ID

10734

Beschreibung

E3805 Long-Term Follow-up 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=F96E0588-18D2-4903-E034-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=F96E0588-18D2-4903-E034-0003BA3F9857

Stichworte

Versionen (3)
  1. 19.09.12 19.09.12 -
  2. 08.01.15 08.01.15 - Martin Dugas
  3. 08.06.15 08.06.15 -
Hochgeladen am

8. Juni 2015

DOI

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Lizenz

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E3805 Long-Term Follow-up Form NCT00309985

Englisch

INSTRUCTIONS: After patient is off treatment, complete this form for each required follow-up report period (see forms submission schedule).

1 Formulare  
Header
Beschreibung

Header

ECOG Protocol Number
Beschreibung

Protocol Number ECOG

Datentyp

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
Beschreibung

Patient ID ECOG

Datentyp

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
Beschreibung

Generic drug form

Datentyp

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
Beschreibung

Registration Number

Datentyp

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
Patient demographics
Beschreibung

Patient demographics

Patient Initials
Beschreibung

Patient Initials

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
ECOG Protocol Number
Beschreibung

Protocol Number ECOG

Datentyp

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
Beschreibung

Patient ID ECOG

Datentyp

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
Participating Group Protocol Number
Beschreibung

Study Number Participating Group

Datentyp

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
Beschreibung

Institution Name

Datentyp

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
Beschreibung

Trial subject ID Participating Group

Datentyp

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
Off protocol treatment period
Beschreibung

Off protocol treatment period

Off Treatment Report Period (since initial registration)
Beschreibung

PersonOff-TreatmentTimePeriodType

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property-2
C25601
UMLS 2011AA Property-2
C1518544
NCI Thesaurus Property-3
C25207
UMLS 2011AA Property-3
C0040223
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Data amendment
Beschreibung

Data amendment

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

Data amended

Datentyp

text

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

Data amended date

Datentyp

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
Vital Status
Beschreibung

Vital Status

Patient's Vital Status
Beschreibung

Patient Status

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS CUI-1
C3846084
NCI Thesaurus ValueDomain
C18003
NCI Thesaurus ValueDomain-2
C25688
NCI Thesaurus Property
C25717
Date of last contact or death
Beschreibung

Date last contact

Datentyp

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS CUI-1
C0805839
NCI Thesaurus Property
C25461
NCI Thesaurus Property-2
C25551
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
Primary Cause of Death (if applicable)
Beschreibung

Primary Cause of Death

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS CUI-1
C0007465
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C28554
NCI Thesaurus ValueDomain-2
C25251
Describe cause of death
Beschreibung

Cause of Death, specify

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C0007465
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1521902
NCI Thesaurus Property
C28554
Section II - Reporting Period
Beschreibung

Section II - Reporting Period

Reporting Period Start Date
Beschreibung

Reporting Period Start Date

Datentyp

date

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25616
UMLS CUI-1
C2361257
NCI Thesaurus Property-2
C25651
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25431
Reporting Period End Date
Beschreibung

Reporting Period End Date

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2361259
NCI Thesaurus Property
C25616
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property-2
C25651
Notice Of New Primary (including Second Colon Primary)
Beschreibung

Notice Of New Primary (including Second Colon Primary)

Has a new primary cancer or MDS been diagnosed that has not been previously reported? (If new primary site is AML/MDS, submit NCI AML/MDS form If new primary site is other than AML/MDS, submit ECOG Second Primary Form)
Beschreibung

NewCancerDiagnosisInd-3

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C25586
UMLS 2011AA ObjectClass
C0205314
NCI Thesaurus ObjectClass-2
C9305
UMLS 2011AA ObjectClass-2
C0006826
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
Site of New Primary (s)
Beschreibung

NewCancerSiteText

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C25586
UMLS 2011AA ObjectClass
C0205314
NCI Thesaurus Property
C25341
UMLS 2011AA Property
C0450429
NCI Thesaurus ObjectClass-2
C9305
UMLS 2011AA ObjectClass-2
C0006826
Section Ii-therapy Administered Androgen Deprivation
Beschreibung

Section Ii-therapy Administered Androgen Deprivation

Did the patient receive androgen suppression
Beschreibung

PatientAndrogenSuppressionTherapyReceivedInd-2

Datentyp

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25639
UMLS 2011AA Property
C1514756
NCI Thesaurus Property-2
C15368
NCI Thesaurus Property-3
C15676
UMLS 2011AA Property-2
C1515985
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Mark an 'X' if continuing
Beschreibung

TherapyContinueText

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus Property
C53279
UMLS 2011AA Property
C0549178
NCI Thesaurus ObjectClass
C15368
Start date of Androgen Deprivation (If yes M D Y)
Beschreibung

AndrogenSuppressionTherapyAdministrationBeginDate

Datentyp

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
Did patient have medical castration
Beschreibung

MedicalCastrationPerformedInd-2

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass
C15743
UMLS 2011AA ObjectClass
C1513054
Did patient have surgical castration
Beschreibung

SurgicalCastrationPerformedInd-2

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass
C15198
UMLS 2011AA ObjectClass
C0007344
Did patient have combined androgen blockade for longer than 30 days
Beschreibung

AndrogenSuppressionCombinedTherapyGreaterThanMonthAdministrationInd-2

Datentyp

boolean

Alias
NCI Thesaurus ObjectClass
C25454
UMLS 2011AA ObjectClass
C0205195
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus ObjectClass-3
C15676
UMLS 2011AA ObjectClass-2
C1515985
NCI Thesaurus Property
C29846
UMLS 2011AA Property
C0439231
NCI Thesaurus Property-2
C61584
UMLS 2011AA Property-2
C0439093
NCI Thesaurus Property-3
C25409
UMLS 2011AA Property-3
C1533734
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Treatment For Hormone Refractory Disease
Beschreibung

Treatment For Hormone Refractory Disease

Date of first therapy for Hormone Refractory Prostate Cancer (HRPC)
Beschreibung

HormoneRefractoryProstateCarcinomaTherapyAdministrationFirstDate

Datentyp

date

Alias
NCI Thesaurus ObjectClass
C38014
UMLS 2011AA ObjectClass
C0205269
NCI Thesaurus ObjectClass-2
C4863
UMLS 2011AA ObjectClass-2
C0600139
NCI Thesaurus ObjectClass-3
C2315
UMLS 2011AA ObjectClass-3
C0019932
NCI Thesaurus Property
C15368
NCI Thesaurus Property-2
C25409
UMLS 2011AA Property
C1533734
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25509
UMLS 2011AA ValueDomain-2
C1279901
Was therapy given for Hormone Refractory Prostate Cancer this reporting period
Beschreibung

HormoneRefractoryProstateCarcinomaTherapyCurrentClinicalTrialPeriodAdministrationInd-3

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C38014
UMLS 2011AA ObjectClass
C0205269
NCI Thesaurus ObjectClass-2
C4863
UMLS 2011AA ObjectClass-2
C0600139
NCI Thesaurus ObjectClass-3
C2315
UMLS 2011AA ObjectClass-3
C0019932
NCI Thesaurus Property
C25471
UMLS 2011AA Property
C0521116
NCI Thesaurus Property-2
C15368
NCI Thesaurus Property-3
C25409
UMLS 2011AA Property-2
C1533734
NCI Thesaurus Property-4
C71737
UMLS 2011AA Property-3
C2347804
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Date of first therapy for hormone refractory prostate cancer this reporting period (M D Y HRPC)
Beschreibung

HormoneRefractoryProstateCarcinomaTherapyCurrentClinicalTrialPeriodAdministrationDate

Datentyp

date

Alias
NCI Thesaurus ObjectClass
C38014
UMLS 2011AA ObjectClass
C0205269
NCI Thesaurus ObjectClass-2
C4863
UMLS 2011AA ObjectClass-2
C0600139
NCI Thesaurus ObjectClass-3
C2315
UMLS 2011AA ObjectClass-3
C0019932
NCI Thesaurus Property
C25471
UMLS 2011AA Property
C0521116
NCI Thesaurus Property-2
C15368
NCI Thesaurus Property-3
C25409
UMLS 2011AA Property-2
C1533734
NCI Thesaurus Property-4
C71737
UMLS 2011AA Property-3
C2347804
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Chemotherapy-Docetaxel
Beschreibung

DocetaxelChemotherapyAgentAdministrationInd-3

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus ObjectClass-2
C1526
UMLS 2011AA ObjectClass-2
C0246415
NCI Thesaurus ObjectClass-3
C1708
UMLS 2011AA ObjectClass-3
C0450442
NCI Thesaurus Property
C25409
UMLS 2011AA Property
C1533734
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Chemotherapy-Other
Beschreibung

OtherChemotherapyAgentAdministrationInd-3

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C17649
UMLS 2011AA ObjectClass
C0205394
NCI Thesaurus ObjectClass-2
C15632
UMLS 2011AA ObjectClass-2
C0392920
NCI Thesaurus ObjectClass-3
C1708
UMLS 2011AA ObjectClass-3
C0450442
NCI Thesaurus Property
C25409
UMLS 2011AA Property
C1533734
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Other, specify
Beschreibung

OtherChemotherapyAgentAdministrationSpecify

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C17649
UMLS 2011AA ObjectClass
C0205394
NCI Thesaurus ObjectClass-2
C15632
UMLS 2011AA ObjectClass-2
C0392920
NCI Thesaurus ObjectClass-3
C1708
UMLS 2011AA ObjectClass-3
C0450442
NCI Thesaurus Property
C25409
UMLS 2011AA Property
C1533734
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Hormonal therapy
Beschreibung

HormoneTherapyAdministeredInd-3

Datentyp

text

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
Other, specify
Beschreibung

HormoneTherapyAdministeredSpecify

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Immunotherapy/BRM
Beschreibung

BiologicalResponseModifierImmunotherapyAdministeredInd-2

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C15262
UMLS 2011AA ObjectClass
C0021083
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ObjectClass-2
C308
UMLS 2011AA ObjectClass-2
C0005525
Immunotherapy/BRM-Specify
Beschreibung

BiologicalResponseModifierImmunotherapyAdministeredSpecify

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C15262
UMLS 2011AA ObjectClass
C0021083
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ObjectClass-2
C308
UMLS 2011AA ObjectClass-2
C0005525
Radiotherapy
Beschreibung

RadiationTherapyAdministeredInd-3

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C15313
UMLS 2011AA ObjectClass
C1522449
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Other therapy (including investigational agents or herbal /complementary therapies given by physician with therapeutic intent)
Beschreibung

Non-protocolTherapyOtherAdministeredInd-3

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C25590
UMLS 2011AA ObjectClass
C1518384
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Specify (including investigational agents or herbal /complementary therapies given by physician with therapeutic intent)
Beschreibung

Non-ProtocolTherapyOtherAdministeredSpecify

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C25590
UMLS 2011AA ObjectClass
C1518384
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Disease Follow-up Status
Beschreibung

Disease Follow-up Status

Has the patient had a documented assessment for this cancer (serological this reporting period)
Beschreibung

CancerFollow-upSerologicalAssessmentInd-3

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus Property-2
C16033
UMLS 2011AA Property-2
C1522577
NCI Thesaurus Property-3
C41264
UMLS 2011AA Property-3
C0205473
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
If unknown, explain (please)
Beschreibung

CancerUnknownFollow-upAssessmentSpecify

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus Property-2
C17998
UMLS 2011AA Property-2
C0439673
NCI Thesaurus Property-3
C16033
UMLS 2011AA Property-3
C1522577
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Date of last assessment (serological)
Beschreibung

CancerFollow-upSerologicalAssessmentDate

Datentyp

date

Alias
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus Property-2
C16033
UMLS 2011AA Property-2
C1522577
NCI Thesaurus Property-3
C41264
UMLS 2011AA Property-3
C0205473
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Has the patient developed a first progression (or relapse) that has not been previously reported? (clinical or serological)
Beschreibung

DiseaseProgressionInd-3

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25331
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
If unknown, please explain
Beschreibung

ProgressiveDiseaseUnknownAssessmentSpecify

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus ObjectClass-2
C25254
UMLS 2011AA ObjectClass-2
C0205329
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus Property-2
C17998
UMLS 2011AA Property-2
C0439673
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Date of Progression (relapse)
Beschreibung

DiseaseProgressionDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus Property
C25331
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
Sites of Progression
Beschreibung

Progression Sites

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0280457
NCI Thesaurus Property
C25341
NCI Thesaurus ObjectClass
C25331
Did a physician make a formal diagnosis of progressive disease? (HRPC)
Beschreibung

PhysicianProgressiveDiagnosisInd-3

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C25741
UMLS 2011AA ObjectClass
C0031831
NCI Thesaurus Property
C25254
UMLS 2011AA Property
C0205329
NCI Thesaurus Property-2
C15220
UMLS 2011AA Property-2
C0011900
Specify basis of progression (If no or unknown)
Beschreibung

ProgressionDiagnosisSpecify

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C25331
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
Post Hormone Refractory Disease
Beschreibung

Post Hormone Refractory Disease

Did the patient experience clinical progression? (not previously reported)
Beschreibung

ClinicalProgressionPresentInd-3

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C25398
UMLS 2011AA ObjectClass
C0205210
NCI Thesaurus ObjectClass-2
C25331
Date of Last Clinical Assessment (M D Y)
Beschreibung

Follow-Up Date

Datentyp

date

Alias
NCI Thesaurus ObjectClass
C9305
UMLS CUI-1
C3694716
NCI Thesaurus Property
C16033
NCI Thesaurus Property-2
C25365
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
Adverse Events
Beschreibung

Adverse Events

Has the patient experienced any severe long term toxicity that has not been previously reported (prior to diagnosis of progression/relapse)
Beschreibung

RadiationTherapyOncologyGroupAdverseEventRelapseReportInd-3

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C19778
UMLS 2011AA ObjectClass
C1514695
NCI Thesaurus ObjectClass-2
C41331
UMLS 2011AA ObjectClass-2
C0877248
NCI Thesaurus Property
C18265
NCI Thesaurus Property-2
C25375
UMLS 2011AA Property
C0684224
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Non-protocol Therapy
Beschreibung

Non-protocol Therapy

Has the patient received any non-protocol cancer therapy prior to first progression (not previously reported)
Beschreibung

Non-ProtocolTherapyPriorCancerProgressionAdministrationInd-3

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C25590
UMLS 2011AA ObjectClass
C1518384
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property-2
C19987
UMLS 2011AA Property-2
C0242656
NCI Thesaurus Property-3
C25409
UMLS 2011AA Property-3
C1533734
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Comments
Beschreibung

Comments

Investigator Signature
Beschreibung

Investigator Signature

Datentyp

text

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

Investigator Signature Date

Datentyp

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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Ähnliche Modelle

INSTRUCTIONS: After patient is off treatment, complete this form for each required follow-up report period (see forms submission schedule).

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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 Group
Patient demographics
Patient Initials
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
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)
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
Off protocol treatment period
Item
Off Treatment Report Period (since initial registration)
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25601 (NCI Thesaurus Property-2)
C1518544 (UMLS 2011AA Property-2)
C25207 (NCI Thesaurus Property-3)
C0040223 (UMLS 2011AA Property-3)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.1
Code List
Off Treatment Report Period (since initial registration)
CL Item
3 Months (3 Months Post Registration)
CL Item
6 Months (6 Months Post Registration)
CL Item
9 Months (9 Months Post Registration)
CL Item
12 Months (12 Months Post Registration)
CL Item
15 Months (15 Months Post Registration)
CL Item
18 Months (18 Months Post Registration)
CL Item
21 Months Post Registration (21 Months Post Registration)
CL Item
2 Years (24 Months Post Registration)
CL Item
30 Months (30 Months Post Registration)
CL Item
3 Years (36 Months Post Registration)
CL Item
42 Months (42 Months Post Registration)
CL Item
4 Years (48 Months Post Registration)
CL Item
54 Months (54 Months Post Registration)
CL Item
5 Years (60 Months Post Registration)
CL Item
6 Years (72 Months Post-Registration)
CL Item
84 Months Post Registration (84 Months Post-Registration)
CL Item
8 Years (96 Months Post-Registration)
CL Item
9 Years (108 Months Post-Registration)
CL Item
10 Years (120 Months Post-Registration)
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
Vital Status
Item
Patient's Vital Status
text
C16960 (NCI Thesaurus ObjectClass)
C3846084 (UMLS CUI-1)
C18003 (NCI Thesaurus ValueDomain)
C25688 (NCI Thesaurus ValueDomain-2)
C25717 (NCI Thesaurus Property)
CL.2
Code List
Patient's Vital Status
CL Item
Alive (Alive)
CL Item
Dead (Dead)
Date last contact
Item
Date of last contact or death
date
C16960 (NCI Thesaurus ObjectClass)
C0805839 (UMLS CUI-1)
C25461 (NCI Thesaurus Property)
C25551 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Item
Primary Cause of Death (if applicable)
text
C25638 (NCI Thesaurus ValueDomain)
C0007465 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C28554 (NCI Thesaurus Property)
C25251 (NCI Thesaurus ValueDomain-2)
CL.3
Code List
Primary Cause of Death (if applicable)
CL Item
Due To Protocol Treatment (Due to protocol treatment)
CL Item
Due To This Disease (Due to this disease)
CL Item
Due To Other Cause (Due to other cause)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Cause of Death, specify
Item
Describe cause of death
text
C25685 (NCI Thesaurus ValueDomain)
C0007465 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1521902 (UMLS CUI-2)
C28554 (NCI Thesaurus Property)
Item Group
Section II - Reporting Period
Reporting Period Start Date
Item
Reporting Period Start Date
date
C15368 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C2361257 (UMLS CUI-1)
C25651 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
Reporting Period End Date
Item
Reporting Period End Date
date
C25164 (NCI Thesaurus ValueDomain)
C2361259 (UMLS CUI-1)
C25616 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)
C25651 (NCI Thesaurus Property-2)
Item Group
Notice Of New Primary (including Second Colon Primary)
Item
Has a new primary cancer or MDS been diagnosed that has not been previously reported? (If new primary site is AML/MDS, submit NCI AML/MDS form If new primary site is other than AML/MDS, submit ECOG Second Primary Form)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
CL.4
Code List
Has a new primary cancer or MDS been diagnosed that has not been previously reported? (If new primary site is AML/MDS, submit NCI AML/MDS form If new primary site is other than AML/MDS, submit ECOG Second Primary Form)
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)
NewCancerSiteText
Item
Site of New Primary (s)
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
Item Group
Section Ii-therapy Administered Androgen Deprivation
PatientAndrogenSuppressionTherapyReceivedInd-2
Item
Did the patient receive androgen suppression
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C15368 (NCI Thesaurus Property-2)
C15676 (NCI Thesaurus Property-3)
C1515985 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
TherapyContinueText
Item
Mark an 'X' if continuing
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C53279 (NCI Thesaurus Property)
C0549178 (UMLS 2011AA Property)
C15368 (NCI Thesaurus ObjectClass)
AndrogenSuppressionTherapyAdministrationBeginDate
Item
Start date of Androgen Deprivation (If yes M D Y)
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)
MedicalCastrationPerformedInd-2
Item
Did patient have medical castration
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15743 (NCI Thesaurus ObjectClass)
C1513054 (UMLS 2011AA ObjectClass)
SurgicalCastrationPerformedInd-2
Item
Did patient have surgical castration
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15198 (NCI Thesaurus ObjectClass)
C0007344 (UMLS 2011AA ObjectClass)
AndrogenSuppressionCombinedTherapyGreaterThanMonthAdministrationInd-2
Item
Did patient have combined androgen blockade for longer than 30 days
boolean
C25454 (NCI Thesaurus ObjectClass)
C0205195 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C15676 (NCI Thesaurus ObjectClass-3)
C1515985 (UMLS 2011AA ObjectClass-2)
C29846 (NCI Thesaurus Property)
C0439231 (UMLS 2011AA Property)
C61584 (NCI Thesaurus Property-2)
C0439093 (UMLS 2011AA Property-2)
C25409 (NCI Thesaurus Property-3)
C1533734 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item Group
Treatment For Hormone Refractory Disease
HormoneRefractoryProstateCarcinomaTherapyAdministrationFirstDate
Item
Date of first therapy for Hormone Refractory Prostate Cancer (HRPC)
date
C38014 (NCI Thesaurus ObjectClass)
C0205269 (UMLS 2011AA ObjectClass)
C4863 (NCI Thesaurus ObjectClass-2)
C0600139 (UMLS 2011AA ObjectClass-2)
C2315 (NCI Thesaurus ObjectClass-3)
C0019932 (UMLS 2011AA ObjectClass-3)
C15368 (NCI Thesaurus Property)
C25409 (NCI Thesaurus Property-2)
C1533734 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25509 (NCI Thesaurus ValueDomain-2)
C1279901 (UMLS 2011AA ValueDomain-2)
Item
Was therapy given for Hormone Refractory Prostate Cancer this reporting period
text
C38014 (NCI Thesaurus ObjectClass)
C0205269 (UMLS 2011AA ObjectClass)
C4863 (NCI Thesaurus ObjectClass-2)
C0600139 (UMLS 2011AA ObjectClass-2)
C2315 (NCI Thesaurus ObjectClass-3)
C0019932 (UMLS 2011AA ObjectClass-3)
C25471 (NCI Thesaurus Property)
C0521116 (UMLS 2011AA Property)
C15368 (NCI Thesaurus Property-2)
C25409 (NCI Thesaurus Property-3)
C1533734 (UMLS 2011AA Property-2)
C71737 (NCI Thesaurus Property-4)
C2347804 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.9
Code List
Was therapy given for Hormone Refractory Prostate Cancer this reporting period
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)
HormoneRefractoryProstateCarcinomaTherapyCurrentClinicalTrialPeriodAdministrationDate
Item
Date of first therapy for hormone refractory prostate cancer this reporting period (M D Y HRPC)
date
C38014 (NCI Thesaurus ObjectClass)
C0205269 (UMLS 2011AA ObjectClass)
C4863 (NCI Thesaurus ObjectClass-2)
C0600139 (UMLS 2011AA ObjectClass-2)
C2315 (NCI Thesaurus ObjectClass-3)
C0019932 (UMLS 2011AA ObjectClass-3)
C25471 (NCI Thesaurus Property)
C0521116 (UMLS 2011AA Property)
C15368 (NCI Thesaurus Property-2)
C25409 (NCI Thesaurus Property-3)
C1533734 (UMLS 2011AA Property-2)
C71737 (NCI Thesaurus Property-4)
C2347804 (UMLS 2011AA Property-3)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item
Chemotherapy-Docetaxel
text
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C1526 (NCI Thesaurus ObjectClass-2)
C0246415 (UMLS 2011AA ObjectClass-2)
C1708 (NCI Thesaurus ObjectClass-3)
C0450442 (UMLS 2011AA ObjectClass-3)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.10
Code List
Chemotherapy-Docetaxel
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
Chemotherapy-Other
text
C17649 (NCI Thesaurus ObjectClass)
C0205394 (UMLS 2011AA ObjectClass)
C15632 (NCI Thesaurus ObjectClass-2)
C0392920 (UMLS 2011AA ObjectClass-2)
C1708 (NCI Thesaurus ObjectClass-3)
C0450442 (UMLS 2011AA ObjectClass-3)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.11
Code List
Chemotherapy-Other
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)
OtherChemotherapyAgentAdministrationSpecify
Item
Other, specify
text
C17649 (NCI Thesaurus ObjectClass)
C0205394 (UMLS 2011AA ObjectClass)
C15632 (NCI Thesaurus ObjectClass-2)
C0392920 (UMLS 2011AA ObjectClass-2)
C1708 (NCI Thesaurus ObjectClass-3)
C0450442 (UMLS 2011AA ObjectClass-3)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Item
Hormonal therapy
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
CL.12
Code List
Hormonal therapy
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)
HormoneTherapyAdministeredSpecify
Item
Other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
BiologicalResponseModifierImmunotherapyAdministeredInd-2
Item
Immunotherapy/BRM
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15262 (NCI Thesaurus ObjectClass)
C0021083 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C308 (NCI Thesaurus ObjectClass-2)
C0005525 (UMLS 2011AA ObjectClass-2)
BiologicalResponseModifierImmunotherapyAdministeredSpecify
Item
Immunotherapy/BRM-Specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C15262 (NCI Thesaurus ObjectClass)
C0021083 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C308 (NCI Thesaurus ObjectClass-2)
C0005525 (UMLS 2011AA ObjectClass-2)
Item
Radiotherapy
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
CL.14
Code List
Radiotherapy
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
Other therapy (including investigational agents or herbal /complementary therapies given by physician with therapeutic intent)
text
C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.15
Code List
Other therapy (including investigational agents or herbal /complementary therapies given by physician with therapeutic intent)
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)
Non-ProtocolTherapyOtherAdministeredSpecify
Item
Specify (including investigational agents or herbal /complementary therapies given by physician with therapeutic intent)
text
C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Item Group
Disease Follow-up Status
Item
Has the patient had a documented assessment for this cancer (serological this reporting period)
text
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C16033 (NCI Thesaurus Property-2)
C1522577 (UMLS 2011AA Property-2)
C41264 (NCI Thesaurus Property-3)
C0205473 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.16
Code List
Has the patient had a documented assessment for this cancer (serological this reporting period)
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)
CancerUnknownFollow-upAssessmentSpecify
Item
If unknown, explain (please)
text
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C17998 (NCI Thesaurus Property-2)
C0439673 (UMLS 2011AA Property-2)
C16033 (NCI Thesaurus Property-3)
C1522577 (UMLS 2011AA Property-3)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
CancerFollow-upSerologicalAssessmentDate
Item
Date of last assessment (serological)
date
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C16033 (NCI Thesaurus Property-2)
C1522577 (UMLS 2011AA Property-2)
C41264 (NCI Thesaurus Property-3)
C0205473 (UMLS 2011AA Property-3)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item
Has the patient developed a first progression (or relapse) that has not been previously reported? (clinical or serological)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25331 (NCI Thesaurus Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
CL.17
Code List
Has the patient developed a first progression (or relapse) that has not been previously reported? (clinical or serological)
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)
ProgressiveDiseaseUnknownAssessmentSpecify
Item
If unknown, please explain
text
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25254 (NCI Thesaurus ObjectClass-2)
C0205329 (UMLS 2011AA ObjectClass-2)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C17998 (NCI Thesaurus Property-2)
C0439673 (UMLS 2011AA Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
DiseaseProgressionDate
Item
Date of Progression (relapse)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C25331 (NCI Thesaurus Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
Progression Sites
Item
Sites of Progression
text
C25704 (NCI Thesaurus ValueDomain)
C0280457 (UMLS CUI-1)
C25341 (NCI Thesaurus Property)
C25331 (NCI Thesaurus ObjectClass)
Item
Did a physician make a formal diagnosis of progressive disease? (HRPC)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25741 (NCI Thesaurus ObjectClass)
C0031831 (UMLS 2011AA ObjectClass)
C25254 (NCI Thesaurus Property)
C0205329 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property-2)
C0011900 (UMLS 2011AA Property-2)
CL.18
Code List
Did a physician make a formal diagnosis of progressive disease? (HRPC)
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)
ProgressionDiagnosisSpecify
Item
Specify basis of progression (If no or unknown)
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25331 (NCI Thesaurus ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
Item Group
Post Hormone Refractory Disease
Item
Did the patient experience clinical progression? (not previously reported)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C25398 (NCI Thesaurus ObjectClass)
C0205210 (UMLS 2011AA ObjectClass)
C25331 (NCI Thesaurus ObjectClass-2)
CL.19
Code List
Did the patient experience clinical progression? (not previously reported)
CL Item
Yes (YES)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus-3)
C1705108 (UMLS 2011AA-4)
CL Item
No (NO)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C49487 (NCI Thesaurus-3)
C1298908 (UMLS 2011AA-4)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Follow-Up Date
Item
Date of Last Clinical Assessment (M D Y)
date
C9305 (NCI Thesaurus ObjectClass)
C3694716 (UMLS CUI-1)
C16033 (NCI Thesaurus Property)
C25365 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Item Group
Adverse Events
Item
Has the patient experienced any severe long term toxicity that has not been previously reported (prior to diagnosis of progression/relapse)
text
C19778 (NCI Thesaurus ObjectClass)
C1514695 (UMLS 2011AA ObjectClass)
C41331 (NCI Thesaurus ObjectClass-2)
C0877248 (UMLS 2011AA ObjectClass-2)
C18265 (NCI Thesaurus Property)
C25375 (NCI Thesaurus Property-2)
C0684224 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.20
Code List
Has the patient experienced any severe long term toxicity that has not been previously reported (prior to diagnosis of progression/relapse)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item Group
Non-protocol Therapy
Item
Has the patient received any non-protocol cancer therapy prior to first progression (not previously reported)
text
C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C19987 (NCI Thesaurus Property-2)
C0242656 (UMLS 2011AA Property-2)
C25409 (NCI Thesaurus Property-3)
C1533734 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.21
Code List
Has the patient received any non-protocol cancer therapy prior to first progression (not previously reported)
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
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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