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. Mark an X in the appropriate box for fields with a choice...

1 formularios

StudyEvent: CALGB 90203: 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. Mark an X in the appropriate box for fields with a choice...

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de datos

Alias

Header

Item Group

Ccrr Module For Calgb 90202: Skeletal Survey Form

CALGBFormIdentifierNumber

Item

CALGB Form (C-1244)

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C19464 (NCI Thesaurus ObjectClass)
C0376315 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25442 (NCI Thesaurus ObjectClass)
C1516238 (UMLS 2011AA ObjectClass)

ProtocolCALGBIdentifierNumber

Item

CALGB Study No.

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)
C25442 (NCI Thesaurus Property)
C1516238 (UMLS 2011AA Property)

PatientCALGBIdentifierNumber

Item

CALGB 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)
C25442 (NCI Thesaurus Property)
C1516238 (UMLS 2011AA Property)

TreatmentReportingPeriodBeginDate

Item

Reporting Period Start Date (mm/dd/yyyy)

date

C15368 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25651 (NCI Thesaurus Property)
C0700287 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)

TreatmentReportingPeriodEndDate

Item

Reporting Period End Date (mm/dd/yyyy)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C15368 (NCI Thesaurus ObjectClass)
C25651 (NCI Thesaurus Property)
C0700287 (UMLS 2011AA Property)

DataAmendedInd-3

Item

Are data amended

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)

CL.1

Code List

Are data amended

CL Item

Yes (yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

PatientInitialsName

Item

Patient Initials (Last, First Middle)

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)

PatientMedicalRecordNumber

Item

Patient Hospital No.

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25261 (NCI Thesaurus Property)
C0205476 (UMLS 2011AA Property)
C25198 (NCI Thesaurus Property)
C0034869 (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)

ParticipatingGroupName

Item

Participating Group

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25608 (NCI Thesaurus ObjectClass)
C0679823 (UMLS 2011AA ObjectClass)
C17005 (NCI Thesaurus ObjectClass)
C1257890 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

ProtocolParticipatingIdentifierNumber

Item

Participating Group Study No.

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)

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)

Vital Status

Item Group

Vital Status

PatientVitalStatus

Item

Patient Vital Status (Mark one with an X.)

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)

CL.2

Code List

Patient Vital Status (Mark one with an X.)

CL Item

Alive (Alive)

CL Item

Dead (Dead)

CL Item

Lost To Follow-up (Lost to follow-up)

PatientDeathPrimaryReason

Item

Primary Cause of Death (Mark one with an X.)

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)

CL.3

Code List

Primary Cause of Death (Mark one with an X.)

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)

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)

PatientLastContactDate

Item

Date of Last Contact or Death (mm dd yyyy)

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)

PerformanceStatusAssessmentEasternCooperativeOncologyGroupScale

Item

ECOG Performance Status (Mark one with an X.)

text

C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain)
C1512162 (UMLS 2011AA ValueDomain)
C20641 (NCI Thesaurus ObjectClass)
C1518965 (UMLS 2011AA ObjectClass)

CL.4

Code List

ECOG Performance Status (Mark one with an X.)

CL Item

Fully Active, Able To Carry On All Pre-disease Performance Without Restriction. (0)

CL Item

Restricted In Physically Strenuous Activity But Ambulatory And Able To Carry Out Work Of A Light Or Sedentary Nature, E.g., Light Housework, Office Work. (1)

CL Item

Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities. Up And About More Than 50% Of Waking Hours. (2)

CL Item

Capable Of Only Limited Selfcare, Confined To Bed Or Chair More Than 50% Of Waking Hours. (3)

CL Item

Completely Disabled. Cannot Carry On Any Selfcare. Totally Confined To Bed Or Chair. (4)

Disease Assessment

Item Group

Disease Follow-up Status

CancerFollow-upStatusInd-3

Item

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

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C16033 (NCI Thesaurus Property)
C1522577 (UMLS 2011AA Property)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)

CL.5

Code List

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

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

AssessmentMethodType

Item

Method of Evaluation (s Mark all that apply with an X.)

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)

CL.9

Code List

Method of Evaluation (s Mark all that apply with an X.)

CL Item

Digital Rectal Examination (Digital rectal exam)

C17631 (NCI Thesaurus)
C1384593 (UMLS 2011AA)

CL Item

Pathologic (Pathologic)

C25610 (NCI Thesaurus)
C1521733 (UMLS 2011AA)

CL Item

Radiographic (Radiographic)

AssessmentMethodSpecify

Item

Other Specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)

PatientMedicalExaminationDate

Item

Date of examination (Recommeded Term to replace CRF Text "date" - specify mm dd yyyy)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25305 (NCI Thesaurus Property)
C0582103 (UMLS 2011AA Property)

AssessmentPerformedDate

Item

Date of Assessment (specify mm dd yyyy)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)

LaboratoryProcedureProstate-SpecificAntigenTumorMarkerResultDate

Item

Date of PSA Assessment (Recommended Term to replace CRF Text "date" - specify mm dd yyyy)

date

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C17525 (NCI Thesaurus Property)
C0138741 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C17220 (NCI Thesaurus Property)
C0041365 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)

Notice of Progression

Item Group

Notice Of Progression

BiochemicalProgressionPresentInd-3

Item

Has the patient been diagnosed with a first biochemical progression? (PSA)

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C25331 (NCI Thesaurus ObjectClass)
C25434 (NCI Thesaurus ObjectClass)
C0205474 (UMLS 2011AA ObjectClass)

CL.7

Code List

Has the patient been diagnosed with a first biochemical progression? (PSA)

CL Item

No (NO)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (YES)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

BiochemicalProgressionFirstDate

Item

Date of First Biochemical Progression (PSA)

date

C25331 (NCI Thesaurus ObjectClass)
C25434 (NCI Thesaurus ObjectClass)
C0205474 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25509 (NCI Thesaurus ValueDomain)
C1279901 (UMLS 2011AA ValueDomain)

AssessmentMethodType

Item

Method of Evaluation (s Mark all that apply with an X.)

text

CL.9

Code List

Method of Evaluation (s Mark all that apply with an X.)

CL Item

Digital Rectal Examination (Digital rectal exam)

C17631 (NCI Thesaurus)
C1384593 (UMLS 2011AA)

CL Item

Pathologic (Pathologic)

C25610 (NCI Thesaurus)
C1521733 (UMLS 2011AA)

CL Item

Radiographic (Radiographic)

LaboratoryProcedureProstate-SpecificAntigenCancerProgressionOutcomeValue

Item

PSA Value at Progression (Recommended Term for CRF Text "PSA Value at first Progression" - ng/mL)

double

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C17525 (NCI Thesaurus Property)
C0138741 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C19987 (NCI Thesaurus Property)
C0242656 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

BiochemicalProgressionConfirmedDate

Item

Biochemical progression confirmed date (Recommended Term for CRF Text "Biochemical progression confirmation date" - mm dd yyyy)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25458 (NCI Thesaurus Property)
C0750484 (UMLS 2011AA Property)
C25331 (NCI Thesaurus ObjectClass)
C25434 (NCI Thesaurus ObjectClass)
C0205474 (UMLS 2011AA ObjectClass)

CancerProgressionFirstLocalDiagnosisInd-3

Item

Has the patient been diagnosed with a first local recurrence (e.g., prostate bed)

text

C19987 (NCI Thesaurus ObjectClass)
C0242656 (UMLS 2011AA ObjectClass)
C67263 (NCI Thesaurus Property)
C0205276 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

CL.8

Code List

Has the patient been diagnosed with a first local recurrence (e.g., prostate bed)

CL Item

No (NO)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (YES)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

LocalRecurrenceFirstDiagnosisDate

Item

Date of first local recurrence (mm dd yyyy)

date

C3352 (NCI Thesaurus ObjectClass)
C0034897 (UMLS 2011AA ObjectClass)
C25388 (NCI Thesaurus ObjectClass)
C1947913 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

DiseaseProgressionBoneFirstObservedInd-3

Item

Has patient been diagnosed with first bone progression

text

C12366 (NCI Thesaurus ObjectClass)
C0262950 (UMLS 2011AA ObjectClass)
C17747 (NCI Thesaurus ObjectClass)
C0242656 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25599 (NCI Thesaurus Property)
C1441672 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25755 (NCI Thesaurus ValueDomain)
C0871261 (UMLS 2011AA ValueDomain)

CL.10

Code List

Has patient been diagnosed with first bone progression

CL Item

No (no)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

DiseaseProgressionBoneFirstObservedDate

Item

Date of first bone progression (per bone scan mm dd yyyy)

date

C12366 (NCI Thesaurus ObjectClass)
C0262950 (UMLS 2011AA ObjectClass)
C17747 (NCI Thesaurus ObjectClass)
C0242656 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25599 (NCI Thesaurus Property)
C1441672 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

FirstProgressionDistantPresentInd-3

Item

Has the patient been diagnosed with first distant recurrence/progression? (Recommended Term for CRF Text "Has patient been diagnosed with first distant non-bone progression")

text

C19987 (NCI Thesaurus ObjectClass)
C0242656 (UMLS 2011AA ObjectClass)
C25321 (NCI Thesaurus Property)
C0443203 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

CL.11

Code List

Has the patient been diagnosed with first distant recurrence/progression? (Recommended Term for CRF Text "Has patient been diagnosed with first distant non-bone progression")

CL Item

No (NO)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (YES)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

DistantProgressionFirstDate

Item

Date of First Distant Progression (non-bone recurrence/ - mm dd yyyy)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25331 (NCI Thesaurus ObjectClass)
C25509 (NCI Thesaurus ValueDomain)
C1279901 (UMLS 2011AA ValueDomain)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)

DistantProgressionFirstSite

Item

Site of First Distant Progression (Specify Mark all that apply with an X. - Recommended Term for CRF Text "Sites of first distant non-bone progression")

text

C25331 (NCI Thesaurus ObjectClass)
C25321 (NCI Thesaurus ObjectClass)
C0443203 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)

CL.12

Code List

Site of First Distant Progression (Specify Mark all that apply with an X. - Recommended Term for CRF Text "Sites of first distant non-bone progression")

CL Item

Lymph Nodes (Lymph nodes)

CL Item

Liver (Liver)

C12392 (NCI Thesaurus)
C0023884 (UMLS 2011AA)

CL Item

Lung (Lung)

C12468 (NCI Thesaurus)
C0024109 (UMLS 2011AA)

CL Item

Pleura (Pleura)

C12469 (NCI Thesaurus)
C0032225 (UMLS 2011AA)

CL Item

Central Nervous System/brain (Central nervous system/Brain)

CL Item

Other Specify (Other)

MalignantNeoplasmProgressionLymphNodeAnatomicSite

Item

Lymph Nodes Specify

text

C25331 (NCI Thesaurus ObjectClass)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C12745 (NCI Thesaurus Property)
C0024204 (UMLS 2011AA Property)
C25421 (NCI Thesaurus Property)
C0002808 (UMLS 2011AA Property)
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)

FirstProgressionDistantSiteSpecify

Item

Other specify

text

C25331 (NCI Thesaurus ObjectClass)
C25509 (NCI Thesaurus ObjectClass)
C1279901 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25321 (NCI Thesaurus Property)
C0443203 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)

Postoperative Therapy

Item Group

Treatment Status

AdjuvantPostoperativeRadiationTherapyAdministeredInd-3

Item

Did patient start adjuvant postoperative radiotherapy?

text

C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C28006 (NCI Thesaurus ObjectClass)
C0032790 (UMLS 2011AA ObjectClass)
C2140 (NCI Thesaurus ObjectClass)
C0001552 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

CL.13

Code List

Did patient start adjuvant postoperative radiotherapy?

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

AdjuvantPostoperativeRadiationTherapyOccurrenceInterval

Item

When was adjuvant radiotherapy initiated

text

C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C28006 (NCI Thesaurus ObjectClass)
C0032790 (UMLS 2011AA ObjectClass)
C2140 (NCI Thesaurus ObjectClass)
C0001552 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25543 (NCI Thesaurus ValueDomain)
C1272706 (UMLS 2011AA ValueDomain)

CL.14

Code List

When was adjuvant radiotherapy initiated

CL Item

Within 6 Months After Surgery (Within 6 months after surgery)

CL Item

More Than 6 Months After Surgery (More than 6 months after surgery)

AdjuvantPostoperativeRadiationTherapyBeginDate

Item

Postoperative Radiation Therapy Start Date (Recommended Term for CRF Text "Prostate EBRT external beam radiation therapy start date" mm dd yyyy)

date

C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C28006 (NCI Thesaurus ObjectClass)
C0032790 (UMLS 2011AA ObjectClass)
C2140 (NCI Thesaurus ObjectClass)
C0001552 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)

AdjuvantPostoperativeRadiationTherapyEndDate

Item

Postoperative Radiation Therapy End Date (Recommended Term for CRF Text "Prostate EBRT external beam radiation therapy end date" mm dd yyyy)

date

C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C28006 (NCI Thesaurus ObjectClass)
C0032790 (UMLS 2011AA ObjectClass)
C2140 (NCI Thesaurus ObjectClass)
C0001552 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

ExternalBeamRadiationTherapyAdministeredTotalDose

Item

Total dose administered (cGy)

double

C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C15751 (NCI Thesaurus ObjectClass)
C1517033 (UMLS 2011AA ObjectClass)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

RTGynecologicSite

Item

Radiation Therapy Site (Recommended Term for CRF Text "Sites irradiated")

text

C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C28016 (NCI Thesaurus Property)
C0205480 (UMLS 2011AA Property)

CL.15

Code List

Radiation Therapy Site (Recommended Term for CRF Text "Sites irradiated")

CL Item

Pelvic Region (Pelvis)

CL Item

Other Specify (Other)

RadiationTherapySiteSpecify

Item

Other specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)

AndrogenSuppressionTherapyAdministrationInd-2

Item

Did patient receive androgen deprivation therapy?

text

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C15676 (NCI Thesaurus ObjectClass)
C1515985 (UMLS 2011AA ObjectClass)

CL.16

Code List

Did patient receive androgen deprivation therapy?

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

HormoneTherapyLuteinizingHormone-releasingHormoneAgonistAdministrationName

Item

LHRH agonist therapy (Recommended Term for CRF Text "Postoperative LHRH Agonist Type" - Mark one with an X.)

text

C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)
C1910 (NCI Thesaurus Property)
C1518041 (UMLS 2011AA Property)

CL.17

Code List

LHRH agonist therapy (Recommended Term for CRF Text "Postoperative LHRH Agonist Type" - Mark one with an X.)

CL Item

Goserelin (Goserelin (Zoladex))

C1374 (NCI Thesaurus)
C0120107 (UMLS 2011AA)

CL Item

Leuprolide Acetate (Leuprolide (Lupron))

C1319 (NCI Thesaurus)
C0085272 (UMLS 2011AA)
C1319 (NCI Thesaurus)
C0085272 (UMLS 2011AA)

CL Item

Leuprolide Acetate (Leuprolide (Eligard))

C1319 (NCI Thesaurus)
C0085272 (UMLS 2011AA)
C1319 (NCI Thesaurus)
C0085272 (UMLS 2011AA)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

HormoneTherapyLuteinizingHormone-releasingHormoneAgonistAdministrationSpecify

Item

Other specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C1910 (NCI Thesaurus Property)
C1518041 (UMLS 2011AA Property)

HormoneTherapyLuteinizingHormone-releasingHormoneAgonistAdministrationBeginDate

Item

LHRH agonist start date (Recommended Term for CRF Text "Postoperative LHRH agonist start date" mm dd yyyy)

date

C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C1910 (NCI Thesaurus Property)
C1518041 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)

HormoneTherapyLuteinizingHormone-releasingHormoneAgonistAdministrationEndDate

Item

LHRH agonist last administered date (Recommended Term for CRF Text "Postoperative LHRH agonist end date" mm dd yyyy)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C1910 (NCI Thesaurus Property)
C1518041 (UMLS 2011AA Property)

HormoneTherapyLuteinizingHormone-releasingHormoneAgonistAdministrationTotalDose

Item

LHRH Agonist Total Dose (Recommended Term for CRF Text "Postoperative LHRH agonist total dose to date" mg)

double

C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C1910 (NCI Thesaurus Property)
C1518041 (UMLS 2011AA Property)
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)

OrchiectomyDate

Item

Date of orchiectomy (specify if applicable mm dd yyyy)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15288 (NCI Thesaurus ObjectClass)
C0007347 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)

OralAntiandrogenTherapyAgentAdministeredName

Item

Oral antiandrogen therapy (Recommended Term for CRF Text "Postoperative oral antiandrogen type" Mark one with an X.)

text

C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25311 (NCI Thesaurus ObjectClass)
C0442027 (UMLS 2011AA ObjectClass)
C15481 (NCI Thesaurus ObjectClass)
C0279492 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)

CL.18

Code List

Oral antiandrogen therapy (Recommended Term for CRF Text "Postoperative oral antiandrogen type" Mark one with an X.)

CL Item

Bicalutamide (Bicalutamide (Casodex))

C1599 (NCI Thesaurus)
C0285590 (UMLS 2011AA)

CL Item

Flutamide (Flutamide (Eulexin))

C509 (NCI Thesaurus)
C0016384 (UMLS 2011AA)

CL Item

Nilutamide (Nilutamide (Nilandron))

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

OralAntiandrogenTherapyAgentAdministeredSpecify

Item

Other specify

text

C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25311 (NCI Thesaurus ObjectClass)
C0442027 (UMLS 2011AA ObjectClass)
C15481 (NCI Thesaurus ObjectClass)
C0279492 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)

OralAntiandrogenTherapyAgentAdministeredBeginDate

Item

Oral Antiandrogen Start Date (Recommended Term for CRF Text "Postoperative oral antiandrogen start date" mm dd yyyy)

date

C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25311 (NCI Thesaurus ObjectClass)
C0442027 (UMLS 2011AA ObjectClass)
C15481 (NCI Thesaurus ObjectClass)
C0279492 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)

OralAntiandrogenTherapyAgentAdministeredEndDate

Item

Oral antiandrogen last administered date (Recommended Term for CRF Text "Postoperative oral antiandrogen start date" mm dd yyyy)

date

C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25311 (NCI Thesaurus ObjectClass)
C0442027 (UMLS 2011AA ObjectClass)
C15481 (NCI Thesaurus ObjectClass)
C0279492 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

OralAntiandrogenTherapyAgentAdministeredDailyDose

Item

Oral antiandrogen Total Daily Dose (Recommended Term for CRF Text "Postoperative Oral antiandrogen dose to date" mg)

double

C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25311 (NCI Thesaurus ObjectClass)
C0442027 (UMLS 2011AA ObjectClass)
C15481 (NCI Thesaurus ObjectClass)
C0279492 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25473 (NCI Thesaurus ValueDomain)
C0332173 (UMLS 2011AA ValueDomain)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)

Postoperative Therapy (continued)

Item Group

Postoperative Therapy (continued)

Non-protocolTherapyAdministeredInd-3

Item

Is the patient receiving any non-protocol cancer therapy not previously reported?

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass)
C1518384 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

CL.19

Code List

Is the patient receiving any non-protocol cancer therapy not previously reported?

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

Non-ProtocolTherapyAdministeredType

Item

Non-Protocol Therapy Type (*Non-protocol therapy type: 1=Radiation to pelvis; 2=Radiation to other sites, specify; 3=Surgery; 4=Chemotherapy; 5=Hormone; 6=Other, specify)

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass)
C1518384 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

CL.20

Code List

Non-Protocol Therapy Type (*Non-protocol therapy type: 1=Radiation to pelvis; 2=Radiation to other sites, specify; 3=Surgery; 4=Chemotherapy; 5=Hormone; 6=Other, specify)

CL Item

Radiation To Pelvis (Radiation to pelvis)

CL Item

Radiation To Other Sites, Specify (Radiation to other sites)

CL Item

Surgery (Surgery)

C17173 (NCI Thesaurus)
C0038894 (UMLS 2011AA)

CL Item

Chemotherapy (Chemotherapy)

C15632 (NCI Thesaurus)
C0392920 (UMLS 2011AA)

CL Item

Hormones (Hormones)

CL Item

Other Specify (Other)

Non-protocolTherapyAdministeredBeginDate

Item

Start Date of Non-protocol Therapy (mm dd yyyy)

date

C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass)
C1518384 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)

Non-ProtocolTherapyOtherAdministeredSpecify

Item

Specify

text

C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass)
C1518384 (UMLS 2011AA ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)

Notice of New Primary

Item Group

Notice Of New Primary

NewCancerDiagnosisInd-3

Item

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

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)

CL.21

Code List

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

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

MedDRACode

Item

MedDRA disease code (New Primary Tumor Site * MedDRA Disease Code=Disease Site table 10000884=AML; 1004146=BCC; 10018192=Bladder; 10007959=Brain; 10010029=Colorectal; ... 10018864=Other - hematologic, specify; 10029000=Other - solid, specify; 99999999=Unknown)

double

C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
CL104089 (NCI Metathesaurus ObjectClass)

NewCancerDiagnosisDate

Item

New Primary Cancer Date

date

C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)

NewCancerAnatomicSiteSpecify

Item

Specify disease site (If code=10018664 or 10029000, - below Recommended Term to replace CRF Text "specify")

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)

Long-Term Toxicity

Item Group

Long-term Toxicity

RTOGAdverseEventReportInd-3

Item

Has the patient experienced (prior to diagnosis of recurrence or second primary) any severe (Grade >=3), long term toxicity that has not been previously reported (*Long-term toxicity is any toxicity that lasts 30 days or longer)

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C19778 (NCI Thesaurus ObjectClass)
C1514695 (UMLS 2011AA ObjectClass)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25375 (NCI Thesaurus Property)
C0684224 (UMLS 2011AA Property)

CL.22

Code List

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

SecondPrimaryNeoplasmDiagnosisType

Item

Specify type and/or site (If non-AML/MDS secondary malignancy occurs,)

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25251 (NCI Thesaurus ObjectClass)
C0205225 (UMLS 2011AA ObjectClass)
C25666 (NCI Thesaurus ObjectClass)
C0205436 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

Footer

Item Group

Footer

ResponsiblePersonName

Item

Completed by (Last name, First name)

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

FormCompleteDate

Item

Date Form Completed (mm dd yyyy)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C40988 (NCI Thesaurus ObjectClass)
C1516308 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain)

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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. Mark an X in the appropriate box for fields with a choice...

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