ID

2787

Beskrivning

NCIC-PR.11 Form 5AS - Active Surveillance Form Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=0EF81D84-2928-1CED-E044-0003BA3F9857

Länk

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=0EF81D84-2928-1CED-E044-0003BA3F9857

Nyckelord

Uppladdad den

19 september 2012

DOI

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Creative Commons BY-NC 3.0 Legacy

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Prostate Cancer NCT00499174 Follow-Up - NCIC-PR.11 Form 5AS - Active Surveillance Form - 2457525v1.0

model
Detaljer

These modules will be used on the majority of NCIC CTG case report forms submitted for CDE Review

1 Formulär

StudyEvent: NCIC-PR.11 Form 5AS - Active Surveillance Form
1. These modules will be used on the majority of NCIC CTG case report forms submitted for CDE Review

Name

Typ

Description | Question | Decode (Coded Value)

Datatyp

Alias

Patient Information

Item Group

Patient Information

PatientNationalCancerInstituteofCanadaIdentifierNumber

Item

NCIC Patient ID (NCIC CTG Patient Serial Number issued at the time of randomization)

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)
C25582 (NCI Thesaurus Property)
C1513884 (UMLS 2011AA Property)

PatientInitialsName

Item

Patient Initials (first-middle-last)

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 Medical Record Number (if permitted by IRB)

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)

PatientMultipleClinicalTrialsCooperativeGroupIdentifierNumber

Item

Intergroup Patient Serial No

text

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C17648 (NCI Thesaurus Property)
C0439064 (UMLS 2011AA Property)
C18205 (NCI Thesaurus Property)
C1521808 (UMLS 2011AA Property)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)

InstitutionName

Item

Institution Name

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C21541 (NCI Thesaurus ValueDomain)
C0018704 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

NCIInstitutionIdentifierCode

Item

NCI Institution Number (CTEP assigned)

text

C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C19202 (NCI Thesaurus ObjectClass)
C1513882 (UMLS 2011AA ObjectClass)

InvestigatorFirstName

Item

Investigator First Name

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)

InvestigatorLastName

Item

Investigator Last Name

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
C25551 (NCI Thesaurus Property)
C1517741 (UMLS 2011AA Property)

PhysicianInvestigatorIdentifierNumber

Item

Investigator Number (NCI Investigator Number)

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25741 (NCI Thesaurus ObjectClass)
C0031831 (UMLS 2011AA ObjectClass)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)

Month of Report

Item Group

Month Of Report

VisitReportMonthCount

Item

Month of report (circle one)

text

C29846 (NCI Thesaurus Property)
C0439231 (UMLS 2011AA Property)
C25375 (NCI Thesaurus ObjectClass)
C0684224 (UMLS 2011AA ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25716 (NCI Thesaurus ObjectClass)
C0545082 (UMLS 2011AA ObjectClass)

CL.1

Code List

Month of report (circle one)

CL Item

3 (3)

CL Item

6 (6)

CL Item

9 (9)

CL Item

12 (12)

CL Item

15 (15)

CL Item

18 (18)

CL Item

21 (21)

CL Item

24 (24)

CL Item

30 (30)

CL Item

36 (36)

CL Item

42 (42)

CL Item

48 (48)

CL Item

54 (54)

CL Item

60 (60)

CL Item

Other Month (OTHER)

VisitReportMonthSpecify

Item

Other

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C29846 (NCI Thesaurus Property)
C0439231 (UMLS 2011AA Property)
C25375 (NCI Thesaurus ObjectClass)
C0684224 (UMLS 2011AA ObjectClass)
C25716 (NCI Thesaurus ObjectClass)
C0545082 (UMLS 2011AA ObjectClass)

Physical Exam

Item Group

Physical Exam

CancerFollow-UpStatusDate

Item

Date of Last Clinical Assessment (yyyy - mmm - dd)

date

C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C16033 (NCI Thesaurus Property)
C1522577 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)

PerformanceStatusAssessmentEasternCooperativeOncologyGroupScale

Item

ECOG Performance Status (check one)

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.2

Code List

ECOG Performance Status (check one)

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)

Digital Rectal Exam

Item Group

Digital Rectal Exam

PatientMedicalExaminationDate

Item

Date of exam (yyyy mmm dd)

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)

ProstateMalignantNeoplasmPalpableNoduleInd-3

Item

Was the nodule palpable

text

C12410 (NCI Thesaurus ObjectClass)
C0033572 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25606 (NCI Thesaurus Property)
C0522499 (UMLS 2011AA Property)
C3280 (NCI Thesaurus Property)
C0028259 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

CL.3

Code List

Was the nodule palpable

CL Item

No (NO)

CL Item

Yes (YES)

ProstateMalignantNeoplasmPalpableNoduleType

Item

Nodule is (If yes, CRF: Nodule is)

text

C12410 (NCI Thesaurus ObjectClass)
C0033572 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25606 (NCI Thesaurus Property)
C0522499 (UMLS 2011AA Property)
C3280 (NCI Thesaurus Property)
C0028259 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.4

Code List

Nodule is (If yes, CRF: Nodule is)

CL Item

Mildly Suspicious For Cancer (Mildly suspicious for prostate cancer)

CL Item

Moderately Suspicious For Cancer (Moderately suspicious for prostate cancer)

CL Item

Highly Suspicious For Cancer (Highly suspicious for prostate cancer)

TumorMaximumDiameterMeasurement

Item

Maximum Diameter (cm)

double

C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C25285 (NCI Thesaurus Property)
C1301886 (UMLS 2011AA Property)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25564 (NCI Thesaurus Property)
C0806909 (UMLS 2011AA Property)

PSA Measurements

Item Group

Psa Measurements

LaboratoryProcedureProstate-SpecificAntigenTumorMarkerResultValue

Item

PSA Value (total) (The biologic variation in PSA is substantial. To minimize the impact of a non-significant rise in PSA reflecting random fluctuation, patients should have a minimum of 5...)

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)
C17220 (NCI Thesaurus Property)
C0041365 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

AssessmentLabUOM

Item

Units (* ng/mL, ug/L)

text

C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C37984 (NCI Thesaurus Property)
C0022877 (UMLS 2011AA Property)
C25709 (NCI Thesaurus ValueDomain)
C1519795 (UMLS 2011AA ValueDomain)

CL.5

Code List

Units (* ng/mL, ug/L)

CL Item

Micrograms Per Liter (mcg/L)

CL Item

Nanograms Per Milliliter (ng/mL)

LaboratoryProcedureProstate-SpecificAntigenTumorMarkerResultDate

Item

Date of PSA Assessment (yyyy mmm dd)

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)

Prostate-SpecificAntigenDoubleTestVelocityRate

Item

PSA Doubling Time (CRF: PSA Doubling-time years)

double

C17525 (NCI Thesaurus ObjectClass)
C0138741 (UMLS 2011AA ObjectClass)
C25636 (NCI Thesaurus ValueDomain)
C1521828 (UMLS 2011AA ValueDomain)
C20119 (NCI Thesaurus Property)
C1518823 (UMLS 2011AA Property)
CL236500 (NCI Metathesaurus Property)

AssessmentMethodType

Item

Method

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.6

Code List

Method

CL Item

Nomograms (MSK Nomogram)

C1450294 (NCI Metathesaurus)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

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)

BiochemicalProgressionPresentInd-3

Item

Has the patient been diagnosed with a first biochemical progression?

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?

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 (If yes, yyyy mmm dd)

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)

Histology/Grade

Item Group

Histology/grade

SpecimenGleasonScoreDate

Item

Date Surgical Gleason Score Obtained (yyyy mmm dd CRF: Date Surgical Gleason Score Obtained)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C28084 (NCI Thesaurus Property)
C0332326 (UMLS 2011AA Property)

SpecimenGleasonScoreType

Item

Gleason Score Based on Specimen Type

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C28084 (NCI Thesaurus ObjectClass)
C0332326 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)

CL.8

Code List

Gleason Score Based on Specimen Type

CL Item

Fine Needle Aspiration Biopsy (Fine Needle Aspirate)

CL Item

Biopsy (Biopsy)

C15189 (NCI Thesaurus)
C0005558 (UMLS 2011AA)
C15189 (NCI Thesaurus)
C0005558 (UMLS 2011AA)

CL Item

Surgical Specimen (Surgical specimen)

GleasonScorePrimaryPatternValue

Item

Gleason Score, Primary Pattern (1-5)

double

C25251 (NCI Thesaurus Property)
C0205225 (UMLS 2011AA Property)
C28084 (NCI Thesaurus ObjectClass)
C0332326 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25336 (NCI Thesaurus Property)
C0449774 (UMLS 2011AA Property)

GleasonScoreSecondaryPatternValue

Item

Gleason Score, Secondary Pattern (1-5)

double

C25667 (NCI Thesaurus Property)
C0175668 (UMLS 2011AA Property)
C28084 (NCI Thesaurus ObjectClass)
C0332326 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25336 (NCI Thesaurus Property)
C0449774 (UMLS 2011AA Property)

GleasonScoreCombinedPatternValue

Item

Gleason Score, Combined (sum of the primary and secondary)

double

C25454 (NCI Thesaurus Property)
C0205195 (UMLS 2011AA Property)
C28084 (NCI Thesaurus ObjectClass)
C0332326 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25336 (NCI Thesaurus Property)
C0449774 (UMLS 2011AA Property)

FirstProgressionHistologicDiagnosisInd-3

Item

Has the patient developed a first histologic progression (Histologic progression is defined as Gleason pattern of predominant 4 or higher i.e., Gleason 7 4+3 or higher in the re-biopsy of prostate)

text

C25331 (NCI Thesaurus ObjectClass)
C25509 (NCI Thesaurus ObjectClass)
C1279901 (UMLS 2011AA ObjectClass)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

CL.9

Code List

Has the patient developed a first histologic progression (Histologic progression is defined as Gleason pattern of predominant 4 or higher i.e., Gleason 7 4+3 or higher in the re-biopsy of prostate)

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)

FirstProgressionHistologicDiagnosisDate

Item

Date of First Histologic Progression (If yes, yyyy mmm dd CRF: Date of First Histologic Progression)

date

C25331 (NCI Thesaurus ObjectClass)
C25509 (NCI Thesaurus ObjectClass)
C1279901 (UMLS 2011AA ObjectClass)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

Clinical Progression

Item Group

Clinical Progression

FirstProgressionLocalAnatomicLocationInd-3

Item

Has the patient developed a first local progression

text

C25331 (NCI Thesaurus ObjectClass)
C25509 (NCI Thesaurus ObjectClass)
C1279901 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25421 (NCI Thesaurus Property)
C0002808 (UMLS 2011AA Property)
C0443133 (NCI Metathesaurus Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

CL.10

Code List

Has the patient developed a first local 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)

FirstProgressionLocalAnatomicLocationDate

Item

Date of First Local Progression (If yes, yyyy mmm dd)

date

C25331 (NCI Thesaurus ObjectClass)
C25509 (NCI Thesaurus ObjectClass)
C1279901 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25421 (NCI Thesaurus Property)
C0002808 (UMLS 2011AA Property)
C0443133 (NCI Metathesaurus Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)

CancerProgressionDistantFirstDistantDiagnosisInd

Item

Has the patient been diagnosed with first distant 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)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)

CL.11

Code List

Has the patient been diagnosed with first distant progression?

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

DistantProgressionFirstDate

Item

Date of First Distant Progression (If yes, yyyy mmm dd)

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)

Adverse Event Status

Item Group

Adverse Event Status

AdverseEventNewPeriodicPersistentReportInd-3

Item

Has the patient experienced any new or continuing symptoms or adverse events since the last report? (possibly, probably or definitely related to protocol therapy)

text

C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25586 (NCI Thesaurus Property)
C0205314 (UMLS 2011AA Property)
C25375 (NCI Thesaurus Property)
C0684224 (UMLS 2011AA Property)
C43623 (NCI Thesaurus Property)
C0205322 (UMLS 2011AA Property)
CL158136 (NCI Metathesaurus Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

CL.12

Code List

Has the patient experienced any new or continuing symptoms or adverse events since the last report? (possibly, probably or definitely related to protocol therapy)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CTCAdverseEventAttributionScale

Item

CTC Adverse Event Attribution Code (** 1=unrelated, 2=unlikely, 3=possible, 4=probable, 5=definite)

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.34

Code List

CTC Adverse Event Attribution Code (** 1=unrelated, 2=unlikely, 3=possible, 4=probable, 5=definite)

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)

AdverseEventSeriousnessAttributionScale

Item

Seriousness Attributed to Adverse Event (Enter appropriate code as follows: 0=not serious; 1=death; 2=life threatening; 3=hospitalization, initial or prolonged; 4=disability...)

text

C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25358 (NCI Thesaurus Property)
C0596130 (UMLS 2011AA Property)

CL.16

Code List

Seriousness Attributed to Adverse Event (Enter appropriate code as follows: 0=not serious; 1=death; 2=life threatening; 3=hospitalization, initial or prolonged; 4=disability...)

CL Item

Not Serious (Not serious)

CL Item

Death (Death)

C28554 (NCI Thesaurus)
C0011065 (UMLS 2011AA)

CL Item

Life Threatening (Life threatening)

CL Item

Hospitalized (Hospitalization, initial or prolonged)

CL Item

Disability (Disability/incapacity)

C21007 (NCI Thesaurus)
C0231170 (UMLS 2011AA)

CL Item

Congenital Anomaly (Congenital anomaly)

CL Item

Intervention Required (Required intervention to prevent permanent impairment/damage)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

SeriousAdverseEventReportInd-3

Item

SAE report submitted (NCIC CTG use only Default=N enter Y only for adverse events recorded on SAE report)

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25375 (NCI Thesaurus Property)
C0684224 (UMLS 2011AA Property)
C54035 (NCI Thesaurus ObjectClass)
C0205404 (UMLS 2011AA ObjectClass)

CL.17

Code List

SAE report submitted (NCIC CTG use only Default=N enter Y only for adverse events recorded on SAE report)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

AdverseEventCommonTerminologyforAdverseEventsVersion4TermName

Item

CTC Adverse Event Term

text

C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C49704 (NCI Thesaurus Property)
C1516728 (UMLS 2011AA Property)
C45559 (NCI Thesaurus Property)
C1705313 (UMLS 2011AA Property)
C45255 (NCI Thesaurus ValueDomain)
C1708523 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ValueDomain)
C1516728 (UMLS 2011AA ValueDomain)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)
C45559 (NCI Thesaurus ValueDomain)
C1705313 (UMLS 2011AA ValueDomain)
C25714 (NCI Thesaurus ValueDomain)
C0333052 (UMLS 2011AA ValueDomain)

AdverseEventSeverityGrade

Item

Grade (Grade according to NCI CTCAE, Version 4.0)

text

C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C48309 (NCI Thesaurus Property)
C0441800 (UMLS 2011AA Property)
C49705 (NCI Thesaurus Property)
C1710065 (UMLS 2011AA Property)
C25676 (NCI Thesaurus Property)
C0439793 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ValueDomain)
C0877248 (UMLS 2011AA ValueDomain)
C48309 (NCI Thesaurus ValueDomain)
C0441800 (UMLS 2011AA ValueDomain)
C25676 (NCI Thesaurus ValueDomain)
C0439793 (UMLS 2011AA ValueDomain)

CL.33

Code List

Grade (Grade according to NCI CTCAE, Version 4.0)

CL Item

Absent Adverse Event (0)

C75533 (NCI Thesaurus)
C2699517 (UMLS 2011AA)

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)

CL Item

Life Threatening Adverse Event (4)

C84266 (NCI Thesaurus)
C1517874 (UMLS 2011AA)

CL Item

Death Related To Adverse Event (5)

C48275 (NCI Thesaurus)
C1705232 (UMLS 2011AA)

Therapy for Lower Urinary Tract Symptoms/Prostate Cancer since the last report

Item Group

Therapy For Lower Urinary Tract Symptoms/prostate Cancer Since The Last Report

Non-protocolTherapy5Alpha-ReductaseInhibitorAdministeredInd-2

Item

Non-protocol 5 alpha reductase inhibitors

text

C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass)
C1518384 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C2319 (NCI Thesaurus Property)
C1318898 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

CL.18

Code List

Non-protocol 5 alpha reductase inhibitors

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

Non-protocolTherapy5Alpha-ReductaseInhibitorAdministeredText

Item

Agent

text

C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass)
C1518384 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C2319 (NCI Thesaurus Property)
C1318898 (UMLS 2011AA Property)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)

Non-protocolTherapy5Alpha-ReductaseInhibitorAdministeredReason

Item

Reason for use

text

C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass)
C1518384 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C2319 (NCI Thesaurus Property)
C1318898 (UMLS 2011AA Property)
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)

Non-protocolTherapyNonsteroidalAntiandrogenAdministeredInd-2

Item

Non-protocol non-steroidal antiandrogen therapy

text

C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass)
C1518384 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
CL316360 (NCI Metathesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

CL.19

Code List

Non-protocol non-steroidal antiandrogen therapy

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

Non-protocolTherapyNonsteroidalAntiandrogenAdministeredText

Item

Agent

text

C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass)
C1518384 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
CL316360 (NCI Metathesaurus Property)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)

HormoneTherapyNon-ProtocolGonadotropin-ReleasingHormoneAnalogAdministeredInd-2

Item

Non-protocol LHRH analogues

text

C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25590 (NCI Thesaurus Property)
C1518384 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C2022 (NCI Thesaurus Property)
C1268900 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

CL.20

Code List

Non-protocol LHRH analogues

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

HormoneTherapyNon-ProtocolGonadotropin-ReleasingHormoneAnalogAdministeredText

Item

Agent

text

C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25590 (NCI Thesaurus Property)
C1518384 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C2022 (NCI Thesaurus Property)
C1268900 (UMLS 2011AA Property)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)

Non-protocolSurgeryPerformedInd-3

Item

Non-Protocol Surgery? (for prostate cancer)

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C25590 (NCI Thesaurus ObjectClass)
C1518384 (UMLS 2011AA ObjectClass)

CL.21

Code List

Non-Protocol Surgery? (for prostate cancer)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

Non-ProtocolTherapyAdministeredDate

Item

Date of Non-protocol therapy (If yes, Date of Non-protocol surgery yyyy-mmm-dd)

date

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

Non-ProtocolSurgeryProcedureText

Item

Non-Protocol Surgery Type

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)
C25590 (NCI Thesaurus ObjectClass)
C1518384 (UMLS 2011AA ObjectClass)

Non-protocolRadiationTherapyAdministeredInd-3

Item

Non-Protocol Radiation Therapy? (for prostate cancer)

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25590 (NCI Thesaurus ObjectClass)
C1518384 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

CL.22

Code List

Non-Protocol Radiation Therapy? (for prostate cancer)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

Non-ProtocolRadiationTherapyAdministeredBeginDate

Item

Non-Protocol Radiation Therapy Start Date (If yes, yyyy-mmm-dd)

date

C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA 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-ProtocolRTAdministeredText

Item

Non-Protocol RT Type

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25590 (NCI Thesaurus ObjectClass)
C1518384 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

TherapyComplementaryandAlternativeMedicineAdministeredInd-2

Item

Complementary and alternative medicines (for lower urinary tract symptoms or prostate cancer? CRF: Complementary and Alternative Medicines)

text

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C15178 (NCI Thesaurus Property)
C0002346 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

CL.23

Code List

Complementary and alternative medicines (for lower urinary tract symptoms or prostate cancer? CRF: Complementary and Alternative Medicines)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

TherapyComplementaryandAlternativeMedicineAdministeredText

Item

Agent (If yes, *e.g. Saw Palmetto, Vitamin B/E, Selenium, Lycopene CRF: Agent)

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C15178 (NCI Thesaurus Property)
C0002346 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

Non-protocolTherapyOtherAdministeredInd-3

Item

Other Non-Protocol Therapy (for prostate cancer?)

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)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

CL.24

Code List

Other Non-Protocol Therapy (for prostate cancer?)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

Non-protocolTherapyOtherAdministeredName

Item

Name of Other Non-Protocol Therapy (If yes, for prostate cancer)

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)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)

Non-ProtocolTherapyFirstAdministeredDate

Item

Date of First Non-Protocol Therapy (for Prostate Cancer yyyy-mmm-dd)

date

C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass)
C1518384 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)

Non-ProtocolTherapyFirstAdministeredDate

Item

Date of First Non-Protocol Therapy (for Prostate Cancer yyyy-mmm-dd)

date

Non-ProtocolTherapyFirstAdministeredDate

Item

Date of First Non-Protocol Therapy (for Prostate Cancer yyyy-mmm-dd)

date

Non-ProtocolTherapyFirstAdministeredDate

Item

Date of First Non-Protocol Therapy (for Prostate Cancer yyyy-mmm-dd)

date

Other Malignancies or Marrow Dysplasia

Item Group

Other Malignancies Or Marrow Dysplasia

NewCancerDiagnosisInd-3

Item

Has a new primary cancer or MDS been diagnosed that has not been previously reported? (myelodysplastic syndrome)

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.25

Code List

Has a new primary cancer or MDS been diagnosed that has not been previously reported? (myelodysplastic syndrome)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

NewCancerDiagnosisDate

Item

Date of Diagnosis (yyyy-mmm-dd)

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)

ProstateMalignantFindingText

Item

Malignancy Type (e.g., bladder)

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C12410 (NCI Thesaurus ObjectClass)
C0033572 (UMLS 2011AA ObjectClass)
C14143 (NCI Thesaurus Property)
C0205282 (UMLS 2011AA Property)
C3367 (NCI Thesaurus Property)
C0037088 (UMLS 2011AA Property)

NewCancerDiagnosisText

Item

New Primary Diagnosis (Histology/Cytopathology)

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (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)

CTCAdverseEventAttributionScale

Item

CTC Adverse Event Attribution Code (** 1=unrelated, 2=unlikely, 3=possible, 4=probable, 5=definite)

text

CL.34

Code List

CTC Adverse Event Attribution Code (** 1=unrelated, 2=unlikely, 3=possible, 4=probable, 5=definite)

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)

Continuation of Active Surveillance

Item Group

End Of Active Surveillance

ProtocolActivitySurveillanceDiscontinuedInd-2

Item

Will this patient continue on active surveillance

text

C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C43431 (NCI Thesaurus ObjectClass)
C0441655 (UMLS 2011AA ObjectClass)
C25484 (NCI Thesaurus Property)
C1444662 (UMLS 2011AA Property)
C15719 (NCI Thesaurus Property)
C0733511 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

CL.27

Code List

Will this patient continue on active surveillance

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

ProtocolActivitySurveillanceDiscontinuedDate

Item

Date of the decision to stop active surveillance (If no, yyyy mmm dd CRF: Date of the decision to stop active surveillance)

date

C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C43431 (NCI Thesaurus ObjectClass)
C0441655 (UMLS 2011AA ObjectClass)
C25484 (NCI Thesaurus Property)
C1444662 (UMLS 2011AA Property)
C15719 (NCI Thesaurus Property)
C0733511 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

ProtocolActivitySurveillanceDiscontinuedReason

Item

Reason active surveillance was stopped

text

C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C43431 (NCI Thesaurus ObjectClass)
C0441655 (UMLS 2011AA ObjectClass)
C25484 (NCI Thesaurus Property)
C1444662 (UMLS 2011AA Property)
C15719 (NCI Thesaurus Property)
C0733511 (UMLS 2011AA Property)
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)

CL.28

Code List

Reason active surveillance was stopped

CL Item

Biochemical/psa Doubling-time (Biochemical/PSA doubling-time)

CL Item

Histologic/grade Progression (Histologic/Grade progression)

CL Item

Clinical Progression (Clinical progression (local/distant))

CL Item

Patient Choice (Patient choice)

CL Item

Clinical Judgement (Clinical judgement)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

ProtocolActivitySurveillanceDiscontinuedSpecify

Item

Other specify

text

C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C43431 (NCI Thesaurus ObjectClass)
C0441655 (UMLS 2011AA ObjectClass)
C25484 (NCI Thesaurus Property)
C1444662 (UMLS 2011AA Property)
C15719 (NCI Thesaurus Property)
C0733511 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)

ProtocolActivitySurveillancePatientDiscontinuedText

Item

Patient choice Reason

text

C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C43431 (NCI Thesaurus ObjectClass)
C0441655 (UMLS 2011AA ObjectClass)
C16960 (NCI Thesaurus Property)
C0030705 (UMLS 2011AA Property)
C25484 (NCI Thesaurus Property)
C1444662 (UMLS 2011AA Property)
C15719 (NCI Thesaurus Property)
C0733511 (UMLS 2011AA Property)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)

CTCAdverseEventAttributionScale

Item

CTC Adverse Event Attribution Code (** 1=unrelated, 2=unlikely, 3=possible, 4=probable, 5=definite)

text

CL.34

Code List

CTC Adverse Event Attribution Code (** 1=unrelated, 2=unlikely, 3=possible, 4=probable, 5=definite)

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)

ProtocolActivitySurveillancePhysicianDiscontinuedText

Item

Clinical judgement Reason

text

C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C43431 (NCI Thesaurus ObjectClass)
C0441655 (UMLS 2011AA ObjectClass)
C25741 (NCI Thesaurus Property)
C0031831 (UMLS 2011AA Property)
C25484 (NCI Thesaurus Property)
C1444662 (UMLS 2011AA Property)
C15719 (NCI Thesaurus Property)
C0733511 (UMLS 2011AA Property)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)

RadicalProstateTherapyParticipatingInd-2

Item

Will the patient receive radical prostatectomy or radiation therapy

text

C12410 (NCI Thesaurus ObjectClass)
C0033572 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass)
C0439807 (NCI Metathesaurus ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

CL.29

Code List

Will the patient receive radical prostatectomy or radiation therapy

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

RadiationTherapyProcedureType

Item

Radiation Therapy Type (**Please complete the Patient Specific Radiotherapy Facility Questionnaire, a Form 4 and follow the schedule of investigations listed in protocol section 9.2.)

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25218 (NCI Thesaurus Property)
C1948041 (UMLS 2011AA Property)

CL.31

Code List

Radiation Therapy Type (**Please complete the Patient Specific Radiotherapy Facility Questionnaire, a Form 4 and follow the schedule of investigations listed in protocol section 9.2.)

CL Item

External Beam Radiation Therapy (External beam)

C15751 (NCI Thesaurus)
C1517033 (UMLS 2011AA)

CL Item

Prostate Implant Brachytherapy (Permanent prostate brachytherapy)

CL044586 (NCI Metathesaurus)

CL Item

High-dose Rate Brachytherapy (High dose rate temporary brachytherapy)

C15651 (NCI Thesaurus)
C0454270 (UMLS 2011AA)

RadicalProstateTherapyNotParticipatingDate

Item

Date of the decision that the patient will not receive radical prostatectomy or radiation therapy (If no, yyyy mmm dd)

date

C12410 (NCI Thesaurus ObjectClass)
C0033572 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass)
C0439807 (NCI Metathesaurus ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

RadicalProstateTherapyNotParticipatingReason

Item

Reason patient will not receive radical prostatectomy or radiation therapy

text

C12410 (NCI Thesaurus ObjectClass)
C0033572 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass)
C0439807 (NCI Metathesaurus ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)

CL.32

Code List

Reason patient will not receive radical prostatectomy or radiation therapy

CL Item

Patient Off-treatment For Other Complicating Disease (Patient off treatment for other complicating disease)

CL Item

Adverse Event/side Effects/complications (Adverse events/side effects/complications)

CL Item

Patient Withdrawal Or Refusal Before Beginning Protocol Therapy (Patient withdrawal/refusal of radical intervention)

CL Item

Disease Progression (Distant progression during active surveillance)

C17747 (NCI Thesaurus)
C0242656 (UMLS 2011AA)

CL Item

Death (Death on-study)

C28554 (NCI Thesaurus)
C0011065 (UMLS 2011AA)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

Off-treatmentReasonSpecify

Item

Other specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)

AdverseEventCommonTerminologyforAdverseEventsVersion4TermName

Item

CTC Adverse Event Term

text

AdverseEventSeverityGrade

Item

Grade (Grade according to NCI CTCAE, Version 4.0)

text

CL.33

Code List

Grade (Grade according to NCI CTCAE, Version 4.0)

CL Item

Absent Adverse Event (0)

C75533 (NCI Thesaurus)
C2699517 (UMLS 2011AA)

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)

CL Item

Life Threatening Adverse Event (4)

C84266 (NCI Thesaurus)
C1517874 (UMLS 2011AA)

CL Item

Death Related To Adverse Event (5)

C48275 (NCI Thesaurus)
C1705232 (UMLS 2011AA)

TreatmentPlannedProcedure

Item

Planned Therapeutic Action for this patient (Please complete a Form 5 and follow the schedule of investigations listed in protocol section 9.2)

text

C15368 (NCI Thesaurus ObjectClass)
C25619 (NCI Thesaurus Property)
C1301732 (UMLS 2011AA Property)
C25218 (NCI Thesaurus ValueDomain)
C1948041 (UMLS 2011AA ValueDomain)

TreatmentPlannedProcedure

Item

Planned Therapeutic Action for this patient (Please complete a Form 5 and follow the schedule of investigations listed in protocol section 9.2)

text

C15368 (NCI Thesaurus ObjectClass)
C25619 (NCI Thesaurus Property)
C1301732 (UMLS 2011AA Property)
C25218 (NCI Thesaurus ValueDomain)
C1948041 (UMLS 2011AA ValueDomain)

Prostate Tissue Samples

Item Group

Correlative Studies

TissueSpecimenCollectedInd-2

Item

Was tissue collected for tumor banking (at the time of randomization)

text

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C12801 (NCI Thesaurus ObjectClass)
C0040300 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C25452 (NCI Thesaurus Property)

CL.35

Code List

Was tissue collected for tumor banking (at the time of randomization)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

TissueSpecimenCollectedInterval

Item

This tissue was collected for

text

C12801 (NCI Thesaurus ObjectClass)
C0040300 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C25452 (NCI Thesaurus Property)
C25543 (NCI Thesaurus ValueDomain)
C1272706 (UMLS 2011AA ValueDomain)

CL.36

Code List

This tissue was collected for

CL Item

Year (1 year)

C29848 (NCI Thesaurus)
C0439234 (UMLS 2011AA)

CL Item

4 Years (4 years)

CL Item

7 Years (7 years)

CL Item

10 Years (10 years)

CL Item

15 Years Post Registration (15 years)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

TissueSpecimenCollectedPeriodSpecify

Item

Other

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C12801 (NCI Thesaurus ObjectClass)
C0040300 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C25452 (NCI Thesaurus Property)

TissueSampleNotCollectedReasonText

Item

Reason (Please provide)

text

C19697 (NCI Thesaurus ObjectClass)
C1292533 (UMLS 2011AA ObjectClass)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C25452 (NCI Thesaurus Property)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)

Quality of Life Questionnaire

Item Group

Quality Of Life Questionnaire

QOLCompleteAssessmentIndicator

Item

Was QoL Questionnaire completed?

text

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C17047 (NCI Thesaurus ObjectClass)
C0518214 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)

CL.37

Code List

Was QoL Questionnaire completed?

CL Item

Yes: C49488 (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No: C49487 (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Not Applicable (Not Applicable)

C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)

QualityofLifeCompleteAssessmentDate

Item

Date Questionnaire Completed (yyyy mmm dd Please submit quality of life questionnaires)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C17047 (NCI Thesaurus ObjectClass)
C0518214 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25367 (NCI Thesaurus Property)

PatientIncompleteQuestionnaireReason

Item

Reason Questionnaire was not Completed (check one)

text

C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C0034394 (NCI Metathesaurus Property)

CL.38

Code List

Reason Questionnaire was not Completed (check one)

CL Item

Patient Refused (Patient refused)

CL Item

Patient Refused Due To Illness (Patient refused due to illness)

CL Item

Patient Unable To Be Contacted (Patient unable to be contacted)

CL Item

Questionnaire Not Completed Due To Institutional Error (Questionnaire not completed due to institutional error)

CL Item

Other Reason (Other reason)

PatientIncompleteQuestionnaireOtherSpecify

Item

Other reason, specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus ValueDomain)
C0205394 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C0034394 (NCI Metathesaurus Property)

Comments

Item Group

Comments

ResearchCommentsText

Item

Comments

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS 2011AA Property)

Supporting Documentation

Item Group

Supporting Documentation

Form Completion

Item Group

Investigator Signature

ResponsiblePersonLastName

Item

Person Completing Form, Last Name

text

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25551 (NCI Thesaurus Property)
C1517741 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)

ResponsiblePersonFirstName

Item

Person Completing Form, First Name

text

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)

FormOriginalCompleteDate

Item

Date Form Originally Completed (yyyy - mmm - dd)

date

C19464 (NCI Thesaurus ObjectClass)
C0376315 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25604 (NCI Thesaurus Property)
C0205313 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)

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Prostate Cancer NCT00499174 Follow-Up - NCIC-PR.11 Form 5AS - Active Surveillance Form - 2457525v1.0

These modules will be used on the majority of NCIC CTG case report forms submitted for CDE Review

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