ID

7694

Beschreibung

NCIC MA.32 Baseline Report A Phase III Randomized Trial of Metformin vs Placebo in Early Stage Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=81E21D11-128C-1198-E040-BB89AD434372

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=81E21D11-128C-1198-E040-BB89AD434372

Stichworte

  1. 27.08.12 27.08.12 -
  2. 11.08.14 11.08.14 - Martin Dugas
  3. 11.08.14 11.08.14 - Martin Dugas
  4. 11.08.14 11.08.14 - Martin Dugas
  5. 26.11.14 26.11.14 - Martin Dugas
  6. 09.01.15 09.01.15 - Martin Dugas
Hochgeladen am

9. Januar 2015

DOI

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Breast Cancer NCT01101438 Pre-Study - NCIC MA.32 Baseline Report - 3027459v1.0

Aim - The aim of the Baseline Folder is to collect information about patient status at the time of randomization. Completion - The Baseline Report Folder must be completed within 6 weeks after randomization Timing of Investigations - The timing of protocol-required pre-treatment investigations covered by the Baseline Report is as follows: (Please note: Some protocol required pre-treatment investigations are collected on the Eligibility Checklist, so they are not repeated on this Report. Please refer to the protocol (section 6.0) for a complete list of required pre-treatment investigations.) ¿ Adverse Events (AEs) ¿ within 14 days before first treatment Note: Correlative Studies details will be reported in the separate correlative studies folder.

Tobacco Smoking History - Baseline
Beschreibung

Tobacco Smoking History - Baseline

Has the patient previously been a smoker?
Beschreibung

Smoking use

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C3241966
NCI Thesaurus ObjectClass
C17934
NCI Thesaurus Property
C25340
Does the patient currently smoke
Beschreibung

Current Smoker

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C3241966
NCI Thesaurus Property
C25471
NCI Thesaurus ObjectClass
C17934
NCI Metathesaurus Property
C0449865
Average number of cigarettes smoked per day
Beschreibung

Smoker amount smoked

Datentyp

float

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1608325
NCI Thesaurus ObjectClass
C17934
NCI Thesaurus Property
C25340
Date of quitting smoking
Beschreibung

SmokingDiscontinuedDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25484
UMLS 2011AA Property
C1444662
NCI Thesaurus ObjectClass
C17934
UMLS 2011AA ObjectClass
C0453996
Smoking history
Beschreibung

CurrentSmokingHistoryType

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C25471
UMLS 2011AA ObjectClass
C0521116
NCI Thesaurus ObjectClass-2
C17934
UMLS 2011AA ObjectClass-2
C0453996
NCI Thesaurus Property
C18772
UMLS 2011AA Property
C0262926
Date started smoking
Beschreibung

SmokingUseBeginDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25431
UMLS 2011AA ValueDomain-2
C0439659
NCI Thesaurus ObjectClass
C17934
UMLS 2011AA ObjectClass
C0453996
NCI Thesaurus Property
C25340
UMLS 2011AA Property
C0457083
Number of years smoked cigarettes
Beschreibung

CigarettesSmokingYearNumber

Datentyp

float

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C1802
UMLS 2011AA ObjectClass
C0677453
NCI Thesaurus ValueDomain-2
C29848
UMLS 2011AA ValueDomain-2
C0439234
NCI Thesaurus Property
C17934
UMLS 2011AA Property
C0453996
Average per day over lifetime of smoking
Beschreibung

CigaretteSmokingLifetimeUseAverageNumber

Datentyp

float

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C18270
UMLS 2011AA ObjectClass
C0700219
NCI Thesaurus Property
C25340
UMLS 2011AA Property
C0457083
NCI Thesaurus Property-2
C19662
UMLS 2011AA Property-2
C1517878
Number pack years smoked
Beschreibung

CigaretteSmokingHistoryPackYearAmount

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C17934
UMLS 2011AA ObjectClass
C0453996
NCI Thesaurus Property
C18772
UMLS 2011AA Property
C0262926
NCI Thesaurus ValueDomain
C25417
Alcohol Consumption - Question
Beschreibung

Alcohol Consumption - Question

Alcohol Use in the Past Year
Beschreibung

AlcoholConsumptionPastYearIndicator

Datentyp

boolean

Alias
NCI Thesaurus ObjectClass
C2190
UMLS 2011AA ObjectClass
C0001962
NCI Thesaurus Property
C29848
UMLS 2011AA Property
C0439234
NCI Thesaurus Property-2
C25340
UMLS 2011AA Property-2
C0457083
NCI Thesaurus Property-3
C25609
UMLS 2011AA Property-3
C1444637
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Average Alcohol Consumption
Beschreibung

AlcoholCurrentUseRangeType

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C25471
UMLS 2011AA Property
C0521116
NCI Thesaurus ObjectClass
C2190
UMLS 2011AA ObjectClass
C0001962
NCI Thesaurus Property-2
C25340
UMLS 2011AA Property-2
C0457083
Bilateral Breast Carcinoma - Question
Beschreibung

Bilateral Breast Carcinoma - Question

Was this subject enrolled as having bilateral breast carcinoma
Beschreibung

BilateralBreastCarcinomaPatientClinicalTrialEnrollmentInd-2

Datentyp

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass-2
C13332
UMLS 2011AA ObjectClass-2
C0238767
NCI Thesaurus ObjectClass-3
C4872
UMLS 2011AA ObjectClass-3
C0678222
NCI Thesaurus Property
C71104
UMLS 2011AA Property
C0008976
NCI Thesaurus Property-2
C37948
UMLS 2011AA Property-2
C1516879
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Bilateral Breast Carcinoma
Beschreibung

Bilateral Breast Carcinoma

Pathologic T Stage
Beschreibung

BreastTumorPathologicTStage

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C12971
UMLS 2011AA ObjectClass-2
C0006141
NCI Thesaurus Property
C25610
UMLS 2011AA Property
C1521733
NCI Thesaurus Property-2
C25728
UMLS 2011AA Property-2
C0475455
NCI Thesaurus ValueDomain
C16899
UMLS 2011AA ValueDomain
C1300072
Pathologic N Stage
Beschreibung

BreastTumorPathologicNStage

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C12971
UMLS 2011AA ObjectClass-2
C0006141
NCI Thesaurus Property
C25610
UMLS 2011AA Property
C1521733
NCI Thesaurus Property-2
C25580
UMLS 2011AA Property-2
C0456532
NCI Thesaurus ValueDomain
C16899
UMLS 2011AA ValueDomain
C1300072
Pathologic M Stage
Beschreibung

BreastTumorPathologicMStage

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C12971
UMLS 2011AA ObjectClass-2
C0006141
NCI Thesaurus Property
C25610
UMLS 2011AA Property
C1521733
NCI Thesaurus Property-2
C25727
UMLS 2011AA Property-2
C0456533
NCI Thesaurus ValueDomain
C16899
UMLS 2011AA ValueDomain
C1300072
Was sentinel node sampling performed
Beschreibung

SentinelNodeBiopsyInd-3

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C15189
UMLS 2011AA Property
C0005558
NCI Thesaurus ObjectClass
C12947
UMLS 2011AA ObjectClass
C1522495
Sentinel Node Biopsy Date
Beschreibung

SentinelNodeBiopsyDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus Property
C15189
UMLS 2011AA Property
C0005558
NCI Thesaurus ObjectClass
C12947
UMLS 2011AA ObjectClass
C1522495
Number of Sentinel Nodes Examined
Beschreibung

SentinelNodeExaminedCount

Datentyp

float

Alias
NCI Thesaurus Property
C25500
UMLS 2011AA Property
C0332128
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
NCI Thesaurus ObjectClass
C12947
UMLS 2011AA ObjectClass
C1522495
Number of Positive Sentinel Nodes
Beschreibung

SentinelNodePositiveAssessmentCount

Datentyp

float

Alias
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Metathesaurus Property
C0205159
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
NCI Thesaurus ObjectClass
C12947
UMLS 2011AA ObjectClass
C1522495
Was axillary dissection performed?
Beschreibung

AxillaryNodeDissectionInd-3

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C15227
UMLS 2011AA Property
C0012737
NCI Thesaurus ObjectClass
C12904
UMLS 2011AA ObjectClass
C0729594
Date of Axillary Node Biopsy
Beschreibung

AxillaryLymphNodeCoreBiopsyFine-NeedleAspirationLymphNodeBiopsyPriorClinicalStudyPerformedDate

Datentyp

date

Alias
NCI Thesaurus ObjectClass
C15680
UMLS 2011AA ObjectClass
C1318309
NCI Thesaurus ObjectClass-2
C15361
UMLS 2011AA ObjectClass-2
C1510483
NCI Thesaurus ObjectClass-3
C51900
UMLS 2011AA ObjectClass-3
C0193842
NCI Thesaurus ObjectClass-4
C12904
UMLS 2011AA ObjectClass-4
C0729594
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus Property-2
C25629
UMLS 2011AA Property-2
C0332152
NCI Thesaurus Property-3
C15206
UMLS 2011AA Property-3
C0008972
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Number of axillary nodes examined
Beschreibung

AxillaryNodeExaminedTotalCount

Datentyp

float

Alias
NCI Thesaurus ValueDomain
C25304
UMLS 2011AA ValueDomain
C0439810
NCI Thesaurus Property
C25500
UMLS 2011AA Property
C0332128
NCI Thesaurus ValueDomain-2
C25463
UMLS 2011AA ValueDomain-2
C0750480
NCI Thesaurus ObjectClass
C12904
UMLS 2011AA ObjectClass
C0729594
Number of positive axillary nodes
Beschreibung

PositiveAxillaryNodeExaminedTotalCount

Datentyp

float

Alias
NCI Thesaurus ObjectClass
C25246
UMLS 2011AA ObjectClass
C1446409
NCI Thesaurus ObjectClass-2
C12904
UMLS 2011AA ObjectClass-2
C0729594
NCI Thesaurus Property
C25500
UMLS 2011AA Property
C0332128
NCI Thesaurus ValueDomain
C25304
UMLS 2011AA ValueDomain
C0439810
NCI Thesaurus ValueDomain-2
C25463
UMLS 2011AA ValueDomain-2
C0750480
Number of Lymph Nodes Examined
Beschreibung

LymphNodeExaminedCount

Datentyp

float

Alias
NCI Thesaurus Property
C25500
UMLS 2011AA Property
C0332128
NCI Thesaurus ObjectClass
C12745
UMLS 2011AA ObjectClass
C0024204
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
Number of Positive Lymph Nodes
Beschreibung

LymphNodePositiveCount

Datentyp

float

Alias
NCI Thesaurus Property
C25246
UMLS 2011AA Property
C1446409
NCI Thesaurus ObjectClass
C12745
UMLS 2011AA ObjectClass
C0024204
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
Baseline Adverse Events - Question
Beschreibung

Baseline Adverse Events - Question

Did the participant report any symptoms or adverse events?
Beschreibung

SymptomorAdverseEventOccurrenceInd

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Metathesaurus Property
CL209504
Baseline Advers Events
Beschreibung

Baseline Advers Events

CTCAE Term
Beschreibung

AdverseEventCommonTerminologyforAdverseEventsVersion4TermName

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C49704
UMLS 2011AA Property
C1516728
NCI Thesaurus Property-2
C45559
UMLS 2011AA Property-2
C1705313
NCI Thesaurus ValueDomain
C45255
UMLS 2011AA ValueDomain
C1708523
NCI Thesaurus ValueDomain-2
C49704
UMLS 2011AA ValueDomain-2
C1516728
NCI Thesaurus ValueDomain-3
C42614
UMLS 2011AA ValueDomain-3
C0027365
NCI Thesaurus ValueDomain-4
C45559
UMLS 2011AA ValueDomain-4
C1705313
NCI Thesaurus ValueDomain-5
C25714
UMLS 2011AA ValueDomain-5
C0333052
Grade
Beschreibung

CommonToxicityCriteriaAdverseEventReportingGrade

Datentyp

float

Alias
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C25651
UMLS 2011AA Property
C0700287
NCI Thesaurus ValueDomain
C18000
UMLS 2011AA ValueDomain
C0919553
NCI Thesaurus Property-2
C25365
UMLS 2011AA Property-2
C0678257
AE Ongoing
Beschreibung

AdverseEventContinueIndicator

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C53279
UMLS 2011AA Property
C0549178
Cardiovascular History - Question
Beschreibung

Cardiovascular History - Question

Has the patient suffered cardiovascular disease?
Beschreibung

CardiovascularDiseasePresentInd-2

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C25292
UMLS 2011AA ObjectClass
C0007226
NCI Thesaurus ObjectClass-2
C2991
UMLS 2011AA ObjectClass-2
C0012634
Cardiovascular History
Beschreibung

Cardiovascular History

Problem, cardiovascular
Beschreibung

CardiacDiseaseAssessmentType

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ObjectClass
C13306
UMLS 2011AA ObjectClass
C1522601
NCI Thesaurus ObjectClass-2
C2991
UMLS 2011AA ObjectClass-2
C0012634
Specify
Beschreibung

CardiacDiseaseAssessmentSpecify

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ObjectClass
C13306
UMLS 2011AA ObjectClass
C1522601
NCI Thesaurus ObjectClass-2
C2991
UMLS 2011AA ObjectClass-2
C0012634
Baseline Concomitant Medications
Beschreibung

Baseline Concomitant Medications

Did the participant report taking any concomitant medication
Beschreibung

ConcomitantMedicationUseInd-3

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C459
UMLS 2011AA ObjectClass
C0013227
NCI Thesaurus ObjectClass-2
C25730
UMLS 2011AA ObjectClass-2
C0521115
NCI Thesaurus Property
C25340
UMLS 2011AA Property
C0457083
Concomitant Medication
Beschreibung

Concomitant Medication

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C2347852
NCI Thesaurus ObjectClass
C459
NCI Thesaurus Property
C25639
NCI Thesaurus ObjectClass-2
C25730
Reason for Administration
Beschreibung

Concomitant Medication Use Indication

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C459
UMLS CUI-1
C2826696
NCI Thesaurus ObjectClass-2
C25730
NCI Thesaurus Property
C25382
NCI Thesaurus ValueDomain
C25704
NCI Thesaurus ValueDomain-2
C25638
Is this medication continuing?
Beschreibung

Medication continued

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS CUI-1
C0013227
NCI Thesaurus ObjectClass
C459
UMLS CUI-2
C0549178
NCI Thesaurus Property
C25409
NCI Metathesaurus Property
C0750536
Adjuvant Radiation Therapy
Beschreibung

Adjuvant Radiation Therapy

Has the patient received adjuvant RT
Beschreibung

AdjuvantRadiationTherapyAdministeredInd-3

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C15313
UMLS 2011AA ObjectClass
C1522449
NCI Thesaurus ObjectClass-2
C2140
UMLS 2011AA ObjectClass-2
C0001552
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Date Adjuvant Radiation Therapy Started
Beschreibung

AdjuvantRadiationTherapyBeginDate

Datentyp

date

Alias
NCI Thesaurus ObjectClass
C15313
UMLS 2011AA ObjectClass
C1522449
NCI Thesaurus ObjectClass-2
C2140
UMLS 2011AA ObjectClass-2
C0001552
NCI Thesaurus Property
C25431
UMLS 2011AA Property
C0439659
NCI Thesaurus Property-2
C25275
UMLS 2011AA Property-2
C2745955
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25431
UMLS 2011AA ValueDomain-2
C0439659
Date Adjuvant Radiation Therapy Ended
Beschreibung

AdjuvantRadiationTherapyEndDate

Datentyp

date

Alias
NCI Thesaurus ObjectClass
C15313
UMLS 2011AA ObjectClass
C1522449
NCI Thesaurus ObjectClass-2
C2140
UMLS 2011AA ObjectClass-2
C0001552
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
Total Dose of Radiation Therapy (cGy)
Beschreibung

Radiation Therapy Total Dose

Datentyp

float

Alias
NCI Thesaurus ValueDomain
C25304
UMLS CUI-1
C2169193
NCI Thesaurus ObjectClass
C15313
NCI Thesaurus ValueDomain-2
C25488
NCI Thesaurus Property
C25382
Systemic Therapy
Beschreibung

Systemic Therapy

Has the patient received systemic therapy?
Beschreibung

SystemicTherapyAdministeredInd-3

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C15698
UMLS 2011AA ObjectClass
C1515119
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Agent Name
Beschreibung

Agent

Datentyp

text

Alias
NCI Thesaurus Property
C25364
UMLS CUI-1
C1521826
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus ValueDomain
C1708
NCI Thesaurus ValueDomain-2
C42614
Non-protocol Therapy Start Date
Beschreibung

Non-protocolTherapyAdministeredBeginDate

Datentyp

date

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C25590
UMLS 2011AA ObjectClass
C1518384
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25431
UMLS 2011AA ValueDomain-2
C0439659
Continuing
Beschreibung

Non-ProtocolTherapyContinueInd-2

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C25590
UMLS 2011AA ObjectClass
C1518384
NCI Thesaurus Property
C54064
Non-protocol Therapy End Date
Beschreibung

Non-protocolTherapyAdministeredEndDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C25590
UMLS 2011AA ObjectClass
C1518384
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Therapy Intent
Beschreibung

TreatmentRegimenType

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C15697
UMLS 2011AA Property
C0040808
Specify
Beschreibung

TherapyRegimenSpecify

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C15697
UMLS 2011AA Property
C0040808
Major Medical Problems At Baseline
Beschreibung

Major Medical Problems At Baseline

Concomitant Diseases and/or Relevant Medical Conditions
Beschreibung

PatientHistoryText

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C18772
UMLS 2011AA Property
C0262926
Ongoing
Beschreibung

PatientMedicalHistoryBaselineProblemInd-2

Datentyp

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass-2
C18772
UMLS 2011AA ObjectClass-2
C0262926
NCI Thesaurus Property
C25213
UMLS 2011AA Property
C1442488
NCI Thesaurus Property-2
C28020
UMLS 2011AA Property-2
C0033213
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Ongoing
Beschreibung

PatientMedicalHistoryBaselineProblemInd-2

Datentyp

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass-2
C18772
UMLS 2011AA ObjectClass-2
C0262926
NCI Thesaurus Property
C25213
UMLS 2011AA Property
C1442488
NCI Thesaurus Property-2
C28020
UMLS 2011AA Property-2
C0033213
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Other Clinical Trial Participation
Beschreibung

Other Clinical Trial Participation

Is the subject participating in another clinical trial of Breast Cancer treatment
Beschreibung

PatientBreastMalignantNeoplasmOtherClinicalTrialParticipantInd-2

Datentyp

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property-2
C12971
UMLS 2011AA Property-2
C0006141
NCI Thesaurus Property-3
C9305
UMLS 2011AA Property-3
C0006826
NCI Thesaurus Property-4
C29867
UMLS 2011AA Property-4
C0679646
NCI Thesaurus Property-5
C71104
UMLS 2011AA Property-5
C0008976
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Clinical Trial Protocol ID
Beschreibung

ClinicalTrialProtocolIdentifier64CharacterText

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ValueDomain-2
C45253
UMLS 2011AA ValueDomain-2
C1547402
Clinical Trial Sponsor Name
Beschreibung

ClinicalTrialSponsorName64CharacterText

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C48355
UMLS 2011AA ObjectClass
C1711305
NCI Thesaurus ObjectClass-2
C71104
UMLS 2011AA ObjectClass-2
C0008976
NCI Thesaurus Property
C42614
UMLS 2011AA Property
C0027365
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ValueDomain-2
C45253
UMLS 2011AA ValueDomain-2
C1547402
Patient Entry Date
Beschreibung

PatientEnrollmentDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893

Ähnliche Modelle

Aim - The aim of the Baseline Folder is to collect information about patient status at the time of randomization. Completion - The Baseline Report Folder must be completed within 6 weeks after randomization Timing of Investigations - The timing of protocol-required pre-treatment investigations covered by the Baseline Report is as follows: (Please note: Some protocol required pre-treatment investigations are collected on the Eligibility Checklist, so they are not repeated on this Report. Please refer to the protocol (section 6.0) for a complete list of required pre-treatment investigations.) ¿ Adverse Events (AEs) ¿ within 14 days before first treatment Note: Correlative Studies details will be reported in the separate correlative studies folder.

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Tobacco Smoking History - Baseline
Item
Has the patient previously been a smoker?
text
C38148 (NCI Thesaurus ValueDomain)
C3241966 (UMLS CUI-1)
C17934 (NCI Thesaurus ObjectClass)
C25340 (NCI Thesaurus Property)
Code List
Has the patient previously been a smoker?
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus-3)
C1705108 (UMLS 2011AA-4)
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C49487 (NCI Thesaurus-3)
C1298908 (UMLS 2011AA-4)
CL Item
Unknown (unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
C17998 (NCI Thesaurus-3)
C0439673 (UMLS 2011AA-4)
Current Smoker
Item
Does the patient currently smoke
boolean
C38148 (NCI Thesaurus ValueDomain)
C3241966 (UMLS CUI-1)
C25471 (NCI Thesaurus Property)
C17934 (NCI Thesaurus ObjectClass)
C0449865 (NCI Metathesaurus Property)
Smoker amount smoked
Item
Average number of cigarettes smoked per day
float
C25337 (NCI Thesaurus ValueDomain)
C1608325 (UMLS CUI-1)
C17934 (NCI Thesaurus ObjectClass)
C25340 (NCI Thesaurus Property)
SmokingDiscontinuedDate
Item
Date of quitting smoking
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25484 (NCI Thesaurus Property)
C1444662 (UMLS 2011AA Property)
C17934 (NCI Thesaurus ObjectClass)
C0453996 (UMLS 2011AA ObjectClass)
Item
Smoking history
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25471 (NCI Thesaurus ObjectClass)
C0521116 (UMLS 2011AA ObjectClass)
C17934 (NCI Thesaurus ObjectClass-2)
C0453996 (UMLS 2011AA ObjectClass-2)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
Code List
Smoking history
CL Item
Pipe Or Cigar Smoker Only (Pipe or cigar smoker only)
CL Item
100 Or Fewer Cigarettes During Lifetime (100 or fewer cigarettes during lifetime)
CL Item
Greater Than 100 Cigarettes During Lifetime (greater than 100 cigarettes during lifetime)
SmokingUseBeginDate
Item
Date started smoking
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)
C17934 (NCI Thesaurus ObjectClass)
C0453996 (UMLS 2011AA ObjectClass)
C25340 (NCI Thesaurus Property)
C0457083 (UMLS 2011AA Property)
CigarettesSmokingYearNumber
Item
Number of years smoked cigarettes
float
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C1802 (NCI Thesaurus ObjectClass)
C0677453 (UMLS 2011AA ObjectClass)
C29848 (NCI Thesaurus ValueDomain-2)
C0439234 (UMLS 2011AA ValueDomain-2)
C17934 (NCI Thesaurus Property)
C0453996 (UMLS 2011AA Property)
CigaretteSmokingLifetimeUseAverageNumber
Item
Average per day over lifetime of smoking
float
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C18270 (NCI Thesaurus ObjectClass)
C0700219 (UMLS 2011AA ObjectClass)
C25340 (NCI Thesaurus Property)
C0457083 (UMLS 2011AA Property)
C19662 (NCI Thesaurus Property-2)
C1517878 (UMLS 2011AA Property-2)
CigaretteSmokingHistoryPackYearAmount
Item
Number pack years smoked
text
C17934 (NCI Thesaurus ObjectClass)
C0453996 (UMLS 2011AA ObjectClass)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
C25417 (NCI Thesaurus ValueDomain)
Item Group
Alcohol Consumption - Question
AlcoholConsumptionPastYearIndicator
Item
Alcohol Use in the Past Year
boolean
C2190 (NCI Thesaurus ObjectClass)
C0001962 (UMLS 2011AA ObjectClass)
C29848 (NCI Thesaurus Property)
C0439234 (UMLS 2011AA Property)
C25340 (NCI Thesaurus Property-2)
C0457083 (UMLS 2011AA Property-2)
C25609 (NCI Thesaurus Property-3)
C1444637 (UMLS 2011AA Property-3)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
Item
Average Alcohol Consumption
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25471 (NCI Thesaurus Property)
C0521116 (UMLS 2011AA Property)
C2190 (NCI Thesaurus ObjectClass)
C0001962 (UMLS 2011AA ObjectClass)
C25340 (NCI Thesaurus Property-2)
C0457083 (UMLS 2011AA Property-2)
Code List
Average Alcohol Consumption
CL Item
Less Than 1 Drink Per Month (Less than 1 drink per month)
CL Item
1 To 5 Drinks Per Month (1 to 5 drinks per month)
CL Item
1 To 10 Drinks Per Week (1 to 10 drinks per week)
CL Item
11 To 30 Drinks Per Week (11 to 30 drinks per week)
CL Item
More Than 30 Drinks Per Week (More than 30 drinks per week)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item Group
Bilateral Breast Carcinoma - Question
BilateralBreastCarcinomaPatientClinicalTrialEnrollmentInd-2
Item
Was this subject enrolled as having bilateral breast carcinoma
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C13332 (NCI Thesaurus ObjectClass-2)
C0238767 (UMLS 2011AA ObjectClass-2)
C4872 (NCI Thesaurus ObjectClass-3)
C0678222 (UMLS 2011AA ObjectClass-3)
C71104 (NCI Thesaurus Property)
C0008976 (UMLS 2011AA Property)
C37948 (NCI Thesaurus Property-2)
C1516879 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item Group
Bilateral Breast Carcinoma
Item
Pathologic T Stage
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
C25610 (NCI Thesaurus Property)
C1521733 (UMLS 2011AA Property)
C25728 (NCI Thesaurus Property-2)
C0475455 (UMLS 2011AA Property-2)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
Code List
Pathologic T Stage
CL Item
No Evidence Of Primary Tumor (T0)
CL Item
Tumor 2 Cm Or Less In Greatest Dimension (T1)
CL Item
Tumor More Than 0.1 Cm But Not More Than 0.5 Cm In Greatest Dimension (T1a)
CL Item
Tumor More Than 0.5 Cm But Not More Than 1 Cm In Greatest Dimension (T1b)
CL Item
Tumor More Than 1 Cm But Not More Than 2 Cm In Greatest Dimension (T1c)
CL Item
Microinvasion 0.1 Cm Or Less In Greatest Dimension (T1mic)
CL Item
Tumor More Than 2 Cm But Not More Than 5 Cm In Greatest Dimension (T2)
CL Item
Tumor More Than 5 Cm In Greatest Dimension (T3)
CL Item
Tumor Of Any Size With Direct (T4)
CL Item
Extension To Chest Wall (T4a)
CL Item
Edema (including Peau D'orange) Or Ulceration Of The Skin Of The Breast Or Satellite Skin Nodules Confined To The Same Breast (T4b)
CL Item
Both T4a And T4b (T4c)
CL Item
Inflammatory Carcinoma (T4d)
C0334385 (NCI Metathesaurus)
CL Item
Carcinoma In Situ: Intraductal Carcinoma, Lobular Carcinoma In Situ, Or Paget's Disease Of The Nipple With No Tumor (Tis)
CL Item
Ductal Carcinoma In Situ (Tis (DCIS))
CL Item
Lobular Carcinoma In Situ (Tis (LCIS))
CL Item
Paget's Disease Of The Nipple With No Tumor. [note: Paget's Disease Associated With A Tumor Is Classified According To The Size Of The Tumor.] (Tis (Paget's))
CL Item
Primary Tumor Cannot Be Assessed (TX)
Item
Pathologic N Stage
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
C25610 (NCI Thesaurus Property)
C1521733 (UMLS 2011AA Property)
C25580 (NCI Thesaurus Property-2)
C0456532 (UMLS 2011AA Property-2)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
Code List
Pathologic N Stage
CL Item
No Regional Lymph Node Metastasis Histologically, No Additional Examination For Isolated Tumor Cells (itc) (pN0)
CL Item
No Regional Lymph Node Metastasis Histologically, Positive Ihc, No Ihc Cluster >0.2 Mm (pN0(i+))
CL Item
No Regional Lymph Node Metastasis Histologically, Negative Ihc (pN0(i-))
CL Item
No Regionally Lymph Node Metastasis Histologically, Positive Molecular Findings (rt-pcr) (pN0(mol+))
CL Item
No Regional Lymph Node Metastasis Histologically, Negative Molecular Findings (rt-pcr) (pN0(mol-))
CL Item
Metastasis In 1 To 3 Axillary Lymph Nodes, And/or In Internal Mammary Nodes With Microscopic Disease Detected By Sln Dissection But Not Clinically Apparent (pN1)
CL Item
Metastasis In 1 To 3 Axillary Lymph Nodes (pN1a)
CL Item
Metastasis In Internal Mammary Nodes With Microscopic Disease Detected By Sln Dissection But Not Clinically Apparent (pN1b)
CL Item
Metastasis In 1 To 3 Axillary Lymph Nodes And In Internal Mammary Lymph Nodes With Microscopic Disease Detected By Sln Dissection But Not Clinically Apparent. (pN1c)
CL Item
Micrometastasis (>0.2 Mm But <=2.0 Mm) (pN1mi)
CL Item
Metastasis In 4 To 9 Axillary Lymph Nodes, Or In Clinically Apparent ** Internal Mammary Lymph Nodes In The Absence Of Axillary Lymph Node Metastasis To Ipsilateral Axillary Lymph Node(s) Fixed To Each Other Or To Other Structures (pN2)
CL Item
Metastasis In 4 To 9 Axillary Lymph Nodes (at Least 1 Tumor Deposit >2.0 Mm) (pN2a)
CL Item
Metastasis In Clinically Apparent* Internal Mammary Lymph Nodes In The Absence Of Axillary Lymph Node Metastasis (pN2b)
CL Item
Metastasis In >= Axillary Lymph Nodes, Or In Infraclavicular Lymph Nodes, Or In Clinically Apparent* Ipsilateral Internal Mammary Lymph Node(s) In The Presence Of 1 Or More Positive Axillary Lymph Node(s); Or, In >3 Axillary Lymph Nodes With Clinically N (pN3)
CL Item
Metastasis In >=10 Axillary Lymph Nodes (at Least 1 Tumor Deposit >2.0 Mm); Or, Metastasis To The Infraclavicular Lymph Nodes (pN3a)
CL Item
Metastasis In Clinically Apparent* Ipsilateral Internal Mammary Lymph Nodes In The Presence Of >=1 Positive Axillary Lymph Node(s); Or, In >3 Axillary Lymph Nodes And In Internal Mammary Lymph Nodes With Microscopic Disease Detected By Sentinel Lymph Node (pN3b)
CL Item
Metastasis In Ipsilateral Supraclavicular Lymph Nodes (pN3c)
CL Item
Regional Lymph Nodes Cannot Be Assessed (e.g., Not Removed For Pathologic Study Or Previously Removed) (pNX)
Item
Pathologic M Stage
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
C25610 (NCI Thesaurus Property)
C1521733 (UMLS 2011AA Property)
C25727 (NCI Thesaurus Property-2)
C0456533 (UMLS 2011AA Property-2)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
Code List
Pathologic M Stage
CL Item
No Distant Metastasis (M0)
CL Item
Distant Metastasis (M1)
C18206 (NCI Thesaurus)
C1269798 (UMLS 2011AA)
CL Item
Distant Metastasis Cannot Be Assessed (MX)
SentinelNodeBiopsyInd-3
Item
Was sentinel node sampling performed
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15189 (NCI Thesaurus Property)
C0005558 (UMLS 2011AA Property)
C12947 (NCI Thesaurus ObjectClass)
C1522495 (UMLS 2011AA ObjectClass)
SentinelNodeBiopsyDate
Item
Sentinel Node Biopsy Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C15189 (NCI Thesaurus Property)
C0005558 (UMLS 2011AA Property)
C12947 (NCI Thesaurus ObjectClass)
C1522495 (UMLS 2011AA ObjectClass)
SentinelNodeExaminedCount
Item
Number of Sentinel Nodes Examined
float
C25500 (NCI Thesaurus Property)
C0332128 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C12947 (NCI Thesaurus ObjectClass)
C1522495 (UMLS 2011AA ObjectClass)
SentinelNodePositiveAssessmentCount
Item
Number of Positive Sentinel Nodes
float
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C0205159 (NCI Metathesaurus Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C12947 (NCI Thesaurus ObjectClass)
C1522495 (UMLS 2011AA ObjectClass)
AxillaryNodeDissectionInd-3
Item
Was axillary dissection performed?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15227 (NCI Thesaurus Property)
C0012737 (UMLS 2011AA Property)
C12904 (NCI Thesaurus ObjectClass)
C0729594 (UMLS 2011AA ObjectClass)
AxillaryLymphNodeCoreBiopsyFine-NeedleAspirationLymphNodeBiopsyPriorClinicalStudyPerformedDate
Item
Date of Axillary Node Biopsy
date
C15680 (NCI Thesaurus ObjectClass)
C1318309 (UMLS 2011AA ObjectClass)
C15361 (NCI Thesaurus ObjectClass-2)
C1510483 (UMLS 2011AA ObjectClass-2)
C51900 (NCI Thesaurus ObjectClass-3)
C0193842 (UMLS 2011AA ObjectClass-3)
C12904 (NCI Thesaurus ObjectClass-4)
C0729594 (UMLS 2011AA ObjectClass-4)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C15206 (NCI Thesaurus Property-3)
C0008972 (UMLS 2011AA Property-3)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
AxillaryNodeExaminedTotalCount
Item
Number of axillary nodes examined
float
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25500 (NCI Thesaurus Property)
C0332128 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain-2)
C0750480 (UMLS 2011AA ValueDomain-2)
C12904 (NCI Thesaurus ObjectClass)
C0729594 (UMLS 2011AA ObjectClass)
PositiveAxillaryNodeExaminedTotalCount
Item
Number of positive axillary nodes
float
C25246 (NCI Thesaurus ObjectClass)
C1446409 (UMLS 2011AA ObjectClass)
C12904 (NCI Thesaurus ObjectClass-2)
C0729594 (UMLS 2011AA ObjectClass-2)
C25500 (NCI Thesaurus Property)
C0332128 (UMLS 2011AA Property)
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25463 (NCI Thesaurus ValueDomain-2)
C0750480 (UMLS 2011AA ValueDomain-2)
LymphNodeExaminedCount
Item
Number of Lymph Nodes Examined
float
C25500 (NCI Thesaurus Property)
C0332128 (UMLS 2011AA Property)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
LymphNodePositiveCount
Item
Number of Positive Lymph Nodes
float
C25246 (NCI Thesaurus Property)
C1446409 (UMLS 2011AA Property)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
Item Group
Baseline Adverse Events - Question
SymptomorAdverseEventOccurrenceInd
Item
Did the participant report any symptoms or adverse events?
boolean
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
CL209504 (NCI Metathesaurus Property)
Item Group
Baseline Advers Events
AdverseEventCommonTerminologyforAdverseEventsVersion4TermName
Item
CTCAE Term
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C49704 (NCI Thesaurus Property)
C1516728 (UMLS 2011AA Property)
C45559 (NCI Thesaurus Property-2)
C1705313 (UMLS 2011AA Property-2)
C45255 (NCI Thesaurus ValueDomain)
C1708523 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ValueDomain-2)
C1516728 (UMLS 2011AA ValueDomain-2)
C42614 (NCI Thesaurus ValueDomain-3)
C0027365 (UMLS 2011AA ValueDomain-3)
C45559 (NCI Thesaurus ValueDomain-4)
C1705313 (UMLS 2011AA ValueDomain-4)
C25714 (NCI Thesaurus ValueDomain-5)
C0333052 (UMLS 2011AA ValueDomain-5)
CommonToxicityCriteriaAdverseEventReportingGrade
Item
Grade
float
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C25651 (NCI Thesaurus Property)
C0700287 (UMLS 2011AA Property)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property-2)
C0678257 (UMLS 2011AA Property-2)
AdverseEventContinueIndicator
Item
AE Ongoing
boolean
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C53279 (NCI Thesaurus Property)
C0549178 (UMLS 2011AA Property)
Item Group
Cardiovascular History - Question
CardiovascularDiseasePresentInd-2
Item
Has the patient suffered cardiovascular disease?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C25292 (NCI Thesaurus ObjectClass)
C0007226 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus ObjectClass-2)
C0012634 (UMLS 2011AA ObjectClass-2)
Item Group
Cardiovascular History
Item
Problem, cardiovascular
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C13306 (NCI Thesaurus ObjectClass)
C1522601 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus ObjectClass-2)
C0012634 (UMLS 2011AA ObjectClass-2)
Code List
Problem, cardiovascular
CL Item
Myocardial Infarction (Myocardial Infarction)
C27996 (NCI Thesaurus)
C0027051 (UMLS 2011AA)
CL Item
Transient Ischemic Attack Cerebrovascular Accident (Stroke / transient inschemic attack TIA)
C50781 (NCI Thesaurus)
C0007787 (UMLS 2011AA)
C3390 (NCI Thesaurus-3)
C0038454 (UMLS 2011AA-4)
CL Item
New Or Worsening Angina (New or worsening angina)
CL Item
Angina Requiring Transluminal Coronary Angioplasty (Angina requiring transluminal coronary angioplasty)
CL Item
Angina Requiring Coronary Artery Bypass Graft (Angina requiring coronary artery bypass graft)
CL Item
Thromboembolism (Thromboembolic Event)
C28195 (NCI Thesaurus)
C0040038 (UMLS 2011AA)
CL Item
Other (Other)
CardiacDiseaseAssessmentSpecify
Item
Specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C13306 (NCI Thesaurus ObjectClass)
C1522601 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus ObjectClass-2)
C0012634 (UMLS 2011AA ObjectClass-2)
Item Group
Baseline Concomitant Medications
ConcomitantMedicationUseInd-3
Item
Did the participant report taking any concomitant medication
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C25730 (NCI Thesaurus ObjectClass-2)
C0521115 (UMLS 2011AA ObjectClass-2)
C25340 (NCI Thesaurus Property)
C0457083 (UMLS 2011AA Property)
Concomitant Medication
Item
Concomitant Medication
text
C25704 (NCI Thesaurus ValueDomain)
C2347852 (UMLS CUI-1)
C459 (NCI Thesaurus ObjectClass)
C25639 (NCI Thesaurus Property)
C25730 (NCI Thesaurus ObjectClass-2)
Concomitant Medication Use Indication
Item
Reason for Administration
text
C459 (NCI Thesaurus ObjectClass)
C2826696 (UMLS CUI-1)
C25730 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property)
C25704 (NCI Thesaurus ValueDomain)
C25638 (NCI Thesaurus ValueDomain-2)
Medication continued
Item
Is this medication continuing?
boolean
C38147 (NCI Thesaurus ValueDomain)
C0013227 (UMLS CUI-1)
C459 (NCI Thesaurus ObjectClass)
C0549178 (UMLS CUI-2)
C25409 (NCI Thesaurus Property)
C0750536 (NCI Metathesaurus Property)
Item Group
Adjuvant Radiation Therapy
AdjuvantRadiationTherapyAdministeredInd-3
Item
Has the patient received adjuvant RT
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C2140 (NCI Thesaurus ObjectClass-2)
C0001552 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
AdjuvantRadiationTherapyBeginDate
Item
Date Adjuvant Radiation Therapy Started
date
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C2140 (NCI Thesaurus ObjectClass-2)
C0001552 (UMLS 2011AA ObjectClass-2)
C25431 (NCI Thesaurus Property)
C0439659 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property-2)
C2745955 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)
AdjuvantRadiationTherapyEndDate
Item
Date Adjuvant Radiation Therapy Ended
date
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C2140 (NCI Thesaurus ObjectClass-2)
C0001552 (UMLS 2011AA 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)
Radiation Therapy Total Dose
Item
Total Dose of Radiation Therapy (cGy)
float
C25304 (NCI Thesaurus ValueDomain)
C2169193 (UMLS CUI-1)
C15313 (NCI Thesaurus ObjectClass)
C25488 (NCI Thesaurus ValueDomain-2)
C25382 (NCI Thesaurus Property)
Item Group
Systemic Therapy
Item
Has the patient received systemic therapy?
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15698 (NCI Thesaurus ObjectClass)
C1515119 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Code List
Has the patient received systemic therapy?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Agent
Item
Agent Name
text
C25364 (NCI Thesaurus Property)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
Non-protocolTherapyAdministeredBeginDate
Item
Non-protocol Therapy Start Date
date
C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)
Non-ProtocolTherapyContinueInd-2
Item
Continuing
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass)
C54064 (NCI Thesaurus Property)
Non-protocolTherapyAdministeredEndDate
Item
Non-protocol Therapy End Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Item
Therapy Intent
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C15697 (NCI Thesaurus Property)
C0040808 (UMLS 2011AA Property)
Code List
Therapy Intent
CL Item
Adjuvant (Adjuvant)
C25722 (NCI Thesaurus)
C1522673 (UMLS 2011AA)
CL Item
Neoadjuvant Therapy (Neoadjuvant)
C15665 (NCI Thesaurus)
C0600558 (UMLS 2011AA)
CL Item
Advanced/recurrent/metastatic Disease (Advanced/recurrent/metastatic disease)
CL Item
Other Specify (Other)
TherapyRegimenSpecify
Item
Specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C15697 (NCI Thesaurus Property)
C0040808 (UMLS 2011AA Property)
Item Group
Major Medical Problems At Baseline
PatientHistoryText
Item
Concomitant Diseases and/or Relevant Medical Conditions
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
PatientMedicalHistoryBaselineProblemInd-2
Item
Ongoing
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C18772 (NCI Thesaurus ObjectClass-2)
C0262926 (UMLS 2011AA ObjectClass-2)
C25213 (NCI Thesaurus Property)
C1442488 (UMLS 2011AA Property)
C28020 (NCI Thesaurus Property-2)
C0033213 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientMedicalHistoryBaselineProblemInd-2
Item
Ongoing
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C18772 (NCI Thesaurus ObjectClass-2)
C0262926 (UMLS 2011AA ObjectClass-2)
C25213 (NCI Thesaurus Property)
C1442488 (UMLS 2011AA Property)
C28020 (NCI Thesaurus Property-2)
C0033213 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item Group
Other Clinical Trial Participation
PatientBreastMalignantNeoplasmOtherClinicalTrialParticipantInd-2
Item
Is the subject participating in another clinical trial of Breast Cancer treatment
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C12971 (NCI Thesaurus Property-2)
C0006141 (UMLS 2011AA Property-2)
C9305 (NCI Thesaurus Property-3)
C0006826 (UMLS 2011AA Property-3)
C29867 (NCI Thesaurus Property-4)
C0679646 (UMLS 2011AA Property-4)
C71104 (NCI Thesaurus Property-5)
C0008976 (UMLS 2011AA Property-5)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
ClinicalTrialProtocolIdentifier64CharacterText
Item
Clinical Trial Protocol ID
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C45253 (NCI Thesaurus ValueDomain-2)
C1547402 (UMLS 2011AA ValueDomain-2)
ClinicalTrialSponsorName64CharacterText
Item
Clinical Trial Sponsor Name
text
C48355 (NCI Thesaurus ObjectClass)
C1711305 (UMLS 2011AA ObjectClass)
C71104 (NCI Thesaurus ObjectClass-2)
C0008976 (UMLS 2011AA ObjectClass-2)
C42614 (NCI Thesaurus Property)
C0027365 (UMLS 2011AA Property)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C45253 (NCI Thesaurus ValueDomain-2)
C1547402 (UMLS 2011AA ValueDomain-2)
PatientEnrollmentDate
Item
Patient Entry Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)

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