ID

11047

Beschrijving

E1805 On-Study Form Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=0F2A22D3-D6F2-3C2D-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=0F2A22D3-D6F2-3C2D-E044-0003BA3F9857

Trefwoorden

Versies (3)
  1. 19-09-12 19-09-12 -
  2. 09-01-15 09-01-15 - Martin Dugas
  3. 16-06-15 16-06-15 -
Geüploaded op

16 juni 2015

DOI

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Licentie

Creative Commons BY-NC 3.0 Legacy
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E1805 On-Study Form

Engels

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

1 Formulieren  
Header
Beschrijving

Header

ECOG Protocol Number
Beschrijving

Protocol Number ECOG

Datatype

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
Beschrijving

Patient ID ECOG

Datatype

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
Beschrijving

Generic drug form

Datatype

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
Beschrijving

Registration Number

Datatype

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
Beschrijving

Clinical Trial Period

Datatype

text

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

Patient demographics

Patient Initials (Last, First)
Beschrijving

Patient Initials

Datatype

text

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

Study Number Participating Group

Datatype

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
Participating Group Patient ID
Beschrijving

Trial subject ID Participating Group

Datatype

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
Institution/Affiliate
Beschrijving

Institution Name

Datatype

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
ECOG Performance Status
Beschrijving

ECOG Performance Status

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS CUI-1
C1520224
NCI Thesaurus Property
C25367
NCI Thesaurus ValueDomain-2
C25491
NCI Thesaurus ObjectClass
C20641
Data amendment
Beschrijving

Data amendment

Please mark an 'X' if data have been amended. (Please circle amended items in red)
Beschrijving

Data amended

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Date data amended (s - MM/DD/YYYY)
Beschrijving

Data amended date

Datatype

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
Description Of Primary Disease
Beschrijving

Description Of Primary Disease

Date of Initial Diagnosis of Primary Tumor (MM/DD/YYYY)
Beschrijving

FirstBiopsyPositiveDate

Datatype

date

Alias
NCI Thesaurus ObjectClass
C15189
UMLS 2011AA ObjectClass
C0005558
NCI Thesaurus ObjectClass-2
C25509
UMLS 2011AA ObjectClass-2
C1279901
NCI Thesaurus Property
C25246
UMLS 2011AA Property
C1446409
NCI Thesaurus Property-2
C25275
UMLS 2011AA Property-2
C2745955
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
Pathologic T Stage
Beschrijving

ProstateTumorPathologicTStage

Datatype

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
Mark an 'X' if unknown
Beschrijving

DataUnknownText

Datatype

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
Pathologic N Stage
Beschrijving

ProstateTumorPathologicNStage

Datatype

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
Beschrijving

ProstateTumorPathologicMStage

Datatype

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
Beschrijving

ProstateTumorClinicalTStage

Datatype

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
Beschrijving

ProstateTumorClinicalNStage

Datatype

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
Beschrijving

ProstateTumorClinicalMStage

Datatype

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
Gleason Score, Primary Pattern (01-105, -1 = unknown - The most frequent pattern gleason grade among all available specimens.)
Beschrijving

GleasonScorePrimaryPatternValue

Datatype

float

Alias
NCI Thesaurus Property
C25251
UMLS 2011AA Property
C0205225
NCI Thesaurus ObjectClass
C28084
UMLS 2011AA ObjectClass
C0332326
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus Property-2
C25336
UMLS 2011AA Property-2
C0449774
Gleason Score, Secondary Pattern (01-105, -1 = unknown - The second most frequent pattern gleason grade among all available specimens.)
Beschrijving

GleasonScoreSecondaryPatternValue

Datatype

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
Radiographic Evidence
Beschrijving

Radiographic Evidence

Radiographic evidence of pathologically enlarged pelvic nodes
Beschrijving

PathologicIncreaseSizePelvicLymphNodeRadiographyDetectedInd-2

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C25610
UMLS 2011AA ObjectClass
C1521733
NCI Thesaurus ObjectClass-2
C12363
UMLS 2011AA ObjectClass-2
C0729595
NCI Thesaurus ObjectClass-3
C25533
UMLS 2011AA ObjectClass-3
C0442805
NCI Thesaurus ObjectClass-4
C25681
UMLS 2011AA ObjectClass-4
C0456389
NCI Thesaurus Property
C38101
UMLS 2011AA Property
C1962945
NCI Thesaurus Property-2
C25481
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Radiographic evidence of pathologically enlarged retroperitoneal lymph nodes
Beschrijving

PathologicIncreaseSizeRetroperitonealLymphNodeRadiographyDetectedInd-2

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C25610
UMLS 2011AA ObjectClass
C1521733
NCI Thesaurus ObjectClass-2
C12745
UMLS 2011AA ObjectClass-2
C0024204
NCI Thesaurus ObjectClass-3
C28256
UMLS 2011AA ObjectClass-3
C0035359
NCI Thesaurus ObjectClass-4
C25533
UMLS 2011AA ObjectClass-4
C0442805
NCI Thesaurus ObjectClass-5
C25681
UMLS 2011AA ObjectClass-5
C0456389
NCI Thesaurus Property
C38101
UMLS 2011AA Property
C1962945
NCI Thesaurus Property-2
C25481
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Androgen Deprivation
Beschrijving

Androgen Deprivation

Baseline PSA Value (ng/ml)
Beschrijving

LaboratoryProcedureBaselineProstate-SpecificAntigenOutcomeValue

Datatype

float

Maateenheden
  • 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 (MM/DD/YYYY)
Beschrijving

PSA date

Datatype

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
Prior Treatment
Beschrijving

Prior Treatment

Chemotherapy
Beschrijving

ChemotherapyAdministeredInd-2

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Specify agent (s)
Beschrijving

PriorChemotherapyRegimenText

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus Property
C15697
UMLS 2011AA Property
C0040808
Date Prior Chemotherapy Ended (MM/DD/YYYY)
Beschrijving

PriorChemotherapyAdministeredEndDate

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Radiation Therapy
Beschrijving

RTTreatmentInd-3

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C15313
UMLS 2011AA ObjectClass
C1522449
NCI Thesaurus Property
C15368
Specify Site (If yes:)
Beschrijving

RTSite,LocationName

Datatype

text

Date Prior RT Ended (MM/DD/YYYY)
Beschrijving

PriorRTEndDate

Datatype

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 Immunotherapy
Beschrijving

PriorImmunotherapyAdministeredInd-3

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C15262
UMLS 2011AA ObjectClass
C0021083
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Date Prior Immunotherapy Ended (If yes: - MM/DD/YYYY)
Beschrijving

PriorImmunotherapyEndDate

Datatype

date

Alias
NCI Thesaurus ObjectClass
C15262
UMLS 2011AA ObjectClass
C0021083
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
Hormonal therapy
Beschrijving

HormoneTherapyAdministeredInd-3

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Date Prior hormonal therapy Ended (MM/DD/YYYY)
Beschrijving

PriorHormonalTherapyEndDate

Datatype

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
Bisphosphonates
Beschrijving

PriorBiphosphonateTherapyAdministeredInd-2

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C443
UMLS 2011AA ObjectClass
C0012544
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus ObjectClass-3
C15368
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Bisphosphonates continuing
Beschrijving

ChemotherapyContinuousBiphosphonateAdministrationInd-2

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus Property
C443
UMLS 2011AA Property
C0012544
NCI Thesaurus Property-2
C53279
UMLS 2011AA Property-2
C0549178
NCI Thesaurus Property-3
C25409
UMLS 2011AA Property-3
C1533734
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Gene Therapy
Beschrijving

PriorGeneTherapyAdministeredInd-3

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus ObjectClass-2
C15238
UMLS 2011AA ObjectClass-2
C0017296
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Prostatectomy
Beschrijving

PriorProstatectomyPerformedInd-3

Datatype

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
Other Prior Therapy
Beschrijving

PriorTherapyOtherAdministeredInd-3

Datatype

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
Name of other prior therapy (If yes,)
Beschrijving

PriorTherapyOtherName

Datatype

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
Comments
Beschrijving

Comments

Investigator Signature
Beschrijving

Investigator Signature

Datatype

text

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

Investigator Signature Date

Datatype

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
Comments
Beschrijving

Comments

Datatype

text

Alias
UMLS CUI-1
C0947611
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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 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Header
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)
Item Group
Patient demographics
Patient Initials
Item
Patient Initials (Last, First)
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)
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)
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)
Item
ECOG 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
ECOG 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)
Item Group
Data amendment
Data amended
Item
Please mark an 'X' if data have been amended. (Please circle amended items in red)
text
C25704 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Data amended date
Item
Date data amended (s - MM/DD/YYYY)
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
Description Of Primary Disease
FirstBiopsyPositiveDate
Item
Date of Initial Diagnosis of Primary Tumor (MM/DD/YYYY)
date
C15189 (NCI Thesaurus ObjectClass)
C0005558 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus ObjectClass-2)
C1279901 (UMLS 2011AA ObjectClass-2)
C25246 (NCI Thesaurus Property)
C1446409 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property-2)
C2745955 (UMLS 2011AA Property-2)
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.3
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)
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
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.4
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.5
Code List
Pathologic M Stage
CL Item
Distant Metastasis Cannot Be Assessed (not Evaluated By Any Modality) (MX)
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) With Or Without Bone Disease (M1c)
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.6
Code List
Clinical T Stage
CL Item
Primary Tumor Cannot Be Assessed (TX)
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)
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.7
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.8
Code List
Clinical M Stage
CL Item
Distant Metastasis Cannot Be Assessed (MX)
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)
GleasonScorePrimaryPatternValue
Item
Gleason Score, Primary Pattern (01-105, -1 = unknown - The most frequent pattern gleason grade among all available specimens.)
float
C25251 (NCI Thesaurus Property)
C0205225 (UMLS 2011AA Property)
C28084 (NCI Thesaurus ObjectClass)
C0332326 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25336 (NCI Thesaurus Property-2)
C0449774 (UMLS 2011AA Property-2)
GleasonScoreSecondaryPatternValue
Item
Gleason Score, Secondary Pattern (01-105, -1 = unknown - The second most frequent pattern gleason grade among all available specimens.)
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)
Item Group
Radiographic Evidence
PathologicIncreaseSizePelvicLymphNodeRadiographyDetectedInd-2
Item
Radiographic evidence of pathologically enlarged pelvic nodes
boolean
C25610 (NCI Thesaurus ObjectClass)
C1521733 (UMLS 2011AA ObjectClass)
C12363 (NCI Thesaurus ObjectClass-2)
C0729595 (UMLS 2011AA ObjectClass-2)
C25533 (NCI Thesaurus ObjectClass-3)
C0442805 (UMLS 2011AA ObjectClass-3)
C25681 (NCI Thesaurus ObjectClass-4)
C0456389 (UMLS 2011AA ObjectClass-4)
C38101 (NCI Thesaurus Property)
C1962945 (UMLS 2011AA Property)
C25481 (NCI Thesaurus Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PathologicIncreaseSizeRetroperitonealLymphNodeRadiographyDetectedInd-2
Item
Radiographic evidence of pathologically enlarged retroperitoneal lymph nodes
boolean
C25610 (NCI Thesaurus ObjectClass)
C1521733 (UMLS 2011AA ObjectClass)
C12745 (NCI Thesaurus ObjectClass-2)
C0024204 (UMLS 2011AA ObjectClass-2)
C28256 (NCI Thesaurus ObjectClass-3)
C0035359 (UMLS 2011AA ObjectClass-3)
C25533 (NCI Thesaurus ObjectClass-4)
C0442805 (UMLS 2011AA ObjectClass-4)
C25681 (NCI Thesaurus ObjectClass-5)
C0456389 (UMLS 2011AA ObjectClass-5)
C38101 (NCI Thesaurus Property)
C1962945 (UMLS 2011AA Property)
C25481 (NCI Thesaurus Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (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 (MM/DD/YYYY)
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
Prior Treatment
ChemotherapyAdministeredInd-2
Item
Chemotherapy
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
PriorChemotherapyRegimenText
Item
Specify agent (s)
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C15697 (NCI Thesaurus Property)
C0040808 (UMLS 2011AA Property)
PriorChemotherapyAdministeredEndDate
Item
Date Prior Chemotherapy Ended (MM/DD/YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
RTTreatmentInd-3
Item
Radiation Therapy
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)
RTSite,LocationName
Item
Specify Site (If yes:)
text
PriorRTEndDate
Item
Date Prior RT Ended (MM/DD/YYYY)
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)
PriorImmunotherapyAdministeredInd-3
Item
Prior Immunotherapy
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15262 (NCI Thesaurus ObjectClass)
C0021083 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
PriorImmunotherapyEndDate
Item
Date Prior Immunotherapy Ended (If yes: - MM/DD/YYYY)
date
C15262 (NCI Thesaurus ObjectClass)
C0021083 (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)
HormoneTherapyAdministeredInd-3
Item
Hormonal therapy
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
PriorHormonalTherapyEndDate
Item
Date Prior hormonal therapy Ended (MM/DD/YYYY)
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)
PriorBiphosphonateTherapyAdministeredInd-2
Item
Bisphosphonates
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C443 (NCI Thesaurus ObjectClass)
C0012544 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C15368 (NCI Thesaurus ObjectClass-3)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
ChemotherapyContinuousBiphosphonateAdministrationInd-2
Item
Bisphosphonates continuing
boolean
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C443 (NCI Thesaurus Property)
C0012544 (UMLS 2011AA Property)
C53279 (NCI Thesaurus Property-2)
C0549178 (UMLS 2011AA Property-2)
C25409 (NCI Thesaurus Property-3)
C1533734 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PriorGeneTherapyAdministeredInd-3
Item
Gene Therapy
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15238 (NCI Thesaurus ObjectClass-2)
C0017296 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
PriorProstatectomyPerformedInd-3
Item
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)
PriorTherapyOtherAdministeredInd-3
Item
Other Prior Therapy
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)
PriorTherapyOtherName
Item
Name of other prior therapy (If yes,)
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)
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)
Comments
Item
Comments
text
C0947611 (UMLS CUI-1)
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