ID

10839

Descrizione

CALGB: 80405 ON-STUDY FORM NCT00265850 Cetuximab and/or Bevacizumab Combined With Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=F39D0458-B14A-5DB0-E034-0003BA3F9857

collegamento

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=F39D0458-B14A-5DB0-E034-0003BA3F9857

Keywords

Kolorektale Tumoren

Clinical Trial

On-Study Form

Caricato su

9 giugno 2015

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 3.0 Legacy

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CALGB: 80405 ON-STUDY FORM NCT00265850

model
Dettagli

INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted.

1 moduli

StudyEvent: CALGB: 80405 ON-STUDY FORM
1. INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted.

Name

genere

Description | Question | Decode (Coded Value)

Tipo di dati

Alias

Header

Item Group

Header

Form ID CALGB

Item

CALGB Form

text

C25337 (NCI Thesaurus ValueDomain)
C3262252 (UMLS CUI-1)
C19464 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus ObjectClass-2)

Protocol ID CALGB

Item

CALGB Study No

text

C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus Property-2)

Trial subject ID CALGB

Item

CALGB Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus Property-2)

FirstProtocolTreatmentBeginDate

Item

Start date of first treatment

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)
C25509 (NCI Thesaurus ObjectClass-2)
C1279901 (UMLS 2011AA ObjectClass-2)

Data amended

Item

Are data amended

boolean

C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)

Patient demographics

Item Group

Patient demographics

Patient Initials

Item

Patient Initials

text

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

Patient Hospital No

Item

Patient Hospital No

text

C25337 (NCI Thesaurus ValueDomain)
C0421459 (UMLS CUI-1)
C16960 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
C16696 (NCI Thesaurus ObjectClass)

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)

Participating Group

Item

Participating Group

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

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)

PATIENT DESCRIPTION

Item Group

Patient Description

ColorectalCancerOriginalDiagnosisDate

Item

Date of original diagnosis of colorectal cancer (MM DD YYYY)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25604 (NCI Thesaurus Property)
C0205313 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property-2)
C0011900 (UMLS 2011AA Property-2)
C0009402 (NCI Metathesaurus ObjectClass)

MedDRACode

Item

MedDRA Code (disease)

float

C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
CL104089 (NCI Metathesaurus ObjectClass)

PriorCancerDiagnosisInd-3

Item

Has the patient had any prior cancer diagnosed? (other than colorectal?)

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)

PriorCancerTypeText

Item

Type of Prior Cancer (If Yes,)

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)

PriorCancerDiagnosisDate

Item

Prior Cancer Diagnosis Date (year YYYY)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)

Trial subject ID SWOG

Item

SWOG Patient ID (from SWOG SpecTrak System)

text

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)

LAB DATA AT PROTOCOL ENTRY

Item Group

Lab Data At Protocol Entry

Leukocytes (WBC)

Item

Peripheral WBC Count

float

C25294 (NCI Thesaurus ObjectClass)
C0023508 (UMLS CUI-1)
C12529 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C38024 (NCI Thesaurus ValueDomain-2)

Neutrophil count

Item

Absolute neutrophil count

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)

Neutrophil percentage

Item

Peripheral Neutrophils (%)

float

C25294 (NCI Thesaurus ObjectClass)
C1171400 (UMLS CUI-1)
C12533 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C25613 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)

LaboratoryProcedureHemoglobinResultSpecifiedValue

Item

Hemoglobin

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)

Platelets

Item

Peripheral platelet count

float

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

HepaticBilirubinLabValue

Item

Bilirubin

float

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)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LaboratoryProcedureMagnesiumResultSpecifiedValue

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)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C38024 (NCI Thesaurus ValueDomain-2)
C0205369 (UMLS 2011AA ValueDomain-2)

HepaticSGOT(AST)LabUnspecifiedValue

Item

SGOT

float

C13308 (NCI Thesaurus ObjectClass)
C0205054 (UMLS 2011AA ObjectClass)
C25202 (NCI Thesaurus Property)
C0242192 (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)

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)

RenalCreatinineLabSpecifiedValue

Item

Creatinine

float

C25225 (NCI Thesaurus ObjectClass)
C0022646 (UMLS 2011AA ObjectClass)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property-2)
C0022885 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

Creatinine, serum ULN

Item

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)

Albumin

Item

Albumin

float

C20200 (NCI Thesaurus Property)
C0201838 (UMLS CUI-1)
C214 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)

LDH

Item

Lactate Dehydrogenase (LDH)

float

C20200 (NCI Thesaurus Property)
C0202113 (UMLS CUI-1)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C25184 (NCI Thesaurus Property-2)

UrinalysisProteinLevelAmount

Item

Urinalysis result (Mark one with an X)

text

C17241 (NCI Thesaurus ObjectClass)
C0042014 (UMLS 2011AA ObjectClass)
C17021 (NCI Thesaurus Property)
C0033684 (UMLS 2011AA Property)
C25417 (NCI Thesaurus ValueDomain)
C25554 (NCI Thesaurus Property-2)
C0441889 (UMLS 2011AA Property-2)

CL.3

Code List

Urinalysis result (Mark one with an X)

CL Item

0 (0)

C0919414 (NCI Metathesaurus)

CL Item

1+ (1+)

CL Item

2+ (2+)

CL Item

3+ (3+)

CL Item

4+ (4+)

UrinaryProteinCollectionValue

Item

Protein from 24 hour urine collection (for patients who have > 2+ proteinuria)

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)

ColorectalCancerDescriptionDiseaseType

Item

Disease description (Mark one with an X)

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C0009402 (NCI Metathesaurus ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
C0012634 (NCI Metathesaurus Property)

CL.4

Code List

Disease description (Mark one with an X)

CL Item

Locally Advanced (Locally advanced)

CL Item

Metastatic (Metastatic)

C14174 (NCI Thesaurus)
C0036525 (UMLS 2011AA)

ColorectalCancerInvolvedDiseaseSite

Item

Currently involved sites of disease (Mark all that apply with an X.)

text

C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
C25547 (NCI Thesaurus Property)
C0009402 (NCI Metathesaurus ObjectClass)
C0012634 (NCI Metathesaurus Property)

CL.5

Code List

Currently involved sites of disease (Mark all that apply with an X.)

CL Item

Primary Site Or Tumor Bed (Primary site or tumor bed)

CL Item

Liver (Liver)

C12392 (NCI Thesaurus)
C0023884 (UMLS 2011AA)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

CL Item

Bone (Bone)

C12366 (NCI Thesaurus)
C0262950 (UMLS 2011AA)

CL Item

Cns/brain (CNS/Brain)

CL Item

Intra-abdominal (Intra-abdominal)

CL Item

Lung (Lung)

C12468 (NCI Thesaurus)
C0024109 (UMLS 2011AA)

ColorectalCancerIntentTreatmentType

Item

Intent of treatment (Mark one with an X.)

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus Property)
C0009402 (NCI Metathesaurus ObjectClass)
C25725 (NCI Thesaurus Property-2)
C1283828 (UMLS 2011AA Property)

CL.6

Code List

Intent of treatment (Mark one with an X.)

CL Item

Palliative (Palliative)

CL Item

Neoadjuvant Chemotherapy With The Potential For Resection Of All Sites Of Metastatic Disease (Neoadjuvant chemotherapy with the potential for resection of all sites of metastatic disease)

For patients who consented to the correlative sciences companion study

Item Group

For Patients Who Consented To The Correlative Sciences Companion Study

BloodSpecimenCollectionTime

Item

Specimen collected time (Serum)

time

C12434 (NCI Thesaurus ObjectClass)
C0229664 (UMLS 2011AA ObjectClass)
C25207 (NCI Thesaurus ValueDomain)
C0040223 (UMLS 2011AA ValueDomain)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
C25452 (NCI Thesaurus Property)

CollectionBloodHourFastingSpecify

Item

Number of hours between last meal and blood collection

text

C12434 (NCI Thesaurus ObjectClass)
C0229664 (UMLS 2011AA ObjectClass)
C25453 (NCI Thesaurus ObjectClass-2)
C1516698 (UMLS 2011AA ObjectClass-2)
C25529 (NCI Thesaurus Property)
C0439227 (UMLS 2011AA Property)
C0015663 (NCI Metathesaurus Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)

PRIOR THERAPY DATA

Item Group

Prior Therapy Data

SurgicalProcedureColorectalCarcinomaPerformedMostRecentDate

Item

Date of last surgical resection for colorectal cancer (If applicable, submit operative and pathology reports.)

date

C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C2955 (NCI Thesaurus Property-2)
C0009402 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25577 (NCI Thesaurus ValueDomain-2)
C1513491 (UMLS 2011AA ValueDomain-2)

PriorChemotherapyAdministeredInd-3

Item

Prior Systemic Chemotherapy

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (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)

PriorAgentColorectalCancerTherapyType

Item

specify agents (If Yes, Mark one with an X.)

text

C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C15368 (NCI Thesaurus Property)
C0009402 (NCI Metathesaurus Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.8

Code List

specify agents (If Yes, Mark one with an X.)

CL Item

5fu Based Therapy (5FU based therapy)

CL Item

Irinotecan (Irinotecan)

CL Item

Oxaliplatin (Oxaliplatin)

C1181 (NCI Thesaurus)
C0069717 (UMLS 2011AA)

CL Item

Cetuximab (Cetuximab)

C1723 (NCI Thesaurus)
C0879636 (UMLS 2011AA)

CL Item

Bevacizumab (Bevacizumab)

C2039 (NCI Thesaurus)
C0796392 (UMLS 2011AA)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

PriorAgentColorectalCancerTherapySpecify

Item

Other, specify

text

C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C15368 (NCI Thesaurus Property)
C0009402 (NCI Metathesaurus Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)

PriorChemotherapyAdministeredBeginDate

Item

Prior Chemotherapy Begin Date

date

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)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)

PriorChemotherapyAdministeredEndDate

Item

Prior Chemotherapy End Date

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)

PatientChemotherapyMetastasisColorectalCarcinomaPersonalMedicalHistoryInd-2

Item

Prior chemotherapy for advanced or 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)

Prior Radiation Therapy

Item

Prior radiation therapy (with or without radiosensitizing chemotherapy)

boolean

C38148 (NCI Thesaurus ValueDomain)
C1522449 (UMLS CUI-1)
C15313 (NCI Thesaurus ObjectClass)
C0332152 (UMLS CUI-2)
C25629 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property)

Radiation Therapy Start Date

Item

RT begin date

date

C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS CUI-1)
C25431 (NCI Thesaurus Property)
C0808070 (UMLS CUI-2)
C25275 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)

Radiation Therapy End Date

Item

RT End Date

date

C25164 (NCI Thesaurus ValueDomain)
C1522449 (UMLS CUI-1)
C15313 (NCI Thesaurus ObjectClass)
C0806020 (UMLS CUI-2)
C25275 (NCI Thesaurus Property)
C25496 (NCI Thesaurus Property-2)

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)

PatientWarfarinTreatmentInd-2

Item

is the patient receiving a stable dose of warfarin and has an in-range INR or receiving a stable dose of heparin (If yes,)

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)

ArterialThrombosisRiskFactorType

Item

Arterial thrombotic event risk factors (Mark all that apply with an X.)

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C0221464 (NCI Metathesaurus ObjectClass)
C0040053 (NCI Metathesaurus ObjectClass-2)
C17103 (NCI Thesaurus Property)
C0035648 (UMLS 2011AA Property)

CL.13

Code List

Arterial thrombotic event risk factors (Mark all that apply with an X.)

CL Item

Prior Arterial Thrombotic Event (Prior arterial thrombotic event)

CL Item

Prior Coronary Artery Disease (Prior coronary artery disease)

CL Item

History Of Hypertension (History of hypertension)

CL Item

History Of Smoking (History of smoking)

CL Item

History Of Hyperlipidemia (History of hyperlipidemia)

CL Item

Diabetes (Diabetes)

CL Item

Peripheral Vascular Disease (Peripheral vascular disease)

CL Item

No Risk Factors (No risk factors)

ArterialThrombosisPriorEventType

Item

Prior ATE code

text

C26891 (NCI Thesaurus ObjectClass)
C0040053 (UMLS 2011AA ObjectClass)
C0221464 (NCI Metathesaurus ObjectClass)
C25499 (NCI Thesaurus Property)
C0441471 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.14

Code List

Prior ATE code

CL Item

Cardiac Stenting/angioplasty (Cardiac stenting/angioplasty)

CL Item

Cva (CVA)

CL Item

Mi (MI)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

CL Item

Tia (TIA)

CL Item

Unstable Angina (Unstable angina)

C66911 (NCI Thesaurus)
C0002965 (UMLS 2011AA)

ArterialThrombosisPriorEventSpecify

Item

Other, specify

text

C26891 (NCI Thesaurus ObjectClass)
C0040053 (UMLS 2011AA ObjectClass)
C0221464 (NCI Metathesaurus ObjectClass)
C25499 (NCI Thesaurus Property)
C0441471 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)

PriorArterialThrombosisEventDate

Item

Prior ATE onset date (of most recent events)

date

C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C0221464 (NCI Metathesaurus ObjectClass)
C0040053 (NCI Metathesaurus ObjectClass-2)
C25499 (NCI Thesaurus Property)
C0441471 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

PatientHistoryHemorrhageEventInd-2

Item

Does patient have history of significant bleeding episodes

boolean

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25499 (NCI Thesaurus Property)
C0441471 (UMLS 2011AA Property)
C26791 (NCI Thesaurus Property-2)
C0019080 (UMLS 2011AA Property-2)
C1321503 (NCI Metathesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PatientHistoryHemorrhageEventText

Item

Specify type

text

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25499 (NCI Thesaurus Property)
C0441471 (UMLS 2011AA Property)
C26791 (NCI Thesaurus Property-2)
C0019080 (UMLS 2011AA Property-2)
C1321503 (NCI Metathesaurus Property)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)

PatientHistoryHemorrhageEventDate

Item

Date (MM DD YYYY)

date

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25499 (NCI Thesaurus Property)
C0441471 (UMLS 2011AA Property)
C26791 (NCI Thesaurus Property-2)
C0019080 (UMLS 2011AA Property-2)
C1321503 (NCI Metathesaurus Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

PatientHistoryGIPerforationInd-2

Item

Does patient have history of GI perforation

boolean

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C34082 (NCI Thesaurus Property)
C0017189 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property-2)
C0262926 (UMLS 2011AA Property-2)
C4080 (NCI Thesaurus Property-3)
C0549099 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PersonGastrointestinalTractPerforationPersonalMedicalHistoryDate

Item

Specify date of onset (MM DD YYYY)

date

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C34082 (NCI Thesaurus Property)
C0017189 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property-2)
C0262926 (UMLS 2011AA Property-2)
C4080 (NCI Thesaurus Property-3)
C0549099 (UMLS 2011AA Property-3)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

Person Completing Form

Item

Completed by

text

C25191 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)

Form Completion Date

Item

Date Form Originally Completed (MM DD YYYY)

date

C19464 (NCI Thesaurus ObjectClass)
C1549507 (UMLS CUI-1)
C25250 (NCI Thesaurus Property)
C25604 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)

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CALGB: 80405 ON-STUDY FORM NCT00265850

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