ID

8873

Description

NSABP Protocol B-42 - Protocol Entry Form Worksheet Letrozole in Treating Postmenopausal Women Who Have Received Hormone Therapy for Hormone Receptor-Positive Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=17AF2627-D64B-3BA6-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=17AF2627-D64B-3BA6-E044-0003BA3F9857

Keywords

Clinical Trial

Registration

Breast Neoplasms

Uploaded on

January 9, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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Breast Cancer NCT00382070 Registration - NSABP Protocol B-42 - Protocol Entry Form Worksheet - 2494107v1.0

model
Details

Submit every 6 months from date of randomization for the first 5 years; yearly thereafter, and when a protocol event occurs. Fax Form F to 412-622-2111

1 forms

StudyEvent: NSABP Protocol B-42 - Protocol Entry Form Worksheet
1. Submit every 6 months from date of randomization for the first 5 years; yearly thereafter, and when a protocol event occurs. Fax Form F to 412-622-2111

Name

Type

Description | Question | Decode (Coded Value)

Data type

Alias

Header

Item Group

Header

Patient Initials Last

Item

Last

text

C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1517741 (UMLS CUI-2)
C25536 (NCI Thesaurus Property)
C25551 (NCI Thesaurus Property-2)

Patient Initials First

Item

First

text

C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C0205435 (UMLS CUI-2)
C25536 (NCI Thesaurus Property)
C25509 (NCI Thesaurus Property-2)

PatientMiddleInitialsName

Item

Middle

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)
C25569 (NCI Thesaurus Property-2)
C0444598 (UMLS 2011AA Property-2)

ClinicalTrialSiteNameText

Item

Site Name

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15207 (NCI Thesaurus ObjectClass)
C37901 (NCI Thesaurus Property)
C0205145 (UMLS 2011AA Property)
C42614 (NCI Thesaurus ValueDomain-2)
C0027365 (UMLS 2011AA ValueDomain-2)

Patient Birth Date

Item

Patient Birth Date

date

C25164 (NCI Thesaurus ValueDomain)
C0421451 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C25155 (NCI Thesaurus Property)

TreatingPhysicianName

Item

Treating physician

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25741 (NCI Thesaurus ObjectClass)
C0031831 (UMLS 2011AA ObjectClass)
C25705 (NCI Thesaurus ObjectClass-2)
C1522326 (UMLS 2011AA ObjectClass-2)

Social Security Number

Item

Patient Social Security Number (USA Only)

text

C25337 (NCI Thesaurus ValueDomain)
C1301821 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25686 (NCI Thesaurus Property)

Protocol Eligibility

Item Group

Unnamed2

NSABPPatientClinicalTrialEligibilityCriteriaB-42Type

Item

Eligibility Criteria

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C15818 (NCI Thesaurus ObjectClass-2)
C1513905 (UMLS 2011AA ObjectClass-2)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)

CL.1

Code List

Eligibility Criteria

CL Item

Postmenopausal (Postmenopausal)

C15421 (NCI Thesaurus)
C0232970 (UMLS 2011AA)

CL Item

Disease-free From Initial Breast Cancer Diagnosis (Disease-free from initial breast cancer diagnosis)

CL Item

Histologically-confirmed Invasive Breast Carcinoma By Diagnostic Core Needle Biopsy Or Final Pathologic Evaluation Of Surgical Specimen (Histologically-confirmed invasive breast carcinoma by diagnostic core needle biopsy or final pathologic evaluation of surgical specimen)

CL Item

Primary Tumor Was Er-positive And/or Pgr-positive (Primary tumor was ER-positive and/or PgR-positive)

CL Item

No History Of Non-traumatic Osteoporotic Bone Fractures (No history of non-traumatic osteoporotic bone fractures)

CL Item

No Diagnosis Of Bilateral Breast Cancer Including Dcis (synchronous Or Metachronous) (No diagnosis of bilateral breast cancer including DCIS (synchronous or metachronous))

CL Item

No Other Malignancies Within Past 5 Years (No other malignancies within past 5 years)

CL Item

Not Currently On Sex Hormonal Therapy (Not currently on sex hormonal therapy)

CL Item

All Other Protocol Criteria Met (All other protocol criteria met)

Race

Item Group

Race

Racial Group

Item

Race

text

C25372 (NCI Thesaurus ValueDomain)
C0034510 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C17049 (NCI Thesaurus Property)

CL.2

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.3

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)

Ethnic Group

Item

Ethnicity

text

C25372 (NCI Thesaurus ValueDomain)
C0015031 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C16564 (NCI Thesaurus Property)

CL.4

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)

PatientAddressCountryCode

Item

Country of residence

text

C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25407 (NCI Thesaurus Property)
C1442065 (UMLS 2011AA Property)

CL.5

Code List

Country of residence

CL Item

Usa (US)

CL Item

Puerto Rico (PR)

C17043 (NCI Thesaurus)
C0034044 (UMLS 2011AA)

CL Item

Canada (CA)

C16380 (NCI Thesaurus)
C0006823 (UMLS 2011AA)

CL Item

Other (Other)

Country of current residence

Item

Country of Residence (Other)

text

C16960 (NCI Thesaurus ObjectClass)
C3258975 (UMLS CUI-1)
C25464 (NCI Thesaurus ValueDomain)
C25407 (NCI Thesaurus Property)
C42614 (NCI Thesaurus ValueDomain-2)

PatientAddressPostalCode

Item

Patient Zip Code (USA)

text

Consent

Item Group

Consent

PatientConsentType

Item

Patient consents to

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)

CL.6

Code List

Patient consents to

CL Item

Future Cancer Research (Future Cancer Research)

CL Item

Future Contact (Future Contact)

CL Item

Future Other Research (Future Other Research)

Pre-Entry Evaluation

Item Group

Unnamed4

InformedConsentFormSignedDate

Item

Date Informed Consent Signed

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)

TreatmentPlannedBeginDate

Item

Planned Date of Treatment Initiation (Should begin within 30 days following randomization. Allow 7+ days after randomization for drug distribution.)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)
C25619 (NCI Thesaurus Property)
C1301732 (UMLS 2011AA Property)

PatientPHIConsentIndicator

Item

Has the patient authorized the release of Protected Health Information to the NSABP?

boolean

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)

PersonalMedicalHistoryPhysicalExaminationPerformedDate

Item

Date of Pre-entry History & Physical Exam (must be within 3 months prior to randomization)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C18772 (NCI Thesaurus ObjectClass-2)
C0262926 (UMLS 2011AA ObjectClass-2)

MammogramPerformedMostRecentDate

Item

Date of Most Recent Mammogram (must be within 12 months prior to randomization)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20178 (NCI Thesaurus ObjectClass)
C0024671 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25577 (NCI Thesaurus ValueDomain-2)
C1513491 (UMLS 2011AA ValueDomain-2)

BilateralMastectomyPerformedInd-2

Item

Did the patient have a bilateral mastectomy

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15277 (NCI Thesaurus ObjectClass)
C0024881 (UMLS 2011AA ObjectClass)
C13332 (NCI Thesaurus ObjectClass-2)
C0238767 (UMLS 2011AA ObjectClass-2)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)

BoneMineralDensityAssessmentMostRecentDate

Item

Date of Most Recent Bone Mineral Density Test (BMDmust be within 12 months prior to randomization)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C61545 (NCI Thesaurus ObjectClass)
C0177804 (UMLS 2011AA ObjectClass)
C25577 (NCI Thesaurus ValueDomain-2)
C1513491 (UMLS 2011AA ValueDomain-2)

BoneMineralDensityLumbarSacralVertebraResultScore

Item

Lumbar-Sacral Spine

float

C49566 (NCI Thesaurus ObjectClass)
C1704651 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C34004 (NCI Thesaurus Property-2)
C0024090 (UMLS 2011AA Property-2)
C12853 (NCI Thesaurus Property-3)
C1261045 (UMLS 2011AA Property-3)
C25338 (NCI Thesaurus ValueDomain)
C0449820 (UMLS 2011AA ValueDomain)

BoneMineralDensityHipResultScore

Item

Total Hip

float

C64193 (NCI Thesaurus Property)
C0019552 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C61545 (NCI Thesaurus ObjectClass)
C0177804 (UMLS 2011AA ObjectClass)
C25338 (NCI Thesaurus ValueDomain)
C0449820 (UMLS 2011AA ValueDomain)

BoneMineralDensityFemoralNeckResultScore

Item

Femoral Neck

float

C12717 (NCI Thesaurus Property)
C0015811 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C61545 (NCI Thesaurus ObjectClass)
C0177804 (UMLS 2011AA ObjectClass)
C25338 (NCI Thesaurus ValueDomain)
C0449820 (UMLS 2011AA ValueDomain)

LaboratoryProcedureLipidResultDate

Item

Date of Protocol-Qualifying Lipid Profile

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)
C616 (NCI Thesaurus Property-2)
C0023779 (UMLS 2011AA Property-2)

BreastNeoplasmFirstDiagnosisDate

Item

Date of Initial Breast Cancer Diagnosis

date

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property-2)
C0011900 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

PrimarySurgeryPriorPerformedDate

Item

Date of Prior Primary Surgery

date

C25251 (NCI Thesaurus ObjectClass)
C0205225 (UMLS 2011AA ObjectClass)
C15329 (NCI Thesaurus ObjectClass-2)
C0543467 (UMLS 2011AA ObjectClass-2)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

BreastCarcinomaTherapyAdministeredType

Item

Type of surgery

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C4872 (NCI Thesaurus ObjectClass)
C0678222 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

CL.9

Code List

Type of surgery

CL Item

Lumpectomy + Axillary Staging + Rt (Lumpectomy + Axillary Staging + RT)

CL Item

Total Mastectomy + Axillary Staging (Total Mastectomy + Axillary Staging)

LymphNodePathologicInvolvementType

Item

Pathologic Lymph Node Assessment

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25610 (NCI Thesaurus Property)
C1521733 (UMLS 2011AA Property)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25548 (NCI Thesaurus Property-2)
C1314939 (UMLS 2011AA Property-2)

CL.10

Code List

Pathologic Lymph Node Assessment

CL Item

Negative (negative)

C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)

CL Item

Positive (positive)

C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)

ERLevelTumorStatus

Item

Receptor Status, ER

text

C3262 (NCI Thesaurus ValueDomain)
C0027651 (UMLS 2011AA ValueDomain)
C17069 (NCI Thesaurus ObjectClass)
C0034804 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain-2)
C0449438 (UMLS 2011AA ValueDomain-2)
C25554 (NCI Thesaurus Property)
C0441889 (UMLS 2011AA Property)

CL.11

Code List

Receptor Status, ER

CL Item

Positive (Positive)

C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)

CL Item

Negative (Negative)

C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

PgRStatusType

Item

Receptor Status, PgR

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C17075 (NCI Thesaurus ObjectClass)
C0034833 (UMLS 2011AA ObjectClass)
C0678257 (NCI Metathesaurus Property)

CL.12

Code List

Receptor Status, PgR

CL Item

Positive (Positive)

C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)

CL Item

Negative (Negative)

C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

EpidermalGrowthFactorReceptorAssessmentInd-2

Item

Was HER2 testing performed

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25217 (NCI Thesaurus Property)
C1516048 (UMLS 2011AA Property)
C17068 (NCI Thesaurus ObjectClass)
C0034802 (UMLS 2011AA ObjectClass)

HER2/neuStatusType

Item

HER-2/neu status

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C17756 (NCI Thesaurus ObjectClass)
C0242957 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)

CL.14

Code List

HER-2/neu status

CL Item

Positive (Positive)

C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)

CL Item

Negative (Negative)

C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

Adjuvant Hormonal Therapy History and Status

Item Group

Therapy Status

PriorTamoxifenAdministeredInd-3

Item

Did this patient receive any tamoxifen?

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C855 (NCI Thesaurus ObjectClass)
C0039286 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

PriorTamoxifenAdministeredMonthDuration

Item

Total Duration (Must be =< 36 months)

float

C855 (NCI Thesaurus ObjectClass)
C0039286 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C29846 (NCI Thesaurus ValueDomain)
C0439231 (UMLS 2011AA ValueDomain)
C25330 (NCI Thesaurus ValueDomain-2)
C0449238 (UMLS 2011AA ValueDomain-2)

TamoxifenTreatmentEndDate

Item

Tamoxifen Treatment End Date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C855 (NCI Thesaurus ObjectClass)
C0039286 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)
C25496 (NCI Thesaurus ValueDomain-2)
C2746065 (UMLS 2011AA ValueDomain-2)

PriorAromataseInhibitorReceivedMonthDuration

Item

Cumulative Duration of AIs (# months)

float

C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C1740 (NCI Thesaurus ObjectClass-2)
C0593802 (UMLS 2011AA ObjectClass-2)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C29846 (NCI Thesaurus ValueDomain)
C0439231 (UMLS 2011AA ValueDomain)
C25330 (NCI Thesaurus ValueDomain-2)
C0449238 (UMLS 2011AA ValueDomain-2)

AromataseInhibitorMostRecentReceivedText

Item

Which aromatase inhibitor was most recently being taken

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C1740 (NCI Thesaurus ObjectClass)
C0593802 (UMLS 2011AA ObjectClass)
C25577 (NCI Thesaurus Property-2)
C1513491 (UMLS 2011AA Property-2)

AromataseInhibitorCurrentAdministeredInd-2

Item

Is the patient currently receiving an AI

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25471 (NCI Thesaurus Property)
C0521116 (UMLS 2011AA Property)
C1740 (NCI Thesaurus ObjectClass)
C0593802 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)

AromataseInhibitorHormoneTherapyAdministeredEndDate

Item

Aromatase inhibitor treatment end date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C1740 (NCI Thesaurus ObjectClass-2)
C0593802 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

NationalSurgicalAdjuvantBreastandBowelProjectPatientLetrozoleClinicalStudyEnrollmentInd-2

Item

Was the patient on the B-42 Letrozole Registration Program

boolean

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C15818 (NCI Thesaurus ObjectClass-2)
C1513905 (UMLS 2011AA ObjectClass-2)
C1527 (NCI Thesaurus Property)
C0246421 (UMLS 2011AA Property)
C15206 (NCI Thesaurus Property-2)
C0008972 (UMLS 2011AA Property-2)
C37948 (NCI Thesaurus Property-3)
C1516879 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PatientNationalSurgicalAdjuvantBreastProjectLetrozoleRegistrationIdentifierNumber

Item

Registration number (If Yes,)

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)
C1527 (NCI Thesaurus Property-2)
C0246421 (UMLS 2011AA Property-2)

In the opinion of the investigator, is the patient eligible?

Item Group

Unnamed4

Eligibility for trial

Item

In the opinion of the investigator, is the patient eligible?

boolean

C38148 (NCI Thesaurus ValueDomain)
C1302261 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25171 (NCI Thesaurus Property)

PersonNationalSurgicalAdjuvantBreastandBowelProjectClinicalStudyParticipationInd-3

Item

Has the patient participated in any other NSABP trial

boolean

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C15818 (NCI Thesaurus Property-2)
C1513905 (UMLS 2011AA Property-2)
C15206 (NCI Thesaurus Property-3)
C0008972 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

PersonNationalSurgicalAdjuvantBreastandBowelProjectClinicalStudyParticipationNumber

Item

Patient ID#

text

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C15818 (NCI Thesaurus Property-2)
C1513905 (UMLS 2011AA Property-2)
C15206 (NCI Thesaurus Property-3)
C0008972 (UMLS 2011AA Property-3)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)

Patient Characteristics

Item Group

Patient Characteristics

Patient Height

Item

Height (cm)

float

C25209 (NCI Thesaurus ValueDomain)
C0489786 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25347 (NCI Thesaurus Property)

Patient Weight

Item

Weight (kg)

float

C25209 (NCI Thesaurus ValueDomain)
C0005910 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)

Cardiac History

Item Group

Cardiac History

PatientMedicalConditionCurrentType

Item

Medical Condition

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25261 (NCI Thesaurus Property)
C0205476 (UMLS 2011AA Property)
C25457 (NCI Thesaurus Property-2)
C0348080 (UMLS 2011AA Property-2)

CL.20

Code List

Medical Condition

CL Item

Hypertension (hypertension)

C3117 (NCI Thesaurus)
C0020538 (UMLS 2011AA)

CL Item

Ischemic Heart Disease (Ischemic Heart Disease)

C50625 (NCI Thesaurus)
C0151744 (UMLS 2011AA)

CL Item

Congestive Heart Failure (Congestive Heart Failure)

C3080 (NCI Thesaurus)
C0018802 (UMLS 2011AA)

CL Item

Atrial Fibrillation: C50466 (Atrial Arrhythmia)

C50466 (NCI Thesaurus)
C0004238 (UMLS 2011AA)

CL Item

Ventricular Arrhythmia (Ventricular Arrhythmia)

C26924 (NCI Thesaurus)
C0085612 (UMLS 2011AA)

CL Item

Diabetes (diabetes)

CL Item

Elevated Fasting Lipid Profile (Elevated Fasting Lipid Profile)

ConcomitantMedicationUseInd-3

Item

Medications (in the 12 months prior to study entry)

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C25730 (NCI Thesaurus ObjectClass-2)
C0521115 (UMLS 2011AA ObjectClass-2)
C25340 (NCI Thesaurus Property)
C0457083 (UMLS 2011AA Property)

Research Comments

Item

Comments (Optional)

text

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

Cardiac History - Other

Item Group

Cardiac History - Other

PostDiagnosisSmokingDailyUseInd-2

Item

Has the patient smoked daily for at least 3 months at any time since her breast cancer diagnosis

boolean

C38008 (NCI Thesaurus ObjectClass)
C0687676 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus ObjectClass-2)
C0011900 (UMLS 2011AA ObjectClass-2)
C17934 (NCI Thesaurus ObjectClass-3)
C0453996 (UMLS 2011AA ObjectClass-3)
C25473 (NCI Thesaurus Property)
C0332173 (UMLS 2011AA Property)
C0449865 (NCI Metathesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

FirstDegreeRelativeCardiovascularDisorderDeathInd-2

Item

Does the patient have any first degree relatives who died from heart disease before the age of 55 ("First degree relatives" include parent, children, brothers, and sisters)

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C28554 (NCI Thesaurus Property)
C0011065 (UMLS 2011AA Property)
C2931 (NCI Thesaurus Property-2)
C0007222 (UMLS 2011AA Property-2)
C21481 (NCI Thesaurus ObjectClass)
C1517194 (UMLS 2011AA ObjectClass)

Concomitant Medications

Item Group

Concomitant Medications

AgentClassificationName

Item

Agent Category

text

C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25161 (NCI Thesaurus Property)
C0008902 (UMLS 2011AA Property)
C0027365 (NCI Metathesaurus ValueDomain)

CL.24

Code List

Agent Category

CL Item

Bisphosphonate (Bisphosphonate)

CL Item

Calcium (Calcium)

C331 (NCI Thesaurus)
C0006675 (UMLS 2011AA)

CL Item

Other Medication For Bone Density (Other Medication for Bone Density)

CL Item

Lipid Lowering Drug (Lipid Lowering Drug)

CL Item

Cardiovascular Medication #1 (Cardiovascular Medication #1)

CL Item

Cardiovascular Medication #2 (Cardiovascular Medication #2)

CL Item

Cardiovascular Medication #3 (Cardiovascular Medication #3)

Agent

Item

Agent Name

text

C25364 (NCI Thesaurus Property)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)

AgentDuringRandomizationAdministeredInd-2

Item

Taking at time of randomization?

boolean

C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25196 (NCI Thesaurus Property)
C0034656 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C25490 (NCI Thesaurus Property-3)
C0347984 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

AgentPostRandomizationAdministeredInd-2

Item

Continuing after Randomization

boolean

C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25196 (NCI Thesaurus Property)
C0034656 (UMLS 2011AA Property)
C38008 (NCI Thesaurus Property-2)
C0687676 (UMLS 2011AA Property-2)
C25382 (NCI Thesaurus Property-3)
C1521801 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

Footer Module

Item Group

Footer Module

Person Completing Form

Item

Completed by

text

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

ResponsiblePersonSignatureDate

Item

Date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25657 (NCI Thesaurus ObjectClass-2)
C1273518 (UMLS 2011AA ObjectClass-2)
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)

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Model comments :

Itemgroup comments for :

Item comments for :

Breast Cancer NCT00382070 Registration - NSABP Protocol B-42 - Protocol Entry Form Worksheet - 2494107v1.0

Submit every 6 months from date of randomization for the first 5 years; yearly thereafter, and when a protocol event occurs. Fax Form F to 412-622-2111

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