ID

7785

Beschreibung

CALGB 40503 ON-STUDY FORM Tamoxifen or Letrozole With or Without Bevacizumab in Treating Women With Stage III or Stage IV Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=24087EF3-EA58-6B28-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=24087EF3-EA58-6B28-E044-0003BA3F9857

Stichworte

Versionen (2)
  1. 26.08.12 26.08.12 -
  2. 09.01.15 09.01.15 - Martin Dugas
Hochgeladen am

9. Januar 2015

DOI

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Lizenz

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Breast Cancer NCT00601900 On-Study - CALGB 40503 ON-STUDY FORM - 2551476v1.0

Englisch

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. For optimal accuracy use black ink.

1 Formulare  
Header
Beschreibung

Header

CALGB Form
Beschreibung

Form ID CALGB

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3262252
NCI Thesaurus ObjectClass
C19464
UMLS CUI-2
C1516238
NCI Thesaurus Property
C25364
NCI Thesaurus ObjectClass-2
C25442
CALGB Study No.
Beschreibung

Protocol ID CALGB

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1516238
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25442
CALGB Patient ID
Beschreibung

Trial subject ID CALGB

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1516238
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25442
Are data amended
Beschreibung

Data amended

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Unnamed2
Beschreibung

Unnamed2

Patient Initials (Last, First Middle)
Beschreibung

Patient Initials

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Patient Hospital No.
Beschreibung

Medical Record Number

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1301894
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25261
NCI Thesaurus Property-2
C25198
Institution/Affiliate
Beschreibung

Institution Name

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C25454
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass-2
C21541
NCI Thesaurus Property
C25364
NCI Thesaurus ValueDomain
C25191
NCI Thesaurus ValueDomain-2
C21541
Participating Group
Beschreibung

Participating Group

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2347449
NCI Thesaurus ObjectClass
C25608
NCI Thesaurus ObjectClass-2
C17005
NCI Thesaurus Property
C25364
Participating Group Study No.
Beschreibung

Study Number Participating Group

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Participating Group Patient ID
Beschreibung

Trial subject ID Participating Group

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Patient Characteristics
Beschreibung

Patient Characteristics

ECOG Performance Status (Mark one with an X.)
Beschreibung

ECOG Performance Status

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS CUI-1
C1520224
NCI Thesaurus Property
C25367
NCI Thesaurus ValueDomain-2
C25491
NCI Thesaurus ObjectClass
C20641
Menstrual period within the last 12 months?
Beschreibung

MenstrualPeriod12MonthsIndicator

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Metathesaurus ObjectClass
C0025329
NCI Metathesaurus Property
C0814444
Date of last menstrual cycle (MM DD YYYY)
Beschreibung

LastMenstrualCycleOccurrenceDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25551
UMLS 2011AA ObjectClass
C1517741
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
NCI Thesaurus ObjectClass-2
C16838
UMLS 2011AA ObjectClass-2
C0025329
Ovarian Function Suppression Type (If the patient was pre-menopausal)
Beschreibung

OvarianAntiestrogenHormoneTherapyAdministeredType

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus ObjectClass-2
C15757
UMLS 2011AA ObjectClass-2
C0854638
NCI Thesaurus ObjectClass-3
C28047
UMLS 2011AA ObjectClass-3
C0205065
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
MedDRA Disease Code
Beschreibung

MedDRACode

Datentyp

float

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Metathesaurus ObjectClass
CL104089
Disease Description
Beschreibung

Disease Description

ER status (Mark one with an X.)
Beschreibung

ERLevelTumorStatus

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C3262
UMLS 2011AA ValueDomain
C0027651
NCI Thesaurus ObjectClass
C17069
UMLS 2011AA ObjectClass
C0034804
NCI Thesaurus ValueDomain-2
C25688
UMLS 2011AA ValueDomain-2
C0449438
NCI Thesaurus Property
C25554
UMLS 2011AA Property
C0441889
Other, specify
Beschreibung

ERAssayPerformedTime

Datentyp

text

Alias
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ValueDomain
C25207
UMLS 2011AA ValueDomain
C0040223
NCI Thesaurus ObjectClass
C17069
UMLS 2011AA ObjectClass
C0034804
NCI Thesaurus ObjectClass-2
C16341
UMLS 2011AA ObjectClass-2
C0005507
PgR status (Mark one with an X.)
Beschreibung

PgRStatusType

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C17075
UMLS 2011AA ObjectClass
C0034833
NCI Metathesaurus Property
C0678257
Timing of assay (Mark one with an X.)
Beschreibung

TumorMarkerVisitCollectedType

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ValueDomain-2
C25452
NCI Thesaurus ObjectClass
C17220
UMLS 2011AA ObjectClass
C0041365
NCI Thesaurus Property
C25716
UMLS 2011AA Property
C0545082
Timing of assay (Mark one with an X.)
Beschreibung

TumorMarkerVisitCollectedType

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ValueDomain-2
C25452
NCI Thesaurus ObjectClass
C17220
UMLS 2011AA ObjectClass
C0041365
NCI Thesaurus Property
C25716
UMLS 2011AA Property
C0545082
Other, specify
Beschreibung

PgRAssayPerformedTime

Datentyp

text

Alias
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ValueDomain
C25207
UMLS 2011AA ValueDomain
C0040223
NCI Thesaurus ObjectClass
C17075
UMLS 2011AA ObjectClass
C0034833
NCI Thesaurus ObjectClass-2
C16341
UMLS 2011AA ObjectClass-2
C0005507
Date of Initial Diagnosis of Primary Tumor (MM DD YYYY)
Beschreibung

FirstBiopsyPositiveDate

Datentyp

date

Alias
NCI Thesaurus ObjectClass
C15189
UMLS 2011AA ObjectClass
C0005558
NCI Thesaurus ObjectClass-2
C25509
UMLS 2011AA ObjectClass-2
C1279901
NCI Thesaurus Property
C25246
UMLS 2011AA Property
C1446409
NCI Thesaurus Property-2
C25275
UMLS 2011AA Property-2
C2745955
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
Date Progressive or Metastatic Disease First Diagnosed (MM DD YYYY)
Beschreibung

DiseaseRecurrenceDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus Property
C3352
UMLS 2011AA Property
C0034897
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
Site Of Progression Or Recurrence
Beschreibung

Site Of Progression Or Recurrence

Sites of Progression (s)
Beschreibung

Progression Site

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C13717
UMLS CUI-1
C0242656
NCI Thesaurus Property
C25341
UMLS CUI-2
C1515974
NCI Thesaurus ObjectClass
C25331
Other specify
Beschreibung

Progression Site, specify

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C0242656
NCI Thesaurus Property
C25341
UMLS CUI-2
C1515974
NCI Thesaurus ObjectClass
C25331
Required Laboratory Values
Beschreibung

Required Laboratory Values

Peripheral Granulocytes Count (x 10^3/mmicroL)
Beschreibung

Granulocyte count

Datentyp

float

Maßeinheiten
  • 1000/uL
Alias
NCI Thesaurus Property
C20200
UMLS CUI-1
C0857490
NCI Thesaurus Property-2
C12530
NCI Thesaurus ValueDomain
C25463
NCI Thesaurus ObjectClass
C25294
1000/uL
Peripheral Platelet Count (x 10^3/mmicroL)
Beschreibung

Platelets

Datentyp

float

Maßeinheiten
  • 1000/uL
Alias
NCI Thesaurus Property
C20200
UMLS CUI-1
C0005821
NCI Thesaurus Property-2
C12520
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25712
1000/uL
Creatinine (mg/dL)
Beschreibung

Creatinine, Serum

Datentyp

float

Maßeinheiten
  • mg/dL
Alias
NCI Thesaurus Property
C20200
UMLS CUI-1
C0201976
NCI Thesaurus Property-2
C399
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25712
mg/dL
Bilirubin (mg/dL)
Beschreibung

LaboratoryProcedureTotalBilirubinResultValue

Datentyp

float

Maßeinheiten
  • mg/dL
Alias
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property-2
C38037
UMLS 2011AA Property-2
C0201913
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
mg/dL
Bilirubin ULN (mg/dL)
Beschreibung

Bilirubin, Total ULN

Datentyp

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0201913
NCI Thesaurus Property
C20200
UMLS CUI-2
C1519815
NCI Thesaurus Property-2
C38037
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25706
SGPT (ALT) (U/L)
Beschreibung

SGPT (ALT)

Datentyp

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0201836
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C25293
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus ValueDomain-2
C25712
SGPT (ALT) ULN (U/L)
Beschreibung

LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultUpperLimitofNormalValue

Datentyp

float

Alias
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property-2
C25293
UMLS 2011AA Property-2
C0376147
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25706
UMLS 2011AA ValueDomain-2
C1519815
SGOT (AST) (U/L)
Beschreibung

SGOT (AST)

Datentyp

float

Maßeinheiten
  • U/L
Alias
NCI Thesaurus Property
C25202
UMLS CUI-1
C0201899
NCI Thesaurus Property-2
C20200
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25712
U/L
SGOT (AST) ULN (U/L)
Beschreibung

LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedUpperLimitofNormalValue

Datentyp

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C25202
UMLS 2011AA Property
C0242192
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25706
UMLS 2011AA ValueDomain-2
C1519815
International Normalization Ratio (INR)
Beschreibung

INR

Datentyp

float

Alias
NCI Thesaurus Property
C20200
UMLS CUI-1
C0525032
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property-2
C25352
NCI Thesaurus ValueDomain
C25712
Urinalysis
Beschreibung

Urinalysis

Urine Protein (Mark one with an X.)
Beschreibung

UrinalysisProteinLevelAmount

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C17241
UMLS 2011AA ObjectClass
C0042014
NCI Thesaurus Property
C17021
UMLS 2011AA Property
C0033684
NCI Thesaurus ValueDomain
C25417
NCI Thesaurus Property-2
C25554
UMLS 2011AA Property-2
C0441889
Protein from 24 hour Urine Collection (g of protein / 24 hours)
Beschreibung

UrinaryProteinCollectionValue

Datentyp

float

Maßeinheiten
  • g/24 hours
Alias
NCI Thesaurus Property
C25453
UMLS 2011AA Property
C1516698
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ObjectClass
C17021
UMLS 2011AA ObjectClass
C0033684
g/24 hours
Urine Protein/Creatinine Ratio (UPC Or if UPC<=1)
Beschreibung

UrinaryCreatinineProteinAssessmentValue

Datentyp

float

Alias
NCI Thesaurus ObjectClass
C25711
UMLS 2011AA ObjectClass
C1524119
NCI Thesaurus ObjectClass-2
C17021
UMLS 2011AA ObjectClass-2
C0033684
NCI Metathesaurus ObjectClass
C0010294
NCI Thesaurus Property
C25367
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
Immunohistochemistry
Beschreibung

Immunohistochemistry

Immunohistochemistry Kit or Test Type (Mark all that apply with an X.)
Beschreibung

PathologyTissueSpecimenAntibodyStainingMethodType

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C12801
UMLS 2011AA ObjectClass
C0040300
NCI Thesaurus ObjectClass-2
C19157
UMLS 2011AA ObjectClass-2
C0370003
NCI Thesaurus ObjectClass-3
C18189
UMLS 2011AA ObjectClass-3
C0030664
NCI Thesaurus Property
C16295
UMLS 2011AA Property
C0003241
NCI Thesaurus Property-2
C23010
UMLS 2011AA Property-2
C0487602
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
FISH Kit or Test Type (Mark all that apply with an X.)
Beschreibung

FISHAssessmentTestType

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus ObjectClass-2
C17563
UMLS 2011AA ObjectClass-2
C0162789
NCI Thesaurus Property
C25294
UMLS 2011AA Property
C0022885
Final Diagnosis with HER2/neu (Mark one with an X.)
Beschreibung

DiseaseFinalDiagnosisHER2/neuType

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
NCI Thesaurus Property-2
C25508
UMLS 2011AA Property-2
C0205088
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ValueDomain-2
C17756
UMLS 2011AA ValueDomain-2
C0242957
Prior Treatment - Systemic Regimens
Beschreibung

Prior Treatment - Systemic Regimens

Prior anthracycline Treatment
Beschreibung

PriorAnthracyclineTherapyRegimenInd-2

Datentyp

boolean

Alias
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus ObjectClass-3
C1594
UMLS 2011AA ObjectClass-2
C0003234
NCI Thesaurus Property
C15697
UMLS 2011AA Property
C0040808
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Prior Treatment Regimen Name (s Include all therapies chemotherapy, hormonal, radiotherapy, etc.)
Beschreibung

PriorTreatmentRegimenName

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus Property
C15697
UMLS 2011AA Property
C0040808
NCI Thesaurus ValueDomain
C42614
UMLS 2011AA ValueDomain
C0027365
Prior Treatment Regimen Start Date (MM DD YYYY)
Beschreibung

PriorTreatmentRegimenBeginDate

Datentyp

date

Alias
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus Property
C15697
UMLS 2011AA Property
C0040808
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25431
UMLS 2011AA ValueDomain-2
C0439659
Prior Treatment Regimen End Date (MM DD YYYY)
Beschreibung

PriorTreatmentRegimenEndDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus Property
C15697
UMLS 2011AA Property
C0040808
Footer Module
Beschreibung

Footer Module

Completed by
Beschreibung

Person Completing Form

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass
C25657
NCI Thesaurus Property
C25364
Date Form Completed
Beschreibung

Date Form Completed

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1115437
NCI Thesaurus ObjectClass
C40988
NCI Thesaurus Property
C25250
NCI Thesaurus ValueDomain-2
C25367
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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. For optimal accuracy use black ink.

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
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)
Data amended
Item
Are data amended
boolean
C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Item Group
Unnamed2
Patient Initials
Item
Patient Initials (Last, First Middle)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Medical Record Number
Item
Patient Hospital No.
text
C25337 (NCI Thesaurus ValueDomain)
C1301894 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25261 (NCI Thesaurus Property)
C25198 (NCI Thesaurus Property-2)
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)
Item Group
Patient Characteristics
Item
ECOG Performance Status (Mark one with an X.)
text
C25664 (NCI Thesaurus ValueDomain)
C1520224 (UMLS CUI-1)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain-2)
C20641 (NCI Thesaurus ObjectClass)
CL.2
Code List
ECOG Performance Status (Mark one with an X.)
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)
MenstrualPeriod12MonthsIndicator
Item
Menstrual period within the last 12 months?
boolean
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C0025329 (NCI Metathesaurus ObjectClass)
C0814444 (NCI Metathesaurus Property)
LastMenstrualCycleOccurrenceDate
Item
Date of last menstrual cycle (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25551 (NCI Thesaurus ObjectClass)
C1517741 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C16838 (NCI Thesaurus ObjectClass-2)
C0025329 (UMLS 2011AA ObjectClass-2)
Item
Ovarian Function Suppression Type (If the patient was pre-menopausal)
text
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C15757 (NCI Thesaurus ObjectClass-2)
C0854638 (UMLS 2011AA ObjectClass-2)
C28047 (NCI Thesaurus ObjectClass-3)
C0205065 (UMLS 2011AA ObjectClass-3)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.4
Code List
Ovarian Function Suppression Type (If the patient was pre-menopausal)
CL Item
Lhrh Agonist (LHRH Agonist)
CL Item
Bilateral Oophorectomy (Bilateral oophorectomy)
MedDRACode
Item
MedDRA Disease Code
float
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
CL104089 (NCI Metathesaurus ObjectClass)
Item Group
Disease Description
Item
ER status (Mark one with an X.)
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.5
Code List
ER status (Mark one with an X.)
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
ERAssayPerformedTime
Item
Other, specify
text
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25207 (NCI Thesaurus ValueDomain)
C0040223 (UMLS 2011AA ValueDomain)
C17069 (NCI Thesaurus ObjectClass)
C0034804 (UMLS 2011AA ObjectClass)
C16341 (NCI Thesaurus ObjectClass-2)
C0005507 (UMLS 2011AA ObjectClass-2)
Item
PgR status (Mark one with an X.)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C17075 (NCI Thesaurus ObjectClass)
C0034833 (UMLS 2011AA ObjectClass)
C0678257 (NCI Metathesaurus Property)
CL.7
Code List
PgR status (Mark one with an X.)
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Timing of assay (Mark one with an X.)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25452 (NCI Thesaurus ValueDomain-2)
C17220 (NCI Thesaurus ObjectClass)
C0041365 (UMLS 2011AA ObjectClass)
C25716 (NCI Thesaurus Property)
C0545082 (UMLS 2011AA Property)
CL.8
Code List
Timing of assay (Mark one with an X.)
CL Item
Initial Diagnosis (Initial diagnosis)
CL Item
At Recurrence (At recurrence)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
Item
Timing of assay (Mark one with an X.)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25452 (NCI Thesaurus ValueDomain-2)
C17220 (NCI Thesaurus ObjectClass)
C0041365 (UMLS 2011AA ObjectClass)
C25716 (NCI Thesaurus Property)
C0545082 (UMLS 2011AA Property)
CL.8
Code List
Timing of assay (Mark one with an X.)
CL Item
Initial Diagnosis (Initial diagnosis)
CL Item
At Recurrence (At recurrence)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
PgRAssayPerformedTime
Item
Other, specify
text
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25207 (NCI Thesaurus ValueDomain)
C0040223 (UMLS 2011AA ValueDomain)
C17075 (NCI Thesaurus ObjectClass)
C0034833 (UMLS 2011AA ObjectClass)
C16341 (NCI Thesaurus ObjectClass-2)
C0005507 (UMLS 2011AA ObjectClass-2)
FirstBiopsyPositiveDate
Item
Date of Initial Diagnosis of Primary Tumor (MM DD YYYY)
date
C15189 (NCI Thesaurus ObjectClass)
C0005558 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus ObjectClass-2)
C1279901 (UMLS 2011AA ObjectClass-2)
C25246 (NCI Thesaurus Property)
C1446409 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property-2)
C2745955 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
DiseaseRecurrenceDate
Item
Date Progressive or Metastatic Disease First Diagnosed (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C3352 (NCI Thesaurus Property)
C0034897 (UMLS 2011AA Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
Item Group
Site Of Progression Or Recurrence
Item
Sites of Progression (s)
text
C13717 (NCI Thesaurus ValueDomain)
C0242656 (UMLS CUI-1)
C25341 (NCI Thesaurus Property)
C1515974 (UMLS CUI-2)
C25331 (NCI Thesaurus ObjectClass)
CL.9
Code List
Sites of Progression (s)
CL Item
Local-regional (including Ipsilateral Breast; Chest Wall; Axillary, Internal Mammary, And Infraclavicular Nodes; Local-regional Skin And Subcutaneous Tissue) (Local-regional)
CL Item
Ipsilateral Supraclavicular Nodes (Ipsilateral supraclavicular nodes)
CL Item
Contralateral Breast (Opposite breast)
CL Item
Distant Lymph Nodes (Distant nodes)
CL Item
Distant Skin/subcutaneous Tissue (Distant skin/subcutaneous tissue)
CL Item
Bone (Bone)
C12366 (NCI Thesaurus)
C0262950 (UMLS 2011AA)
CL Item
Bone Marrow (Bone marrow)
C12431 (NCI Thesaurus)
C0005953 (UMLS 2011AA)
CL Item
Lung, Nos (Lung)
C12468 (NCI Thesaurus)
C0024109 (UMLS 2011AA)
CL Item
Liver (Liver)
C12392 (NCI Thesaurus)
C0023884 (UMLS 2011AA)
CL Item
Pleura (Pleura)
C12469 (NCI Thesaurus)
C0032225 (UMLS 2011AA)
CL Item
Brain (Brain)
C12439 (NCI Thesaurus)
C0006104 (UMLS 2011AA)
CL Item
Other Cns (Other CNS)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
C17649 (NCI Thesaurus-3)
C0205394 (UMLS 2011AA-4)
Progression Site, specify
Item
Other specify
text
C25685 (NCI Thesaurus ValueDomain)
C0242656 (UMLS CUI-1)
C25341 (NCI Thesaurus Property)
C1515974 (UMLS CUI-2)
C25331 (NCI Thesaurus ObjectClass)
Item Group
Required Laboratory Values
Granulocyte count
Item
Peripheral Granulocytes Count (x 10^3/mmicroL)
float
C20200 (NCI Thesaurus Property)
C0857490 (UMLS CUI-1)
C12530 (NCI Thesaurus Property-2)
C25463 (NCI Thesaurus ValueDomain)
C25294 (NCI Thesaurus ObjectClass)
Platelets
Item
Peripheral Platelet Count (x 10^3/mmicroL)
float
C20200 (NCI Thesaurus Property)
C0005821 (UMLS CUI-1)
C12520 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
Creatinine, Serum
Item
Creatinine (mg/dL)
float
C20200 (NCI Thesaurus Property)
C0201976 (UMLS CUI-1)
C399 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
LaboratoryProcedureTotalBilirubinResultValue
Item
Bilirubin (mg/dL)
float
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C38037 (NCI Thesaurus Property-2)
C0201913 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
Bilirubin, Total ULN
Item
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)
C25706 (NCI Thesaurus ValueDomain-2)
SGPT (ALT)
Item
SGPT (ALT) (U/L)
float
C25294 (NCI Thesaurus ObjectClass)
C0201836 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C25293 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultUpperLimitofNormalValue
Item
SGPT (ALT) ULN (U/L)
float
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
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)
SGOT (AST)
Item
SGOT (AST) (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
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)
INR
Item
International Normalization Ratio (INR)
float
C20200 (NCI Thesaurus Property)
C0525032 (UMLS CUI-1)
C25294 (NCI Thesaurus ObjectClass)
C25352 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
Item Group
Urinalysis
Item
Urine Protein (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.10
Code List
Urine Protein (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 (g of protein / 24 hours)
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)
UrinaryCreatinineProteinAssessmentValue
Item
Urine Protein/Creatinine Ratio (UPC Or if UPC<=1)
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)
Item Group
Immunohistochemistry
Item
Immunohistochemistry Kit or Test Type (Mark all that apply with an X.)
text
C12801 (NCI Thesaurus ObjectClass)
C0040300 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
C18189 (NCI Thesaurus ObjectClass-3)
C0030664 (UMLS 2011AA ObjectClass-3)
C16295 (NCI Thesaurus Property)
C0003241 (UMLS 2011AA Property)
C23010 (NCI Thesaurus Property-2)
C0487602 (UMLS 2011AA Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.11
Code List
Immunohistochemistry Kit or Test Type (Mark all that apply with an X.)
CL Item
Cb-11 Other (CB-11 other)
CL Item
Cb-11/ventana Kit (CB-11/Ventana Kit)
CL Item
Dako Herceptest [tm] (DAKO Herceptest [TM])
Item
FISH Kit or Test Type (Mark all that apply with an X.)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C17563 (NCI Thesaurus ObjectClass-2)
C0162789 (UMLS 2011AA ObjectClass-2)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
CL.12
Code List
FISH Kit or Test Type (Mark all that apply with an X.)
CL Item
Other Specify (Other)
CL Item
Ventana Inform (Ventana INFORM)
CL Item
Vysis/path Vysion[tm] (Vysis/PathVysion)
Item
Final Diagnosis with HER2/neu (Mark one with an X.)
text
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C25508 (NCI Thesaurus Property-2)
C0205088 (UMLS 2011AA Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C17756 (NCI Thesaurus ValueDomain-2)
C0242957 (UMLS 2011AA ValueDomain-2)
CL.13
Code List
Final Diagnosis with HER2/neu (Mark one with an X.)
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
Item Group
Prior Treatment - Systemic Regimens
PriorAnthracyclineTherapyRegimenInd-2
Item
Prior anthracycline Treatment
boolean
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C1594 (NCI Thesaurus ObjectClass-3)
C0003234 (UMLS 2011AA ObjectClass-2)
C15697 (NCI Thesaurus Property)
C0040808 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PriorTreatmentRegimenName
Item
Prior Treatment Regimen Name (s Include all therapies chemotherapy, hormonal, radiotherapy, etc.)
text
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C15697 (NCI Thesaurus Property)
C0040808 (UMLS 2011AA Property)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)
PriorTreatmentRegimenBeginDate
Item
Prior Treatment Regimen Start Date (MM DD YYYY)
date
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C15697 (NCI Thesaurus Property)
C0040808 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)
PriorTreatmentRegimenEndDate
Item
Prior Treatment Regimen End Date (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C15697 (NCI Thesaurus Property)
C0040808 (UMLS 2011AA Property)
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)
Date Form Completed
Item
Date Form Completed
date
C25164 (NCI Thesaurus ValueDomain)
C1115437 (UMLS CUI-1)
C40988 (NCI Thesaurus ObjectClass)
C25250 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)
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