ID

2881

Beschreibung

NCIC-PR.11 Form 5S - Follow-Up after Distant Progression Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=0EF819B0-5956-1C96-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=0EF819B0-5956-1C96-E044-0003BA3F9857

Stichworte

Versionen (3)
  1. 19.09.12 19.09.12 -
  2. 09.01.15 09.01.15 - Martin Dugas
  3. 17.09.21 17.09.21 -
Hochgeladen am

19. September 2012

DOI

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Lizenz

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Prostate Cancer NCT00499174 Follow-Up - NCIC-PR.11 Form 5S - Follow-Up after Distant Progression - 2457398v1.0

Englisch

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

1 Formulare  
  1. StudyEvent: NCIC-PR.11 Form 5S - Follow-Up after Distant Progression
    1. These modules will be used on the majority of NCIC CTG case report forms submitted for CDE Review
Patient Information
Beschreibung

Patient Information

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

PatientNationalCancerInstituteofCanadaIdentifierNumber

Datentyp

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)
Beschreibung

PatientInitialsName

Datentyp

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)
Beschreibung

PatientMedicalRecordNumber

Datentyp

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
Beschreibung

PatientMultipleClinicalTrialsCooperativeGroupIdentifierNumber

Datentyp

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
Beschreibung

InstitutionName

Datentyp

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)
Beschreibung

NCIInstitutionIdentifierCode

Datentyp

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
Beschreibung

InvestigatorFirstName

Datentyp

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
Beschreibung

InvestigatorLastName

Datentyp

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)
Beschreibung

PhysicianInvestigatorIdentifierNumber

Datentyp

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
Beschreibung

Month Of Report

Month of report (circle one)
Beschreibung

VisitReportMonthCount

Datentyp

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
Beschreibung

VisitReportMonthSpecify

Datentyp

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
Beschreibung

Physical Exam

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

CancerFollow-UpStatusDate

Datentyp

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
Adverse Event Status
Beschreibung

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)
Beschreibung

AdverseEventNewPeriodicPersistentReportInd-3

Datentyp

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 Term (CTCAE Version 4.0)
Beschreibung

AdverseEventCommonTerminologyforAdverseEventsVersion4TermName

Datentyp

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 (Worst this time period If event no present, leave this field blank.)
Beschreibung

AdverseEventSeverityGrade

Datentyp

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
CTC Adverse Event Attribution Code (*Serious Adverse Event form required only if malignancy is thought to be possibly, probably, or definitely related to protocol therapy. See protocol...)
Beschreibung

CTCAdverseEventAttributionScale

Datentyp

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...)
Beschreibung

AdverseEventSeriousnessAttributionScale

Datentyp

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)
Beschreibung

SeriousAdverseEventReportInd-3

Datentyp

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

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

Non-protocol 5 alpha reductase inhibitors
Beschreibung

Non-protocolTherapy5Alpha-ReductaseInhibitorAdministeredInd-2

Datentyp

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
Beschreibung

Non-protocolTherapy5Alpha-ReductaseInhibitorAdministeredText

Datentyp

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
Beschreibung

Non-protocolTherapy5Alpha-ReductaseInhibitorAdministeredReason

Datentyp

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
Beschreibung

Non-protocolTherapyNonsteroidalAntiandrogenAdministeredInd-2

Datentyp

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
Beschreibung

Non-protocolTherapyNonsteroidalAntiandrogenAdministeredText

Datentyp

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
Beschreibung

HormoneTherapyNon-ProtocolGonadotropin-ReleasingHormoneAnalogAdministeredInd-2

Datentyp

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
Beschreibung

HormoneTherapyNon-ProtocolGonadotropin-ReleasingHormoneAnalogAdministeredText

Datentyp

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 )
Beschreibung

Non-protocolSurgeryPerformedInd-3

Datentyp

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 )
Beschreibung

Non-ProtocolTherapyAdministeredDate

Datentyp

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
Beschreibung

Non-ProtocolSurgeryProcedureText

Datentyp

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 )
Beschreibung

Non-protocolRadiationTherapyAdministeredInd-3

Datentyp

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 )
Beschreibung

Non-ProtocolRadiationTherapyAdministeredBeginDate

Datentyp

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
Beschreibung

Non-ProtocolRTAdministeredText

Datentyp

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)
Beschreibung

TherapyComplementaryandAlternativeMedicineAdministeredInd-2

Datentyp

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)
Beschreibung

TherapyComplementaryandAlternativeMedicineAdministeredText

Datentyp

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)
Beschreibung

Non-protocolTherapyOtherAdministeredInd-3

Datentyp

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 )
Beschreibung

Non-protocolTherapyOtherAdministeredName

Datentyp

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)
Beschreibung

Non-ProtocolTherapyFirstAdministeredDate

Datentyp

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)
Beschreibung

Non-ProtocolTherapyFirstAdministeredDate

Datentyp

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)
Beschreibung

Non-ProtocolTherapyFirstAdministeredDate

Datentyp

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)
Beschreibung

Non-ProtocolTherapyFirstAdministeredDate

Datentyp

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
Beschreibung

Other Malignancies Or Marrow Dysplasia

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

NewCancerDiagnosisInd-3

Datentyp

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)
Beschreibung

NewCancerDiagnosisDate

Datentyp

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)
Beschreibung

ProstateMalignantFindingText

Datentyp

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)
Beschreibung

NewCancerDiagnosisText

Datentyp

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 (*Serious Adverse Event form required only if malignancy is thought to be possibly, probably, or definitely related to protocol therapy. See protocol...)
Beschreibung

CTCAdverseEventAttributionScale

Datentyp

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
Comments
Beschreibung

Comments

Comments
Beschreibung

ResearchCommentsText

Datentyp

text

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

Supporting Documentation

Investigator Signature
Beschreibung

Investigator Signature

Person Completing Form, Last Name
Beschreibung

ResponsiblePersonLastName

Datentyp

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
Beschreibung

ResponsiblePersonFirstName

Datentyp

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)
Beschreibung

FormOriginalCompleteDate

Datentyp

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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Ähnliche Modelle

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

1 Formulare
  1. StudyEvent: NCIC-PR.11 Form 5S - Follow-Up after Distant Progression
    1. These modules will be used on the majority of NCIC CTG case report forms submitted for CDE Review
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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
6 (6)
CL Item
12 (12)
CL Item
18 (18)
CL Item
24 (24)
CL Item
36 (36)
CL Item
48 (48)
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 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.2
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 Term (CTCAE Version 4.0)
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)
CL.3
Code List
CTC Adverse Event Term (CTCAE Version 4.0)
CL Item
Fatigue (Fatigue)
CL Item
Diarrhea (Diarrhea)
CL Item
Proctitis (Proctitis)
CL Item
Abdominal Pain (Abdominal pain)
C26682 (NCI Thesaurus)
C0000737 (UMLS 2011AA)
CL Item
Alopecia (Alopecia)
CL Item
Non-infectious Cystitis (Cystitis noninfective)
C78250 (NCI Thesaurus)
C0403632 (UMLS 2011AA)
CL Item
Urinary Incontinence (Urinary incontinence)
CL Item
Urinary Frequency (Urinary frequency)
CL Item
Urinary Retention (Urinary retention)
CL Item
Impotence (Erectile dysfunction)
Item
Grade (Worst this time period If event no present, leave this field blank.)
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.4
Code List
Grade (Worst this time period If event no present, leave this field blank.)
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
CTC Adverse Event Attribution Code (*Serious Adverse Event form required only if malignancy is thought to be possibly, probably, or definitely related to protocol therapy. See protocol...)
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.16
Code List
CTC Adverse Event Attribution Code (*Serious Adverse Event form required only if malignancy is thought to be possibly, probably, or definitely related to protocol therapy. See protocol...)
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.6
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.7
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)
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.8
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.9
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.10
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.11
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.12
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.13
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.14
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.15
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 (*Serious Adverse Event form required only if malignancy is thought to be possibly, probably, or definitely related to protocol therapy. See protocol...)
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.16
Code List
CTC Adverse Event Attribution Code (*Serious Adverse Event form required only if malignancy is thought to be possibly, probably, or definitely related to protocol therapy. See protocol...)
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
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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