ID

5541

Beschrijving

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

Trefwoorden

Kolorektale Tumoren

Geüploaded op

8 augustus 2014

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0 Legacy

Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren

Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Colorectal Cancer NCT01189227 Registration - NSABP C-11 OPEN Worksheet for Form Entry - 3105627v1.0

model
Details

No Instruction available.

1 Formulieren

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

Name

Type

Description | Question | Decode (Coded Value)

Datatype

Alias

Header Module

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)

Race

Item Group

Race

RaceCategoryText

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)

Demographics

Item Group

Person Completing Form, Last Name

PatientPaymentType

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)

PatientEthnicGroupCategory

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)

PersonAddressCountryCode

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

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)

PersonGenderTextType

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)

Patient Consent

Item Group

Unnamed4

PatientBloodSpecimenConsentInd-2

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)

PatientMalignantNeoplasmConsentInd-2

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)

BloodTissueSpecimenOtherDiseasesandDisordersResearchConsentInd-3

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)

TissueSpecimenMalignantNeoplasmRelatedResearchConsentInd-3

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)

PatientPHIConsentIndicator

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)

ChemotherapyPreoperativeOxaliplatinAdministeredInd-2

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)

Page Headers

Item Group

Page Headers

PatientInitialsName

Item

Patient Initials

text

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)

Section 1 - Surgery and Pathology

Item Group

Surgery For Primary Colorectal Tumor

ColorectalAdenocarcinomaHistologicConfirmationDiagnosisInd-2

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)

PrimaryTumorRegionalLymphNodeExcisionInd-2

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)

PrimaryTumorRegionalLymphNodeSingleSurgicalProcedureExcisionInd-2

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)

RadialSurgicalMarginNoMicroscopicInvolvementInd-3

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)

ExtrahepaticMetastasisDiagnosisInd-2

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)

PriorNeoadjuvantTherapyChemotherapyColorectalNeoplasmReceiveInd-2

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)

ChemotherapyLastAdministeredValue

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)

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)

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

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)

Section 2 - Imaging Studies

Item Group

Section 2

ImagingMethodType

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)

EvaluationPerformedInd-3

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

Section 2 -Imaging Studies (continued)

Item Group

Section 2 (continued)

HepaticMetastasisMedicalImagingDiagnosisInd-2

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)

ExtrahepaticMetastasisMedicalImagingDiagnosisInd-2

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)

Section 3 - Baseline Values (I)

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)

PerformanceStatusAssessmentEasternCooperativeOncologyGroupScale

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)

Section 3 - Baseline Values (II)

Item Group

Section 3 (continued)

LaboratoryProcedureAspartateAminotransferaseMeasurementAssessmentsInd-2

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)

LaboratoryProcedureAlkalinePhosphataseAssessmentInd-2

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)

LaboratoryProcedureBilirubinAssessmentInd-2

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

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)

LaboratoryProcedureCreatinineAssessmentInd-2

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)

Section 3 - Baseline Values (III)

Item Group

Section 3 (continued)

LaboratoryProcedureAbsoluteNeutrophilCountAssessmentInd-2

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)

LaboratoryProcedurePlateletAssessmentInd-2

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)

LaboratoryProcedureHemoglobinAssessmentInd-2

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)

LaboratoryProcedureCarcinoembryonicAntigenAssessmentInd-2

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)

LaboratoryProcedureCreatinineClearanceAssessmentInd-2

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

Section 4 - Patient History, Current and Recent Conditions

Item Group

Section 4

DiabetesMellitusPersonalMedicalHistoryInd-2

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)

AnalSmallBowelAppendixCarcinomaDiagnosisInd-2

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)

PatientColorectalMalignantNeoplasmEligibilityDeterminationInd-2

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)

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?

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)

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.)

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

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

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?

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)

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)?

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

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

PatientChemotherapyMetastasisColorectalCarcinomaPersonalMedicalHistoryInd-2

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)

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?

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)

HepaticLesionAblationTherapyIntentInd-2

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)

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?

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

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

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?

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)

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)?

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

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CongestiveHeartFailureHistoryInd-2

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)

PatientWarfarinTreatmentInd-2

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)

PatientInflammatoryBowelDiseasePersonalMedicalHistoryInd-2

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)

PatientInfectionInd-2

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)

PatientHemorrhagePre-ExistingConditionEligibilityInd-2

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)

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?

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)

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)?

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

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

DiseaseStatusIndicator

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)

PriorTherapyCompleteRegimenInd-3

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)

PatientElevatedBilirubinPersonalMedicalHistoryInd-2

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)

HomozygousUGT1A1*28AlleleGenePresentInd-2

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)

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?

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)

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?

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

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

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?

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)

PriorInvestigationalTherapiesAdministeredInd-2

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)

FemalePatientPotentialPregnancyInd-2

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)

PatientPregnancyTestIndicator

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)

PatientPregnancyInd-2

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)

Terug naar het begin van de pagina

ID

Beschrijving

Link

Trefwoorden

Versies (5)

Geüploaded op

DOI

Licentie

Model Commentaren :

Itemgroep Commentaren voor :

Item Commentaren voor :

Colorectal Cancer NCT01189227 Registration - NSABP C-11 OPEN Worksheet for Form Entry - 3105627v1.0

No Instruction available.

Beschrijving

Beschrijving

Datatype

Alias

Beschrijving

Datatype

Alias

Beschrijving

Datatype

Alias

Beschrijving

Datatype

Alias

Beschrijving

Beschrijving

Datatype

Alias

Beschrijving

Beschrijving

Datatype

Alias

Beschrijving

Datatype

Alias

Beschrijving

Datatype

Alias

Beschrijving

Datatype

Alias

Beschrijving

Datatype

Alias

Beschrijving

Datatype

Alias

Beschrijving

Datatype

Alias

Beschrijving

Beschrijving

Datatype

Alias

Beschrijving

Datatype

Alias

Beschrijving

Datatype

Alias

Beschrijving

Datatype

Alias

Beschrijving

Datatype

Alias

Beschrijving

Datatype

Alias

Beschrijving

Datatype

Alias

Beschrijving

Datatype

Alias

Beschrijving

Beschrijving

Datatype