ID

43386

Beschrijving

E1105 On-Study Form NCT00520975 First-Line Chemotherapy and Trastuzumab With or Without Bevacizumab in Treating Patients With Metastatic Breast Cancer That Overexpresses HER-2/NEU Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=171FAB32-7984-3641-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=171FAB32-7984-3641-E044-0003BA3F9857

Trefwoorden

  1. 26-08-12 26-08-12 -
  2. 09-01-15 09-01-15 - Martin Dugas
  3. 18-06-15 18-06-15 -
  4. 20-09-21 20-09-21 -
Geüploaded op

20 september 2021

DOI

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Licentie

Creative Commons BY-NC 3.0 Legacy

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E1105 On-Study Form NCT00520975

INSTRUCTIONS: Use this form to capture the first occurrence of non-protocol anti-tumor therapy per registration step

Header
Beschrijving

Header

ECOG Protocol Number
Beschrijving

Protocol Number ECOG

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1512162
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25491
ECOG Patient ID
Beschrijving

Patient ID ECOG

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1512162
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25491
DCI Name
Beschrijving

Generic drug form

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C3242750
NCI Thesaurus Property
C19464
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus ObjectClass-2
C25452
Registration Step
Beschrijving

Registration Number

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1514821
NCI Thesaurus ObjectClass
C25646
UMLS CUI-2
C0237753
NCI Thesaurus Property
C16154
NCI Thesaurus ValueDomain-2
C16154
Reporting Period
Beschrijving

Clinical Trial Period

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C2347804
NCI Thesaurus ObjectClass
C25214
NCI Thesaurus Property
C25616
NCI Thesaurus ObjectClass-2
C25651
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
ECOG Performance Status (Day 1 of this cycle)
Beschrijving

ECOG Performance Status

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS CUI-1
C1520224
NCI Thesaurus Property
C25367
NCI Thesaurus ValueDomain-2
C25491
NCI Thesaurus ObjectClass
C20641
Participating Group Protocol Number
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

Trial subject ID Participating Group

Datatype

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
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
Data amendment
Beschrijving

Data amendment

Please mark an 'X' if data have been amended.
Beschrijving

Data amended

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Date data amended
Beschrijving

Data amended date

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
UMLS CUI-2
C0011008
NCI Thesaurus Property
C25416
NCI Thesaurus ValueDomain-2
C25367
Pre-registration Evaluation
Beschrijving

Pre-registration Evaluation

Height
Beschrijving

Patient Height

Datatype

float

Maateenheden
  • cm
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0489786
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25347
cm
Weight
Beschrijving

Patient Weight

Datatype

float

Maateenheden
  • Kg
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0005910
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25208
Kg
Carboplatin planned
Beschrijving

CarboplatinTreatmentPlannedInd-2

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C1282
UMLS 2011AA ObjectClass
C0079083
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus Property
C25619
UMLS 2011AA Property
C1301732
Menopausal status
Beschrijving

PatientMenopauseStatus

Datatype

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C3231
UMLS 2011AA Property
C0025320
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
Urine Protein/Creatinine Ratio
Beschrijving

UrinaryCreatinineProteinAssessmentValue

Datatype

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
Date lab assessment performed
Beschrijving

Laboratory Procedure Date

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0022885
NCI Thesaurus Property
C25214
UMLS CUI-2
C0011008
NCI Thesaurus Property-2
C38000
NCI Thesaurus ObjectClass
C25294
Protein from 24 hour Urine Collection
Beschrijving

UrinaryProteinCollectionValue

Datatype

float

Maateenheden
  • 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
Prior Treatment
Beschrijving

Prior Treatment

Most Extensive Primary Surgery
Beschrijving

BreastPrimarySurgicalProcedurePerformedType

Datatype

text

Alias
NCI Thesaurus ObjectClass
C25251
UMLS 2011AA ObjectClass
C0205225
NCI Thesaurus ObjectClass-2
C12971
UMLS 2011AA ObjectClass-2
C0006141
NCI Thesaurus ObjectClass-3
C15329
UMLS 2011AA ObjectClass-3
C0543467
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Mark an 'X' if not done
Beschrijving

DataUnknownText

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C17998
UMLS 2011AA Property
C0439673
Date of Most Extensive Primary Surgery
Beschrijving

PrimarySurgeryDate

Datatype

date

Alias
NCI Thesaurus ObjectClass
C25251
UMLS 2011AA ObjectClass
C0205225
NCI Thesaurus ObjectClass-2
C15329
UMLS 2011AA ObjectClass-2
C0543467
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
Prior Hormonal Therapy (in adjuvant or metastatic setting)
Beschrijving

PriorHormonalTherapyAdministeredInd-3

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus ObjectClass-2
C15445
UMLS 2011AA ObjectClass-2
C0279025
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
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
Prior Therapy Stop Date (most recent Lapatinib)
Beschrijving

PriorTherapyEndDate

Datatype

date

Alias
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
NCI Thesaurus Property-2
C25496
UMLS 2011AA Property-2
C2746065
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Prior Radiation Therapy
Beschrijving

Prior Radiation Therapy

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C1522449
NCI Thesaurus ObjectClass
C15313
UMLS CUI-2
C0332152
NCI Thesaurus ObjectClass-2
C25629
NCI Thesaurus Property
C25382
Prior Taxane Therapy (in the adjuvant or neoadjuvant setting)
Beschrijving

PriorChemotherapyTaxaneCompoundAdministeredInd-2

Datatype

boolean

Alias
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
NCI Thesaurus Property-2
C1490
UMLS 2011AA Property-2
C0796419
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Prior Doxorubicin Therapy (in the adjuvant or neoadjuvant setting)
Beschrijving

PriorChemotherapyDoxorubicinAdministeredInd-2

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus Property
C456
UMLS 2011AA Property
C0013089
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Agent Total Cumulative Dose (mg - if yes:)
Beschrijving

Cumulative Dose Agent

Datatype

float

Alias
NCI Thesaurus ObjectClass
C1708
UMLS CUI-1
C2986497
NCI Thesaurus ObjectClass-2
C25470
UMLS CUI-2
C1521826
NCI Thesaurus Property
C25304
NCI Thesaurus Property-2
C25256
NCI Thesaurus ValueDomain
C25304
NCI Thesaurus ValueDomain-2
C25488
Prior Epirubicin Therapy (in the adjuvant or neoadjuvant setting)
Beschrijving

PriorChemotherapyEpirubicinHydrochlorideAdministeredInd-2

Datatype

boolean

Alias
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
NCI Thesaurus Property-2
C474
UMLS 2011AA Property-2
C0282387
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Prior Trastuzumab Therapy (in the adjuvant setting)
Beschrijving

PriorChemotherapyTrastuzumabAdministeredInd-2

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus Property
C1647
UMLS 2011AA Property
C0338204
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Prior Lapatinib Therapy (in the adjuvant or neoadjuvant setting?)
Beschrijving

PriorChemotherapyLapatinibAdministeredInd-2

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus Property
C26653
UMLS 2011AA Property
C1173538
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Prior Other Chemotherapy (in the adjuvant or metastatic setting)
Beschrijving

PriorChemotherapyOtherAdministeredInd-2

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Prior Chemotherapy End Date (other - if yes:)
Beschrijving

PriorChemotherapyAdministeredEndDate

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
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
Disease Description
Beschrijving

Disease Description

Date of Definitive Histologic Diagnosis of Primary Tumor
Beschrijving

PrimaryTumorDiagnosisDate

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C25251
UMLS 2011AA ObjectClass-2
C0205225
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
Contralateral diagnosis date (if applicable)
Beschrijving

ContralateralBreastCancerDiagnosisDate

Datatype

date

Alias
NCI Thesaurus ObjectClass
C12971
UMLS 2011AA ObjectClass
C0006141
NCI Thesaurus ObjectClass-2
C9305
UMLS 2011AA ObjectClass-2
C0006826
NCI Thesaurus ObjectClass-3
C25307
UMLS 2011AA ObjectClass-3
C0441988
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Date of First Local-Regional Recurrence
Beschrijving

RecurrentDiseaseFirstLocal-RegionalDiagnosisDate

Datatype

date

Alias
NCI Thesaurus ObjectClass
C38155
UMLS 2011AA ObjectClass
C0277556
NCI Thesaurus Property
C25388
UMLS 2011AA Property
C1947913
NCI Thesaurus Property-2
C25509
UMLS 2011AA Property-2
C1279901
NCI Thesaurus Property-3
C15220
UMLS 2011AA Property-3
C0011900
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Date of Initial Diagnosis of Metastatic Disease
Beschrijving

MetastaticDiseaseInitialDiagnosisDate

Datatype

date

Alias
NCI Thesaurus ObjectClass
C14174
UMLS 2011AA ObjectClass
C0036525
NCI Thesaurus ObjectClass-2
C2991
UMLS 2011AA ObjectClass-2
C0012634
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
NCI Thesaurus Property-2
C15220
UMLS 2011AA Property-2
C0011900
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
ER Status
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
PgR Status
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
Her2/neu expression status by immunohistochemistry (DAKO HercepTest)
Beschrijving

BreastCytogeneticsHER2/neuPolyclonalAntibodyTestScore

Datatype

text

Alias
NCI Thesaurus ObjectClass
C12971
UMLS 2011AA ObjectClass
C0006141
NCI Thesaurus ObjectClass-2
C16487
UMLS 2011AA ObjectClass-2
C0010802
NCI Thesaurus Property
C25294
UMLS 2011AA Property
C0022885
NCI Thesaurus Property-2
C17756
UMLS 2011AA Property-2
C0242957
NCI Thesaurus Property-3
C61381
UMLS 2011AA Property-3
C0312586
NCI Thesaurus ValueDomain
C25338
UMLS 2011AA ValueDomain
C0449820
FISH HER2/neu chromosome 17 Ratio (_._)
Beschrijving

FISHAssessmentChromosome17ResultHER2NeuNumber

Datatype

float

Alias
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus ObjectClass-2
C17563
UMLS 2011AA ObjectClass-2
C0162789
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C13212
UMLS 2011AA Property-2
C0008659
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ValueDomain-2
C17756
UMLS 2011AA ValueDomain-2
C0242957
Local-regional (Sites of Involvement At Study Entry - Record an answer for each site including "Other)
Beschrijving

Local-RegionalBreastInvolvedInd-3

Datatype

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C12971
UMLS 2011AA ObjectClass
C0006141
NCI Thesaurus ObjectClass-2
C25388
UMLS 2011AA ObjectClass-2
C1947913
NCI Thesaurus Property
C25547
Ipsilateral supraclavicular nodes
Beschrijving

IpsilateralSupraclavicularLymphNodeInvolvedInd-3

Datatype

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25547
NCI Thesaurus ObjectClass
C12903
UMLS 2011AA ObjectClass
C0229730
NCI Thesaurus ObjectClass-2
C25308
UMLS 2011AA ObjectClass-2
C0441989
Opposite Breast
Beschrijving

OppositeBreastInvolvedInd-3

Datatype

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C12971
UMLS 2011AA ObjectClass
C0006141
NCI Thesaurus Property
C25547
NCI Thesaurus ObjectClass-2
C25602
UMLS 2011AA ObjectClass-2
C1521805
Distant Lymph Nodes
Beschrijving

DistantLymphNodeInvolvedInd-3

Datatype

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C12745
UMLS 2011AA ObjectClass
C0024204
NCI Thesaurus ObjectClass-2
C25321
UMLS 2011AA ObjectClass-2
C0443203
NCI Thesaurus Property
C25547
Distant Skin/subcutaneous Tissue
Beschrijving

DistantTissueSubcutaneousInvolvedSkinInd-3

Datatype

text

Alias
NCI Thesaurus ObjectClass
C25321
UMLS 2011AA ObjectClass
C0443203
NCI Thesaurus ObjectClass-2
C12801
UMLS 2011AA ObjectClass-2
C0040300
NCI Thesaurus Property
C25547
NCI Thesaurus Property-2
C13353
UMLS 2011AA Property
C0443315
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ValueDomain-2
C12470
UMLS 2011AA ValueDomain-2
C1123023
Bone
Beschrijving

BoneInvolvedInd-3

Datatype

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C12366
UMLS 2011AA ObjectClass
C0262950
NCI Thesaurus Property
C25547
Bone Marrow
Beschrijving

BoneMarrowInvolvementInd-3

Datatype

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C12431
UMLS 2011AA ObjectClass
C0005953
NCI Thesaurus Property
C25548
UMLS 2011AA Property
C1314939
Lung
Beschrijving

LungInvolvedInd-3

Datatype

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C12468
UMLS 2011AA ObjectClass
C0024109
NCI Thesaurus Property
C25547
Liver
Beschrijving

MalignantNeoplasmLiverMetastaticInvolvementInd-3

Datatype

text

Alias
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C14174
UMLS 2011AA Property
C0036525
NCI Thesaurus Property-2
C12392
UMLS 2011AA Property-2
C0023884
NCI Thesaurus Property-3
C25548
UMLS 2011AA Property-3
C1314939
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Pleura
Beschrijving

PleuraInvolvedInd-3

Datatype

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C12469
UMLS 2011AA ObjectClass
C0032225
NCI Thesaurus Property
C25547
Brain
Beschrijving

BrainInvolvedInd-3

Datatype

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C12439
UMLS 2011AA ObjectClass
C0006104
NCI Thesaurus Property
C25547
Other CNS
Beschrijving

OtherCNSInvolvedSiteInd-3

Datatype

text

Alias
NCI Thesaurus ObjectClass
C17649
UMLS 2011AA ObjectClass
C0205394
NCI Thesaurus ObjectClass-2
C12438
UMLS 2011AA ObjectClass-2
C3714787
NCI Thesaurus Property
C25341
UMLS 2011AA Property
C0450429
NCI Thesaurus Property-2
C25547
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Other (Second)
Beschrijving

MalignantNeoplasmMetastaticInvolvementInd-3

Datatype

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C14174
UMLS 2011AA Property
C0036525
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property-2
C25548
UMLS 2011AA Property-2
C1314939
Other specify (Second)
Beschrijving

TumorExtensionSpecify

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus Property
C25270
UMLS 2011AA Property
C0231448
Comments
Beschrijving

Comments

Investigator Signature
Beschrijving

Investigator Signature

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C2346576
NCI Thesaurus Property
C25678
NCI Thesaurus ObjectClass
C17089
Investigator Signature Date
Beschrijving

Investigator Signature Date

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2346576
NCI Thesaurus Property
C25678
UMLS CUI-2
C0011008
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C17089

Similar models

INSTRUCTIONS: Use this form to capture the first occurrence of non-protocol anti-tumor therapy per registration step

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Header
Protocol Number ECOG
Item
ECOG Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Patient ID ECOG
Item
ECOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Generic drug form
Item
DCI Name
text
C25191 (NCI Thesaurus ValueDomain)
C3242750 (UMLS CUI-1)
C19464 (NCI Thesaurus Property)
C25474 (NCI Thesaurus ObjectClass)
C25452 (NCI Thesaurus ObjectClass-2)
Registration Number
Item
Registration Step
text
C25337 (NCI Thesaurus ValueDomain)
C1514821 (UMLS CUI-1)
C25646 (NCI Thesaurus ObjectClass)
C0237753 (UMLS CUI-2)
C16154 (NCI Thesaurus Property)
C16154 (NCI Thesaurus ValueDomain-2)
Item
Reporting Period
text
C25284 (NCI Thesaurus ValueDomain)
C2347804 (UMLS CUI-1)
C25214 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C25651 (NCI Thesaurus ObjectClass-2)
Code List
Reporting Period
CL Item
Baseline (Baseline)
C25213 (NCI Thesaurus)
C1442488 (UMLS 2011AA)
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)
Item
ECOG Performance Status (Day 1 of this cycle)
text
C25664 (NCI Thesaurus ValueDomain)
C1520224 (UMLS CUI-1)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain-2)
C20641 (NCI Thesaurus ObjectClass)
Code List
ECOG Performance Status (Day 1 of this cycle)
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)
CL Item
Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities. Up And About More Than 50% Of Waking Hours. (2)
CL Item
Capable Of Only Limited Selfcare, Confined To Bed Or Chair More Than 50% Of Waking Hours. (3)
CL Item
Completely Disabled. Cannot Carry On Any Selfcare. Totally Confined To Bed Or Chair. (4)
Study Number Participating Group
Item
Participating Group Protocol Number
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)
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)
Item Group
Data amendment
Data amended
Item
Please mark an 'X' if data have been amended.
text
C25704 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Data amended date
Item
Date data amended
date
C25164 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C0011008 (UMLS CUI-2)
C25416 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)
Item Group
Pre-registration Evaluation
Patient Height
Item
Height
float
C25209 (NCI Thesaurus ValueDomain)
C0489786 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25347 (NCI Thesaurus Property)
Patient Weight
Item
Weight
float
C25209 (NCI Thesaurus ValueDomain)
C0005910 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)
CarboplatinTreatmentPlannedInd-2
Item
Carboplatin planned
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C1282 (NCI Thesaurus ObjectClass)
C0079083 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C25619 (NCI Thesaurus Property)
C1301732 (UMLS 2011AA Property)
Item
Menopausal status
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3231 (NCI Thesaurus Property)
C0025320 (UMLS 2011AA Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
Code List
Menopausal status
CL Item
Postmenopausal (Postmenopausal)
C15421 (NCI Thesaurus)
C0232970 (UMLS 2011AA)
C15421 (NCI Thesaurus-3)
C0232970 (UMLS 2011AA-4)
C15421 (NCI Thesaurus-5)
C0232970 (UMLS 2011AA-6)
CL Item
Premenopausal (Premenopausal)
C15491 (NCI Thesaurus)
C0279752 (UMLS 2011AA)
CL Item
Perimenopausal (Perimenopausal)
C15692 (NCI Thesaurus)
C3839366 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
UrinaryCreatinineProteinAssessmentValue
Item
Urine Protein/Creatinine Ratio
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)
Laboratory Procedure Date
Item
Date lab assessment performed
date
C25164 (NCI Thesaurus ValueDomain)
C0022885 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C38000 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
UrinaryProteinCollectionValue
Item
Protein from 24 hour Urine Collection
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)
Item Group
Prior Treatment
Item
Most Extensive Primary Surgery
text
C25251 (NCI Thesaurus ObjectClass)
C0205225 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
C15329 (NCI Thesaurus ObjectClass-3)
C0543467 (UMLS 2011AA ObjectClass-3)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
Code List
Most Extensive Primary Surgery
CL Item
Partial Mastectomy, Lumpectomy Or Excisional Biopsy (Partial mastectomy/lumpectomy/excisional biopsy)
CL Item
Mastectomy, Nos (Mastectomy NOS)
CL Item
None (None)
C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)
DataUnknownText
Item
Mark an 'X' if not done
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C17998 (NCI Thesaurus Property)
C0439673 (UMLS 2011AA Property)
PrimarySurgeryDate
Item
Date of Most Extensive Primary Surgery
date
C25251 (NCI Thesaurus ObjectClass)
C0205225 (UMLS 2011AA ObjectClass)
C15329 (NCI Thesaurus ObjectClass-2)
C0543467 (UMLS 2011AA ObjectClass-2)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
PriorHormonalTherapyAdministeredInd-3
Item
Prior Hormonal Therapy (in adjuvant or metastatic setting)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15445 (NCI Thesaurus ObjectClass-2)
C0279025 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
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)
Code List
Prior Treatment Regimen Type
CL Item
Adjuvant (Adjuvant)
C25722 (NCI Thesaurus)
C1522673 (UMLS 2011AA)
CL Item
Metastatic (Metastatic)
C14174 (NCI Thesaurus)
C0036525 (UMLS 2011AA)
PriorTherapyEndDate
Item
Prior Therapy Stop Date (most recent Lapatinib)
date
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25496 (NCI Thesaurus Property-2)
C2746065 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Prior Radiation Therapy
Item
Prior Radiation Therapy
boolean
C38148 (NCI Thesaurus ValueDomain)
C1522449 (UMLS CUI-1)
C15313 (NCI Thesaurus ObjectClass)
C0332152 (UMLS CUI-2)
C25629 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property)
PriorChemotherapyTaxaneCompoundAdministeredInd-2
Item
Prior Taxane Therapy (in the adjuvant or neoadjuvant setting)
boolean
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)
C1490 (NCI Thesaurus Property-2)
C0796419 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PriorChemotherapyDoxorubicinAdministeredInd-2
Item
Prior Doxorubicin Therapy (in the adjuvant or neoadjuvant setting)
boolean
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C456 (NCI Thesaurus Property)
C0013089 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Cumulative Dose Agent
Item
Agent Total Cumulative Dose (mg - if yes:)
float
C1708 (NCI Thesaurus ObjectClass)
C2986497 (UMLS CUI-1)
C25470 (NCI Thesaurus ObjectClass-2)
C1521826 (UMLS CUI-2)
C25304 (NCI Thesaurus Property)
C25256 (NCI Thesaurus Property-2)
C25304 (NCI Thesaurus ValueDomain)
C25488 (NCI Thesaurus ValueDomain-2)
PriorChemotherapyEpirubicinHydrochlorideAdministeredInd-2
Item
Prior Epirubicin Therapy (in the adjuvant or neoadjuvant setting)
boolean
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)
C474 (NCI Thesaurus Property-2)
C0282387 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PriorChemotherapyTrastuzumabAdministeredInd-2
Item
Prior Trastuzumab Therapy (in the adjuvant setting)
boolean
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C1647 (NCI Thesaurus Property)
C0338204 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PriorChemotherapyLapatinibAdministeredInd-2
Item
Prior Lapatinib Therapy (in the adjuvant or neoadjuvant setting?)
boolean
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C26653 (NCI Thesaurus Property)
C1173538 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PriorChemotherapyOtherAdministeredInd-2
Item
Prior Other Chemotherapy (in the adjuvant or metastatic setting)
boolean
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PriorChemotherapyAdministeredEndDate
Item
Prior Chemotherapy End Date (other - if yes:)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Item Group
Disease Description
PrimaryTumorDiagnosisDate
Item
Date of Definitive Histologic Diagnosis of Primary Tumor
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25251 (NCI Thesaurus ObjectClass-2)
C0205225 (UMLS 2011AA ObjectClass-2)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
ContralateralBreastCancerDiagnosisDate
Item
Contralateral diagnosis date (if applicable)
date
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
C25307 (NCI Thesaurus ObjectClass-3)
C0441988 (UMLS 2011AA ObjectClass-3)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
RecurrentDiseaseFirstLocal-RegionalDiagnosisDate
Item
Date of First Local-Regional Recurrence
date
C38155 (NCI Thesaurus ObjectClass)
C0277556 (UMLS 2011AA ObjectClass)
C25388 (NCI Thesaurus Property)
C1947913 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property-2)
C1279901 (UMLS 2011AA Property-2)
C15220 (NCI Thesaurus Property-3)
C0011900 (UMLS 2011AA Property-3)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
MetastaticDiseaseInitialDiagnosisDate
Item
Date of Initial Diagnosis of Metastatic Disease
date
C14174 (NCI Thesaurus ObjectClass)
C0036525 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus ObjectClass-2)
C0012634 (UMLS 2011AA ObjectClass-2)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property-2)
C0011900 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item
ER Status
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)
Code List
ER Status
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
CL Item
Not Done (NOT DONE)
CL281691 (NCI Metathesaurus)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
PgR Status
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C17075 (NCI Thesaurus ObjectClass)
C0034833 (UMLS 2011AA ObjectClass)
C0678257 (NCI Metathesaurus Property)
Code List
PgR Status
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
CL Item
Not Done (NOT DONE)
CL281691 (NCI Metathesaurus)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Her2/neu expression status by immunohistochemistry (DAKO HercepTest)
text
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C16487 (NCI Thesaurus ObjectClass-2)
C0010802 (UMLS 2011AA ObjectClass-2)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C17756 (NCI Thesaurus Property-2)
C0242957 (UMLS 2011AA Property-2)
C61381 (NCI Thesaurus Property-3)
C0312586 (UMLS 2011AA Property-3)
C25338 (NCI Thesaurus ValueDomain)
C0449820 (UMLS 2011AA ValueDomain)
Code List
Her2/neu expression status by immunohistochemistry (DAKO HercepTest)
CL Item
0 (0)
C0919414 (NCI Metathesaurus)
CL Item
1+ (1+)
CL Item
2+ (2+)
CL Item
3+ (3+)
CL Item
Not Done: C49484 (not done)
C49484 (NCI Thesaurus)
C1272696 (UMLS 2011AA)
FISHAssessmentChromosome17ResultHER2NeuNumber
Item
FISH HER2/neu chromosome 17 Ratio (_._)
float
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C17563 (NCI Thesaurus ObjectClass-2)
C0162789 (UMLS 2011AA ObjectClass-2)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C13212 (NCI Thesaurus Property-2)
C0008659 (UMLS 2011AA Property-2)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C17756 (NCI Thesaurus ValueDomain-2)
C0242957 (UMLS 2011AA ValueDomain-2)
Item
Local-regional (Sites of Involvement At Study Entry - Record an answer for each site including "Other)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C25388 (NCI Thesaurus ObjectClass-2)
C1947913 (UMLS 2011AA ObjectClass-2)
C25547 (NCI Thesaurus Property)
Code List
Local-regional (Sites of Involvement At Study Entry - Record an answer for each site including "Other)
CL Item
No (NO)
CL Item
Yes (YES)
CL Item
Unknown (UNKNOWN)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Ipsilateral supraclavicular nodes
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25547 (NCI Thesaurus Property)
C12903 (NCI Thesaurus ObjectClass)
C0229730 (UMLS 2011AA ObjectClass)
C25308 (NCI Thesaurus ObjectClass-2)
C0441989 (UMLS 2011AA ObjectClass-2)
Code List
Ipsilateral supraclavicular nodes
CL Item
No (NO)
CL Item
Yes (YES)
CL Item
Unknown (UNKNOWN)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Opposite Breast
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C25547 (NCI Thesaurus Property)
C25602 (NCI Thesaurus ObjectClass-2)
C1521805 (UMLS 2011AA ObjectClass-2)
Code List
Opposite Breast
CL Item
No (NO)
CL Item
Yes (YES)
CL Item
Unknown (UNKNOWN)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Distant Lymph Nodes
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25321 (NCI Thesaurus ObjectClass-2)
C0443203 (UMLS 2011AA ObjectClass-2)
C25547 (NCI Thesaurus Property)
Code List
Distant Lymph Nodes
CL Item
No (NO)
CL Item
Yes (YES)
CL Item
Unknown (UNKNOWN)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Distant Skin/subcutaneous Tissue
text
C25321 (NCI Thesaurus ObjectClass)
C0443203 (UMLS 2011AA ObjectClass)
C12801 (NCI Thesaurus ObjectClass-2)
C0040300 (UMLS 2011AA ObjectClass-2)
C25547 (NCI Thesaurus Property)
C13353 (NCI Thesaurus Property-2)
C0443315 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12470 (NCI Thesaurus ValueDomain-2)
C1123023 (UMLS 2011AA ValueDomain-2)
Code List
Distant Skin/subcutaneous Tissue
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Bone
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12366 (NCI Thesaurus ObjectClass)
C0262950 (UMLS 2011AA ObjectClass)
C25547 (NCI Thesaurus Property)
Code List
Bone
CL Item
No (NO)
CL Item
Yes (YES)
CL Item
Unknown (UNKNOWN)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Bone Marrow
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12431 (NCI Thesaurus ObjectClass)
C0005953 (UMLS 2011AA ObjectClass)
C25548 (NCI Thesaurus Property)
C1314939 (UMLS 2011AA Property)
Code List
Bone Marrow
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Lung
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12468 (NCI Thesaurus ObjectClass)
C0024109 (UMLS 2011AA ObjectClass)
C25547 (NCI Thesaurus Property)
Code List
Lung
CL Item
No (NO)
CL Item
Yes (YES)
CL Item
Unknown (UNKNOWN)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Liver
text
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C14174 (NCI Thesaurus Property)
C0036525 (UMLS 2011AA Property)
C12392 (NCI Thesaurus Property-2)
C0023884 (UMLS 2011AA Property-2)
C25548 (NCI Thesaurus Property-3)
C1314939 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
Code List
Liver
CL Item
No (NO)
CL Item
Unknown (UNKNOWN)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Yes (YES)
Item
Pleura
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12469 (NCI Thesaurus ObjectClass)
C0032225 (UMLS 2011AA ObjectClass)
C25547 (NCI Thesaurus Property)
Code List
Pleura
CL Item
No (NO)
CL Item
Yes (YES)
CL Item
Unknown (UNKNOWN)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Brain
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12439 (NCI Thesaurus ObjectClass)
C0006104 (UMLS 2011AA ObjectClass)
C25547 (NCI Thesaurus Property)
Code List
Brain
CL Item
No (NO)
CL Item
Yes (YES)
CL Item
Unknown (UNKNOWN)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Other CNS
text
C17649 (NCI Thesaurus ObjectClass)
C0205394 (UMLS 2011AA ObjectClass)
C12438 (NCI Thesaurus ObjectClass-2)
C3714787 (UMLS 2011AA ObjectClass-2)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25547 (NCI Thesaurus Property-2)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
Code List
Other CNS
CL Item
No (NO)
CL Item
Yes (YES)
CL Item
Unknown (UNKNOWN)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Other (Second)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C14174 (NCI Thesaurus Property)
C0036525 (UMLS 2011AA Property)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25548 (NCI Thesaurus Property-2)
C1314939 (UMLS 2011AA Property-2)
Code List
Other (Second)
CL Item
No (NO)
CL Item
Yes (YES)
CL Item
Unknown (UNKNOWN)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
TumorExtensionSpecify
Item
Other specify (Second)
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25270 (NCI Thesaurus Property)
C0231448 (UMLS 2011AA Property)
Item Group
Comments
Investigator Signature
Item
Investigator Signature
text
C25704 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
Investigator Signature Date
Item
Investigator Signature Date
date
C25164 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C25367 (NCI Thesaurus ValueDomain-2)
C17089 (NCI Thesaurus ObjectClass)

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