ID

6671

Description

CALGB 40601 FOLLOW-UP FORM Paclitaxel and Trastuzumab With or Without Lapatinib in Treating Patients With Stage II or Stage III Breast Cancer That Can Be Removed by Surgery Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=3A098B5D-E41F-1055-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=3A098B5D-E41F-1055-E044-0003BA3F9857

Keywords

  1. 8/27/12 8/27/12 -
  2. 1/8/15 1/8/15 - Martin Dugas
  3. 1/9/15 1/9/15 - Martin Dugas
  4. 6/21/15 6/21/15 -
Uploaded on

January 8, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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Breast Cancer NCT00770809 Follow-Up - CALGB 40601 FOLLOW-UP FORM - 2681705v1.0

INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink.

Header
Description

Header

CALGB Form
Description

Form ID CALGB

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3262252
NCI Thesaurus ObjectClass
C19464
UMLS CUI-2
C1516238
NCI Thesaurus Property
C25364
NCI Thesaurus ObjectClass-2
C25442
CALGB Study No
Description

Protocol ID CALGB

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1516238
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25442
CALGB Patient ID
Description

Trial subject ID CALGB

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1516238
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25442
Reporting Period Start Date
Description

Reporting Period Start Date

Data type

date

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25616
UMLS CUI-1
C2361257
NCI Thesaurus Property-2
C25651
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25431
Reporting Period End Date (date of last contact or death)
Description

Reporting Period End Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2361259
NCI Thesaurus Property
C25616
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property-2
C25651
Are data amended
Description

Data amended

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Unnamed2
Description

Unnamed2

Patient Initials
Description

Patient Initials

Data type

text

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

Medical Record Number

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1301894
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25261
NCI Thesaurus Property-2
C25198
Institution/Affiliate
Description

Institution Name

Data type

text

Alias
NCI Thesaurus ObjectClass
C25454
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass-2
C21541
NCI Thesaurus Property
C25364
NCI Thesaurus ValueDomain
C25191
NCI Thesaurus ValueDomain-2
C21541
Participating Group
Description

Participating Group

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2347449
NCI Thesaurus ObjectClass
C25608
NCI Thesaurus ObjectClass-2
C17005
NCI Thesaurus Property
C25364
Participating Group Study No.
Description

Study Number Participating Group

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Participating Group Patient ID
Description

Trial subject ID Participating Group

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Vital Status
Description

Vital Status

Patient's vital status (Mark one with an X.)
Description

Patient Status

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS CUI-1
C3846084
NCI Thesaurus ValueDomain
C18003
NCI Thesaurus ValueDomain-2
C25688
NCI Thesaurus Property
C25717
Primary cause of death (Mark one with an X.)
Description

Primary Cause of Death

Data type

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS CUI-1
C0007465
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C28554
NCI Thesaurus ValueDomain-2
C25251
Describe cause of death
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
Did the patient continue treatment with AC?
Description

NeoadjuvantTherapyFollow-upCyclophosphamideDoxorubicinAdministrationInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16033
UMLS 2011AA ObjectClass
C1522577
NCI Thesaurus ObjectClass-2
C15665
UMLS 2011AA ObjectClass-2
C0600558
NCI Thesaurus Property
C456
UMLS 2011AA Property
C0013089
NCI Thesaurus Property-2
C405
UMLS 2011AA Property-2
C0010583
NCI Thesaurus Property-3
C25409
UMLS 2011AA Property-3
C1533734
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Treatment Regimen
Description

TherapeuticProcedureRegimenType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C49236
UMLS 2011AA ObjectClass
C0087111
NCI Thesaurus Property
C15697
UMLS 2011AA Property
C0040808
Did the patient continue treatment with trastuzumab?
Description

NeoadjuvantTherapyFollow-upTrastuzumabAdministrationInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16033
UMLS 2011AA ObjectClass
C1522577
NCI Thesaurus ObjectClass-2
C15665
UMLS 2011AA ObjectClass-2
C0600558
NCI Thesaurus Property
C1647
UMLS 2011AA Property
C0338204
NCI Thesaurus Property-2
C25409
UMLS 2011AA Property-2
C1533734
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Treatment start date
Description

NeoadjuvantTherapyFollow-upTrastuzumabAdministrationBeginDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C16033
UMLS 2011AA ObjectClass
C1522577
NCI Thesaurus ObjectClass-2
C15665
UMLS 2011AA ObjectClass-2
C0600558
NCI Thesaurus Property
C1647
UMLS 2011AA Property
C0338204
NCI Thesaurus Property-2
C25409
UMLS 2011AA Property-2
C1533734
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25431
UMLS 2011AA ValueDomain-2
C0439659
Treatment end date
Description

NeoadjuvantTherapyFollow-upTrastuzumabAdministrationEndDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C16033
UMLS 2011AA ObjectClass
C1522577
NCI Thesaurus ObjectClass-2
C15665
UMLS 2011AA ObjectClass-2
C0600558
NCI Thesaurus Property
C1647
UMLS 2011AA Property
C0338204
NCI Thesaurus Property-2
C25409
UMLS 2011AA Property-2
C1533734
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Did the patient continue treatment with endocrine therapy for ER/PgR positive disease?
Description

NeoadjuvantTherapyFollow-upEndocrineTherapyAdministrationInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16033
UMLS 2011AA ObjectClass
C1522577
NCI Thesaurus ObjectClass-2
C15665
UMLS 2011AA ObjectClass-2
C0600558
NCI Thesaurus Property
C15445
UMLS 2011AA Property
C0279025
NCI Thesaurus Property-2
C25409
UMLS 2011AA Property-2
C1533734
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Treatment start date
Description

NeoadjuvantTherapyFollow-upEndocrineTherapyAdministrationBeginDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C16033
UMLS 2011AA ObjectClass
C1522577
NCI Thesaurus ObjectClass-2
C15665
UMLS 2011AA ObjectClass-2
C0600558
NCI Thesaurus Property
C15445
UMLS 2011AA Property
C0279025
NCI Thesaurus Property-2
C25409
UMLS 2011AA Property-2
C1533734
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25431
UMLS 2011AA ValueDomain-2
C0439659
Treatment end date
Description

NeoadjuvantTherapyFollow-upEndocrineTherapyAdministrationEndDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C16033
UMLS 2011AA ObjectClass
C1522577
NCI Thesaurus ObjectClass-2
C15665
UMLS 2011AA ObjectClass-2
C0600558
NCI Thesaurus Property
C15445
UMLS 2011AA Property
C0279025
NCI Thesaurus Property-2
C25409
UMLS 2011AA Property-2
C1533734
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Has the patient had a documented clinical assessment for this cancer
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
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
Was patient restaged during this time period (If Yes, complete the following questions and submit C-817 Follow-Up Solid Tumor Measurement Form)
Description

BreastNewStageInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25586
UMLS 2011AA Property
C0205314
NCI Thesaurus ObjectClass
C12971
UMLS 2011AA ObjectClass
C0006141
NCI Thesaurus Property-2
C16899
UMLS 2011AA Property-2
C1300072
Overall Tumor Response
Description

OverallTumorResponseType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C25605
UMLS 2011AA ObjectClass-2
C1561607
NCI Thesaurus Property
C25755
UMLS 2011AA Property
C0871261
CR First Observed Date (MM DD YYYY)
Description

Complete Response First Observed Date

Data type

date

Alias
NCI Thesaurus ObjectClass
C25755
UMLS CUI-1
C0677874
NCI Thesaurus ObjectClass-2
C25250
UMLS CUI-2
C1115465
NCI Thesaurus Property
C25509
NCI Thesaurus Property-2
C25599
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
PR First Observed Date (MM DD YYYY)
Description

Partial Response First Observed Date

Data type

date

Alias
NCI Thesaurus ObjectClass
C25755
UMLS CUI-1
C1521726
NCI Thesaurus ObjectClass-2
C25378
UMLS CUI-2
C1115465
NCI Thesaurus Property
C25509
NCI Thesaurus Property-2
C25599
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
Notice Of Progression
Description

Notice Of Progression

Has the patient been diagnosed with a first local-regional progression (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 Progression
Description

Local-RegionalProgressionFirstDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C25331
NCI Thesaurus ObjectClass-2
C25388
UMLS 2011AA ObjectClass
C1947913
NCI Thesaurus Property
C25509
UMLS 2011AA Property
C1279901
NCI Thesaurus Property-2
C25275
UMLS 2011AA Property-2
C2745955
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25509
UMLS 2011AA ValueDomain-2
C1279901
Site of First Local-Regional Progression
Description

BreastFirstProgressionLocal-RegionalSite

Data type

text

Alias
NCI Thesaurus ValueDomain
C13717
UMLS 2011AA ValueDomain
C1515974
NCI Thesaurus Property
C25331
NCI Thesaurus ObjectClass
C12971
UMLS 2011AA ObjectClass
C0006141
NCI Thesaurus Property-2
C25509
UMLS 2011AA Property
C1279901
Has the patient been diagnosed with first distant progression?
Description

Neoplasm recurrence, Distal

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C19987
UMLS CUI-1
C0027627
NCI Thesaurus Property
C25321
NCI Thesaurus Property-2
C25509
NCI Thesaurus Property-3
C15220
NCI Thesaurus ValueDomain
C25180
Date of First Distant Progression
Description

Date of Neoplasm distal recurrence

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0027627
NCI Thesaurus ObjectClass
C25331
NCI Thesaurus ValueDomain-2
C25509
UMLS CUI-2
C0011008
NCI Thesaurus Property
C25275
Site 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
How was this progression information obtained?
Description

ProgressionAssessmentSource

Data type

text

Alias
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ObjectClass
C25331
NCI Thesaurus ValueDomain
C25683
UMLS 2011AA ValueDomain
C0449416
How was this progression information obtained?
Description

ProgressionAssessmentSource

Data type

text

Alias
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ObjectClass
C25331
NCI Thesaurus ValueDomain
C25683
UMLS 2011AA ValueDomain
C0449416
Expected Adverse Events
Description

Expected Adverse Events

Has the patient experienced any grade >= 2 treatment related adverse event? (prior to diagnosis of recurrence or new malignancy)
Description

Adverse Event

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25648
UMLS CUI-1
C0877248
NCI Thesaurus ObjectClass-2
C41331
NCI Thesaurus ObjectClass-3
C15368
NCI Metathesaurus Property
C0684224
NCI Thesaurus ValueDomain
C38148
MedDRA Code
Description

MedDRACode

Data type

float

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Metathesaurus ObjectClass
CL104089
CTC adverse event term
Description

CommonToxicityCriteriaAdverseEventTermType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C45559
UMLS 2011AA Property
C1705313
CTC AE grade (^2)
Description

CommonToxicityCriteriaAdverseEventGrade

Data type

float

Alias
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus ValueDomain
C18000
UMLS 2011AA ValueDomain
C0919553
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
CTC AE Attribution Code (^2)
Description

CTCAdverseEventAttributionScale

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C25358
UMLS 2011AA Property
C0596130
Adverse Event Onset Date
Description

CTCAdverseEventOnsetDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C25279
UMLS 2011AA Property
C0332162
Comments
Description

Comments

COMMENTS
Description

Research Comments

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
Completed by (Last name, First name)
Description

Person Completing Form

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass
C25657
NCI Thesaurus Property
C25364
Date form completed (MM DD YYYY)
Description

Date Form Completed

Data type

date

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

Similar models

INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink.

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
Form ID CALGB
Item
CALGB Form
text
C25337 (NCI Thesaurus ValueDomain)
C3262252 (UMLS CUI-1)
C19464 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus ObjectClass-2)
Protocol ID CALGB
Item
CALGB Study No
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus Property-2)
Trial subject ID CALGB
Item
CALGB Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus Property-2)
Reporting Period Start Date
Item
Reporting Period Start Date
date
C15368 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C2361257 (UMLS CUI-1)
C25651 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
Reporting Period End Date
Item
Reporting Period End Date (date of last contact or death)
date
C25164 (NCI Thesaurus ValueDomain)
C2361259 (UMLS CUI-1)
C25616 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)
C25651 (NCI Thesaurus Property-2)
Data amended
Item
Are data amended
boolean
C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Item Group
Unnamed2
Patient Initials
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Medical Record Number
Item
Patient Hospital No.
text
C25337 (NCI Thesaurus ValueDomain)
C1301894 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25261 (NCI Thesaurus Property)
C25198 (NCI Thesaurus Property-2)
Institution Name
Item
Institution/Affiliate
text
C25454 (NCI Thesaurus ObjectClass)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)
Participating Group
Item
Participating Group
text
C25191 (NCI Thesaurus ValueDomain)
C2347449 (UMLS CUI-1)
C25608 (NCI Thesaurus ObjectClass)
C17005 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
Study Number Participating Group
Item
Participating Group Study No.
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Trial subject ID Participating Group
Item
Participating Group Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Item Group
Vital Status
Item
Patient's vital status (Mark one with an X.)
text
C16960 (NCI Thesaurus ObjectClass)
C3846084 (UMLS CUI-1)
C18003 (NCI Thesaurus ValueDomain)
C25688 (NCI Thesaurus ValueDomain-2)
C25717 (NCI Thesaurus Property)
Code List
Patient's vital status (Mark one with an X.)
CL Item
Alive (Alive)
CL Item
Dead (Dead)
Item
Primary cause of death (Mark one with an X.)
text
C25638 (NCI Thesaurus ValueDomain)
C0007465 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C28554 (NCI Thesaurus Property)
C25251 (NCI Thesaurus ValueDomain-2)
Code List
Primary cause of death (Mark one with an X.)
CL Item
Due To This Disease (Due to this disease)
CL Item
Due To Protocol Treatment (Due to protocol treatment)
CL Item
Due To Other Cause (Due to other cause)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Cause of Death, specify
Item
Describe cause of death
text
C25685 (NCI Thesaurus ValueDomain)
C0007465 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1521902 (UMLS CUI-2)
C28554 (NCI Thesaurus Property)
NeoadjuvantTherapyFollow-upCyclophosphamideDoxorubicinAdministrationInd-2
Item
Did the patient continue treatment with AC?
boolean
C16033 (NCI Thesaurus ObjectClass)
C1522577 (UMLS 2011AA ObjectClass)
C15665 (NCI Thesaurus ObjectClass-2)
C0600558 (UMLS 2011AA ObjectClass-2)
C456 (NCI Thesaurus Property)
C0013089 (UMLS 2011AA Property)
C405 (NCI Thesaurus Property-2)
C0010583 (UMLS 2011AA Property-2)
C25409 (NCI Thesaurus Property-3)
C1533734 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item
Treatment Regimen
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C49236 (NCI Thesaurus ObjectClass)
C0087111 (UMLS 2011AA ObjectClass)
C15697 (NCI Thesaurus Property)
C0040808 (UMLS 2011AA Property)
Code List
Treatment Regimen
CL Item
Classical (Classical)
CL Item
Dose Dense (Dose dense)
NeoadjuvantTherapyFollow-upTrastuzumabAdministrationInd-2
Item
Did the patient continue treatment with trastuzumab?
boolean
C16033 (NCI Thesaurus ObjectClass)
C1522577 (UMLS 2011AA ObjectClass)
C15665 (NCI Thesaurus ObjectClass-2)
C0600558 (UMLS 2011AA ObjectClass-2)
C1647 (NCI Thesaurus Property)
C0338204 (UMLS 2011AA Property)
C25409 (NCI Thesaurus Property-2)
C1533734 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
NeoadjuvantTherapyFollow-upTrastuzumabAdministrationBeginDate
Item
Treatment start date
date
C16033 (NCI Thesaurus ObjectClass)
C1522577 (UMLS 2011AA ObjectClass)
C15665 (NCI Thesaurus ObjectClass-2)
C0600558 (UMLS 2011AA ObjectClass-2)
C1647 (NCI Thesaurus Property)
C0338204 (UMLS 2011AA Property)
C25409 (NCI Thesaurus Property-2)
C1533734 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)
NeoadjuvantTherapyFollow-upTrastuzumabAdministrationEndDate
Item
Treatment end date
date
C16033 (NCI Thesaurus ObjectClass)
C1522577 (UMLS 2011AA ObjectClass)
C15665 (NCI Thesaurus ObjectClass-2)
C0600558 (UMLS 2011AA ObjectClass-2)
C1647 (NCI Thesaurus Property)
C0338204 (UMLS 2011AA Property)
C25409 (NCI Thesaurus Property-2)
C1533734 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
NeoadjuvantTherapyFollow-upEndocrineTherapyAdministrationInd-2
Item
Did the patient continue treatment with endocrine therapy for ER/PgR positive disease?
boolean
C16033 (NCI Thesaurus ObjectClass)
C1522577 (UMLS 2011AA ObjectClass)
C15665 (NCI Thesaurus ObjectClass-2)
C0600558 (UMLS 2011AA ObjectClass-2)
C15445 (NCI Thesaurus Property)
C0279025 (UMLS 2011AA Property)
C25409 (NCI Thesaurus Property-2)
C1533734 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
NeoadjuvantTherapyFollow-upEndocrineTherapyAdministrationBeginDate
Item
Treatment start date
date
C16033 (NCI Thesaurus ObjectClass)
C1522577 (UMLS 2011AA ObjectClass)
C15665 (NCI Thesaurus ObjectClass-2)
C0600558 (UMLS 2011AA ObjectClass-2)
C15445 (NCI Thesaurus Property)
C0279025 (UMLS 2011AA Property)
C25409 (NCI Thesaurus Property-2)
C1533734 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)
NeoadjuvantTherapyFollow-upEndocrineTherapyAdministrationEndDate
Item
Treatment end date
date
C16033 (NCI Thesaurus ObjectClass)
C1522577 (UMLS 2011AA ObjectClass)
C15665 (NCI Thesaurus ObjectClass-2)
C0600558 (UMLS 2011AA ObjectClass-2)
C15445 (NCI Thesaurus Property)
C0279025 (UMLS 2011AA Property)
C25409 (NCI Thesaurus Property-2)
C1533734 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Documented clinical assessment for this cancer
Item
Has the patient had a documented clinical assessment for this cancer
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
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)
BreastNewStageInd-3
Item
Was patient restaged during this time period (If Yes, complete the following questions and submit C-817 Follow-Up Solid Tumor Measurement Form)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25586 (NCI Thesaurus Property)
C0205314 (UMLS 2011AA Property)
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C16899 (NCI Thesaurus Property-2)
C1300072 (UMLS 2011AA Property-2)
Item
Overall Tumor Response
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25605 (NCI Thesaurus ObjectClass-2)
C1561607 (UMLS 2011AA ObjectClass-2)
C25755 (NCI Thesaurus Property)
C0871261 (UMLS 2011AA Property)
Code List
Overall Tumor Response
CL Item
Complete Response (CR)
CL Item
Partial Response (PR)
C18212 (NCI Thesaurus)
Complete Response First Observed Date
Item
CR First Observed Date (MM DD YYYY)
date
C25755 (NCI Thesaurus ObjectClass)
C0677874 (UMLS CUI-1)
C25250 (NCI Thesaurus ObjectClass-2)
C1115465 (UMLS CUI-2)
C25509 (NCI Thesaurus Property)
C25599 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Partial Response First Observed Date
Item
PR First Observed Date (MM DD YYYY)
date
C25755 (NCI Thesaurus ObjectClass)
C1521726 (UMLS CUI-1)
C25378 (NCI Thesaurus ObjectClass-2)
C1115465 (UMLS CUI-2)
C25509 (NCI Thesaurus Property)
C25599 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Item Group
Notice Of Progression
Neoplasm Recurrence, locoregional
Item
Has the patient been diagnosed with a first local-regional progression (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)
Local-RegionalProgressionFirstDate
Item
Date of First Local-Regional Progression
date
C25331 (NCI Thesaurus ObjectClass)
C25388 (NCI Thesaurus ObjectClass-2)
C1947913 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property-2)
C2745955 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25509 (NCI Thesaurus ValueDomain-2)
C1279901 (UMLS 2011AA ValueDomain-2)
Item
Site of First Local-Regional Progression
text
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
C25331 (NCI Thesaurus Property)
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus Property-2)
C1279901 (UMLS 2011AA Property)
Code List
Site of First Local-Regional Progression
CL Item
Ipsilateral Breast (Ipsilateral breast)
CL Item
Axillary Nodes (Axillary nodes)
CL Item
Supraclavicular Nodes (Supraclavicular nodes)
CL Item
Infraclavicular Nodes (Infraclavicular nodes)
CL Item
Chest Wall (Chest wall)
CL035093 (NCI Metathesaurus)
C62484 (NCI Thesaurus)
C0205076 (UMLS 2011AA)
CL Item
Internal Mammary Nodes (Internal mammary nodes)
CL Item
Axilla (Axilla)
C12674 (NCI Thesaurus)
C0004454 (UMLS 2011AA)
Neoplasm recurrence, Distal
Item
Has the patient been diagnosed with first distant progression?
boolean
C19987 (NCI Thesaurus ObjectClass)
C0027627 (UMLS CUI-1)
C25321 (NCI Thesaurus Property)
C25509 (NCI Thesaurus Property-2)
C15220 (NCI Thesaurus Property-3)
C25180 (NCI Thesaurus ValueDomain)
Date of Neoplasm distal recurrence
Item
Date of First Distant Progression
date
C25164 (NCI Thesaurus ValueDomain)
C0027627 (UMLS CUI-1)
C25331 (NCI Thesaurus ObjectClass)
C25509 (NCI Thesaurus ValueDomain-2)
C0011008 (UMLS CUI-2)
C25275 (NCI Thesaurus Property)
RecurrentDiseaseFirstDistantDiagnosisText
Item
Site 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
How was this progression information obtained?
text
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25331 (NCI Thesaurus ObjectClass)
C25683 (NCI Thesaurus ValueDomain)
C0449416 (UMLS 2011AA ValueDomain)
Code List
How was this progression information obtained?
CL Item
Clinical Assessment (Clinical assessment)
CL Item
Patient Self Report Only (Patient self-report only)
Item
How was this progression information obtained?
text
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25331 (NCI Thesaurus ObjectClass)
C25683 (NCI Thesaurus ValueDomain)
C0449416 (UMLS 2011AA ValueDomain)
Code List
How was this progression information obtained?
CL Item
Clinical Assessment (Clinical assessment)
CL Item
Patient Self Report Only (Patient self-report only)
Item Group
Expected Adverse Events
Adverse Event
Item
Has the patient experienced any grade >= 2 treatment related adverse event? (prior to diagnosis of recurrence or new malignancy)
boolean
C25648 (NCI Thesaurus ObjectClass)
C0877248 (UMLS CUI-1)
C41331 (NCI Thesaurus ObjectClass-2)
C15368 (NCI Thesaurus ObjectClass-3)
C0684224 (NCI Metathesaurus Property)
C38148 (NCI Thesaurus ValueDomain)
MedDRACode
Item
MedDRA Code
float
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
CL104089 (NCI Metathesaurus ObjectClass)
Item
CTC adverse event term
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C45559 (NCI Thesaurus Property)
C1705313 (UMLS 2011AA Property)
Code List
CTC adverse event term
CL Item
Peripheral Motor Neuropathy (Neuropathy: motor)
C3500 (NCI Thesaurus)
C0018995 (UMLS 2011AA)
CL Item
Peripheral Sensory Neuropathy (Neuropathy: sensory)
C3501 (NCI Thesaurus)
C0151313 (UMLS 2011AA)
CommonToxicityCriteriaAdverseEventGrade
Item
CTC AE grade (^2)
float
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Item
CTC AE Attribution Code (^2)
text
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C25358 (NCI Thesaurus Property)
C0596130 (UMLS 2011AA Property)
Code List
CTC AE Attribution Code (^2)
CL Item
Unrelated (unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
CL Item
Unlikely (unlikely)
CL Item
Possible (possible)
C0332149 (NCI Metathesaurus)
CL Item
Probable (probable)
C0332148 (NCI Metathesaurus)
CL Item
Definite (definite)
CL209464 (NCI Metathesaurus)
CTCAdverseEventOnsetDate
Item
Adverse Event Onset Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C25279 (NCI Thesaurus Property)
C0332162 (UMLS 2011AA Property)
Item Group
Comments
Research Comments
Item
COMMENTS
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
Person Completing Form
Item
Completed by (Last name, First name)
text
C25191 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
Date Form Completed
Item
Date form completed (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C1115437 (UMLS CUI-1)
C40988 (NCI Thesaurus ObjectClass)
C25250 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)

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