ID

7463

Beschreibung

Southwest Oncology Group S0600 Prestudy Form Irinotecan and Cetuximab With or Without Bevacizumab in Treating Patients With Metastatic Colorectal Cancer That Progressed During First-Line Therapy Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=153FB385-1447-52C3-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=153FB385-1447-52C3-E044-0003BA3F9857

Stichworte

Kolorektale Tumoren

Klinische Studie [Dokumenttyp]

Registration

Hochgeladen am

9. Januar 2015

DOI

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Lizenz

Creative Commons BY-NC 3.0 Legacy

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Colorectal Cancer NCT00499369 Pre-Study - Southwest Oncology Group S0600 Prestudy Form - 2484582v1.0

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1 Formulare

StudyEvent: Southwest Oncology Group S0600 Prestudy Form
1. No Instruction available.

Name

Typ

Description | Question | Decode (Coded Value)

Datentyp

Alias

Header

Item Group

Header

Trial subject ID SWOG

Item

SWOG Patient ID

float

C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1519429 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25699 (NCI Thesaurus Property-2)

Protocol ID SWOG

Item

SWOG Study No.

text

C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1519429 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25699 (NCI Thesaurus Property-2)

Registration Number

Item

Registration Step

text

C25337 (NCI Thesaurus ValueDomain)
C1514821 (UMLS CUI-1)
C25646 (NCI Thesaurus ObjectClass)
C0237753 (UMLS CUI-2)
C16154 (NCI Thesaurus Property)
C16154 (NCI Thesaurus ValueDomain-2)

Patient Initials

Item

Patient Initials (L, F M)

text

C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)

Institution Name

Item

Institution/Affiliate

text

C25454 (NCI Thesaurus ObjectClass)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)

Investigator Name

Item

Physician

text

C25191 (NCI Thesaurus ValueDomain)
C2826892 (UMLS CUI-1)
C25364 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
C25644 (NCI Thesaurus ObjectClass-2)

Participating Group

Item

Participating Group Name

text

C25191 (NCI Thesaurus ValueDomain)
C2347449 (UMLS CUI-1)
C25608 (NCI Thesaurus ObjectClass)
C17005 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)

Study Number Participating Group

Item

Participating Group Study No.

text

C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)

Trial subject ID Participating Group

Item

Participating Group Patient ID (Place an X in appropriate boxes. Circle AMENDED items in red and write AMENDED across the top of the form.)

text

C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)

Eligibility Verification:

Item Group

Eligibility Verification:

Patient and Disease Description

Item Group

Disease Description

ECOG Performance Status

Item

Performance Status

text

C25664 (NCI Thesaurus ValueDomain)
C1520224 (UMLS CUI-1)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain-2)
C20641 (NCI Thesaurus ObjectClass)

CL.1

Code List

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)

CL Item

Dead (5)

First-LineTherapyProgressionChemotherapyRegimenDate

Item

Date of progression on first-line chemotherapy

date

C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25331 (NCI Thesaurus ObjectClass-2)
C45792 (NCI Thesaurus ObjectClass-3)
C1708063 (UMLS 2011AA ObjectClass-2)
C15697 (NCI Thesaurus Property)
C0040808 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

Laboratory Values

Item Group

Laboratory Values

Neutrophil count

Item

ANC (/mcL)

float

C25294 (NCI Thesaurus ObjectClass)
C0200633 (UMLS CUI-1)
C12533 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C25304 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)

LaboratoryProcedureNeutrophilResultLowerLimitofNormalValue

Item

Absolute neutrophil count LLN

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C12533 (NCI Thesaurus Property)
C0027950 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C1518030 (UMLS 2011AA ValueDomain-2)

Platelets

Item

Peripheral Platelet Count (/mcL)

float

C20200 (NCI Thesaurus Property)
C0005821 (UMLS CUI-1)
C12520 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)

Platelets LLN

Item

Peripheral platelet count, LLN

float

C25294 (NCI Thesaurus ObjectClass)
C0005821 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C1518030 (UMLS CUI-2)
C12520 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)

LaboratoryProcedureHemoglobinResultSpecifiedValue

Item

Hemoglobin (g/dL)

float

C16676 (NCI Thesaurus Property)
C0019046 (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)

Hemoglobin LLN

Item

Hemoglobin (Hgb) (g/dl), LLN

float

C25294 (NCI Thesaurus ObjectClass)
C0019046 (UMLS CUI-1)
C16676 (NCI Thesaurus Property)
C1518030 (UMLS CUI-2)
C20200 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C38024 (NCI Thesaurus ValueDomain-2)
C25555 (NCI Thesaurus ValueDomain-3)

FullDoseAnticoagulantAgentCurrentUseInd-2

Item

Patient receiving full-dose anticoagulants

boolean

C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
C263 (NCI Thesaurus ObjectClass-2)
C0003280 (UMLS 2011AA ObjectClass-2)
C25517 (NCI Thesaurus ObjectClass-3)
C0443225 (UMLS 2011AA ObjectClass-3)
C25471 (NCI Thesaurus Property)
C0521116 (UMLS 2011AA Property)
C25340 (NCI Thesaurus Property-2)
C0457083 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

INR

Item

International Normalization Ratio (INR) (If yes,)

float

C20200 (NCI Thesaurus Property)
C0525032 (UMLS CUI-1)
C25294 (NCI Thesaurus ObjectClass)
C25352 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)

MalignantNeoplasmLiverMetastaticInvolvementInd-3

Item

Liver metastases (Hepatic:)

boolean

C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C14174 (NCI Thesaurus Property)
C0036525 (UMLS 2011AA Property)
C12392 (NCI Thesaurus Property-2)
C0023884 (UMLS 2011AA Property-2)
C25548 (NCI Thesaurus Property-3)
C1314939 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

TotalBilirubinHepaticLabUnspecifiedValue

Item

Total Bilirubin (mg/dL)

float

C25304 (NCI Thesaurus ObjectClass)
C0439810 (UMLS 2011AA ObjectClass)
C305 (NCI Thesaurus ObjectClass-2)
C0005437 (UMLS 2011AA ObjectClass-2)
C13308 (NCI Thesaurus Property)
C0205054 (UMLS 2011AA Property)
C37984 (NCI Thesaurus Property-2)
C0022877 (UMLS 2011AA Property-2)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)

Bilirubin, Total ULN

Item

Total bilirubin ULN (mg/dL)

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)

SGOT (AST)

Item

SGOT (U/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 (U/L)

float

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)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)

HepaticSGPT(ALT)LabUnspecifiedValue

Item

SGPT (U/L)

float

C13308 (NCI Thesaurus ObjectClass)
C0205054 (UMLS 2011AA ObjectClass)
C37984 (NCI Thesaurus Property)
C0022877 (UMLS 2011AA Property)
C25293 (NCI Thesaurus Property-2)
C0376147 (UMLS 2011AA Property-2)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)

LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultUpperLimitofNormalValue

Item

SGPT (ALT) ULN (U/L)

float

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

PatientCreatinineSerumValue

Item

Serum Creatinine (mg/dL)

float

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C13325 (NCI Thesaurus Property)
C0229671 (UMLS 2011AA Property)
C399 (NCI Thesaurus Property-2)
C0010294 (UMLS 2011AA Property-2)

Creatinine, serum ULN

Item

Serum Creatinine ULN

float

C25294 (NCI Thesaurus ObjectClass)
C0201976 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C1519815 (UMLS CUI-2)
C399 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)

Creatinine Clearance

Item

Creatinine Clearance (Measured - OR)

float

C20200 (NCI Thesaurus Property)
C0373595 (UMLS CUI-1)
C25747 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)

LaboratoryProcedureCreatinineClearanceOutcomeEstimateValue

Item

Estimated creatinine clearance (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)

UrinaryCreatinineProteinAssessmentValue

Item

UPC ratio

float

C25711 (NCI Thesaurus ObjectClass)
C1524119 (UMLS 2011AA ObjectClass)
C17021 (NCI Thesaurus ObjectClass-2)
C0033684 (UMLS 2011AA ObjectClass-2)
C0010294 (NCI Metathesaurus ObjectClass)
C25367 (NCI Thesaurus Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

UrinaryProteinCollectionValue

Item

Protein from 24 hour Urine Collection (if > 0.5, then 24 hour:)

float

C25453 (NCI Thesaurus Property)
C1516698 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C17021 (NCI Thesaurus ObjectClass)
C0033684 (UMLS 2011AA ObjectClass)

LaboratoryProcedureCalciumCationElectrolytesOutcomeValue

Item

Ionized serum calcium

float

C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C464 (NCI Thesaurus Property-2)
C0013832 (UMLS 2011AA Property-2)
C61660 (NCI Thesaurus Property-3)
C0596235 (UMLS 2011AA Property-3)

LaboratoryProcedureCalciumCationElectrolytesOutcomeLowerLimitofNormalValue

Item

Ionized serum calcium, LLN

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C464 (NCI Thesaurus Property-2)
C0013832 (UMLS 2011AA Property-2)
C61660 (NCI Thesaurus Property-3)
C0596235 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C1518030 (UMLS 2011AA ValueDomain-2)

LaboratoryProcedureCalciumElectrolytesOutcomeValue

Item

Serum calcium

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C331 (NCI Thesaurus Property)
C0006675 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C464 (NCI Thesaurus Property-3)
C0013832 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LaboratoryProcedureSerumCalciumOutcomeLowerLimitofNormalValue

Item

Serum calcium, LLN

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C331 (NCI Thesaurus Property)
C0006675 (UMLS 2011AA Property)
C13325 (NCI Thesaurus Property-2)
C0229671 (UMLS 2011AA Property-2)
C20200 (NCI Thesaurus Property-3)
C1274040 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C1518030 (UMLS 2011AA ValueDomain-2)

LaboratoryProcedureMagnesiumResultUnspecifiedValue

Item

Magnesium

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C29239 (NCI Thesaurus Property-2)
C0024467 (UMLS 2011AA Property-2)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)

LaboratoryProcedureMagnesiumResultUnspecifiedLowerLimitofNormalValue

Item

Magnesium, LLN

float

LaboratoryProcedureSodiumElectrolytesOutcomeSpecifiedValue

Item

Sodium

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C830 (NCI Thesaurus Property-2)
C0037473 (UMLS 2011AA Property-2)
C464 (NCI Thesaurus Property-3)
C0013832 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LaboratoryProcedureSodiumElectrolytesOutcomeLowerLimitofNormalValue

Item

Sodium LLN

float

LaboratoryProcedurePotassiumElectrolytesOutcomeSpecifiedValue

Item

Potassium

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C464 (NCI Thesaurus Property-2)
C0013832 (UMLS 2011AA Property-2)
C765 (NCI Thesaurus Property-3)
C0032821 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LaboratoryProcedurePotassiumElectrolytesOutcomeLowerLimitNormalValue

Item

Potassium LLN

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C464 (NCI Thesaurus Property-2)
C0013832 (UMLS 2011AA Property-2)
C765 (NCI Thesaurus Property-3)
C0032821 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C1518030 (UMLS 2011AA ValueDomain-2)

LaboratoryProcedureBicarbonateOutcomeUnspecifiedValue

Item

Bicarbonate

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C37918 (NCI Thesaurus Property-2)
C0005367 (UMLS 2011AA Property-2)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)

LaboratoryProcedureBicarbonateOutcomeUnspecifiedLowerLimitofNormalValue

Item

Bicarbonate, LLN

float

LaboratoryProcedureChlorideIonElectrolytesOutcomeSpecifiedValue

Item

Chloride

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C464 (NCI Thesaurus Property-2)
C0013832 (UMLS 2011AA Property-2)
C1741 (NCI Thesaurus Property-3)
C0596019 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LaboratoryProcedureChlorideIonElectrolytesOutcomeLowerLimitofNormalValue

Item

Chloride LLN

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C464 (NCI Thesaurus Property-2)
C0013832 (UMLS 2011AA Property-2)
C1741 (NCI Thesaurus Property-3)
C0596019 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C1518030 (UMLS 2011AA ValueDomain-2)

AssessmentLabUOM

Item

Units

text

C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C37984 (NCI Thesaurus Property)
C0022877 (UMLS 2011AA Property)
C25709 (NCI Thesaurus ValueDomain)
C1519795 (UMLS 2011AA ValueDomain)

CL.18

Code List

Units

CL Item

Millimole Per Liter (mmol/L)

AssessmentLabUOM

Item

Units

text

CL.18

Code List

Units

CL Item

Millimole Per Liter (mmol/L)

AssessmentLabUOM

Item

Units

text

CL.18

Code List

Units

CL Item

Millimole Per Liter (mmol/L)

AssessmentLabUOM

Item

Units

text

CL.18

Code List

Units

CL Item

Millimole Per Liter (mmol/L)

AssessmentLabUOM

Item

Units

text

CL.18

Code List

Units

CL Item

Millimole Per Liter (mmol/L)

AssessmentLabUOM

Item

Units

text

CL.18

Code List

Units

CL Item

Millimole Per Liter (mmol/L)

AssessmentLabUOM

Item

Units

text

CL.18

Code List

Units

CL Item

Millimole Per Liter (mmol/L)

AssessmentLabUOM

Item

Units

text

CL.18

Code List

Units

CL Item

Millimole Per Liter (mmol/L)

AssessmentLabUOM

Item

Units

text

CL.18

Code List

Units

CL Item

Millimole Per Liter (mmol/L)

AssessmentLabUOM

Item

Units

text

CL.18

Code List

Units

CL Item

Millimole Per Liter (mmol/L)

AssessmentLabUOM

Item

Units

text

CL.18

Code List

Units

CL Item

Millimole Per Liter (mmol/L)

AssessmentLabUOM

Item

Units

text

CL.18

Code List

Units

CL Item

Millimole Per Liter (mmol/L)

AssessmentLabUOM

Item

Units

text

CL.18

Code List

Units

CL Item

Millimole Per Liter (mmol/L)

AssessmentLabUOM

Item

Units

text

CL.18

Code List

Units

CL Item

Millimole Per Liter (mmol/L)

AssessmentLabUOM

Item

Units

text

CL.18

Code List

Units

CL Item

Millimole Per Liter (mmol/L)

SpecimenCollectedDate

Item

Collection Date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C25452 (NCI Thesaurus Property)
C25275 (NCI Thesaurus Property-2)
C2745955 (UMLS 2011AA Property)

SpecimenCollectedDate

Item

Collection Date

date

SpecimenCollectedDate

Item

Collection Date

date

SpecimenCollectedDate

Item

Collection Date

date

SpecimenCollectedDate

Item

Collection Date

date

SpecimenCollectedDate

Item

Collection Date

date

SpecimenCollectedDate

Item

Collection Date

date

SpecimenCollectedDate

Item

Collection Date

date

SpecimenCollectedDate

Item

Collection Date

date

SpecimenCollectedDate

Item

Collection Date

date

SpecimenCollectedDate

Item

Collection Date

date

SpecimenCollectedDate

Item

Collection Date

date

SpecimenCollectedDate

Item

Collection Date

date

SpecimenCollectedDate

Item

Collection Date

date

SpecimenCollectedDate

Item

Collection Date

date

SpecimenCollectedDate

Item

Collection Date

date

SpecimenCollectedDate

Item

Collection Date

date

SpecimenCollectedDate

Item

Collection Date

date

SpecimenCollectedDate

Item

Collection Date

date

SpecimenCollectedDate

Item

Collection Date

date

SpecimenCollectedDate

Item

Collection Date

date

Systolic blood pressure

Item

Blood Pressure (Cardiovascular:)

float

C25209 (NCI Thesaurus ValueDomain)
C0871470 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C25298 (NCI Thesaurus ObjectClass)

Diastolic blood pressure

Item

Blood Pressure

float

C25209 (NCI Thesaurus ValueDomain)
C0428883 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C25299 (NCI Thesaurus ObjectClass)

Additional Prestudy Data:

Item Group

Additional Prestudy Data:

DiseaseInvolvementSite

Item

Site of Involvement (s - select all that apply for current disease:)

text

C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25548 (NCI Thesaurus Property)
C1314939 (UMLS 2011AA Property)

CL.19

Code List

Site of Involvement (s - select all that apply for current disease:)

CL Item

Primary Site/direct Extension (Primary site/direct extension)

CL Item

Regional Lymph Nodes (Regional lymph nodes)

CL Item

Distant Lymph Nodes (Distant lymph nodes)

CL Item

Lung (Lung)

C12468 (NCI Thesaurus)
C0024109 (UMLS 2011AA)

CL Item

Pleura (Pleura)

C12469 (NCI Thesaurus)
C0032225 (UMLS 2011AA)

CL Item

Liver (Liver)

C12392 (NCI Thesaurus)
C0023884 (UMLS 2011AA)

CL Item

Bone (Bone)

C12366 (NCI Thesaurus)
C0262950 (UMLS 2011AA)

CL Item

Other Abdominal (Other abdominal)

CL Item

Other Specify (Other)

Prior Treatment Related To This Cancer

Item Group

Prior Treatment Related To This Cancer

SWOGPriorTherapyAdministeredType

Item

Prior Therapy Type (select ALL that apply)

text

C25699 (NCI Thesaurus ObjectClass)
C1519429 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C15368 (NCI Thesaurus ObjectClass-3)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.20

Code List

Prior Therapy Type (select ALL that apply)

CL Item

Chemotherapy Single Agent Systemic (Chemotherapy single agent systemic)

CL Item

Chemotherapy Multiple Agents Systemic (Chemotherapy multiple agents systemic)

CL040135 (NCI Metathesaurus)

CL Item

Chemotherapy Non-cytotoxic (Chemotherapy non-cytotoxic)

CL Item

Chemotherapy Nos (Chemotherapy NOS)

CL Item

Radiotherapy (Radiotherapy)

CL Item

Surgery (Surgery)

C17173 (NCI Thesaurus)
C0038894 (UMLS 2011AA)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

PriorChemotherapyRegimenNumber

Item

Number of prior chemotherapy regimens

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C15697 (NCI Thesaurus Property)
C0040808 (UMLS 2011AA Property)

PriorChemotherapyAdministeredEndDate

Item

Date Prior Chemotherapy Ended

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

LastBevacizumabPriorAdministeredDate

Item

Date prior bevacizumab ended

date

C2039 (NCI Thesaurus ObjectClass)
C0796392 (UMLS 2011AA ObjectClass)
C25551 (NCI Thesaurus ObjectClass-2)
C1517741 (UMLS 2011AA ObjectClass-2)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

First-LineTherapyChemotherapyRegimenType

Item

Front-line chemotherapy regimen (select one)

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C15697 (NCI Thesaurus Property)
C0040808 (UMLS 2011AA Property)
C45792 (NCI Thesaurus ObjectClass-2)
C1708063 (UMLS 2011AA ObjectClass-2)

CL.21

Code List

Front-line chemotherapy regimen (select one)

CL Item

Fluorouracil/leucovorin Calcium/oxaliplatin (FOLFOX)

C11197 (NCI Thesaurus)
C0392943 (UMLS 2011AA)

CL Item

First-line Therapy With Folfox-bev, Xelox-bev, Or Flox-bev With Discontinuation Of Oxaliplatin And Then Addition Of Fluoropyrimidine (OPTIMOX)

CL Item

Capecitabine/oxaliplatin/bevacizumab (xelox) (XELOX)

PriorRadiationTherapyAdministeredEndDate

Item

Prior radiation therapy stop date (if applicable)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

RecentSurgeryDate

Item

Date of Most Recent Surgery (major if applicable)

date

C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C25280 (NCI Thesaurus ObjectClass-2)
C0332185 (UMLS 2011AA ObjectClass-2)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)

SWOGPriorTherapyAdministrationSpecify

Item

Other therapy, specify

text

C25699 (NCI Thesaurus ObjectClass)
C1519429 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C15368 (NCI Thesaurus ObjectClass-3)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)

Comments

Item Group

Comments

Research Comments

Item

Comments

text

C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)

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Modell Kommentare :

Itemgroup Kommentare für :

Item Kommentare für :

Colorectal Cancer NCT00499369 Pre-Study - Southwest Oncology Group S0600 Prestudy Form - 2484582v1.0

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