ID

2787

Descripción

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

Link

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

Palabras clave

Versiones (4)
  1. 19/9/12 19/9/12 -
  2. 9/1/15 9/1/15 - Martin Dugas
  3. 9/1/15 9/1/15 - Martin Dugas
  4. 20/9/21 20/9/21 -
Subido en

19 de septiembre de 2012

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

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

Inglés

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

1 formularios  
Patient Information
Descripción

Patient Information

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

PatientNationalCancerInstituteofCanadaIdentifierNumber

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C25582
UMLS 2011AA Property
C1513884
Patient Initials (first-middle-last)
Descripción

PatientInitialsName

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
Patient Medical Record Number (if permitted by IRB)
Descripción

PatientMedicalRecordNumber

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25261
UMLS 2011AA Property
C0205476
NCI Thesaurus Property
C25198
UMLS 2011AA Property
C0034869
Intergroup Patient Serial No
Descripción

PatientMultipleClinicalTrialsCooperativeGroupIdentifierNumber

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C17648
UMLS 2011AA Property
C0439064
NCI Thesaurus Property
C18205
UMLS 2011AA Property
C1521808
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
Institution Name
Descripción

InstitutionName

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C21541
UMLS 2011AA ObjectClass
C0018704
NCI Thesaurus ValueDomain
C21541
UMLS 2011AA ValueDomain
C0018704
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Institution Number (CTEP assigned)
Descripción

NCIInstitutionIdentifierCode

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus ObjectClass
C21541
UMLS 2011AA ObjectClass
C0018704
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C19202
UMLS 2011AA ObjectClass
C1513882
Investigator First Name
Descripción

InvestigatorFirstName

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C25509
UMLS 2011AA Property
C1279901
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173
Investigator Last Name
Descripción

InvestigatorLastName

Tipo de datos

text

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

PhysicianInvestigatorIdentifierNumber

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C25741
UMLS 2011AA ObjectClass
C0031831
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173
Month Of Report
Descripción

Month Of Report

Month of report (circle one)
Descripción

VisitReportMonthCount

Tipo de datos

text

Alias
NCI Thesaurus Property
C29846
UMLS 2011AA Property
C0439231
NCI Thesaurus ObjectClass
C25375
UMLS 2011AA ObjectClass
C0684224
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
NCI Thesaurus ObjectClass
C25716
UMLS 2011AA ObjectClass
C0545082
Other
Descripción

VisitReportMonthSpecify

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C29846
UMLS 2011AA Property
C0439231
NCI Thesaurus ObjectClass
C25375
UMLS 2011AA ObjectClass
C0684224
NCI Thesaurus ObjectClass
C25716
UMLS 2011AA ObjectClass
C0545082
Physical Exam
Descripción

Physical Exam

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

CancerFollow-UpStatusDate

Tipo de datos

date

Alias
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C16033
UMLS 2011AA Property
C1522577
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
ECOG Performance Status (check one)
Descripción

PerformanceStatusAssessmentEasternCooperativeOncologyGroupScale

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
NCI Thesaurus Property
C25367
NCI Thesaurus ValueDomain
C25491
UMLS 2011AA ValueDomain
C1512162
NCI Thesaurus ObjectClass
C20641
UMLS 2011AA ObjectClass
C1518965
Digital Rectal Exam
Descripción

Digital Rectal Exam

Date of exam (yyyy mmm dd)
Descripción

PatientMedicalExaminationDate

Tipo de datos

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25305
UMLS 2011AA Property
C0582103
Was the nodule palpable
Descripción

ProstateMalignantNeoplasmPalpableNoduleInd-3

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C12410
UMLS 2011AA ObjectClass
C0033572
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C25606
UMLS 2011AA Property
C0522499
NCI Thesaurus Property
C3280
UMLS 2011AA Property
C0028259
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Nodule is (If yes, CRF: Nodule is)
Descripción

ProstateMalignantNeoplasmPalpableNoduleType

Tipo de datos

text

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

TumorMaximumDiameterMeasurement

Tipo de datos

double

Alias
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
NCI Thesaurus Property
C25285
UMLS 2011AA Property
C1301886
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus Property
C25564
UMLS 2011AA Property
C0806909
Psa Measurements
Descripción

Psa Measurements

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...)
Descripción

LaboratoryProcedureProstate-SpecificAntigenTumorMarkerResultValue

Tipo de datos

double

Unidades de medida
  • ng/ml
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C17525
UMLS 2011AA Property
C0138741
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C17220
UMLS 2011AA Property
C0041365
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
ng/ml
Units (* ng/mL, ug/L)
Descripción

AssessmentLabUOM

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus Property
C37984
UMLS 2011AA Property
C0022877
NCI Thesaurus ValueDomain
C25709
UMLS 2011AA ValueDomain
C1519795
Date of PSA Assessment (yyyy mmm dd)
Descripción

LaboratoryProcedureProstate-SpecificAntigenTumorMarkerResultDate

Tipo de datos

date

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C17525
UMLS 2011AA Property
C0138741
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C17220
UMLS 2011AA Property
C0041365
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
PSA Doubling Time (CRF: PSA Doubling-time years)
Descripción

Prostate-SpecificAntigenDoubleTestVelocityRate

Tipo de datos

double

Alias
NCI Thesaurus ObjectClass
C17525
UMLS 2011AA ObjectClass
C0138741
NCI Thesaurus ValueDomain
C25636
UMLS 2011AA ValueDomain
C1521828
NCI Thesaurus Property
C20119
UMLS 2011AA Property
C1518823
NCI Metathesaurus Property
CL236500
Method
Descripción

AssessmentMethodType

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus Property
C16847
UMLS 2011AA Property
C0449851
Other Specify
Descripción

AssessmentMethodSpecify

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus Property
C16847
UMLS 2011AA Property
C0449851
Has the patient been diagnosed with a first biochemical progression?
Descripción

BiochemicalProgressionPresentInd-3

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C25331
NCI Thesaurus ObjectClass
C25434
UMLS 2011AA ObjectClass
C0205474
Date of First Biochemical Progression (If yes, yyyy mmm dd)
Descripción

BiochemicalProgressionFirstDate

Tipo de datos

date

Alias
NCI Thesaurus ObjectClass
C25331
NCI Thesaurus ObjectClass
C25434
UMLS 2011AA ObjectClass
C0205474
NCI Thesaurus Property
C25509
UMLS 2011AA Property
C1279901
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25509
UMLS 2011AA ValueDomain
C1279901
Histology/grade
Descripción

Histology/grade

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

SpecimenGleasonScoreDate

Tipo de datos

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C19157
UMLS 2011AA ObjectClass
C0370003
NCI Thesaurus Property
C28084
UMLS 2011AA Property
C0332326
Gleason Score Based on Specimen Type
Descripción

SpecimenGleasonScoreType

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C19157
UMLS 2011AA ObjectClass
C0370003
NCI Thesaurus ObjectClass
C28084
UMLS 2011AA ObjectClass
C0332326
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Gleason Score, Primary Pattern (1-5)
Descripción

GleasonScorePrimaryPatternValue

Tipo de datos

double

Alias
NCI Thesaurus Property
C25251
UMLS 2011AA Property
C0205225
NCI Thesaurus ObjectClass
C28084
UMLS 2011AA ObjectClass
C0332326
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus Property
C25336
UMLS 2011AA Property
C0449774
Gleason Score, Secondary Pattern (1-5)
Descripción

GleasonScoreSecondaryPatternValue

Tipo de datos

double

Alias
NCI Thesaurus Property
C25667
UMLS 2011AA Property
C0175668
NCI Thesaurus ObjectClass
C28084
UMLS 2011AA ObjectClass
C0332326
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus Property
C25336
UMLS 2011AA Property
C0449774
Gleason Score, Combined (sum of the primary and secondary)
Descripción

GleasonScoreCombinedPatternValue

Tipo de datos

double

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

FirstProgressionHistologicDiagnosisInd-3

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C25331
NCI Thesaurus ObjectClass
C25509
UMLS 2011AA ObjectClass
C1279901
NCI Thesaurus Property
C25526
UMLS 2011AA Property
C0205462
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Date of First Histologic Progression (If yes, yyyy mmm dd CRF: Date of First Histologic Progression)
Descripción

FirstProgressionHistologicDiagnosisDate

Tipo de datos

date

Alias
NCI Thesaurus ObjectClass
C25331
NCI Thesaurus ObjectClass
C25509
UMLS 2011AA ObjectClass
C1279901
NCI Thesaurus Property
C25526
UMLS 2011AA Property
C0205462
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Clinical Progression
Descripción

Clinical Progression

Has the patient developed a first local progression
Descripción

FirstProgressionLocalAnatomicLocationInd-3

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C25331
NCI Thesaurus ObjectClass
C25509
UMLS 2011AA ObjectClass
C1279901
NCI Thesaurus Property
C25341
UMLS 2011AA Property
C0450429
NCI Thesaurus Property
C25421
UMLS 2011AA Property
C0002808
NCI Metathesaurus Property
C0443133
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Date of First Local Progression (If yes, yyyy mmm dd)
Descripción

FirstProgressionLocalAnatomicLocationDate

Tipo de datos

date

Alias
NCI Thesaurus ObjectClass
C25331
NCI Thesaurus ObjectClass
C25509
UMLS 2011AA ObjectClass
C1279901
NCI Thesaurus Property
C25341
UMLS 2011AA Property
C0450429
NCI Thesaurus Property
C25421
UMLS 2011AA Property
C0002808
NCI Metathesaurus Property
C0443133
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
Has the patient been diagnosed with first distant progression?
Descripción

CancerProgressionDistantFirstDistantDiagnosisInd

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C19987
UMLS 2011AA ObjectClass
C0242656
NCI Thesaurus Property
C25321
UMLS 2011AA Property
C0443203
NCI Thesaurus Property
C25509
UMLS 2011AA Property
C1279901
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Date of First Distant Progression (If yes, yyyy mmm dd)
Descripción

DistantProgressionFirstDate

Tipo de datos

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25331
NCI Thesaurus ValueDomain
C25509
UMLS 2011AA ValueDomain
C1279901
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
Adverse Event Status
Descripción

Adverse Event Status

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

AdverseEventNewPeriodicPersistentReportInd-3

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25586
UMLS 2011AA Property
C0205314
NCI Thesaurus Property
C25375
UMLS 2011AA Property
C0684224
NCI Thesaurus Property
C43623
UMLS 2011AA Property
C0205322
NCI Metathesaurus Property
CL158136
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
CTC Adverse Event Attribution Code (** 1=unrelated, 2=unlikely, 3=possible, 4=probable, 5=definite)
Descripción

CTCAdverseEventAttributionScale

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C25358
UMLS 2011AA Property
C0596130
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...)
Descripción

AdverseEventSeriousnessAttributionScale

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25358
UMLS 2011AA Property
C0596130
SAE report submitted (NCIC CTG use only Default=N enter Y only for adverse events recorded on SAE report)
Descripción

SeriousAdverseEventReportInd-3

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25375
UMLS 2011AA Property
C0684224
NCI Thesaurus ObjectClass
C54035
UMLS 2011AA ObjectClass
C0205404
CTC Adverse Event Term
Descripción

AdverseEventCommonTerminologyforAdverseEventsVersion4TermName

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C49704
UMLS 2011AA Property
C1516728
NCI Thesaurus Property
C45559
UMLS 2011AA Property
C1705313
NCI Thesaurus ValueDomain
C45255
UMLS 2011AA ValueDomain
C1708523
NCI Thesaurus ValueDomain
C49704
UMLS 2011AA ValueDomain
C1516728
NCI Thesaurus ValueDomain
C42614
UMLS 2011AA ValueDomain
C0027365
NCI Thesaurus ValueDomain
C45559
UMLS 2011AA ValueDomain
C1705313
NCI Thesaurus ValueDomain
C25714
UMLS 2011AA ValueDomain
C0333052
Grade (Grade according to NCI CTCAE, Version 4.0)
Descripción

AdverseEventSeverityGrade

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C48309
UMLS 2011AA Property
C0441800
NCI Thesaurus Property
C49705
UMLS 2011AA Property
C1710065
NCI Thesaurus Property
C25676
UMLS 2011AA Property
C0439793
NCI Thesaurus ValueDomain
C41331
UMLS 2011AA ValueDomain
C0877248
NCI Thesaurus ValueDomain
C48309
UMLS 2011AA ValueDomain
C0441800
NCI Thesaurus ValueDomain
C25676
UMLS 2011AA ValueDomain
C0439793
Therapy For Lower Urinary Tract Symptoms/prostate Cancer Since The Last Report
Descripción

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

Non-protocol 5 alpha reductase inhibitors
Descripción

Non-protocolTherapy5Alpha-ReductaseInhibitorAdministeredInd-2

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass
C25590
UMLS 2011AA ObjectClass
C1518384
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus Property
C2319
UMLS 2011AA Property
C1318898
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Agent
Descripción

Non-protocolTherapy5Alpha-ReductaseInhibitorAdministeredText

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass
C25590
UMLS 2011AA ObjectClass
C1518384
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus Property
C2319
UMLS 2011AA Property
C1318898
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
Reason for use
Descripción

Non-protocolTherapy5Alpha-ReductaseInhibitorAdministeredReason

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass
C25590
UMLS 2011AA ObjectClass
C1518384
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus Property
C2319
UMLS 2011AA Property
C1318898
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
Non-protocol non-steroidal antiandrogen therapy
Descripción

Non-protocolTherapyNonsteroidalAntiandrogenAdministeredInd-2

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass
C25590
UMLS 2011AA ObjectClass
C1518384
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Metathesaurus Property
CL316360
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Agent
Descripción

Non-protocolTherapyNonsteroidalAntiandrogenAdministeredText

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass
C25590
UMLS 2011AA ObjectClass
C1518384
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Metathesaurus Property
CL316360
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
Non-protocol LHRH analogues
Descripción

HormoneTherapyNon-ProtocolGonadotropin-ReleasingHormoneAnalogAdministeredInd-2

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property
C25590
UMLS 2011AA Property
C1518384
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus Property
C2022
UMLS 2011AA Property
C1268900
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Agent
Descripción

HormoneTherapyNon-ProtocolGonadotropin-ReleasingHormoneAnalogAdministeredText

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property
C25590
UMLS 2011AA Property
C1518384
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus Property
C2022
UMLS 2011AA Property
C1268900
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
Non-Protocol Surgery? (for prostate cancer)
Descripción

Non-protocolSurgeryPerformedInd-3

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass
C15329
UMLS 2011AA ObjectClass
C0543467
NCI Thesaurus ObjectClass
C25590
UMLS 2011AA ObjectClass
C1518384
Date of Non-protocol therapy (If yes, Date of Non-protocol surgery yyyy-mmm-dd)
Descripción

Non-ProtocolTherapyAdministeredDate

Tipo de datos

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass
C25590
UMLS 2011AA ObjectClass
C1518384
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Non-Protocol Surgery Type
Descripción

Non-ProtocolSurgeryProcedureText

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C15329
UMLS 2011AA ObjectClass
C0543467
NCI Thesaurus Property
C15368
NCI Thesaurus ObjectClass
C25590
UMLS 2011AA ObjectClass
C1518384
Non-Protocol Radiation Therapy? (for prostate cancer)
Descripción

Non-protocolRadiationTherapyAdministeredInd-3

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C15313
UMLS 2011AA ObjectClass
C1522449
NCI Thesaurus ObjectClass
C25590
UMLS 2011AA ObjectClass
C1518384
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Non-Protocol Radiation Therapy Start Date (If yes, yyyy-mmm-dd)
Descripción

Non-ProtocolRadiationTherapyAdministeredBeginDate

Tipo de datos

date

Alias
NCI Thesaurus ObjectClass
C15313
UMLS 2011AA ObjectClass
C1522449
NCI Thesaurus ObjectClass
C25590
UMLS 2011AA ObjectClass
C1518384
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25431
UMLS 2011AA ValueDomain
C0439659
Non-Protocol RT Type
Descripción

Non-ProtocolRTAdministeredText

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C15313
UMLS 2011AA ObjectClass
C1522449
NCI Thesaurus ObjectClass
C25590
UMLS 2011AA ObjectClass
C1518384
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Complementary and alternative medicines (for lower urinary tract symptoms or prostate cancer? CRF: Complementary and Alternative Medicines)
Descripción

TherapyComplementaryandAlternativeMedicineAdministeredInd-2

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C15178
UMLS 2011AA Property
C0002346
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Agent (If yes, *e.g. Saw Palmetto, Vitamin B/E, Selenium, Lycopene CRF: Agent)
Descripción

TherapyComplementaryandAlternativeMedicineAdministeredText

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C15178
UMLS 2011AA Property
C0002346
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Other Non-Protocol Therapy (for prostate cancer?)
Descripción

Non-protocolTherapyOtherAdministeredInd-3

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass
C25590
UMLS 2011AA ObjectClass
C1518384
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Name of Other Non-Protocol Therapy (If yes, for prostate cancer)
Descripción

Non-protocolTherapyOtherAdministeredName

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass
C25590
UMLS 2011AA ObjectClass
C1518384
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C42614
UMLS 2011AA ValueDomain
C0027365
Date of First Non-Protocol Therapy (for Prostate Cancer yyyy-mmm-dd)
Descripción

Non-ProtocolTherapyFirstAdministeredDate

Tipo de datos

date

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass
C25590
UMLS 2011AA ObjectClass
C1518384
NCI Thesaurus Property
C25509
UMLS 2011AA Property
C1279901
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
Date of First Non-Protocol Therapy (for Prostate Cancer yyyy-mmm-dd)
Descripción

Non-ProtocolTherapyFirstAdministeredDate

Tipo de datos

date

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass
C25590
UMLS 2011AA ObjectClass
C1518384
NCI Thesaurus Property
C25509
UMLS 2011AA Property
C1279901
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
Date of First Non-Protocol Therapy (for Prostate Cancer yyyy-mmm-dd)
Descripción

Non-ProtocolTherapyFirstAdministeredDate

Tipo de datos

date

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass
C25590
UMLS 2011AA ObjectClass
C1518384
NCI Thesaurus Property
C25509
UMLS 2011AA Property
C1279901
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
Date of First Non-Protocol Therapy (for Prostate Cancer yyyy-mmm-dd)
Descripción

Non-ProtocolTherapyFirstAdministeredDate

Tipo de datos

date

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass
C25590
UMLS 2011AA ObjectClass
C1518384
NCI Thesaurus Property
C25509
UMLS 2011AA Property
C1279901
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
Other Malignancies Or Marrow Dysplasia
Descripción

Other Malignancies Or Marrow Dysplasia

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

NewCancerDiagnosisInd-3

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C25586
UMLS 2011AA ObjectClass
C0205314
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
Date of Diagnosis (yyyy-mmm-dd)
Descripción

NewCancerDiagnosisDate

Tipo de datos

date

Alias
NCI Thesaurus ObjectClass
C25586
UMLS 2011AA ObjectClass
C0205314
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
Malignancy Type (e.g., bladder)
Descripción

ProstateMalignantFindingText

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C12410
UMLS 2011AA ObjectClass
C0033572
NCI Thesaurus Property
C14143
UMLS 2011AA Property
C0205282
NCI Thesaurus Property
C3367
UMLS 2011AA Property
C0037088
New Primary Diagnosis (Histology/Cytopathology)
Descripción

NewCancerDiagnosisText

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C25586
UMLS 2011AA ObjectClass
C0205314
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
CTC Adverse Event Attribution Code (** 1=unrelated, 2=unlikely, 3=possible, 4=probable, 5=definite)
Descripción

CTCAdverseEventAttributionScale

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C25358
UMLS 2011AA Property
C0596130
End Of Active Surveillance
Descripción

End Of Active Surveillance

Will this patient continue on active surveillance
Descripción

ProtocolActivitySurveillanceDiscontinuedInd-2

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus ObjectClass
C43431
UMLS 2011AA ObjectClass
C0441655
NCI Thesaurus Property
C25484
UMLS 2011AA Property
C1444662
NCI Thesaurus Property
C15719
UMLS 2011AA Property
C0733511
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Date of the decision to stop active surveillance (If no, yyyy mmm dd CRF: Date of the decision to stop active surveillance)
Descripción

ProtocolActivitySurveillanceDiscontinuedDate

Tipo de datos

date

Alias
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus ObjectClass
C43431
UMLS 2011AA ObjectClass
C0441655
NCI Thesaurus Property
C25484
UMLS 2011AA Property
C1444662
NCI Thesaurus Property
C15719
UMLS 2011AA Property
C0733511
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Reason active surveillance was stopped
Descripción

ProtocolActivitySurveillanceDiscontinuedReason

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus ObjectClass
C43431
UMLS 2011AA ObjectClass
C0441655
NCI Thesaurus Property
C25484
UMLS 2011AA Property
C1444662
NCI Thesaurus Property
C15719
UMLS 2011AA Property
C0733511
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
Other specify
Descripción

ProtocolActivitySurveillanceDiscontinuedSpecify

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus ObjectClass
C43431
UMLS 2011AA ObjectClass
C0441655
NCI Thesaurus Property
C25484
UMLS 2011AA Property
C1444662
NCI Thesaurus Property
C15719
UMLS 2011AA Property
C0733511
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Patient choice Reason
Descripción

ProtocolActivitySurveillancePatientDiscontinuedText

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus ObjectClass
C43431
UMLS 2011AA ObjectClass
C0441655
NCI Thesaurus Property
C16960
UMLS 2011AA Property
C0030705
NCI Thesaurus Property
C25484
UMLS 2011AA Property
C1444662
NCI Thesaurus Property
C15719
UMLS 2011AA Property
C0733511
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
CTC Adverse Event Attribution Code (** 1=unrelated, 2=unlikely, 3=possible, 4=probable, 5=definite)
Descripción

CTCAdverseEventAttributionScale

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C25358
UMLS 2011AA Property
C0596130
Clinical judgement Reason
Descripción

ProtocolActivitySurveillancePhysicianDiscontinuedText

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus ObjectClass
C43431
UMLS 2011AA ObjectClass
C0441655
NCI Thesaurus Property
C25741
UMLS 2011AA Property
C0031831
NCI Thesaurus Property
C25484
UMLS 2011AA Property
C1444662
NCI Thesaurus Property
C15719
UMLS 2011AA Property
C0733511
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
Will the patient receive radical prostatectomy or radiation therapy
Descripción

RadicalProstateTherapyParticipatingInd-2

Tipo de datos

text

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

RadiationTherapyProcedureType

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C15313
UMLS 2011AA ObjectClass
C1522449
NCI Thesaurus Property
C25218
UMLS 2011AA Property
C1948041
Date of the decision that the patient will not receive radical prostatectomy or radiation therapy (If no, yyyy mmm dd)
Descripción

RadicalProstateTherapyNotParticipatingDate

Tipo de datos

date

Alias
NCI Thesaurus ObjectClass
C12410
UMLS 2011AA ObjectClass
C0033572
NCI Thesaurus ObjectClass
C15368
NCI Metathesaurus ObjectClass
C0439807
NCI Thesaurus Property
C25608
UMLS 2011AA Property
C0679823
NCI Thesaurus Property
C25594
UMLS 2011AA Property
C1518422
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Reason patient will not receive radical prostatectomy or radiation therapy
Descripción

RadicalProstateTherapyNotParticipatingReason

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C12410
UMLS 2011AA ObjectClass
C0033572
NCI Thesaurus ObjectClass
C15368
NCI Metathesaurus ObjectClass
C0439807
NCI Thesaurus Property
C25608
UMLS 2011AA Property
C0679823
NCI Thesaurus Property
C25594
UMLS 2011AA Property
C1518422
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
Other specify
Descripción

Off-treatmentReasonSpecify

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C25601
UMLS 2011AA ObjectClass
C1518544
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
CTC Adverse Event Term
Descripción

AdverseEventCommonTerminologyforAdverseEventsVersion4TermName

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C49704
UMLS 2011AA Property
C1516728
NCI Thesaurus Property
C45559
UMLS 2011AA Property
C1705313
NCI Thesaurus ValueDomain
C45255
UMLS 2011AA ValueDomain
C1708523
NCI Thesaurus ValueDomain
C49704
UMLS 2011AA ValueDomain
C1516728
NCI Thesaurus ValueDomain
C42614
UMLS 2011AA ValueDomain
C0027365
NCI Thesaurus ValueDomain
C45559
UMLS 2011AA ValueDomain
C1705313
NCI Thesaurus ValueDomain
C25714
UMLS 2011AA ValueDomain
C0333052
Grade (Grade according to NCI CTCAE, Version 4.0)
Descripción

AdverseEventSeverityGrade

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C48309
UMLS 2011AA Property
C0441800
NCI Thesaurus Property
C49705
UMLS 2011AA Property
C1710065
NCI Thesaurus Property
C25676
UMLS 2011AA Property
C0439793
NCI Thesaurus ValueDomain
C41331
UMLS 2011AA ValueDomain
C0877248
NCI Thesaurus ValueDomain
C48309
UMLS 2011AA ValueDomain
C0441800
NCI Thesaurus ValueDomain
C25676
UMLS 2011AA ValueDomain
C0439793
Planned Therapeutic Action for this patient (Please complete a Form 5 and follow the schedule of investigations listed in protocol section 9.2)
Descripción

TreatmentPlannedProcedure

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25619
UMLS 2011AA Property
C1301732
NCI Thesaurus ValueDomain
C25218
UMLS 2011AA ValueDomain
C1948041
Planned Therapeutic Action for this patient (Please complete a Form 5 and follow the schedule of investigations listed in protocol section 9.2)
Descripción

TreatmentPlannedProcedure

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25619
UMLS 2011AA Property
C1301732
NCI Thesaurus ValueDomain
C25218
UMLS 2011AA ValueDomain
C1948041
Correlative Studies
Descripción

Correlative Studies

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

TissueSpecimenCollectedInd-2

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C12801
UMLS 2011AA ObjectClass
C0040300
NCI Thesaurus ObjectClass
C19157
UMLS 2011AA ObjectClass
C0370003
NCI Thesaurus Property
C25452
This tissue was collected for
Descripción

TissueSpecimenCollectedInterval

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C12801
UMLS 2011AA ObjectClass
C0040300
NCI Thesaurus ObjectClass
C19157
UMLS 2011AA ObjectClass
C0370003
NCI Thesaurus Property
C25452
NCI Thesaurus ValueDomain
C25543
UMLS 2011AA ValueDomain
C1272706
Other
Descripción

TissueSpecimenCollectedPeriodSpecify

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C12801
UMLS 2011AA ObjectClass
C0040300
NCI Thesaurus ObjectClass
C19157
UMLS 2011AA ObjectClass
C0370003
NCI Thesaurus Property
C25452
Reason (Please provide)
Descripción

TissueSampleNotCollectedReasonText

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C19697
UMLS 2011AA ObjectClass
C1292533
NCI Thesaurus Property
C25594
UMLS 2011AA Property
C1518422
NCI Thesaurus Property
C25452
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
Quality Of Life Questionnaire
Descripción

Quality Of Life Questionnaire

Was QoL Questionnaire completed?
Descripción

QOLCompleteAssessmentIndicator

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C17047
UMLS 2011AA ObjectClass
C0518214
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
Date Questionnaire Completed (yyyy mmm dd Please submit quality of life questionnaires)
Descripción

QualityofLifeCompleteAssessmentDate

Tipo de datos

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C17047
UMLS 2011AA ObjectClass
C0518214
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Thesaurus Property
C25367
Reason Questionnaire was not Completed (check one)
Descripción

PatientIncompleteQuestionnaireReason

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Metathesaurus Property
C0034394
Other reason, specify
Descripción

PatientIncompleteQuestionnaireOtherSpecify

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ValueDomain
C17649
UMLS 2011AA ValueDomain
C0205394
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Metathesaurus Property
C0034394
Comments
Descripción

Comments

Comments
Descripción

ResearchCommentsText

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
UMLS 2011AA Property
C0282411
Supporting Documentation
Descripción

Supporting Documentation

Investigator Signature
Descripción

Investigator Signature

Person Completing Form, Last Name
Descripción

ResponsiblePersonLastName

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus ObjectClass
C25657
UMLS 2011AA ObjectClass
C1273518
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C25551
UMLS 2011AA Property
C1517741
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
Person Completing Form, First Name
Descripción

ResponsiblePersonFirstName

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus ObjectClass
C25657
UMLS 2011AA ObjectClass
C1273518
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C25509
UMLS 2011AA Property
C1279901
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
Date Form Originally Completed (yyyy - mmm - dd)
Descripción

FormOriginalCompleteDate

Tipo de datos

date

Alias
NCI Thesaurus ObjectClass
C19464
UMLS 2011AA ObjectClass
C0376315
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Thesaurus Property
C25604
UMLS 2011AA Property
C0205313
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
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Similar models

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

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
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)
Item Group
Month Of Report
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Item Group
Clinical Progression
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)
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)
Item Group
Adverse Event Status
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)
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)
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)
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)
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)
Item Group
Therapy For Lower Urinary Tract Symptoms/prostate Cancer Since The Last Report
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)
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)
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)
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)
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)
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)
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
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
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
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)
Item Group
Other Malignancies Or Marrow Dysplasia
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)
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)
Item Group
End Of Active Surveillance
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)
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)
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)
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)
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)
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)
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
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)
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)
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)
Item Group
Correlative Studies
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)
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)
Item Group
Quality Of Life Questionnaire
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)
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)
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)
Item Group
Supporting Documentation
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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