ID

5541

Description

NSABP C-11 OPEN Worksheet for Form Entry Combination Chemotherapy Before or After Surgery in Treating Patients With Colorectal Cancer With Liver Metastases That Could Be Removed By Surgery Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=8836C32C-ED52-3A5B-E040-BB89AD436D98

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=8836C32C-ED52-3A5B-E040-BB89AD436D98

Keywords

Versions (5)
  1. 8/27/12 8/27/12 -
  2. 8/8/14 8/8/14 - Martin Dugas
  3. 1/9/15 1/9/15 - Martin Dugas
  4. 1/9/15 1/9/15 - Martin Dugas
  5. 9/20/21 9/20/21 -
Uploaded on

August 8, 2014

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Colorectal Cancer NCT01189227 Registration - NSABP C-11 OPEN Worksheet for Form Entry - 3105627v1.0

English

No Instruction available.

1 forms  
  1. StudyEvent: NSABP C-11 OPEN Worksheet for Form Entry
    1. No Instruction available.
Unnamed1
Description

Unnamed1

Patient Initials
Description

PatientInitialsName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
Site Name
Description

ClinicalTrialSiteNameText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C15207
NCI Thesaurus Property
C37901
UMLS 2011AA Property
C0205145
NCI Thesaurus ValueDomain
C42614
UMLS 2011AA ValueDomain
C0027365
Patient Birth Date (Month Day Year)
Description

PatientBirthDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus Property
C25155
UMLS 2011AA Property
C0005615
Treating physician
Description

TreatingPhysicianName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C25741
UMLS 2011AA ObjectClass
C0031831
NCI Thesaurus ObjectClass
C25705
UMLS 2011AA ObjectClass
C1522326
Race
Description

Race

Race
Description

RaceCategoryText

Data type

text

Alias
NCI Thesaurus Property
C25372
UMLS 2011AA Property
C0683312
NCI Thesaurus ValueDomain
C25372
UMLS 2011AA ValueDomain
C0683312
NCI Thesaurus ObjectClass
C17049
UMLS 2011AA ObjectClass
C0034510
Person Completing Form, Last Name
Description

Person Completing Form, Last Name

Method of Payment (mark primary method only)
Description

PatientPaymentType

Data type

text

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

PatientEthnicGroupCategory

Data type

text

Alias
NCI Thesaurus ValueDomain
C25372
UMLS 2011AA ValueDomain
C0683312
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C16564
UMLS 2011AA Property
C0015031
Country of residence
Description

PersonAddressCountryCode

Data type

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25407
UMLS 2011AA Property
C1442065
Other
Description

OtherPatientAddressCountrySpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C17649
UMLS 2011AA ObjectClass
C0205394
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25407
UMLS 2011AA Property
C1442065
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ValueDomain
C25464
UMLS 2011AA ValueDomain
C0454664
Patient Zip Code (USA)
Description

PersonAddressPostalCode

Data type

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25407
UMLS 2011AA Property
C1442065
Patient Social Security Number (USA only)
Description

PatientSSNNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25686
UMLS 2011AA Property
C1301821
Patient gender
Description

PersonGenderTextType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C17357
UMLS 2011AA Property
C0079399
Unnamed4
Description

Unnamed4

Did the patient consent to use of blood samples for testing related to C-11?
Description

PatientBloodSpecimenConsentInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C12434
UMLS 2011AA Property
C0229664
NCI Thesaurus Property
C19157
UMLS 2011AA Property
C0370003
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Did the patient consent to use of tissue and blood samples for future research to learn about, prevent, or treat cancer?
Description

PatientMalignantNeoplasmConsentInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C9305
UMLS 2011AA Property
C0006826
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
Did the patient consent to use of tissue and blood samples for research about other problems?
Description

BloodTissueSpecimenOtherDiseasesandDisordersResearchConsentInd-3

Data type

text

Alias
NCI Thesaurus ObjectClass
C12801
UMLS 2011AA ObjectClass
C0040300
NCI Thesaurus ObjectClass
C12434
UMLS 2011AA ObjectClass
C0229664
NCI Thesaurus ObjectClass
C19157
UMLS 2011AA ObjectClass
C0370003
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property
C15319
NCI Thesaurus Property
C2991
UMLS 2011AA Property
C0012634
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Did the patient consent to future contact about more research?
Description

TissueSpecimenMalignantNeoplasmRelatedResearchConsentInd-3

Data type

text

Alias
NCI Thesaurus ObjectClass
C12801
UMLS 2011AA ObjectClass
C0040300
NCI Thesaurus ObjectClass
C19157
UMLS 2011AA ObjectClass
C0370003
NCI Thesaurus Property
C15319
NCI Thesaurus Property
C25648
UMLS 2011AA Property
C0439849
NCI Thesaurus Property
C9305
UMLS 2011AA Property
C0006826
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Has the patient authorized the release of Protected Health Information to the NSABP?
Description

PatientPHIConsentIndicator

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
Date Informed Consent Signed (Month Day Year)
Description

InformedConsentFormSignedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus ObjectClass
C16468
UMLS 2011AA ObjectClass
C0009797
NCI Thesaurus Property
C25679
Number of liver metastases on pre-entry evaluation
Description

HepaticMetastasisPriorClinicalStudyDiagnosisCount

Data type

double

Alias
NCI Thesaurus ObjectClass
C13308
UMLS 2011AA ObjectClass
C0205054
NCI Thesaurus ObjectClass
C19151
UMLS 2011AA ObjectClass
C0027627
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
NCI Thesaurus Property
C15206
UMLS 2011AA Property
C0008972
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
Has the patient received prior oxaliplatin therapy?
Description

ChemotherapyPreoperativeOxaliplatinAdministeredInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus Property
C1181
UMLS 2011AA Property
C0069717
NCI Thesaurus Property
C54732
UMLS 2011AA Property
C0445204
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Page Headers
Description

Page Headers

Patient Initials
Description

PatientInitialsName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
NSABP Patient ID
Description

PatientNationalSurgicalAdjuvantBreastProjectIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C15818
UMLS 2011AA Property
C1513905
Surgery For Primary Colorectal Tumor
Description

Surgery For Primary Colorectal Tumor

Was a diagnosis of colorectal adenocarcinoma confirmed histologically?
Description

ColorectalAdenocarcinomaHistologicConfirmationDiagnosisInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C2852
UMLS 2011AA ObjectClass
C0001418
NCI Thesaurus ObjectClass
C13363
UMLS 2011AA ObjectClass
C0555952
NCI Thesaurus Property
C25458
UMLS 2011AA Property
C0750484
NCI Thesaurus Property
C25526
UMLS 2011AA Property
C0205462
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Date of Report (A copy of the pathology report must be provided.)
Description

LaboratoryFindingReportDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25375
UMLS 2011AA Property
C0684224
NCI Thesaurus ObjectClass
C38470
When were suspicious liver metastases first detected on imaging?
Description

ComputedTomographyDiagnosticImagingLiverMetastasisPresentDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C16502
UMLS 2011AA ObjectClass
C0011923
NCI Thesaurus ObjectClass
C17204
UMLS 2011AA ObjectClass
C0040405
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus Property
C12392
UMLS 2011AA Property
C0023884
NCI Thesaurus Property
C19151
UMLS 2011AA Property
C0027627
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Have the primary tumor and regional nodes been resected?
Description

PrimaryTumorRegionalLymphNodeExcisionInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass
C25251
UMLS 2011AA ObjectClass
C0205225
NCI Thesaurus Property
C15232
UMLS 2011AA Property
C0728940
NCI Thesaurus Property
C49018
UMLS 2011AA Property
C1184738
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Is there a plan to resect the primary tumor and the liver metastases in a single surgical procedure?
Description

PrimaryTumorRegionalLymphNodeSingleSurgicalProcedureExcisionInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass
C25251
UMLS 2011AA ObjectClass
C0205225
NCI Thesaurus Property
C15329
UMLS 2011AA Property
C0543467
NCI Thesaurus Property
C15232
UMLS 2011AA Property
C0728940
NCI Thesaurus Property
C48440
UMLS 2011AA Property
C0205171
NCI Thesaurus Property
C49018
UMLS 2011AA Property
C1184738
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Were the surgical margins clear?
Description

RadialSurgicalMarginNoMicroscopicInvolvementInd-3

Data type

text

Alias
NCI Thesaurus ObjectClass
C41227
UMLS 2011AA ObjectClass
C0229985
NCI Thesaurus ObjectClass
C25314
UMLS 2011AA ObjectClass
C0442038
NCI Thesaurus Property
C25252
UMLS 2011AA Property
C0205288
NCI Thesaurus Property
C25548
UMLS 2011AA Property
C1314939
NCI Metathesaurus Property
C0028423
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Was there evidence of extrahepatic disease?
Description

ExtrahepaticMetastasisDiagnosisInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C19151
UMLS 2011AA ObjectClass
C0027627
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
NCI Thesaurus ObjectClass
C28358
UMLS 2011AA ObjectClass
C1517058
Did the patient have chemotherapy for the primary colorectal disease?
Description

PriorNeoadjuvantTherapyChemotherapyColorectalNeoplasmReceiveInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus ObjectClass
C15665
UMLS 2011AA ObjectClass
C0600558
NCI Thesaurus Property
C13363
UMLS 2011AA Property
C0555952
NCI Thesaurus Property
C25639
UMLS 2011AA Property
C1514756
NCI Metathesaurus Property
CL053268
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Approximately when was the last dose of chemotherapy?
Description

ChemotherapyLastAdministeredValue

Data type

text

Alias
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus Property
C25551
UMLS 2011AA Property
C1517741
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
In the past four weeks, has a hepatic surgeon determined that the patient's liver metastases are resectable based on the following criteria? (- A complete resection can be performed in a single operation AND - There are at least two uninvolved contiguous segments of the liver)
Description

LiverMetastasisPatientSurgeonDecisionEligibilityDeterminationInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass
C12392
UMLS 2011AA ObjectClass
C0023884
NCI Thesaurus ObjectClass
C19151
UMLS 2011AA ObjectClass
C0027627
NCI Thesaurus Property
C18071
UMLS 2011AA Property
C0582175
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
NCI Thesaurus Property
C53285
UMLS 2011AA Property
C0679006
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Date of Assessment (Month Day Year)
Description

AssessmentPerformedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25367
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
Section 2
Description

Section 2

List of Imaging Evaluations Performed
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
Evaluation Performed?
Description

EvaluationPerformedInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C25214
UMLS 2011AA ObjectClass
C0220825
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
Date of Assessment (Month Day Year)
Description

AssessmentPerformedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25367
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
Section 2 (continued)
Description

Section 2 (continued)

Were hepatic metastases evident on one or more scans?
Description

HepaticMetastasisMedicalImagingDiagnosisInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C13308
UMLS 2011AA ObjectClass
C0205054
NCI Thesaurus ObjectClass
C19151
UMLS 2011AA ObjectClass
C0027627
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
NCI Thesaurus Property
C16831
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Were extrahepatic metastases evident on one or more scans?
Description

ExtrahepaticMetastasisMedicalImagingDiagnosisInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C19151
UMLS 2011AA ObjectClass
C0027627
NCI Thesaurus ObjectClass
C28358
UMLS 2011AA ObjectClass
C1517058
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
NCI Thesaurus Property
C16831
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Patient Characteristics
Description

Patient Characteristics

Patient Height (cm)
Description

PatientHeightMeasurement

Data type

double

Measurement units
  • cm
Alias
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25347
UMLS 2011AA Property
C0489786
cm
Patient Weight (kg)
Description

PatientWeightMeasurement

Data type

double

Measurement units
  • Kg
Alias
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25208
UMLS 2011AA Property
C0043100
Kg
ECOG Performance Status
Description

PerformanceStatusAssessmentEasternCooperativeOncologyGroupScale

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
NCI Thesaurus Property
C25367
NCI Thesaurus ValueDomain
C25491
UMLS 2011AA ValueDomain
C1512162
NCI Thesaurus ObjectClass
C20641
UMLS 2011AA ObjectClass
C1518965
Blood Pressure, Systolic
Description

Systolic blood pressure

Data type

double

Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0871470
NCI Thesaurus Property
C25214
NCI Thesaurus ObjectClass
C25298
Blood pressure, Diastolic
Description

Diastolic blood pressure

Data type

double

Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0428883
NCI Thesaurus Property
C25214
NCI Thesaurus ObjectClass
C25299
Section 3 (continued)
Description

Section 3 (continued)

AST
Description

LaboratoryProcedureAspartateAminotransferaseMeasurementAssessmentsInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25367
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C64467
UMLS 2011AA Property
C0201899
SGOT (AST) (Patient Value units/L)
Description

LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultSpecifiedValue

Data type

double

Measurement units
  • U/L
Alias
NCI Thesaurus Property
C25202
UMLS 2011AA Property
C0242192
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
U/L
SGOT (AST) ULN
Description

LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedUpperLimitofNormalValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C25202
UMLS 2011AA Property
C0242192
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25706
UMLS 2011AA ValueDomain
C1519815
Date of Collection (Month Day Year)
Description

LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25202
UMLS 2011AA Property
C0242192
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
Alkaline Phosphatase
Description

LaboratoryProcedureAlkalinePhosphataseAssessmentInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25367
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C16276
UMLS 2011AA Property
C0002059
Alkaline Phosphatase (Patient Value units/L)
Description

LaboratoryProcedureAlkalinePhosphataseResultValue

Data type

double

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
C16276
UMLS 2011AA Property
C0002059
Alkaline Phosphatase ULN
Description

LaboratoryProcedureAlkalinePhosphataseResultUpperLimitNormalValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C16276
UMLS 2011AA Property
C0002059
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25706
UMLS 2011AA ValueDomain
C1519815
Date of Collection (Month Day Year)
Description

LaboratoryProcedureAlkalinePhosphataseResultDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C16276
UMLS 2011AA Property
C0002059
Total Bilirubin
Description

LaboratoryProcedureBilirubinAssessmentInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25367
NCI Thesaurus Property
C305
UMLS 2011AA Property
C0005437
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
Total Bilirubin (Patient Value mg/dL)
Description

LaboratoryProcedureTotalBilirubinResultSpecifiedValue

Data type

double

Measurement units
  • 1000/uL
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C38037
UMLS 2011AA Property
C0201913
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C38024
UMLS 2011AA ValueDomain
C0205369
1000/uL
Total bilirubin ULN
Description

LaboratoryProcedureTotalBilirubinResultSpecifiedUpperLimitofNormalValue

Data type

double

Measurement units
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C38037
UMLS 2011AA Property
C0201913
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C38024
UMLS 2011AA ValueDomain
C0205369
NCI Thesaurus ValueDomain
C25706
UMLS 2011AA ValueDomain
C1519815
mg/dL
Date of Collection (Month Day Year)
Description

LaboratoryProcedureBilirubinOutcomeDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C305
UMLS 2011AA Property
C0005437
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
Serum Creatinine
Description

LaboratoryProcedureCreatinineAssessmentInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25367
NCI Thesaurus Property
C399
UMLS 2011AA Property
C0010294
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
Serum creatinine (Patient Value mg/dL)
Description

LaboratoryProcedureCreatinineResultSpecifiedValue

Data type

double

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

LaboratoryProcedureCreatinineResultUpperLimitofNormalValue

Data type

double

Measurement units
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C399
UMLS 2011AA Property
C0010294
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25706
UMLS 2011AA ValueDomain
C1519815
mg/dL
Date of Collection (Month Day Year )
Description

LaboratoryProcedureCreatinineClearanceOutcomeDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C25747
UMLS 2011AA Property
C0373595
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
Section 3 (continued)
Description

Section 3 (continued)

ANC
Description

LaboratoryProcedureAbsoluteNeutrophilCountAssessmentInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25367
NCI Thesaurus Property
C63321
UMLS 2011AA Property
C0948762
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
ANC (Patient Value thousand/mm^3)
Description

LaboratoryProcedureAbsoluteNeutrophilCountResultUnspecifiedValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C63321
UMLS 2011AA Property
C0948762
NCI Thesaurus ValueDomain
C38046
UMLS 2011AA ValueDomain
C0205370
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
Date of Collection (Month Day Year )
Description

LaboratoryProcedureAbsoluteNeutrophilCountResultDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C63321
UMLS 2011AA Property
C0948762
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
Platelet Count
Description

LaboratoryProcedurePlateletAssessmentInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25367
NCI Thesaurus Property
C12520
UMLS 2011AA Property
C0005821
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
Platelet count (Patient Value thousand/mm^3)
Description

LaboratoryProcedurePlateletResultSpecifiedValue

Data type

double

Measurement units
  • 1000/uL
Alias
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C12520
UMLS 2011AA Property
C0005821
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
1000/uL
Date of Collection (Month Day Year )
Description

LaboratoryProcedurePlateletResultDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C12520
UMLS 2011AA Property
C0005821
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
Hemoglobin
Description

LaboratoryProcedureHemoglobinAssessmentInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25367
NCI Thesaurus Property
C16676
UMLS 2011AA Property
C0019046
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
Hemoglobin (Patient Value g/dL)
Description

LaboratoryProcedureHemoglobinResultSpecifiedValue

Data type

double

Measurement units
  • g/dL
Alias
NCI Thesaurus Property
C16676
UMLS 2011AA Property
C0019046
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
g/dL
Date of Collection (Month Day Year )
Description

LaboratoryProcedureHemoglobinResultDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C16676
UMLS 2011AA Property
C0019046
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
CEA
Description

LaboratoryProcedureCarcinoembryonicAntigenAssessmentInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25367
NCI Thesaurus Property
C25159
UMLS 2011AA Property
C0007082
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
CEA (Patient Value ng/mL)
Description

LaboratoryProcedureCarcinoembryonicAntigenOutcomeValue

Data type

text

Alias
NCI Thesaurus Property
C25159
UMLS 2011AA Property
C0007082
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
Date of Collection (Month Day Year )
Description

LaboratoryProcedureCarcinoembryonicAntigenOutcomeDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25159
UMLS 2011AA Property
C0007082
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
Calculated Creatinine Clearance
Description

LaboratoryProcedureCreatinineClearanceAssessmentInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25367
NCI Thesaurus Property
C25747
UMLS 2011AA Property
C0373595
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
Calculated creatinine clearance (Patient Value mL/min)
Description

LaboratoryProcedureCreatinineClearanceOutcomeEstimateValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C25747
UMLS 2011AA Property
C0373595
NCI Thesaurus ValueDomain
C25498
UMLS 2011AA ValueDomain
C0750572
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
Date of Collection (Month Day Year )
Description

LaboratoryProcedureCreatinineClearanceOutcomeDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C25747
UMLS 2011AA Property
C0373595
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
Section 4
Description

Section 4

Does the patient have a history of diabetes mellitus?
Description

DiabetesMellitusPersonalMedicalHistoryInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C2985
UMLS 2011AA ObjectClass
C0011849
NCI Thesaurus Property
C18772
UMLS 2011AA Property
C0262926
Does the patient have a diagnosis of anal, small bowel or appendiceal carcinoma?
Description

AnalSmallBowelAppendixCarcinomaDiagnosisInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C12386
UMLS 2011AA ObjectClass
C0021852
NCI Thesaurus ObjectClass
C2916
UMLS 2011AA ObjectClass
C0007097
NCI Thesaurus ObjectClass
C12380
UMLS 2011AA ObjectClass
C0003617
NCI Thesaurus ObjectClass
C28048
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Has the patient been diagnosed with colorectal malignant diseases other than adenocarcinoma, e.g., sarcoma, lymphoma, carcinoid?
Description

PatientColorectalMalignantNeoplasmEligibilityDeterminationInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C13363
UMLS 2011AA Property
C0555952
NCI Thesaurus Property
C9305
UMLS 2011AA Property
C0006826
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Does the patient have an unresected primary tumor in the colon or rectum with significant symptoms related to obstruction or that will require radiation therapy?
Description

ColorectalNeoplasmPatientObstructionRadiationTherapyEligibilityDeterminationInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass
C13363
UMLS 2011AA ObjectClass
C0555952
NCI Thesaurus Property
C15313
UMLS 2011AA Property
C1522449
NCI Thesaurus Property
C3284
UMLS 2011AA Property
C0028778
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Does the patient have a history of or current evidence of extrahepatic metastases? (Exclude regional nodes that are suspicious on imaging and associated with the primary colorectal cancer if the nodes will be resected with the primary tumor after randomization.)
Description

ExtrahepaticMetastasisPersonalMedicalHistoryInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C19151
UMLS 2011AA ObjectClass
C0027627
NCI Thesaurus ObjectClass
C28358
UMLS 2011AA ObjectClass
C1517058
NCI Thesaurus Property
C18772
UMLS 2011AA Property
C0262926
Does the patient's disease demonstrate radiographic evidence of metastases to portal lymph nodes (node > 1 cm in diameter) not proven by biopsy to be negative?
Description

PatientLymphNodeMetastasisEligibilityDeterminationInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C12745
UMLS 2011AA Property
C0024204
NCI Thesaurus Property
C19151
UMLS 2011AA Property
C0027627
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Has the patient received previous hepatic-directed therapy including hepatic resection and/or ablation, hepatic arterial infusion therapy, or hepatic radiation therapy (exluding incisional or excisional biopsy)?
Description

PatientPriorHepaticTreatmentEligibilityDeterminationInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C13308
UMLS 2011AA Property
C0205054
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property
C15368
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Has the patient received previous chemotherapy or any other systemic therapy for metastatic colorectal cancer?
Description

PatientChemotherapyMetastasisColorectalCarcinomaPersonalMedicalHistoryInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C15632
UMLS 2011AA Property
C0392920
NCI Thesaurus Property
C19151
UMLS 2011AA Property
C0027627
NCI Thesaurus Property
C2955
UMLS 2011AA Property
C0009402
NCI Thesaurus Property
C18772
UMLS 2011AA Property
C0262926
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Has the patient had a portal vein embolization (PVE) or other hepatic preconditioning techniques already performed or are preconditioning techniques such as PVE planned for this patient?
Description

SurgicalProcedurePortalVeinExcisionPerformedInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C15329
UMLS 2011AA ObjectClass
C0543467
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus Property
C15232
UMLS 2011AA Property
C0728940
NCI Thesaurus Property
C33343
UMLS 2011AA Property
C0032718
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Is there intent to use ablation to treat any hepatic lesion for this patient?
Description

HepaticLesionAblationTherapyIntentInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus ObjectClass
C13308
UMLS 2011AA ObjectClass
C0205054
NCI Thesaurus ObjectClass
C20985
UMLS 2011AA ObjectClass
C0547070
NCI Thesaurus Property
C25725
UMLS 2011AA Property
C1283828
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Does the patient have pre-existing chronic hepatic disease (e.g., chronic active hepatitis, cirrhosis) that, in the opinion of the investigator and hepatic surgeon, would limit the patient's ability to undergo hepatic metastasectomy?
Description

PatientPriorChronicHepaticDiseaseorDisorderEligibilityDeterminationInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C13308
UMLS 2011AA Property
C0205054
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property
C2991
UMLS 2011AA Property
C0012634
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
NCI Thesaurus Property
C14141
UMLS 2011AA Property
C0205191
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Does the patient have grade 3 or 4 anorexia, grade 3 nausea, or >= grade 2 vomiting (per CTCAE v4.0) related to metastatic disease?
Description

AdverseEventMetastasisAssociatedInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C19151
UMLS 2011AA Property
C0027627
NCI Thesaurus Property
C25281
UMLS 2011AA Property
C0332281
Does the patient have paresthesias, peripheral sensory neuropathy, or peripheral motor neuropathy >= grade 2 per CTCAE v4.0 (Exclude grade 2 neuropathy in patients who will receive FOLFIRI in this study)?
Description

AdverseEventNeuropathyAssociatedInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C4731
UMLS 2011AA Property
C0031117
NCI Thesaurus Property
C25281
UMLS 2011AA Property
C0332281
Does the patient have a documented history of congestive heart failure requiring chronic medical therapy?
Description

CongestiveHeartFailureHistoryInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C3080
UMLS 2011AA ObjectClass
C0018802
NCI Thesaurus Property
C18772
UMLS 2011AA Property
C0262926
Does the patient require therapeutic doses of coumadin or equivalent?
Description

PatientWarfarinTreatmentInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C15368
NCI Metathesaurus Property
C0043031
Does the patient have active inflammatory bowel disease?
Description

PatientInflammatoryBowelDiseasePersonalMedicalHistoryInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C3138
UMLS 2011AA Property
C0021390
NCI Thesaurus Property
C18772
UMLS 2011AA Property
C0262926
Does the patient have an active infection or chronic infection requiring chronic suppressive antibiotics?
Description

PatientInfectionInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C26726
UMLS 2011AA Property
C0009450
Does the patient have any known bleeding diathesis or coagulopathy?
Description

PatientHemorrhagePre-ExistingConditionEligibilityInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C26791
UMLS 2011AA Property
C0019080
NCI Metathesaurus Property
CL232826
Does the patient have symptomatic interstitial pneumonitis or is the patient asymptomatic with definitive evidence of interstitial pneumonitis described on CT scan, MRI, or chest x-ray?
Description

PatientInterstitialDiseaseLungPersonalMedicalHistoryInd-3

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C12468
UMLS 2011AA Property
C0024109
NCI Thesaurus Property
C18772
UMLS 2011AA Property
C0262926
NCI Thesaurus Property
C62410
UMLS 2011AA Property
C1881236
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Has the patient had other malignancies (other than carcinoma in situ of the cervix, colorectal carcinoma in situ, melanoma in situ, or basal cell or squamous cell carcinoma of the skin that has been treated)?
Description

PatientNeoplasmPersonalMedicalHistoryInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C3262
UMLS 2011AA Property
C0027651
NCI Thesaurus Property
C18772
UMLS 2011AA Property
C0262926
Is patient considered to be disease-free?
Description

DiseaseStatusIndicator

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Metathesaurus Property
C0449438
Did the patient complete therapy for the malignancies >= 1 year ago?
Description

PriorTherapyCompleteRegimenInd-3

Data type

text

Alias
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Thesaurus Property
C15697
UMLS 2011AA Property
C0040808
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Is the patient known to have Gilbert's Syndrome?
Description

PatientElevatedBilirubinPersonalMedicalHistoryInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C27088
UMLS 2011AA Property
C0311468
NCI Thesaurus Property
C18772
UMLS 2011AA Property
C0262926
Is the patient known to be homozygous for the UGT1A1 28 allele?
Description

HomozygousUGT1A1*28AlleleGenePresentInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C45826
UMLS 2011AA ObjectClass
C0019904
NCI Thesaurus ObjectClass
C16612
UMLS 2011AA ObjectClass
C0017337
NCI Thesaurus ObjectClass
C72564
UMLS 2011AA ObjectClass
C2825127
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Has the patient experienced a previous serious hypersensitivity reaction to any of the agents the patient will receive as part of the C-11 trial?
Description

PatientClinicalStudyAgentHypersensitivityPersonalMedicalHistoryInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C3114
UMLS 2011AA Property
C0020517
NCI Thesaurus Property
C1708
UMLS 2011AA Property
C0450442
NCI Thesaurus Property
C15206
UMLS 2011AA Property
C0008972
NCI Thesaurus Property
C18772
UMLS 2011AA Property
C0262926
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Does the patient have any other serious concomitant medical condition that, in the opinion of the investigator, would compromise the safety of the patient, compromise the patient's ability to participate in the study, or cause a delay in the initiation of therapy (surgery or chemotherapy) longer than 4 weeks following randomization?
Description

ConcomitantDiseasePersonalMedicalHistoryInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus ObjectClass
C25730
UMLS 2011AA ObjectClass
C0521115
NCI Thesaurus Property
C18772
UMLS 2011AA Property
C0262926
Does the patient have psychiatric or addictive disorders or other condition that, in the opinion of the investigator, would preclude the patient from meeting the study requirements?
Description

PatientStudyRequirementInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C38015
Has the patient taken any investigational product within the past 30 days?
Description

PriorInvestigationalTherapiesAdministeredInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Metathesaurus ObjectClass
C0949266
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Is the patient a woman of child-bearing potential? (The following questions are to be completed for female patients only.)
Description

FemalePatientPotentialPregnancyInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass
C16576
UMLS 2011AA ObjectClass
C0015780
NCI Thesaurus Property
C25742
UMLS 2011AA Property
C0032961
NCI Metathesaurus Property
C0237399
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Was a pregnancy test performed?
Description

PatientPregnancyTestIndicator

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Metathesaurus Property
C0032976
Date of pregnancy test
Description

PatientMostRecentPregnancyTestDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Metathesaurus Property
C0032976
NCI Thesaurus Property
C25577
UMLS 2011AA Property
C1513491
Is the patient pregnant or lactating at time of study entry?
Description

PatientPregnancyInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25742
UMLS 2011AA Property
C0032961
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1 forms
  1. StudyEvent: NSABP C-11 OPEN Worksheet for Form Entry
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Unnamed1
PatientInitialsName
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
ClinicalTrialSiteNameText
Item
Site Name
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15207 (NCI Thesaurus ObjectClass)
C37901 (NCI Thesaurus Property)
C0205145 (UMLS 2011AA Property)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)
PatientBirthDate
Item
Patient Birth Date (Month Day Year)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25367 (NCI Thesaurus ValueDomain)
C25155 (NCI Thesaurus Property)
C0005615 (UMLS 2011AA Property)
TreatingPhysicianName
Item
Treating physician
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25741 (NCI Thesaurus ObjectClass)
C0031831 (UMLS 2011AA ObjectClass)
C25705 (NCI Thesaurus ObjectClass)
C1522326 (UMLS 2011AA ObjectClass)
Item Group
Race
Item
Race
text
C25372 (NCI Thesaurus Property)
C0683312 (UMLS 2011AA Property)
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C17049 (NCI Thesaurus ObjectClass)
C0034510 (UMLS 2011AA ObjectClass)
CL.1
Code List
Race
CL Item
A Person Having Origins In Any Of The Original Peoples Of Europe, The Middle East, Or North Africa. (White)
C41261 (NCI Thesaurus)
C0007457 (UMLS 2011AA)
CL Item
A Person Having Origins In Any Of The Black Racial Groups Of Africa. Terms Such As "haitian" Or "negro" Can Be Used In Addition To "black Or African American." (Black or African American)
C16352 (NCI Thesaurus)
C0085756 (UMLS 2011AA)
CL Item
A Person Having Origins In Any Of The Original Peoples Of Hawaii, Guam, Samoa, Or Other Pacific Islands. (Native Hawaiian or other Pacific Islander)
C41219 (NCI Thesaurus)
C1513907 (UMLS 2011AA)
CL Item
A Person Having Origins In Any Of The Original Peoples Of The Far East, Southeast Asia, Or The Indian Subcontinent Including, For Example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, The Philippine Islands, Thailand, And Vietnam. (Asian)
C41260 (NCI Thesaurus)
C0078988 (UMLS 2011AA)
CL Item
A Person Having Origins In Any Of The Original Peoples Of North And South America (including Central America), And Who Maintains Tribal Affiliation Or Community Attachment. (American Indian or Alaska Native)
C41259 (NCI Thesaurus)
C1515945 (UMLS 2011AA)
CL Item
Could Not Be Determined Or Unsure (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item Group
Person Completing Form, Last Name
Item
Method of Payment (mark primary method only)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25371 (NCI Thesaurus Property)
C0680264 (UMLS 2011AA Property)
CL.2
Code List
Method of Payment (mark primary method only)
CL Item
Private Insurance (Private Insurance)
CL Item
Medicare (Medicare)
C16665 (NCI Thesaurus)
C0018717 (UMLS 2011AA)
CL Item
Medicare And Private Insurance (Medicare and Private Insurance)
CL Item
Medicaid (Medicaid)
C0025071 (NCI Metathesaurus)
CL Item
Medicaid And Medicare (Medicaid and Medicare)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Military Or Veterans Sponsored Nos (Military or Veterans Sponsored, Not Otherwise Specified (NOS))
CL Item
Military Sponsored (including Champus & Tricare) (Military Sponsored (including CHAMPUS & TRICARE))
CL Item
Veterans Sponsored (Veterans Sponsored)
CL Item
Self Pay (no Insurance) (Self Pay (No Insurance))
CL Item
No Means Of Payment (no Insurance) (No means of payment (no insurance))
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Ethnicity
text
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C16564 (NCI Thesaurus Property)
C0015031 (UMLS 2011AA Property)
CL.3
Code List
Ethnicity
CL Item
A Person Of Mexican, Puerto Rican, Cuban, Central Or South American Or Other Spanish Culture Or Origin, Regardless Of Race. (HISPANIC OR LATINO)
C17459 (NCI Thesaurus)
C0086409 (UMLS 2011AA)
CL Item
A Person Not Meeting The Definition For Hispanic Or Latino. (NOT HISPANIC OR LATINO)
C41222 (NCI Thesaurus)
C1518424 (UMLS 2011AA)
CL Item
Could Not Be Determined Or Unsure (UNKNOWN)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Country of residence
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25407 (NCI Thesaurus Property)
C1442065 (UMLS 2011AA Property)
CL.4
Code List
Country of residence
CL Item
Usa (US)
CL Item
Canada (CA)
C16380 (NCI Thesaurus)
C0006823 (UMLS 2011AA)
CL Item
Puerto Rico (PR)
C17043 (NCI Thesaurus)
C0034044 (UMLS 2011AA)
CL Item
Other (Other)
OtherPatientAddressCountrySpecify
Item
Other
text
C17649 (NCI Thesaurus ObjectClass)
C0205394 (UMLS 2011AA ObjectClass)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25407 (NCI Thesaurus Property)
C1442065 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25464 (NCI Thesaurus ValueDomain)
C0454664 (UMLS 2011AA ValueDomain)
PersonAddressPostalCode
Item
Patient Zip Code (USA)
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25407 (NCI Thesaurus Property)
C1442065 (UMLS 2011AA Property)
PatientSSNNumber
Item
Patient Social Security Number (USA only)
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25686 (NCI Thesaurus Property)
C1301821 (UMLS 2011AA Property)
Item
Patient gender
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C17357 (NCI Thesaurus Property)
C0079399 (UMLS 2011AA Property)
CL.5
Code List
Patient gender
CL Item
Male Gender (Male)
C46109 (NCI Thesaurus)
C1706180 (UMLS 2011AA)
CL Item
Female Gender (Female)
C46110 (NCI Thesaurus)
C0015780 (UMLS 2011AA)
Item Group
Unnamed4
Item
Did the patient consent to use of blood samples for testing related to C-11?
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C12434 (NCI Thesaurus Property)
C0229664 (UMLS 2011AA Property)
C19157 (NCI Thesaurus Property)
C0370003 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.6
Code List
Did the patient consent to use of blood samples for testing related to C-11?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Did the patient consent to use of tissue and blood samples for future research to learn about, prevent, or treat cancer?
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus Property)
C0006826 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
CL.7
Code List
Did the patient consent to use of tissue and blood samples for future research to learn about, prevent, or treat cancer?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Did the patient consent to use of tissue and blood samples for research about other problems?
text
C12801 (NCI Thesaurus ObjectClass)
C0040300 (UMLS 2011AA ObjectClass)
C12434 (NCI Thesaurus ObjectClass)
C0229664 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C15319 (NCI Thesaurus Property)
C2991 (NCI Thesaurus Property)
C0012634 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.8
Code List
Did the patient consent to use of tissue and blood samples for research about other problems?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Did the patient consent to future contact about more research?
text
C12801 (NCI Thesaurus ObjectClass)
C0040300 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C15319 (NCI Thesaurus Property)
C25648 (NCI Thesaurus Property)
C0439849 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property)
C0006826 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.9
Code List
Did the patient consent to future contact about more research?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Has the patient authorized the release of Protected Health Information to the NSABP?
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
CL.10
Code List
Has the patient authorized the release of Protected Health Information to the NSABP?
CL Item
Yes: C49488 (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No: C49487 (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
InformedConsentFormSignedDate
Item
Date Informed Consent Signed (Month Day Year)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
HepaticMetastasisPriorClinicalStudyDiagnosisCount
Item
Number of liver metastases on pre-entry evaluation
double
C13308 (NCI Thesaurus ObjectClass)
C0205054 (UMLS 2011AA ObjectClass)
C19151 (NCI Thesaurus ObjectClass)
C0027627 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C15206 (NCI Thesaurus Property)
C0008972 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
Item
Has the patient received prior oxaliplatin therapy?
text
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C1181 (NCI Thesaurus Property)
C0069717 (UMLS 2011AA Property)
C54732 (NCI Thesaurus Property)
C0445204 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.11
Code List
Has the patient received prior oxaliplatin therapy?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item Group
Page Headers
PatientInitialsName
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
PatientNationalSurgicalAdjuvantBreastProjectIdentifierNumber
Item
NSABP Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C15818 (NCI Thesaurus Property)
C1513905 (UMLS 2011AA Property)
Item Group
Surgery For Primary Colorectal Tumor
Item
Was a diagnosis of colorectal adenocarcinoma confirmed histologically?
text
C2852 (NCI Thesaurus ObjectClass)
C0001418 (UMLS 2011AA ObjectClass)
C13363 (NCI Thesaurus ObjectClass)
C0555952 (UMLS 2011AA ObjectClass)
C25458 (NCI Thesaurus Property)
C0750484 (UMLS 2011AA Property)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.12
Code List
Was a diagnosis of colorectal adenocarcinoma confirmed histologically?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
LaboratoryFindingReportDate
Item
Date of Report (A copy of the pathology report must be provided.)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25375 (NCI Thesaurus Property)
C0684224 (UMLS 2011AA Property)
C38470 (NCI Thesaurus ObjectClass)
ComputedTomographyDiagnosticImagingLiverMetastasisPresentDate
Item
When were suspicious liver metastases first detected on imaging?
date
C16502 (NCI Thesaurus ObjectClass)
C0011923 (UMLS 2011AA ObjectClass)
C17204 (NCI Thesaurus ObjectClass)
C0040405 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C12392 (NCI Thesaurus Property)
C0023884 (UMLS 2011AA Property)
C19151 (NCI Thesaurus Property)
C0027627 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item
Have the primary tumor and regional nodes been resected?
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25251 (NCI Thesaurus ObjectClass)
C0205225 (UMLS 2011AA ObjectClass)
C15232 (NCI Thesaurus Property)
C0728940 (UMLS 2011AA Property)
C49018 (NCI Thesaurus Property)
C1184738 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.13
Code List
Have the primary tumor and regional nodes been resected?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Is there a plan to resect the primary tumor and the liver metastases in a single surgical procedure?
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25251 (NCI Thesaurus ObjectClass)
C0205225 (UMLS 2011AA ObjectClass)
C15329 (NCI Thesaurus Property)
C0543467 (UMLS 2011AA Property)
C15232 (NCI Thesaurus Property)
C0728940 (UMLS 2011AA Property)
C48440 (NCI Thesaurus Property)
C0205171 (UMLS 2011AA Property)
C49018 (NCI Thesaurus Property)
C1184738 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.14
Code List
Is there a plan to resect the primary tumor and the liver metastases in a single surgical procedure?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Were the surgical margins clear?
text
C41227 (NCI Thesaurus ObjectClass)
C0229985 (UMLS 2011AA ObjectClass)
C25314 (NCI Thesaurus ObjectClass)
C0442038 (UMLS 2011AA ObjectClass)
C25252 (NCI Thesaurus Property)
C0205288 (UMLS 2011AA Property)
C25548 (NCI Thesaurus Property)
C1314939 (UMLS 2011AA Property)
C0028423 (NCI Metathesaurus Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.15
Code List
Were the surgical margins clear?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Was there evidence of extrahepatic disease?
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C19151 (NCI Thesaurus ObjectClass)
C0027627 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C28358 (NCI Thesaurus ObjectClass)
C1517058 (UMLS 2011AA ObjectClass)
CL.16
Code List
Was there evidence of extrahepatic disease?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Did the patient have chemotherapy for the primary colorectal disease?
text
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15665 (NCI Thesaurus ObjectClass)
C0600558 (UMLS 2011AA ObjectClass)
C13363 (NCI Thesaurus Property)
C0555952 (UMLS 2011AA Property)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
CL053268 (NCI Metathesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.17
Code List
Did the patient have chemotherapy for the primary colorectal disease?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Approximately when was the last dose of chemotherapy?
text
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25551 (NCI Thesaurus Property)
C1517741 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
CL.18
Code List
Approximately when was the last dose of chemotherapy?
CL Item
0-6 Months Ago (0-6 months ago)
CL Item
7-12 Months Ago (7-12 months ago)
CL Item
13-24 Months Ago (13-24 months ago)
CL Item
>24 Months Ago (>24 months ago)
Item
In the past four weeks, has a hepatic surgeon determined that the patient's liver metastases are resectable based on the following criteria? (- A complete resection can be performed in a single operation AND - There are at least two uninvolved contiguous segments of the liver)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C12392 (NCI Thesaurus ObjectClass)
C0023884 (UMLS 2011AA ObjectClass)
C19151 (NCI Thesaurus ObjectClass)
C0027627 (UMLS 2011AA ObjectClass)
C18071 (NCI Thesaurus Property)
C0582175 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C53285 (NCI Thesaurus Property)
C0679006 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.19
Code List
In the past four weeks, has a hepatic surgeon determined that the patient's liver metastases are resectable based on the following criteria? (- A complete resection can be performed in a single operation AND - There are at least two uninvolved contiguous segments of the liver)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
AssessmentPerformedDate
Item
Date of Assessment (Month Day Year)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
Item Group
Section 2
Item
List of Imaging Evaluations Performed
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)
CL.20
Code List
List of Imaging Evaluations Performed
CL Item
Computed Tomography Contrast Positron Emission Tomography (PET-CT scan with contrast)
C17007 (NCI Thesaurus)
C0032743 (UMLS 2011AA)
C17204 (NCI Thesaurus)
C0040405 (UMLS 2011AA)
C70754 (NCI Thesaurus)
C1979874 (UMLS 2011AA)
CL Item
Positron Emission Tomography (PET scan)
C17007 (NCI Thesaurus)
C0032743 (UMLS 2011AA)
CL Item
Computed Tomography No Contrast Positron Emission Tomography (PET-CT scan without contrast)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C17007 (NCI Thesaurus)
C0032743 (UMLS 2011AA)
C17204 (NCI Thesaurus)
C0040405 (UMLS 2011AA)
C70754 (NCI Thesaurus)
C1979874 (UMLS 2011AA)
CL Item
Contrast Chest Computed Tomography (CT scan with contrast, chest)
C17204 (NCI Thesaurus)
C0040405 (UMLS 2011AA)
C25389 (NCI Thesaurus)
C0817096 (UMLS 2011AA)
C70754 (NCI Thesaurus)
C1979874 (UMLS 2011AA)
CL Item
Contrast Abdominal Cavity Computed Tomography (CT scan with contrast, abdomen)
C17204 (NCI Thesaurus)
C0040405 (UMLS 2011AA)
C12664 (NCI Thesaurus)
C0230168 (UMLS 2011AA)
C70754 (NCI Thesaurus)
C1979874 (UMLS 2011AA)
CL Item
Contrast Abdominal Cavity Magnetic Resonance Imaging (MRI with contrast, abdomen)
C12664 (NCI Thesaurus)
C0230168 (UMLS 2011AA)
C16809 (NCI Thesaurus)
C0024485 (UMLS 2011AA)
C70754 (NCI Thesaurus)
C1979874 (UMLS 2011AA)
CL Item
Contrast Pelvis Computed Tomography (CT scan with contrast, pelvis)
C17204 (NCI Thesaurus)
C0040405 (UMLS 2011AA)
C12767 (NCI Thesaurus)
C0030797 (UMLS 2011AA)
C70754 (NCI Thesaurus)
C1979874 (UMLS 2011AA)
CL Item
Contrast Pelvis Magnetic Resonance Imaging (MRI with contrast, pelvis)
C12767 (NCI Thesaurus)
C0030797 (UMLS 2011AA)
C16809 (NCI Thesaurus)
C0024485 (UMLS 2011AA)
C70754 (NCI Thesaurus)
C1979874 (UMLS 2011AA)
Item
Evaluation Performed?
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus ObjectClass)
C0220825 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
CL.21
Code List
Evaluation Performed?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
AssessmentPerformedDate
Item
Date of Assessment (Month Day Year)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
Item Group
Section 2 (continued)
Item
Were hepatic metastases evident on one or more scans?
text
C13308 (NCI Thesaurus ObjectClass)
C0205054 (UMLS 2011AA ObjectClass)
C19151 (NCI Thesaurus ObjectClass)
C0027627 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C16831 (NCI Thesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.22
Code List
Were hepatic metastases evident on one or more scans?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Were extrahepatic metastases evident on one or more scans?
text
C19151 (NCI Thesaurus ObjectClass)
C0027627 (UMLS 2011AA ObjectClass)
C28358 (NCI Thesaurus ObjectClass)
C1517058 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C16831 (NCI Thesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.23
Code List
Were extrahepatic metastases evident on one or more scans?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item Group
Patient Characteristics
PatientHeightMeasurement
Item
Patient Height (cm)
double
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25347 (NCI Thesaurus Property)
C0489786 (UMLS 2011AA Property)
PatientWeightMeasurement
Item
Patient Weight (kg)
double
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25208 (NCI Thesaurus Property)
C0043100 (UMLS 2011AA Property)
Item
ECOG Performance Status
text
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain)
C1512162 (UMLS 2011AA ValueDomain)
C20641 (NCI Thesaurus ObjectClass)
C1518965 (UMLS 2011AA ObjectClass)
CL.24
Code List
ECOG Performance Status
CL Item
Fully Active, Able To Carry On All Pre-disease Performance Without Restriction. (0)
CL Item
Restricted In Physically Strenuous Activity But Ambulatory And Able To Carry Out Work Of A Light Or Sedentary Nature, E.g., Light Housework, Office Work. (1)
CL Item
Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities. Up And About More Than 50% Of Waking Hours. (2)
CL Item
Capable Of Only Limited Selfcare, Confined To Bed Or Chair More Than 50% Of Waking Hours. (3)
CL Item
Completely Disabled. Cannot Carry On Any Selfcare. Totally Confined To Bed Or Chair. (4)
Systolic blood pressure
Item
Blood Pressure, Systolic
double
C25209 (NCI Thesaurus ValueDomain)
C0871470 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C25298 (NCI Thesaurus ObjectClass)
Diastolic blood pressure
Item
Blood pressure, Diastolic
double
C25209 (NCI Thesaurus ValueDomain)
C0428883 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C25299 (NCI Thesaurus ObjectClass)
Item Group
Section 3 (continued)
Item
AST
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C64467 (NCI Thesaurus Property)
C0201899 (UMLS 2011AA Property)
CL.25
Code List
AST
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultSpecifiedValue
Item
SGOT (AST) (Patient Value units/L)
double
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedUpperLimitofNormalValue
Item
SGOT (AST) ULN
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultDate
Item
Date of Collection (Month Day Year)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
Item
Alkaline Phosphatase
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C16276 (NCI Thesaurus Property)
C0002059 (UMLS 2011AA Property)
CL.26
Code List
Alkaline Phosphatase
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
LaboratoryProcedureAlkalinePhosphataseResultValue
Item
Alkaline Phosphatase (Patient Value units/L)
double
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C16276 (NCI Thesaurus Property)
C0002059 (UMLS 2011AA Property)
LaboratoryProcedureAlkalinePhosphataseResultUpperLimitNormalValue
Item
Alkaline Phosphatase ULN
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C16276 (NCI Thesaurus Property)
C0002059 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
LaboratoryProcedureAlkalinePhosphataseResultDate
Item
Date of Collection (Month Day Year)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C16276 (NCI Thesaurus Property)
C0002059 (UMLS 2011AA Property)
Item
Total Bilirubin
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C305 (NCI Thesaurus Property)
C0005437 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
CL.27
Code List
Total Bilirubin
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
LaboratoryProcedureTotalBilirubinResultSpecifiedValue
Item
Total Bilirubin (Patient Value mg/dL)
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C38037 (NCI Thesaurus Property)
C0201913 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C38024 (NCI Thesaurus ValueDomain)
C0205369 (UMLS 2011AA ValueDomain)
LaboratoryProcedureTotalBilirubinResultSpecifiedUpperLimitofNormalValue
Item
Total bilirubin ULN
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C38037 (NCI Thesaurus Property)
C0201913 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C38024 (NCI Thesaurus ValueDomain)
C0205369 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
LaboratoryProcedureBilirubinOutcomeDate
Item
Date of Collection (Month Day Year)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C305 (NCI Thesaurus Property)
C0005437 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
Item
Serum Creatinine
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
CL.28
Code List
Serum Creatinine
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
LaboratoryProcedureCreatinineResultSpecifiedValue
Item
Serum creatinine (Patient Value mg/dL)
double
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureCreatinineResultUpperLimitofNormalValue
Item
Serum Creatinine ULN
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
LaboratoryProcedureCreatinineClearanceOutcomeDate
Item
Date of Collection (Month Day Year )
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25747 (NCI Thesaurus Property)
C0373595 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
Item Group
Section 3 (continued)
Item
ANC
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C63321 (NCI Thesaurus Property)
C0948762 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
CL.29
Code List
ANC
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
LaboratoryProcedureAbsoluteNeutrophilCountResultUnspecifiedValue
Item
ANC (Patient Value thousand/mm^3)
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C63321 (NCI Thesaurus Property)
C0948762 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureAbsoluteNeutrophilCountResultDate
Item
Date of Collection (Month Day Year )
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C63321 (NCI Thesaurus Property)
C0948762 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
Item
Platelet Count
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C12520 (NCI Thesaurus Property)
C0005821 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
CL.30
Code List
Platelet Count
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
LaboratoryProcedurePlateletResultSpecifiedValue
Item
Platelet count (Patient Value thousand/mm^3)
double
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12520 (NCI Thesaurus Property)
C0005821 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedurePlateletResultDate
Item
Date of Collection (Month Day Year )
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12520 (NCI Thesaurus Property)
C0005821 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
Item
Hemoglobin
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C16676 (NCI Thesaurus Property)
C0019046 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
CL.31
Code List
Hemoglobin
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
LaboratoryProcedureHemoglobinResultSpecifiedValue
Item
Hemoglobin (Patient Value g/dL)
double
C16676 (NCI Thesaurus Property)
C0019046 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureHemoglobinResultDate
Item
Date of Collection (Month Day Year )
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16676 (NCI Thesaurus Property)
C0019046 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
Item
CEA
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C25159 (NCI Thesaurus Property)
C0007082 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
CL.32
Code List
CEA
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
LaboratoryProcedureCarcinoembryonicAntigenOutcomeValue
Item
CEA (Patient Value ng/mL)
text
C25159 (NCI Thesaurus Property)
C0007082 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureCarcinoembryonicAntigenOutcomeDate
Item
Date of Collection (Month Day Year )
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25159 (NCI Thesaurus Property)
C0007082 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
Item
Calculated Creatinine Clearance
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C25747 (NCI Thesaurus Property)
C0373595 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
CL.33
Code List
Calculated Creatinine Clearance
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
LaboratoryProcedureCreatinineClearanceOutcomeEstimateValue
Item
Calculated creatinine clearance (Patient Value mL/min)
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25747 (NCI Thesaurus Property)
C0373595 (UMLS 2011AA Property)
C25498 (NCI Thesaurus ValueDomain)
C0750572 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureCreatinineClearanceOutcomeDate
Item
Date of Collection (Month Day Year )
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25747 (NCI Thesaurus Property)
C0373595 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
Item
Does the patient have a history of diabetes mellitus?
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C2985 (NCI Thesaurus ObjectClass)
C0011849 (UMLS 2011AA ObjectClass)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
CL.34
Code List
Does the patient have a history of diabetes mellitus?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Does the patient have a diagnosis of anal, small bowel or appendiceal carcinoma?
text
C12386 (NCI Thesaurus ObjectClass)
C0021852 (UMLS 2011AA ObjectClass)
C2916 (NCI Thesaurus ObjectClass)
C0007097 (UMLS 2011AA ObjectClass)
C12380 (NCI Thesaurus ObjectClass)
C0003617 (UMLS 2011AA ObjectClass)
C28048 (NCI Thesaurus ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.35
Code List
Does the patient have a diagnosis of anal, small bowel or appendiceal carcinoma?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Has the patient been diagnosed with colorectal malignant diseases other than adenocarcinoma, e.g., sarcoma, lymphoma, carcinoid?
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C13363 (NCI Thesaurus Property)
C0555952 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property)
C0006826 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.36
Code List
Has the patient been diagnosed with colorectal malignant diseases other than adenocarcinoma, e.g., sarcoma, lymphoma, carcinoid?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Does the patient have an unresected primary tumor in the colon or rectum with significant symptoms related to obstruction or that will require radiation therapy?
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C13363 (NCI Thesaurus ObjectClass)
C0555952 (UMLS 2011AA ObjectClass)
C15313 (NCI Thesaurus Property)
C1522449 (UMLS 2011AA Property)
C3284 (NCI Thesaurus Property)
C0028778 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.37
Code List
Does the patient have an unresected primary tumor in the colon or rectum with significant symptoms related to obstruction or that will require radiation therapy?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Does the patient have a history of or current evidence of extrahepatic metastases? (Exclude regional nodes that are suspicious on imaging and associated with the primary colorectal cancer if the nodes will be resected with the primary tumor after randomization.)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C19151 (NCI Thesaurus ObjectClass)
C0027627 (UMLS 2011AA ObjectClass)
C28358 (NCI Thesaurus ObjectClass)
C1517058 (UMLS 2011AA ObjectClass)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
CL.38
Code List
Does the patient have a history of or current evidence of extrahepatic metastases? (Exclude regional nodes that are suspicious on imaging and associated with the primary colorectal cancer if the nodes will be resected with the primary tumor after randomization.)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Does the patient's disease demonstrate radiographic evidence of metastases to portal lymph nodes (node > 1 cm in diameter) not proven by biopsy to be negative?
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C12745 (NCI Thesaurus Property)
C0024204 (UMLS 2011AA Property)
C19151 (NCI Thesaurus Property)
C0027627 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.39
Code List
Does the patient's disease demonstrate radiographic evidence of metastases to portal lymph nodes (node > 1 cm in diameter) not proven by biopsy to be negative?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Has the patient received previous hepatic-directed therapy including hepatic resection and/or ablation, hepatic arterial infusion therapy, or hepatic radiation therapy (exluding incisional or excisional biopsy)?
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C13308 (NCI Thesaurus Property)
C0205054 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C15368 (NCI Thesaurus Property)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.40
Code List
Has the patient received previous hepatic-directed therapy including hepatic resection and/or ablation, hepatic arterial infusion therapy, or hepatic radiation therapy (exluding incisional or excisional biopsy)?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Has the patient received previous chemotherapy or any other systemic therapy for metastatic colorectal cancer?
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C15632 (NCI Thesaurus Property)
C0392920 (UMLS 2011AA Property)
C19151 (NCI Thesaurus Property)
C0027627 (UMLS 2011AA Property)
C2955 (NCI Thesaurus Property)
C0009402 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.41
Code List
Has the patient received previous chemotherapy or any other systemic therapy for metastatic colorectal cancer?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Has the patient had a portal vein embolization (PVE) or other hepatic preconditioning techniques already performed or are preconditioning techniques such as PVE planned for this patient?
text
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15232 (NCI Thesaurus Property)
C0728940 (UMLS 2011AA Property)
C33343 (NCI Thesaurus Property)
C0032718 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.42
Code List
Has the patient had a portal vein embolization (PVE) or other hepatic preconditioning techniques already performed or are preconditioning techniques such as PVE planned for this patient?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Is there intent to use ablation to treat any hepatic lesion for this patient?
text
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C13308 (NCI Thesaurus ObjectClass)
C0205054 (UMLS 2011AA ObjectClass)
C20985 (NCI Thesaurus ObjectClass)
C0547070 (UMLS 2011AA ObjectClass)
C25725 (NCI Thesaurus Property)
C1283828 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.43
Code List
Is there intent to use ablation to treat any hepatic lesion for this patient?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Does the patient have pre-existing chronic hepatic disease (e.g., chronic active hepatitis, cirrhosis) that, in the opinion of the investigator and hepatic surgeon, would limit the patient's ability to undergo hepatic metastasectomy?
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C13308 (NCI Thesaurus Property)
C0205054 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C2991 (NCI Thesaurus Property)
C0012634 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C14141 (NCI Thesaurus Property)
C0205191 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.44
Code List
Does the patient have pre-existing chronic hepatic disease (e.g., chronic active hepatitis, cirrhosis) that, in the opinion of the investigator and hepatic surgeon, would limit the patient's ability to undergo hepatic metastasectomy?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Does the patient have grade 3 or 4 anorexia, grade 3 nausea, or >= grade 2 vomiting (per CTCAE v4.0) related to metastatic disease?
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C19151 (NCI Thesaurus Property)
C0027627 (UMLS 2011AA Property)
C25281 (NCI Thesaurus Property)
C0332281 (UMLS 2011AA Property)
CL.45
Code List
Does the patient have grade 3 or 4 anorexia, grade 3 nausea, or >= grade 2 vomiting (per CTCAE v4.0) related to metastatic disease?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Does the patient have paresthesias, peripheral sensory neuropathy, or peripheral motor neuropathy >= grade 2 per CTCAE v4.0 (Exclude grade 2 neuropathy in patients who will receive FOLFIRI in this study)?
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C4731 (NCI Thesaurus Property)
C0031117 (UMLS 2011AA Property)
C25281 (NCI Thesaurus Property)
C0332281 (UMLS 2011AA Property)
CL.46
Code List
Does the patient have paresthesias, peripheral sensory neuropathy, or peripheral motor neuropathy >= grade 2 per CTCAE v4.0 (Exclude grade 2 neuropathy in patients who will receive FOLFIRI in this study)?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Does the patient have a documented history of congestive heart failure requiring chronic medical therapy?
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C3080 (NCI Thesaurus ObjectClass)
C0018802 (UMLS 2011AA ObjectClass)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
CL.47
Code List
Does the patient have a documented history of congestive heart failure requiring chronic medical therapy?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Does the patient require therapeutic doses of coumadin or equivalent?
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)
C0043031 (NCI Metathesaurus Property)
CL.48
Code List
Does the patient require therapeutic doses of coumadin or equivalent?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Does the patient have active inflammatory bowel disease?
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3138 (NCI Thesaurus Property)
C0021390 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
CL.49
Code List
Does the patient have active inflammatory bowel disease?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Does the patient have an active infection or chronic infection requiring chronic suppressive antibiotics?
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C26726 (NCI Thesaurus Property)
C0009450 (UMLS 2011AA Property)
CL.50
Code List
Does the patient have an active infection or chronic infection requiring chronic suppressive antibiotics?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Does the patient have any known bleeding diathesis or coagulopathy?
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C26791 (NCI Thesaurus Property)
C0019080 (UMLS 2011AA Property)
CL232826 (NCI Metathesaurus Property)
CL.51
Code List
Does the patient have any known bleeding diathesis or coagulopathy?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Does the patient have symptomatic interstitial pneumonitis or is the patient asymptomatic with definitive evidence of interstitial pneumonitis described on CT scan, MRI, or chest x-ray?
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C12468 (NCI Thesaurus Property)
C0024109 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
C62410 (NCI Thesaurus Property)
C1881236 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.52
Code List
Does the patient have symptomatic interstitial pneumonitis or is the patient asymptomatic with definitive evidence of interstitial pneumonitis described on CT scan, MRI, or chest x-ray?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Has the patient had other malignancies (other than carcinoma in situ of the cervix, colorectal carcinoma in situ, melanoma in situ, or basal cell or squamous cell carcinoma of the skin that has been treated)?
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3262 (NCI Thesaurus Property)
C0027651 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
CL.53
Code List
Has the patient had other malignancies (other than carcinoma in situ of the cervix, colorectal carcinoma in situ, melanoma in situ, or basal cell or squamous cell carcinoma of the skin that has been treated)?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Is patient considered to be disease-free?
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C0449438 (NCI Metathesaurus Property)
CL.54
Code List
Is patient considered to be disease-free?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Did the patient complete therapy for the malignancies >= 1 year ago?
text
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C15697 (NCI Thesaurus Property)
C0040808 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.55
Code List
Did the patient complete therapy for the malignancies >= 1 year ago?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Is the patient known to have Gilbert's Syndrome?
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C27088 (NCI Thesaurus Property)
C0311468 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
CL.56
Code List
Is the patient known to have Gilbert's Syndrome?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Is the patient known to be homozygous for the UGT1A1 28 allele?
text
C45826 (NCI Thesaurus ObjectClass)
C0019904 (UMLS 2011AA ObjectClass)
C16612 (NCI Thesaurus ObjectClass)
C0017337 (UMLS 2011AA ObjectClass)
C72564 (NCI Thesaurus ObjectClass)
C2825127 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.57
Code List
Is the patient known to be homozygous for the UGT1A1 28 allele?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Has the patient experienced a previous serious hypersensitivity reaction to any of the agents the patient will receive as part of the C-11 trial?
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3114 (NCI Thesaurus Property)
C0020517 (UMLS 2011AA Property)
C1708 (NCI Thesaurus Property)
C0450442 (UMLS 2011AA Property)
C15206 (NCI Thesaurus Property)
C0008972 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.58
Code List
Has the patient experienced a previous serious hypersensitivity reaction to any of the agents the patient will receive as part of the C-11 trial?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Does the patient have any other serious concomitant medical condition that, in the opinion of the investigator, would compromise the safety of the patient, compromise the patient's ability to participate in the study, or cause a delay in the initiation of therapy (surgery or chemotherapy) longer than 4 weeks following randomization?
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25730 (NCI Thesaurus ObjectClass)
C0521115 (UMLS 2011AA ObjectClass)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
CL.59
Code List
Does the patient have any other serious concomitant medical condition that, in the opinion of the investigator, would compromise the safety of the patient, compromise the patient's ability to participate in the study, or cause a delay in the initiation of therapy (surgery or chemotherapy) longer than 4 weeks following randomization?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Does the patient have psychiatric or addictive disorders or other condition that, in the opinion of the investigator, would preclude the patient from meeting the study requirements?
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C38015 (NCI Thesaurus Property)
CL.60
Code List
Does the patient have psychiatric or addictive disorders or other condition that, in the opinion of the investigator, would preclude the patient from meeting the study requirements?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Has the patient taken any investigational product within the past 30 days?
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C0949266 (NCI Metathesaurus ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
CL.61
Code List
Has the patient taken any investigational product within the past 30 days?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Is the patient a woman of child-bearing potential? (The following questions are to be completed for female patients only.)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C16576 (NCI Thesaurus ObjectClass)
C0015780 (UMLS 2011AA ObjectClass)
C25742 (NCI Thesaurus Property)
C0032961 (UMLS 2011AA Property)
C0237399 (NCI Metathesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.62
Code List
Is the patient a woman of child-bearing potential? (The following questions are to be completed for female patients only.)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Was a pregnancy test performed?
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C0032976 (NCI Metathesaurus Property)
CL.63
Code List
Was a pregnancy test performed?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
PatientMostRecentPregnancyTestDate
Item
Date of pregnancy test
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C0032976 (NCI Metathesaurus Property)
C25577 (NCI Thesaurus Property)
C1513491 (UMLS 2011AA Property)
Item
Is the patient pregnant or lactating at time of study entry?
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25742 (NCI Thesaurus Property)
C0032961 (UMLS 2011AA Property)
CL.64
Code List
Is the patient pregnant or lactating at time of study entry?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
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