ID

6343

Description

ECOG E3805 On-Study Form Androgen Ablation Therapy With or Without Chemotherapy in Treating Patients With Metastatic Prostate Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=F96DE7A1-1997-4F8E-E034-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=F96DE7A1-1997-4F8E-E034-0003BA3F9857

Keywords

Versions (3)
  1. 12/18/14 12/18/14 - Martin Dugas
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 6/16/15 6/16/15 -
Uploaded on

December 18, 2014

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Prostate Cancer NCT00309985 On-Study - ECOG E3805 On-Study Form - 2233653v1.0

English

INSTRUCTIONS: Use this form to capture the first occurrence of non-protocol anti-tumor therapy per registration step

1 forms  
Unnamed1
Description

Unnamed1

ECOG Protocol Number
Description

ProtocolECOGIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C25491
UMLS 2011AA Property
C1512162
ECOG Patient ID
Description

PatientECOGIdentifierNumber

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
C25491
UMLS 2011AA Property
C1512162
DCI Name
Description

CollectedDataFormName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus Property
C19464
UMLS 2011AA Property
C0376315
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus ObjectClass
C25452
Registration Step
Description

RegistrationStepNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25646
UMLS 2011AA ObjectClass
C1514821
NCI Thesaurus Property
C16154
UMLS 2011AA Property
C1704379
NCI Thesaurus ValueDomain
C16154
UMLS 2011AA ValueDomain
C1704379
Reporting Period
Description

ReportingEvaluationPeriodType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C25214
UMLS 2011AA ObjectClass
C0220825
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus ObjectClass
C25651
UMLS 2011AA ObjectClass
C0700287
Unnamed2
Description

Unnamed2

ECOG Protocol Number
Description

ProtocolECOGIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C25491
UMLS 2011AA Property
C1512162
Patient Initials
Description

PatientInitialsName

Data type

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
ECOG Patient ID
Description

PatientECOGIdentifierNumber

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
C25491
UMLS 2011AA Property
C1512162
Participating Group Protocol Number
Description

ProtocolParticipatingIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C25608
UMLS 2011AA Property
C0679823
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Institution/Affiliate
Description

CombinedInstitutionName

Data type

text

Alias
NCI Thesaurus ObjectClass
C25454
UMLS 2011AA ObjectClass
C0205195
NCI Thesaurus ObjectClass
C21541
UMLS 2011AA ObjectClass
C0018704
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ValueDomain
C21541
UMLS 2011AA ValueDomain
C0018704
Participating Group Patient ID
Description

PatientParticipatingIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25608
UMLS 2011AA Property
C0679823
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Unnamed3
Description

Unnamed3

Please mark an 'X' if data have been amended.
Description

DataAmendedText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C25416
UMLS 2011AA Property
C1691222
Date data amended
Description

DataAmendedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C25416
UMLS 2011AA Property
C1691222
NCI Thesaurus ValueDomain
C25367
Performance Status
Description

Performance Status

Performance Status
Description

PerformanceStatusAssessmentEasternCooperativeOncologyGroupScale

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
NCI Thesaurus Property
C25367
NCI Thesaurus ValueDomain
C25491
UMLS 2011AA ValueDomain
C1512162
NCI Thesaurus ObjectClass
C20641
UMLS 2011AA ObjectClass
C1518965
Weight (Day 1 - kg)
Description

PatientWeightMeasurement

Data type

double

Measurement units
  • Kg
Alias
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25208
UMLS 2011AA Property
C0043100
Kg
Height (cm)
Description

PatientHeightMeasurement

Data type

double

Measurement units
  • cm
Alias
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25347
UMLS 2011AA Property
C0489786
cm
Description Of Primary Disease
Description

Description Of Primary Disease

Gleason Grade, Primary
Description

GleasonScorePrimaryPatternValue

Data type

double

Alias
NCI Thesaurus Property
C25251
UMLS 2011AA Property
C0205225
NCI Thesaurus ObjectClass
C28084
UMLS 2011AA ObjectClass
C0332326
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus Property
C25336
UMLS 2011AA Property
C0449774
Mark an 'X' if unknown
Description

DataUnknownText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C17998
UMLS 2011AA Property
C0439673
Mark an 'X' if unknown
Description

DataUnknownText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C17998
UMLS 2011AA Property
C0439673
Mark an 'X' if unknown
Description

DataUnknownText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C17998
UMLS 2011AA Property
C0439673
Gleason Grade, Secondary
Description

GleasonScoreSecondaryPatternValue

Data type

double

Alias
NCI Thesaurus Property
C25667
UMLS 2011AA Property
C0175668
NCI Thesaurus ObjectClass
C28084
UMLS 2011AA ObjectClass
C0332326
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus Property
C25336
UMLS 2011AA Property
C0449774
PSA Value at Diagnosis
Description

LaboratoryProcedureFirstDiagnosisProstate-SpecificAntigenOutcomeValue

Data type

double

Measurement units
  • ng/ml
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C17525
UMLS 2011AA Property
C0138741
NCI Thesaurus Property
C25509
UMLS 2011AA Property
C1279901
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
ng/ml
Date of diagnosis
Description

NewCancerDiagnosisDate

Data type

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
Pathologic T Stage
Description

ProstateTumorPathologicTStage

Data type

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass
C12410
UMLS 2011AA ObjectClass
C0033572
NCI Thesaurus Property
C25610
UMLS 2011AA Property
C1521733
NCI Thesaurus Property
C25728
UMLS 2011AA Property
C0475455
NCI Thesaurus ValueDomain
C16899
UMLS 2011AA ValueDomain
C1300072
Pathologic N Stage
Description

ProstateTumorPathologicNStage

Data type

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass
C12410
UMLS 2011AA ObjectClass
C0033572
NCI Thesaurus Property
C25610
UMLS 2011AA Property
C1521733
NCI Thesaurus Property
C25580
UMLS 2011AA Property
C0456532
NCI Thesaurus ValueDomain
C16899
UMLS 2011AA ValueDomain
C1300072
Pathologic M Stage
Description

ProstateTumorPathologicMStage

Data type

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass
C12410
UMLS 2011AA ObjectClass
C0033572
NCI Thesaurus Property
C25610
UMLS 2011AA Property
C1521733
NCI Thesaurus Property
C25727
UMLS 2011AA Property
C0456533
NCI Thesaurus ValueDomain
C16899
UMLS 2011AA ValueDomain
C1300072
Clinical T Stage
Description

ProstateTumorClinicalTStage

Data type

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass
C12410
UMLS 2011AA ObjectClass
C0033572
NCI Thesaurus Property
C25398
UMLS 2011AA Property
C0205210
NCI Thesaurus Property
C25728
UMLS 2011AA Property
C0475455
NCI Thesaurus ValueDomain
C16899
UMLS 2011AA ValueDomain
C1300072
Clinical N Stage
Description

ProstateTumorClinicalNStage

Data type

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass
C12410
UMLS 2011AA ObjectClass
C0033572
NCI Thesaurus Property
C25398
UMLS 2011AA Property
C0205210
NCI Thesaurus Property
C25580
UMLS 2011AA Property
C0456532
NCI Thesaurus ValueDomain
C16899
UMLS 2011AA ValueDomain
C1300072
Clinical M Stage
Description

ProstateTumorClinicalMStage

Data type

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass
C12410
UMLS 2011AA ObjectClass
C0033572
NCI Thesaurus Property
C25398
UMLS 2011AA Property
C0205210
NCI Thesaurus Property
C25727
UMLS 2011AA Property
C0456533
NCI Thesaurus ValueDomain
C16899
UMLS 2011AA ValueDomain
C1300072
Extent Of Disease
Description

Extent Of Disease

Did the patient have High or Low Volume Disease
Description

DiseaseExtentType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property
C25332
UMLS 2011AA Property
C0439792
Visceral disease (Nature of High Volume Disease - Extensive Disease - NOTE: High Volume Disease Extensive Disease: Metastases involving at least one lesion in any bony structure beyond the vertebral column and pelvic bone or any involvement with viscera. In the absence of visceral lesions, there must be 4 or more bone lesions.)
Description

VisceralNeoplasmPresentInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C25315
UMLS 2011AA ObjectClass
C0442045
Lung (Visceral)
Description

MalignantNeoplasmLungMetastaticInvolvementInd-3

Data type

text

Alias
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C14174
UMLS 2011AA Property
C0036525
NCI Thesaurus Property
C12468
UMLS 2011AA Property
C0024109
NCI Thesaurus Property
C25548
UMLS 2011AA Property
C1314939
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Liver (Visceral)
Description

MalignantNeoplasmLiverMetastaticInvolvementInd-3

Data type

text

Alias
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C14174
UMLS 2011AA Property
C0036525
NCI Thesaurus Property
C12392
UMLS 2011AA Property
C0023884
NCI Thesaurus Property
C25548
UMLS 2011AA Property
C1314939
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Other (Visceral)
Description

MalignantNeoplasmMetastaticInvolvementInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C14174
UMLS 2011AA Property
C0036525
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C25548
UMLS 2011AA Property
C1314939
Other visceral specify
Description

MalignantNeoplasmVisceralMetastaticInvolvementSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C14174
UMLS 2011AA Property
C0036525
NCI Thesaurus Property
C25548
UMLS 2011AA Property
C1314939
NCI Thesaurus Property
C25315
UMLS 2011AA Property
C0442045
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
4 or more bone lesions
Description

MultipleBoneLesionPresentInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C12366
UMLS 2011AA ObjectClass
C0262950
NCI Thesaurus ObjectClass
C17648
UMLS 2011AA ObjectClass
C0439064
Bone Metastasis (If High Volume Disease Extensive Disease, answer each of the following)
Description

MalignantNeoplasmBoneMetastaticInvolvementInd-3

Data type

text

Alias
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C14174
UMLS 2011AA Property
C0036525
NCI Thesaurus Property
C12366
UMLS 2011AA Property
C0262950
NCI Thesaurus Property
C25548
UMLS 2011AA Property
C1314939
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Number of bone metastases (If yes: - Are any of the following involved?)
Description

MalignantNeoplasmBoneMetastaticInvolvementCount

Data type

double

Alias
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C14174
UMLS 2011AA Property
C0036525
NCI Thesaurus Property
C12366
UMLS 2011AA Property
C0262950
NCI Thesaurus Property
C25548
UMLS 2011AA Property
C1314939
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
Vertebral column
Description

MalignantNeoplasmVertebralColumnMetastaticInvolvementInd-3

Data type

text

Alias
NCI Thesaurus ObjectClass
C12366
UMLS 2011AA ObjectClass
C0262950
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C14174
UMLS 2011AA Property
C0036525
NCI Thesaurus Property
C25548
UMLS 2011AA Property
C1314939
NCI Thesaurus Property
C12998
UMLS 2011AA Property
C0037949
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Pelvic bone
Description

MalignantNeoplasmPelvicBoneMetastaticInvolvementInd-3

Data type

text

Alias
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C14174
UMLS 2011AA Property
C0036525
NCI Thesaurus Property
C25548
UMLS 2011AA Property
C1314939
NCI Thesaurus Property
C33287
UMLS 2011AA Property
C0030786
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Ribs
Description

MalignantNeoplasmRibMetastaticInvolvementInd-3

Data type

text

Alias
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C14174
UMLS 2011AA Property
C0036525
NCI Thesaurus Property
C12782
UMLS 2011AA Property
C0035561
NCI Thesaurus Property
C25548
UMLS 2011AA Property
C1314939
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Arms
Description

MalignantNeoplasmArmMetastaticInvolvementInd-3

Data type

text

Alias
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C14174
UMLS 2011AA Property
C0036525
NCI Thesaurus Property
C32141
UMLS 2011AA Property
C1140618
NCI Thesaurus Property
C25548
UMLS 2011AA Property
C1314939
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Legs
Description

MalignantNeoplasmLegMetastaticInvolvementInd-3

Data type

text

Alias
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C14174
UMLS 2011AA Property
C0036525
NCI Thesaurus Property
C32974
UMLS 2011AA Property
C1140621
NCI Thesaurus Property
C25548
UMLS 2011AA Property
C1314939
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Skull
Description

MalignantNeoplasmSkullMetastaticInvolvementInd-3

Data type

text

Alias
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C14174
UMLS 2011AA Property
C0036525
NCI Thesaurus Property
C25548
UMLS 2011AA Property
C1314939
NCI Thesaurus Property
C12789
UMLS 2011AA Property
C0037303
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Other
Description

MalignantNeoplasmOtherBoneMetastaticInvolvementInd-3

Data type

text

Alias
NCI Thesaurus ObjectClass
C17649
UMLS 2011AA ObjectClass
C0205394
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property
C14174
UMLS 2011AA Property
C0036525
NCI Thesaurus Property
C12366
UMLS 2011AA Property
C0262950
NCI Thesaurus Property
C25548
UMLS 2011AA Property
C1314939
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Specify
Description

MalignantNeoplasmOtherBoneMetastaticInvolvementSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C17649
UMLS 2011AA ObjectClass
C0205394
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property
C14174
UMLS 2011AA Property
C0036525
NCI Thesaurus Property
C12366
UMLS 2011AA Property
C0262950
NCI Thesaurus Property
C25548
UMLS 2011AA Property
C1314939
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Prior Treatment
Description

Prior Treatment

Prior Surgery
Description

PriorSurgeryPerformedInd-3

Data type

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
C25629
UMLS 2011AA ObjectClass
C0332152
Prior Prostatectomy
Description

PriorProstatectomyPerformedInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus ObjectClass
C15307
UMLS 2011AA ObjectClass
C0033573
Prior Orchiectomy
Description

PriorOrchiectomyPerformedInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus ObjectClass
C15288
UMLS 2011AA ObjectClass
C0007347
Date of prior surgery (most recent)
Description

PriorSurgeryDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C15329
UMLS 2011AA ObjectClass
C0543467
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
Prior Radiation Therapy
Description

PriorRTAdministeredInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C15313
UMLS 2011AA ObjectClass
C1522449
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
RT Purpose Type (If yes,)
Description

RTPurposeType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C15313
UMLS 2011AA ObjectClass
C1522449
NCI Thesaurus Property
C25634
UMLS 2011AA Property
C1285529
Date Prior RT Ended
Description

PriorRTEndDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C15313
UMLS 2011AA ObjectClass
C1522449
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
NCI Thesaurus Property
C25496
UMLS 2011AA Property
C2746065
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Prior RT Site
Description

PriorRTSite

Data type

text

Alias
NCI Thesaurus ValueDomain
C13717
UMLS 2011AA ValueDomain
C1515974
NCI Thesaurus Property
C25341
UMLS 2011AA Property
C0450429
NCI Thesaurus ObjectClass
C15313
UMLS 2011AA ObjectClass
C1522449
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
Prior Hormonal Therapy (NOTE: ADT received within 120 days prior to randomization should NOT be coded in this section. Please report details of prior ADT in the Androgen Deprivation section on page 3.)
Description

PriorHormonalTherapyAdministeredInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Was prior hormonal therapy adjuvant? (If yes,)
Description

AdjuvantHormonalTherapyPriorAdministeredInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus ObjectClass
C2140
UMLS 2011AA ObjectClass
C0001552
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Date Prior hormonal therapy Ended
Description

PriorHormonalTherapyEndDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
NCI Thesaurus Property
C25496
UMLS 2011AA Property
C2746065
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Prior Hormonal Therapy Type
Description

PriorHormonalTherapyName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
Any Other Prior Therapy? (excluding chemotherapy)
Description

PriorTherapyOtherAdministeredInd-3

Data type

text

Alias
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Date Other Prior Therapy Ended
Description

PriorTherapyOtherEndDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Name of other prior therapies
Description

PriorTherapyOtherName

Data type

text

Alias
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ValueDomain
C42614
UMLS 2011AA ValueDomain
C0027365
Has or will the patient received bisphosphonates (or other FDA approved drugs for delaying skeletal related events) at the start of ADT?
Description

TherapeuticProcedureBiphosphonateAntiandrogenTherapyAdministeredInd-3

Data type

text

Alias
NCI Thesaurus ObjectClass
C49236
UMLS 2011AA ObjectClass
C0087111
NCI Thesaurus Property
C443
UMLS 2011AA Property
C0012544
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus Property
C15481
UMLS 2011AA Property
C0279492
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Androgen Deprivation
Description

Androgen Deprivation

Baseline PSA Value (ng/ml)
Description

LaboratoryProcedureBaselineProstate-SpecificAntigenOutcomeValue

Data type

double

Measurement units
  • ng/ml
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C17525
UMLS 2011AA Property
C0138741
NCI Thesaurus Property
C25213
UMLS 2011AA Property
C1442488
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
ng/ml
Date of PSA Assessment
Description

LaboratoryProcedureProstate-SpecificAntigenTumorMarkerResultDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C17525
UMLS 2011AA Property
C0138741
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C17220
UMLS 2011AA Property
C0041365
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
Baseline Psa Value
Description

Baseline Psa Value

Has patient begun Androgen Deprivation
Description

AndrogenSuppressionTherapyAdministrationInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25409
UMLS 2011AA Property
C1533734
NCI Thesaurus ObjectClass
C15676
UMLS 2011AA ObjectClass
C1515985
Start date of Androgen Deprivation
Description

AndrogenSuppressionTherapyAdministrationBeginDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass
C15676
UMLS 2011AA ObjectClass
C1515985
NCI Thesaurus Property
C25409
UMLS 2011AA Property
C1533734
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25431
UMLS 2011AA ValueDomain
C0439659
Date of PSA Assessment
Description

LaboratoryProcedureProstate-SpecificAntigenTumorMarkerResultDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C17525
UMLS 2011AA Property
C0138741
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C17220
UMLS 2011AA Property
C0041365
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
Date of PSA Assessment
Description

LaboratoryProcedureProstate-SpecificAntigenTumorMarkerResultDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C17525
UMLS 2011AA Property
C0138741
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C17220
UMLS 2011AA Property
C0041365
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
Pre-ADT PSA
Description

LaboratoryProcedureBaselineProstate-SpecificAntigenPriorAntiandrogenTherapyOutcomeValue

Data type

double

Measurement units
  • ng/ml
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C17525
UMLS 2011AA Property
C0138741
NCI Thesaurus Property
C25213
UMLS 2011AA Property
C1442488
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property
C15481
UMLS 2011AA Property
C0279492
NCI Metathesaurus Property
CL025479
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
ng/ml
Type of Androgen Deprivation
Description

AndrogenSuppressionTherapyAdministrationType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25409
UMLS 2011AA Property
C1533734
NCI Thesaurus ObjectClass
C15676
UMLS 2011AA ObjectClass
C1515985
Is androgen blockade planned to be continued?
Description

AndrogenSuppressionTherapyContinuedAdministrationInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass
C15676
UMLS 2011AA ObjectClass
C1515985
NCI Thesaurus Property
C25409
UMLS 2011AA Property
C1533734
NCI Metathesaurus Property
C0750536
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Highest PSA (since start of ADT)
Description

LaboratoryProcedureHighestLevelProstate-SpecificAntigenResultValue

Data type

double

Measurement units
  • ng/ml
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C17525
UMLS 2011AA Property
C0138741
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C25525
UMLS 2011AA Property
C1522410
NCI Thesaurus Property
C25554
UMLS 2011AA Property
C0441889
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
ng/ml
Lowest PSA (since start of ADT)
Description

LaboratoryProcedureLowestLevelProstate-SpecificAntigenResultValue

Data type

double

Measurement units
  • ng/ml
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C17525
UMLS 2011AA Property
C0138741
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C25554
UMLS 2011AA Property
C0441889
NCI Thesaurus Property
C43517
UMLS 2011AA Property
C1708760
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
ng/ml
Metabolic Syndrome
Description

Metabolic Syndrome

Fasting AM glucose > 110 mg/dl
Description

HyperglycemiaPresentInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C26797
UMLS 2011AA ObjectClass
C0020456
Hypertension (SBP >= 140 and/or DBP <= 90 mmHG)
Description

HypertensionPresentInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C3117
UMLS 2011AA ObjectClass
C0020538
Obesity (BMI >= 30 kg/m^2)
Description

ObesityPresentInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C3283
UMLS 2011AA ObjectClass
C0028754
Hypertriglyceridemia (triglycerides > 150 mg/dl)
Description

HypertriglyceridemiaPresentInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C37971
UMLS 2011AA ObjectClass
C1522137
HDL >40 mg/dl
Description

HighDensityLipoproteinHighPresentInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus Property
C25227
UMLS 2011AA Property
C0205250
NCI Thesaurus ObjectClass
C25186
UMLS 2011AA ObjectClass
C0023821
At the time of study entry was patient receiving metformin
Description

MetforminHydrochlorideAgentCurrentAdministeredInd-3

Data type

text

Alias
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ObjectClass
C29251
UMLS 2011AA ObjectClass
C0591573
NCI Thesaurus Property
C25471
UMLS 2011AA Property
C0521116
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Is treatment with metformin planning on being continued while on study
Description

MetforminHydrochlorideAgentConcurrentAdministeredInd-3

Data type

text

Alias
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ObjectClass
C29251
UMLS 2011AA ObjectClass
C0591573
NCI Thesaurus Property
C25456
UMLS 2011AA Property
C0205420
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Baseline Abnormalities
Description

Baseline Abnormalities

CTC Adverse Event Term
Description

CommonToxicityCriteriaAdverseEventTermType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C45559
UMLS 2011AA Property
C1705313
CTC Adverse Event Grade
Description

CommonToxicityCriteriaAdverseEventGrade

Data type

double

Alias
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus ValueDomain
C18000
UMLS 2011AA ValueDomain
C0919553
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Comments
Description

Comments

Investigator Signature
Description

InvestigatorSignatureText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus Property
C25678
UMLS 2011AA Property
C1519316
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173
Investigator Signature Date
Description

InvestigatorSignatureDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25678
UMLS 2011AA Property
C1519316
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173
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Similar models

INSTRUCTIONS: Use this form to capture the first occurrence of non-protocol anti-tumor therapy per registration step

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Unnamed1
ProtocolECOGIdentifierNumber
Item
ECOG Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25491 (NCI Thesaurus Property)
C1512162 (UMLS 2011AA Property)
PatientECOGIdentifierNumber
Item
ECOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25491 (NCI Thesaurus Property)
C1512162 (UMLS 2011AA Property)
CollectedDataFormName
Item
DCI Name
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C19464 (NCI Thesaurus Property)
C0376315 (UMLS 2011AA Property)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25452 (NCI Thesaurus ObjectClass)
RegistrationStepNumber
Item
Registration Step
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25646 (NCI Thesaurus ObjectClass)
C1514821 (UMLS 2011AA ObjectClass)
C16154 (NCI Thesaurus Property)
C1704379 (UMLS 2011AA Property)
C16154 (NCI Thesaurus ValueDomain)
C1704379 (UMLS 2011AA ValueDomain)
Item
Reporting Period
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus ObjectClass)
C0220825 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25651 (NCI Thesaurus ObjectClass)
C0700287 (UMLS 2011AA ObjectClass)
CL.1
Code List
Reporting Period
CL Item
Baseline (Baseline)
C25213 (NCI Thesaurus)
C1442488 (UMLS 2011AA)
Item Group
Unnamed2
ProtocolECOGIdentifierNumber
Item
ECOG Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25491 (NCI Thesaurus Property)
C1512162 (UMLS 2011AA Property)
PatientInitialsName
Item
Patient Initials
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)
PatientECOGIdentifierNumber
Item
ECOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25491 (NCI Thesaurus Property)
C1512162 (UMLS 2011AA Property)
ProtocolParticipatingIdentifierNumber
Item
Participating Group Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
CombinedInstitutionName
Item
Institution/Affiliate
text
C25454 (NCI Thesaurus ObjectClass)
C0205195 (UMLS 2011AA ObjectClass)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ValueDomain)
C0018704 (UMLS 2011AA ValueDomain)
PatientParticipatingIdentifierNumber
Item
Participating Group Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
Item Group
Unnamed3
DataAmendedText
Item
Please mark an 'X' if data have been amended.
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
DataAmendedDate
Item
Date data amended
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain)
Item Group
Performance Status
Item
Performance Status
text
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain)
C1512162 (UMLS 2011AA ValueDomain)
C20641 (NCI Thesaurus ObjectClass)
C1518965 (UMLS 2011AA ObjectClass)
CL.2
Code List
Performance Status
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)
PatientWeightMeasurement
Item
Weight (Day 1 - kg)
double
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25208 (NCI Thesaurus Property)
C0043100 (UMLS 2011AA Property)
PatientHeightMeasurement
Item
Height (cm)
double
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25347 (NCI Thesaurus Property)
C0489786 (UMLS 2011AA Property)
Item Group
Description Of Primary Disease
Item
Gleason Grade, Primary
double
C25251 (NCI Thesaurus Property)
C0205225 (UMLS 2011AA Property)
C28084 (NCI Thesaurus ObjectClass)
C0332326 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25336 (NCI Thesaurus Property)
C0449774 (UMLS 2011AA Property)
CL.3
Code List
Gleason Grade, Primary
CL Item
1 (1)
CL Item
2 (2)
C66833 (NCI Thesaurus)
C0205448 (UMLS 2011AA)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
DataUnknownText
Item
Mark an 'X' if unknown
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C17998 (NCI Thesaurus Property)
C0439673 (UMLS 2011AA Property)
DataUnknownText
Item
Mark an 'X' if unknown
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C17998 (NCI Thesaurus Property)
C0439673 (UMLS 2011AA Property)
DataUnknownText
Item
Mark an 'X' if unknown
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C17998 (NCI Thesaurus Property)
C0439673 (UMLS 2011AA Property)
Item
Gleason Grade, Secondary
double
C25667 (NCI Thesaurus Property)
C0175668 (UMLS 2011AA Property)
C28084 (NCI Thesaurus ObjectClass)
C0332326 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25336 (NCI Thesaurus Property)
C0449774 (UMLS 2011AA Property)
CL.4
Code List
Gleason Grade, Secondary
CL Item
1 (1)
CL Item
2 (2)
C66833 (NCI Thesaurus)
C0205448 (UMLS 2011AA)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
LaboratoryProcedureFirstDiagnosisProstate-SpecificAntigenOutcomeValue
Item
PSA Value at Diagnosis
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C17525 (NCI Thesaurus Property)
C0138741 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
NewCancerDiagnosisDate
Item
Date of diagnosis
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)
Item
Pathologic T Stage
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12410 (NCI Thesaurus ObjectClass)
C0033572 (UMLS 2011AA ObjectClass)
C25610 (NCI Thesaurus Property)
C1521733 (UMLS 2011AA Property)
C25728 (NCI Thesaurus Property)
C0475455 (UMLS 2011AA Property)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
CL.5
Code List
Pathologic T Stage
CL Item
Organ Confined (pT2)
CL Item
Unilateral (pT2a)
C28012 (NCI Thesaurus)
C0205092 (UMLS 2011AA)
CL Item
Bilateral (pT2b)
C13332 (NCI Thesaurus)
C0238767 (UMLS 2011AA)
C13332 (NCI Thesaurus)
C0238767 (UMLS 2011AA)
CL Item
Extraprostatic Extension (pT3)
CL Item
Extraprostatic Extension (pT3a)
CL Item
Seminal Vesicle Invasion (pT3b)
CL Item
Invasion Of Bladder, Rectum (pT4)
Item
Pathologic N Stage
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12410 (NCI Thesaurus ObjectClass)
C0033572 (UMLS 2011AA ObjectClass)
C25610 (NCI Thesaurus Property)
C1521733 (UMLS 2011AA Property)
C25580 (NCI Thesaurus Property)
C0456532 (UMLS 2011AA Property)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
CL.6
Code List
Pathologic N Stage
CL Item
No Regional Lymph Node Metastasis (N0)
CL Item
Metastatis In Regional Lymph Node Or Nodes (see Ajcc Definition) (N1)
CL Item
Regional Lymph Nodes Cannot Be Assessed (NX)
Item
Pathologic M Stage
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12410 (NCI Thesaurus ObjectClass)
C0033572 (UMLS 2011AA ObjectClass)
C25610 (NCI Thesaurus Property)
C1521733 (UMLS 2011AA Property)
C25727 (NCI Thesaurus Property)
C0456533 (UMLS 2011AA Property)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
CL.7
Code List
Pathologic M Stage
CL Item
No Distant Metastasis (M0)
CL Item
Nonregional Lymph Node(s) (M1a)
CL Item
Bone(s) (M1b)
CL Item
Other Site(s) With Or Without Bone Disease (M1c)
CL Item
Distant Metastasis Cannot Be Assessed (not Evaluated By Any Modality) (MX)
Item
Clinical T Stage
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12410 (NCI Thesaurus ObjectClass)
C0033572 (UMLS 2011AA ObjectClass)
C25398 (NCI Thesaurus Property)
C0205210 (UMLS 2011AA Property)
C25728 (NCI Thesaurus Property)
C0475455 (UMLS 2011AA Property)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
CL.8
Code List
Clinical T Stage
CL Item
No Evidence Of Primary Tumor (T0)
CL Item
Clinically Inapparent Tumor Not Palpable Nor Visible By Imaging (T1)
CL Item
Tumor Incidental Histologic Finding In 5% Or Less Of Tissue Resected (T1a)
CL Item
Tumor Incidental Histologic Finding In More Than 5% Of Tissue Resected (T1b)
CL Item
Tumor Identified By Needle Biopsy (eg, Because Of Elevated Psa) (T1c)
CL Item
Tumor Confined Within The Prostate (T2)
CL Item
Tumor Involves One Lobe (T2a)
CL Item
Tumor Involves Both Lobes (T2b)
CL Item
Tumor Extends Through The Prostate Capule (T3)
CL Item
Extracapsular Extension (unilateral Or Bilateral) (T3a)
CL Item
Tumor Invades Seminal Vesicle(s) (T3b)
CL Item
Tumor Is Fixed Or Invades Adjacent Structures Other Than Seminal Vesicles: Bladder Neck, External Sphincter, Or Rectum, Levator Muscles, And/or Pelvic Wall (T4)
CL Item
Primary Tumor Cannot Be Assessed (TX)
Item
Clinical N Stage
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12410 (NCI Thesaurus ObjectClass)
C0033572 (UMLS 2011AA ObjectClass)
C25398 (NCI Thesaurus Property)
C0205210 (UMLS 2011AA Property)
C25580 (NCI Thesaurus Property)
C0456532 (UMLS 2011AA Property)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
CL.9
Code List
Clinical N Stage
CL Item
No Regional Lymph Node Metastasis (N0)
CL Item
Metastatis In Regional Lymph Node Or Nodes (see Ajcc Definition) (N1)
CL Item
Regional Lymph Nodes Cannot Be Assessed (NX)
Item
Clinical M Stage
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12410 (NCI Thesaurus ObjectClass)
C0033572 (UMLS 2011AA ObjectClass)
C25398 (NCI Thesaurus Property)
C0205210 (UMLS 2011AA Property)
C25727 (NCI Thesaurus Property)
C0456533 (UMLS 2011AA Property)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
CL.10
Code List
Clinical M Stage
CL Item
No Distant Metastasis (M0)
CL Item
Distant Metastasis (M1)
C18206 (NCI Thesaurus)
C1269798 (UMLS 2011AA)
CL Item
Nonregional Lymph Node(s) (M1a)
CL Item
Bone(s) (M1b)
CL Item
Other Site(s) (M1c)
CL Item
Distant Metastasis Cannot Be Assessed (MX)
Item Group
Extent Of Disease
Item
Did the patient have High or Low Volume Disease
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25332 (NCI Thesaurus Property)
C0439792 (UMLS 2011AA Property)
CL.11
Code List
Did the patient have High or Low Volume Disease
CL Item
High Volume (High Volume)
CL Item
Low Volume (Low Volume)
Item
Visceral disease (Nature of High Volume Disease - Extensive Disease - NOTE: High Volume Disease Extensive Disease: Metastases involving at least one lesion in any bony structure beyond the vertebral column and pelvic bone or any involvement with viscera. In the absence of visceral lesions, there must be 4 or more bone lesions.)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C25315 (NCI Thesaurus ObjectClass)
C0442045 (UMLS 2011AA ObjectClass)
CL.12
Code List
Visceral disease (Nature of High Volume Disease - Extensive Disease - NOTE: High Volume Disease Extensive Disease: Metastases involving at least one lesion in any bony structure beyond the vertebral column and pelvic bone or any involvement with viscera. In the absence of visceral lesions, there must be 4 or more bone lesions.)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Lung (Visceral)
text
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C14174 (NCI Thesaurus Property)
C0036525 (UMLS 2011AA Property)
C12468 (NCI Thesaurus Property)
C0024109 (UMLS 2011AA Property)
C25548 (NCI Thesaurus Property)
C1314939 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.13
Code List
Lung (Visceral)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Liver (Visceral)
text
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C14174 (NCI Thesaurus Property)
C0036525 (UMLS 2011AA Property)
C12392 (NCI Thesaurus Property)
C0023884 (UMLS 2011AA Property)
C25548 (NCI Thesaurus Property)
C1314939 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.14
Code List
Liver (Visceral)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Other (Visceral)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C14174 (NCI Thesaurus Property)
C0036525 (UMLS 2011AA Property)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25548 (NCI Thesaurus Property)
C1314939 (UMLS 2011AA Property)
CL.15
Code List
Other (Visceral)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
MalignantNeoplasmVisceralMetastaticInvolvementSpecify
Item
Other visceral specify
text
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C14174 (NCI Thesaurus Property)
C0036525 (UMLS 2011AA Property)
C25548 (NCI Thesaurus Property)
C1314939 (UMLS 2011AA Property)
C25315 (NCI Thesaurus Property)
C0442045 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Item
4 or more bone lesions
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C12366 (NCI Thesaurus ObjectClass)
C0262950 (UMLS 2011AA ObjectClass)
C17648 (NCI Thesaurus ObjectClass)
C0439064 (UMLS 2011AA ObjectClass)
CL.16
Code List
4 or more bone lesions
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Not Evaluable (Not evaluable)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Bone Metastasis (If High Volume Disease Extensive Disease, answer each of the following)
text
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C14174 (NCI Thesaurus Property)
C0036525 (UMLS 2011AA Property)
C12366 (NCI Thesaurus Property)
C0262950 (UMLS 2011AA Property)
C25548 (NCI Thesaurus Property)
C1314939 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.17
Code List
Bone Metastasis (If High Volume Disease Extensive Disease, answer each of the following)
CL Item
No (NO)
CL Item
Yes (YES)
MalignantNeoplasmBoneMetastaticInvolvementCount
Item
Number of bone metastases (If yes: - Are any of the following involved?)
double
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C14174 (NCI Thesaurus Property)
C0036525 (UMLS 2011AA Property)
C12366 (NCI Thesaurus Property)
C0262950 (UMLS 2011AA Property)
C25548 (NCI Thesaurus Property)
C1314939 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
Item
Vertebral column
text
C12366 (NCI Thesaurus ObjectClass)
C0262950 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C14174 (NCI Thesaurus Property)
C0036525 (UMLS 2011AA Property)
C25548 (NCI Thesaurus Property)
C1314939 (UMLS 2011AA Property)
C12998 (NCI Thesaurus Property)
C0037949 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.18
Code List
Vertebral column
CL Item
No (NO)
CL Item
Yes (YES)
Item
Pelvic bone
text
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C14174 (NCI Thesaurus Property)
C0036525 (UMLS 2011AA Property)
C25548 (NCI Thesaurus Property)
C1314939 (UMLS 2011AA Property)
C33287 (NCI Thesaurus Property)
C0030786 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.19
Code List
Pelvic bone
CL Item
No (NO)
CL Item
Yes (YES)
Item
Ribs
text
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C14174 (NCI Thesaurus Property)
C0036525 (UMLS 2011AA Property)
C12782 (NCI Thesaurus Property)
C0035561 (UMLS 2011AA Property)
C25548 (NCI Thesaurus Property)
C1314939 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.20
Code List
Ribs
CL Item
No (NO)
CL Item
Yes (YES)
Item
Arms
text
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C14174 (NCI Thesaurus Property)
C0036525 (UMLS 2011AA Property)
C32141 (NCI Thesaurus Property)
C1140618 (UMLS 2011AA Property)
C25548 (NCI Thesaurus Property)
C1314939 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.21
Code List
Arms
CL Item
No (NO)
CL Item
Yes (YES)
Item
Legs
text
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C14174 (NCI Thesaurus Property)
C0036525 (UMLS 2011AA Property)
C32974 (NCI Thesaurus Property)
C1140621 (UMLS 2011AA Property)
C25548 (NCI Thesaurus Property)
C1314939 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.22
Code List
Legs
CL Item
No (NO)
CL Item
Yes (YES)
Item
Skull
text
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C14174 (NCI Thesaurus Property)
C0036525 (UMLS 2011AA Property)
C25548 (NCI Thesaurus Property)
C1314939 (UMLS 2011AA Property)
C12789 (NCI Thesaurus Property)
C0037303 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.23
Code List
Skull
CL Item
No (NO)
CL Item
Yes (YES)
Item
Other
text
C17649 (NCI Thesaurus ObjectClass)
C0205394 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C14174 (NCI Thesaurus Property)
C0036525 (UMLS 2011AA Property)
C12366 (NCI Thesaurus Property)
C0262950 (UMLS 2011AA Property)
C25548 (NCI Thesaurus Property)
C1314939 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.24
Code List
Other
CL Item
No (NO)
CL Item
Yes (YES)
MalignantNeoplasmOtherBoneMetastaticInvolvementSpecify
Item
Specify
text
C17649 (NCI Thesaurus ObjectClass)
C0205394 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C14174 (NCI Thesaurus Property)
C0036525 (UMLS 2011AA Property)
C12366 (NCI Thesaurus Property)
C0262950 (UMLS 2011AA Property)
C25548 (NCI Thesaurus Property)
C1314939 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Item Group
Prior Treatment
Item
Prior Surgery
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)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
CL.25
Code List
Prior Surgery
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Prior Prostatectomy
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15307 (NCI Thesaurus ObjectClass)
C0033573 (UMLS 2011AA ObjectClass)
CL.26
Code List
Prior Prostatectomy
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Prior Orchiectomy
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15288 (NCI Thesaurus ObjectClass)
C0007347 (UMLS 2011AA ObjectClass)
CL.27
Code List
Prior Orchiectomy
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
PriorSurgeryDate
Item
Date of prior surgery (most recent)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
Item
Prior Radiation Therapy
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
CL.28
Code List
Prior Radiation Therapy
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
RT Purpose Type (If yes,)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25634 (NCI Thesaurus Property)
C1285529 (UMLS 2011AA Property)
CL.29
Code List
RT Purpose Type (If yes,)
CL Item
Definitive (definitive)
CL Item
Palliative (palliative)
PriorRTEndDate
Item
Date Prior RT Ended
date
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25496 (NCI Thesaurus Property)
C2746065 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
PriorRTSite
Item
Prior RT Site
text
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
Item
Prior Hormonal Therapy (NOTE: ADT received within 120 days prior to randomization should NOT be coded in this section. Please report details of prior ADT in the Androgen Deprivation section on page 3.)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
CL.30
Code List
Prior Hormonal Therapy (NOTE: ADT received within 120 days prior to randomization should NOT be coded in this section. Please report details of prior ADT in the Androgen Deprivation section on page 3.)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Was prior hormonal therapy adjuvant? (If yes,)
text
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C2140 (NCI Thesaurus ObjectClass)
C0001552 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.31
Code List
Was prior hormonal therapy adjuvant? (If yes,)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
PriorHormonalTherapyEndDate
Item
Date Prior hormonal therapy Ended
date
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25496 (NCI Thesaurus Property)
C2746065 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
PriorHormonalTherapyName
Item
Prior Hormonal Therapy Type
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
Item
Any Other Prior Therapy? (excluding chemotherapy)
text
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus 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.32
Code List
Any Other Prior Therapy? (excluding chemotherapy)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
PriorTherapyOtherEndDate
Item
Date Other Prior Therapy Ended
date
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
PriorTherapyOtherName
Item
Name of other prior therapies
text
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)
Item
Has or will the patient received bisphosphonates (or other FDA approved drugs for delaying skeletal related events) at the start of ADT?
text
C49236 (NCI Thesaurus ObjectClass)
C0087111 (UMLS 2011AA ObjectClass)
C443 (NCI Thesaurus Property)
C0012544 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C15481 (NCI Thesaurus Property)
C0279492 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.33
Code List
Has or will the patient received bisphosphonates (or other FDA approved drugs for delaying skeletal related events) at the start of ADT?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Androgen Deprivation
LaboratoryProcedureBaselineProstate-SpecificAntigenOutcomeValue
Item
Baseline PSA Value (ng/ml)
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C17525 (NCI Thesaurus Property)
C0138741 (UMLS 2011AA Property)
C25213 (NCI Thesaurus Property)
C1442488 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureProstate-SpecificAntigenTumorMarkerResultDate
Item
Date of PSA Assessment
date
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C17525 (NCI Thesaurus Property)
C0138741 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C17220 (NCI Thesaurus Property)
C0041365 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
Item Group
Baseline Psa Value
Item
Has patient begun Androgen Deprivation
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C15676 (NCI Thesaurus ObjectClass)
C1515985 (UMLS 2011AA ObjectClass)
CL.34
Code List
Has patient begun Androgen Deprivation
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
AndrogenSuppressionTherapyAdministrationBeginDate
Item
Start date of Androgen Deprivation
date
C15368 (NCI Thesaurus ObjectClass)
C15676 (NCI Thesaurus ObjectClass)
C1515985 (UMLS 2011AA ObjectClass)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)
LaboratoryProcedureProstate-SpecificAntigenTumorMarkerResultDate
Item
Date of PSA Assessment
date
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C17525 (NCI Thesaurus Property)
C0138741 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C17220 (NCI Thesaurus Property)
C0041365 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
LaboratoryProcedureProstate-SpecificAntigenTumorMarkerResultDate
Item
Date of PSA Assessment
date
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C17525 (NCI Thesaurus Property)
C0138741 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C17220 (NCI Thesaurus Property)
C0041365 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
LaboratoryProcedureBaselineProstate-SpecificAntigenPriorAntiandrogenTherapyOutcomeValue
Item
Pre-ADT PSA
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C17525 (NCI Thesaurus Property)
C0138741 (UMLS 2011AA Property)
C25213 (NCI Thesaurus Property)
C1442488 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C15481 (NCI Thesaurus Property)
C0279492 (UMLS 2011AA Property)
CL025479 (NCI Metathesaurus Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
Item
Type of Androgen Deprivation
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C15676 (NCI Thesaurus ObjectClass)
C1515985 (UMLS 2011AA ObjectClass)
CL.35
Code List
Type of Androgen Deprivation
CL Item
Combined (Combined)
C25454 (NCI Thesaurus)
C0205195 (UMLS 2011AA)
CL Item
Hormonal (Hormonal)
C25528 (NCI Thesaurus)
C0458083 (UMLS 2011AA)
CL Item
Surgical (Surgical)
C25698 (NCI Thesaurus)
Item
Is androgen blockade planned to be continued?
text
C15368 (NCI Thesaurus ObjectClass)
C15676 (NCI Thesaurus ObjectClass)
C1515985 (UMLS 2011AA ObjectClass)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C0750536 (NCI Metathesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.36
Code List
Is androgen blockade planned to be continued?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
LaboratoryProcedureHighestLevelProstate-SpecificAntigenResultValue
Item
Highest PSA (since start of ADT)
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C17525 (NCI Thesaurus Property)
C0138741 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25525 (NCI Thesaurus Property)
C1522410 (UMLS 2011AA Property)
C25554 (NCI Thesaurus Property)
C0441889 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureLowestLevelProstate-SpecificAntigenResultValue
Item
Lowest PSA (since start of ADT)
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C17525 (NCI Thesaurus Property)
C0138741 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25554 (NCI Thesaurus Property)
C0441889 (UMLS 2011AA Property)
C43517 (NCI Thesaurus Property)
C1708760 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
Item Group
Metabolic Syndrome
Item
Fasting AM glucose > 110 mg/dl
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C26797 (NCI Thesaurus ObjectClass)
C0020456 (UMLS 2011AA ObjectClass)
CL.37
Code List
Fasting AM glucose > 110 mg/dl
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Hypertension (SBP >= 140 and/or DBP <= 90 mmHG)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C3117 (NCI Thesaurus ObjectClass)
C0020538 (UMLS 2011AA ObjectClass)
CL.38
Code List
Hypertension (SBP >= 140 and/or DBP <= 90 mmHG)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Obesity (BMI >= 30 kg/m^2)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C3283 (NCI Thesaurus ObjectClass)
C0028754 (UMLS 2011AA ObjectClass)
CL.39
Code List
Obesity (BMI >= 30 kg/m^2)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Hypertriglyceridemia (triglycerides > 150 mg/dl)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C37971 (NCI Thesaurus ObjectClass)
C1522137 (UMLS 2011AA ObjectClass)
CL.40
Code List
Hypertriglyceridemia (triglycerides > 150 mg/dl)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
HDL >40 mg/dl
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C25227 (NCI Thesaurus Property)
C0205250 (UMLS 2011AA Property)
C25186 (NCI Thesaurus ObjectClass)
C0023821 (UMLS 2011AA ObjectClass)
CL.41
Code List
HDL >40 mg/dl
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
At the time of study entry was patient receiving metformin
text
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C29251 (NCI Thesaurus ObjectClass)
C0591573 (UMLS 2011AA ObjectClass)
C25471 (NCI Thesaurus Property)
C0521116 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.42
Code List
At the time of study entry was patient receiving metformin
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Is treatment with metformin planning on being continued while on study
text
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C29251 (NCI Thesaurus ObjectClass)
C0591573 (UMLS 2011AA ObjectClass)
C25456 (NCI Thesaurus Property)
C0205420 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.43
Code List
Is treatment with metformin planning on being continued while on study
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Baseline Abnormalities
CommonToxicityCriteriaAdverseEventTermType
Item
CTC Adverse Event Term
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C45559 (NCI Thesaurus Property)
C1705313 (UMLS 2011AA Property)
Item
CTC Adverse Event Grade
double
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.44
Code List
CTC Adverse Event Grade
CL Item
Mild Adverse Event (1)
C41338 (NCI Thesaurus)
C1513302 (UMLS 2011AA)
CL Item
Moderate Adverse Event (2)
C41339 (NCI Thesaurus)
C1513374 (UMLS 2011AA)
CL Item
Severe Adverse Event (3)
C41340 (NCI Thesaurus)
C1519275 (UMLS 2011AA)
CL Item
Life-threatening Or Disabling Adverse Event (4)
Item Group
Comments
InvestigatorSignatureText
Item
Investigator Signature
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
InvestigatorSignatureDate
Item
Investigator Signature Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
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