ID

43185

Description

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

Keywords

Versions (4)
  1. 9/19/12 9/19/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 1/9/15 1/9/15 - Martin Dugas
  4. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

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

English

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

1 forms  
Patient Information
Description

Patient Information

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

PatientNationalCancerInstituteofCanadaIdentifierNumber

Data type

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-2
C25582
UMLS 2011AA Property-2
C1513884
Patient Initials (first-middle-last)
Description

Patient Initials

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Patient Medical Record Number (if permitted by IRB)
Description

Medical Record Number

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1301894
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25261
NCI Thesaurus Property-2
C25198
Intergroup Patient Serial No
Description

PatientMultipleClinicalTrialsCooperativeGroupIdentifierNumber

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property-2
C17648
UMLS 2011AA Property-2
C0439064
NCI Thesaurus Property-3
C18205
UMLS 2011AA Property-3
C1521808
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
Institution Name
Description

Institution Name

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass
C21541
NCI Thesaurus ValueDomain-2
C21541
NCI Thesaurus Property
C25364
NCI Institution Number (CTEP assigned)
Description

NCIInstitutionIdentifierCode

Data type

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-2
C19202
UMLS 2011AA ObjectClass-2
C1513882
Investigator First Name
Description

InvestigatorFirstName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property-2
C25509
UMLS 2011AA Property-2
C1279901
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173
Investigator Last Name
Description

InvestigatorLastName

Data type

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-2
C25551
UMLS 2011AA Property-2
C1517741
Investigator Number (NCI Investigator Number)
Description

PhysicianInvestigatorIdentifierNumber

Data type

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-2
C17089
UMLS 2011AA ObjectClass-2
C0035173
Month Of Report
Description

Month Of Report

Month of report (circle one)
Description

VisitReportMonthCount

Data type

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-2
C25716
UMLS 2011AA ObjectClass-2
C0545082
Other
Description

VisitReportMonthSpecify

Data type

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-2
C25716
UMLS 2011AA ObjectClass-2
C0545082
Physical Exam
Description

Physical Exam

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

Follow-Up Date

Data type

date

Alias
NCI Thesaurus ObjectClass
C9305
UMLS CUI-1
C3694716
NCI Thesaurus Property
C16033
NCI Thesaurus Property-2
C25365
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
ECOG Performance Status (check one)
Description

ECOG Performance Status

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS CUI-1
C1520224
NCI Thesaurus Property
C25367
NCI Thesaurus ValueDomain-2
C25491
NCI Thesaurus ObjectClass
C20641
Digital Rectal Exam
Description

Digital Rectal Exam

Date of exam (yyyy mmm dd)
Description

PatientMedicalExaminationDate

Data type

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
Description

ProstateMalignantNeoplasmPalpableNoduleInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C12410
UMLS 2011AA ObjectClass
C0033572
NCI Thesaurus ObjectClass-2
C9305
UMLS 2011AA ObjectClass-2
C0006826
NCI Thesaurus Property
C25606
UMLS 2011AA Property
C0522499
NCI Thesaurus Property-2
C3280
UMLS 2011AA Property-2
C0028259
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Nodule is (If yes, CRF: Nodule is)
Description

ProstateMalignantNeoplasmPalpableNoduleType

Data type

text

Alias
NCI Thesaurus ObjectClass
C12410
UMLS 2011AA ObjectClass
C0033572
NCI Thesaurus ObjectClass-2
C9305
UMLS 2011AA ObjectClass-2
C0006826
NCI Thesaurus Property
C25606
UMLS 2011AA Property
C0522499
NCI Thesaurus Property-2
C3280
UMLS 2011AA Property-2
C0028259
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Maximum Diameter (cm)
Description

TumorMaximumDiameterMeasurement

Data type

float

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-2
C25564
UMLS 2011AA Property-2
C0806909
Psa Measurements
Description

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...)
Description

PSA

Data type

float

Measurement units
  • ng/ml
Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0138741
NCI Thesaurus Property
C17525
NCI Thesaurus Property-2
C20200
NCI Thesaurus Property-3
C17220
NCI Thesaurus ValueDomain
C25712
ng/ml
Units (* ng/mL, ug/L)
Description

AssessmentLabUOM

Data type

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)
Description

PSA date

Data type

date

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0138741
NCI Thesaurus Property
C17525
UMLS CUI-2
C0011008
NCI Thesaurus Property-2
C20200
NCI Thesaurus Property-3
C17220
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
PSA Doubling Time (CRF: PSA Doubling-time years)
Description

Prostate-SpecificAntigenDoubleTestVelocityRate

Data type

float

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
Description

Evaluation method

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C2911685
NCI Thesaurus ObjectClass
C20989
NCI Thesaurus Property
C16847
Other Specify
Description

Evaluation method, specify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C2911685
NCI Thesaurus ObjectClass
C20989
UMLS CUI-2
C1521902
NCI Thesaurus Property
C16847
Has the patient been diagnosed with a first biochemical progression?
Description

PSA Failure

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C2985506
NCI Thesaurus Property
C25626
NCI Thesaurus ObjectClass
C25331
NCI Thesaurus ObjectClass-2
C25434
Date of First Biochemical Progression (If yes, yyyy mmm dd)
Description

BiochemicalProgressionFirstDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C25331
NCI Thesaurus ObjectClass-2
C25434
UMLS 2011AA ObjectClass
C0205474
NCI Thesaurus Property
C25509
UMLS 2011AA Property
C1279901
NCI Thesaurus Property-2
C25275
UMLS 2011AA Property-2
C2745955
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25509
UMLS 2011AA ValueDomain-2
C1279901
Histology/grade
Description

Histology/grade

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

SpecimenGleasonScoreDate

Data type

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
Description

SpecimenGleasonScoreType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C19157
UMLS 2011AA ObjectClass
C0370003
NCI Thesaurus ObjectClass-2
C28084
UMLS 2011AA ObjectClass-2
C0332326
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Gleason Score, Primary Pattern (1-5)
Description

GleasonScorePrimaryPatternValue

Data type

float

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-2
C25336
UMLS 2011AA Property-2
C0449774
Gleason Score, Secondary Pattern (1-5)
Description

GleasonScoreSecondaryPatternValue

Data type

float

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-2
C25336
UMLS 2011AA Property-2
C0449774
Gleason Score, Combined (sum of the primary and secondary)
Description

GleasonScoreCombinedPatternValue

Data type

float

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-2
C25336
UMLS 2011AA Property-2
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)
Description

FirstProgressionHistologicDiagnosisInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25331
NCI Thesaurus ObjectClass-2
C25509
UMLS 2011AA ObjectClass
C1279901
NCI Thesaurus Property
C25526
UMLS 2011AA Property
C0205462
NCI Thesaurus Property-2
C15220
UMLS 2011AA Property-2
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)
Description

FirstProgressionHistologicDiagnosisDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C25331
NCI Thesaurus ObjectClass-2
C25509
UMLS 2011AA ObjectClass
C1279901
NCI Thesaurus Property
C25526
UMLS 2011AA Property
C0205462
NCI Thesaurus Property-2
C15220
UMLS 2011AA Property-2
C0011900
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Clinical Progression
Description

Clinical Progression

Has the patient developed a first local progression
Description

FirstProgressionLocalAnatomicLocationInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25331
NCI Thesaurus ObjectClass-2
C25509
UMLS 2011AA ObjectClass
C1279901
NCI Thesaurus Property
C25341
UMLS 2011AA Property
C0450429
NCI Thesaurus Property-2
C25421
UMLS 2011AA Property-2
C0002808
NCI Metathesaurus Property
C0443133
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Date of First Local Progression (If yes, yyyy mmm dd)
Description

FirstProgressionLocalAnatomicLocationDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C25331
NCI Thesaurus ObjectClass-2
C25509
UMLS 2011AA ObjectClass
C1279901
NCI Thesaurus Property
C25341
UMLS 2011AA Property
C0450429
NCI Thesaurus Property-2
C25421
UMLS 2011AA Property-2
C0002808
NCI Metathesaurus Property
C0443133
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
Has the patient been diagnosed with first distant progression?
Description

Neoplasm recurrence, Distal

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C19987
UMLS CUI-1
C0027627
NCI Thesaurus Property
C25321
NCI Thesaurus Property-2
C25509
NCI Thesaurus Property-3
C15220
NCI Thesaurus ValueDomain
C25180
Date of First Distant Progression (If yes, yyyy mmm dd)
Description

Date of Neoplasm distal recurrence

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0027627
NCI Thesaurus ObjectClass
C25331
NCI Thesaurus ValueDomain-2
C25509
UMLS CUI-2
C0011008
NCI Thesaurus Property
C25275
Adverse Event Status
Description

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)
Description

AdverseEventNewPeriodicPersistentReportInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25586
UMLS 2011AA Property
C0205314
NCI Thesaurus Property-2
C25375
UMLS 2011AA Property-2
C0684224
NCI Thesaurus Property-3
C43623
UMLS 2011AA Property-3
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)
Description

CTC Adverse Event Attribution Category

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS CUI-1
C1706735
NCI Thesaurus ObjectClass
C49704
NCI Thesaurus Property
C25358
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...)
Description

AdverseEventSeriousnessAttributionScale

Data type

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)
Description

SAE report

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C1519255
NCI Thesaurus ObjectClass
C41331
UMLS CUI-2
C0684224
NCI Thesaurus Property
C25375
NCI Thesaurus ObjectClass-2
C54035
CTC Adverse Event Term
Description

AdverseEventCommonTerminologyforAdverseEventsVersion4TermName

Data type

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C49704
UMLS 2011AA Property
C1516728
NCI Thesaurus Property-2
C45559
UMLS 2011AA Property-2
C1705313
NCI Thesaurus ValueDomain
C45255
UMLS 2011AA ValueDomain
C1708523
NCI Thesaurus ValueDomain-2
C49704
UMLS 2011AA ValueDomain-2
C1516728
NCI Thesaurus ValueDomain-3
C42614
UMLS 2011AA ValueDomain-3
C0027365
NCI Thesaurus ValueDomain-4
C45559
UMLS 2011AA ValueDomain-4
C1705313
NCI Thesaurus ValueDomain-5
C25714
UMLS 2011AA ValueDomain-5
C0333052
Grade (Grade according to NCI CTCAE, Version 4.0)
Description

AdverseEventSeverityGrade

Data type

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C48309
UMLS 2011AA Property
C0441800
NCI Thesaurus Property-2
C49705
UMLS 2011AA Property-2
C1710065
NCI Thesaurus Property-3
C25676
UMLS 2011AA Property-3
C0439793
NCI Thesaurus ValueDomain
C41331
UMLS 2011AA ValueDomain
C0877248
NCI Thesaurus ValueDomain-2
C48309
UMLS 2011AA ValueDomain-2
C0441800
NCI Thesaurus ValueDomain-3
C25676
UMLS 2011AA ValueDomain-3
C0439793
Therapy For Lower Urinary Tract Symptoms/prostate Cancer Since The Last Report
Description

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

Non-protocol 5 alpha reductase inhibitors
Description

Non-protocolTherapy5Alpha-ReductaseInhibitorAdministeredInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C25590
UMLS 2011AA ObjectClass
C1518384
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus Property-2
C2319
UMLS 2011AA Property-2
C1318898
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Agent
Description

Non-protocolTherapy5Alpha-ReductaseInhibitorAdministeredText

Data type

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C25590
UMLS 2011AA ObjectClass
C1518384
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus Property-2
C2319
UMLS 2011AA Property-2
C1318898
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
Reason for use
Description

Non-protocolTherapy5Alpha-ReductaseInhibitorAdministeredReason

Data type

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C25590
UMLS 2011AA ObjectClass
C1518384
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus Property-2
C2319
UMLS 2011AA Property-2
C1318898
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
Non-protocol non-steroidal antiandrogen therapy
Description

Non-protocolTherapyNonsteroidalAntiandrogenAdministeredInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
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
Description

Non-protocolTherapyNonsteroidalAntiandrogenAdministeredText

Data type

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
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
Description

HormoneTherapyNon-ProtocolGonadotropin-ReleasingHormoneAnalogAdministeredInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property
C25590
UMLS 2011AA Property
C1518384
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
NCI Thesaurus Property-3
C2022
UMLS 2011AA Property-3
C1518041
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Agent
Description

HormoneTherapyNon-ProtocolGonadotropin-ReleasingHormoneAnalogAdministeredText

Data type

text

Alias
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property
C25590
UMLS 2011AA Property
C1518384
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
NCI Thesaurus Property-3
C2022
UMLS 2011AA Property-3
C1518041
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
Non-Protocol Surgery? (for prostate cancer)
Description

Non-protocolSurgeryPerformedInd-3

Data type

boolean

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-2
C25590
UMLS 2011AA ObjectClass-2
C1518384
Date of Non-protocol therapy (If yes, Date of Non-protocol surgery yyyy-mmm-dd)
Description

Non-ProtocolTherapyAdministeredDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C25590
UMLS 2011AA ObjectClass
C1518384
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Non-Protocol Surgery Type
Description

Non-ProtocolSurgeryProcedureText

Data type

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-2
C25590
UMLS 2011AA ObjectClass-2
C1518384
Non-Protocol Radiation Therapy? (for prostate cancer)
Description

Non-protocolRadiationTherapyAdministeredInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C15313
UMLS 2011AA ObjectClass
C1522449
NCI Thesaurus ObjectClass-2
C25590
UMLS 2011AA ObjectClass-2
C1518384
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Non-Protocol Radiation Therapy Start Date (If yes, yyyy-mmm-dd)
Description

Non-ProtocolRadiationTherapyAdministeredBeginDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C15313
UMLS 2011AA ObjectClass
C1522449
NCI Thesaurus ObjectClass-2
C25590
UMLS 2011AA ObjectClass-2
C1518384
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25431
UMLS 2011AA ValueDomain-2
C0439659
Non-Protocol RT Type
Description

Non-ProtocolRTAdministeredText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C15313
UMLS 2011AA ObjectClass
C1522449
NCI Thesaurus ObjectClass-2
C25590
UMLS 2011AA ObjectClass-2
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)
Description

TherapyComplementaryandAlternativeMedicineAdministeredInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C15178
UMLS 2011AA Property
C0002346
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
Agent (If yes, *e.g. Saw Palmetto, Vitamin B/E, Selenium, Lycopene CRF: Agent)
Description

TherapyComplementaryandAlternativeMedicineAdministeredText

Data type

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-2
C25382
UMLS 2011AA Property-2
C1521801
Other Non-Protocol Therapy (for prostate cancer?)
Description

Non-protocolTherapyOtherAdministeredInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C25590
UMLS 2011AA ObjectClass
C1518384
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Name of Other Non-Protocol Therapy (If yes, for prostate cancer)
Description

Non-protocolTherapyOtherAdministeredName

Data type

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C25590
UMLS 2011AA ObjectClass
C1518384
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
NCI Thesaurus ValueDomain
C42614
UMLS 2011AA ValueDomain
C0027365
Date of First Non-Protocol Therapy (for Prostate Cancer yyyy-mmm-dd)
Description

Non-ProtocolTherapyFirstAdministeredDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C25590
UMLS 2011AA ObjectClass
C1518384
NCI Thesaurus Property
C25509
UMLS 2011AA Property
C1279901
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
Date of First Non-Protocol Therapy (for Prostate Cancer yyyy-mmm-dd)
Description

Non-ProtocolTherapyFirstAdministeredDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C25590
UMLS 2011AA ObjectClass
C1518384
NCI Thesaurus Property
C25509
UMLS 2011AA Property
C1279901
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
Date of First Non-Protocol Therapy (for Prostate Cancer yyyy-mmm-dd)
Description

Non-ProtocolTherapyFirstAdministeredDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C25590
UMLS 2011AA ObjectClass
C1518384
NCI Thesaurus Property
C25509
UMLS 2011AA Property
C1279901
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
Date of First Non-Protocol Therapy (for Prostate Cancer yyyy-mmm-dd)
Description

Non-ProtocolTherapyFirstAdministeredDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C25590
UMLS 2011AA ObjectClass
C1518384
NCI Thesaurus Property
C25509
UMLS 2011AA Property
C1279901
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
Other Malignancies Or Marrow Dysplasia
Description

Other Malignancies Or Marrow Dysplasia

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

NewCancerDiagnosisInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C25586
UMLS 2011AA ObjectClass
C0205314
NCI Thesaurus ObjectClass-2
C9305
UMLS 2011AA ObjectClass-2
C0006826
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
Date of Diagnosis (yyyy-mmm-dd)
Description

NewCancerDiagnosisDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C25586
UMLS 2011AA ObjectClass
C0205314
NCI Thesaurus ObjectClass-2
C9305
UMLS 2011AA ObjectClass-2
C0006826
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
Malignancy Type (e.g., bladder)
Description

ProstateMalignantFindingText

Data type

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-2
C3367
UMLS 2011AA Property-2
C0037088
New Primary Diagnosis (Histology/Cytopathology)
Description

NewCancerDiagnosisText

Data type

text

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

CTC Adverse Event Attribution Category

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS CUI-1
C1706735
NCI Thesaurus ObjectClass
C49704
NCI Thesaurus Property
C25358
End Of Active Surveillance
Description

End Of Active Surveillance

Will this patient continue on active surveillance
Description

ProtocolActivitySurveillanceDiscontinuedInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus ObjectClass-2
C43431
UMLS 2011AA ObjectClass-2
C0441655
NCI Thesaurus Property
C25484
UMLS 2011AA Property
C1444662
NCI Thesaurus Property-2
C15719
UMLS 2011AA Property-2
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)
Description

ProtocolActivitySurveillanceDiscontinuedDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus ObjectClass-2
C43431
UMLS 2011AA ObjectClass-2
C0441655
NCI Thesaurus Property
C25484
UMLS 2011AA Property
C1444662
NCI Thesaurus Property-2
C15719
UMLS 2011AA Property-2
C0733511
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Reason active surveillance was stopped
Description

ProtocolActivitySurveillanceDiscontinuedReason

Data type

text

Alias
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus ObjectClass-2
C43431
UMLS 2011AA ObjectClass-2
C0441655
NCI Thesaurus Property
C25484
UMLS 2011AA Property
C1444662
NCI Thesaurus Property-2
C15719
UMLS 2011AA Property-2
C0733511
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
Other specify
Description

ProtocolActivitySurveillanceDiscontinuedSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus ObjectClass-2
C43431
UMLS 2011AA ObjectClass-2
C0441655
NCI Thesaurus Property
C25484
UMLS 2011AA Property
C1444662
NCI Thesaurus Property-2
C15719
UMLS 2011AA Property-2
C0733511
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Patient choice Reason
Description

ProtocolActivitySurveillancePatientDiscontinuedText

Data type

text

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

CTC Adverse Event Attribution Category

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS CUI-1
C1706735
NCI Thesaurus ObjectClass
C49704
NCI Thesaurus Property
C25358
Clinical judgement Reason
Description

ProtocolActivitySurveillancePhysicianDiscontinuedText

Data type

text

Alias
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus ObjectClass-2
C43431
UMLS 2011AA ObjectClass-2
C0441655
NCI Thesaurus Property
C25741
UMLS 2011AA Property
C0031831
NCI Thesaurus Property-2
C25484
UMLS 2011AA Property-2
C1444662
NCI Thesaurus Property-3
C15719
UMLS 2011AA Property-3
C0733511
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
Will the patient receive radical prostatectomy or radiation therapy
Description

RadicalProstateTherapyParticipatingInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C12410
UMLS 2011AA ObjectClass
C0033572
NCI Thesaurus ObjectClass-2
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.)
Description

RadiationTherapyProcedureType

Data type

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)
Description

RadicalProstateTherapyNotParticipatingDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C12410
UMLS 2011AA ObjectClass
C0033572
NCI Thesaurus ObjectClass-2
C15368
NCI Metathesaurus ObjectClass
C0439807
NCI Thesaurus Property
C25608
UMLS 2011AA Property
C0679823
NCI Thesaurus Property-2
C25594
UMLS 2011AA Property-2
C1518422
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Reason patient will not receive radical prostatectomy or radiation therapy
Description

RadicalProstateTherapyNotParticipatingReason

Data type

text

Alias
NCI Thesaurus ObjectClass
C12410
UMLS 2011AA ObjectClass
C0033572
NCI Thesaurus ObjectClass-2
C15368
NCI Metathesaurus ObjectClass
C0439807
NCI Thesaurus Property
C25608
UMLS 2011AA Property
C0679823
NCI Thesaurus Property-2
C25594
UMLS 2011AA Property-2
C1518422
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
Other specify
Description

Off Treatment Reason, specify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C1518544
NCI Thesaurus ObjectClass
C25601
UMLS CUI-2
C0566251
NCI Thesaurus Property
C25365
UMLS CUI-3
C1521902
CTC Adverse Event Term
Description

AdverseEventCommonTerminologyforAdverseEventsVersion4TermName

Data type

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C49704
UMLS 2011AA Property
C1516728
NCI Thesaurus Property-2
C45559
UMLS 2011AA Property-2
C1705313
NCI Thesaurus ValueDomain
C45255
UMLS 2011AA ValueDomain
C1708523
NCI Thesaurus ValueDomain-2
C49704
UMLS 2011AA ValueDomain-2
C1516728
NCI Thesaurus ValueDomain-3
C42614
UMLS 2011AA ValueDomain-3
C0027365
NCI Thesaurus ValueDomain-4
C45559
UMLS 2011AA ValueDomain-4
C1705313
NCI Thesaurus ValueDomain-5
C25714
UMLS 2011AA ValueDomain-5
C0333052
Grade (Grade according to NCI CTCAE, Version 4.0)
Description

AdverseEventSeverityGrade

Data type

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C48309
UMLS 2011AA Property
C0441800
NCI Thesaurus Property-2
C49705
UMLS 2011AA Property-2
C1710065
NCI Thesaurus Property-3
C25676
UMLS 2011AA Property-3
C0439793
NCI Thesaurus ValueDomain
C41331
UMLS 2011AA ValueDomain
C0877248
NCI Thesaurus ValueDomain-2
C48309
UMLS 2011AA ValueDomain-2
C0441800
NCI Thesaurus ValueDomain-3
C25676
UMLS 2011AA ValueDomain-3
C0439793
Planned Therapeutic Action for this patient (Please complete a Form 5 and follow the schedule of investigations listed in protocol section 9.2)
Description

TreatmentPlannedProcedure

Data type

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)
Description

TreatmentPlannedProcedure

Data type

text

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

Correlative Studies

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

TissueSpecimenCollectedInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C12801
UMLS 2011AA ObjectClass
C0040300
NCI Thesaurus ObjectClass-2
C19157
UMLS 2011AA ObjectClass-2
C0370003
NCI Thesaurus Property
C25452
This tissue was collected for
Description

TissueSpecimenCollectedInterval

Data type

text

Alias
NCI Thesaurus ObjectClass
C12801
UMLS 2011AA ObjectClass
C0040300
NCI Thesaurus ObjectClass-2
C19157
UMLS 2011AA ObjectClass-2
C0370003
NCI Thesaurus Property
C25452
NCI Thesaurus ValueDomain
C25543
UMLS 2011AA ValueDomain
C1272706
Other
Description

TissueSpecimenCollectedPeriodSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C12801
UMLS 2011AA ObjectClass
C0040300
NCI Thesaurus ObjectClass-2
C19157
UMLS 2011AA ObjectClass-2
C0370003
NCI Thesaurus Property
C25452
Reason (Please provide)
Description

TissueSampleNotCollectedReasonText

Data type

text

Alias
NCI Thesaurus ObjectClass
C19697
UMLS 2011AA ObjectClass
C1292533
NCI Thesaurus Property
C25594
UMLS 2011AA Property
C1518422
NCI Thesaurus Property-2
C25452
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ValueDomain-2
C25638
UMLS 2011AA ValueDomain-2
C0392360
Quality Of Life Questionnaire
Description

Quality Of Life Questionnaire

Was QoL Questionnaire completed?
Description

QOLCompleteAssessmentIndicator

Data type

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)
Description

QualityofLifeCompleteAssessmentDate

Data type

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-2
C25367
Reason Questionnaire was not Completed (check one)
Description

Incomplete documentation, reason

Data type

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS CUI-1
C1548386
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C0566251
NCI Metathesaurus Property
C0034394
Other reason, specify
Description

PatientIncompleteQuestionnaireOtherSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ValueDomain-2
C17649
UMLS 2011AA ValueDomain-2
C0205394
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Metathesaurus Property
C0034394
Comments
Description

Comments

Comments
Description

Research Comments

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
Supporting Documentation
Description

Supporting Documentation

Investigator Signature
Description

Investigator Signature

Person Completing Form, Last Name
Description

Person Completing Form Last Name

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass-2
C25657
UMLS CUI-2
C1301584
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25551
NCI Thesaurus ValueDomain
C25191
Person Completing Form, First Name
Description

Person Completing Form First Name

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass-2
C25657
UMLS CUI-2
C1443235
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25509
NCI Thesaurus ValueDomain
C25191
Date Form Originally Completed (yyyy - mmm - dd)
Description

Form Completion Date

Data type

date

Alias
NCI Thesaurus ObjectClass
C19464
UMLS CUI-1
C1549507
NCI Thesaurus Property
C25250
NCI Thesaurus Property-2
C25604
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
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 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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-2)
C1513884 (UMLS 2011AA Property-2)
Patient Initials
Item
Patient Initials (first-middle-last)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Medical Record Number
Item
Patient Medical Record Number (if permitted by IRB)
text
C25337 (NCI Thesaurus ValueDomain)
C1301894 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25261 (NCI Thesaurus Property)
C25198 (NCI Thesaurus Property-2)
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-2)
C0439064 (UMLS 2011AA Property-2)
C18205 (NCI Thesaurus Property-3)
C1521808 (UMLS 2011AA Property-3)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
Institution Name
Item
Institution Name
text
C25191 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C21541 (NCI Thesaurus ValueDomain-2)
C25364 (NCI Thesaurus 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-2)
C1513882 (UMLS 2011AA ObjectClass-2)
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-2)
C1279901 (UMLS 2011AA Property-2)
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-2)
C1517741 (UMLS 2011AA Property-2)
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-2)
C0035173 (UMLS 2011AA ObjectClass-2)
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-2)
C0545082 (UMLS 2011AA ObjectClass-2)
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-2)
C0545082 (UMLS 2011AA ObjectClass-2)
Item Group
Physical Exam
Follow-Up Date
Item
Date of Last Clinical Assessment (yyyy - mmm - dd)
date
C9305 (NCI Thesaurus ObjectClass)
C3694716 (UMLS CUI-1)
C16033 (NCI Thesaurus Property)
C25365 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Item
ECOG Performance Status (check one)
text
C25664 (NCI Thesaurus ValueDomain)
C1520224 (UMLS CUI-1)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain-2)
C20641 (NCI Thesaurus 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)
ProstateMalignantNeoplasmPalpableNoduleInd-3
Item
Was the nodule palpable
boolean
C12410 (NCI Thesaurus ObjectClass)
C0033572 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
C25606 (NCI Thesaurus Property)
C0522499 (UMLS 2011AA Property)
C3280 (NCI Thesaurus Property-2)
C0028259 (UMLS 2011AA Property-2)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
Item
Nodule is (If yes, CRF: Nodule is)
text
C12410 (NCI Thesaurus ObjectClass)
C0033572 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
C25606 (NCI Thesaurus Property)
C0522499 (UMLS 2011AA Property)
C3280 (NCI Thesaurus Property-2)
C0028259 (UMLS 2011AA Property-2)
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)
float
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-2)
C0806909 (UMLS 2011AA Property-2)
Item Group
Psa Measurements
PSA
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...)
float
C25294 (NCI Thesaurus ObjectClass)
C0138741 (UMLS CUI-1)
C17525 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C17220 (NCI Thesaurus Property-3)
C25712 (NCI Thesaurus 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)
PSA date
Item
Date of PSA Assessment (yyyy mmm dd)
date
C25294 (NCI Thesaurus ObjectClass)
C0138741 (UMLS CUI-1)
C17525 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C20200 (NCI Thesaurus Property-2)
C17220 (NCI Thesaurus Property-3)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Prostate-SpecificAntigenDoubleTestVelocityRate
Item
PSA Doubling Time (CRF: PSA Doubling-time years)
float
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)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C16847 (NCI Thesaurus Property)
CL.6
Code List
Method
CL Item
Nomograms (MSK Nomogram)
C1450294 (NCI Metathesaurus)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
Evaluation method, specify
Item
Other Specify
text
C25685 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C1521902 (UMLS CUI-2)
C16847 (NCI Thesaurus Property)
PSA Failure
Item
Has the patient been diagnosed with a first biochemical progression?
boolean
C38148 (NCI Thesaurus ValueDomain)
C2985506 (UMLS CUI-1)
C25626 (NCI Thesaurus Property)
C25331 (NCI Thesaurus ObjectClass)
C25434 (NCI Thesaurus ObjectClass-2)
BiochemicalProgressionFirstDate
Item
Date of First Biochemical Progression (If yes, yyyy mmm dd)
date
C25331 (NCI Thesaurus ObjectClass)
C25434 (NCI Thesaurus ObjectClass-2)
C0205474 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property-2)
C2745955 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25509 (NCI Thesaurus ValueDomain-2)
C1279901 (UMLS 2011AA ValueDomain-2)
Item 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-2)
C0332326 (UMLS 2011AA ObjectClass-2)
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-3)
C0005558 (UMLS 2011AA-4)
CL Item
Surgical Specimen (Surgical specimen)
GleasonScorePrimaryPatternValue
Item
Gleason Score, Primary Pattern (1-5)
float
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-2)
C0449774 (UMLS 2011AA Property-2)
GleasonScoreSecondaryPatternValue
Item
Gleason Score, Secondary Pattern (1-5)
float
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-2)
C0449774 (UMLS 2011AA Property-2)
GleasonScoreCombinedPatternValue
Item
Gleason Score, Combined (sum of the primary and secondary)
float
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-2)
C0449774 (UMLS 2011AA Property-2)
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)
boolean
C25331 (NCI Thesaurus ObjectClass)
C25509 (NCI Thesaurus ObjectClass-2)
C1279901 (UMLS 2011AA ObjectClass)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property-2)
C0011900 (UMLS 2011AA Property-2)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
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-2)
C1279901 (UMLS 2011AA ObjectClass)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property-2)
C0011900 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item Group
Clinical Progression
FirstProgressionLocalAnatomicLocationInd-3
Item
Has the patient developed a first local progression
boolean
C25331 (NCI Thesaurus ObjectClass)
C25509 (NCI Thesaurus ObjectClass-2)
C1279901 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25421 (NCI Thesaurus Property-2)
C0002808 (UMLS 2011AA Property-2)
C0443133 (NCI Metathesaurus Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
FirstProgressionLocalAnatomicLocationDate
Item
Date of First Local Progression (If yes, yyyy mmm dd)
date
C25331 (NCI Thesaurus ObjectClass)
C25509 (NCI Thesaurus ObjectClass-2)
C1279901 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25421 (NCI Thesaurus Property-2)
C0002808 (UMLS 2011AA Property-2)
C0443133 (NCI Metathesaurus Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Neoplasm recurrence, Distal
Item
Has the patient been diagnosed with first distant progression?
boolean
C19987 (NCI Thesaurus ObjectClass)
C0027627 (UMLS CUI-1)
C25321 (NCI Thesaurus Property)
C25509 (NCI Thesaurus Property-2)
C15220 (NCI Thesaurus Property-3)
C25180 (NCI Thesaurus ValueDomain)
Date of Neoplasm distal recurrence
Item
Date of First Distant Progression (If yes, yyyy mmm dd)
date
C25164 (NCI Thesaurus ValueDomain)
C0027627 (UMLS CUI-1)
C25331 (NCI Thesaurus ObjectClass)
C25509 (NCI Thesaurus ValueDomain-2)
C0011008 (UMLS CUI-2)
C25275 (NCI Thesaurus Property)
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)
boolean
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25586 (NCI Thesaurus Property)
C0205314 (UMLS 2011AA Property)
C25375 (NCI Thesaurus Property-2)
C0684224 (UMLS 2011AA Property-2)
C43623 (NCI Thesaurus Property-3)
C0205322 (UMLS 2011AA Property-3)
CL158136 (NCI Metathesaurus Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
Item
CTC Adverse Event Attribution Code (** 1=unrelated, 2=unlikely, 3=possible, 4=probable, 5=definite)
text
C25664 (NCI Thesaurus ValueDomain)
C1706735 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C25358 (NCI Thesaurus 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)
SAE report
Item
SAE report submitted (NCIC CTG use only Default=N enter Y only for adverse events recorded on SAE report)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1519255 (UMLS CUI-1)
C41331 (NCI Thesaurus ObjectClass)
C0684224 (UMLS CUI-2)
C25375 (NCI Thesaurus Property)
C54035 (NCI Thesaurus ObjectClass-2)
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-2)
C1705313 (UMLS 2011AA Property-2)
C45255 (NCI Thesaurus ValueDomain)
C1708523 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ValueDomain-2)
C1516728 (UMLS 2011AA ValueDomain-2)
C42614 (NCI Thesaurus ValueDomain-3)
C0027365 (UMLS 2011AA ValueDomain-3)
C45559 (NCI Thesaurus ValueDomain-4)
C1705313 (UMLS 2011AA ValueDomain-4)
C25714 (NCI Thesaurus ValueDomain-5)
C0333052 (UMLS 2011AA ValueDomain-5)
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-2)
C1710065 (UMLS 2011AA Property-2)
C25676 (NCI Thesaurus Property-3)
C0439793 (UMLS 2011AA Property-3)
C41331 (NCI Thesaurus ValueDomain)
C0877248 (UMLS 2011AA ValueDomain)
C48309 (NCI Thesaurus ValueDomain-2)
C0441800 (UMLS 2011AA ValueDomain-2)
C25676 (NCI Thesaurus ValueDomain-3)
C0439793 (UMLS 2011AA ValueDomain-3)
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
Non-protocolTherapy5Alpha-ReductaseInhibitorAdministeredInd-2
Item
Non-protocol 5 alpha reductase inhibitors
boolean
C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C2319 (NCI Thesaurus Property-2)
C1318898 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Non-protocolTherapy5Alpha-ReductaseInhibitorAdministeredText
Item
Agent
text
C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C2319 (NCI Thesaurus Property-2)
C1318898 (UMLS 2011AA Property-2)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
Non-protocolTherapy5Alpha-ReductaseInhibitorAdministeredReason
Item
Reason for use
text
C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C2319 (NCI Thesaurus Property-2)
C1318898 (UMLS 2011AA Property-2)
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
Non-protocolTherapyNonsteroidalAntiandrogenAdministeredInd-2
Item
Non-protocol non-steroidal antiandrogen therapy
boolean
C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
CL316360 (NCI Metathesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Non-protocolTherapyNonsteroidalAntiandrogenAdministeredText
Item
Agent
text
C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
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
boolean
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25590 (NCI Thesaurus Property)
C1518384 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C2022 (NCI Thesaurus Property-3)
C1518041 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
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-2)
C1521801 (UMLS 2011AA Property-2)
C2022 (NCI Thesaurus Property-3)
C1518041 (UMLS 2011AA Property-3)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
Non-protocolSurgeryPerformedInd-3
Item
Non-Protocol Surgery? (for prostate cancer)
boolean
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-2)
C1518384 (UMLS 2011AA ObjectClass-2)
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-2)
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-2)
C1518384 (UMLS 2011AA ObjectClass-2)
Non-protocolRadiationTherapyAdministeredInd-3
Item
Non-Protocol Radiation Therapy? (for prostate cancer)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
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-2)
C1518384 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)
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-2)
C1518384 (UMLS 2011AA ObjectClass-2)
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)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C15178 (NCI Thesaurus Property)
C0002346 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
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-2)
C1521801 (UMLS 2011AA Property-2)
Non-protocolTherapyOtherAdministeredInd-3
Item
Other Non-Protocol Therapy (for prostate cancer?)
boolean
C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
Non-protocolTherapyOtherAdministeredName
Item
Name of Other Non-Protocol Therapy (If yes, for prostate cancer)
text
C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
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-2)
C1518384 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Non-ProtocolTherapyFirstAdministeredDate
Item
Date of First Non-Protocol Therapy (for Prostate Cancer yyyy-mmm-dd)
date
C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Non-ProtocolTherapyFirstAdministeredDate
Item
Date of First Non-Protocol Therapy (for Prostate Cancer yyyy-mmm-dd)
date
C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Non-ProtocolTherapyFirstAdministeredDate
Item
Date of First Non-Protocol Therapy (for Prostate Cancer yyyy-mmm-dd)
date
C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
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)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
NewCancerDiagnosisDate
Item
Date of Diagnosis (yyyy-mmm-dd)
date
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
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-2)
C0037088 (UMLS 2011AA Property-2)
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-2)
C0006826 (UMLS 2011AA ObjectClass-2)
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)
C1706735 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C25358 (NCI Thesaurus 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
ProtocolActivitySurveillanceDiscontinuedInd-2
Item
Will this patient continue on active surveillance
boolean
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C43431 (NCI Thesaurus ObjectClass-2)
C0441655 (UMLS 2011AA ObjectClass-2)
C25484 (NCI Thesaurus Property)
C1444662 (UMLS 2011AA Property)
C15719 (NCI Thesaurus Property-2)
C0733511 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
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-2)
C0441655 (UMLS 2011AA ObjectClass-2)
C25484 (NCI Thesaurus Property)
C1444662 (UMLS 2011AA Property)
C15719 (NCI Thesaurus Property-2)
C0733511 (UMLS 2011AA Property-2)
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-2)
C0441655 (UMLS 2011AA ObjectClass-2)
C25484 (NCI Thesaurus Property)
C1444662 (UMLS 2011AA Property)
C15719 (NCI Thesaurus Property-2)
C0733511 (UMLS 2011AA Property-2)
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-2)
C0441655 (UMLS 2011AA ObjectClass-2)
C25484 (NCI Thesaurus Property)
C1444662 (UMLS 2011AA Property)
C15719 (NCI Thesaurus Property-2)
C0733511 (UMLS 2011AA Property-2)
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-2)
C0441655 (UMLS 2011AA ObjectClass-2)
C16960 (NCI Thesaurus Property)
C0030705 (UMLS 2011AA Property)
C25484 (NCI Thesaurus Property-2)
C1444662 (UMLS 2011AA Property-2)
C15719 (NCI Thesaurus Property-3)
C0733511 (UMLS 2011AA Property-3)
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)
C1706735 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C25358 (NCI Thesaurus 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-2)
C0441655 (UMLS 2011AA ObjectClass-2)
C25741 (NCI Thesaurus Property)
C0031831 (UMLS 2011AA Property)
C25484 (NCI Thesaurus Property-2)
C1444662 (UMLS 2011AA Property-2)
C15719 (NCI Thesaurus Property-3)
C0733511 (UMLS 2011AA Property-3)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
RadicalProstateTherapyParticipatingInd-2
Item
Will the patient receive radical prostatectomy or radiation therapy
boolean
C12410 (NCI Thesaurus ObjectClass)
C0033572 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C0439807 (NCI Metathesaurus ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
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-2)
C0439807 (NCI Metathesaurus ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25594 (NCI Thesaurus Property-2)
C1518422 (UMLS 2011AA Property-2)
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-2)
C0439807 (NCI Metathesaurus ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25594 (NCI Thesaurus Property-2)
C1518422 (UMLS 2011AA Property-2)
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 Treatment Reason, specify
Item
Other specify
text
C25685 (NCI Thesaurus ValueDomain)
C1518544 (UMLS CUI-1)
C25601 (NCI Thesaurus ObjectClass)
C0566251 (UMLS CUI-2)
C25365 (NCI Thesaurus Property)
C1521902 (UMLS CUI-3)
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-2)
C1705313 (UMLS 2011AA Property-2)
C45255 (NCI Thesaurus ValueDomain)
C1708523 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ValueDomain-2)
C1516728 (UMLS 2011AA ValueDomain-2)
C42614 (NCI Thesaurus ValueDomain-3)
C0027365 (UMLS 2011AA ValueDomain-3)
C45559 (NCI Thesaurus ValueDomain-4)
C1705313 (UMLS 2011AA ValueDomain-4)
C25714 (NCI Thesaurus ValueDomain-5)
C0333052 (UMLS 2011AA ValueDomain-5)
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-2)
C1710065 (UMLS 2011AA Property-2)
C25676 (NCI Thesaurus Property-3)
C0439793 (UMLS 2011AA Property-3)
C41331 (NCI Thesaurus ValueDomain)
C0877248 (UMLS 2011AA ValueDomain)
C48309 (NCI Thesaurus ValueDomain-2)
C0441800 (UMLS 2011AA ValueDomain-2)
C25676 (NCI Thesaurus ValueDomain-3)
C0439793 (UMLS 2011AA ValueDomain-3)
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
TissueSpecimenCollectedInd-2
Item
Was tissue collected for tumor banking (at the time of randomization)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C12801 (NCI Thesaurus ObjectClass)
C0040300 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
C25452 (NCI Thesaurus Property)
Item
This tissue was collected for
text
C12801 (NCI Thesaurus ObjectClass)
C0040300 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
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-2)
C0370003 (UMLS 2011AA ObjectClass-2)
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-2)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25638 (NCI Thesaurus ValueDomain-2)
C0392360 (UMLS 2011AA ValueDomain-2)
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-2)
Item
Reason Questionnaire was not Completed (check one)
text
C25638 (NCI Thesaurus ValueDomain)
C1548386 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C0566251 (UMLS CUI-2)
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-2)
C0205394 (UMLS 2011AA ValueDomain-2)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C0034394 (NCI Metathesaurus Property)
Item Group
Comments
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
Item Group
Supporting Documentation
Item Group
Investigator Signature
Person Completing Form Last Name
Item
Person Completing Form, Last Name
text
C25190 (NCI Thesaurus ObjectClass)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass-2)
C1301584 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25551 (NCI Thesaurus Property-2)
C25191 (NCI Thesaurus ValueDomain)
Person Completing Form First Name
Item
Person Completing Form, First Name
text
C25190 (NCI Thesaurus ObjectClass)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass-2)
C1443235 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25509 (NCI Thesaurus Property-2)
C25191 (NCI Thesaurus ValueDomain)
Form Completion Date
Item
Date Form Originally Completed (yyyy - mmm - dd)
date
C19464 (NCI Thesaurus ObjectClass)
C1549507 (UMLS CUI-1)
C25250 (NCI Thesaurus Property)
C25604 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
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