ID

11913

Beskrivning

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

Länk

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

Nyckelord

Versioner (4)
  1. 2012-08-26 2012-08-26 -
  2. 2015-01-09 2015-01-09 - Martin Dugas
  3. 2015-06-09 2015-06-09 -
  4. 2015-08-21 2015-08-21 - Martin Dugas
Uppladdad den

21 augusti 2015

DOI

För en begäran logga in.

Licens

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

Engelsk

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 Formulär  
Header
Beskrivning

Header

CALGB Form
Beskrivning

CALGB Form

Datatyp

text

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

Protocol ID CALGB

Datatyp

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
Beskrivning

Trial subject ID CALGB

Datatyp

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
Beskrivning

Data amended

Datatyp

boolean

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

Patient demographics

Patient Initials
Beskrivning

Patient Initials

Datatyp

text

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

PatientHospitalNumber

Datatyp

text

Institution/Affiliate
Beskrivning

Institution Name

Datatyp

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
Beskrivning

Participating Group

Datatyp

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
Beskrivning

Study Number Participating Group

Datatyp

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
Beskrivning

Participating Group Patient ID

Datatyp

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
Beskrivning

Patient Characteristics

Post menopausal
Beskrivning

PatientPostMenopauseIndicator

Datatyp

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
Beskrivning

HormoneTherapyGonadotrophinReleasingHormoneAgonistAdministeredInd-3

Datatyp

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
Beskrivning

Disease Description

ER status (Mark one with an X.)
Beskrivning

ERLevelTumorStatus

Datatyp

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
Beskrivning

ERAssayPerformedTime

Datatyp

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.)
Beskrivning

PgRStatusType

Datatyp

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.)
Beskrivning

TumorMarkerVisitCollectedType

Datatyp

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.)
Beskrivning

TumorMarkerVisitCollectedType

Datatyp

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
Beskrivning

PgRAssayPerformedTime

Datatyp

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
Beskrivning

FirstBiopsyPositiveDate

Datatyp

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
Beskrivning

DiseaseRecurrenceDate

Datatyp

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
Beskrivning

Site Of Progression Or Recurrence

Site of progression (s)
Beskrivning

Progression Site

Datatyp

text

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

Progression Site, specify

Datatyp

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
Beskrivning

Prior Systemic Therapy

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

AdjuvantHormonalTherapyPriorAdministeredInd-3

Datatyp

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.)
Beskrivning

PriorHormonalTherapyMetastatic/RecurrentAdministreredInd-3

Datatyp

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.)
Beskrivning

PriorChemotherapyAdministeredInd-3

Datatyp

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
Beskrivning

PriorChemotherapyMetastatic/RecurrentDiseaseAdministeredInd-3

Datatyp

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 )
Beskrivning

PriorHDC/ASCTAdjuvantAdministeredInd-3

Datatyp

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
Beskrivning

PriorHigh-DoseChemotherapywithStemCellSupportMetastaticRecurrentDiseaseAdministeredInd-3

Datatyp

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
Beskrivning

AdjuvantImmunotherapyPriorAdministeredInd-3

Datatyp

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
Beskrivning

PriorImmunotherapyMetastaticRecurrentDiseaseAdministeredInd-3

Datatyp

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
Beskrivning

AdjuvantTherapyOtherAdministeredPriorInd-3

Datatyp

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
Beskrivning

AdjuvantTherapyOtherAdministeredSpecify

Datatyp

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
Beskrivning

PriorTherapyMetastaticRecurrentDiseaseAdministeredOtherInd-3

Datatyp

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
Beskrivning

PriorTherapyMetastaticRecurrentDiseaseAdministeredSpecify

Datatyp

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
Beskrivning

Prior Systemic Regimens

Prior treatment regimen name (s)
Beskrivning

PriorTreatmentRegimenName

Datatyp

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
Beskrivning

PriorTreatmentRegimenBeginDate

Datatyp

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
Beskrivning

PriorTreatmentRegimenEndDate

Datatyp

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
Beskrivning

PriorTreatmentRegimenType

Datatyp

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
Beskrivning

Required Laboratory Values

Alias
UMLS CUI-1
C0022885
Granulocytes
Beskrivning

Granulocytes

Datatyp

float

Måttenheter
  • 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
Beskrivning

Platelets

Datatyp

float

Måttenheter
  • 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
Beskrivning

Creatinine

Datatyp

float

Måttenheter
  • 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
Beskrivning

Bilirubin, total

Datatyp

float

Måttenheter
  • 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
Beskrivning

Bilirubin ULN

Datatyp

float

Måttenheter
  • 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)
Beskrivning

ALT (SGPT)

Datatyp

float

Måttenheter
  • 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
Beskrivning

ALT (SGPT) ULN

Datatyp

float

Måttenheter
  • 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)
Beskrivning

AST (SGOT)

Datatyp

float

Måttenheter
  • 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
Beskrivning

AST (SGOT) ULN

Datatyp

float

Måttenheter
  • 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.)
Beskrivning

TumorMarkerAvailableAssessmentType

Datatyp

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
Beskrivning

TumorMarkerCEATestValue

Datatyp

float

Måttenheter
  • 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
Beskrivning

CA 15-3

Datatyp

float

Måttenheter
  • 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
Beskrivning

CA 27-29

Datatyp

float

Måttenheter
  • 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
Beskrivning

Person Completing Form

Datatyp

text

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

Date Form Completed

Datatyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1115437
NCI Thesaurus ObjectClass
C40988
NCI Thesaurus Property
C25250
NCI Thesaurus ValueDomain-2
C25367
Tillbaka till toppen

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 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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