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  1. StudyEvent: NSABP C-11 OPEN Worksheet for Form Entry
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Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
Patient Initials
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus 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-2)
C0027365 (UMLS 2011AA ValueDomain-2)
Patient Birth Date
Item
Patient Birth Date (Month Day Year)
date
C25164 (NCI Thesaurus ValueDomain)
C0421451 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C25155 (NCI Thesaurus 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-2)
C1522326 (UMLS 2011AA ObjectClass-2)
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)
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)
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)
C0015031 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C16564 (NCI Thesaurus Property)
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)
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-2)
C0030705 (UMLS 2011AA ObjectClass-2)
C25407 (NCI Thesaurus Property)
C1442065 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25464 (NCI Thesaurus ValueDomain-2)
C0454664 (UMLS 2011AA ValueDomain-2)
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)
Social Security Number
Item
Patient Social Security Number (USA only)
text
C25337 (NCI Thesaurus ValueDomain)
C1301821 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25686 (NCI Thesaurus 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)
Code List
Patient gender
CL Item
Male Gender (Male)
C46109 (NCI Thesaurus)
C1706180 (UMLS 2011AA)
CL Item
Female Gender (Female)
C46110 (NCI Thesaurus)
C0086287 (UMLS 2011AA)
Item Group
Unnamed4
PatientBloodSpecimenConsentInd-2
Item
Did the patient consent to use of blood samples for testing related to C-11?
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C12434 (NCI Thesaurus Property)
C0229664 (UMLS 2011AA Property)
C19157 (NCI Thesaurus Property-2)
C0370003 (UMLS 2011AA Property-2)
C25460 (NCI Thesaurus Property-3)
C1511481 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientMalignantNeoplasmConsentInd-2
Item
Did the patient consent to use of tissue and blood samples for future research to learn about, prevent, or treat cancer?
boolean
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-2)
C1511481 (UMLS 2011AA Property-2)
BloodTissueSpecimenOtherDiseasesandDisordersResearchConsentInd-3
Item
Did the patient consent to use of tissue and blood samples for research about other problems?
boolean
C12801 (NCI Thesaurus ObjectClass)
C0040300 (UMLS 2011AA ObjectClass)
C12434 (NCI Thesaurus ObjectClass-2)
C0229664 (UMLS 2011AA ObjectClass-2)
C19157 (NCI Thesaurus ObjectClass-3)
C0370003 (UMLS 2011AA ObjectClass-3)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C15319 (NCI Thesaurus Property-2)
C2991 (NCI Thesaurus Property-3)
C0012634 (UMLS 2011AA Property-2)
C25460 (NCI Thesaurus Property-4)
C1511481 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
TissueSpecimenMalignantNeoplasmRelatedResearchConsentInd-3
Item
Did the patient consent to future contact about more research?
boolean
C12801 (NCI Thesaurus ObjectClass)
C0040300 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
C15319 (NCI Thesaurus Property)
C25648 (NCI Thesaurus Property-2)
C0439849 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property-3)
C0006826 (UMLS 2011AA Property-2)
C25460 (NCI Thesaurus Property-4)
C1511481 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
PatientPHIConsentIndicator
Item
Has the patient authorized the release of Protected Health Information to the NSABP?
boolean
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
InformedConsentFormSignedDate
Item
Date Informed Consent Signed (Month Day Year)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
HepaticMetastasisPriorClinicalStudyDiagnosisCount
Item
Number of liver metastases on pre-entry evaluation
float
C13308 (NCI Thesaurus ObjectClass)
C0205054 (UMLS 2011AA ObjectClass)
C19151 (NCI Thesaurus ObjectClass-2)
C0027627 (UMLS 2011AA ObjectClass-2)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property-2)
C0011900 (UMLS 2011AA Property-2)
C15206 (NCI Thesaurus Property-3)
C0008972 (UMLS 2011AA Property-3)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
ChemotherapyPreoperativeOxaliplatinAdministeredInd-2
Item
Has the patient received prior oxaliplatin therapy?
boolean
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C1181 (NCI Thesaurus Property)
C0069717 (UMLS 2011AA Property)
C54732 (NCI Thesaurus Property-2)
C0445204 (UMLS 2011AA Property-2)
C25382 (NCI Thesaurus Property-3)
C1521801 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item Group
Page Headers
Patient Initials
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Patient ID NSABP
Item
NSABP Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1513905 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C15818 (NCI Thesaurus Property-2)
Item Group
Surgery For Primary Colorectal Tumor
ColorectalAdenocarcinomaHistologicConfirmationDiagnosisInd-2
Item
Was a diagnosis of colorectal adenocarcinoma confirmed histologically?
boolean
C2852 (NCI Thesaurus ObjectClass)
C0001418 (UMLS 2011AA ObjectClass)
C13363 (NCI Thesaurus ObjectClass-2)
C0555952 (UMLS 2011AA ObjectClass-2)
C25458 (NCI Thesaurus Property)
C0750484 (UMLS 2011AA Property)
C25526 (NCI Thesaurus Property-2)
C0205462 (UMLS 2011AA Property-2)
C15220 (NCI Thesaurus Property-3)
C0011900 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
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-2)
C0040405 (UMLS 2011AA ObjectClass-2)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C12392 (NCI Thesaurus Property-2)
C0023884 (UMLS 2011AA Property-2)
C19151 (NCI Thesaurus Property-3)
C0027627 (UMLS 2011AA Property-3)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
PrimaryTumorRegionalLymphNodeExcisionInd-2
Item
Have the primary tumor and regional nodes been resected?
boolean
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25251 (NCI Thesaurus ObjectClass-2)
C0205225 (UMLS 2011AA ObjectClass-2)
C15232 (NCI Thesaurus Property)
C0728940 (UMLS 2011AA Property)
C49018 (NCI Thesaurus Property-2)
C1184738 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PrimaryTumorRegionalLymphNodeSingleSurgicalProcedureExcisionInd-2
Item
Is there a plan to resect the primary tumor and the liver metastases in a single surgical procedure?
boolean
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25251 (NCI Thesaurus ObjectClass-2)
C0205225 (UMLS 2011AA ObjectClass-2)
C15329 (NCI Thesaurus Property)
C0543467 (UMLS 2011AA Property)
C15232 (NCI Thesaurus Property-2)
C0728940 (UMLS 2011AA Property-2)
C48440 (NCI Thesaurus Property-3)
C0205171 (UMLS 2011AA Property-3)
C49018 (NCI Thesaurus Property-4)
C1184738 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
RadialSurgicalMarginNoMicroscopicInvolvementInd-3
Item
Were the surgical margins clear?
boolean
C41227 (NCI Thesaurus ObjectClass)
C0229985 (UMLS 2011AA ObjectClass)
C25314 (NCI Thesaurus ObjectClass-2)
C0442038 (UMLS 2011AA ObjectClass-2)
C25252 (NCI Thesaurus Property)
C0205288 (UMLS 2011AA Property)
C25548 (NCI Thesaurus Property-2)
C1314939 (UMLS 2011AA Property-2)
C0028423 (NCI Metathesaurus Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
ExtrahepaticMetastasisDiagnosisInd-2
Item
Was there evidence of extrahepatic disease?
boolean
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-2)
C1517058 (UMLS 2011AA ObjectClass-2)
PriorNeoadjuvantTherapyChemotherapyColorectalNeoplasmReceiveInd-2
Item
Did the patient have chemotherapy for the primary colorectal disease?
boolean
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C15665 (NCI Thesaurus ObjectClass-3)
C0600558 (UMLS 2011AA ObjectClass-3)
C13363 (NCI Thesaurus Property)
C0555952 (UMLS 2011AA Property)
C25639 (NCI Thesaurus Property-2)
C1514756 (UMLS 2011AA Property-2)
CL053268 (NCI Metathesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
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-2)
C1521801 (UMLS 2011AA Property-2)
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)
LiverMetastasisPatientSurgeonDecisionEligibilityDeterminationInd-2
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)
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C12392 (NCI Thesaurus ObjectClass-2)
C0023884 (UMLS 2011AA ObjectClass-2)
C19151 (NCI Thesaurus ObjectClass-3)
C0027627 (UMLS 2011AA ObjectClass-3)
C18071 (NCI Thesaurus Property)
C0582175 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
C53285 (NCI Thesaurus Property-3)
C0679006 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Assessment Date
Item
Date of Assessment (Month Day Year)
date
C25164 (NCI Thesaurus ValueDomain)
C2985720 (UMLS CUI-1)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C38000 (NCI Thesaurus 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)
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-3)
C0040405 (UMLS 2011AA-4)
C70754 (NCI Thesaurus-5)
C1979874 (UMLS 2011AA-6)
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-3)
C0032743 (UMLS 2011AA-4)
C17204 (NCI Thesaurus-5)
C0040405 (UMLS 2011AA-6)
C70754 (NCI Thesaurus-7)
C1979874 (UMLS 2011AA-8)
CL Item
Contrast Chest Computed Tomography (CT scan with contrast, chest)
C17204 (NCI Thesaurus)
C0040405 (UMLS 2011AA)
C25389 (NCI Thesaurus-3)
C0817096 (UMLS 2011AA-4)
C70754 (NCI Thesaurus-5)
C1979874 (UMLS 2011AA-6)
CL Item
Contrast Abdominal Cavity Computed Tomography (CT scan with contrast, abdomen)
C17204 (NCI Thesaurus)
C0040405 (UMLS 2011AA)
C12664 (NCI Thesaurus-3)
C0230168 (UMLS 2011AA-4)
C70754 (NCI Thesaurus-5)
C1979874 (UMLS 2011AA-6)
CL Item
Contrast Abdominal Cavity Magnetic Resonance Imaging (MRI with contrast, abdomen)
C12664 (NCI Thesaurus)
C0230168 (UMLS 2011AA)
C16809 (NCI Thesaurus-3)
C0024485 (UMLS 2011AA-4)
C70754 (NCI Thesaurus-5)
C1979874 (UMLS 2011AA-6)
CL Item
Contrast Pelvis Computed Tomography (CT scan with contrast, pelvis)
C17204 (NCI Thesaurus)
C0040405 (UMLS 2011AA)
C12767 (NCI Thesaurus-3)
C0030797 (UMLS 2011AA-4)
C70754 (NCI Thesaurus-5)
C1979874 (UMLS 2011AA-6)
CL Item
Contrast Pelvis Magnetic Resonance Imaging (MRI with contrast, pelvis)
C12767 (NCI Thesaurus)
C0030797 (UMLS 2011AA)
C16809 (NCI Thesaurus-3)
C0024485 (UMLS 2011AA-4)
C70754 (NCI Thesaurus-5)
C1979874 (UMLS 2011AA-6)
EvaluationPerformedInd-3
Item
Evaluation Performed?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus ObjectClass)
C0220825 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
Assessment Date
Item
Date of Assessment (Month Day Year)
date
C25164 (NCI Thesaurus ValueDomain)
C2985720 (UMLS CUI-1)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C38000 (NCI Thesaurus Property)
Item Group
Section 2 (continued)
HepaticMetastasisMedicalImagingDiagnosisInd-2
Item
Were hepatic metastases evident on one or more scans?
boolean
C13308 (NCI Thesaurus ObjectClass)
C0205054 (UMLS 2011AA ObjectClass)
C19151 (NCI Thesaurus ObjectClass-2)
C0027627 (UMLS 2011AA ObjectClass-2)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C16831 (NCI Thesaurus Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
ExtrahepaticMetastasisMedicalImagingDiagnosisInd-2
Item
Were extrahepatic metastases evident on one or more scans?
boolean
C19151 (NCI Thesaurus ObjectClass)
C0027627 (UMLS 2011AA ObjectClass)
C28358 (NCI Thesaurus ObjectClass-2)
C1517058 (UMLS 2011AA ObjectClass-2)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C16831 (NCI Thesaurus Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item Group
Patient Characteristics
Patient Height
Item
Patient Height (cm)
float
C25209 (NCI Thesaurus ValueDomain)
C0489786 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25347 (NCI Thesaurus Property)
Patient Weight
Item
Patient Weight (kg)
float
C25209 (NCI Thesaurus ValueDomain)
C0005910 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)
Item
ECOG Performance Status
text
C25664 (NCI Thesaurus ValueDomain)
C1520224 (UMLS CUI-1)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain-2)
C20641 (NCI Thesaurus ObjectClass)
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
float
C25209 (NCI Thesaurus ValueDomain)
C0871470 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C25298 (NCI Thesaurus ObjectClass)
Diastolic blood pressure
Item
Blood pressure, Diastolic
float
C25209 (NCI Thesaurus ValueDomain)
C0428883 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C25299 (NCI Thesaurus ObjectClass)
Item Group
Section 3 (continued)
LaboratoryProcedureAspartateAminotransferaseMeasurementAssessmentsInd-2
Item
AST
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C64467 (NCI Thesaurus Property-2)
C0201899 (UMLS 2011AA Property)
SGOT (AST)
Item
SGOT (AST) (Patient Value units/L)
float
C25202 (NCI Thesaurus Property)
C0201899 (UMLS CUI-1)
C20200 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedUpperLimitofNormalValue
Item
SGOT (AST) ULN
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)
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-2)
C1274040 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
LaboratoryProcedureAlkalinePhosphataseAssessmentInd-2
Item
Alkaline Phosphatase
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C16276 (NCI Thesaurus Property-2)
C0002059 (UMLS 2011AA Property)
Alkaline Phosphatase
Item
Alkaline Phosphatase (Patient Value units/L)
float
C20200 (NCI Thesaurus Property)
C0201850 (UMLS CUI-1)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C16276 (NCI Thesaurus Property-2)
Alkaline Phosphatase ULN
Item
Alkaline Phosphatase ULN
float
C25294 (NCI Thesaurus ObjectClass)
C0151420 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C16276 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
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-2)
C0002059 (UMLS 2011AA Property-2)
LaboratoryProcedureBilirubinAssessmentInd-2
Item
Total Bilirubin
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C305 (NCI Thesaurus Property-2)
C0005437 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
LaboratoryProcedureTotalBilirubinResultSpecifiedValue
Item
Total Bilirubin (Patient Value mg/dL)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C38037 (NCI Thesaurus Property-2)
C0201913 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C38024 (NCI Thesaurus ValueDomain-2)
C0205369 (UMLS 2011AA ValueDomain-2)
Bilirubin, Total ULN
Item
Total bilirubin ULN
float
C25294 (NCI Thesaurus ObjectClass)
C0201913 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C1519815 (UMLS CUI-2)
C38037 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C38024 (NCI Thesaurus ValueDomain-2)
C25706 (NCI Thesaurus ValueDomain-3)
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-2)
C0005437 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
LaboratoryProcedureCreatinineAssessmentInd-2
Item
Serum Creatinine
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C399 (NCI Thesaurus Property-2)
C0010294 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
Creatinine, Serum
Item
Serum creatinine (Patient Value mg/dL)
float
C20200 (NCI Thesaurus Property)
C0201976 (UMLS CUI-1)
C399 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
Creatinine, serum ULN
Item
Serum Creatinine ULN
float
C25294 (NCI Thesaurus ObjectClass)
C0201976 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C1519815 (UMLS CUI-2)
C399 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
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-2)
C0373595 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
Item Group
Section 3 (continued)
LaboratoryProcedureAbsoluteNeutrophilCountAssessmentInd-2
Item
ANC
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C63321 (NCI Thesaurus Property-2)
C0948762 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
ANC
Item
ANC (Patient Value thousand/mm^3)
float
C25294 (NCI Thesaurus ObjectClass)
C0948762 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C63321 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
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-2)
C0948762 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
LaboratoryProcedurePlateletAssessmentInd-2
Item
Platelet Count
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C12520 (NCI Thesaurus Property-2)
C0005821 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
Platelets
Item
Platelet count (Patient Value thousand/mm^3)
float
C20200 (NCI Thesaurus Property)
C0005821 (UMLS CUI-1)
C12520 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
Platelets date
Item
Date of Collection (Month Day Year )
date
C25164 (NCI Thesaurus ValueDomain)
C0005821 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C12520 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
LaboratoryProcedureHemoglobinAssessmentInd-2
Item
Hemoglobin
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C16676 (NCI Thesaurus Property-2)
C0019046 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
Hemoglobin
Item
Hemoglobin (Patient Value g/dL)
float
C16676 (NCI Thesaurus Property)
C0019046 (UMLS CUI-1)
C20200 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
Hemoglobin Date
Item
Date of Collection (Month Day Year )
date
C25164 (NCI Thesaurus ValueDomain)
C0019046 (UMLS CUI-1)
C16676 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C20200 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
LaboratoryProcedureCarcinoembryonicAntigenAssessmentInd-2
Item
CEA
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C25159 (NCI Thesaurus Property-2)
C0007082 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
LaboratoryProcedureCarcinoembryonicAntigenOutcomeValue
Item
CEA (Patient Value ng/mL)
text
C25159 (NCI Thesaurus Property)
C0007082 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
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-2)
C1274040 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
LaboratoryProcedureCreatinineClearanceAssessmentInd-2
Item
Calculated Creatinine Clearance
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C25747 (NCI Thesaurus Property-2)
C0373595 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
LaboratoryProcedureCreatinineClearanceOutcomeEstimateValue
Item
Calculated creatinine clearance (Patient Value mL/min)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25747 (NCI Thesaurus Property-2)
C0373595 (UMLS 2011AA Property-2)
C25498 (NCI Thesaurus ValueDomain)
C0750572 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
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-2)
C0373595 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
DiabetesMellitusPersonalMedicalHistoryInd-2
Item
Does the patient have a history of diabetes mellitus?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C2985 (NCI Thesaurus ObjectClass)
C0011849 (UMLS 2011AA ObjectClass)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
AnalSmallBowelAppendixCarcinomaDiagnosisInd-2
Item
Does the patient have a diagnosis of anal, small bowel or appendiceal carcinoma?
boolean
C12386 (NCI Thesaurus ObjectClass)
C0021852 (UMLS 2011AA ObjectClass)
C2916 (NCI Thesaurus ObjectClass-2)
C0007097 (UMLS 2011AA ObjectClass-2)
C12380 (NCI Thesaurus ObjectClass-3)
C0003617 (UMLS 2011AA ObjectClass-3)
C28048 (NCI Thesaurus ObjectClass-4)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientColorectalMalignantNeoplasmEligibilityDeterminationInd-2
Item
Has the patient been diagnosed with colorectal malignant diseases other than adenocarcinoma, e.g., sarcoma, lymphoma, carcinoid?
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C13363 (NCI Thesaurus Property)
C0555952 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property-2)
C0006826 (UMLS 2011AA Property-2)
C25171 (NCI Thesaurus Property-3)
C0013893 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
ColorectalNeoplasmPatientObstructionRadiationTherapyEligibilityDeterminationInd-2
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?
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3262 (NCI Thesaurus ObjectClass-2)
C0027651 (UMLS 2011AA ObjectClass-2)
C13363 (NCI Thesaurus ObjectClass-3)
C0555952 (UMLS 2011AA ObjectClass-3)
C15313 (NCI Thesaurus Property)
C1522449 (UMLS 2011AA Property)
C3284 (NCI Thesaurus Property-2)
C0028778 (UMLS 2011AA Property-2)
C25171 (NCI Thesaurus Property-3)
C0013893 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
ExtrahepaticMetastasisPersonalMedicalHistoryInd-2
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.)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C19151 (NCI Thesaurus ObjectClass)
C0027627 (UMLS 2011AA ObjectClass)
C28358 (NCI Thesaurus ObjectClass-2)
C1517058 (UMLS 2011AA ObjectClass-2)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
PatientLymphNodeMetastasisEligibilityDeterminationInd-2
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?
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C12745 (NCI Thesaurus Property)
C0024204 (UMLS 2011AA Property)
C19151 (NCI Thesaurus Property-2)
C0027627 (UMLS 2011AA Property-2)
C25171 (NCI Thesaurus Property-3)
C0013893 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientPriorHepaticTreatmentEligibilityDeterminationInd-2
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)?
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C13308 (NCI Thesaurus Property)
C0205054 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C15368 (NCI Thesaurus Property-3)
C25171 (NCI Thesaurus Property-4)
C0013893 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientChemotherapyMetastasisColorectalCarcinomaPersonalMedicalHistoryInd-2
Item
Has the patient received previous chemotherapy or any other systemic therapy for metastatic colorectal cancer?
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C15632 (NCI Thesaurus Property)
C0392920 (UMLS 2011AA Property)
C19151 (NCI Thesaurus Property-2)
C0027627 (UMLS 2011AA Property-2)
C2955 (NCI Thesaurus Property-3)
C0009402 (UMLS 2011AA Property-3)
C18772 (NCI Thesaurus Property-4)
C0262926 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
SurgicalProcedurePortalVeinExcisionPerformedInd-2
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?
boolean
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15232 (NCI Thesaurus Property-2)
C0728940 (UMLS 2011AA Property-2)
C33343 (NCI Thesaurus Property-3)
C0032718 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
HepaticLesionAblationTherapyIntentInd-2
Item
Is there intent to use ablation to treat any hepatic lesion for this patient?
boolean
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C13308 (NCI Thesaurus ObjectClass-2)
C0205054 (UMLS 2011AA ObjectClass-2)
C20985 (NCI Thesaurus ObjectClass-3)
C0547070 (UMLS 2011AA ObjectClass-3)
C25725 (NCI Thesaurus Property)
C1283828 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientPriorChronicHepaticDiseaseorDisorderEligibilityDeterminationInd-2
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?
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C13308 (NCI Thesaurus Property)
C0205054 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C2991 (NCI Thesaurus Property-3)
C0012634 (UMLS 2011AA Property-3)
C25171 (NCI Thesaurus Property-4)
C0013893 (UMLS 2011AA Property-4)
C14141 (NCI Thesaurus Property-5)
C0205191 (UMLS 2011AA Property-5)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
AdverseEventMetastasisAssociatedInd-2
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?
boolean
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-2)
C0332281 (UMLS 2011AA Property-2)
AdverseEventNeuropathyAssociatedInd-2
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)?
boolean
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-2)
C0332281 (UMLS 2011AA Property-2)
CongestiveHeartFailureHistoryInd-2
Item
Does the patient have a documented history of congestive heart failure requiring chronic medical therapy?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C3080 (NCI Thesaurus ObjectClass)
C0018802 (UMLS 2011AA ObjectClass)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
PatientWarfarinTreatmentInd-2
Item
Does the patient require therapeutic doses of coumadin or equivalent?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)
C0043031 (NCI Metathesaurus Property)
PatientInflammatoryBowelDiseasePersonalMedicalHistoryInd-2
Item
Does the patient have active inflammatory bowel disease?
boolean
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-2)
C0262926 (UMLS 2011AA Property-2)
PatientInfectionInd-2
Item
Does the patient have an active infection or chronic infection requiring chronic suppressive antibiotics?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C26726 (NCI Thesaurus Property)
C0009450 (UMLS 2011AA Property)
PatientHemorrhagePre-ExistingConditionEligibilityInd-2
Item
Does the patient have any known bleeding diathesis or coagulopathy?
boolean
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)
PatientInterstitialDiseaseLungPersonalMedicalHistoryInd-3
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?
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C12468 (NCI Thesaurus Property)
C0024109 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property-2)
C0262926 (UMLS 2011AA Property-2)
C62410 (NCI Thesaurus Property-3)
C1881236 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
PatientNeoplasmPersonalMedicalHistoryInd-2
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)?
boolean
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-2)
C0262926 (UMLS 2011AA Property-2)
DiseaseStatusIndicator
Item
Is patient considered to be disease-free?
boolean
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C0449438 (NCI Metathesaurus Property)
PriorTherapyCompleteRegimenInd-3
Item
Did the patient complete therapy for the malignancies >= 1 year ago?
boolean
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C15697 (NCI Thesaurus Property-2)
C0040808 (UMLS 2011AA Property-2)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
PatientElevatedBilirubinPersonalMedicalHistoryInd-2
Item
Is the patient known to have Gilbert's Syndrome?
boolean
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-2)
C0262926 (UMLS 2011AA Property-2)
HomozygousUGT1A1*28AlleleGenePresentInd-2
Item
Is the patient known to be homozygous for the UGT1A1 28 allele?
boolean
C45826 (NCI Thesaurus ObjectClass)
C0019904 (UMLS 2011AA ObjectClass)
C16612 (NCI Thesaurus ObjectClass-2)
C0017337 (UMLS 2011AA ObjectClass-2)
C72564 (NCI Thesaurus ObjectClass-3)
C2825127 (UMLS 2011AA ObjectClass-3)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientClinicalStudyAgentHypersensitivityPersonalMedicalHistoryInd-2
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?
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3114 (NCI Thesaurus Property)
C0020517 (UMLS 2011AA Property)
C1708 (NCI Thesaurus Property-2)
C0450442 (UMLS 2011AA Property-2)
C15206 (NCI Thesaurus Property-3)
C0008972 (UMLS 2011AA Property-3)
C18772 (NCI Thesaurus Property-4)
C0262926 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
ConcomitantDiseasePersonalMedicalHistoryInd-2
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?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25730 (NCI Thesaurus ObjectClass-2)
C0521115 (UMLS 2011AA ObjectClass-2)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
PatientStudyRequirementInd-2
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?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C38015 (NCI Thesaurus Property)
PriorInvestigationalTherapiesAdministeredInd-2
Item
Has the patient taken any investigational product within the past 30 days?
boolean
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)
FemalePatientPotentialPregnancyInd-2
Item
Is the patient a woman of child-bearing potential? (The following questions are to be completed for female patients only.)
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C16576 (NCI Thesaurus ObjectClass-2)
C0086287 (UMLS 2011AA ObjectClass-2)
C25742 (NCI Thesaurus Property)
C0032961 (UMLS 2011AA Property)
C0237399 (NCI Metathesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientPregnancyTestIndicator
Item
Was a pregnancy test performed?
boolean
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C0032976 (NCI Metathesaurus Property)
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)
PatientPregnancyInd-2
Item
Is the patient pregnant or lactating at time of study entry?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25742 (NCI Thesaurus Property)
C0032961 (UMLS 2011AA Property)

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