ID

6225

Description

E2108 Optimal Systemic Therapy Summary Form Early Surgery or Standard Palliative Therapy in Treating Patients With Stage IV Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=91E1D8B2-2FF5-DD0A-E040-BB89AD434391

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=91E1D8B2-2FF5-DD0A-E040-BB89AD434391

Keywords

  1. 12/18/14 12/18/14 - Martin Dugas
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 6/16/15 6/16/15 -
Uploaded on

December 18, 2014

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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Breast Cancer NCT01242800 Follow-Up - E2108 Optimal Systemic Therapy Summary Form - 3146006v1.0

INSTRUCTIONS: After patient is off treatment, complete this form for each required follow-up report period (see forms submission schedule).

Unnamed1
Description

Unnamed1

ECOG Protocol Number
Description

ProtocolECOGIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C25491
UMLS 2011AA Property
C1512162
ECOG Patient ID
Description

PatientECOGIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C25491
UMLS 2011AA Property
C1512162
DCI Name
Description

CollectedDataFormName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus Property
C19464
UMLS 2011AA Property
C0376315
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus ObjectClass
C25452
Registration Step
Description

RegistrationStepNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25646
UMLS 2011AA ObjectClass
C1514821
NCI Thesaurus Property
C16154
UMLS 2011AA Property
C1704379
NCI Thesaurus ValueDomain
C16154
UMLS 2011AA ValueDomain
C1704379
Unnamed3
Description

Unnamed3

Reporting Period
Description

ReportingEvaluationPeriodType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C25214
UMLS 2011AA ObjectClass
C0220825
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus ObjectClass
C25651
UMLS 2011AA ObjectClass
C0700287
Unnamed2
Description

Unnamed2

Patient Initials (Last, First)
Description

PatientInitialsName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
ECOG Protocol Number
Description

ProtocolECOGIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C25491
UMLS 2011AA Property
C1512162
ECOG Patient ID
Description

PatientECOGIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C25491
UMLS 2011AA Property
C1512162
Participating Group Protocol Number
Description

ProtocolParticipatingIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C25608
UMLS 2011AA Property
C0679823
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Institution/Affiliate
Description

CombinedInstitutionName

Data type

text

Alias
NCI Thesaurus ObjectClass
C25454
UMLS 2011AA ObjectClass
C0205195
NCI Thesaurus ObjectClass
C21541
UMLS 2011AA ObjectClass
C0018704
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ValueDomain
C21541
UMLS 2011AA ValueDomain
C0018704
Participating Group Patient ID
Description

PatientParticipatingIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25608
UMLS 2011AA Property
C0679823
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Unnamed Module 3a
Description

Unnamed Module 3a

Please mark an 'X' if data have been amended. (Please circle amended items in red)
Description

DataAmendedText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C25416
UMLS 2011AA Property
C1691222
Date data amended (M D Y)
Description

DataAmendedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C25416
UMLS 2011AA Property
C1691222
NCI Thesaurus ValueDomain
C25367
Arm A And Arm B
Description

Arm A And Arm B

Date Systemic Therapy Began
Description

SystemicTherapyAdministeredBeginDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C15698
UMLS 2011AA ObjectClass
C1515119
NCI Thesaurus ValueDomain
C25431
UMLS 2011AA ValueDomain
C0439659
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Date Systemic Therapy Ended
Description

SystemicTherapyAdministeredEndDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C15698
UMLS 2011AA ObjectClass
C1515119
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C25496
UMLS 2011AA ValueDomain
C2746065
Vital Status
Description

Vital Status

Patient's Vital Status
Description

PatientVitalStatus

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ValueDomain
C18003
UMLS 2011AA ValueDomain
C0442732
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
NCI Thesaurus Property
C25717
UMLS 2011AA Property
C1148433
Date of Last Contact or Death
Description

PatientLastContactDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25461
UMLS 2011AA Property
C0337611
NCI Thesaurus Property
C25551
UMLS 2011AA Property
C1517741
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
Primary Cause of Death (if applicable)
Description

PatientDeathPrimaryReason

Data type

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C28554
UMLS 2011AA Property
C0011065
NCI Thesaurus ValueDomain
C25251
UMLS 2011AA ValueDomain
C0205225
Describe cause of death
Description

PatientDeathSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C28554
UMLS 2011AA Property
C0011065
Therapy Administered - Chemotherapy
Description

Therapy Administered - Chemotherapy

Has the patient received any chemotherapy during this reporting period? (as part of optimal systemic therapy)
Description

ChemotherapyAdministeredInd

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Chemotherapy Course 1
Description

ChemotherapyFirstCycleAgentName

Data type

text

Alias
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus Property
C25472
UMLS 2011AA Property
C1511572
NCI Thesaurus Property
C25509
UMLS 2011AA Property
C1279901
NCI Thesaurus Property
C1708
UMLS 2011AA Property
C0450442
NCI Thesaurus ValueDomain
C42614
UMLS 2011AA ValueDomain
C0027365
Chemotherapy Course 2
Description

ChemotherapySecondCycleAgentName

Data type

text

Alias
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus Property
C25472
UMLS 2011AA Property
C1511572
NCI Thesaurus Property
C25666
UMLS 2011AA Property
C0205436
NCI Thesaurus Property
C1708
UMLS 2011AA Property
C0450442
NCI Thesaurus ValueDomain
C42614
UMLS 2011AA ValueDomain
C0027365
Chemotherapy Course 3
Description

ChemotherapyThirdCycleAgentName

Data type

text

Alias
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus Property
C25472
UMLS 2011AA Property
C1511572
NCI Thesaurus Property
C1708
UMLS 2011AA Property
C0450442
NCI Thesaurus Property
C25260
UMLS 2011AA Property
C0205437
NCI Thesaurus ValueDomain
C42614
UMLS 2011AA ValueDomain
C0027365
Specify
Description

ChemotherapyAgentSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus ValueDomain
C15368
NCI Thesaurus Property
C1708
UMLS 2011AA Property
C0450442
Therapy Administered - Hormone Therapy
Description

Therapy Administered - Hormone Therapy

Has the patient received any hormone therapy during this reporting period? (as part of optimal systemic therapy)
Description

HormoneTherapyReportPeriodAdministeredInd-3

Data type

text

Alias
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property
C25375
UMLS 2011AA Property
C0684224
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Hormone Therapy Course 1
Description

EndocrineTherapyFirstCycleAgentName

Data type

text

Alias
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property
C25472
UMLS 2011AA Property
C1511572
NCI Thesaurus Property
C25509
UMLS 2011AA Property
C1279901
NCI Thesaurus Property
C1708
UMLS 2011AA Property
C0450442
NCI Thesaurus ValueDomain
C42614
UMLS 2011AA ValueDomain
C0027365
Hormone Therapy Course 2
Description

EndocrineTherapySecondCycleAgentName

Data type

text

Alias
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property
C25472
UMLS 2011AA Property
C1511572
NCI Thesaurus Property
C25666
UMLS 2011AA Property
C0205436
NCI Thesaurus Property
C1708
UMLS 2011AA Property
C0450442
NCI Thesaurus ValueDomain
C42614
UMLS 2011AA ValueDomain
C0027365
Hormone Therapy Course 3
Description

EndocrineTherapyThirdCycleAgentName

Data type

text

Alias
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property
C25472
UMLS 2011AA Property
C1511572
NCI Thesaurus Property
C1708
UMLS 2011AA Property
C0450442
NCI Thesaurus Property
C25260
UMLS 2011AA Property
C0205437
NCI Thesaurus ValueDomain
C42614
UMLS 2011AA ValueDomain
C0027365
Specify
Description

EndocrineTherapyAgentSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus ValueDomain
C15368
NCI Thesaurus Property
C1708
UMLS 2011AA Property
C0450442
Therapy Administered - New Progression
Description

Therapy Administered - New Progression

Has the patient been diagnosed with a new progression? (while receiving systemic therapy)
Description

DiseaseNewProgressionInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25586
UMLS 2011AA Property
C0205314
NCI Thesaurus Property
C25331
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
Basis for Progressive Disease
Description

DiseaseorDisorderNewDiseaseProgressionDiagnosisType

Data type

text

Alias
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property
C25586
UMLS 2011AA Property
C0205314
NCI Thesaurus Property
C17747
UMLS 2011AA Property
C0242656
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Date of Progression
Description

DiseaseProgressionDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus Property
C25331
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
Comments
Description

Comments

Investigator Signature
Description

InvestigatorSignatureText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus Property
C25678
UMLS 2011AA Property
C1519316
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173
Investigator Signature Date
Description

InvestigatorSignatureDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25678
UMLS 2011AA Property
C1519316
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173

Similar models

INSTRUCTIONS: After patient is off treatment, complete this form for each required follow-up report period (see forms submission schedule).

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Unnamed1
ProtocolECOGIdentifierNumber
Item
ECOG Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25491 (NCI Thesaurus Property)
C1512162 (UMLS 2011AA Property)
PatientECOGIdentifierNumber
Item
ECOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25491 (NCI Thesaurus Property)
C1512162 (UMLS 2011AA Property)
CollectedDataFormName
Item
DCI Name
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C19464 (NCI Thesaurus Property)
C0376315 (UMLS 2011AA Property)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25452 (NCI Thesaurus ObjectClass)
RegistrationStepNumber
Item
Registration Step
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25646 (NCI Thesaurus ObjectClass)
C1514821 (UMLS 2011AA ObjectClass)
C16154 (NCI Thesaurus Property)
C1704379 (UMLS 2011AA Property)
C16154 (NCI Thesaurus ValueDomain)
C1704379 (UMLS 2011AA ValueDomain)
Item Group
Unnamed3
Item
Reporting Period
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus ObjectClass)
C0220825 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25651 (NCI Thesaurus ObjectClass)
C0700287 (UMLS 2011AA ObjectClass)
Code List
Reporting Period
CL Item
End Of Treatment - Step 1 (End of Treatment - Step 1)
Item Group
Unnamed2
PatientInitialsName
Item
Patient Initials (Last, First)
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
ProtocolECOGIdentifierNumber
Item
ECOG Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25491 (NCI Thesaurus Property)
C1512162 (UMLS 2011AA Property)
PatientECOGIdentifierNumber
Item
ECOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25491 (NCI Thesaurus Property)
C1512162 (UMLS 2011AA Property)
ProtocolParticipatingIdentifierNumber
Item
Participating Group Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
CombinedInstitutionName
Item
Institution/Affiliate
text
C25454 (NCI Thesaurus ObjectClass)
C0205195 (UMLS 2011AA ObjectClass)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ValueDomain)
C0018704 (UMLS 2011AA ValueDomain)
PatientParticipatingIdentifierNumber
Item
Participating Group Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
Item Group
Unnamed Module 3a
DataAmendedText
Item
Please mark an 'X' if data have been amended. (Please circle amended items in red)
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
DataAmendedDate
Item
Date data amended (M D Y)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain)
Item Group
Arm A And Arm B
SystemicTherapyAdministeredBeginDate
Item
Date Systemic Therapy Began
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15698 (NCI Thesaurus ObjectClass)
C1515119 (UMLS 2011AA ObjectClass)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
SystemicTherapyAdministeredEndDate
Item
Date Systemic Therapy Ended
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15698 (NCI Thesaurus ObjectClass)
C1515119 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25496 (NCI Thesaurus ValueDomain)
C2746065 (UMLS 2011AA ValueDomain)
Item Group
Vital Status
Item
Patient's Vital Status
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C18003 (NCI Thesaurus ValueDomain)
C0442732 (UMLS 2011AA ValueDomain)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
C25717 (NCI Thesaurus Property)
C1148433 (UMLS 2011AA Property)
Code List
Patient's Vital Status
CL Item
Alive (Alive)
CL Item
Dead (Dead)
PatientLastContactDate
Item
Date of Last Contact or Death
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25461 (NCI Thesaurus Property)
C0337611 (UMLS 2011AA Property)
C25551 (NCI Thesaurus Property)
C1517741 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
Item
Primary Cause of Death (if applicable)
text
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C28554 (NCI Thesaurus Property)
C0011065 (UMLS 2011AA Property)
C25251 (NCI Thesaurus ValueDomain)
C0205225 (UMLS 2011AA ValueDomain)
Code List
Primary Cause of Death (if applicable)
CL Item
Due To Protocol Treatment (Due to protocol treatment)
CL Item
Due To This Disease (Due to this disease)
CL Item
Due To Other Cause (Due to other cause)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
PatientDeathSpecify
Item
Describe cause of death
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C28554 (NCI Thesaurus Property)
C0011065 (UMLS 2011AA Property)
Item Group
Therapy Administered - Chemotherapy
Item
Has the patient received any chemotherapy during this reporting period? (as part of optimal systemic therapy)
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Code List
Has the patient received any chemotherapy during this reporting period? (as part of optimal systemic therapy)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Not Applicable (Not Applicable)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
CL Item
Yes, Chemotherapy Completed (Yes, chemotherapy completed)
CL Item
Yes, Chemotherapy Continuing (Yes, chemotherapy continuing)
Item
Chemotherapy Course 1
text
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25472 (NCI Thesaurus Property)
C1511572 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C1708 (NCI Thesaurus Property)
C0450442 (UMLS 2011AA Property)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)
Code List
Chemotherapy Course 1
CL Item
Albumin-bound Paclitaxel (Albumin-bound paclitaxel)
CL Item
Bevacizumab (Bevacizumab)
C2039 (NCI Thesaurus)
C0796392 (UMLS 2011AA)
CL Item
Capecitabine (Capecitabine)
C1794 (NCI Thesaurus)
C0671970 (UMLS 2011AA)
CL Item
Carboplatin (Carboplatin)
C1282 (NCI Thesaurus)
C0079083 (UMLS 2011AA)
CL Item
Cisplatin (Cisplatin)
C376 (NCI Thesaurus)
C0008838 (UMLS 2011AA)
CL Item
Cyclophosphamide (Cyclophosphamide)
C405 (NCI Thesaurus)
C0010583 (UMLS 2011AA)
CL Item
Docetaxel (Docetaxel)
C1526 (NCI Thesaurus)
C0246415 (UMLS 2011AA)
CL Item
Doxorubicin (Doxorubicin)
C456 (NCI Thesaurus)
C0013089 (UMLS 2011AA)
CL Item
Epirubicin (Epirubicin)
C62028 (NCI Thesaurus)
C0014582 (UMLS 2011AA)
CL Item
Fluorouracil (Fluorouracil Cl)
C505 (NCI Thesaurus)
C0016360 (UMLS 2011AA)
CL Item
Gemcitabine (Gemcitabine)
C66876 (NCI Thesaurus)
C0045093 (UMLS 2011AA)
CL Item
Ixabepilone (Ixabepilone)
C37452 (NCI Thesaurus)
C0879430 (UMLS 2011AA)
CL Item
Lapatinib (Lapatinib)
C26653 (NCI Thesaurus)
C1173538 (UMLS 2011AA)
CL Item
Methotrexate (Methotrexate)
C642 (NCI Thesaurus)
C0025677 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Paclitaxel (Paclitaxel)
C1411 (NCI Thesaurus)
C0144576 (UMLS 2011AA)
CL Item
Pegylated Liposomal Doxorubicin (Pegylated liposomal doxorubicin)
CL Item
Trastuzumab (Trastuzumab)
C1647 (NCI Thesaurus)
C0338204 (UMLS 2011AA)
CL Item
Vinorelbine (Vinorelbine)
C1275 (NCI Thesaurus)
C0078257 (UMLS 2011AA)
Item
Chemotherapy Course 2
text
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25472 (NCI Thesaurus Property)
C1511572 (UMLS 2011AA Property)
C25666 (NCI Thesaurus Property)
C0205436 (UMLS 2011AA Property)
C1708 (NCI Thesaurus Property)
C0450442 (UMLS 2011AA Property)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)
Code List
Chemotherapy Course 2
CL Item
Albumin-bound Paclitaxel (Albumin-bound paclitaxel)
CL Item
Bevacizumab (Bevacizumab)
C2039 (NCI Thesaurus)
C0796392 (UMLS 2011AA)
CL Item
Capecitabine (Capecitabine)
C1794 (NCI Thesaurus)
C0671970 (UMLS 2011AA)
CL Item
Carboplatin (Carboplatin)
C1282 (NCI Thesaurus)
C0079083 (UMLS 2011AA)
CL Item
Cisplatin (Cisplatin)
C376 (NCI Thesaurus)
C0008838 (UMLS 2011AA)
CL Item
Cyclophosphamide (Cyclophosphamide)
C405 (NCI Thesaurus)
C0010583 (UMLS 2011AA)
CL Item
Docetaxel (Docetaxel)
C1526 (NCI Thesaurus)
C0246415 (UMLS 2011AA)
CL Item
Doxorubicin (Doxorubicin)
C456 (NCI Thesaurus)
C0013089 (UMLS 2011AA)
CL Item
Epirubicin (Epirubicin)
C62028 (NCI Thesaurus)
C0014582 (UMLS 2011AA)
CL Item
Fluorouracil (Fluorouracil Cl)
C505 (NCI Thesaurus)
C0016360 (UMLS 2011AA)
CL Item
Gemcitabine (Gemcitabine)
C66876 (NCI Thesaurus)
C0045093 (UMLS 2011AA)
CL Item
Ixabepilone (Ixabepilone)
C37452 (NCI Thesaurus)
C0879430 (UMLS 2011AA)
CL Item
Lapatinib (Lapatinib)
C26653 (NCI Thesaurus)
C1173538 (UMLS 2011AA)
CL Item
Methotrexate (Methotrexate)
C642 (NCI Thesaurus)
C0025677 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Paclitaxel (Paclitaxel)
C1411 (NCI Thesaurus)
C0144576 (UMLS 2011AA)
CL Item
Pegylated Liposomal Doxorubicin (Pegylated liposomal doxorubicin)
CL Item
Trastuzumab (Trastuzumab)
C1647 (NCI Thesaurus)
C0338204 (UMLS 2011AA)
CL Item
Vinorelbine (Vinorelbine)
C1275 (NCI Thesaurus)
C0078257 (UMLS 2011AA)
Item
Chemotherapy Course 3
text
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25472 (NCI Thesaurus Property)
C1511572 (UMLS 2011AA Property)
C1708 (NCI Thesaurus Property)
C0450442 (UMLS 2011AA Property)
C25260 (NCI Thesaurus Property)
C0205437 (UMLS 2011AA Property)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)
Code List
Chemotherapy Course 3
CL Item
Albumin-bound Paclitaxel (Albumin-bound paclitaxel)
CL Item
Bevacizumab (Bevacizumab)
C2039 (NCI Thesaurus)
C0796392 (UMLS 2011AA)
CL Item
Capecitabine (Capecitabine)
C1794 (NCI Thesaurus)
C0671970 (UMLS 2011AA)
CL Item
Carboplatin (Carboplatin)
C1282 (NCI Thesaurus)
C0079083 (UMLS 2011AA)
CL Item
Cisplatin (Cisplatin)
C376 (NCI Thesaurus)
C0008838 (UMLS 2011AA)
CL Item
Cyclophosphamide (Cyclophosphamide)
C405 (NCI Thesaurus)
C0010583 (UMLS 2011AA)
CL Item
Docetaxel (Docetaxel)
C1526 (NCI Thesaurus)
C0246415 (UMLS 2011AA)
CL Item
Doxorubicin (Doxorubicin)
C456 (NCI Thesaurus)
C0013089 (UMLS 2011AA)
CL Item
Epirubicin (Epirubicin)
C62028 (NCI Thesaurus)
C0014582 (UMLS 2011AA)
CL Item
Fluorouracil (Fluorouracil Cl)
C505 (NCI Thesaurus)
C0016360 (UMLS 2011AA)
CL Item
Gemcitabine (Gemcitabine)
C66876 (NCI Thesaurus)
C0045093 (UMLS 2011AA)
CL Item
Ixabepilone (Ixabepilone)
C37452 (NCI Thesaurus)
C0879430 (UMLS 2011AA)
CL Item
Lapatinib (Lapatinib)
C26653 (NCI Thesaurus)
C1173538 (UMLS 2011AA)
CL Item
Methotrexate (Methotrexate)
C642 (NCI Thesaurus)
C0025677 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Paclitaxel (Paclitaxel)
C1411 (NCI Thesaurus)
C0144576 (UMLS 2011AA)
CL Item
Pegylated Liposomal Doxorubicin (Pegylated liposomal doxorubicin)
CL Item
Trastuzumab (Trastuzumab)
C1647 (NCI Thesaurus)
C0338204 (UMLS 2011AA)
CL Item
Vinorelbine (Vinorelbine)
C1275 (NCI Thesaurus)
C0078257 (UMLS 2011AA)
ChemotherapyAgentSpecify
Item
Specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ValueDomain)
C1708 (NCI Thesaurus Property)
C0450442 (UMLS 2011AA Property)
Item Group
Therapy Administered - Hormone Therapy
Item
Has the patient received any hormone therapy during this reporting period? (as part of optimal systemic therapy)
text
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25375 (NCI Thesaurus Property)
C0684224 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
Code List
Has the patient received any hormone therapy during this reporting period? (as part of optimal systemic therapy)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Hormone Therapy Course 1
text
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25472 (NCI Thesaurus Property)
C1511572 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C1708 (NCI Thesaurus Property)
C0450442 (UMLS 2011AA Property)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)
Code List
Hormone Therapy Course 1
CL Item
Anastrozole (Anastrozole)
C1607 (NCI Thesaurus)
C0290882 (UMLS 2011AA)
CL Item
Aromatase Inhibitor - Anastrazole (arimidex) (Aromatase Inhibitor - Anastrazole (Arimidex))
CL Item
Aromatase Inhibitor - Exemestane (aromasin) (Aromatase Inhibitor - Exemestane (Aromasin))
CL Item
Aromatase Inhibitor - Letrozole (femara) (Aromatase Inhibitor - Letrozole (Femara))
CL Item
Ethinyl Estradiol (Ethinyl Estradiol)
C486 (NCI Thesaurus)
C0015011 (UMLS 2011AA)
CL Item
Exemestane (Exemestane)
C1097 (NCI Thesaurus)
C0060116 (UMLS 2011AA)
CL Item
Fluoxymesterone (Fluoxymesterone)
C507 (NCI Thesaurus)
C0016366 (UMLS 2011AA)
CL Item
Fulvestrant (Fulvestrant)
C1379 (NCI Thesaurus)
C0701491 (UMLS 2011AA)
CL Item
Letrozole (Letrozole)
C1527 (NCI Thesaurus)
C0246421 (UMLS 2011AA)
CL Item
Megestrol Acetate (Megestrol Acetate)
C1156 (NCI Thesaurus)
C0065879 (UMLS 2011AA)
CL Item
Other (Other)
CL Item
Ovarian Function Suppression (ofs) - Medical Suppression (Ovarian Function Suppression (OFS) - Medical suppression)
CL Item
Ovarian Function Suppression (ofs) - Oophorectomy (Ovarian Function Suppression (OFS) - Oophorectomy)
CL Item
Ovarian Function Suppression (ofs) - Ovarian Radiation (Ovarian Function Suppression (OFS) - Ovarian radiation)
CL Item
Tamoxifen (Tamoxifen)
C855 (NCI Thesaurus)
C0039286 (UMLS 2011AA)
CL Item
Toremifene (Toremifene)
C1256 (NCI Thesaurus)
C0076836 (UMLS 2011AA)
Item
Hormone Therapy Course 2
text
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25472 (NCI Thesaurus Property)
C1511572 (UMLS 2011AA Property)
C25666 (NCI Thesaurus Property)
C0205436 (UMLS 2011AA Property)
C1708 (NCI Thesaurus Property)
C0450442 (UMLS 2011AA Property)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)
Code List
Hormone Therapy Course 2
CL Item
Anastrozole (Anastrozole)
C1607 (NCI Thesaurus)
C0290882 (UMLS 2011AA)
CL Item
Aromatase Inhibitor - Anastrazole (arimidex) (Aromatase Inhibitor - Anastrazole (Arimidex))
CL Item
Aromatase Inhibitor - Exemestane (aromasin) (Aromatase Inhibitor - Exemestane (Aromasin))
CL Item
Aromatase Inhibitor - Letrozole (femara) (Aromatase Inhibitor - Letrozole (Femara))
CL Item
Ethinyl Estradiol (Ethinyl Estradiol)
C486 (NCI Thesaurus)
C0015011 (UMLS 2011AA)
CL Item
Exemestane (Exemestane)
C1097 (NCI Thesaurus)
C0060116 (UMLS 2011AA)
CL Item
Fluoxymesterone (Fluoxymesterone)
C507 (NCI Thesaurus)
C0016366 (UMLS 2011AA)
CL Item
Fulvestrant (Fulvestrant)
C1379 (NCI Thesaurus)
C0701491 (UMLS 2011AA)
CL Item
Letrozole (Letrozole)
C1527 (NCI Thesaurus)
C0246421 (UMLS 2011AA)
CL Item
Megestrol Acetate (Megestrol Acetate)
C1156 (NCI Thesaurus)
C0065879 (UMLS 2011AA)
CL Item
Other (Other)
CL Item
Ovarian Function Suppression (ofs) - Medical Suppression (Ovarian Function Suppression (OFS) - Medical suppression)
CL Item
Ovarian Function Suppression (ofs) - Oophorectomy (Ovarian Function Suppression (OFS) - Oophorectomy)
CL Item
Ovarian Function Suppression (ofs) - Ovarian Radiation (Ovarian Function Suppression (OFS) - Ovarian radiation)
CL Item
Tamoxifen (Tamoxifen)
C855 (NCI Thesaurus)
C0039286 (UMLS 2011AA)
CL Item
Toremifene (Toremifene)
C1256 (NCI Thesaurus)
C0076836 (UMLS 2011AA)
Item
Hormone Therapy Course 3
text
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25472 (NCI Thesaurus Property)
C1511572 (UMLS 2011AA Property)
C1708 (NCI Thesaurus Property)
C0450442 (UMLS 2011AA Property)
C25260 (NCI Thesaurus Property)
C0205437 (UMLS 2011AA Property)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)
Code List
Hormone Therapy Course 3
CL Item
Anastrozole (Anastrozole)
C1607 (NCI Thesaurus)
C0290882 (UMLS 2011AA)
CL Item
Aromatase Inhibitor - Anastrazole (arimidex) (Aromatase Inhibitor - Anastrazole (Arimidex))
CL Item
Aromatase Inhibitor - Exemestane (aromasin) (Aromatase Inhibitor - Exemestane (Aromasin))
CL Item
Aromatase Inhibitor - Letrozole (femara) (Aromatase Inhibitor - Letrozole (Femara))
CL Item
Ethinyl Estradiol (Ethinyl Estradiol)
C486 (NCI Thesaurus)
C0015011 (UMLS 2011AA)
CL Item
Exemestane (Exemestane)
C1097 (NCI Thesaurus)
C0060116 (UMLS 2011AA)
CL Item
Fluoxymesterone (Fluoxymesterone)
C507 (NCI Thesaurus)
C0016366 (UMLS 2011AA)
CL Item
Fulvestrant (Fulvestrant)
C1379 (NCI Thesaurus)
C0701491 (UMLS 2011AA)
CL Item
Letrozole (Letrozole)
C1527 (NCI Thesaurus)
C0246421 (UMLS 2011AA)
CL Item
Megestrol Acetate (Megestrol Acetate)
C1156 (NCI Thesaurus)
C0065879 (UMLS 2011AA)
CL Item
Other (Other)
CL Item
Ovarian Function Suppression (ofs) - Medical Suppression (Ovarian Function Suppression (OFS) - Medical suppression)
CL Item
Ovarian Function Suppression (ofs) - Oophorectomy (Ovarian Function Suppression (OFS) - Oophorectomy)
CL Item
Ovarian Function Suppression (ofs) - Ovarian Radiation (Ovarian Function Suppression (OFS) - Ovarian radiation)
CL Item
Tamoxifen (Tamoxifen)
C855 (NCI Thesaurus)
C0039286 (UMLS 2011AA)
CL Item
Toremifene (Toremifene)
C1256 (NCI Thesaurus)
C0076836 (UMLS 2011AA)
EndocrineTherapyAgentSpecify
Item
Specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ValueDomain)
C1708 (NCI Thesaurus Property)
C0450442 (UMLS 2011AA Property)
Item Group
Therapy Administered - New Progression
Item
Has the patient been diagnosed with a new progression? (while receiving systemic therapy)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25586 (NCI Thesaurus Property)
C0205314 (UMLS 2011AA Property)
C25331 (NCI Thesaurus Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
Code List
Has the patient been diagnosed with a new progression? (while receiving systemic therapy)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Basis for Progressive Disease
text
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25586 (NCI Thesaurus Property)
C0205314 (UMLS 2011AA Property)
C17747 (NCI Thesaurus Property)
C0242656 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
Code List
Basis for Progressive Disease
CL Item
Enlargement Of Existing Sites By 20% Or More (Enlargement of existing sites by 20% or more)
CL Item
New Sites Of Disease (New sites of disease)
CL Item
Symptomatic Deterioration In The Presence Of Radiographic Evidence Of Disease (Symptomatic deterioration in the presence of radiographic evidence of disease)
DiseaseProgressionDate
Item
Date of Progression
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C25331 (NCI Thesaurus Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
Item Group
Comments
InvestigatorSignatureText
Item
Investigator Signature
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
InvestigatorSignatureDate
Item
Investigator Signature Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)

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