ID

43473

Description

NSABP PROTOCOL B-36: FOLLOW-UP FORM Comparison of Two Combination Chemotherapy Regimens in Treating Women With Breast Cancer NCT00087178 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=C89314D7-1DBA-74BA-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=C89314D7-1DBA-74BA-E034-0003BA12F5E7

Keywords

Versions (4)
  1. 8/26/12 8/26/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 4/13/15 4/13/15 - Martin Dugas
  4. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Breast Cancer FOLLOW-UP NSABP B-36 NCT00087178

English

No Instruction available.

1 forms  
  1. StudyEvent: NSABP PROTOCOL B-36: FOLLOW-UP FORM
    1. No Instruction available.
Header
Description

Header

Patient Initials (Last, First Middle)
Description

Patient Initials

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
NSABP Patient ID
Description

Patient ID NSABP

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1513905
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C15818
Institution Name
Description

Institution Name

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass
C21541
NCI Thesaurus ValueDomain-2
C21541
NCI Thesaurus Property
C25364
Affiliate Name
Description

Affiliate Name

Data type

text

Alias
NCI Thesaurus ObjectClass
C21541
UMLS CUI-1
C1510825
NCI Thesaurus ObjectClass-2
C25413
NCI Thesaurus Property
C25364
NCI Thesaurus ValueDomain
C25191
NCI Thesaurus ValueDomain-2
C21541
Person Completing Form (Phone)
Description

Person Completing Form

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass
C25657
NCI Thesaurus Property
C25364
Are data amended (check box if yes, and circle amended items)
Description

Data amended

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Vital Status
Description

Vital Status

Patient's Vital Status
Description

Patient's Vital Status

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus ValueDomain
C18003
NCI Thesaurus ValueDomain-2
C25688
NCI Thesaurus Property
C25365
UMLS CUI-1
C3846084
Date of Last Contact or Death (month day year)
Description

Date last contact

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0805839
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus Property
C25461
Source of Survival Information (if alive)
Description

PersonSurvivalInformationSource

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
NCI Thesaurus ValueDomain
C25683
NCI Thesaurus Property
C48191
NCI Thesaurus Property-2
C17177
UMLS CUI-1
C0807975
Other
Description

Other(specify)

Data type

text

Primary cause of Death (if dead)
Description

PatientDeathPrimaryReason

Data type

text

Alias
NCI Thesaurus ValueDomain
C25638
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C28554
NCI Thesaurus ValueDomain-2
C28554
UMLS CUI-1
C0007465
Describe Cause of Death (provide documentation)
Description

Cause of Death, specify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C0007465
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1521902
NCI Thesaurus Property
C28554
Was there evidence of recurrence at the time of death?
Description

Wasthereevidenceofrecurrenceatthetimeofdeath?

Data type

text

Alias
NCI Thesaurus Property
C28554
NCI Thesaurus ObjectClass
C38155
NCI Thesaurus Property-2
C15220
UMLS CUI-1
C0011065
UMLS CUI-2
C0277556
Cancer Follow-up Status
Description

Cancer Follow-up Status

Has the patient had a documented clinical assessment for this cancer (since submission of the last follow-up form)?
Description

Documented clinical assessment for this cancer

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C1522577
NCI Thesaurus Property
C16033
UMLS CUI-2
C0006826
NCI Thesaurus ObjectClass
C9305
NCI Thesaurus Property-2
C25365
Date of Last Clinical Assessment (if applicable)
Description

Follow-Up Date

Data type

date

Alias
NCI Thesaurus ObjectClass
C9305
UMLS CUI-1
C3694716
NCI Thesaurus Property
C16033
NCI Thesaurus Property-2
C25365
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
First Local-regional Recurrence
Description

First Local-regional Recurrence

Has the patient been diagnosed with first local-regional recurrence (since submission of the last follow-up form)?
Description

Neoplasm Recurrence, locoregional

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C19987
UMLS CUI-1
C0027643
NCI Thesaurus Property
C25388
NCI Thesaurus Property-2
C25509
NCI Thesaurus Property-3
C15220
NCI Thesaurus ValueDomain
C38148
Date of First Local-Regional Recurrence (if applicable)
Description

FirstRecurrenceLocalRegionalDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C3352
UMLS 2011AA ObjectClass
C0034897
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
Site(s) of First Local-Regional Recurrence (mark all ipsilateral sites that apply)
Description

Site(s)ofFirstLocal-RegionalRecurrence

Data type

text

Alias
UMLS CUI-1
C0027643
UMLS CUI-2
C1515974
First Distant Recurrence
Description

First Distant Recurrence

Has the patient been diagnosed with first distant recurrence/progression (since submission of the last follow-up form)?
Description

FirstProgressionDistantPresentInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C19987
NCI Thesaurus Property
C25321
NCI Thesaurus Property-2
C25509
NCI Thesaurus Property-3
C15220
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0456957
Date of First Distant Recurrence (if applicable)
Description

RecurrentDiseaseFirstDistantDiagnosisDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C38155
UMLS 2011AA ObjectClass
C0277556
NCI Thesaurus Property
C25321
UMLS 2011AA Property
C0443203
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
Site(s) of First Distant Recurrence
Description

RecurrentDiseaseFirstDistantDiagnosisText

Data type

text

Alias
NCI Thesaurus ObjectClass
C38155
UMLS 2011AA ObjectClass
C0277556
NCI Thesaurus Property
C25321
UMLS 2011AA Property
C0443203
NCI Thesaurus Property-2
C25509
UMLS 2011AA Property-2
C1279901
NCI Thesaurus Property-3
C15220
UMLS 2011AA Property-3
C0011900
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
New Primary Cancer Or Mds
Description

New Primary Cancer Or Mds

Has a new primary cancer or MDS been diagnosed that has not been previously reported?
Description

NewCancerDiagnosisInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C25586
UMLS 2011AA ObjectClass
C0205314
NCI Thesaurus ObjectClass-2
C9305
UMLS 2011AA ObjectClass-2
C0006826
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
Date of Diagnosis (if applicable)
Description

NewCancerDiagnosisDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
Site(s) of New Primary
Description

NewCancerSiteText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C25586
UMLS 2011AA ObjectClass
C0205314
NCI Thesaurus Property
C25341
UMLS 2011AA Property
C0450429
NCI Thesaurus ObjectClass-2
C9305
UMLS 2011AA ObjectClass-2
C0006826
Patient data
Description

Patient data

Alias
UMLS CUI-1
C2707520
Has the patient had a menstrual period or vaginal bleeding in the last 12 months?
Description

MensesOccurrenceInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
NCI Thesaurus Property
C25275
NCI Thesaurus ObjectClass
C3232
UMLS CUI-1
C0025344
Has the patient had a hysterectomy?
Description

HysterectomyPerformedInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
NCI Thesaurus Property
C38000
NCI Thesaurus ObjectClass
C15256
UMLS CUI-1
C0020699
Has the patient had a bilateral oophorectomy?
Description

BilateralOophorectomyPerformedInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
NCI Thesaurus ObjectClass
C13332
NCI Thesaurus Property
C38000
NCI Thesaurus ObjectClass-2
C15291
UMLS CUI-1
C0029936
Was patient randomized to receive Celecoxib or Placebo?
Description

RandomizedProtocolTherapyPlaceboReceivedInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C42651
NCI Thesaurus ObjectClass-3
C28295
NCI Thesaurus Property
C753
NCI Thesaurus Property-2
C25639
NCI Thesaurus ValueDomain
C38147
Did the patient experience any of the following adverse events that have not been previously reported?
Description

LateAdverseEventOnsetInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
NCI Thesaurus ObjectClass
C41331
NCI Thesaurus Property
C25279
UMLS CUI-1
C0877248
Adverse Events
Description

Adverse Events

Alias
UMLS CUI-1
C0877248
Adverse Event
Description

CommonTerminologyCriteriaforAdverseEventsVersion4.0LowLevelTermName

Data type

text

Alias
NCI Thesaurus ObjectClass
C41331
NCI Thesaurus Property
C49704
NCI Thesaurus Property-2
C45559
NCI Thesaurus ValueDomain
C45255
NCI Thesaurus ValueDomain-2
C49704
NCI Thesaurus ValueDomain-3
C42614
NCI Thesaurus ValueDomain-4
C45559
NCI Thesaurus ValueDomain-5
C25714
UMLS CUI-1
C2826934
Grade
Description

AdverseEventSeverityGrade

Data type

text

Alias
NCI Thesaurus ObjectClass
C41331
NCI Thesaurus Property
C48309
NCI Thesaurus Property-2
C49705
NCI Thesaurus Property-3
C25676
NCI Thesaurus ValueDomain
C41331
NCI Thesaurus ValueDomain-2
C48309
NCI Thesaurus ValueDomain-3
C25676
UMLS CUI-1
C2985921
Late Adverse Events
Description

Late Adverse Events

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C0205087
Has the patient experienced any severe (Grade >= 3) adverse event, possibly related to the chemotherapy, that has not been previously reported?
Description

AdverseEventChemotherapyRelationshipInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
NCI Thesaurus Property
C25648
NCI Thesaurus Property-2
C15632
NCI Thesaurus ObjectClass
C41331
UMLS CUI-1
C2919019
Therapy
Description

Therapy

Alias
UMLS CUI-1
C0087111
Did the patient receive any Herceptin treatment (since randomization since last follow-up)
Description

ImmunotherapyTrastuzumabReceivedInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
NCI Thesaurus Property
C1647
NCI Thesaurus ObjectClass
C15262
NCI Thesaurus Property-2
C25639
UMLS CUI-1
C0338204
Herceptin Treatment Start Date
Description

ImmunotherapyTrastuzumabReceivedBeginDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C15262
NCI Thesaurus Property
C1647
NCI Thesaurus Property-2
C25639
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25431
UMLS CUI-1
C0338204
UMLS CUI-2
C3173309
Did the patient receive any systemic hormonal treatment (since randomization since last follow-up)
Description

PatientSystemicHormoneTherapyReceivedInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C13310
NCI Thesaurus Property-2
C15445
NCI Thesaurus Property-3
C25639
NCI Thesaurus ValueDomain
C38147
UMLS CUI-1
C0279025
UMLS CUI-2
C0205373
Tamoxifen
Description

HormoneTherapyTamoxifenReceivedInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
NCI Thesaurus Property
C855
NCI Thesaurus ObjectClass
C15445
NCI Thesaurus Property-2
C25639
UMLS CUI-1
C0039286
Anastrozole
Description

HormoneTherapyAnastrozoleReceivedInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
NCI Thesaurus Property
C1607
NCI Thesaurus ObjectClass
C15445
NCI Thesaurus Property-2
C25639
UMLS CUI-1
C0290882
Exemestane
Description

HormoneTherapyExemestaneReceivedInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
NCI Thesaurus Property
C1097
NCI Thesaurus ObjectClass
C15445
NCI Thesaurus Property-2
C25639
UMLS CUI-1
C0851344
Letrozole
Description

HormoneTherapyLetrozoleReceivedInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
NCI Thesaurus Property
C1527
NCI Thesaurus ObjectClass
C15445
NCI Thesaurus Property-2
C25639
UMLS CUI-1
C0246421
LHRH agonist
Description

Gonadotropin-ReleasingHormoneAnalogHormoneTherapyReceivedInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
NCI Thesaurus ObjectClass
C15445
NCI Thesaurus Property
C25639
NCI Thesaurus ObjectClass-2
C2022
UMLS CUI-1
C1518041
Other, specify
Description

HormoneTherapyOtherReceivedInd-3

Data type

boolean

Alias
NCI Thesaurus Property
C17649
NCI Thesaurus ValueDomain
C38148
NCI Thesaurus ObjectClass
C15445
NCI Thesaurus Property-2
C25639
UMLS CUI-1
C0279025
UMLS CUI-2
C0205394
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1 forms
  1. StudyEvent: NSABP PROTOCOL B-36: FOLLOW-UP FORM
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
Patient Initials
Item
Patient Initials (Last, First Middle)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Patient ID NSABP
Item
NSABP Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1513905 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C15818 (NCI Thesaurus Property-2)
Institution Name
Item
Institution Name
text
C25191 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C21541 (NCI Thesaurus ValueDomain-2)
C25364 (NCI Thesaurus Property)
Affiliate Name
Item
Affiliate Name
text
C21541 (NCI Thesaurus ObjectClass)
C1510825 (UMLS CUI-1)
C25413 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)
Person Completing Form
Item
Person Completing Form (Phone)
text
C25191 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
Data amended
Item
Are data amended (check box if yes, and circle amended items)
boolean
C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Item Group
Vital Status
Item
Patient's Vital Status
text
C16960 (NCI Thesaurus ObjectClass)
C18003 (NCI Thesaurus ValueDomain)
C25688 (NCI Thesaurus ValueDomain-2)
C25365 (NCI Thesaurus Property)
C3846084 (UMLS CUI-1)
CL.2
Code List
Patient's Vital Status
CL Item
Alive (Alive)
C2584946 (UMLS CUI-1)
CL Item
Dead (Dead)
C0011065 (UMLS CUI-1)
Date last contact
Item
Date of Last Contact or Death (month day year)
date
C25164 (NCI Thesaurus ValueDomain)
C0805839 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C25461 (NCI Thesaurus Property)
Item
Source of Survival Information (if alive)
text
C25190 (NCI Thesaurus ObjectClass)
C25683 (NCI Thesaurus ValueDomain)
C48191 (NCI Thesaurus Property)
C17177 (NCI Thesaurus Property-2)
C0807975 (UMLS CUI-1)
CL.3
Code List
Source of Survival Information (if alive)
CL Item
Documentation Of Hospital Or Clinic Visit (1)
CL Item
Phone Contact To Patient (2)
CL Item
Other (3)
Other(specify)
Item
Other
text
Item
Primary cause of Death (if dead)
text
C25638 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C28554 (NCI Thesaurus Property)
C28554 (NCI Thesaurus ValueDomain-2)
C0007465 (UMLS CUI-1)
CL.4
Code List
Primary cause of Death (if dead)
CL Item
Due To This Disease (1)
CL Item
Due To Protocol Treatment (2)
CL Item
Due To Other Cause, Specify (3)
CL Item
Unknown (4)
Cause of Death, specify
Item
Describe Cause of Death (provide documentation)
text
C25685 (NCI Thesaurus ValueDomain)
C0007465 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1521902 (UMLS CUI-2)
C28554 (NCI Thesaurus Property)
Item
Was there evidence of recurrence at the time of death?
text
C28554 (NCI Thesaurus Property)
C38155 (NCI Thesaurus ObjectClass)
C15220 (NCI Thesaurus Property-2)
C0011065 (UMLS CUI-1)
C0277556 (UMLS CUI-2)
CL.5
Code List
Was there evidence of recurrence at the time of death?
CL Item
Yes, Clinical (Yes, clinical)
CL Item
Yes, Autopsy (Yes, autopsy)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item Group
Cancer Follow-up Status
Documented clinical assessment for this cancer
Item
Has the patient had a documented clinical assessment for this cancer (since submission of the last follow-up form)?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1522577 (UMLS CUI-1)
C16033 (NCI Thesaurus Property)
C0006826 (UMLS CUI-2)
C9305 (NCI Thesaurus ObjectClass)
C25365 (NCI Thesaurus Property-2)
Follow-Up Date
Item
Date of Last Clinical Assessment (if applicable)
date
C9305 (NCI Thesaurus ObjectClass)
C3694716 (UMLS CUI-1)
C16033 (NCI Thesaurus Property)
C25365 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Item Group
First Local-regional Recurrence
Neoplasm Recurrence, locoregional
Item
Has the patient been diagnosed with first local-regional recurrence (since submission of the last follow-up form)?
boolean
C19987 (NCI Thesaurus ObjectClass)
C0027643 (UMLS CUI-1)
C25388 (NCI Thesaurus Property)
C25509 (NCI Thesaurus Property-2)
C15220 (NCI Thesaurus Property-3)
C38148 (NCI Thesaurus ValueDomain)
FirstRecurrenceLocalRegionalDate
Item
Date of First Local-Regional Recurrence (if applicable)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C3352 (NCI Thesaurus ObjectClass)
C0034897 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
Item
Site(s) of First Local-Regional Recurrence (mark all ipsilateral sites that apply)
text
C0027643 (UMLS CUI-1)
C1515974 (UMLS CUI-2)
CL.8
Code List
Site(s) of First Local-Regional Recurrence (mark all ipsilateral sites that apply)
CL Item
Ipsilateral Breast (Ipsilateral breast)
CL Item
Chest Wall (Chest wall)
CL035093 (NCI Metathesaurus)
C62484 (NCI Thesaurus)
C0205076 (UMLS CUI-1)
CL Item
Axilla (Axilla)
C12674 (NCI Thesaurus)
C0004454 (UMLS CUI-1)
CL Item
Axillary Nodes (Axillary nodes)
C0729594 (UMLS CUI-1)
CL Item
Internal Mammary (Internal mammary nodes)
CL Item
Infraclavicular Nodes (Infraclavicular nodes)
C0229743 (UMLS CUI-1)
CL Item
Supraclavicular Nodes (Supraclavicular nodes)
C0229730 (UMLS CUI-1)
Item Group
First Distant Recurrence
Distant metastasis
Item
Has the patient been diagnosed with first distant recurrence/progression (since submission of the last follow-up form)?
boolean
C19987 (NCI Thesaurus ObjectClass)
C25321 (NCI Thesaurus Property)
C25509 (NCI Thesaurus Property-2)
C15220 (NCI Thesaurus Property-3)
C38148 (NCI Thesaurus ValueDomain)
C0456957 (UMLS CUI-1)
RecurrentDiseaseFirstDistantDiagnosisDate
Item
Date of First Distant Recurrence (if applicable)
date
C38155 (NCI Thesaurus ObjectClass)
C0277556 (UMLS 2011AA ObjectClass)
C25321 (NCI Thesaurus Property)
C0443203 (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)
RecurrentDiseaseFirstDistantDiagnosisText
Item
Site(s) of First Distant Recurrence
text
C38155 (NCI Thesaurus ObjectClass)
C0277556 (UMLS 2011AA ObjectClass)
C25321 (NCI Thesaurus Property)
C0443203 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property-2)
C1279901 (UMLS 2011AA Property-2)
C15220 (NCI Thesaurus Property-3)
C0011900 (UMLS 2011AA Property-3)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
Item Group
New Primary Cancer Or Mds
NewCancerDiagnosisInd-3
Item
Has a new primary cancer or MDS been diagnosed that has not been previously reported?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
NewCancerDiagnosisDate
Item
Date of Diagnosis (if applicable)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
NewCancerSiteText
Item
Site(s) of New Primary
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
Item Group
Patient data
C2707520 (UMLS CUI-1)
Menstruation
Item
Has the patient had a menstrual period or vaginal bleeding in the last 12 months?
boolean
C38148 (NCI Thesaurus ValueDomain)
C25275 (NCI Thesaurus Property)
C3232 (NCI Thesaurus ObjectClass)
C0025344 (UMLS CUI-1)
Hysterectomy
Item
Has the patient had a hysterectomy?
boolean
C38148 (NCI Thesaurus ValueDomain)
C38000 (NCI Thesaurus Property)
C15256 (NCI Thesaurus ObjectClass)
C0020699 (UMLS CUI-1)
Oophorectomy
Item
Has the patient had a bilateral oophorectomy?
boolean
C38147 (NCI Thesaurus ValueDomain)
C13332 (NCI Thesaurus ObjectClass)
C38000 (NCI Thesaurus Property)
C15291 (NCI Thesaurus ObjectClass-2)
C0029936 (UMLS CUI-1)
randomized to receive Celecoxib or Placebo
Item
Was patient randomized to receive Celecoxib or Placebo?
boolean
C15368 (NCI Thesaurus ObjectClass)
C42651 (NCI Thesaurus ObjectClass-2)
C28295 (NCI Thesaurus ObjectClass-3)
C753 (NCI Thesaurus Property)
C25639 (NCI Thesaurus Property-2)
C38147 (NCI Thesaurus ValueDomain)
Adverse event
Item
Did the patient experience any of the following adverse events that have not been previously reported?
boolean
C38147 (NCI Thesaurus ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C25279 (NCI Thesaurus Property)
C0877248 (UMLS CUI-1)
Item Group
Adverse Events
C0877248 (UMLS CUI-1)
Item
Adverse Event
text
C41331 (NCI Thesaurus ObjectClass)
C49704 (NCI Thesaurus Property)
C45559 (NCI Thesaurus Property-2)
C45255 (NCI Thesaurus ValueDomain)
C49704 (NCI Thesaurus ValueDomain-2)
C42614 (NCI Thesaurus ValueDomain-3)
C45559 (NCI Thesaurus ValueDomain-4)
C25714 (NCI Thesaurus ValueDomain-5)
C2826934 (UMLS CUI-1)
CL.19
Code List
Adverse Event
CL Item
Acute Coronary Syndrome (Acute coronary syndrome)
E10066 (CTCAE)
C0948089 (UMLS CUI-1)
CL Item
Anorexia (Anorexia)
E12252 (CTCAE)
C0003123 (UMLS CUI-1)
CL Item
Arthralgia (Arthralgia)
E12374 (CTCAE)
C0003862 (UMLS CUI-1)
CL Item
Back Pain (Back pain)
E12388 (CTCAE)
C0004604 (UMLS CUI-1)
CL Item
Cholesterol High (Cholesterol high)
E12127 (CTCAE)
C0020443 (UMLS CUI-1)
CL Item
Constipation (Constipation)
E10562 (CTCAE)
C0009806 (UMLS CUI-1)
CL Item
Depression (Depression)
E12909 (CTCAE)
C0011581 (UMLS CUI-1)
CL Item
Diarrhea (Diarrhea)
E10572 (CTCAE)
C0011991 (UMLS CUI-1)
CL Item
Dizziness (Dizziness)
E12631 (CTCAE)
C0012833 (UMLS CUI-1)
CL Item
Dyspnea (Dyspnea)
E13368 (CTCAE)
C0013404 (UMLS CUI-1)
CL Item
Edema Limbs (Edema limbs)
E11086 (CTCAE)
C1962951 (UMLS CUI-1)
CL Item
Fatigue (Fatigue)
E11098 (CTCAE)
C0015672 (UMLS CUI-1)
CL Item
Headache (Headache)
E12678 (CTCAE)
C0018681 (UMLS CUI-1)
CL Item
Hot Flashes (Hot flashes)
E13781 (CTCAE)
C0600142 (UMLS CUI-1)
CL Item
Hypertriglyceridemia (Hypertriglyceridemia)
E12299 (CTCAE)
C0020557 (UMLS CUI-1)
CL Item
Insomnia (Insomnia)
E12925 (CTCAE)
C0917801 (UMLS CUI-1)
CL Item
Ischemia Cerebrovascular (Ischemia cerebrovascular)
E12702 (CTCAE)
C0917798 (UMLS CUI-1)
CL Item
Myalgia (Myalgia)
E12485 (CTCAE)
C0231528 (UMLS CUI-1)
CL Item
Myocardial Infarction (Myocardial infarction)
E10152 (CTCAE)
C0027051 (UMLS CUI-1)
CL Item
Nausea (Nausea)
E10878 (CTCAE)
C0027497 (UMLS CUI-1)
CL Item
Peripheral Ischemia (Peripheral ischemia)
E13810 (CTCAE)
C0235490 (UMLS CUI-1)
CL Item
Somnolence (Somnolence)
E12814 (CTCAE)
C2830004 (UMLS CUI-1)
CL Item
Stroke (Stroke)
E12826 (CTCAE)
C0038454 (UMLS CUI-1)
CL Item
Thromboembolic Event (Thromboembolic event)
E13825 (CTCAE)
C0040038 (UMLS CUI-1)
CL Item
Transient Ischemic Attacks (Transient ischemic attacks)
E12834 (CTCAE)
C0007787 (UMLS CUI-1)
CL Item
Vaginal Hemorrhage (Vaginal hemorrhage)
E13264 (CTCAE)
C2979982 (UMLS CUI-1)
CL Item
Visceral Arterial Ischemia (Visceral arterial ischemia)
E13843 (CTCAE)
C0853812 (UMLS CUI-1)
Item
Grade
text
C41331 (NCI Thesaurus ObjectClass)
C48309 (NCI Thesaurus Property)
C49705 (NCI Thesaurus Property-2)
C25676 (NCI Thesaurus Property-3)
C41331 (NCI Thesaurus ValueDomain)
C48309 (NCI Thesaurus ValueDomain-2)
C25676 (NCI Thesaurus ValueDomain-3)
C2985921 (UMLS CUI-1)
CL.20
Code List
Grade
CL Item
Mild Adverse Event (1)
C84263 (NCI Thesaurus)
C1513302 (UMLS 2011AA)
CL Item
Moderate Adverse Event (2)
C84264 (NCI Thesaurus)
C1513374 (UMLS 2011AA)
CL Item
Severe Adverse Event (3)
C84265 (NCI Thesaurus)
C2919019 (UMLS 2011AA)
Item Group
Late Adverse Events
C0877248 (UMLS CUI-1)
C0205087 (UMLS CUI-2)
Severe adverse event
Item
Has the patient experienced any severe (Grade >= 3) adverse event, possibly related to the chemotherapy, that has not been previously reported?
boolean
C38147 (NCI Thesaurus ValueDomain)
C25648 (NCI Thesaurus Property)
C15632 (NCI Thesaurus Property-2)
C41331 (NCI Thesaurus ObjectClass)
C2919019 (UMLS CUI-1)
Item Group
Therapy
C0087111 (UMLS CUI-1)
Herceptin
Item
Did the patient receive any Herceptin treatment (since randomization since last follow-up)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1647 (NCI Thesaurus Property)
C15262 (NCI Thesaurus ObjectClass)
C25639 (NCI Thesaurus Property-2)
C0338204 (UMLS CUI-1)
Trastuzumab start date
Item
Herceptin Treatment Start Date
date
C15262 (NCI Thesaurus ObjectClass)
C1647 (NCI Thesaurus Property)
C25639 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C0338204 (UMLS CUI-1)
C3173309 (UMLS CUI-2)
Hormone Therapy, systemic
Item
Did the patient receive any systemic hormonal treatment (since randomization since last follow-up)
boolean
C16960 (NCI Thesaurus ObjectClass)
C13310 (NCI Thesaurus Property)
C15445 (NCI Thesaurus Property-2)
C25639 (NCI Thesaurus Property-3)
C38147 (NCI Thesaurus ValueDomain)
C0279025 (UMLS CUI-1)
C0205373 (UMLS CUI-2)
Tamoxifen
Item
Tamoxifen
boolean
C38148 (NCI Thesaurus ValueDomain)
C855 (NCI Thesaurus Property)
C15445 (NCI Thesaurus ObjectClass)
C25639 (NCI Thesaurus Property-2)
C0039286 (UMLS CUI-1)
Anastrozole
Item
Anastrozole
boolean
C38148 (NCI Thesaurus ValueDomain)
C1607 (NCI Thesaurus Property)
C15445 (NCI Thesaurus ObjectClass)
C25639 (NCI Thesaurus Property-2)
C0290882 (UMLS CUI-1)
Exemestane
Item
Exemestane
boolean
C38148 (NCI Thesaurus ValueDomain)
C1097 (NCI Thesaurus Property)
C15445 (NCI Thesaurus ObjectClass)
C25639 (NCI Thesaurus Property-2)
C0851344 (UMLS CUI-1)
Letrozole
Item
Letrozole
boolean
C38148 (NCI Thesaurus ValueDomain)
C1527 (NCI Thesaurus Property)
C15445 (NCI Thesaurus ObjectClass)
C25639 (NCI Thesaurus Property-2)
C0246421 (UMLS CUI-1)
LHRH agonist
Item
LHRH agonist
boolean
C38148 (NCI Thesaurus ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C25639 (NCI Thesaurus Property)
C2022 (NCI Thesaurus ObjectClass-2)
C1518041 (UMLS CUI-1)
Hormone Therapy, other
Item
Other, specify
boolean
C17649 (NCI Thesaurus Property)
C38148 (NCI Thesaurus ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C25639 (NCI Thesaurus Property-2)
C0279025 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
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