ID

42619

Description

NCIC MA.32 Short Follow-Up 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=81DD7330-A8C4-A3E4-E040-BB89AD43612E

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=81DD7330-A8C4-A3E4-E040-BB89AD43612E

Keywords

  1. 12/15/14 12/15/14 - Martin Dugas
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 9/17/21 9/17/21 -
Uploaded on

September 17, 2021

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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Breast Cancer NCT01101438 Follow-Up - NCIC MA.32 Short Follow-Up Report Form - 3026031v1.0

Aim - The purpose of the Short Follow-Up Report is to collect follow-up information on all patients who have permanently discontinued protocol treatment. Follow-Up visits after end of protocol treatment must occur annually. Each Short Follow-Up Report Folder must contain information for the time interval between the most recent protocol-mandated clinic visit and the current protocol-mandated clinic visit. Completion A Short Follow-Up Report Folder must be completed within 6 weeks after each Follow-Up visit Timing of Investigations - The timing of protocol-required investigations for the interval covered by the Short Follow-Up Report is as follows: ¿ Physical exam - at each clinic visit ¿ Radiology - mammogram (annually from baseline mammogram) of any remaining breast tissue is required until the time of distant recurrence / progression or an incurable non-breast primary malignancy ¿ Adverse Events (AEs) - patients must be evaluated ONLY for adverse events that are related to protocol therapy at each clinic visit (except for cardiovascular adverse events associated with hospitalizations ¿ these need to be reported regardless of attribution).

Physical Exam
Description

Physical Exam

Post-treatment follow-up visit date
Description

Post-treatment follow-up visit date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C16033
UMLS CUI-1
C3694716
Off Treatment Report Period
Description

Off Treatment Report Period

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
NCI Thesaurus Property
C25616
NCI Thesaurus Property-2
C25601
NCI Thesaurus Property-3
C25207
NCI Thesaurus ValueDomain
C25284
Assessment Period, Specify
Description

Assessment Period

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
NCI Thesaurus ObjectClass
C20989
NCI Thesaurus Property
C25616
Visit Type
Description

PatientVisitType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25716
UMLS 2011AA Property
C0545082
Weight (kg)
Description

Patient Weight

Data type

float

Measurement units
  • Kg
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0005910
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25208
Kg
BMI
Description

PersonBodyMassIndexValue

Data type

float

Measurement units
  • kg/m2
Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus Property
C16358
UMLS 2011AA Property
C1305855
NCI Thesaurus ValueDomain-2
C16358
UMLS 2011AA ValueDomain-2
C1305855
kg/m2
Disease Status
Description

Disease Status

Status of Most Recent Clinical Assessment
Description

CancerFollow-UpMostRecentStatus

Data type

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

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
NCI Thesaurus Property
C25458
NCI Thesaurus ObjectClass
C2924
NCI Thesaurus Property-2
C25527
UMLS CUI-1
C1512698
UMLS CUI-2
C0750484
UMLS CUI-3
C0007124
UMLS CUI-4
C0205462
Tumor Laterality (If yes,)
Description

PrimaryTumorLateralityType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C25251
UMLS 2011AA ObjectClass-2
C0205225
NCI Thesaurus Property
C25185
UMLS 2011AA Property
C0332304
Date of radiologic detection of DCIS (If yes,)
Description

DuctalBreastCarcinomainSituHistologicallyRadiologicFindingConfirmedDate

Data type

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

Data type

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

Data type

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

Data type

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

Data type

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

Data type

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

Kit number
Description

BlindedProtocolAgentIdentifierNumber

Data type

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
Date dispensed
Description

TreatmentKitDispenseDate

Data type

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

Data type

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

Data type

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

Data type

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

Data type

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

Data type

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

Data type

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

Data type

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

Data type

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

Data type

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

Data type

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

Data type

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

Data type

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

Data type

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

Data type

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

Data type

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

Data type

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

Data type

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

Data type

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

Data type

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

Data type

float

Alias
NCI Thesaurus Property
C16676
UMLS CUI-1
C0019046
NCI Thesaurus Property-2
C20200
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25712
Hemoglobin (Hgb) (g/dl), LLN
Description

Hemoglobin LLN

Data type

float

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

LaboratoryProcedureHemoglobinResultUpperLimitofNormalValue

Data type

float

Measurement units
  • g/dL
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C16676
UMLS 2011AA Property
C0019046
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25706
UMLS 2011AA ValueDomain-2
C1519815
g/dL
Platelet count
Description

Platelets

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0005821
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C12520
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus ValueDomain-2
C25712
Platelets LLN
Description

Platelets LLN

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0005821
NCI Thesaurus Property
C20200
UMLS CUI-2
C1518030
NCI Thesaurus Property-2
C12520
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25555
Platelets ULN
Description

LaboratoryProcedurePlateletResultUpperLimitofNormalValue

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C12520
UMLS 2011AA Property-2
C0005821
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25706
UMLS 2011AA ValueDomain-2
C1519815
WBC
Description

Leukocytes (WBC)

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0023508
NCI Thesaurus Property
C12529
NCI Thesaurus Property-2
C20200
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus ValueDomain-2
C25712
WBC count (x1000), LLN
Description

LaboratoryProcedureLeukocyteResultLowerLimitofNormalValue

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C12529
UMLS 2011AA Property
C0023516
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25555
UMLS 2011AA ValueDomain-2
C1518030
Peripheral WBC count, ULN
Description

LaboratoryProcedureLeukocyteResultUpperLimitofNormalValue

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C12529
UMLS 2011AA Property
C0023516
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25706
UMLS 2011AA ValueDomain-2
C1519815
Peripheral Granulocytes Count
Description

Granulocyte count

Data type

float

Measurement units
  • 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

LaboratoryProcedureGranulocyteResultLowerLimitofNormalCount

Data type

float

Measurement units
  • mm3
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C12530
UMLS 2011AA Property-2
C0018183
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
NCI Thesaurus ValueDomain-2
C25555
UMLS 2011AA ValueDomain-2
C1518030
mm3
Granulocytes, ULN
Description

LaboratoryProcedureGranulocyteResultUpperLimitofNormalCount

Data type

text

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C12530
UMLS 2011AA Property-2
C0018183
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
NCI Thesaurus ValueDomain-2
C25706
UMLS 2011AA ValueDomain-2
C1519815
Mean Corpuscular Volume
Description

HematologyErythrocyteMeanCorpuscularVolumeLaboratoryUnspecifiedValue

Data type

text

Alias
NCI Thesaurus ObjectClass
C16673
UMLS 2011AA ObjectClass
C0018943
NCI Thesaurus Property
C37984
UMLS 2011AA Property
C0022877
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus Property-2
C64799
UMLS 2011AA Property-2
C1948043
Units
Description

AssessmentLabUOM

Data type

text

Alias
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus Property
C37984
UMLS 2011AA Property
C0022877
NCI Thesaurus ValueDomain
C25709
UMLS 2011AA ValueDomain
C1519795
Units
Description

AssessmentLabUOM

Data type

text

Alias
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus Property
C37984
UMLS 2011AA Property
C0022877
NCI Thesaurus ValueDomain
C25709
UMLS 2011AA ValueDomain
C1519795
Units
Description

AssessmentLabUOM

Data type

text

Alias
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus Property
C37984
UMLS 2011AA Property
C0022877
NCI Thesaurus ValueDomain
C25709
UMLS 2011AA ValueDomain
C1519795
Units
Description

AssessmentLabUOM

Data type

text

Alias
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus Property
C37984
UMLS 2011AA Property
C0022877
NCI Thesaurus ValueDomain
C25709
UMLS 2011AA ValueDomain
C1519795
Units
Description

AssessmentLabUOM

Data type

text

Alias
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus Property
C37984
UMLS 2011AA Property
C0022877
NCI Thesaurus ValueDomain
C25709
UMLS 2011AA ValueDomain
C1519795
Mean Corpuscular Volume, LLN
Description

LaboratoryProcedureErythrocyteMeanCorpuscularVolumeOutcomeLowerLimitofNormalValue

Data type

text

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C64799
UMLS 2011AA Property-2
C1948043
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25555
UMLS 2011AA ValueDomain-2
C1518030
Mean Corpuscular Volume, ULN
Description

LaboratoryProcedureErythrocyteMeanCorpuscularVolumeOutcomeUpperLimitofNormalValue

Data type

text

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C64799
UMLS 2011AA Property-2
C1948043
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25706
UMLS 2011AA ValueDomain-2
C1519815
Biochemistry
Description

Biochemistry

Date Specimen collected (biochemical investigations)
Description

SpecimenCollectedDate

Data type

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
Date
Description

Assessment Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2985720
NCI Thesaurus ObjectClass
C25367
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus Property
C38000
Was sample obtained
Description

SpecimenObtainInd-2

Data type

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

Data type

float

Alias
NCI Thesaurus Property
C20200
UMLS CUI-1
C0201850
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus Property-2
C16276
Alkaline Phosphatase LLN
Description

LaboratoryProcedureAlkalinePhosphataseResultLowerLimitNormalValue

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C16276
UMLS 2011AA Property-2
C0002059
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25555
UMLS 2011AA ValueDomain-2
C1518030
Alkaline Phosphatase ULN
Description

Alkaline Phosphatase ULN

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0151420
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C16276
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25706
SGPT (ALT)
Description

SGPT (ALT)

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0201836
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C25293
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus ValueDomain-2
C25712
SGPT (ALT) LLN
Description

LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultLowerLimitofNormalValue

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C25293
UMLS 2011AA Property-2
C0376147
NCI Thesaurus ValueDomain
C38046
UMLS 2011AA ValueDomain
C0205370
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
NCI Thesaurus ValueDomain-3
C25555
UMLS 2011AA ValueDomain-3
C1518030
SGPT (ALT) ULN
Description

LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultUpperLimitofNormalValue

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C25293
UMLS 2011AA Property-2
C0376147
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25706
UMLS 2011AA ValueDomain-2
C1519815
SGOT (AST)
Description

SGOT (AST)

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0201899
NCI Thesaurus Property
C25202
NCI Thesaurus Property-2
C20200
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus ValueDomain-2
C25712
SGOT (AST) LLN
Description

LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultLowerLimitofNormalValue

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C25202
UMLS 2011AA Property
C0242192
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus ValueDomain
C38046
UMLS 2011AA ValueDomain
C0205370
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
NCI Thesaurus ValueDomain-3
C25555
UMLS 2011AA ValueDomain-3
C1518030
SGOT (AST) ULN
Description

LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedUpperLimitofNormalValue

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C25202
UMLS 2011AA Property
C0242192
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25706
UMLS 2011AA ValueDomain-2
C1519815
Total Bilirubin
Description

Bilirubin, Total

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0201913
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C38037
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus ValueDomain-2
C25712
Total bilirubin LLN
Description

LaboratoryProcedureTotalBilirubinResultLowerLimitofNormalValue

Data type

text

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C38037
UMLS 2011AA Property-2
C0201913
NCI Thesaurus ValueDomain
C25555
UMLS 2011AA ValueDomain
C1518030
NCI Thesaurus ValueDomain-2
C49100
UMLS 2011AA ValueDomain-2
C1704610
Total Bilirubin ULN
Description

Bilirubin, Total ULN

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0201913
NCI Thesaurus Property
C20200
UMLS CUI-2
C1519815
NCI Thesaurus Property-2
C38037
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25706
Serum Creatinine
Description

Creatinine, Serum

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0201976
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C399
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus ValueDomain-2
C25712
Units
Description

AssessmentLabUOM

Data type

text

Alias
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus Property
C37984
UMLS 2011AA Property
C0022877
NCI Thesaurus ValueDomain
C25709
UMLS 2011AA ValueDomain
C1519795
Units
Description

AssessmentLabUOM

Data type

text

Alias
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus Property
C37984
UMLS 2011AA Property
C0022877
NCI Thesaurus ValueDomain
C25709
UMLS 2011AA ValueDomain
C1519795
Units
Description

AssessmentLabUOM

Data type

text

Alias
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus Property
C37984
UMLS 2011AA Property
C0022877
NCI Thesaurus ValueDomain
C25709
UMLS 2011AA ValueDomain
C1519795
Units
Description

AssessmentLabUOM

Data type

text

Alias
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus Property
C37984
UMLS 2011AA Property
C0022877
NCI Thesaurus ValueDomain
C25709
UMLS 2011AA ValueDomain
C1519795
Units
Description

AssessmentLabUOM

Data type

text

Alias
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus Property
C37984
UMLS 2011AA Property
C0022877
NCI Thesaurus ValueDomain
C25709
UMLS 2011AA ValueDomain
C1519795
Serum Creatinine LLN
Description

LaboratoryProcedureCreatinineResultLowerLimitofNormalValue

Data type

float

Measurement units
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C399
UMLS 2011AA Property-2
C0010294
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25555
UMLS 2011AA ValueDomain-2
C1518030
mg/dL
Serum Creatinine ULN
Description

Creatinine, serum ULN

Data type

float

Measurement units
  • 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

LaboratoryProcedureVitaminB12OutcomeValue

Data type

text

Alias
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus Property-2
C939
UMLS 2011AA Property-2
C0042845
Serum Vitamin B12, LLN
Description

LaboratoryProcedureVitaminB12OutcomeLowerLimitofNormalValue

Data type

text

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C939
UMLS 2011AA Property-2
C0042845
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25555
UMLS 2011AA ValueDomain-2
C1518030
Serum Vitamin B12, ULN
Description

LaboratoryProcedureVitaminB12OutcomeUpperLimitofNormalValue

Data type

text

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C939
UMLS 2011AA Property-2
C0042845
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25706
UMLS 2011AA ValueDomain-2
C1519815
Fasting glucose
Description

LaboratoryProcedureFastingPlasmaGlucoseMeasurementOutcomeValue

Data type

float

Measurement units
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C41376
UMLS 2011AA Property-2
C0202042
NCI Thesaurus Property-3
C63663
UMLS 2011AA Property-3
C0015663
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
mg/dL
Fasting glucose, LLN
Description

LaboratoryProcedureFastingPlasmaGlucoseMeasurementOutcomeLowerLimitofNormalValue

Data type

float

Measurement units
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C41376
UMLS 2011AA Property-2
C0202042
NCI Thesaurus Property-3
C63663
UMLS 2011AA Property-3
C0015663
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25555
UMLS 2011AA ValueDomain-2
C1518030
mg/dL
Fasting glucose, ULN
Description

LaboratoryProcedureFastingPlasmaGlucoseMeasurementOutcomeLabUpperLimitNormalValue

Data type

float

Measurement units
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C41376
UMLS 2011AA Property-2
C0202042
NCI Thesaurus Property-3
C63663
UMLS 2011AA Property-3
C0015663
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25706
UMLS 2011AA ValueDomain-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

SeriousAdverseEventReportInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25375
UMLS 2011AA Property
C0684224
NCI Thesaurus ObjectClass-2
C54035
UMLS 2011AA ObjectClass-2
C0205404
Adverse Events On Treatment - Question
Description

Adverse Events On Treatment - Question

Were any additional adverse events experienced by the patient
Description

OtherAdverseEventPresentIndicator

Data type

text

Alias
NCI Thesaurus ObjectClass
C17649
UMLS 2011AA ObjectClass
C0205394
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass-2
C41331
UMLS 2011AA ObjectClass-2
C0877248
Has a new primary cancer or MDS been diagnosed that has not been previously reported?
Description

NewCancerDiagnosisInd-3

Data type

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

Data type

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

Data type

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

Data type

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

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C53279
UMLS 2011AA Property
C0549178
Grade
Description

CommonToxicityCriteriaAdverseEventReportingGrade

Data type

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

Data type

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

Data type

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

Data type

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

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ObjectClass
C13306
UMLS 2011AA ObjectClass
C1522601
NCI Thesaurus ObjectClass-2
C2991
UMLS 2011AA ObjectClass-2
C0012634
Specify
Description

CardiacDiseaseAssessmentSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ObjectClass
C13306
UMLS 2011AA ObjectClass
C1522601
NCI Thesaurus ObjectClass-2
C2991
UMLS 2011AA ObjectClass-2
C0012634
Date of hospital admission
Description

HospitalAdmissionDate

Data type

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

Data type

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

Data type

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

Data type

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

Data type

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

Data type

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

Data type

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

Data type

text

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

Data type

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
Questionnaire
Description

QuestionnaireRequestType

Data type

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

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
NCI Thesaurus ObjectClass
C17048
NCI Thesaurus Property
C48312
Date patient filled out questionnaire
Description

PatientQuestionnaireCompleteDate

Data type

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
Date patient filled out questionnaire
Description

PatientQuestionnaireCompleteDate

Data type

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
Reason questionnaire was not completed
Description

PatientQuestionnaireCompleteNotAdministeredReason

Data type

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

Data type

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

Data type

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

Data type

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

Data type

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

Data type

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

Data type

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

Aim - The purpose of the Short Follow-Up Report is to collect follow-up information on all patients who have permanently discontinued protocol treatment. Follow-Up visits after end of protocol treatment must occur annually. Each Short Follow-Up Report Folder must contain information for the time interval between the most recent protocol-mandated clinic visit and the current protocol-mandated clinic visit. Completion A Short Follow-Up Report Folder must be completed within 6 weeks after each Follow-Up visit Timing of Investigations - The timing of protocol-required investigations for the interval covered by the Short Follow-Up Report is as follows: ¿ Physical exam - at each clinic visit ¿ Radiology - mammogram (annually from baseline mammogram) of any remaining breast tissue is required until the time of distant recurrence / progression or an incurable non-breast primary malignancy ¿ Adverse Events (AEs) - patients must be evaluated ONLY for adverse events that are related to protocol therapy at each clinic visit (except for cardiovascular adverse events associated with hospitalizations ¿ these need to be reported regardless of attribution).

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Physical Exam
Follow-Up visit date
Item
Post-treatment follow-up visit date
date
C25164 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C16033 (NCI Thesaurus Property)
C3694716 (UMLS CUI-1)
Item
Off Treatment Report Period
text
C25190 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C25601 (NCI Thesaurus Property-2)
C25207 (NCI Thesaurus Property-3)
C25284 (NCI Thesaurus ValueDomain)
Code List
Off Treatment Report Period
CL Item
12 Months (12 months)
CL Item
24 Months (24 months)
CL Item
36 Months (36 months)
CL Item
48 Months (48 months)
CL Item
60 Months (60 months)
CL Item
72 Months (72 months)
CL Item
Other (Other)
Assessment Period
Item
Assessment Period, Specify
text
C25685 (NCI Thesaurus ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
Item
Visit Type
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25716 (NCI Thesaurus Property)
C0545082 (UMLS 2011AA Property)
Code List
Visit Type
CL Item
Prior To The Appearance Of Any Invasive Cancer (Prior to the appearance of any invasive cancer)
CL Item
After Local Breast Cancer Recurrence But No Distant Recurrence (After local breast cancer recurrence but no distant recurrence)
CL Item
After Distant Recurrence/progression (After distant recurrence/progression)
CL Item
After Contralateral Breast Carcinoma Only (After contralateral breast carcinoma only)
CL Item
After New Non-breast Primary Malignancy, Treated With Curative Intent (After new non-breast primary malignancy, treated with curative intent)
CL Item
After New Non-breast Primary Malignancy, Incurable (After new non-breast primary malignancy, incurable)
Patient Weight
Item
Weight (kg)
float
C25209 (NCI Thesaurus ValueDomain)
C0005910 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)
PersonBodyMassIndexValue
Item
BMI
float
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C16358 (NCI Thesaurus Property)
C1305855 (UMLS 2011AA Property)
C16358 (NCI Thesaurus ValueDomain-2)
C1305855 (UMLS 2011AA ValueDomain-2)
Item Group
Disease Status
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)
C25458 (NCI Thesaurus Property)
C2924 (NCI Thesaurus ObjectClass)
C25527 (NCI Thesaurus Property-2)
C1512698 (UMLS CUI-1)
C0750484 (UMLS CUI-2)
C0007124 (UMLS CUI-3)
C0205462 (UMLS CUI-4)
PrimaryTumorLateralityType
Item
Tumor Laterality (If yes,)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25251 (NCI Thesaurus ObjectClass-2)
C0205225 (UMLS 2011AA ObjectClass-2)
C25185 (NCI Thesaurus Property)
C0332304 (UMLS 2011AA Property)
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
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)
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)
C0019046 (UMLS CUI-1)
C20200 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
Hemoglobin LLN
Item
Hemoglobin (Hgb) (g/dl), LLN
float
C25294 (NCI Thesaurus ObjectClass)
C0019046 (UMLS CUI-1)
C16676 (NCI Thesaurus Property)
C1518030 (UMLS CUI-2)
C20200 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C38024 (NCI Thesaurus ValueDomain-2)
C25555 (NCI Thesaurus ValueDomain-3)
LaboratoryProcedureHemoglobinResultUpperLimitofNormalValue
Item
Hemoglobin, ULN
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C16676 (NCI Thesaurus Property)
C0019046 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)
Platelets
Item
Platelet count
float
C25294 (NCI Thesaurus ObjectClass)
C0005821 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C12520 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
Platelets LLN
Item
Platelets LLN
float
C25294 (NCI Thesaurus ObjectClass)
C0005821 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C1518030 (UMLS CUI-2)
C12520 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
LaboratoryProcedurePlateletResultUpperLimitofNormalValue
Item
Platelets ULN
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12520 (NCI Thesaurus Property-2)
C0005821 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)
Leukocytes (WBC)
Item
WBC
float
C25294 (NCI Thesaurus ObjectClass)
C0023508 (UMLS CUI-1)
C12529 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
LaboratoryProcedureLeukocyteResultLowerLimitofNormalValue
Item
WBC count (x1000), LLN
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C12529 (NCI Thesaurus Property)
C0023516 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C1518030 (UMLS 2011AA ValueDomain-2)
LaboratoryProcedureLeukocyteResultUpperLimitofNormalValue
Item
Peripheral WBC count, ULN
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C12529 (NCI Thesaurus Property)
C0023516 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-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)
LaboratoryProcedureGranulocyteResultLowerLimitofNormalCount
Item
Peripheral Granulocytes Count LLN
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12530 (NCI Thesaurus Property-2)
C0018183 (UMLS 2011AA Property-2)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C1518030 (UMLS 2011AA ValueDomain-2)
LaboratoryProcedureGranulocyteResultUpperLimitofNormalCount
Item
Granulocytes, ULN
text
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12530 (NCI Thesaurus Property-2)
C0018183 (UMLS 2011AA Property-2)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)
HematologyErythrocyteMeanCorpuscularVolumeLaboratoryUnspecifiedValue
Item
Mean Corpuscular Volume
text
C16673 (NCI Thesaurus ObjectClass)
C0018943 (UMLS 2011AA ObjectClass)
C37984 (NCI Thesaurus Property)
C0022877 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C64799 (NCI Thesaurus Property-2)
C1948043 (UMLS 2011AA Property-2)
AssessmentLabUOM
Item
Units
text
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C37984 (NCI Thesaurus Property)
C0022877 (UMLS 2011AA Property)
C25709 (NCI Thesaurus ValueDomain)
C1519795 (UMLS 2011AA ValueDomain)
AssessmentLabUOM
Item
Units
text
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C37984 (NCI Thesaurus Property)
C0022877 (UMLS 2011AA Property)
C25709 (NCI Thesaurus ValueDomain)
C1519795 (UMLS 2011AA ValueDomain)
AssessmentLabUOM
Item
Units
text
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C37984 (NCI Thesaurus Property)
C0022877 (UMLS 2011AA Property)
C25709 (NCI Thesaurus ValueDomain)
C1519795 (UMLS 2011AA ValueDomain)
AssessmentLabUOM
Item
Units
text
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C37984 (NCI Thesaurus Property)
C0022877 (UMLS 2011AA Property)
C25709 (NCI Thesaurus ValueDomain)
C1519795 (UMLS 2011AA ValueDomain)
AssessmentLabUOM
Item
Units
text
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C37984 (NCI Thesaurus Property)
C0022877 (UMLS 2011AA Property)
C25709 (NCI Thesaurus ValueDomain)
C1519795 (UMLS 2011AA ValueDomain)
LaboratoryProcedureErythrocyteMeanCorpuscularVolumeOutcomeLowerLimitofNormalValue
Item
Mean Corpuscular Volume, LLN
text
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C64799 (NCI Thesaurus Property-2)
C1948043 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C1518030 (UMLS 2011AA ValueDomain-2)
LaboratoryProcedureErythrocyteMeanCorpuscularVolumeOutcomeUpperLimitofNormalValue
Item
Mean Corpuscular Volume, ULN
text
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C64799 (NCI Thesaurus Property-2)
C1948043 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-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)
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)
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)
C0201850 (UMLS CUI-1)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C16276 (NCI Thesaurus Property-2)
LaboratoryProcedureAlkalinePhosphataseResultLowerLimitNormalValue
Item
Alkaline Phosphatase LLN
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C16276 (NCI Thesaurus Property-2)
C0002059 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C1518030 (UMLS 2011AA ValueDomain-2)
Alkaline Phosphatase ULN
Item
Alkaline Phosphatase ULN
float
C25294 (NCI Thesaurus ObjectClass)
C0151420 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C16276 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
SGPT (ALT)
Item
SGPT (ALT)
float
C25294 (NCI Thesaurus ObjectClass)
C0201836 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C25293 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultLowerLimitofNormalValue
Item
SGPT (ALT) LLN
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25293 (NCI Thesaurus Property-2)
C0376147 (UMLS 2011AA Property-2)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
C25555 (NCI Thesaurus ValueDomain-3)
C1518030 (UMLS 2011AA ValueDomain-3)
LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultUpperLimitofNormalValue
Item
SGPT (ALT) ULN
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25293 (NCI Thesaurus Property-2)
C0376147 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)
SGOT (AST)
Item
SGOT (AST)
float
C25294 (NCI Thesaurus ObjectClass)
C0201899 (UMLS CUI-1)
C25202 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultLowerLimitofNormalValue
Item
SGOT (AST) LLN
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
C25555 (NCI Thesaurus ValueDomain-3)
C1518030 (UMLS 2011AA ValueDomain-3)
LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedUpperLimitofNormalValue
Item
SGOT (AST) ULN
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)
Bilirubin, Total
Item
Total Bilirubin
float
C25294 (NCI Thesaurus ObjectClass)
C0201913 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C38037 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
LaboratoryProcedureTotalBilirubinResultLowerLimitofNormalValue
Item
Total bilirubin LLN
text
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C38037 (NCI Thesaurus Property-2)
C0201913 (UMLS 2011AA Property-2)
C25555 (NCI Thesaurus ValueDomain)
C1518030 (UMLS 2011AA ValueDomain)
C49100 (NCI Thesaurus ValueDomain-2)
C1704610 (UMLS 2011AA ValueDomain-2)
Bilirubin, Total ULN
Item
Total Bilirubin ULN
float
C25294 (NCI Thesaurus ObjectClass)
C0201913 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C1519815 (UMLS CUI-2)
C38037 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
Creatinine, Serum
Item
Serum Creatinine
float
C25294 (NCI Thesaurus ObjectClass)
C0201976 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C399 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
AssessmentLabUOM
Item
Units
text
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C37984 (NCI Thesaurus Property)
C0022877 (UMLS 2011AA Property)
C25709 (NCI Thesaurus ValueDomain)
C1519795 (UMLS 2011AA ValueDomain)
AssessmentLabUOM
Item
Units
text
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C37984 (NCI Thesaurus Property)
C0022877 (UMLS 2011AA Property)
C25709 (NCI Thesaurus ValueDomain)
C1519795 (UMLS 2011AA ValueDomain)
AssessmentLabUOM
Item
Units
text
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C37984 (NCI Thesaurus Property)
C0022877 (UMLS 2011AA Property)
C25709 (NCI Thesaurus ValueDomain)
C1519795 (UMLS 2011AA ValueDomain)
AssessmentLabUOM
Item
Units
text
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C37984 (NCI Thesaurus Property)
C0022877 (UMLS 2011AA Property)
C25709 (NCI Thesaurus ValueDomain)
C1519795 (UMLS 2011AA ValueDomain)
AssessmentLabUOM
Item
Units
text
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C37984 (NCI Thesaurus Property)
C0022877 (UMLS 2011AA Property)
C25709 (NCI Thesaurus ValueDomain)
C1519795 (UMLS 2011AA ValueDomain)
LaboratoryProcedureCreatinineResultLowerLimitofNormalValue
Item
Serum Creatinine LLN
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C399 (NCI Thesaurus Property-2)
C0010294 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C1518030 (UMLS 2011AA ValueDomain-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)
LaboratoryProcedureVitaminB12OutcomeValue
Item
Serum Vitamin B12
text
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C939 (NCI Thesaurus Property-2)
C0042845 (UMLS 2011AA Property-2)
LaboratoryProcedureVitaminB12OutcomeLowerLimitofNormalValue
Item
Serum Vitamin B12, LLN
text
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C939 (NCI Thesaurus Property-2)
C0042845 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C1518030 (UMLS 2011AA ValueDomain-2)
LaboratoryProcedureVitaminB12OutcomeUpperLimitofNormalValue
Item
Serum Vitamin B12, ULN
text
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C939 (NCI Thesaurus Property-2)
C0042845 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)
LaboratoryProcedureFastingPlasmaGlucoseMeasurementOutcomeValue
Item
Fasting glucose
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C41376 (NCI Thesaurus Property-2)
C0202042 (UMLS 2011AA Property-2)
C63663 (NCI Thesaurus Property-3)
C0015663 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureFastingPlasmaGlucoseMeasurementOutcomeLowerLimitofNormalValue
Item
Fasting glucose, LLN
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C41376 (NCI Thesaurus Property-2)
C0202042 (UMLS 2011AA Property-2)
C63663 (NCI Thesaurus Property-3)
C0015663 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C1518030 (UMLS 2011AA ValueDomain-2)
LaboratoryProcedureFastingPlasmaGlucoseMeasurementOutcomeLabUpperLimitNormalValue
Item
Fasting glucose, ULN
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C41376 (NCI Thesaurus Property-2)
C0202042 (UMLS 2011AA Property-2)
C63663 (NCI Thesaurus Property-3)
C0015663 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)
Item Group
Serious Adverse Event - Question
SeriousAdverseEventReportInd-2
Item
Did the patient experience a Serious Adverse Event, as defined in protocol section 11, during this reporting period
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25375 (NCI Thesaurus Property)
C0684224 (UMLS 2011AA Property)
C54035 (NCI Thesaurus ObjectClass-2)
C0205404 (UMLS 2011AA ObjectClass-2)
Item Group
Adverse Events On Treatment - Question
Item
Were any additional adverse events experienced by the patient
text
C17649 (NCI Thesaurus ObjectClass)
C0205394 (UMLS 2011AA ObjectClass)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ObjectClass-2)
C0877248 (UMLS 2011AA ObjectClass-2)
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)
C0020672 (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)
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Iron Overload (Iron overload)
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Irregular Menstruation (Irregular menstruation)
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Irritability (Irritability)
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Cerebrovascular Ischemia (Ischemia cerebrovascular)
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Trochlear Nerve Disorder (IVth nerve disorder)
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Jejunal Fistula (Jejunal fistula)
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Jejunal Hemorrhage (Jejunal hemorrhage)
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Jejunal Obstruction (Jejunal obstruction)
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Jejunal Perforation (Jejunal perforation)
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Jejunal Stenosis (Jejunal stenosis)
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Jejunal Ulcer (Jejunal ulcer)
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Joint Effusion (Joint effusion)
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Joint Infection (Joint infection)
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Joint Range Of Motion Decreased (Joint range of motion decreased)
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Cervical Spine Joint Range Of Motion Decreased (Joint range of motion decreased cervical spine)
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