ID

11913

Beschrijving

Randomized Placebo-Controlled Phase III Trial of Letrozole Alone or Letrozole and Tipifarnib (Zarnestra, R115777) for Postmenopausal women with ER/PR+ Tamoxifen resistant MBC CALGB_40301_ON_STUDY_FORM Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=E53B0CD1-788E-25B9-E034-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=E53B0CD1-788E-25B9-E034-0003BA3F9857

Trefwoorden

Versies (4)
  1. 26-08-12 26-08-12 -
  2. 09-01-15 09-01-15 - Martin Dugas
  3. 09-06-15 09-06-15 -
  4. 21-08-15 21-08-15 - Martin Dugas
Geüploaded op

21 augustus 2015

DOI

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Licentie

Creative Commons BY-NC 3.0 Legacy
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On Study Breast Cancer CALGB_40301

Engels

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 Formulieren  
Header
Beschrijving

Header

CALGB Form
Beschrijving

CALGB Form

Datatype

text

Alias
UMLS CUI-1
C3262252
UMLS CUI-2
C1516238
CALGB Study No
Beschrijving

Protocol ID CALGB

Datatype

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
Beschrijving

Trial subject ID CALGB

Datatype

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
Beschrijving

Data amended

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Patient demographics
Beschrijving

Patient demographics

Patient Initials
Beschrijving

Patient Initials

Datatype

text

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

PatientHospitalNumber

Datatype

text

Institution/Affiliate
Beschrijving

Institution Name

Datatype

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
Beschrijving

Participating Group

Datatype

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
Beschrijving

Study Number Participating Group

Datatype

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
Beschrijving

Participating Group Patient ID

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25337
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
UMLS CUI [1]
C2348585
Patient Characteristics
Beschrijving

Patient Characteristics

Post menopausal
Beschrijving

PatientPostMenopauseIndicator

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C25180
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C15421
UMLS CUI [1]
C0232970
Is patient on ovarian suppression with GnRH-A agonist
Beschrijving

HormoneTherapyGonadotrophinReleasingHormoneAgonistAdministeredInd-3

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C15445
NCI Thesaurus Property
C25382
NCI Thesaurus Property-2
C2270
NCI Thesaurus Property-3
C1514
NCI Thesaurus ValueDomain
C38147
UMLS CUI [1]
C1518041
Disease Description
Beschrijving

Disease Description

ER status (Mark one with an X.)
Beschrijving

ERLevelTumorStatus

Datatype

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
Beschrijving

ERAssayPerformedTime

Datatype

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.)
Beschrijving

PgRStatusType

Datatype

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.)
Beschrijving

TumorMarkerVisitCollectedType

Datatype

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.)
Beschrijving

TumorMarkerVisitCollectedType

Datatype

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
Beschrijving

PgRAssayPerformedTime

Datatype

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
Beschrijving

FirstBiopsyPositiveDate

Datatype

date

Alias
NCI Thesaurus ObjectClass
C15189
NCI Thesaurus ObjectClass-2
C25509
NCI Thesaurus Property
C25246
NCI Thesaurus Property-2
C25275
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
UMLS CUI [1]
C2316983
Date progressive or metastatic disease first diagnosed
Beschrijving

DiseaseRecurrenceDate

Datatype

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
Beschrijving

Site Of Progression Or Recurrence

Site of progression (s)
Beschrijving

Progression Site

Datatype

text

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

Progression Site, specify

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C0242656
NCI Thesaurus Property
C25341
UMLS CUI-2
C1515974
NCI Thesaurus ObjectClass
C25331
Prior Systemic Therapy
Beschrijving

Prior Systemic Therapy

Prior adjuvant hormonal therapy (Do not include steroids given with chemotherapy.)
Beschrijving

AdjuvantHormonalTherapyPriorAdministeredInd-3

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus ObjectClass-2
C2140
UMLS 2011AA ObjectClass-2
C0001552
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Prior endocrine therapy for metastasis or recurrence (Do not include steroids given with chemotherapy.)
Beschrijving

PriorHormonalTherapyMetastatic/RecurrentAdministreredInd-3

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C25629
NCI Thesaurus ObjectClass-2
C15445
NCI Thesaurus Property
C25382
NCI Thesaurus Property-2
C25567
NCI Thesaurus ValueDomain
C38148
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0279025
Prior adjuvant chemotherapy (Include pre-op chemotherapy at diagnosis.)
Beschrijving

PriorChemotherapyAdministeredInd-3

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Prior chemotherapy for metastasis or recurrence
Beschrijving

PriorChemotherapyMetastatic/RecurrentDiseaseAdministeredInd-3

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C15632
NCI Thesaurus ObjectClass-2
C25629
NCI Thesaurus Property
C14174
NCI Thesaurus Property-2
C38155
NCI Thesaurus Property-3
C25382
NCI Thesaurus ValueDomain
C38148
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0277556
Prior adjuvant high dose chemotherapy/Autologous stem cell transplant (HDC/ASCT )
Beschrijving

PriorHDC/ASCTAdjuvantAdministeredInd-3

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus ObjectClass-2
C38722
UMLS 2011AA ObjectClass-2
C1512429
NCI Thesaurus Property
C2140
UMLS 2011AA Property
C0001552
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Prior High-Dose Chemotherapy with Autologous Stem Cell Transplant for metastasis or recurrence
Beschrijving

PriorHigh-DoseChemotherapywithStemCellSupportMetastaticRecurrentDiseaseAdministeredInd-3

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C25629
NCI Thesaurus ObjectClass-2
C38722
NCI Thesaurus Property
C14174
NCI Thesaurus Property-2
C38155
NCI Thesaurus Property-3
C25382
NCI Thesaurus ValueDomain
C38148
UMLS CUI [1,1]
C1512429
UMLS CUI [1,2]
C0277556
Prior adjuvant immunotherapy
Beschrijving

AdjuvantImmunotherapyPriorAdministeredInd-3

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C15262
NCI Thesaurus ObjectClass-2
C2140
NCI Thesaurus Property
C25629
NCI Thesaurus Property-2
C25382
NCI Thesaurus ValueDomain
C38148
UMLS CUI [1]
C1514455
Prior immunotherapy for metastasis or recurrence
Beschrijving

PriorImmunotherapyMetastaticRecurrentDiseaseAdministeredInd-3

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C15262
NCI Thesaurus ObjectClass-2
C25629
NCI Thesaurus Property
C14174
NCI Thesaurus Property-2
C38155
NCI Thesaurus Property-3
C25382
NCI Thesaurus ValueDomain
C38148
UMLS CUI [1,1]
C0021083
UMLS CUI [1,2]
C0277556
Prior adjuvant other therapy
Beschrijving

AdjuvantTherapyOtherAdministeredPriorInd-3

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C2140
NCI Thesaurus Property
C17649
NCI Thesaurus Property-2
C25382
NCI Thesaurus ValueDomain
C38148
NCI Thesaurus ValueDomain-2
C25629
UMLS CUI [1]
C1514456
Prior other adjuvant therapy
Beschrijving

AdjuvantTherapyOtherAdministeredSpecify

Datatype

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C2140
NCI Thesaurus Property
C17649
NCI Thesaurus Property-2
C25382
NCI Thesaurus ValueDomain
C25685
UMLS CUI [1]
C1514456
Prior other therapy for metastasis or recurrence
Beschrijving

PriorTherapyMetastaticRecurrentDiseaseAdministeredOtherInd-3

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C25629
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus Property
C14174
NCI Thesaurus Property-2
C38155
NCI Thesaurus Property-3
C25382
NCI Thesaurus ValueDomain
C17649
NCI Thesaurus ValueDomain-2
C38148
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0277556
Prior therapy for metastatic or recurrent disease
Beschrijving

PriorTherapyMetastaticRecurrentDiseaseAdministeredSpecify

Datatype

text

Alias
NCI Thesaurus ObjectClass
C25629
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus Property
C14174
NCI Thesaurus Property-2
C38155
NCI Thesaurus Property-3
C25382
NCI Thesaurus ValueDomain
C25685
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0277556
Prior Systemic Regimens
Beschrijving

Prior Systemic Regimens

Prior treatment regimen name (s)
Beschrijving

PriorTreatmentRegimenName

Datatype

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
Start date
Beschrijving

PriorTreatmentRegimenBeginDate

Datatype

date

Alias
NCI Thesaurus ObjectClass
C25629
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus Property
C15697
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25431
UMLS CUI [1]
C3173309
End date
Beschrijving

PriorTreatmentRegimenEndDate

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ObjectClass
C25629
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus Property
C15697
UMLS CUI [1]
C1531784
Prior treatment regimen type
Beschrijving

PriorTreatmentRegimenType

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus Property
C15697
UMLS 2011AA Property
C0040808
Required Laboratory Values
Beschrijving

Required Laboratory Values

Alias
UMLS CUI-1
C0022885
Granulocytes
Beschrijving

Granulocytes

Datatype

float

Maateenheden
  • 1000/uL
Alias
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C12530
NCI Thesaurus ValueDomain
C25463
NCI Thesaurus ObjectClass
C25294
UMLS CUI [1]
C0857490
1000/uL
Platelet count
Beschrijving

Platelets

Datatype

float

Maateenheden
  • 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
Beschrijving

Creatinine

Datatype

float

Maateenheden
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25225
NCI Thesaurus Property
C399
NCI Thesaurus Property-2
C25294
NCI Thesaurus ValueDomain
C25712
UMLS CUI [1]
C0201976
mg/dL
Bilirubin, total
Beschrijving

Bilirubin, total

Datatype

float

Maateenheden
  • mg/dL
Alias
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C305
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25712
UMLS CUI [1]
C0201913
mg/dL
Bilirubin ULN
Beschrijving

Bilirubin ULN

Datatype

float

Maateenheden
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C305
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25706
UMLS CUI [1,1]
C0005437
UMLS CUI [1,2]
C1519815
mg/dL
ALT (SGPT)
Beschrijving

ALT (SGPT)

Datatype

float

Maateenheden
  • U/L
Alias
NCI Thesaurus Property
C20200
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property-2
C25293
NCI Thesaurus ValueDomain
C25688
UMLS CUI [1]
C0201836
U/L
ALT (SGPT) ULN
Beschrijving

ALT (SGPT) ULN

Datatype

float

Maateenheden
  • U/L
Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C25293
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25706
UMLS CUI [1,1]
C0376147
UMLS CUI [1,2]
C1519815
U/L
AST (SGOT)
Beschrijving

AST (SGOT)

Datatype

float

Maateenheden
  • U/L
Alias
NCI Thesaurus ObjectClass
C13308
NCI Thesaurus Property
C25202
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus Property-2
C37984
NCI Thesaurus ValueDomain-2
C25712
UMLS CUI [1]
C0201899
U/L
AST (SGOT) ULN
Beschrijving

AST (SGOT) ULN

Datatype

float

Maateenheden
  • U/L
Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C25202
NCI Thesaurus Property-2
C20200
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25706
UMLS CUI [1,1]
C0242192
UMLS CUI [1,2]
C1519815
U/L
Was tumor marker information available for the following (Mark all that apply with an X.)
Beschrijving

TumorMarkerAvailableAssessmentType

Datatype

integer

Alias
NCI Thesaurus ValueDomain
C25284
NCI Thesaurus Property
C20989
NCI Thesaurus ObjectClass
C17220
NCI Thesaurus Property-2
C25429
UMLS CUI [1]
C0041365
Carcinoembryonic Antigen
Beschrijving

TumorMarkerCEATestValue

Datatype

float

Maateenheden
  • µg/L
Alias
NCI Thesaurus Property
C25159
NCI Thesaurus Property-2
C25294
NCI Thesaurus ObjectClass
C17220
NCI Thesaurus ValueDomain
C25712
UMLS CUI [1]
C0201933
µg/L
CA 15-3
Beschrijving

CA 15-3

Datatype

float

Maateenheden
  • kU/L
Alias
NCI Thesaurus ValueDomain
C25294
NCI Thesaurus ObjectClass
C17220
NCI Thesaurus ValueDomain-2
C25712
NCI Metathesaurus Property
CL122032
UMLS CUI [1]
C0201547
kU/L
CA 27-29
Beschrijving

CA 27-29

Datatype

float

Maateenheden
  • U/ml
Alias
NCI Thesaurus Property
C25294
NCI Thesaurus ObjectClass
C17220
NCI Thesaurus ValueDomain
C25712
NCI Metathesaurus Property
C0291672
UMLS CUI [1]
C2919221
U/ml
Completed by
Beschrijving

Person Completing Form

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass
C25657
NCI Thesaurus Property
C25364
Date form completed
Beschrijving

Date Form Completed

Datatype

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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Similar models

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 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Header
CALGB Form
Item
CALGB Form
text
C3262252 (UMLS CUI-1)
C1516238 (UMLS CUI-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
Patient demographics
Patient Initials
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
PatientHospitalNumber
Item
Patient Hospital No
text
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)
C16960 (NCI Thesaurus ObjectClass)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
C2348585 (UMLS CUI [1])
Item Group
Patient Characteristics
Post menopausal
Item
Post menopausal
boolean
C25180 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C15421 (NCI Thesaurus Property)
C0232970 (UMLS CUI [1])
GnRH-A agonist
Item
Is patient on ovarian suppression with GnRH-A agonist
boolean
C15445 (NCI Thesaurus ObjectClass)
C25382 (NCI Thesaurus Property)
C2270 (NCI Thesaurus Property-2)
C1514 (NCI Thesaurus Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1518041 (UMLS CUI [1])
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.4
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.6
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.7
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.7
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)
Diagnosis date
Item
Date of initial diagnosis of primary tumor
date
C15189 (NCI Thesaurus ObjectClass)
C25509 (NCI Thesaurus ObjectClass-2)
C25246 (NCI Thesaurus Property)
C25275 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C2316983 (UMLS CUI [1])
DiseaseRecurrenceDate
Item
Date progressive or metastatic disease first diagnosed
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
Site 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.8
Code List
Site 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 skin)
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
Prior Systemic Therapy
AdjuvantHormonalTherapyPriorAdministeredInd-3
Item
Prior adjuvant hormonal therapy (Do not include steroids given with chemotherapy.)
boolean
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C2140 (NCI Thesaurus ObjectClass-2)
C0001552 (UMLS 2011AA ObjectClass-2)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
Prior endocrine therapy for metastasis or recurrence
Item
Prior endocrine therapy for metastasis or recurrence (Do not include steroids given with chemotherapy.)
boolean
C25629 (NCI Thesaurus ObjectClass)
C15445 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property)
C25567 (NCI Thesaurus Property-2)
C38148 (NCI Thesaurus ValueDomain)
C1514463 (UMLS CUI [1,1])
C0279025 (UMLS CUI [1,2])
PriorChemotherapyAdministeredInd-3
Item
Prior adjuvant chemotherapy (Include pre-op chemotherapy at diagnosis.)
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)
Prior chemotherapy for metastasis or recurrence
Item
Prior chemotherapy for metastasis or recurrence
boolean
C15632 (NCI Thesaurus ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C14174 (NCI Thesaurus Property)
C38155 (NCI Thesaurus Property-2)
C25382 (NCI Thesaurus Property-3)
C38148 (NCI Thesaurus ValueDomain)
C0392920 (UMLS CUI [1,1])
C0277556 (UMLS CUI [1,2])
PriorHDC/ASCTAdjuvantAdministeredInd-3
Item
Prior adjuvant high dose chemotherapy/Autologous stem cell transplant (HDC/ASCT )
boolean
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C38722 (NCI Thesaurus ObjectClass-2)
C1512429 (UMLS 2011AA ObjectClass-2)
C2140 (NCI Thesaurus Property)
C0001552 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
Prior HDC/ASCT for metastasis or recurrence
Item
Prior High-Dose Chemotherapy with Autologous Stem Cell Transplant for metastasis or recurrence
boolean
C25629 (NCI Thesaurus ObjectClass)
C38722 (NCI Thesaurus ObjectClass-2)
C14174 (NCI Thesaurus Property)
C38155 (NCI Thesaurus Property-2)
C25382 (NCI Thesaurus Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512429 (UMLS CUI [1,1])
C0277556 (UMLS CUI [1,2])
Prior adjuvant immunotherapy
Item
Prior adjuvant immunotherapy
boolean
C15262 (NCI Thesaurus ObjectClass)
C2140 (NCI Thesaurus ObjectClass-2)
C25629 (NCI Thesaurus Property)
C25382 (NCI Thesaurus Property-2)
C38148 (NCI Thesaurus ValueDomain)
C1514455 (UMLS CUI [1])
Prior immunotherapy for metastasis or recurrence
Item
Prior immunotherapy for metastasis or recurrence
boolean
C15262 (NCI Thesaurus ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C14174 (NCI Thesaurus Property)
C38155 (NCI Thesaurus Property-2)
C25382 (NCI Thesaurus Property-3)
C38148 (NCI Thesaurus ValueDomain)
C0021083 (UMLS CUI [1,1])
C0277556 (UMLS CUI [1,2])
Prior adjuvant other therapy
Item
Prior adjuvant other therapy
boolean
C15368 (NCI Thesaurus ObjectClass)
C2140 (NCI Thesaurus ObjectClass-2)
C17649 (NCI Thesaurus Property)
C25382 (NCI Thesaurus Property-2)
C38148 (NCI Thesaurus ValueDomain)
C25629 (NCI Thesaurus ValueDomain-2)
C1514456 (UMLS CUI [1])
Prior other adjuvant therapy
Item
Prior other adjuvant therapy
text
C15368 (NCI Thesaurus ObjectClass)
C2140 (NCI Thesaurus ObjectClass-2)
C17649 (NCI Thesaurus Property)
C25382 (NCI Thesaurus Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1514456 (UMLS CUI [1])
Prior other therapy for metastasis or recurrence
Item
Prior other therapy for metastasis or recurrence
boolean
C25629 (NCI Thesaurus ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C14174 (NCI Thesaurus Property)
C38155 (NCI Thesaurus Property-2)
C25382 (NCI Thesaurus Property-3)
C17649 (NCI Thesaurus ValueDomain)
C38148 (NCI Thesaurus ValueDomain-2)
C1514463 (UMLS CUI [1,1])
C0277556 (UMLS CUI [1,2])
Prior therapy for metastatic or recurrent disease
Item
Prior therapy for metastatic or recurrent disease
text
C25629 (NCI Thesaurus ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C14174 (NCI Thesaurus Property)
C38155 (NCI Thesaurus Property-2)
C25382 (NCI Thesaurus Property-3)
C25685 (NCI Thesaurus ValueDomain)
C1514463 (UMLS CUI [1,1])
C0277556 (UMLS CUI [1,2])
Item Group
Prior Systemic Regimens
PriorTreatmentRegimenName
Item
Prior treatment regimen name (s)
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)
Treatment start date
Item
Start date
date
C25629 (NCI Thesaurus ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C15697 (NCI Thesaurus Property)
C25164 (NCI Thesaurus ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C3173309 (UMLS CUI [1])
Treatment end date
Item
End date
date
C25164 (NCI Thesaurus ValueDomain)
C25629 (NCI Thesaurus ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C15697 (NCI Thesaurus Property)
C1531784 (UMLS CUI [1])
Item
Prior treatment regimen type
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C15697 (NCI Thesaurus Property)
C0040808 (UMLS 2011AA Property)
CL.19
Code List
Prior treatment regimen type
CL Item
Adjuvant (Adjuvant)
C25722 (NCI Thesaurus)
C1522673 (UMLS 2011AA)
CL Item
Advanced (Advanced)
C25411 (NCI Thesaurus)
C0205179 (UMLS 2011AA)
Item Group
Required Laboratory Values
C0022885 (UMLS CUI-1)
Granulocyte count
Item
Granulocytes
float
C20200 (NCI Thesaurus Property)
C12530 (NCI Thesaurus Property-2)
C25463 (NCI Thesaurus ValueDomain)
C25294 (NCI Thesaurus ObjectClass)
C0857490 (UMLS CUI [1])
Platelets
Item
Platelet count
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
float
C25225 (NCI Thesaurus ObjectClass)
C399 (NCI Thesaurus Property)
C25294 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C0201976 (UMLS CUI [1])
Bilirubin, total
Item
Bilirubin, total
float
C20200 (NCI Thesaurus Property)
C305 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C0201913 (UMLS CUI [1])
Bilirubin ULN
Item
Bilirubin ULN
float
C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C305 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C0005437 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
ALT
Item
ALT (SGPT)
float
C20200 (NCI Thesaurus Property)
C25294 (NCI Thesaurus ObjectClass)
C25293 (NCI Thesaurus Property-2)
C25688 (NCI Thesaurus ValueDomain)
C0201836 (UMLS CUI [1])
ALT ULN
Item
ALT (SGPT) ULN
float
C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C25293 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C0376147 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
AST
Item
AST (SGOT)
float
C13308 (NCI Thesaurus ObjectClass)
C25202 (NCI Thesaurus Property)
C38046 (NCI Thesaurus ValueDomain)
C37984 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain-2)
C0201899 (UMLS CUI [1])
AST ULN
Item
AST (SGOT) ULN
float
C25294 (NCI Thesaurus ObjectClass)
C25202 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C0242192 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
Item
Was tumor marker information available for the following (Mark all that apply with an X.)
integer
C25284 (NCI Thesaurus ValueDomain)
C20989 (NCI Thesaurus Property)
C17220 (NCI Thesaurus ObjectClass)
C25429 (NCI Thesaurus Property-2)
C0041365 (UMLS CUI [1])
CL.20
Code List
Was tumor marker information available for the following (Mark all that apply with an X.)
CL Item
CEA (1)
C0201933 (UMLS CUI-1)
CL Item
CA 15-3 (2)
C0201547 (UMLS CUI-1)
CL Item
CA 27-29 (3)
C2919221 (UMLS CUI-1)
CEA
Item
Carcinoembryonic Antigen
float
C25159 (NCI Thesaurus Property)
C25294 (NCI Thesaurus Property-2)
C17220 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C0201933 (UMLS CUI [1])
CA 15-3
Item
CA 15-3
float
C25294 (NCI Thesaurus ValueDomain)
C17220 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain-2)
CL122032 (NCI Metathesaurus Property)
C0201547 (UMLS CUI [1])
CA 27-29
Item
CA 27-29
float
C25294 (NCI Thesaurus Property)
C17220 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C0291672 (NCI Metathesaurus Property)
C2919221 (UMLS CUI [1])
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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