (UMLS 2011AA Property-2)
    Item Group
    Kit Return - Question
    TreatmentKitReturnInd-2
    Item
    Have any treatment kits been returned this reporting period
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C15368 (NCI Thesaurus ObjectClass)
    C42793 (NCI Thesaurus ObjectClass-2)
    C0812225 (UMLS 2011AA ObjectClass)
    C71900 (NCI Thesaurus Property)
    C0332156 (UMLS 2011AA Property)
    Item Group
    Kit Return
    BlindedProtocolAgentIdentifierNumber
    Item
    Kit number
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C41161 (NCI Thesaurus ObjectClass)
    C1521826 (UMLS 2011AA ObjectClass)
    C49068 (NCI Thesaurus ObjectClass-2)
    C0150108 (UMLS 2011AA ObjectClass-2)
    PillsRemainingCount
    Item
    Number of pills returned
    float
    C25463 (NCI Thesaurus ValueDomain)
    C0750480 (UMLS 2011AA ValueDomain)
    C25394 (NCI Thesaurus ObjectClass)
    C0994475 (UMLS 2011AA ObjectClass)
    C25649 (NCI Thesaurus Property)
    C1527428 (UMLS 2011AA Property)
    Item Group
    Kit Dispension - Question
    TreatmentKitDispenseInd-2
    Item
    Have any treatment kits been dispensed this reporting period
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C15368 (NCI Thesaurus ObjectClass)
    C42793 (NCI Thesaurus ObjectClass-2)
    C0812225 (UMLS 2011AA ObjectClass)
    C64658 (NCI Thesaurus Property)
    C1880359 (UMLS 2011AA Property)
    Item Group
    Kit Dispensation
    TreatmentKitDispenseDate
    Item
    Date dispensed
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C15368 (NCI Thesaurus ObjectClass)
    C42793 (NCI Thesaurus ObjectClass-2)
    C0812225 (UMLS 2011AA ObjectClass)
    C64658 (NCI Thesaurus Property)
    C1880359 (UMLS 2011AA Property)
    Item Group
    Metformin/placebo Administration - Ramp-up
    Treatment Start Date
    Item
    Date of Initial Dose
    date
    C15368 (NCI Thesaurus ObjectClass)
    C25509 (NCI Thesaurus Property)
    C3173309 (UMLS CUI-1)
    C25256 (NCI Thesaurus Property-2)
    C25164 (NCI Thesaurus ValueDomain)
    C25431 (NCI Thesaurus ValueDomain-2)
    TherapyFullDoseScheduleDate
    Item
    Date subject scheduled to begin full dose
    date
    C15368 (NCI Thesaurus ObjectClass)
    C25488 (NCI Thesaurus Property)
    C0178602 (UMLS 2011AA Property)
    C25211 (NCI Thesaurus Property-2)
    C0086960 (UMLS 2011AA Property-2)
    C25517 (NCI Thesaurus Property-3)
    C0443225 (UMLS 2011AA Property-3)
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    TherapyFullDoseAdministrationDate
    Item
    Date subject reports full dose begun
    date
    C15368 (NCI Thesaurus ObjectClass)
    C25488 (NCI Thesaurus Property)
    C0178602 (UMLS 2011AA Property)
    C25409 (NCI Thesaurus Property-2)
    C1533734 (UMLS 2011AA Property-2)
    C25517 (NCI Thesaurus Property-3)
    C0443225 (UMLS 2011AA Property-3)
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    Item Group
    Metformin/placebo Administration
    ClinicalStudyProtocolMedicationDailySelf-AdministeredInd-2
    Item
    Has subject taken protocol medication every day
    boolean
    C25320 (NCI Thesaurus ObjectClass)
    C1507394 (UMLS 2011AA ObjectClass)
    C459 (NCI Thesaurus ObjectClass-2)
    C0013227 (UMLS 2011AA ObjectClass-2)
    C25473 (NCI Thesaurus Property)
    C0332173 (UMLS 2011AA Property)
    C25670 (NCI Thesaurus Property-2)
    C1519231 (UMLS 2011AA Property-2)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    PillsNegationTakenCount
    Item
    How many pills does the subject report having missed (If no,)
    float
    C25594 (NCI Thesaurus Property)
    C1518422 (UMLS 2011AA Property)
    C25463 (NCI Thesaurus ValueDomain)
    C0750480 (UMLS 2011AA ValueDomain)
    C25394 (NCI Thesaurus ObjectClass)
    C0994475 (UMLS 2011AA ObjectClass)
    C25701 (NCI Thesaurus Property-2)
    C1883727 (UMLS 2011AA Property-2)
    Item
    Dose Modification Reason (If no, please enter the reasons for dose modifications in the table below:)
    text
    C25638 (NCI Thesaurus ValueDomain)
    C1707811 (UMLS CUI-1)
    C25488 (NCI Thesaurus ObjectClass)
    C0392360 (UMLS CUI-2)
    C25572 (NCI Thesaurus Property)
    Code List
    Dose Modification Reason (If no, please enter the reasons for dose modifications in the table below:)
    CL Item
    Hold For Procedure (Hold for procedure)
    CL Item
    Dosing Error (Dosing error)
    CL Item
    Intercurrent Illness (Intercurrent illness)
    CL Item
    Patient Forgot (Patient forgot)
    CL Item
    Patient Request (Patient request)
    CL Item
    Adverse Event (Adverse event)
    C41331 (NCI Thesaurus)
    C0877248 (UMLS 2011AA)
    CL Item
    Other (Other)
    C17649 (NCI Thesaurus)
    C0205394 (UMLS 2011AA)
    Dose Modification Reason, other
    Item
    Specify
    text
    C25685 (NCI Thesaurus ValueDomain)
    C1707811 (UMLS CUI-1)
    C25488 (NCI Thesaurus ObjectClass)
    C3840932 (UMLS CUI-2)
    C25572 (NCI Thesaurus Property)
    Dose Increased
    Item
    Was this dose modification or addition/omission as per protocol guidelines
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1707810 (UMLS CUI-1)
    C25488 (NCI Thesaurus ObjectClass)
    C25572 (NCI Thesaurus Property)
    Item Group
    Radiology Investigations - Question
    Item
    Was a mammogram performed
    text
    C20178 (NCI Thesaurus ObjectClass)
    C0024671 (UMLS 2011AA ObjectClass)
    C38000 (NCI Thesaurus Property)
    C0884358 (UMLS 2011AA Property)
    C49797 (NCI Thesaurus ValueDomain)
    C1708496 (UMLS 2011AA ValueDomain)
    Code List
    Was a mammogram performed
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Not Applicable (Not Applicable)
    C48660 (NCI Thesaurus)
    C1272460 (UMLS 2011AA)
    Item
    Mammogram laterality
    text
    C13717 (NCI Thesaurus ValueDomain)
    C1515974 (UMLS 2011AA ValueDomain)
    C20178 (NCI Thesaurus ObjectClass)
    C0024671 (UMLS 2011AA ObjectClass)
    C38000 (NCI Thesaurus Property)
    C0884358 (UMLS 2011AA Property)
    Code List
    Mammogram laterality
    CL Item
    Bilateral (Bilateral)
    C13332 (NCI Thesaurus)
    C0238767 (UMLS 2011AA)
    CL Item
    Unilateral (unilateral)
    C28012 (NCI Thesaurus)
    C0205092 (UMLS 2011AA)
    Item
    Specify side
    text
    C20178 (NCI Thesaurus ObjectClass)
    C0024671 (UMLS 2011AA ObjectClass)
    C28012 (NCI Thesaurus Property)
    C0205092 (UMLS 2011AA Property)
    C38000 (NCI Thesaurus Property-2)
    C0884358 (UMLS 2011AA Property-2)
    C13717 (NCI Thesaurus ValueDomain)
    C1515974 (UMLS 2011AA ValueDomain)
    C25306 (NCI Thesaurus ValueDomain-2)
    C0441987 (UMLS 2011AA ValueDomain-2)
    Code List
    Specify side
    CL Item
    Right (Right)
    C25228 (NCI Thesaurus)
    C0205090 (UMLS 2011AA)
    CL Item
    Left (Left)
    C25229 (NCI Thesaurus)
    C0205091 (UMLS 2011AA)
    DiagnosticImagingRecurrentDiseasePerformedInd-3
    Item
    Was imaging done to assess for recurrence (other than mammogram)
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C16502 (NCI Thesaurus ObjectClass)
    C0011923 (UMLS 2011AA ObjectClass)
    C38000 (NCI Thesaurus Property)
    C0884358 (UMLS 2011AA Property)
    C38155 (NCI Thesaurus Property-2)
    C0277556 (UMLS 2011AA Property-2)
    Item Group
    Radiology Investigations
    Item
    Type of imaging
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C16847 (NCI Thesaurus Property)
    C0449851 (UMLS 2011AA Property)
    C16502 (NCI Thesaurus ObjectClass)
    C0011923 (UMLS 2011AA ObjectClass)
    Code List
    Type of imaging
    CL Item
    Mammography (Mammography)
    C16818 (NCI Thesaurus)
    C0024671 (UMLS 2011AA)
    CL Item
    Magnetic Resonance Imaging (MRI)
    C16809 (NCI Thesaurus)
    C0024485 (UMLS 2011AA)
    CL Item
    Scan - Bone (Scan - bone)
    CL Item
    Scan - Ct Abdomen (Scan - CT abdomen)
    CL Item
    Scan - Ct Brain (Scan - CT brain)
    CL Item
    Scan - Ct Chest (Scan - CT chest)
    CL Item
    Scan - Ct Pelvis (Scan - CT pelvis)
    CL Item
    Ultrasound - Abdomen (Ultrasound - abdomen)
    CL Item
    Ultrasound - Pelvis (Ultrasound - pelvis)
    CL Item
    Xray - Chest (Xray - chest)
    CL Item
    Other (Other)
    C17649 (NCI Thesaurus)
    C0205394 (UMLS 2011AA)
    ImagingMethodSpecify
    Item
    Specify
    text
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
    C16847 (NCI Thesaurus Property)
    C0449851 (UMLS 2011AA Property)
    C16502 (NCI Thesaurus ObjectClass)
    C0011923 (UMLS 2011AA ObjectClass)
    DiagnosticImagingProcedureDate
    Item
    Date of test
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25367 (NCI Thesaurus ValueDomain-2)
    C16502 (NCI Thesaurus ObjectClass)
    C0011923 (UMLS 2011AA ObjectClass)
    C25218 (NCI Thesaurus Property)
    C1948041 (UMLS 2011AA Property)
    Item
    Result
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C20989 (NCI Thesaurus ObjectClass)
    C0031809 (UMLS 2011AA ObjectClass)
    C25651 (NCI Thesaurus ValueDomain-2)
    C0700287 (UMLS 2011AA ValueDomain-2)
    C19477 (NCI Thesaurus Property)
    C1704254 (UMLS 2011AA Property)
    Code List
    Result
    CL Item
    Normal (Normal)
    C14165 (NCI Thesaurus)
    C0205307 (UMLS 2011AA)
    CL Item
    Abnormal, Malignant (Abnormal, malignant)
    CL Item
    Abnormal, Non-malignant (Abnormal, non-malignant)
    Item Group
    Hematology
    HematologySpecimenCollectedDate
    Item
    Lab, Hematology, Sample Collection Date
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C16673 (NCI Thesaurus ObjectClass)
    C0018943 (UMLS 2011AA ObjectClass)
    C19157 (NCI Thesaurus ObjectClass-2)
    C0370003 (UMLS 2011AA ObjectClass-2)
    C25452 (NCI Thesaurus Property)
    Laboratory Procedure Date
    Item
    Date
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0022885 (UMLS CUI-1)
    C25214 (NCI Thesaurus Property)
    C0011008 (UMLS CUI-2)
    C38000 (NCI Thesaurus Property-2)
    C25294 (NCI Thesaurus ObjectClass)
    BloodSpecimenCollectedInd-3
    Item
    Was sample obtained
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C12434 (NCI Thesaurus ObjectClass)
    C0229664 (UMLS 2011AA ObjectClass)
    C19157 (NCI Thesaurus ObjectClass-2)
    C0370003 (UMLS 2011AA ObjectClass-2)
    C25452 (NCI Thesaurus Property)
    Hemoglobin
    Item
    Hemoglobin
    float
    C16676 (NCI Thesaurus Property)
    C20200 (NCI Thesaurus Property-2)
    C25294 (NCI Thesaurus ObjectClass)
    C25712 (NCI Thesaurus ValueDomain)
    C0019046 (UMLS CUI [1])
    Hemoglobin LLN
    Item
    Hemoglobin LLN
    float
    C25294 (NCI Thesaurus ObjectClass)
    C16676 (NCI Thesaurus Property)
    C20200 (NCI Thesaurus Property-2)
    C25712 (NCI Thesaurus ValueDomain)
    C38024 (NCI Thesaurus ValueDomain-2)
    C25555 (NCI Thesaurus ValueDomain-3)
    C0019046 (UMLS CUI [1,1])
    C1518030 (UMLS CUI [1,2])
    Hemoglobin ULN
    Item
    Hemoglobin ULN
    float
    C25294 (NCI Thesaurus ObjectClass)
    C16676 (NCI Thesaurus Property)
    C20200 (NCI Thesaurus Property-2)
    C25712 (NCI Thesaurus ValueDomain)
    C25706 (NCI Thesaurus ValueDomain-2)
    C0019046 (UMLS CUI [1,1])
    C1519815 (UMLS CUI [1,2])
    Platelets
    Item
    Peripheral Platelet Count
    float
    C25294 (NCI Thesaurus ObjectClass)
    C20200 (NCI Thesaurus Property)
    C12520 (NCI Thesaurus Property-2)
    C38046 (NCI Thesaurus ValueDomain)
    C25712 (NCI Thesaurus ValueDomain-2)
    C0005821 (UMLS CUI [1])
    Platelets LLN
    Item
    Platelets LLN
    float
    C25294 (NCI Thesaurus ObjectClass)
    C20200 (NCI Thesaurus Property)
    C12520 (NCI Thesaurus Property-2)
    C25712 (NCI Thesaurus ValueDomain)
    C25555 (NCI Thesaurus ValueDomain-2)
    C0005821 (UMLS CUI [1,1])
    C1518030 (UMLS CUI [1,2])
    Platelets ULN
    Item
    Platelets ULN
    float
    C25294 (NCI Thesaurus ObjectClass)
    C20200 (NCI Thesaurus Property)
    C12520 (NCI Thesaurus Property-2)
    C25712 (NCI Thesaurus ValueDomain)
    C25706 (NCI Thesaurus ValueDomain-2)
    C0005821 (UMLS CUI [1,1])
    C1519815 (UMLS CUI [1,2])
    Leukocytes (WBC)
    Item
    WBC
    float
    C25294 (NCI Thesaurus ObjectClass)
    C12529 (NCI Thesaurus Property)
    C20200 (NCI Thesaurus Property-2)
    C38046 (NCI Thesaurus ValueDomain)
    C25712 (NCI Thesaurus ValueDomain-2)
    C0023508 (UMLS CUI [1])
    WBC LLN
    Item
    WBC LLN
    float
    C25294 (NCI Thesaurus ObjectClass)
    C12529 (NCI Thesaurus Property)
    C20200 (NCI Thesaurus Property-2)
    C25712 (NCI Thesaurus ValueDomain)
    C25555 (NCI Thesaurus ValueDomain-2)
    C0023508 (UMLS CUI [1,1])
    C1518030 (UMLS CUI [1,2])
    WBC ULN
    Item
    WBC ULN
    float
    C25294 (NCI Thesaurus ObjectClass)
    C12529 (NCI Thesaurus Property)
    C20200 (NCI Thesaurus Property-2)
    C25712 (NCI Thesaurus ValueDomain)
    C25706 (NCI Thesaurus ValueDomain-2)
    C0023508 (UMLS CUI [1,1])
    C1519815 (UMLS CUI [1,2])
    Granulocyte count
    Item
    Peripheral Granulocytes Count
    float
    C20200 (NCI Thesaurus Property)
    C0857490 (UMLS CUI-1)
    C12530 (NCI Thesaurus Property-2)
    C25463 (NCI Thesaurus ValueDomain)
    C25294 (NCI Thesaurus ObjectClass)
    Granulocyte count LLN
    Item
    Peripheral Granulocytes Count LLN
    float
    C25294 (NCI Thesaurus ObjectClass)
    C20200 (NCI Thesaurus Property)
    C12530 (NCI Thesaurus Property-2)
    C25463 (NCI Thesaurus ValueDomain)
    C25555 (NCI Thesaurus ValueDomain-2)
    C0857490 (UMLS CUI [1,1])
    C1518030 (UMLS CUI [1,2])
    Granulocyte count ULN
    Item
    Peripheral Granulocytes Count ULN
    float
    C25294 (NCI Thesaurus ObjectClass)
    C20200 (NCI Thesaurus Property)
    C12530 (NCI Thesaurus Property-2)
    C25463 (NCI Thesaurus ValueDomain)
    C25706 (NCI Thesaurus ValueDomain-2)
    C0857490 (UMLS CUI [1,1])
    C1519815 (UMLS CUI [1,2])
    MCV
    Item
    Mean Corpuscular Volume
    float
    C16673 (NCI Thesaurus ObjectClass)
    C37984 (NCI Thesaurus Property)
    C25712 (NCI Thesaurus ValueDomain)
    C64799 (NCI Thesaurus Property-2)
    C1948043 (UMLS CUI [1])
    MCV LLN
    Item
    Mean Corpuscular Volume LLN
    float
    C25294 (NCI Thesaurus ObjectClass)
    C20200 (NCI Thesaurus Property)
    C64799 (NCI Thesaurus Property-2)
    C25712 (NCI Thesaurus ValueDomain)
    C25555 (NCI Thesaurus ValueDomain-2)
    C1948043 (UMLS CUI [1,1])
    C1518030 (UMLS CUI [1,2])
    MCV ULN
    Item
    Mean Corpuscular Volume ULN
    float
    C25294 (NCI Thesaurus ObjectClass)
    C20200 (NCI Thesaurus Property)
    C64799 (NCI Thesaurus Property-2)
    C25712 (NCI Thesaurus ValueDomain)
    C25706 (NCI Thesaurus ValueDomain-2)
    C1948043 (UMLS CUI [1,1])
    C1519815 (UMLS CUI [1,2])
    Item Group
    Biochemistry
    SpecimenCollectedDate
    Item
    Date Specimen collected (biochemical investigations)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C19157 (NCI Thesaurus ObjectClass)
    C0370003 (UMLS 2011AA ObjectClass)
    C25452 (NCI Thesaurus Property)
    C25275 (NCI Thesaurus Property-2)
    C2745955 (UMLS 2011AA Property)
    SpecimenObtainInd-2
    Item
    Was sample obtained
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C19157 (NCI Thesaurus ObjectClass)
    C0370003 (UMLS 2011AA ObjectClass)
    C52349 (NCI Thesaurus Property)
    C1301820 (UMLS 2011AA Property)
    Alkaline Phosphatase
    Item
    Alkaline Phosphatase
    float
    C20200 (NCI Thesaurus Property)
    C25294 (NCI Thesaurus ObjectClass)
    C25712 (NCI Thesaurus ValueDomain)
    C16276 (NCI Thesaurus Property-2)
    C0201850 (UMLS CUI [1])
    Alkaline Phosphatase LLN
    Item
    Alkaline Phosphatase LLN
    float
    C25294 (NCI Thesaurus ObjectClass)
    C20200 (NCI Thesaurus Property)
    C16276 (NCI Thesaurus Property-2)
    C25712 (NCI Thesaurus ValueDomain)
    C25555 (NCI Thesaurus ValueDomain-2)
    C0002059 (UMLS CUI [1,1])
    C1518030 (UMLS CUI [1,2])
    Alkaline Phosphatase ULN
    Item
    Alkaline Phosphatase ULN
    float
    C25294 (NCI Thesaurus ObjectClass)
    C20200 (NCI Thesaurus Property)
    C16276 (NCI Thesaurus Property-2)
    C25712 (NCI Thesaurus ValueDomain)
    C25706 (NCI Thesaurus ValueDomain-2)
    C0151420 (UMLS CUI [1,1])
    C1519815 (UMLS CUI [1,2])
    ALT
    Item
    ALT (SGPT)
    float
    C25294 (NCI Thesaurus ObjectClass)
    C20200 (NCI Thesaurus Property)
    C25293 (NCI Thesaurus Property-2)
    C38046 (NCI Thesaurus ValueDomain)
    C25712 (NCI Thesaurus ValueDomain-2)
    C0201836 (UMLS CUI [1])
    ALT LLN
    Item
    ALT LLN
    float
    C25294 (NCI Thesaurus ObjectClass)
    C20200 (NCI Thesaurus Property)
    C25293 (NCI Thesaurus Property-2)
    C38046 (NCI Thesaurus ValueDomain)
    C25712 (NCI Thesaurus ValueDomain-2)
    C25555 (NCI Thesaurus ValueDomain-3)
    C0201836 (UMLS CUI [1,1])
    C1518030 (UMLS CUI [1,2])
    ALT ULN
    Item
    ALT (SGPT) ULN
    float
    C25294 (NCI Thesaurus ObjectClass)
    C20200 (NCI Thesaurus Property)
    C25293 (NCI Thesaurus Property-2)
    C25712 (NCI Thesaurus ValueDomain)
    C25706 (NCI Thesaurus ValueDomain-2)
    C0376147 (UMLS CUI [1,1])
    C1519815 (UMLS CUI [1,2])
    AST
    Item
    AST (SGOT)
    float
    C25294 (NCI Thesaurus ObjectClass)
    C25202 (NCI Thesaurus Property)
    C20200 (NCI Thesaurus Property-2)
    C38046 (NCI Thesaurus ValueDomain)
    C25712 (NCI Thesaurus ValueDomain-2)
    C0201899 (UMLS CUI [1])
    AST LLN
    Item
    AST LLN
    float
    C25294 (NCI Thesaurus ObjectClass)
    C25202 (NCI Thesaurus Property)
    C20200 (NCI Thesaurus Property-2)
    C38046 (NCI Thesaurus ValueDomain)
    C25712 (NCI Thesaurus ValueDomain-2)
    C25555 (NCI Thesaurus ValueDomain-3)
    C0242192 (UMLS CUI [1,1])
    C1518030 (UMLS CUI [1,2])
    AST ULN
    Item
    AST (SGOT) ULN
    float
    C25294 (NCI Thesaurus ObjectClass)
    C25202 (NCI Thesaurus Property)
    C20200 (NCI Thesaurus Property-2)
    C25712 (NCI Thesaurus ValueDomain)
    C25706 (NCI Thesaurus ValueDomain-2)
    C0242192 (UMLS CUI [1,1])
    C1519815 (UMLS CUI [1,2])
    Bilirubin, total
    Item
    Total Bilirubin
    float
    C25294 (NCI Thesaurus ObjectClass)
    C20200 (NCI Thesaurus Property)
    C38037 (NCI Thesaurus Property-2)
    C38046 (NCI Thesaurus ValueDomain)
    C25712 (NCI Thesaurus ValueDomain-2)
    C0201913 (UMLS CUI [1])
    Bilirubin, total LLN
    Item
    Total bilirubin LLN
    float
    C25294 (NCI Thesaurus ObjectClass)
    C20200 (NCI Thesaurus Property)
    C38037 (NCI Thesaurus Property-2)
    C25555 (NCI Thesaurus ValueDomain)
    C49100 (NCI Thesaurus ValueDomain-2)
    C0201913 (UMLS CUI [1,1])
    C1518030 (UMLS CUI [1,2])
    Bilirubin, total ULN
    Item
    Total bilirubin ULN
    float
    C25294 (NCI Thesaurus ObjectClass)
    C20200 (NCI Thesaurus Property)
    C38037 (NCI Thesaurus Property-2)
    C25712 (NCI Thesaurus ValueDomain)
    C25706 (NCI Thesaurus ValueDomain-2)
    C0201913 (UMLS CUI [1,1])
    C1519815 (UMLS CUI [1,2])
    Creatinine, Serum
    Item
    Creatinine
    float
    C25294 (NCI Thesaurus ObjectClass)
    C20200 (NCI Thesaurus Property)
    C399 (NCI Thesaurus Property-2)
    C38046 (NCI Thesaurus ValueDomain)
    C25712 (NCI Thesaurus ValueDomain-2)
    C0201976 (UMLS CUI [1])
    Creatinine, Serum LLN
    Item
    Creatinine LLN
    float
    C25294 (NCI Thesaurus ObjectClass)
    C20200 (NCI Thesaurus Property)
    C399 (NCI Thesaurus Property-2)
    C25712 (NCI Thesaurus ValueDomain)
    C25555 (NCI Thesaurus ValueDomain-2)
    C0201976 (UMLS CUI [1,1])
    C1518030 (UMLS CUI [1,2])
    Creatinine, serum ULN
    Item
    Serum Creatinine ULN
    float
    C25294 (NCI Thesaurus ObjectClass)
    C0201976 (UMLS CUI-1)
    C20200 (NCI Thesaurus Property)
    C1519815 (UMLS CUI-2)
    C399 (NCI Thesaurus Property-2)
    C25712 (NCI Thesaurus ValueDomain)
    C25706 (NCI Thesaurus ValueDomain-2)
    Vitamin B12
    Item
    Serum Vitamin B12
    float
    C20200 (NCI Thesaurus Property)
    C25294 (NCI Thesaurus ObjectClass)
    C25712 (NCI Thesaurus ValueDomain)
    C939 (NCI Thesaurus Property-2)
    C0202252 (UMLS CUI [1])
    Vitamin B12 LLN
    Item
    Serum Vitamin B12 LLN
    float
    C25294 (NCI Thesaurus ObjectClass)
    C20200 (NCI Thesaurus Property)
    C939 (NCI Thesaurus Property-2)
    C25712 (NCI Thesaurus ValueDomain)
    C25555 (NCI Thesaurus ValueDomain-2)
    C0202252 (UMLS CUI [1,1])
    C1518030 (UMLS CUI [1,2])
    Vitamin B12 ULN
    Item
    Serum Vitamin B12 ULN
    float
    C25294 (NCI Thesaurus ObjectClass)
    C20200 (NCI Thesaurus Property)
    C939 (NCI Thesaurus Property-2)
    C25712 (NCI Thesaurus ValueDomain)
    C25706 (NCI Thesaurus ValueDomain-2)
    C0202252 (UMLS CUI [1,1])
    C1519815 (UMLS CUI [1,2])
    Fasting glucose
    Item
    Fasting glucose
    float
    C25294 (NCI Thesaurus ObjectClass)
    C20200 (NCI Thesaurus Property)
    C41376 (NCI Thesaurus Property-2)
    C63663 (NCI Thesaurus Property-3)
    C25712 (NCI Thesaurus ValueDomain)
    C0202045 (UMLS CUI [1])
    Fasting glucose LLN
    Item
    Fasting glucose, LLN
    float
    C25294 (NCI Thesaurus ObjectClass)
    C20200 (NCI Thesaurus Property)
    C41376 (NCI Thesaurus Property-2)
    C63663 (NCI Thesaurus Property-3)
    C25712 (NCI Thesaurus ValueDomain)
    C25555 (NCI Thesaurus ValueDomain-2)
    C0202045 (UMLS CUI [1,1])
    C1518030 (UMLS CUI [1,2])
    Fasting glucose ULN
    Item
    Fasting glucose, ULN
    float
    C25294 (NCI Thesaurus ObjectClass)
    C20200 (NCI Thesaurus Property)
    C41376 (NCI Thesaurus Property-2)
    C63663 (NCI Thesaurus Property-3)
    C25712 (NCI Thesaurus ValueDomain)
    C25706 (NCI Thesaurus ValueDomain-2)
    C0202045 (UMLS CUI [1,1])
    C1519815 (UMLS CUI [1,2])
    Item Group
    Serious Adverse Event - Question
    SAE
    Item
    Did the patient experience a Serious Adverse Event, as defined in protocol section 11, during this reporting period
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C41331 (NCI Thesaurus ObjectClass)
    C25375 (NCI Thesaurus Property)
    C54035 (NCI Thesaurus ObjectClass-2)
    C1519255 (UMLS CUI [1])
    Item Group
    Adverse Events On Treatment - Question
    Item
    Were any additional adverse events experienced by the patient
    text
    C17649 (NCI Thesaurus ObjectClass)
    C25180 (NCI Thesaurus ValueDomain)
    C25626 (NCI Thesaurus Property)
    C41331 (NCI Thesaurus ObjectClass-2)
    C0877248 (UMLS CUI [1])
    Code List
    Were any additional adverse events experienced by the patient
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Not Assessed (Not assessed)
    NewCancerDiagnosisInd-3
    Item
    Has a new primary cancer or MDS been diagnosed that has not been previously reported?
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C25586 (NCI Thesaurus ObjectClass)
    C0205314 (UMLS 2011AA ObjectClass)
    C9305 (NCI Thesaurus ObjectClass-2)
    C0006826 (UMLS 2011AA ObjectClass-2)
    C15220 (NCI Thesaurus Property)
    C0011900 (UMLS 2011AA Property)
    DiabetesMellitusNewInd-3
    Item
    Has there been a new diagnosis of diabetes since the last report
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C25586 (NCI Thesaurus Property)
    C0205314 (UMLS 2011AA Property)
    C2985 (NCI Thesaurus ObjectClass)
    C0011849 (UMLS 2011AA ObjectClass)
    C15220 (NCI Thesaurus Property-2)
    C0011900 (UMLS 2011AA Property-2)
    Item Group
    Adverse Events
    AdverseEventContinueReportInd-2
    Item
    Would you like to carry forward the adverse events (indicated as continuing) from the previous reporting period
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C53279 (NCI Thesaurus Property)
    C0549178 (UMLS 2011AA Property)
    C25375 (NCI Thesaurus Property-2)
    C0684224 (UMLS 2011AA Property-2)
    Item
    CTCAE Term
    text
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C49704 (NCI Thesaurus Property)
    C1516728 (UMLS 2011AA Property)
    C45559 (NCI Thesaurus Property-2)
    C1705313 (UMLS 2011AA Property-2)
    C45255 (NCI Thesaurus ValueDomain)
    C1708523 (UMLS 2011AA ValueDomain)
    C49704 (NCI Thesaurus ValueDomain-2)
    C1516728 (UMLS 2011AA ValueDomain-2)
    C42614 (NCI Thesaurus ValueDomain-3)
    C0027365 (UMLS 2011AA ValueDomain-3)
    C45559 (NCI Thesaurus ValueDomain-4)
    C1705313 (UMLS 2011AA ValueDomain-4)
    C25714 (NCI Thesaurus ValueDomain-5)
    C0333052 (UMLS 2011AA ValueDomain-5)
    Code List
    CTCAE Term
    CL Item
    Abdominal Distention (Abdominal distension)
    C78161 (NCI Thesaurus)
    C0000731 (UMLS 2011AA)
    CL Item
    Abdominal Infection (Abdominal infection)
    C35669 (NCI Thesaurus)
    C1112209 (UMLS 2011AA)
    CL Item
    Abdominal Pain (Abdominal pain)
    C26682 (NCI Thesaurus)
    C0000737 (UMLS 2011AA)
    CL Item
    Abdominal Soft Tissue Necrotic Lesion (Abdominal soft tissue necrosis)
    CL Item
    Abducens Nerve Disorder (Abducens nerve disorder)
    CL Item
    Accessory Nerve Disorder (Accessory nerve disorder)
    CL Item
    Acidosis (Acidosis)
    C28228 (NCI Thesaurus)
    C0220981 (UMLS 2011AA)
    CL Item
    Vestibulocochlear Nerve Disorder (Acoustic nerve disorder NOS)
    CL Item
    Prolonged Partial Thromboplastin Time (Activated partial thromboplastin time prolonged)
    CL Item
    Acute Coronary Syndrome (Acute coronary syndrome)
    CL Item
    Acute Renal Failure (Acute kidney injury)
    CL Item
    Adrenal Gland Insufficiency (Adrenal insufficiency)
    C26691 (NCI Thesaurus)
    C0001623 (UMLS 2011AA)
    CL Item
    Adult Respiratory Distress Syndrome (Adult respiratory distress syndrome)
    CL Item
    Agitation (Agitation)
    CL Item
    Akathisia (Akathisia)
    CL Item
    Alanine Aminotransferase Increased (Alanine aminotransferase increased)
    CL Item
    Alcohol Intolerance (Alcohol intolerance)
    C78167 (NCI Thesaurus)
    C0151474 (UMLS 2011AA)
    CL Item
    Blood Alkaline Phosphatase Increased (Alkaline phosphatase increased)
    C35607 (NCI Thesaurus)
    C0852911 (UMLS 2011AA)
    CL Item
    Alkalosis (Alkalosis)
    C37909 (NCI Thesaurus)
    C0002063 (UMLS 2011AA)
    CL Item
    Hypersensitivity (Allergic reaction)
    C3114 (NCI Thesaurus)
    C0020517 (UMLS 2011AA)
    CL Item
    Allergic Rhinitis (Allergic rhinitis)
    CL Item
    Alopecia (Alopecia)
    CL Item
    Amnesia (Amnesia)
    C2867 (NCI Thesaurus)
    C0002622 (UMLS 2011AA)
    CL Item
    Anorectal Fistula (Anal fistula)
    CL Item
    Anal Hemorrhage (Anal hemorrhage)
    CL Item
    Anal Mucositis (Anal mucositis)
    CL Item
    Anal Necrotic Lesion (Anal necrosis)
    C78171 (NCI Thesaurus)
    C1697981 (UMLS 2011AA)
    CL Item
    Anal Pain (Anal pain)
    CL Item
    Anal Stenosis (Anal stenosis)
    CL Item
    Anal Ulcer (Anal ulcer)
    CL Item
    Anaphylactic Shock (Anaphylaxis)
    CL Item
    Anemia (Anemia)
    CL Item
    Ankle Fracture (Ankle fracture)
    CL Item
    Anorectal Infection (Anorectal infection)
    CL Item
    Anorexia (Anorexia)
    C2875 (NCI Thesaurus)
    C0003123 (UMLS 2011AA)
    CL Item
    Anorgasmia (Anorgasmia)
    CL Item
    Anxiety (Anxiety)
    CL Item
    Aortic Injury (Aortic injury)
    CL Item
    Aortic Valve Disorder (Aortic valve disease)
    CL Item
    Aphonia (Aphonia)
    CL Item
    Apnea (Apnea)
    C26698 (NCI Thesaurus)
    C0003578 (UMLS 2011AA)
    CL Item
    Acute Appendicitis (Appendicitis)
    CL Item
    Acute Perforated Appendicitis (Appendicitis perforated)
    CL Item
    Arachnoiditis (Arachnoiditis)
    CL Item
    Arterial Injury (Arterial injury)
    CL Item
    Arteritis (Arteritis infective)
    C34399 (NCI Thesaurus)
    C0003860 (UMLS 2011AA)
    CL Item
    Arthralgia (Arthralgia)
    C50464 (NCI Thesaurus)
    C0003862 (UMLS 2011AA)
    CL Item
    Arthritis (Arthritis)
    CL Item
    Ascites (Ascites)
    C2885 (NCI Thesaurus)
    C0003962 (UMLS 2011AA)
    CL Item
    Aspartate Aminotransferase Increased (Aspartate aminotransferase increased)
    CL Item
    Aspiration (Aspiration)
    C15631 (NCI Thesaurus)
    C0349707 (UMLS 2011AA)
    CL Item
    Cardiac Arrest (Asystole)
    CL Item
    Ataxia (Ataxia)
    CL Item
    Atelectasis (Atelectasis)
    CL Item
    Atrial Fibrillation (Atrial fibrillation)
    CL Item
    Atrial Flutter (Atrial flutter)
    CL Item
    Av Block Third Degree (Atrioventricular block complete)
    C50501 (NCI Thesaurus)
    C0151517 (UMLS 2011AA)
    CL Item
    Av Block First Degree (Atrioventricular block first degree)
    C62015 (NCI Thesaurus)
    C0085614 (UMLS 2011AA)
    CL Item
    Autoimmune Disease (Autoimmune disorder)
    CL Item
    Bone Necrosis (Avascular necrosis)
    CL Item
    Azoospermia (Azoospermia)
    CL Item
    Back Pain (Back pain)
    CL Item
    Bile Duct Stenosis (Bile duct stenosis)
    CL Item
    Biliary Anastomotic Leakage (Biliary anastomotic leak)
    CL Item
    Biliary Fistula (Biliary fistula)
    CL Item
    Cholangitis (Biliary tract infection)
    CL Item
    Bladder Anastomotic Leakage (Bladder anastomotic leak)
    CL Item
    Cystitis (Bladder infection)
    C26738 (NCI Thesaurus)
    C0010692 (UMLS 2011AA)
    CL Item
    Bladder Perforation (Bladder perforation)
    CL Item
    Bladder Spasm (Bladder spasm)
    CL Item
    Bloating (Bloating)
    CL Item
    Hematopoietic And Lymphoid System Disorder Other Specify (Blood and lymphatic system disorders - Other, specify)
    CL Item
    Abnormal Blood Antidiuretic Hormone (Blood antidiuretic hormone abnormal)
    C78214 (NCI Thesaurus)
    C0853592 (UMLS 2011AA)
    CL Item
    Elevated Bilirubin (Blood bilirubin increased)
    C27088 (NCI Thesaurus)
    C0311468 (UMLS 2011AA)
    CL Item
    Blood Corticotrophin Decreased (Blood corticotrophin decreased)
    CL Item
    Abnormal Blood Gonadotrophin (Blood gonadotrophin abnormal)
    C78216 (NCI Thesaurus)
    C0853603 (UMLS 2011AA)
    CL Item
    Abnormal Blood Prolactin (Blood prolactin abnormal)
    C78217 (NCI Thesaurus)
    C0853620 (UMLS 2011AA)
    CL Item
    Blurred Vision (Blurred vision)
    CL Item
    Body Odor (Body odor)
    CL Item
    Bone Infection (Bone infection)
    CL Item
    Hypocellular Bone Marrow (Bone marrow hypocellular)
    C35167 (NCI Thesaurus)
    C0151773 (UMLS 2011AA)
    CL Item
    Bone Pain (Bone pain)
    CL Item
    Brachial Plexopathy (Brachial plexopathy)
    CL Item
    Breast Atrophy (Breast atrophy)
    CL Item
    Mastitis (Breast infection)
    C53662 (NCI Thesaurus)
    C0024894 (UMLS 2011AA)
    CL Item
    Breast Pain (Breast pain)
    CL Item
    Bronchial Fistula (Bronchial fistula)
    CL Item
    Bronchitis (Bronchial infection)
    C2911 (NCI Thesaurus)
    C0006277 (UMLS 2011AA)
    CL Item
    Bronchial Obstruction (Bronchial obstruction)
    CL Item
    Bronchial Stricture (Bronchial stricture)
    CL Item
    Bronchopleural Fistula (Bronchopleural fistula)
    CL Item
    Bronchial Hemorrhage (Bronchopulmonary hemorrhage)
    CL Item
    Bronchospasm (Bronchospasm)
    CL Item
    Bruise (Bruising)
    CL Item
    Bullous Dermatitis (Bullous dermatitis)
    CL Item
    Burn (Burn)
    C34441 (NCI Thesaurus)
    C0006434 (UMLS 2011AA)
    CL Item
    Buttock Pain (Buttock pain)
    CL Item
    Capillary Leak Syndrome Capillary Leak Syndrome (Capillary leak syndrome)
    CL Item
    Decreased Carbon Monoxide Diffusing Capacity (Carbon monoxide diffusing capacity decreased)
    C78229 (NCI Thesaurus)
    C1697788 (UMLS 2011AA)
    CL Item
    Cardiac Arrest (Cardiac arrest)
    CL Item
    Heart Disorder Other Specify (Cardiac disorders - Other, specify)
    CL Item
    Blood Cardiac Troponin I Increased (Cardiac troponin I increased)
    C78230 (NCI Thesaurus)
    C0852692 (UMLS 2011AA)
    CL Item
    Blood Cardiac Troponin T Increased (Cardiac troponin T increased)
    C78231 (NCI Thesaurus)
    C0852680 (UMLS 2011AA)
    CL Item
    Cataract (Cataract)
    CL Item
    Catheter-related Infection (Catheter related infection)
    CL Item
    Cd4 Lymphocytes Decreased (CD4 lymphocytes decreased)
    CL Item
    Cecal Hemorrhage (Cecal hemorrhage)
    CL Item
    Cecal Infection (Cecal infection)
    CL Item
    Central Nervous System Necrotic Lesion (Central nervous system necrosis)
    CL Item
    Cerebrospinal Fluid Leakage (Cerebrospinal fluid leakage)
    CL Item
    Infectious Cervicitis (Cervicitis infection)
    CL Item
    Cheilitis (Cheilitis)
    C79545 (NCI Thesaurus)
    C0007971 (UMLS 2011AA)
    CL Item
    Angina (Chest pain - cardiac)
    CL Item
    Chest Wall Pain (Chest wall pain)
    CL Item
    Chills (Chills)
    CL Item
    Cholecystitis (Cholecystitis)
    CL Item
    Hypercholesterolemia (Cholesterol high)
    CL Item
    Chronic Kidney Disease (Chronic kidney disease)
    CL Item
    Chylothorax (Chylothorax)
    CL Item
    Cognitive Disturbance (Cognitive disturbance)
    CL Item
    Colitis (Colitis)
    CL Item
    Colonic Fistula (Colonic fistula)
    CL Item
    Colonic Hemorrhage (Colonic hemorrhage)
    CL Item
    Colonic Obstruction (Colonic obstruction)
    CL Item
    Colonic Perforation (Colonic perforation)
    CL Item
    Colonic Stenosis (Colonic stenosis)
    CL Item
    Colonic Ulcer (Colonic ulcer)
    CL Item
    Concentration Impairment (Concentration impairment)
    CL Item
    Heart Conduction Disorder (Conduction disorder)
    CL Item
    Confusion (Confusion)
    CL Item
    Congenital, Familial And Genetic Disorder Class Other Specify (Congenital, familial and genetic disorders - Other, specify)
    CL Item
    Conjunctivitis (Conjunctivitis)
    CL Item
    Acute Contagious Conjunctivitis (Conjunctivitis infective)
    CL Item
    Constipation (Constipation)
    CL Item
    Constrictive Pericarditis (Constrictive pericarditis)
    CL Item
    Keratitis (Corneal infection)
    CL Item
    Corneal Ulcer (Corneal ulcer)
    CL Item
    Cough (Cough)
    CL Item
    Creatine Phosphokinase Increased (CPK increased)
    C78247 (NCI Thesaurus)
    C0151576 (UMLS 2011AA)
    CL Item
    Cranial Nerve Infection (Cranial nerve infection)
    CL Item
    Increased Creatinine (Creatinine increased)
    C78249 (NCI Thesaurus)
    C0151578 (UMLS 2011AA)
    CL Item
    Cushingoid (Cushingoid)
    CL Item
    Non-infectious Cystitis (Cystitis noninfective)
    C78250 (NCI Thesaurus)
    C0403632 (UMLS 2011AA)
    CL Item
    Cytokine Release Syndrome (Cytokine release syndrome)
    CL Item
    Neonatal Death (Death neonatal)
    CL Item
    Death (Death NOS)
    C28554 (NCI Thesaurus)
    C0011065 (UMLS 2011AA)
    CL Item
    Dehydration (Dehydration)
    CL Item
    Delayed Orgasm (Delayed orgasm)
    CL Item
    Delayed Puberty (Delayed puberty)
    CL Item
    Delirium (Delirium)
    CL Item
    Delusion (Delusions)
    CL Item
    Caries (Dental caries)
    CL Item
    Depressed Level Of Consciousness (Depressed level of consciousness)
    CL Item
    Depression (Depression)
    CL Item
    Radiation-induced Dermatitis (Dermatitis radiation)
    CL Item
    Prosthesis-related Infection (Device related infection)
    CL Item
    Diarrhea (Diarrhea)
    CL Item
    Disseminated Intravascular Coagulation (Disseminated intravascular coagulation)
    C2992 (NCI Thesaurus)
    C0012739 (UMLS 2011AA)
    CL Item
    Dizziness (Dizziness)
    CL Item
    Dry Eye Syndrome (Dry eye)
    C34553 (NCI Thesaurus)
    C0013238 (UMLS 2011AA)
    CL Item
    Xerostomia (Dry mouth)
    C26917 (NCI Thesaurus)
    C0043352 (UMLS 2011AA)
    CL Item
    Dry Skin (Dry Skin)
    CL Item
    Duodenal Fistula (Duodenal fistula)
    CL Item
    Duodenal Hemorrhage (Duodenal hemorrhage)
    CL Item
    Duodenal Infection (Duodenal infection)
    CL Item
    Duodenal Obstruction (Duodenal obstruction)
    CL Item
    Duodenal Perforation (Duodenal perforation)
    CL Item
    Duodenal Stenosis (Duodenal stenosis)
    CL Item
    Duodenal Ulcer (Duodenal ulcer)
    C26755 (NCI Thesaurus)
    C0013295 (UMLS 2011AA)
    CL Item
    Dysarthria (Dysarthria)
    CL Item
    Dysesthesia (Dysesthesia)
    C28246 (NCI Thesaurus)
    C0392699 (UMLS 2011AA)
    CL Item
    Dysgeusia (Dysgeusia)
    C28145 (NCI Thesaurus)
    C0013378 (UMLS 2011AA)
    CL Item
    Dysmenorrhea (Dysmenorrhea)
    C34559 (NCI Thesaurus)
    C0013390 (UMLS 2011AA)
    CL Item
    Dyspareunia (Dyspareunia)
    C2997 (NCI Thesaurus)
    C1384606 (UMLS 2011AA)
    CL Item
    Dyspepsia (Dyspepsia)
    C26756 (NCI Thesaurus)
    C0013395 (UMLS 2011AA)
    CL Item
    Dysphagia (Dysphagia)
    C2980 (NCI Thesaurus)
    C0011168 (UMLS 2011AA)
    CL Item
    Dysphasia (Dysphasia)
    C35546 (NCI Thesaurus)
    C0973461 (UMLS 2011AA)
    CL Item
    Dyspnea (Dyspnea)
    CL Item
    Ear And Labyrinth Disorder Class Other Specify (Ear and labyrinth disorders - Other, specify)
    CL Item
    Earache (Ear pain)
    CL Item
    Cerebral Edema (Edema cerebral)
    C4909 (NCI Thesaurus)
    C0006114 (UMLS 2011AA)
    CL Item
    Face Edema (Edema face)
    C78289 (NCI Thesaurus)
    C0542571 (UMLS 2011AA)
    CL Item
    Edema Limbs (Edema limbs)
    C78262 (NCI Thesaurus)
    C0085649 (UMLS 2011AA)
    CL Item
    Edema Trunk (Edema trunk)
    C78263 (NCI Thesaurus)
    C0578541 (UMLS 2011AA)
    CL Item
    Ejaculation Disorder (Ejaculation disorder)
    C78264 (NCI Thesaurus)
    C0235969 (UMLS 2011AA)
    CL Item
    Ejection Fraction Decreased (Ejection fraction decreased)
    C83492 (NCI Thesaurus)
    C0743400 (UMLS 2011AA)
    CL Item
    Prolonged Qt Interval (Electrocardiogram QT corrected interval prolonged)
    C71034 (NCI Thesaurus)
    C0151878 (UMLS 2011AA)
    CL Item
    Infectious Encephalitis (Encephalitis infection)
    C79550 (NCI Thesaurus)
    C0596773 (UMLS 2011AA)
    CL Item
    Infectious Encephalomyelitis (Encephalomyelitis infection)
    C79551 (NCI Thesaurus)
    C0856705 (UMLS 2011AA)
    CL Item
    Encephalopathy (Encephalopathy)
    CL Item
    Infective Endocarditis (Endocarditis infective)
    CL Item
    Endocrine Disorder Other Specify (Endocrine disorders - Other, specify)
    CL Item
    Endophthalmitis (Endophthalmitis)
    CL Item
    Enterocolitis (Enterocolitis)
    CL Item
    Infectious Enterocolitis (Enterocolitis infectious)
    CL Item
    Enterovesical Fistula (Enterovesical fistula)
    CL Item
    Epistaxis (Epistaxis)
    CL Item
    Impotence (Erectile dysfunction)
    CL Item
    Erythema Multiforme (Erythema multiforme)
    CL Item
    Erythroderma (Erythroderma)
    CL Item
    Esophageal Anastomotic Leakage (Esophageal anastomotic leak)
    CL Item
    Esophageal Fistula (Esophageal fistula)
    CL Item
    Esophageal Hemorrhage (Esophageal hemorrhage)
    CL Item
    Esophageal Infection (Esophageal infection)
    CL Item
    Esophageal Necrotic Lesion (Esophageal necrosis)
    CL Item
    Esophageal Obstruction (Esophageal obstruction)
    CL Item
    Esophageal Pain (Esophageal pain)
    CL Item
    Perforation Of Esophagus (Esophageal perforation)
    CL Item
    Esophageal Stricture (Esophageal stenosis)
    CL Item
    Esophageal Ulcer (Esophageal ulcer)
    CL Item
    Esophageal Varices Hemorrhage (Esophageal varices hemorrhage)
    CL Item
    Esophagitis (Esophagitis)
    CL Item
    Euphoria (Euphoria)
    C34598 (NCI Thesaurus)
    C0235146 (UMLS 2011AA)
    CL Item
    Exostosis (Exostosis)
    CL Item
    External Ear Inflammation (External ear inflammation)
    C79601 (NCI Thesaurus)
    C0029878 (UMLS 2011AA)
    CL Item
    External Ear Pain (External ear pain)
    CL Item
    Extraocular Muscle Paresis (Extraocular muscle paresis)
    C78286 (NCI Thesaurus)
    C0262918 (UMLS 2011AA)
    CL Item
    Extrapyramidal Disorder (Extrapyramidal disorder)
    C79593 (NCI Thesaurus)
    C0015371 (UMLS 2011AA)
    CL Item
    Eye Disorder Other Specify (Eye disorders - Other, specify)
    CL Item
    Eye Infection (Eye infection)
    C45372 (NCI Thesaurus)
    C0015403 (UMLS 2011AA)
    CL Item
    Eye Pain (Eye pain)
    C78287 (NCI Thesaurus)
    C0151827 (UMLS 2011AA)
    CL Item
    Eyelid Function Disorder (Eyelid function disorder)
    C78288 (NCI Thesaurus)
    C0854286 (UMLS 2011AA)
    CL Item
    Facial Muscle Weakness (Facial muscle weakness)
    C78290 (NCI Thesaurus)
    C0427055 (UMLS 2011AA)
    CL Item
    Facial Nerve Disorder (Facial nerve disorder)
    C27594 (NCI Thesaurus)
    C0015464 (UMLS 2011AA)
    CL Item
    Facial Pain (Facial pain)
    C79594 (NCI Thesaurus)
    C0015468 (UMLS 2011AA)
    CL Item
    Fall (Fall)
    C50558 (NCI Thesaurus)
    C0085639 (UMLS 2011AA)
    CL Item
    Fallopian Tube Anastomotic Leakage (Fallopian tube anastomotic leak)
    C78292 (NCI Thesaurus)
    C1698039 (UMLS 2011AA)
    CL Item
    Fallopian Tube Obstruction (Fallopian tube obstruction)
    C78293 (NCI Thesaurus)
    C0041274 (UMLS 2011AA)
    CL Item
    Fallopian Tube Perforation (Fallopian tube perforation)
    C78294 (NCI Thesaurus)
    C1557983 (UMLS 2011AA)
    CL Item
    Fallopian Tube Stenosis (Fallopian tube stenosis)
    C78295 (NCI Thesaurus)
    C0459524 (UMLS 2011AA)
    CL Item
    Adipose Tissue Atrophy (Fat atrophy)
    C78297 (NCI Thesaurus)
    C0333650 (UMLS 2011AA)
    CL Item
    Fatigue (Fatigue)
    CL Item
    Neutropenic Fever (Febrile neutropenia)
    CL Item
    Fecal Incontinence (Fecal incontinence)
    CL Item
    Female Genital Tract Fistula (Female genital tract fistula)
    C78298 (NCI Thesaurus)
    C0269131 (UMLS 2011AA)
    CL Item
    Acquired Feminization (Feminization acquired)
    C78299 (NCI Thesaurus)
    C0877195 (UMLS 2011AA)
    CL Item
    Intrauterine Fetal Death (Fetal death)
    C50620 (NCI Thesaurus)
    C0015927 (UMLS 2011AA)
    CL Item
    Fetal Growth Retardation (Fetal growth retardation)
    CL Item
    Fever (Fever)
    CL Item
    Fibrinogen Decreased (Fibrinogen decreased)
    CL Item
    Deep Connective Tissue Fibrosis (Fibrosis deep connective tissue)
    CL Item
    Flank Pain (Flank pain)
    CL Item
    Flasher (Flashing lights)
    CL Item
    Flatulence (Flatulence)
    CL Item
    Floaters (Floaters)
    CL Item
    Flu-like Symptoms (Flu like symptoms)
    CL Item
    Flushing (Flushing)
    CL Item
    Decreased Forced Expiratory Volume (Forced expiratory volume decreased)
    CL Item
    Fracture (Fracture)
    CL Item
    Gait Disturbance (Gait disturbance)
    CL Item
    Gallbladder Fistula (Gallbladder fistula)
    CL Item
    Gallbladder Infection (Gallbladder infection)
    CL Item
    Gallbladder Necrotic Lesion (Gallbladder necrosis)
    CL Item
    Gallbladder Obstruction (Gallbladder obstruction)
    CL Item
    Gallbladder Pain (Gallbladder pain)
    CL Item
    Gallbladder Perforation (Gallbladder perforation)
    CL Item
    Gastric Anastomotic Leakage (Gastric anastomotic leak)
    CL Item
    Gastric Fistula (Gastric fistula)
    CL Item
    Gastric Hemorrhage (Gastric hemorrhage)
    CL Item
    Gastric Necrotic Lesion (Gastric necrosis)
    CL Item
    Gastric Perforation (Gastric perforation)
    CL Item
    Gastric Stenosis (Gastric stenosis)
    CL Item
    Gastric Ulcer (Gastric ulcer)
    CL Item
    Gastritis (Gastritis)
    CL Item
    Gastroesophageal Reflux Disease (Gastroesophageal reflux disease)
    CL Item
    Gastrointestinal System Anastomotic Leakage (Gastrointestinal anastomotic leak)
    CL Item
    Gastrointestinal Disorder Other Specify (Gastrointestinal disorders - Other, specify)
    CL Item
    Gastrointestinal Fistula (Gastrointestinal fistula)
    CL Item
    Gastrointestinal Pain (Gastrointestinal pain)
    CL Item
    Gastrointestinal Stoma Necrotic Lesion (Gastrointestinal stoma necrosis)
    CL Item
    Gastroparesis (Gastroparesis)
    CL Item
    General Disorders And Administration Site Conditions Class Other Specify (General disorders and administration site conditions - Other, specify)
    CL Item
    Generalized Muscle Weakness (Generalized muscle weakness)
    CL Item
    Genital Edema (Genital edema)
    CL Item
    Gamma-glutamyltransferase Increased (GGT increased)
    CL Item
    Gingival Pain (Gingival pain)
    CL Item
    Glaucoma (Glaucoma)
    CL Item
    Glossopharyngeal Nerve Disorder (Glossopharyngeal nerve disorder)
    CL Item
    Glucose Intolerance (Glucose intolerance)
    C34646 (NCI Thesaurus)
    C0271650 (UMLS 2011AA)
    CL Item
    Accelerated Growth (Growth accelerated)
    CL Item
    Abnormal Growth Hormone (Growth hormone abnormal)
    CL Item
    Growth Retardation (Growth suppression)
    CL Item
    Gum Infection (Gum infection)
    CL Item
    Gynecomastia (Gynecomastia)
    CL Item
    Hallucination (Hallucinations)
    CL Item
    Haptoglobin Decreased (Haptoglobin decreased)
    CL Item
    Head Soft Tissue Necrotic Lesion (Head soft tissue necrosis)
    CL Item
    Headache (Headache)
    CL Item
    Hearing Impairment (Hearing impaired)
    CL Item
    Heart Failure (Heart failure)
    CL Item
    Hematoma (Hematoma)
    C50579 (NCI Thesaurus)
    C0018944 (UMLS 2011AA)
    CL Item
    Hematosalpinx (Hematosalpinx)
    CL Item
    Hematuria (Hematuria)
    CL Item
    Hemoglobin Increased (Hemoglobin increased)
    CL Item
    Hemoglobinuria (Hemoglobinuria)
    CL Item
    Hemolysis (Hemolysis)
    CL Item
    Hemolytic Uremic Syndrome (Hemolytic uremic syndrome)
    CL Item
    Hemorrhoidal Hemorrhage (Hemorrhoidal hemorrhage)
    CL Item
    Hemorrhoid (Hemorrhoids)
    CL Item
    Hepatic Failure (Hepatic failure)
    CL Item
    Hepatic Hemorrhage (Hepatic hemorrhage)
    CL Item
    Hepatic Infection (Hepatic infection)
    CL Item
    Hepatic Necrotic Lesion (Hepatic necrosis)
    CL Item
    Hepatic Pain (Hepatic pain)
    CL Item
    Viral Hepatitis (Hepatitis viral)
    CL Item
    Liver And Biliary Tract Disorder Other Specify (Hepatobiliary disorders - Other, specify)
    CL Item
    Hiccough (Hiccups)
    CL Item
    Hip Fracture (Hip fracture)
    CL Item
    Hirsutism (Hirsutism)
    CL Item
    Hoarseness (Hoarseness)
    CL Item
    Hot Flashes (Hot flashes)
    CL Item
    Hydrocephalus (Hydrocephalus)
    CL Item
    Hypercalcemia (Hypercalcemia)
    CL Item
    Hyperglycemia (Hyperglycemia)
    CL Item
    Hyperhidrosis (Hyperhidrosis)
    C78345 (NCI Thesaurus)
    C0020458 (UMLS 2011AA)
    CL Item
    Hyperkalemia (Hyperkalemia)
    C37968 (NCI Thesaurus)
    C0020461 (UMLS 2011AA)
    CL Item
    Hypermagnesemia (Hypermagnesemia)
    C37969 (NCI Thesaurus)
    C1522135 (UMLS 2011AA)
    CL Item
    Hypernatremia (Hypernatremia)
    C37970 (NCI Thesaurus)
    C1522136 (UMLS 2011AA)
    CL Item
    Hyperparathyroidism (Hyperparathyroidism)
    CL Item
    Hypersomnia (Hypersomnia)
    C78346 (NCI Thesaurus)
    C0917799 (UMLS 2011AA)
    CL Item
    Hypertension (Hypertension)
    CL Item
    Hyperthyroidism (Hyperthyroidism)
    CL Item
    Hypertrichosis (Hypertrichosis)
    C79597 (NCI Thesaurus)
    C0020555 (UMLS 2011AA)
    CL Item
    Hypertriglyceridemia (Hypertriglyceridemia)
    C37971 (NCI Thesaurus)
    C1522137 (UMLS 2011AA)
    CL Item
    Hyperuricemia (Hyperuricemia)
    C3961 (NCI Thesaurus)
    C0740394 (UMLS 2011AA)
    CL Item
    Hypoalbuminemia (Hypoalbuminemia)
    C37972 (NCI Thesaurus)
    C0239981 (UMLS 2011AA)
    CL Item
    Hypocalcemia (Hypocalcemia)
    C37973 (NCI Thesaurus)
    C0020598 (UMLS 2011AA)
    CL Item
    Hypoglossal Nerve Disorder (Hypoglossal nerve disorder)
    C26954 (NCI Thesaurus)
    C0152181 (UMLS 2011AA)
    CL Item
    Hypoglycemia (Hypoglycemia)
    CL Item
    Hypohidrosis (Hypohidrosis)
    C34718 (NCI Thesaurus)
    C0020620 (UMLS 2011AA)
    CL Item
    Hypokalemia (Hypokalemia)
    C37974 (NCI Thesaurus)
    C0020621 (UMLS 2011AA)
    CL Item
    Hypomagnesemia (Hypomagnesemia)
    C37975 (NCI Thesaurus)
    C0151723 (UMLS 2011AA)
    CL Item
    Hyponatremia (Hyponatremia)
    C37976 (NCI Thesaurus)
    C0020625 (UMLS 2011AA)
    CL Item
    Hypoparathyroidism (Hypoparathyroidism)
    C78350 (NCI Thesaurus)
    C0020626 (UMLS 2011AA)
    CL Item
    Hypophosphatemia (Hypophosphatemia)
    C37977 (NCI Thesaurus)
    C0085682 (UMLS 2011AA)
    CL Item
    Hypotension (Hypotension)
    CL Item
    Hypothermia (Hypothermia)
    C78351 (NCI Thesaurus)
    C2364050 (UMLS 2011AA)
    CL Item
    Hypothyroidism (Hypothyroidism)
    C26800 (NCI Thesaurus)
    C0020676 (UMLS 2011AA)
    CL Item
    Hypoxia (Hypoxia)
    CL Item
    Ileal Fistula (Ileal fistula)
    CL Item
    Ileal Hemorrhage (Ileal hemorrhage)
    CL Item
    Ileal Obstruction (Ileal obstruction)
    CL Item
    Ileal Perforation (Ileal perforation)
    CL Item
    Ileal Stenosis (Ileal stenosis)
    CL Item
    Ileal Ulcer (Ileal ulcer)
    CL Item
    Ileus (Ileus)
    CL Item
    Immune System Disorder Other Specify (Immune system disorders - Other, specify)
    CL Item
    Infection Other Specify (Infections and infestations - Other, specify)
    CL Item
    Infectious Myositis (Infective myositis)
    CL Item
    Infusion-related Reaction (Infusion related reaction)
    CL Item
    Infusion Site Extravasation (Infusion site extravasation)
    CL Item
    Injection Site Reaction (Injection site reaction)
    CL Item
    Injury To Carotid Artery (Injury to carotid artery)
    CL Item
    Injury To Inferior Vena Cava (Injury to inferior vena cava)
    CL Item
    Injury To Jugular Vein (Injury to jugular vein)
    CL Item
    Injury To Superior Vena Cava (Injury to superior vena cava)
    CL Item
    Injury, Poisoning And Procedural Complication Class Other Specify (Injury, poisoning and procedural complications - Other, specify)
    CL Item
    Inr Increased (INR increased)
    CL Item
    Insomnia (Insomnia)
    CL Item
    Intestinal Stoma Leakage (Intestinal stoma leak)
    CL Item
    Intestinal Stoma Obstruction (Intestinal stoma obstruction)
    CL Item
    Intestinal Stoma Site Hemorrhage (Intestinal stoma site bleeding)
    CL Item
    Intra-abdominal Hemorrhage (Intra-abdominal hemorrhage)
    CL Item
    Intracranial Hemorrhage (Intracranial hemorrhage)
    CL Item
    Intraoperative Arterial Injury (Intraoperative arterial injury)
    CL Item
    Intraoperative Breast Injury (Intraoperative breast injury)
    CL Item
    Intraoperative Cardiac Injury (Intraoperative cardiac injury)
    CL Item
    Intraoperative Ear Injury (Intraoperative ear injury)
    CL Item
    Intraoperative Endocrine Injury (Intraoperative endocrine injury)
    CL Item
    Intraoperative Gastrointestinal Injury (Intraoperative gastrointestinal injury)
    CL Item
    Intraoperative Head And Neck Injury (Intraoperative head and neck injury)
    CL Item
    Intraoperative Hemorrhage (Intraoperative hemorrhage)
    CL Item
    Intraoperative Hepatobiliary Injury (Intraoperative hepatobiliary injury)
    CL Item
    Intraoperative Musculoskeletal Injury (Intraoperative musculoskeletal injury)
    CL Item
    Intraoperative Neurological Injury (Intraoperative neurological injury)
    CL Item
    Intraoperative Ocular Injury (Intraoperative ocular injury)
    CL Item
    Intraoperative Renal Injury (Intraoperative renal injury)
    CL Item
    Intraoperative Reproductive System Injury (Intraoperative reproductive tract injury)
    CL Item
    Intraoperative Respiratory Injury (Intraoperative respiratory injury)
    CL Item
    Intraoperative Skin Injury (Intraoperative skin injury)
    CL Item
    Intraoperative Splenic Injury (Intraoperative splenic injury)
    CL Item
    Intraoperative Urinary System Injury (Intraoperative urinary injury)
    CL Item
    Intraoperative Venous Injury (Intraoperative venous injury)
    CL Item
    Investigation Other Specify (Investigations - Other, specify)
    CL Item
    Iron Overload (Iron overload)
    CL Item
    Irregular Menstruation (Irregular menstruation)
    CL Item
    Irritability (Irritability)
    CL Item
    Cerebrovascular Ischemia (Ischemia cerebrovascular)
    CL Item
    Trochlear Nerve Disorder (IVth nerve disorder)
    CL Item
    Jejunal Fistula (Jejunal fistula)
    CL Item
    Jejunal Hemorrhage (Jejunal hemorrhage)
    CL Item
    Jejunal Obstruction (Jejunal obstruction)
    CL Item
    Jejunal Perforation (Jejunal perforation)
    CL Item
    Jejunal Stenosis (Jejunal stenosis)
    CL Item
    Jejunal Ulcer (Jejunal ulcer)
    CL Item
    Joint Effusion (Joint effusion)
    CL Item
    Joint Infection (Joint infection)
    CL Item
    Joint Range Of Motion Decreased (Joint range of motion decreased)
    CL Item
    Cervical Spine Joint Range Of Motion Decreased (Joint range of motion decreased cervical spine)
    CL Item
    Lumbar Spine Joint Range Of Motion Decreased (Joint range of motion decreased lumbar spine)
    CL Item
    Keratitis (Keratitis)
    CL Item
    Kidney Anastomotic Leakage (Kidney anastomotic leak)
    CL Item
    Pyelonephritis (Kidney infection)
    CL Item
    Kyphosis (Kyphosis)
    CL Item
    Lactation Disorder (Lactation disorder)
    CL Item
    Large Intestinal Anastomotic Leakage (Large intestinal anastomotic leak)
    CL Item
    Laryngeal Edema (Laryngeal edema)
    CL Item
    Laryngeal Fistula (Laryngeal fistula)
    CL Item
    Laryngeal Hemorrhage (Laryngeal hemorrhage)
    CL Item
    Laryngitis (Laryngeal inflammation)
    CL Item
    Laryngeal Mucositis (Laryngeal mucositis)
    CL Item
    Laryngeal Obstruction (Laryngeal obstruction)
    CL Item
    Laryngeal Stenosis (Laryngeal stenosis)
    CL Item
    Laryngitis (Laryngitis)
    CL Item
    Laryngopharyngeal Dysesthesia (Laryngopharyngeal dysesthesia)
    CL Item
    Laryngospasm (Laryngospasm)
    CL Item
    Left Ventricular Systolic Dysfunction (Left ventricular systolic dysfunction)
    CL Item
    Lethargy (Lethargy)
    CL Item
    Chemotherapy-related Leukemia (Leukemia secondary to oncology chemotherapy)
    CL Item
    Leukocytosis (Leukocytosis)
    CL Item
    Leukoencephalopathy (Leukoencephalopathy)
    CL Item
    Decreased Libido (Libido decreased)
    CL Item
    Increased Libido (Libido increased)
    CL Item
    Lip Infection (Lip infection)
    CL Item
    Lip Pain (Lip pain)
    CL Item
    Lipase Increased (Lipase increased)
    CL Item
    Lipohypertrophy (Lipohypertrophy)
    CL Item
    Localized Edema (Localized edema)
    CL Item
    Lordosis (Lordosis)
    CL Item
    Lower Gastrointestinal Hemorrhage (Lower gastrointestinal hemorrhage)
    CL Item
    Infectious Lung Disorder (Lung infection)
    CL Item
    Lymphadenitis (Lymph gland infection)
    CL Item
    Lymph Leakage (Lymph leakage)
    CL Item
    Lymph Node Pain (Lymph node pain)
    CL Item
    Lymphedema (Lymphedema)
    CL Item
    Lymphocele (Lymphocele)
    CL Item
    Lymphopenia (Lymphocyte count decreased)
    CL Item
    Lymphocytosis (Lymphocyte count increased)
    CL Item
    Malabsorption Syndrome (Malabsorption)
    CL Item
    Malaise (Malaise)
    CL Item
    Mania (Mania)
    CL Item
    Mediastinal Hemorrhage (Mediastinal hemorrhage)
    CL Item
    Mediastinitis (Mediastinal infection)
    CL Item
    Memory Impairment (Memory impairment)
    C78444 (NCI Thesaurus)
    C0233794 (UMLS 2011AA)
    CL Item
    Meningismus (Meningismus)
    CL Item
    Meningitis (Meningitis)
    CL Item
    Menopause (Menopause)
    CL Item
    Menorrhagia (Menorrhagia)
    CL Item
    Metabolism And Nutrition Disorder Class Other Specify (Metabolism and nutrition disorders - Other, specify)
    CL Item
    Otitis Media (Middle ear inflammation)
    CL Item
    Mitral Valve Disorder (Mitral valve disease)
    CL Item
    Av Block Second Degree Mobitz Type Ii (Mobitz (type) II atrioventricular block)
    CL Item
    Av Block Second Degree Mobitz Type I (Mobitz type I)
    CL Item
    Involuntary Movements (Movements involuntary)
    CL Item
    Mucosal Infection (Mucosal infection)
    CL Item
    Stomatitis (Mucositis oral)
    CL Item
    Multiple Organ Failure (Multi-organ failure)
    CL Item
    Muscle Weakness Left-sided (Muscle weakness left-sided)
    CL Item
    Muscle Weakness Lower Limb (Muscle weakness lower limb)
    CL Item
    Muscle Weakness Right-sided (Muscle weakness right-sided)
    CL Item
    Muscle Weakness Trunk (Muscle weakness trunk)
    CL Item
    Muscle Weakness Upper Limb (Muscle weakness upper limb)
    CL Item
    Connective And Soft Tissue Disorder Other Specify (Musculoskeletal and connective tissue disorder - Other, specify)
    CL Item
    Musculoskeletal Deformity (Musculoskeletal deformity)
    CL Item
    Myalgia (Myalgia)
    C27009 (NCI Thesaurus)
    C0231528 (UMLS 2011AA)
    CL Item
    Myelitis (Myelitis)
    CL Item
    Mds (Myelodysplastic syndrome)
    CL Item
    Myocardial Infarction (Myocardial infarction)
    C27996 (NCI Thesaurus)
    C0027051 (UMLS 2011AA)
    CL Item
    Myocarditis (Myocarditis)
    C34831 (NCI Thesaurus)
    C0027059 (UMLS 2011AA)
    CL Item
    Myositis (Myositis)
    CL Item
    Nail Discoloration (Nail discoloration)
    CL Item
    Nail Infection (Nail infection)
    CL Item
    Nail Loss (Nail loss)
    CL Item
    Nail Ridging (Nail ridging)
    CL Item
    Nasal Congestion (Nasal congestion)
    CL Item
    Nausea (Nausea)
    CL Item
    Neck Edema (Neck edema)
    CL Item
    Neck Pain (Neck pain)
    CL Item
    Neck Soft Tissue Necrotic Lesion (Neck soft tissue necrosis)
    CL Item
    Neoplasm Other Specify (Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify)
    CL Item
    Nervous System Disorder Other Specify (Nervous system disorders - Other, specify)
    CL Item
    Neuralgia (Neuralgia)
    CL Item
    Neutrophil Count Decreased (Neutrophil count decreased)
    CL Item
    Night Blindness (Night blindness)
    CL Item
    Nipple Deformity (Nipple deformity)
    CL Item
    Non-cardiac Chest Pain (Non-cardiac chest pain)
    CL Item
    Nystagmus (Nystagmus)
    C3282 (NCI Thesaurus)
    C0028738 (UMLS 2011AA)
    CL Item
    Obesity (Obesity)
    CL Item
    Gastric Obstruction (Obstruction gastric)
    CL Item
    Oculomotor Nerve Disorder (Oculomotor nerve disorder)
    CL Item
    Olfactory Nerve Disorder (Olfactory nerve disorder)
    CL Item
    Oligospermia (Oligospermia)
    CL Item
    Optic Nerve Disorder (Optic nerve disorder)
    CL Item
    Oral Cavity Fistula (Oral cavity fistula)
    CL Item
    Burning Mouth Syndrome (Oral dysesthesia)
    CL Item
    Oral Hemorrhage (Oral hemorrhage)
    CL Item
    Oral Pain (Oral pain)
    CL Item
    Osteonecrosis Of Jaw (Osteonecrosis of jaw)
    CL Item
    Osteoporosis (Osteoporosis)
    CL Item
    External Ear Infection (Otitis externa)
    C3299 (NCI Thesaurus)
    C0021355 (UMLS 2011AA)
    CL Item
    Otitis Media (Otitis media)
    CL Item
    Ovarian Hemorrhage (Ovarian hemorrhage)
    CL Item
    Ovarian Infection (Ovarian infection)
    CL Item
    Ovarian Rupture (Ovarian rupture)
    CL Item
    Ovulatory Pain (Ovulation pain)
    CL Item
    Pain (Pain)
    C3303 (NCI Thesaurus)
    C0030193 (UMLS 2011AA)
    CL Item
    Pain In Extremity (Pain in extremity)
    CL Item
    Skin Pain (Pain of skin)
    CL Item
    Palmar-plantar Erythodysthesia (Palmar-plantar erythrodysesthesia syndrome)
    CL Item
    Palpitation (Palpitations)
    CL Item
    Pancreatic Infection (Pancreas infection)
    CL Item
    Pancreatic Anastomotic Leakage (Pancreatic anastomotic leak)
    CL Item
    Pancreatic Duct Stenosis (Pancreatic duct stenosis)
    CL Item
    Pancreatic Enzymes Decreased (Pancreatic enzymes decreased)
    CL Item
    Pancreatic Fistula (Pancreatic fistula)
    CL Item
    Pancreatic Hemorrhage (Pancreatic hemorrhage)
    CL Item
    Pancreatic Necrotic Lesion (Pancreatic necrosis)
    CL Item
    Pancreatitis (Pancreatitis)
    C3306 (NCI Thesaurus)
    C0030305 (UMLS 2011AA)
    CL Item
    Papilledema (Papilledema)
    C3307 (NCI Thesaurus)
    C0030353 (UMLS 2011AA)
    CL Item
    Papulopustular Rash (Papulopustular rash)
    CL Item
    Paresthesia (Paresthesia)
    CL Item
    Paronychia (Paronychia)
    CL Item
    Paroxysmal Atrial Tachycardia (Paroxysmal atrial tachycardia)
    CL Item
    Pelvic Floor Muscle Weakness (Pelvic floor muscle weakness)
    CL Item
    Pelvic Inflammatory Disease (Pelvic infection)
    CL Item
    Pelvic Pain (Pelvic pain)
    CL Item
    Pelvic Soft Tissue Necrotic Lesion (Pelvic soft tissue necrosis)
    CL Item
    Penile Infection (Penile infection)
    CL Item
    Penile Pain (Penile pain)
    CL Item
    Bile Duct Perforation (Perforation bile duct)
    CL Item
    Pericardial Effusion (Pericardial effusion)
    CL Item
    Cardiac Tamponade (Pericardial tamponade)
    CL Item
    Pericarditis (Pericarditis)
    CL Item
    Perineal Pain (Perineal pain)
    CL Item
    Periodontal Disorder (Periodontal disease)
    CL Item
    Periorbital Edema (Periorbital edema)
    CL Item
    Periorbital Infection (Periorbital infection)
    C78531 (NCI Thesaurus)
    C0948065 (UMLS 2011AA)
    CL Item
    Peripheral Ischemia (Peripheral ischemia)
    C78535 (NCI Thesaurus)
    C0235490 (UMLS 2011AA)
    CL Item
    Peripheral Motor Neuropathy (Peripheral motor neuropathy)
    C3500 (NCI Thesaurus)
    C0018995 (UMLS 2011AA)
    CL Item
    Peripheral Nervous System Infectious Disorder (Peripheral nerve infection)
    C27589 (NCI Thesaurus)
    C1278821 (UMLS 2011AA)
    CL Item
    Peripheral Sensory Neuropathy (Peripheral sensory neuropathy)
    C3501 (NCI Thesaurus)
    C0151313 (UMLS 2011AA)
    CL Item
    Peritoneal Infection (Peritoneal infection)
    C78540 (NCI Thesaurus)
    C0851980 (UMLS 2011AA)
    CL Item
    Peritoneal Necrotic Lesion (Peritoneal necrosis)
    C78543 (NCI Thesaurus)
    C1696082 (UMLS 2011AA)
    CL Item
    Personality Change (Personality change)
    C78548 (NCI Thesaurus)
    C0240735 (UMLS 2011AA)
    CL Item
    Phantom Pain (Phantom pain)
    C79703 (NCI Thesaurus)
    C0031315 (UMLS 2011AA)
    CL Item
    Pharyngeal Anastomotic Leakage (Pharyngeal anastomotic leak)
    C78550 (NCI Thesaurus)
    C1696702 (UMLS 2011AA)
    CL Item
    Pharyngeal Fistula (Pharyngeal fistula)
    C78551 (NCI Thesaurus)
    C1536454 (UMLS 2011AA)
    CL Item
    Pharyngeal Hemorrhage (Pharyngeal hemorrhage)
    C26986 (NCI Thesaurus)
    C0576995 (UMLS 2011AA)
    CL Item
    Pharyngeal Mucositis (Pharyngeal mucositis)
    C78553 (NCI Thesaurus)
    C1699324 (UMLS 2011AA)
    CL Item
    Pharyngeal Necrotic Lesion (Pharyngeal necrosis)
    C78554 (NCI Thesaurus)
    C1696156 (UMLS 2011AA)
    CL Item
    Pharyngeal Stenosis (Pharyngeal stenosis)
    C78555 (NCI Thesaurus)
    C0396006 (UMLS 2011AA)
    CL Item
    Pharyngitis (Pharyngitis)
    C26851 (NCI Thesaurus)
    C0031350 (UMLS 2011AA)
    CL Item
    Pharyngolaryngeal Pain (Pharyngolaryngeal pain)
    C78556 (NCI Thesaurus)
    C0858635 (UMLS 2011AA)
    CL Item
    Phlebitis (Phlebitis)
    C38003 (NCI Thesaurus)
    C0031542 (UMLS 2011AA)
    CL Item
    Infective Phlebitis (Phlebitis infective)
    C78558 (NCI Thesaurus)
    C1112243 (UMLS 2011AA)
    CL Item
    Photophobia (Photophobia)
    CL Item
    Photosensitivity (Photosensitivity)
    C38004 (NCI Thesaurus)
    C0349506 (UMLS 2011AA)
    CL Item
    Thrombocytopenia (Platelet count decreased)
    C3408 (NCI Thesaurus)
    C0040034 (UMLS 2011AA)
    CL Item
    Pleural Effusion (Pleural effusion)
    C3331 (NCI Thesaurus)
    C0021071 (UMLS 2011AA)
    CL Item
    Hemothorax (Pleural hemorrhage)
    C50582 (NCI Thesaurus)
    C0019123 (UMLS 2011AA)
    CL Item
    Pleural Infection (Pleural infection)
    CL Item
    Pleuritic Pain (Pleuritic pain)
    C78564 (NCI Thesaurus)
    C0008033 (UMLS 2011AA)
    CL Item
    Pneumonia (Pneumonitis)
    CL Item
    Pneumothorax (Pneumothorax)
    C38006 (NCI Thesaurus)
    C0032326 (UMLS 2011AA)
    CL Item
    Portal Hypertension (Portal Hypertension)
    CL Item
    Portal Vein Thrombosis (Portal vein thrombosis)
    C78565 (NCI Thesaurus)
    C0155773 (UMLS 2011AA)
    CL Item
    Post-nasal Drip (Postnasal drip)
    C78566 (NCI Thesaurus)
    C0032781 (UMLS 2011AA)
    CL Item
    Postoperative Bleeding (Postoperative hemorrhage)
    C34938 (NCI Thesaurus)
    C0032788 (UMLS 2011AA)
    CL Item
    Thoracic Procedure Postoperative Complication (Postoperative thoracic procedure complication)
    CL Item
    Precocious Puberty (Precocious puberty)
    CL Item
    Pregnancy, Puerperium And Perinatal Condition Class Other Specify (Pregnancy, puerperium and perinatal conditions - Other, specify)
    CL Item
    Premature Labor (Premature delivery)
    CL Item
    Premature Menopause (Premature menopause)
    CL Item
    Presyncope (Presyncope)
    CL Item
    Proctitis (Proctitis)
    CL Item
    Productive Cough (Productive cough)
    CL Item
    Intestinal Stoma Prolapse (Prolapse of intestinal stoma)
    CL Item
    Urostomy Prolapse (Prolapse of urostomy)
    CL Item
    Prostatic Infection (Prostate infection)
    CL Item
    Prostatic Hemorrhage (Prostatic hemorrhage)
    CL Item
    Prostatic Obstruction (Prostatic obstruction)
    CL Item
    Prostatic Pain (Prostatic pain)
    CL Item
    Proteinuria (Proteinuria)
    CL Item
    Pruritus (Pruritus)
    CL Item
    Psychiatric Disorder Other Specify (Psychiatric disorders - Other, specify)
    CL Item
    Psychosis (Psychosis)
    CL Item
    Pulmonary Edema (Pulmonary edema)
    CL Item
    Pulmonary Fibrosis (Pulmonary fibrosis)
    CL Item
    Pulmonary Fistula (Pulmonary fistula)
    CL Item
    Pulmonary Hypertension (Pulmonary hypertension)
    CL Item
    Pulmonary Valve Disorder (Pulmonary valve disease)
    CL Item
    Purpura (Purpura)
    CL Item
    Pyramidal Tract Dysfunction (Pyramidal tract syndrome)
    CL Item
    Radiation-recall Dermatitis (Radiation recall reaction (dermatologic))
    CL Item
    Radiculitis (Radiculitis)
    CL Item
    Acneiform Dermatitis (Rash acneiform)
    CL Item
    Maculopapular Lesion (Rash maculo-papular)
    CL Item
    Papulopustular Rash (Rash pustular)
    CL Item
    Rectal Anastomotic Leakage (Rectal anastomotic leak)
    CL Item
    Rectal Fistula (Rectal fistula)
    CL Item
    Rectal Hemorrhage (Rectal hemorrhage)
    CL Item
    Rectal Mucositis (Rectal mucositis)
    CL Item
    Rectal Necrotic Lesion (Rectal necrosis)
    CL Item
    Rectal Obstruction (Rectal obstruction)
    CL Item
    Rectal Pain (Rectal pain)
    CL Item
    Rectal Perforation (Rectal perforation)
    CL Item
    Rectal Stenosis (Rectal stenosis)
    CL Item
    Rectal Ulcer (Rectal ulcer)
    CL Item
    Recurrent Laryngeal Nerve Paralysis (Recurrent laryngeal nerve palsy)
    CL Item
    Urinary Tract Disorder Other Specify (Renal and urinary disorders - Other, specify)
    CL Item
    Renal Stone (Renal calculi)
    CL Item
    Renal Colic (Renal colic)
    CL Item
    Renal Hemorrhage (Renal hemorrhage)
    CL Item
    Reproductive System And Breast Disorder Class Other Specify (Reproductive system and breast disorders - Other, specify)
    CL Item
    Respiratory Failure (Respiratory failure)
    CL Item
    Respiratory And Thoracic Disorder Other Specify (Respiratory, thoracic and mediastinal disorders - Other, specify)
    CL Item
    Restlessness (Restlessness)
    CL Item
    Restrictive Cardiomyopathy (Restrictive cardiomyopathy)
    CL Item
    Retinal Detachment (Retinal detachment)
    CL Item
    Retinal Tear (Retinal tear)
    CL Item
    Retinal Vascular Disorder (Retinal vascular disorder)
    CL Item
    Retinoic Acid Syndrome (Retinoic acid syndrome)
    CL Item
    Retinopathy (Retinopathy)
    CL Item
    Retroperitoneal Hemorrhage (Retroperitoneal hemorrhage)
    CL Item
    Reversible Posterior Leukoencephalopathy Syndrome (Reversible posterior leukoencephalopathy syndrome)
    CL Item
    Infectious Rhinitis (Rhinitis infective)
    CL Item
    Right Ventricular Dysfunction (Right ventricular dysfunction)
    CL Item
    Salivary Duct Inflammation (Salivary duct inflammation)
    CL Item
    Salivary Gland Fistula (Salivary gland fistula)
    CL Item
    Salivary Gland Infection (Salivary gland infection)
    CL Item
    Scalp Pain (Scalp pain)
    CL Item
    Sclera Disorder (Scleral disorder)
    CL Item
    Scoliosis (Scoliosis)
    C78603 (NCI Thesaurus)
    C0036439 (UMLS 2011AA)
    CL Item
    Scrotal Infection (Scrotal infection)
    C78606 (NCI Thesaurus)
    C1299539 (UMLS 2011AA)
    CL Item
    Scrotal Pain (Scrotal pain)
    C78607 (NCI Thesaurus)
    C0236078 (UMLS 2011AA)
    CL Item
    Seizure (Seizure)
    CL Item
    Septicemia (Sepsis)
    CL Item
    Seroma (Seroma)
    C50739 (NCI Thesaurus)
    C0262627 (UMLS 2011AA)
    CL Item
    Serum Amylase Increased (Serum amylase increased)
    C78608 (NCI Thesaurus)
    C0476327 (UMLS 2011AA)
    CL Item
    Serum Sickness (Serum sickness)
    C79718 (NCI Thesaurus)
    C0036830 (UMLS 2011AA)
    CL Item
    Sick Sinus Syndrome (Sick sinus syndrome)
    C62244 (NCI Thesaurus)
    C0037052 (UMLS 2011AA)
    CL Item
    Sinus Bradycardia (Sinus bradycardia)
    CL Item
    Paranasal Sinus Disorder (Sinus disorder)
    C26843 (NCI Thesaurus)
    C0030469 (UMLS 2011AA)
    CL Item
    Sinus Pain (Sinus pain)
    C78609 (NCI Thesaurus)
    C0522251 (UMLS 2011AA)
    CL Item
    Sinus Tachycardia (Sinus tachycardia)
    CL Item
    Sinusitis (Sinusitis)
    CL Item
    Skin Disorder Other Specify (Skin and subcutaneous tissue disorders - Other, specify)
    CL Item
    Skin Atrophy (Skin atrophy)
    CL Item
    Skin Hyperpigmentation (Skin hyperpigmentation)
    C79731 (NCI Thesaurus)
    C0162834 (UMLS 2011AA)
    CL Item
    Skin Hypopigmentation (Skin hypopigmentation)
    C78610 (NCI Thesaurus)
    C0162835 (UMLS 2011AA)
    CL Item
    Skin Induration (Skin induration)
    C78611 (NCI Thesaurus)
    C0241075 (UMLS 2011AA)
    CL Item
    Skin Infection (Skin infection)
    C35025 (NCI Thesaurus)
    C0037278 (UMLS 2011AA)
    CL Item
    Skin Ulcer (Skin ulceration)
    C54247 (NCI Thesaurus)
    C0037299 (UMLS 2011AA)
    CL Item
    Sleep Apnea (Sleep apnea)
    CL Item
    Small Intestinal Anastomotic Leakage (Small intestinal anastomotic leak)
    C78612 (NCI Thesaurus)
    C1698195 (UMLS 2011AA)
    CL Item
    Small Intestinal Mucositis (Small intestinal mucositis)
    C78613 (NCI Thesaurus)
    C1698626 (UMLS 2011AA)
    CL Item
    Small Intestinal Obstruction (Small intestinal obstruction)
    C78615 (NCI Thesaurus)
    C0235329 (UMLS 2011AA)
    CL Item
    Small Intestinal Perforation (Small intestinal perforation)
    C78616 (NCI Thesaurus)
    C0151739 (UMLS 2011AA)
    CL Item
    Small Intestinal Stenosis (Small intestinal stenosis)
    C78617 (NCI Thesaurus)
    C0151924 (UMLS 2011AA)
    CL Item
    Small Intestinal Infection (Small intestine infection)
    C78618 (NCI Thesaurus)
    C1698036 (UMLS 2011AA)
    CL Item
    Small Intestinal Ulcer (Small intestine ulcer)
    CL Item
    Sneezing (Sneezing)
    CL Item
    Social Circumstances Other Specify (Social circumstances - Other, specify)
    CL Item
    Soft Tissue Infection (Soft tissue infection)
    CL Item
    Lower Limb Soft Tissue Necrotic Lesion (Soft tissue necrosis lower limb)
    CL Item
    Upper Limb Soft Tissue Necrotic Lesion (Soft tissue necrosis upper limb)
    CL Item
    Somnolence (Somnolence)
    CL Item
    Sore Throat (Sore throat)
    CL Item
    Spasticity (Spasticity)
    CL Item
    Spermatic Cord Anastomotic Leakage (Spermatic cord anastomotic leak)
    C78622 (NCI Thesaurus)
    C1699328 (UMLS 2011AA)
    CL Item
    Spermatic Cord Hemorrhage (Spermatic cord hemorrhage)
    CL Item
    Spermatic Cord Obstruction (Spermatic cord obstruction)
    CL Item
    Vertebral Fracture (Spinal fracture)
    CL Item
    Splenic Disorder (Spleen disorder)
    CL Item
    Splenic Infection (Splenic infection)
    CL Item
    Gastrointestinal Stoma Stenosis (Stenosis of gastrointestinal stoma)
    C78628 (NCI Thesaurus)
    C1699177 (UMLS 2011AA)
    CL Item
    Stevens-johnson Syndrome (Stevens-Johnson syndrome)
    CL Item
    Stoma Site Infection (Stoma site infection)
    CL Item
    Stomach Pain (Stomach pain)
    CL Item
    Stomal Ulcer (Stomal ulcer)
    CL Item
    Stridor (Stridor)
    CL Item
    Cerebrovascular Accident (Stroke)
    CL Item
    Sudden Cardiac Death (Sudden death NOS)
    CL Item
    Suicidal Ideation (Suicidal ideation)
    CL Item
    Suicide Attempt (Suicide attempt)
    CL Item
    Superficial Soft Tissue Fibrosis (Superficial soft tissue fibrosis)
    CL Item
    Superficial Thrombophlebitis (Superficial thrombophlebitis)
    CL Item
    Superior Vena Cava Syndrome (Superior vena cava syndrome)
    CL Item
    Supraventricular Tachycardia (Supraventricular tachycardia)
    CL Item
    Intervention Or Procedure Other Specify (Surgical and medical procedures - Other, specify)
    CL Item
    Syncope (Syncope)
    CL Item
    Telangiectasia (Telangiectasia)
    CL Item
    Testicular Disorder (Testicular disorder)
    CL Item
    Testicular Hemorrhage (Testicular hemorrhage)
    CL Item
    Testicular Pain (Testicular pain)
    CL Item
    Thromboembolism (Thromboembolic event)
    CL Item
    Thrombotic Thrombocytopenic Purpura (Thrombotic thrombocytopenic purpura)
    CL Item
    Tinnitus (Tinnitus)
    CL Item
    Dental Developmental Disorder (Tooth development disorder)
    CL Item
    Tooth Discoloration (Tooth discoloration)
    CL Item
    Tooth Infection (Tooth infection)
    CL Item
    Toothache (Toothache)
    C78640 (NCI Thesaurus)
    C0040460 (UMLS 2011AA)
    CL Item
    Toxic Epidermal Necrolysis (Toxic epidermal necrolysis)
    C79777 (NCI Thesaurus)
    C0014518 (UMLS 2011AA)
    CL Item
    Tracheal Fistula (Tracheal fistula)
    C78641 (NCI Thesaurus)
    C0340214 (UMLS 2011AA)
    CL Item
    Tracheal Hemorrhage (Tracheal hemorrhage)
    C78642 (NCI Thesaurus)
    C0340220 (UMLS 2011AA)
    CL Item
    Tracheal Mucositis (Tracheal mucositis)
    C78644 (NCI Thesaurus)
    C1699329 (UMLS 2011AA)
    CL Item
    Tracheal Obstruction (Tracheal obstruction)
    C78645 (NCI Thesaurus)
    C0340221 (UMLS 2011AA)
    CL Item
    Tracheal Stenosis (Tracheal stenosis)
    C78646 (NCI Thesaurus)
    C0040583 (UMLS 2011AA)
    CL Item
    Tracheitis (Tracheitis)
    C78647 (NCI Thesaurus)
    C1868703 (UMLS 2011AA)
    CL Item
    Tracheostomy Site Bleeding (Tracheostomy site bleeding)
    C78648 (NCI Thesaurus)
    C1699657 (UMLS 2011AA)
    CL Item
    Transient Ischemic Attack (Transient ischemic attacks)
    C50781 (NCI Thesaurus)
    C0007787 (UMLS 2011AA)
    CL Item
    Therapy-related Malignant Neoplasm (Treatment related secondary malignancy)
    CL Item
    Tremor (Tremor)
    CL Item
    Tricuspid Valve Disorder (Tricuspid valve disease)
    CL Item
    Trigeminal Nerve Disorder (Trigeminal nerve disorder)
    CL Item
    Trismus (Trismus)
    CL Item
    Tumor Lysis Syndrome (Tumor lysis syndrome)
    CL Item
    Tumor Pain (Tumor pain)
    CL Item
    Typhlitis (Typhlitis)
    CL Item
    Unequal Limb Length (Unequal limb length)
    CL Item
    Unintended Pregnancy (Unintended pregnancy)
    CL Item
    Upper Gastrointestinal Hemorrhage (Upper gastrointestinal hemorrhage)
    CL Item
    Upper Respiratory Tract Infection (Upper respiratory infection)
    CL Item
    Ureteric Anastomotic Leakage (Ureteric anastomotic leak)
    CL Item
    Urethral Anastomotic Leakage (Urethral anastomotic leak)
    CL Item
    Urethral Infection (Urethral infection)
    CL Item
    Urinary Tract Fistula (Urinary fistula)
    CL Item
    Urinary Frequency (Urinary frequency)
    CL Item
    Urinary Incontinence (Urinary incontinence)
    CL Item
    Urinary Retention (Urinary retention)
    CL Item
    Urinary Tract Infection (Urinary tract infection)
    CL Item
    Urinary Tract Obstruction (Urinary tract obstruction)
    CL Item
    Urinary Tract Pain (Urinary tract pain)
    CL Item
    Urinary Urgency (Urinary urgency)
    CL Item
    Urine Discoloration (Urine discoloration)
    CL Item
    Urine Output Decreased (Urine output decreased)
    CL Item
    Urostomy Leakage (Urostomy leak)
    C78679 (NCI Thesaurus)
    C1698193 (UMLS 2011AA)
    CL Item
    Urostomy Obstruction (Urostomy obstruction)
    CL Item
    Urostomy Site Bleeding (Urostomy site bleeding)
    CL Item
    Urostomy Stenosis (Urostomy stenosis)
    CL Item
    Urticaria (Urticaria)
    C3432 (NCI Thesaurus)
    C0042109 (UMLS 2011AA)
    CL Item
    Uterine Anastomotic Leakage (Uterine anastomotic leak)
    C78684 (NCI Thesaurus)
    C1699812 (UMLS 2011AA)
    CL Item
    Uterine Fistula (Uterine fistula)
    CL Item
    Uterine Hemorrhage (Uterine hemorrhage)
    CL Item
    Endometritis (Uterine infection)
    C26764 (NCI Thesaurus)
    C0014179 (UMLS 2011AA)
    CL Item
    Uterine Obstruction (Uterine obstruction)
    CL Item
    Uterine Pain (Uterine pain)
    CL Item
    Uterine Perforation (Uterine perforation)
    CL Item
    Uveitis (Uveitis)
    CL Item
    Vaginal Anastomotic Leakage (Vaginal anastomotic leak)
    C78698 (NCI Thesaurus)
    C1698194 (UMLS 2011AA)
    CL Item
    Vaginal Discharge (Vaginal discharge)
    C50795 (NCI Thesaurus)
    C0227791 (UMLS 2011AA)
    CL Item
    Vaginal Dryness (Vaginal dryness)
    CL Item
    Vaginal Fistula (Vaginal fistula)
    CL Item
    Vaginal Hemorrhage (Vaginal hemorrhage)
    CL Item
    Vaginitis (Vaginal infection)
    C26911 (NCI Thesaurus)
    C0042267 (UMLS 2011AA)
    CL Item
    Vaginitis (Vaginal inflammation)
    C26911 (NCI Thesaurus)
    C0042267 (UMLS 2011AA)
    CL Item
    Vaginal Obstruction (Vaginal obstruction)
    C78700 (NCI Thesaurus)
    C1408443 (UMLS 2011AA)
    CL Item
    Vaginal Pain (Vaginal pain)
    C78701 (NCI Thesaurus)
    C0236082 (UMLS 2011AA)
    CL Item
    Vaginal Perforation (Vaginal perforation)
    C78702 (NCI Thesaurus)
    C1696155 (UMLS 2011AA)
    CL Item
    Vaginal Stricture (Vaginal stricture)
    C36064 (NCI Thesaurus)
    C0269208 (UMLS 2011AA)
    CL Item
    Vaginismus (Vaginismus)
    CL Item
    Vagus Nerve Disorder (Vagus nerve disorder)
    C27591 (NCI Thesaurus)
    C0152179 (UMLS 2011AA)
    CL Item
    Vas Deferens Anastomotic Leakage (Vas deferens anastomotic leak)
    C78704 (NCI Thesaurus)
    C1699326 (UMLS 2011AA)
    CL Item
    Vascular Access Complication (Vascular access complication)
    C78709 (NCI Thesaurus)
    C0920165 (UMLS 2011AA)
    CL Item
    Vascular Disorder Other Specify (Vascular disorders - Other, specify)
    CL Item
    Vasculitis (Vasculitis)
    CL Item
    Vasovagal Reaction (Vasovagal reaction)
    C50798 (NCI Thesaurus)
    C1710621 (UMLS 2011AA)
    CL Item
    Venous Injury (Venous injury)
    C78711 (NCI Thesaurus)
    C0340770 (UMLS 2011AA)
    CL Item
    Ventricular Arrhythmia (Ventricular arrhythmia)
    C26924 (NCI Thesaurus)
    C0085612 (UMLS 2011AA)
    CL Item
    Ventricular Fibrillation (Ventricular fibrillation)
    C50799 (NCI Thesaurus)
    C0042510 (UMLS 2011AA)
    CL Item
    Ventricular Tachycardia (Ventricular tachycardia)
    C50802 (NCI Thesaurus)
    C0042514 (UMLS 2011AA)
    CL Item
    Vertigo (Vertigo)
    C38057 (NCI Thesaurus)
    C0042571 (UMLS 2011AA)
    CL Item
    Internal Ear Disorder (Vestibular disorder)
    C27166 (NCI Thesaurus)
    C0042594 (UMLS 2011AA)
    CL Item
    Virilization (Virilization)
    C79859 (NCI Thesaurus)
    C0042755 (UMLS 2011AA)
    CL Item
    Visceral Artery Ischemia (Visceral arterial ischemia)
    C78712 (NCI Thesaurus)
    C0853812 (UMLS 2011AA)
    CL Item
    Abnormal Vital Capacity (Vital capacity abnormal)
    CL Item
    Vitreous Hemorrhage (Vitreous hemorrhage)
    C50469 (NCI Thesaurus)
    C0042909 (UMLS 2011AA)
    CL Item
    Voice Alternation (Voice alteration)
    C61043 (NCI Thesaurus)
    C0518179 (UMLS 2011AA)
    CL Item
    Vomiting (Vomiting)
    C3442 (NCI Thesaurus)
    C0042963 (UMLS 2011AA)
    CL Item
    Vulval Infection (Vulval infection)
    C78716 (NCI Thesaurus)
    C1699561 (UMLS 2011AA)
    CL Item
    Watering Eyes (Watering eyes)
    C78717 (NCI Thesaurus)
    C0152227 (UMLS 2011AA)
    CL Item
    Weight Gain (Weight gain)
    C62754 (NCI Thesaurus)
    C0043094 (UMLS 2011AA)
    CL Item
    Weight Loss (Weight loss)
    C3445 (NCI Thesaurus)
    C0043096 (UMLS 2011AA)
    CL Item
    Wheezing (Wheezing)
    CL Item
    Leukopenia (White blood cell decreased)
    C26816 (NCI Thesaurus)
    C0023530 (UMLS 2011AA)
    CL Item
    Wolff-parkinson-white Syndrome (Wolff-Parkinson-White Syndrome)
    CL Item
    Wound Complication (Wound complication)
    C78719 (NCI Thesaurus)
    C1096106 (UMLS 2011AA)
    CL Item
    Wound Dehiscence (Wound dehiscence)
    C50863 (NCI Thesaurus)
    C0259768 (UMLS 2011AA)
    CL Item
    Wound Infection (Wound infection)
    C45234 (NCI Thesaurus)
    C0043241 (UMLS 2011AA)
    CL Item
    Wrist Fracture (Wrist fracture)
    C80517 (NCI Thesaurus)
    C0435630 (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
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Not Assessed (Not assessed)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CommonToxicityCriteriaAdverseEventReportingGrade
    Item
    Grade
    float
    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-2)
    C0678257 (UMLS 2011AA Property-2)
    Item
    Seriousness Attributed to Adverse Event
    text
    C25664 (NCI Thesaurus ValueDomain)
    C0349674 (UMLS 2011AA ValueDomain)
    C41331 (NCI Thesaurus ObjectClass)
    C0877248 (UMLS 2011AA ObjectClass)
    C25358 (NCI Thesaurus Property)
    C0596130 (UMLS 2011AA Property)
    Code List
    Seriousness Attributed to Adverse Event
    CL Item
    Congenital Anomaly (Congenital anomaly)
    CL Item
    Death (Death)
    C28554 (NCI Thesaurus)
    C0011065 (UMLS 2011AA)
    CL Item
    Disability (Disability/incapacity)
    C21007 (NCI Thesaurus)
    C0231170 (UMLS 2011AA)
    CL Item
    Hospitalized (Hospitalization, initial or prolonged)
    CL Item
    Life Threatening (Life threatening)
    CL Item
    Not Serious (Not serious)
    CL Item
    Intervention Required (Required intervention to prevent permanent impairment/damage)
    Item
    Attribution
    text
    C25664 (NCI Thesaurus ValueDomain)
    C1706735 (UMLS CUI-1)
    C49704 (NCI Thesaurus ObjectClass)
    C25358 (NCI Thesaurus Property)
    Code List
    Attribution
    CL Item
    Definite (Definite)
    CL209464 (NCI Metathesaurus)
    CL Item
    Possible (Possible)
    C0332149 (NCI Metathesaurus)
    CL Item
    Probable (Probable)
    C0332148 (NCI Metathesaurus)
    CL Item
    Unlikely (Unlikely)
    CL Item
    Unrelated (Unrelated)
    C25328 (NCI Thesaurus)
    C0445356 (UMLS 2011AA)
    Item Group
    Cardiovascular Morbidity - Question
    HospitalizationCardiovascularDisorderAttributionInd-2
    Item
    Has there been a hospitalization for a cardiovascular event since the last report
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C25179 (NCI Thesaurus ObjectClass)
    C0019993 (UMLS 2011AA ObjectClass)
    C2931 (NCI Thesaurus Property)
    C0007222 (UMLS 2011AA Property)
    C25358 (NCI Thesaurus Property-2)
    C0596130 (UMLS 2011AA Property-2)
    Item Group
    Cardiovascular Mobidity
    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-2)
    C0012634 (UMLS 2011AA ObjectClass-2)
    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-3)
    C0038454 (UMLS 2011AA-4)
    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-2)
    C0012634 (UMLS 2011AA ObjectClass-2)
    HospitalAdmissionDate
    Item
    Date of hospital admission
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C16696 (NCI Thesaurus ObjectClass)
    C0019994 (UMLS 2011AA ObjectClass)
    C25385 (NCI Thesaurus Property)
    C0809949 (UMLS 2011AA Property)
    Item Group
    Cancer Treatment Since Last Report ¿ Question
    Item
    Has patient received any new treatment for breast cancer since the last report
    text
    C4872 (NCI Thesaurus ObjectClass)
    C0678222 (UMLS 2011AA ObjectClass)
    C15368 (NCI Thesaurus ObjectClass-2)
    C25586 (NCI Thesaurus Property)
    C0205314 (UMLS 2011AA Property)
    C25382 (NCI Thesaurus Property-2)
    C1521801 (UMLS 2011AA Property-2)
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    Code List
    Has patient received any new treatment for breast cancer since the last report
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Unknown (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    Item Group
    Cancer Treatment Since Last Report
    Item
    Non-Protocol Therapy Type
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C15368 (NCI Thesaurus ObjectClass)
    C25590 (NCI Thesaurus ObjectClass-2)
    C1518384 (UMLS 2011AA ObjectClass)
    C25382 (NCI Thesaurus Property)
    C1521801 (UMLS 2011AA Property)
    Code List
    Non-Protocol Therapy Type
    CL Item
    Systemic Therapy (Systemic therapy)
    CL Item
    Radiation Therapy (Radiation therapy)
    C15313 (NCI Thesaurus)
    C1522449 (UMLS 2011AA)
    CL Item
    Surgery (Surgery)
    C17173 (NCI Thesaurus)
    C0038894 (UMLS 2011AA)
    CL Item
    Other Specify (Other)
    Non-ProtocolTherapyAdministeredSpecify
    Item
    Specify
    text
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
    C15368 (NCI Thesaurus ObjectClass)
    C25590 (NCI Thesaurus ObjectClass-2)
    C1518384 (UMLS 2011AA ObjectClass)
    C25382 (NCI Thesaurus Property)
    C1521801 (UMLS 2011AA Property)
    Non-protocolTherapyOtherAdministeredName
    Item
    Name of Other Non-Protocol Therapy
    text
    C15368 (NCI Thesaurus ObjectClass)
    C25590 (NCI Thesaurus ObjectClass-2)
    C1518384 (UMLS 2011AA ObjectClass)
    C17649 (NCI Thesaurus Property)
    C0205394 (UMLS 2011AA Property)
    C25382 (NCI Thesaurus Property-2)
    C1521801 (UMLS 2011AA Property-2)
    C42614 (NCI Thesaurus ValueDomain)
    C0027365 (UMLS 2011AA ValueDomain)
    Non-protocolSurgeryPerformedType
    Item
    Non protocol surgery
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C38000 (NCI Thesaurus Property)
    C0884358 (UMLS 2011AA Property)
    C15329 (NCI Thesaurus ObjectClass)
    C0543467 (UMLS 2011AA ObjectClass)
    C25590 (NCI Thesaurus ObjectClass-2)
    C1518384 (UMLS 2011AA ObjectClass-2)
    Non-protocolTherapyAdministeredBeginDate
    Item
    Non-protocol Therapy Start Date
    date
    C15368 (NCI Thesaurus ObjectClass)
    C25590 (NCI Thesaurus ObjectClass-2)
    C1518384 (UMLS 2011AA ObjectClass)
    C25382 (NCI Thesaurus Property)
    C1521801 (UMLS 2011AA Property)
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25431 (NCI Thesaurus ValueDomain-2)
    C0439659 (UMLS 2011AA ValueDomain-2)
    Item Group
    Major Medical Problems
    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 Group
    Quality Of Life Questionnaire
    PatientQuestionnaireCompleteInd-2
    Item
    Was this subject one of the sub-set of subjects who completed questionnaires at baseline
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25250 (NCI Thesaurus Property)
    C0205197 (UMLS 2011AA Property)
    C17048 (NCI Thesaurus Property-2)
    C0034394 (UMLS 2011AA Property-2)
    PatientQuestionnaireCompleteDate
    Item
    Date patient filled out questionnaire
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25250 (NCI Thesaurus Property)
    C0205197 (UMLS 2011AA Property)
    C17048 (NCI Thesaurus Property-2)
    C0034394 (UMLS 2011AA Property-2)
    Item
    Questionnaire
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C17048 (NCI Thesaurus ObjectClass)
    C0034394 (UMLS 2011AA ObjectClass)
    C48312 (NCI Thesaurus Property)
    C1272683 (UMLS 2011AA Property)
    Code List
    Questionnaire
    CL Item
    Quality Of Life (Quality of Life)
    CL Item
    Nhs Ii - Physical Activity (NHS II - Physical Activity)
    CL Item
    Block Alive Screener (Block Alive screener)
    QuestionnaireRequestInd-2
    Item
    Done
    boolean
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    C17048 (NCI Thesaurus ObjectClass)
    C0034394 (UMLS 2011AA ObjectClass)
    C48312 (NCI Thesaurus Property)
    C1272683 (UMLS 2011AA Property)
    Item
    Reason questionnaire was not completed
    text
    C25638 (NCI Thesaurus ValueDomain)
    C0392360 (UMLS 2011AA ValueDomain)
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C25250 (NCI Thesaurus Property)
    C0205197 (UMLS 2011AA Property)
    C17048 (NCI Thesaurus Property-2)
    C0034394 (UMLS 2011AA Property-2)
    Code List
    Reason questionnaire was not completed
    CL Item
    Patient Kept Appointment For Examination, But Could Not Complete Questionnaire Due To Illness (Patient kept appointment for examination, but could not complete questionnaire due to illness)
    CL Item
    Patient Kept Appointment For Examination, But Refused To Complete Questionnaire For Reasons Other Than Illness (Patient kept appointment for examination, but refused to complete questionnaire for reasons other)
    CL Item
    Patient Did Not Keep Appointment (Patient did not keep appointment)
    CL Item
    Patient Could Not Be Contacted (Patient could not be contacted)
    CL Item
    Test Omitted Due To Institution/investigator Error (Questionnaire not administered due to institutional error)
    CL Item
    Other Reason (Other reason)
    Quality-of-LifeAssessmentOtherIncompleteSpecify
    Item
    Specify
    text
    C25685 (NCI Thesaurus ValueDomain)
    C1521902 (UMLS 2011AA ValueDomain)
    C17649 (NCI Thesaurus Property)
    C0205394 (UMLS 2011AA Property)
    C49160 (NCI Thesaurus Property-2)
    C0205257 (UMLS 2011AA Property-2)
    C15584 (NCI Thesaurus ObjectClass)
    C0281588 (UMLS 2011AA ObjectClass)
    Item Group
    Comments
    Research Comments
    Item
    Comments
    text
    C25704 (NCI Thesaurus ValueDomain)
    C0947611 (UMLS CUI-1)
    C15319 (NCI Thesaurus ObjectClass)
    C25393 (NCI Thesaurus Property)
    Item Group
    Contact Information
    CRAName
    Item
    CRA Name
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C25465 (NCI Thesaurus ObjectClass)
    C1516627 (UMLS 2011AA ObjectClass)
    ClinicalResearchAssociatePersonTelephoneNumber
    Item
    Phone number
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C25190 (NCI Thesaurus ObjectClass)
    C0027361 (UMLS 2011AA ObjectClass)
    C25395 (NCI Thesaurus Property)
    C0039457 (UMLS 2011AA Property)
    C25465 (NCI Thesaurus ObjectClass-2)
    C1516627 (UMLS 2011AA ObjectClass-2)
    ClinicalResearchAssociatePersonFaxNumber
    Item
    Fax Number
    text
    C25337 (NCI Thesaurus ValueDomain)
    C0237753 (UMLS 2011AA ValueDomain)
    C25190 (NCI Thesaurus ObjectClass)
    C0027361 (UMLS 2011AA ObjectClass)
    C25465 (NCI Thesaurus ObjectClass-2)
    C1516627 (UMLS 2011AA ObjectClass-2)
    C25210 (NCI Thesaurus Property)
    C0085205 (UMLS 2011AA Property)
    Institution Name
    Item
    Institution Name
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1301943 (UMLS CUI-1)
    C21541 (NCI Thesaurus ObjectClass)
    C21541 (NCI Thesaurus ValueDomain-2)
    C25364 (NCI Thesaurus Property)

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