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.

1 forms

StudyEvent: CALGB 40601 FOLLOW-UP FORM
1. 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

Header

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)

Unnamed2

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)

VITAL STATUS

Item Group

Vital Status

Patient 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)

CL.2

Code List

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

CL Item

Alive (Alive)

CL Item

Dead (Dead)

Primary Cause of Death

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)

CL.3

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)

TherapeuticProcedureRegimenType

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)

CL.5

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)

OverallTumorResponseType

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)

CL.10

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)

NOTICE OF PROGRESSION

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)

BreastFirstProgressionLocal-RegionalSite

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)

CL.12

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)

ProgressionAssessmentSource

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)

CL.15

Code List

How was this progression information obtained?

CL Item

Clinical Assessment (Clinical assessment)

CL Item

Patient Self Report Only (Patient self-report only)

ProgressionAssessmentSource

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)

CL.15

Code List

How was this progression information obtained?

CL Item

Clinical Assessment (Clinical assessment)

CL Item

Patient Self Report Only (Patient self-report only)

LONG TERM ADVERSE EVENTS

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)

CommonToxicityCriteriaAdverseEventTermType

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)

CL.17

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)

CTCAdverseEventAttributionScale

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)

CL.19

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)

COMMENTS

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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