ID

11063

Description

ECOG E3805 On-Study Form NCT00309985 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

June 16, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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ECOG E3805 On-Study Form NCT00309985

English

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

1 forms  
ECOG clinical trial administrative data
Description

ECOG clinical trial administrative data

ECOG Protocol Number
Description

Protocol Number ECOG

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1512162
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25491
ECOG Patient ID
Description

Patient ID ECOG

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1512162
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25491
DCI Name
Description

Generic drug form

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C3242750
NCI Thesaurus Property
C19464
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus ObjectClass-2
C25452
Registration Step
Description

Registration Number

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1514821
NCI Thesaurus ObjectClass
C25646
UMLS CUI-2
C0237753
NCI Thesaurus Property
C16154
NCI Thesaurus ValueDomain-2
C16154
Reporting Period
Description

Clinical Trial Period

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C2347804
NCI Thesaurus ObjectClass
C25214
NCI Thesaurus Property
C25616
NCI Thesaurus ObjectClass-2
C25651
Patient Initials
Description

Patient Initials

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Participating Group Protocol Number
Description

Study Number Participating Group

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Institution/Affiliate
Description

Institution Name

Data type

text

Alias
NCI Thesaurus ObjectClass
C25454
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass-2
C21541
NCI Thesaurus Property
C25364
NCI Thesaurus ValueDomain
C25191
NCI Thesaurus ValueDomain-2
C21541
Participating Group Patient ID
Description

Trial subject ID Participating Group

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Data amendment
Description

Data amendment

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

Data amended

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Date data amended
Description

Data amended date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
UMLS CUI-2
C0011008
NCI Thesaurus Property
C25416
NCI Thesaurus ValueDomain-2
C25367
Patient status
Description

Patient status

Performance Status
Description

ECOG Performance Status

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS CUI-1
C1520224
NCI Thesaurus Property
C25367
NCI Thesaurus ValueDomain-2
C25491
NCI Thesaurus ObjectClass
C20641
Weight (Day 1 - kg)
Description

Patient Weight

Data type

float

Measurement units
  • Kg
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0005910
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25208
Kg
Height (cm)
Description

Patient Height

Data type

float

Measurement units
  • cm
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0489786
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25347
cm
Description Of Primary Disease
Description

Description Of Primary Disease

Gleason Grade, Primary
Description

GleasonScorePrimaryPatternValue

Data type

float

Alias
NCI Thesaurus Property
C25251
UMLS 2011AA Property
C0205225
NCI Thesaurus ObjectClass
C28084
UMLS 2011AA ObjectClass
C0332326
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus Property-2
C25336
UMLS 2011AA Property-2
C0449774
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

float

Alias
NCI Thesaurus Property
C25667
UMLS 2011AA Property
C0175668
NCI Thesaurus ObjectClass
C28084
UMLS 2011AA ObjectClass
C0332326
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus Property-2
C25336
UMLS 2011AA Property-2
C0449774
PSA Value at Diagnosis
Description

LaboratoryProcedureFirstDiagnosisProstate-SpecificAntigenOutcomeValue

Data type

float

Measurement units
  • ng/ml
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C17525
UMLS 2011AA Property
C0138741
NCI Thesaurus Property-2
C25509
UMLS 2011AA Property-2
C1279901
NCI Thesaurus Property-3
C20200
UMLS 2011AA Property-3
C1274040
NCI Thesaurus Property-4
C15220
UMLS 2011AA Property-4
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-2
C9305
UMLS 2011AA ObjectClass-2
C0006826
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
Pathologic T Stage
Description

ProstateTumorPathologicTStage

Data type

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C12410
UMLS 2011AA ObjectClass-2
C0033572
NCI Thesaurus Property
C25610
UMLS 2011AA Property
C1521733
NCI Thesaurus Property-2
C25728
UMLS 2011AA Property-2
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-2
C12410
UMLS 2011AA ObjectClass-2
C0033572
NCI Thesaurus Property
C25610
UMLS 2011AA Property
C1521733
NCI Thesaurus Property-2
C25580
UMLS 2011AA Property-2
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-2
C12410
UMLS 2011AA ObjectClass-2
C0033572
NCI Thesaurus Property
C25610
UMLS 2011AA Property
C1521733
NCI Thesaurus Property-2
C25727
UMLS 2011AA Property-2
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-2
C12410
UMLS 2011AA ObjectClass-2
C0033572
NCI Thesaurus Property
C25398
UMLS 2011AA Property
C0205210
NCI Thesaurus Property-2
C25728
UMLS 2011AA Property-2
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-2
C12410
UMLS 2011AA ObjectClass-2
C0033572
NCI Thesaurus Property
C25398
UMLS 2011AA Property
C0205210
NCI Thesaurus Property-2
C25580
UMLS 2011AA Property-2
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-2
C12410
UMLS 2011AA ObjectClass-2
C0033572
NCI Thesaurus Property
C25398
UMLS 2011AA Property
C0205210
NCI Thesaurus Property-2
C25727
UMLS 2011AA Property-2
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

boolean

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-2
C25315
UMLS 2011AA ObjectClass-2
C0442045
Lung (Visceral)
Description

MalignantNeoplasmLungMetastaticInvolvementInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C14174
UMLS 2011AA Property
C0036525
NCI Thesaurus Property-2
C12468
UMLS 2011AA Property-2
C0024109
NCI Thesaurus Property-3
C25548
UMLS 2011AA Property-3
C1314939
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Liver (Visceral)
Description

MalignantNeoplasmLiverMetastaticInvolvementInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C14174
UMLS 2011AA Property
C0036525
NCI Thesaurus Property-2
C12392
UMLS 2011AA Property-2
C0023884
NCI Thesaurus Property-3
C25548
UMLS 2011AA Property-3
C1314939
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Other (Visceral)
Description

MalignantNeoplasmMetastaticInvolvementInd-3

Data type

boolean

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-2
C25548
UMLS 2011AA Property-2
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-2
C25548
UMLS 2011AA Property-2
C1314939
NCI Thesaurus Property-3
C25315
UMLS 2011AA Property-3
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-2
C12366
UMLS 2011AA ObjectClass-2
C0262950
NCI Thesaurus ObjectClass-3
C17648
UMLS 2011AA ObjectClass-3
C0439064
Bone Metastasis (If High Volume Disease Extensive Disease, answer each of the following)
Description

MalignantNeoplasmBoneMetastaticInvolvementInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C14174
UMLS 2011AA Property
C0036525
NCI Thesaurus Property-2
C12366
UMLS 2011AA Property-2
C0262950
NCI Thesaurus Property-3
C25548
UMLS 2011AA Property-3
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

float

Alias
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C14174
UMLS 2011AA Property
C0036525
NCI Thesaurus Property-2
C12366
UMLS 2011AA Property-2
C0262950
NCI Thesaurus Property-3
C25548
UMLS 2011AA Property-3
C1314939
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
Vertebral column
Description

MalignantNeoplasmVertebralColumnMetastaticInvolvementInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C12366
UMLS 2011AA ObjectClass
C0262950
NCI Thesaurus ObjectClass-2
C9305
UMLS 2011AA ObjectClass-2
C0006826
NCI Thesaurus Property
C14174
UMLS 2011AA Property
C0036525
NCI Thesaurus Property-2
C25548
UMLS 2011AA Property-2
C1314939
NCI Thesaurus Property-3
C12998
UMLS 2011AA Property-3
C0037949
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Pelvic bone
Description

MalignantNeoplasmPelvicBoneMetastaticInvolvementInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C14174
UMLS 2011AA Property
C0036525
NCI Thesaurus Property-2
C25548
UMLS 2011AA Property-2
C1314939
NCI Thesaurus Property-3
C33287
UMLS 2011AA Property-3
C0030786
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Ribs
Description

MalignantNeoplasmRibMetastaticInvolvementInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C14174
UMLS 2011AA Property
C0036525
NCI Thesaurus Property-2
C12782
UMLS 2011AA Property-2
C0035561
NCI Thesaurus Property-3
C25548
UMLS 2011AA Property-3
C1314939
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Arms
Description

MalignantNeoplasmArmMetastaticInvolvementInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C14174
UMLS 2011AA Property
C0036525
NCI Thesaurus Property-2
C32141
UMLS 2011AA Property-2
C1140618
NCI Thesaurus Property-3
C25548
UMLS 2011AA Property-3
C1314939
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Legs
Description

MalignantNeoplasmLegMetastaticInvolvementInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C14174
UMLS 2011AA Property
C0036525
NCI Thesaurus Property-2
C32974
UMLS 2011AA Property-2
C1140621
NCI Thesaurus Property-3
C25548
UMLS 2011AA Property-3
C1314939
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Skull
Description

MalignantNeoplasmSkullMetastaticInvolvementInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C14174
UMLS 2011AA Property
C0036525
NCI Thesaurus Property-2
C25548
UMLS 2011AA Property-2
C1314939
NCI Thesaurus Property-3
C12789
UMLS 2011AA Property-3
C0037303
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Other
Description

MalignantNeoplasmOtherBoneMetastaticInvolvementInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C17649
UMLS 2011AA ObjectClass
C0205394
NCI Thesaurus ObjectClass-2
C9305
UMLS 2011AA ObjectClass-2
C0006826
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property-2
C14174
UMLS 2011AA Property-2
C0036525
NCI Thesaurus Property-3
C12366
UMLS 2011AA Property-3
C0262950
NCI Thesaurus Property-4
C25548
UMLS 2011AA Property-4
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-2
C9305
UMLS 2011AA ObjectClass-2
C0006826
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property-2
C14174
UMLS 2011AA Property-2
C0036525
NCI Thesaurus Property-3
C12366
UMLS 2011AA Property-3
C0262950
NCI Thesaurus Property-4
C25548
UMLS 2011AA Property-4
C1314939
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Prior Treatment
Description

Prior Treatment

Prior Surgery
Description

Prior Surgery

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0744961
NCI Thesaurus Property
C38000
NCI Thesaurus ObjectClass
C15329
NCI Thesaurus ObjectClass-2
C25629
Prior Prostatectomy
Description

PriorProstatectomyPerformedInd-3

Data type

boolean

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-2
C15307
UMLS 2011AA ObjectClass-2
C0033573
Prior Orchiectomy
Description

PriorOrchiectomyPerformedInd-2

Data type

boolean

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-2
C15288
UMLS 2011AA ObjectClass-2
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-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
Prior Radiation Therapy
Description

Prior Radiation Therapy

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C1522449
NCI Thesaurus ObjectClass
C15313
UMLS CUI-2
C0332152
NCI Thesaurus ObjectClass-2
C25629
NCI Thesaurus Property
C25382
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-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
NCI Thesaurus Property-2
C25496
UMLS 2011AA Property-2
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-2
C25629
UMLS 2011AA ObjectClass-2
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

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus ObjectClass-2
C15445
UMLS 2011AA ObjectClass-2
C0279025
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Was prior hormonal therapy adjuvant? (If yes,)
Description

AdjuvantHormonalTherapyPriorAdministeredInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus ObjectClass-2
C2140
UMLS 2011AA ObjectClass-2
C0001552
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
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-2
C15445
UMLS 2011AA ObjectClass-2
C0279025
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
NCI Thesaurus Property-2
C25496
UMLS 2011AA Property-2
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-2
C15445
UMLS 2011AA ObjectClass-2
C0279025
Any Other Prior Therapy? (excluding chemotherapy)
Description

PriorTherapyOtherAdministeredInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Date Other Prior Therapy Ended
Description

PriorTherapyOtherEndDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property-2
C25275
UMLS 2011AA Property-2
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-2
C15368
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property-2
C25364
UMLS 2011AA Property-2
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

boolean

Alias
NCI Thesaurus ObjectClass
C49236
UMLS 2011AA ObjectClass
C0087111
NCI Thesaurus Property
C443
UMLS 2011AA Property
C0012544
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
NCI Thesaurus Property-3
C15481
UMLS 2011AA Property-3
C0279492
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Androgen Deprivation
Description

Androgen Deprivation

Baseline PSA Value (ng/ml)
Description

LaboratoryProcedureBaselineProstate-SpecificAntigenOutcomeValue

Data type

float

Measurement units
  • ng/ml
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C17525
UMLS 2011AA Property
C0138741
NCI Thesaurus Property-2
C25213
UMLS 2011AA Property-2
C1442488
NCI Thesaurus Property-3
C20200
UMLS 2011AA Property-3
C1274040
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
ng/ml
Date of PSA Assessment
Description

PSA date

Data type

date

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0138741
NCI Thesaurus Property
C17525
UMLS CUI-2
C0011008
NCI Thesaurus Property-2
C20200
NCI Thesaurus Property-3
C17220
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
Baseline Psa Value
Description

Baseline Psa Value

Has patient begun Androgen Deprivation
Description

AndrogenSuppressionTherapyAdministrationInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25409
UMLS 2011AA Property
C1533734
NCI Thesaurus ObjectClass-2
C15676
UMLS 2011AA ObjectClass
C1515985
Start date of Androgen Deprivation
Description

AndrogenSuppressionTherapyAdministrationBeginDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C15676
UMLS 2011AA ObjectClass
C1515985
NCI Thesaurus Property
C25409
UMLS 2011AA Property
C1533734
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25431
UMLS 2011AA ValueDomain-2
C0439659
Pre-ADT PSA
Description

LaboratoryProcedureBaselineProstate-SpecificAntigenPriorAntiandrogenTherapyOutcomeValue

Data type

float

Measurement units
  • ng/ml
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C17525
UMLS 2011AA Property
C0138741
NCI Thesaurus Property-2
C25213
UMLS 2011AA Property-2
C1442488
NCI Thesaurus Property-3
C25629
UMLS 2011AA Property-3
C0332152
NCI Thesaurus Property-4
C15481
UMLS 2011AA Property-4
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-2
C15676
UMLS 2011AA ObjectClass
C1515985
Is androgen blockade planned to be continued?
Description

AndrogenSuppressionTherapyContinuedAdministrationInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
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

float

Measurement units
  • ng/ml
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C17525
UMLS 2011AA Property
C0138741
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus Property-3
C25525
UMLS 2011AA Property-3
C1522410
NCI Thesaurus Property-4
C25554
UMLS 2011AA Property-4
C0441889
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
ng/ml
Lowest PSA (since start of ADT)
Description

LaboratoryProcedureLowestLevelProstate-SpecificAntigenResultValue

Data type

float

Measurement units
  • ng/ml
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C17525
UMLS 2011AA Property
C0138741
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus Property-3
C25554
UMLS 2011AA Property-3
C0441889
NCI Thesaurus Property-4
C43517
UMLS 2011AA Property-4
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-2
C25227
UMLS 2011AA Property-2
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-2
C29251
UMLS 2011AA ObjectClass-2
C0591573
NCI Thesaurus Property
C25471
UMLS 2011AA Property
C0521116
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
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-2
C29251
UMLS 2011AA ObjectClass-2
C0591573
NCI Thesaurus Property
C25456
UMLS 2011AA Property
C0205420
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Baseline Abnormalities
Description

Baseline Abnormalities

CTC Adverse Event Term
Description

CTC Adverse Event Term

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C1516728
NCI Thesaurus ObjectClass
C49704
UMLS CUI-2
C2826934
NCI Thesaurus Property
C45559
CTC Adverse Event Grade
Description

CTC Adverse Event Grade

Data type

float

Alias
NCI Thesaurus ObjectClass
C49704
UMLS CUI-1
C2985911
NCI Thesaurus ValueDomain
C18000
NCI Thesaurus Property
C25365
Comments
Description

Comments

Investigator Signature
Description

Investigator Signature

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C2346576
NCI Thesaurus Property
C25678
NCI Thesaurus ObjectClass
C17089
Investigator Signature Date
Description

Investigator Signature Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2346576
NCI Thesaurus Property
C25678
UMLS CUI-2
C0011008
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C17089
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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
ECOG clinical trial administrative data
Protocol Number ECOG
Item
ECOG Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Patient ID ECOG
Item
ECOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Generic drug form
Item
DCI Name
text
C25191 (NCI Thesaurus ValueDomain)
C3242750 (UMLS CUI-1)
C19464 (NCI Thesaurus Property)
C25474 (NCI Thesaurus ObjectClass)
C25452 (NCI Thesaurus ObjectClass-2)
Registration Number
Item
Registration Step
text
C25337 (NCI Thesaurus ValueDomain)
C1514821 (UMLS CUI-1)
C25646 (NCI Thesaurus ObjectClass)
C0237753 (UMLS CUI-2)
C16154 (NCI Thesaurus Property)
C16154 (NCI Thesaurus ValueDomain-2)
Item
Reporting Period
text
C25284 (NCI Thesaurus ValueDomain)
C2347804 (UMLS CUI-1)
C25214 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C25651 (NCI Thesaurus ObjectClass-2)
CL.1
Code List
Reporting Period
CL Item
Baseline (Baseline)
C25213 (NCI Thesaurus)
C1442488 (UMLS 2011AA)
Patient Initials
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Study Number Participating Group
Item
Participating Group Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Institution Name
Item
Institution/Affiliate
text
C25454 (NCI Thesaurus ObjectClass)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)
Trial subject ID Participating Group
Item
Participating Group Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Item Group
Data amendment
Data amended
Item
Please mark an 'X' if data have been amended.
text
C25704 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Data amended date
Item
Date data amended
date
C25164 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C0011008 (UMLS CUI-2)
C25416 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)
Item Group
Patient status
Item
Performance Status
text
C25664 (NCI Thesaurus ValueDomain)
C1520224 (UMLS CUI-1)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain-2)
C20641 (NCI Thesaurus ObjectClass)
CL.2
Code List
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)
Patient Weight
Item
Weight (Day 1 - kg)
float
C25209 (NCI Thesaurus ValueDomain)
C0005910 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)
Patient Height
Item
Height (cm)
float
C25209 (NCI Thesaurus ValueDomain)
C0489786 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25347 (NCI Thesaurus Property)
Item Group
Description Of Primary Disease
GleasonScorePrimaryPatternValue
Item
Gleason Grade, Primary
float
C25251 (NCI Thesaurus Property)
C0205225 (UMLS 2011AA Property)
C28084 (NCI Thesaurus ObjectClass)
C0332326 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25336 (NCI Thesaurus Property-2)
C0449774 (UMLS 2011AA Property-2)
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)
GleasonScoreSecondaryPatternValue
Item
Gleason Grade, Secondary
float
C25667 (NCI Thesaurus Property)
C0175668 (UMLS 2011AA Property)
C28084 (NCI Thesaurus ObjectClass)
C0332326 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25336 (NCI Thesaurus Property-2)
C0449774 (UMLS 2011AA Property-2)
LaboratoryProcedureFirstDiagnosisProstate-SpecificAntigenOutcomeValue
Item
PSA Value at Diagnosis
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C17525 (NCI Thesaurus Property)
C0138741 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property-2)
C1279901 (UMLS 2011AA Property-2)
C20200 (NCI Thesaurus Property-3)
C1274040 (UMLS 2011AA Property-3)
C15220 (NCI Thesaurus Property-4)
C0011900 (UMLS 2011AA Property-4)
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-2)
C0006826 (UMLS 2011AA ObjectClass-2)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Item
Pathologic T Stage
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12410 (NCI Thesaurus ObjectClass-2)
C0033572 (UMLS 2011AA ObjectClass-2)
C25610 (NCI Thesaurus Property)
C1521733 (UMLS 2011AA Property)
C25728 (NCI Thesaurus Property-2)
C0475455 (UMLS 2011AA Property-2)
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-3)
C0238767 (UMLS 2011AA-4)
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-2)
C0033572 (UMLS 2011AA ObjectClass-2)
C25610 (NCI Thesaurus Property)
C1521733 (UMLS 2011AA Property)
C25580 (NCI Thesaurus Property-2)
C0456532 (UMLS 2011AA Property-2)
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-2)
C0033572 (UMLS 2011AA ObjectClass-2)
C25610 (NCI Thesaurus Property)
C1521733 (UMLS 2011AA Property)
C25727 (NCI Thesaurus Property-2)
C0456533 (UMLS 2011AA Property-2)
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-2)
C0033572 (UMLS 2011AA ObjectClass-2)
C25398 (NCI Thesaurus Property)
C0205210 (UMLS 2011AA Property)
C25728 (NCI Thesaurus Property-2)
C0475455 (UMLS 2011AA Property-2)
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-2)
C0033572 (UMLS 2011AA ObjectClass-2)
C25398 (NCI Thesaurus Property)
C0205210 (UMLS 2011AA Property)
C25580 (NCI Thesaurus Property-2)
C0456532 (UMLS 2011AA Property-2)
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-2)
C0033572 (UMLS 2011AA ObjectClass-2)
C25398 (NCI Thesaurus Property)
C0205210 (UMLS 2011AA Property)
C25727 (NCI Thesaurus Property-2)
C0456533 (UMLS 2011AA Property-2)
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)
VisceralNeoplasmPresentInd-3
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.)
boolean
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-2)
C0442045 (UMLS 2011AA ObjectClass-2)
MalignantNeoplasmLungMetastaticInvolvementInd-3
Item
Lung (Visceral)
boolean
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C14174 (NCI Thesaurus Property)
C0036525 (UMLS 2011AA Property)
C12468 (NCI Thesaurus Property-2)
C0024109 (UMLS 2011AA Property-2)
C25548 (NCI Thesaurus Property-3)
C1314939 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
MalignantNeoplasmLiverMetastaticInvolvementInd-3
Item
Liver (Visceral)
boolean
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C14174 (NCI Thesaurus Property)
C0036525 (UMLS 2011AA Property)
C12392 (NCI Thesaurus Property-2)
C0023884 (UMLS 2011AA Property-2)
C25548 (NCI Thesaurus Property-3)
C1314939 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
MalignantNeoplasmMetastaticInvolvementInd-3
Item
Other (Visceral)
boolean
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-2)
C1314939 (UMLS 2011AA Property-2)
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-2)
C1314939 (UMLS 2011AA Property-2)
C25315 (NCI Thesaurus Property-3)
C0442045 (UMLS 2011AA Property-3)
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-2)
C0262950 (UMLS 2011AA ObjectClass-2)
C17648 (NCI Thesaurus ObjectClass-3)
C0439064 (UMLS 2011AA ObjectClass-3)
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)
MalignantNeoplasmBoneMetastaticInvolvementInd-3
Item
Bone Metastasis (If High Volume Disease Extensive Disease, answer each of the following)
boolean
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C14174 (NCI Thesaurus Property)
C0036525 (UMLS 2011AA Property)
C12366 (NCI Thesaurus Property-2)
C0262950 (UMLS 2011AA Property-2)
C25548 (NCI Thesaurus Property-3)
C1314939 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
MalignantNeoplasmBoneMetastaticInvolvementCount
Item
Number of bone metastases (If yes: - Are any of the following involved?)
float
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C14174 (NCI Thesaurus Property)
C0036525 (UMLS 2011AA Property)
C12366 (NCI Thesaurus Property-2)
C0262950 (UMLS 2011AA Property-2)
C25548 (NCI Thesaurus Property-3)
C1314939 (UMLS 2011AA Property-3)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
MalignantNeoplasmVertebralColumnMetastaticInvolvementInd-3
Item
Vertebral column
boolean
C12366 (NCI Thesaurus ObjectClass)
C0262950 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
C14174 (NCI Thesaurus Property)
C0036525 (UMLS 2011AA Property)
C25548 (NCI Thesaurus Property-2)
C1314939 (UMLS 2011AA Property-2)
C12998 (NCI Thesaurus Property-3)
C0037949 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
MalignantNeoplasmPelvicBoneMetastaticInvolvementInd-3
Item
Pelvic bone
boolean
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C14174 (NCI Thesaurus Property)
C0036525 (UMLS 2011AA Property)
C25548 (NCI Thesaurus Property-2)
C1314939 (UMLS 2011AA Property-2)
C33287 (NCI Thesaurus Property-3)
C0030786 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
MalignantNeoplasmRibMetastaticInvolvementInd-3
Item
Ribs
boolean
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C14174 (NCI Thesaurus Property)
C0036525 (UMLS 2011AA Property)
C12782 (NCI Thesaurus Property-2)
C0035561 (UMLS 2011AA Property-2)
C25548 (NCI Thesaurus Property-3)
C1314939 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
MalignantNeoplasmArmMetastaticInvolvementInd-3
Item
Arms
boolean
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C14174 (NCI Thesaurus Property)
C0036525 (UMLS 2011AA Property)
C32141 (NCI Thesaurus Property-2)
C1140618 (UMLS 2011AA Property-2)
C25548 (NCI Thesaurus Property-3)
C1314939 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
MalignantNeoplasmLegMetastaticInvolvementInd-3
Item
Legs
boolean
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C14174 (NCI Thesaurus Property)
C0036525 (UMLS 2011AA Property)
C32974 (NCI Thesaurus Property-2)
C1140621 (UMLS 2011AA Property-2)
C25548 (NCI Thesaurus Property-3)
C1314939 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
MalignantNeoplasmSkullMetastaticInvolvementInd-3
Item
Skull
boolean
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C14174 (NCI Thesaurus Property)
C0036525 (UMLS 2011AA Property)
C25548 (NCI Thesaurus Property-2)
C1314939 (UMLS 2011AA Property-2)
C12789 (NCI Thesaurus Property-3)
C0037303 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
MalignantNeoplasmOtherBoneMetastaticInvolvementInd-3
Item
Other
boolean
C17649 (NCI Thesaurus ObjectClass)
C0205394 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C14174 (NCI Thesaurus Property-2)
C0036525 (UMLS 2011AA Property-2)
C12366 (NCI Thesaurus Property-3)
C0262950 (UMLS 2011AA Property-3)
C25548 (NCI Thesaurus Property-4)
C1314939 (UMLS 2011AA Property-4)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
MalignantNeoplasmOtherBoneMetastaticInvolvementSpecify
Item
Specify
text
C17649 (NCI Thesaurus ObjectClass)
C0205394 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C14174 (NCI Thesaurus Property-2)
C0036525 (UMLS 2011AA Property-2)
C12366 (NCI Thesaurus Property-3)
C0262950 (UMLS 2011AA Property-3)
C25548 (NCI Thesaurus Property-4)
C1314939 (UMLS 2011AA Property-4)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Item Group
Prior Treatment
Prior Surgery
Item
Prior Surgery
boolean
C38148 (NCI Thesaurus ValueDomain)
C0744961 (UMLS CUI-1)
C38000 (NCI Thesaurus Property)
C15329 (NCI Thesaurus ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
PriorProstatectomyPerformedInd-3
Item
Prior Prostatectomy
boolean
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-2)
C0033573 (UMLS 2011AA ObjectClass-2)
PriorOrchiectomyPerformedInd-2
Item
Prior Orchiectomy
boolean
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-2)
C0007347 (UMLS 2011AA ObjectClass-2)
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-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
Prior Radiation Therapy
Item
Prior Radiation Therapy
boolean
C38148 (NCI Thesaurus ValueDomain)
C1522449 (UMLS CUI-1)
C15313 (NCI Thesaurus ObjectClass)
C0332152 (UMLS CUI-2)
C25629 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property)
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-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25496 (NCI Thesaurus Property-2)
C2746065 (UMLS 2011AA Property-2)
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-2)
C0332152 (UMLS 2011AA ObjectClass-2)
PriorHormonalTherapyAdministeredInd-3
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.)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15445 (NCI Thesaurus ObjectClass-2)
C0279025 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
AdjuvantHormonalTherapyPriorAdministeredInd-2
Item
Was prior hormonal therapy adjuvant? (If yes,)
boolean
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C2140 (NCI Thesaurus ObjectClass-2)
C0001552 (UMLS 2011AA ObjectClass-2)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PriorHormonalTherapyEndDate
Item
Date Prior hormonal therapy Ended
date
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15445 (NCI Thesaurus ObjectClass-2)
C0279025 (UMLS 2011AA ObjectClass-2)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25496 (NCI Thesaurus Property-2)
C2746065 (UMLS 2011AA Property-2)
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-2)
C0279025 (UMLS 2011AA ObjectClass-2)
PriorTherapyOtherAdministeredInd-3
Item
Any Other Prior Therapy? (excluding chemotherapy)
boolean
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
PriorTherapyOtherEndDate
Item
Date Other Prior Therapy Ended
date
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property-2)
C2745955 (UMLS 2011AA Property-2)
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-2)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property-2)
C0600091 (UMLS 2011AA Property-2)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)
TherapeuticProcedureBiphosphonateAntiandrogenTherapyAdministeredInd-3
Item
Has or will the patient received bisphosphonates (or other FDA approved drugs for delaying skeletal related events) at the start of ADT?
boolean
C49236 (NCI Thesaurus ObjectClass)
C0087111 (UMLS 2011AA ObjectClass)
C443 (NCI Thesaurus Property)
C0012544 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C15481 (NCI Thesaurus Property-3)
C0279492 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
Item Group
Androgen Deprivation
LaboratoryProcedureBaselineProstate-SpecificAntigenOutcomeValue
Item
Baseline PSA Value (ng/ml)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C17525 (NCI Thesaurus Property)
C0138741 (UMLS 2011AA Property)
C25213 (NCI Thesaurus Property-2)
C1442488 (UMLS 2011AA Property-2)
C20200 (NCI Thesaurus Property-3)
C1274040 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
PSA date
Item
Date of PSA Assessment
date
C25294 (NCI Thesaurus ObjectClass)
C0138741 (UMLS CUI-1)
C17525 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C20200 (NCI Thesaurus Property-2)
C17220 (NCI Thesaurus Property-3)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Item Group
Baseline Psa Value
AndrogenSuppressionTherapyAdministrationInd-2
Item
Has patient begun Androgen Deprivation
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C15676 (NCI Thesaurus ObjectClass-2)
C1515985 (UMLS 2011AA ObjectClass)
AndrogenSuppressionTherapyAdministrationBeginDate
Item
Start date of Androgen Deprivation
date
C15368 (NCI Thesaurus ObjectClass)
C15676 (NCI Thesaurus ObjectClass-2)
C1515985 (UMLS 2011AA ObjectClass)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)
LaboratoryProcedureBaselineProstate-SpecificAntigenPriorAntiandrogenTherapyOutcomeValue
Item
Pre-ADT PSA
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C17525 (NCI Thesaurus Property)
C0138741 (UMLS 2011AA Property)
C25213 (NCI Thesaurus Property-2)
C1442488 (UMLS 2011AA Property-2)
C25629 (NCI Thesaurus Property-3)
C0332152 (UMLS 2011AA Property-3)
C15481 (NCI Thesaurus Property-4)
C0279492 (UMLS 2011AA Property-4)
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-2)
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)
AndrogenSuppressionTherapyContinuedAdministrationInd-2
Item
Is androgen blockade planned to be continued?
boolean
C15368 (NCI Thesaurus ObjectClass)
C15676 (NCI Thesaurus ObjectClass-2)
C1515985 (UMLS 2011AA ObjectClass)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C0750536 (NCI Metathesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
LaboratoryProcedureHighestLevelProstate-SpecificAntigenResultValue
Item
Highest PSA (since start of ADT)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C17525 (NCI Thesaurus Property)
C0138741 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25525 (NCI Thesaurus Property-3)
C1522410 (UMLS 2011AA Property-3)
C25554 (NCI Thesaurus Property-4)
C0441889 (UMLS 2011AA Property-4)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureLowestLevelProstate-SpecificAntigenResultValue
Item
Lowest PSA (since start of ADT)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C17525 (NCI Thesaurus Property)
C0138741 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25554 (NCI Thesaurus Property-3)
C0441889 (UMLS 2011AA Property-3)
C43517 (NCI Thesaurus Property-4)
C1708760 (UMLS 2011AA Property-4)
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-2)
C0205250 (UMLS 2011AA Property-2)
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-2)
C0591573 (UMLS 2011AA ObjectClass-2)
C25471 (NCI Thesaurus Property)
C0521116 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
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-2)
C0591573 (UMLS 2011AA ObjectClass-2)
C25456 (NCI Thesaurus Property)
C0205420 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
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
CTC Adverse Event Term
Item
CTC Adverse Event Term
text
C25284 (NCI Thesaurus ValueDomain)
C1516728 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C2826934 (UMLS CUI-2)
C45559 (NCI Thesaurus Property)
CTC Adverse Event Grade
Item
CTC Adverse Event Grade
float
C49704 (NCI Thesaurus ObjectClass)
C2985911 (UMLS CUI-1)
C18000 (NCI Thesaurus ValueDomain)
C25365 (NCI Thesaurus Property)
Item Group
Comments
Investigator Signature
Item
Investigator Signature
text
C25704 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
Investigator Signature Date
Item
Investigator Signature Date
date
C25164 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C25367 (NCI Thesaurus ValueDomain-2)
C17089 (NCI Thesaurus ObjectClass)
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