ID

3274

Beschreibung

CALGB 90203: Chemohormonal Treatment Form [Form C-1240 v1 11/08/2006] Surgery With or Without Docetaxel and Leuprolide or Goserelin in Treating Patients With High-Risk Localized Prostate Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=1F187698-E2E9-7108-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=1F187698-E2E9-7108-E044-0003BA3F9857

Stichworte

Versionen (3)
  1. 19.09.12 19.09.12 -
  2. 09.01.15 09.01.15 - Martin Dugas
  3. 16.06.15 16.06.15 -
Hochgeladen am

19. September 2012

DOI

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Lizenz

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Prostate Cancer NCT00430183 Treatment - CALGB 90203: Chemohormonal Treatment Form - 2525831v1.0

Englisch

Instructions: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink. Mark an X in the appropriate box for fields with a choice...

1 Formulare  
Unnamed1
Beschreibung

Unnamed1

CALGB Form (C-1241)
Beschreibung

CALGBFormIdentifierNumber

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C19464
UMLS 2011AA ObjectClass
C0376315
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C25442
UMLS 2011AA ObjectClass
C1516238
CALGB Study No.
Beschreibung

ProtocolCALGBIdentifierNumber

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C25442
UMLS 2011AA Property
C1516238
CALGB Patient ID
Beschreibung

PatientCALGBIdentifierNumber

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C25442
UMLS 2011AA Property
C1516238
Cycle Start Date (mm dd yyyy)
Beschreibung

TreatmentCourseBeginDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ValueDomain
C25431
UMLS 2011AA ValueDomain
C0439659
NCI Thesaurus Property
C25379
UMLS 2011AA Property
C0750729
Cycle end date (mm dd yyyy)
Beschreibung

TreatmentCourseEndDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25379
UMLS 2011AA Property
C0750729
Are data amended
Beschreibung

DataAmendedInd-3

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C25416
UMLS 2011AA Property
C1691222
Unnamed2
Beschreibung

Unnamed2

Patient Initials (Last, First Middle)
Beschreibung

PatientInitialsName

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
Patient Hospital No.
Beschreibung

PatientMedicalRecordNumber

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25261
UMLS 2011AA Property
C0205476
NCI Thesaurus Property
C25198
UMLS 2011AA Property
C0034869
Institution/Affiliate
Beschreibung

CombinedInstitutionName

Datentyp

text

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

ParticipatingGroupName

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C25608
UMLS 2011AA ObjectClass
C0679823
NCI Thesaurus ObjectClass
C17005
UMLS 2011AA ObjectClass
C1257890
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Participating Group Study No.
Beschreibung

ProtocolParticipatingIdentifierNumber

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C25608
UMLS 2011AA Property
C0679823
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Participating Group Patient ID
Beschreibung

PatientParticipatingIdentifierNumber

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25608
UMLS 2011AA Property
C0679823
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Additional Instructions
Beschreibung

Additional Instructions

Cycle Number
Beschreibung

TherapyCourseNumber

Datentyp

double

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25379
UMLS 2011AA Property
C0750729
Height (cm)
Beschreibung

PatientHeightMeasurement

Datentyp

double

Maßeinheiten
  • cm
Alias
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25347
UMLS 2011AA Property
C0489786
cm
Weight (kg)
Beschreibung

PatientWeightMeasurement

Datentyp

double

Maßeinheiten
  • Kg
Alias
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25208
UMLS 2011AA Property
C0043100
Kg
BSA (m^2)
Beschreibung

PatientBodySurfaceAreaMeasurement

Datentyp

double

Alias
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25157
UMLS 2011AA Property
C0005902
Unnamed3
Beschreibung

Unnamed3

Agent Name (Docetaxel #628503)
Beschreibung

AgentName

Datentyp

text

Alias
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ValueDomain
C1708
UMLS 2011AA ValueDomain
C0450442
NCI Thesaurus ValueDomain
C42614
UMLS 2011AA ValueDomain
C0027365
Agent Dose (mg)
Beschreibung

AgentAdministeredDose

Datentyp

double

Alias
NCI Thesaurus ValueDomain
C25488
UMLS 2011AA ValueDomain
C0178602
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ValueDomain
C1708
UMLS 2011AA ValueDomain
C0450442
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Dose modification (1 Dose Modification codes: 0=No dose modification; 1=Dose held not given; 2=Dose delayed; 3=Dose reduced; 4=Dose delayed and reduced; 5=Dose discontinued; 6=Dosing error)
Beschreibung

DoseModificationStatus

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C25488
UMLS 2011AA ObjectClass
C0178602
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
NCI Thesaurus Property
C25572
Dose Modification Reason (2 Dose modification reason codes: 1=Adverse event; 2=Hypersensitiv... 99=Other. Do not report a dose modification reason for subsequent weeks or cycles that continue the same dose modification. Dose changes due to BSA do not constitute dose modifications.)
Beschreibung

DoseModificationReason

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
NCI Thesaurus ObjectClass
C25488
UMLS 2011AA ObjectClass
C0178602
NCI Thesaurus Property
C25572
If dose modification reason = 99, specify
Beschreibung

DoseModificationReasonSpecify

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C25488
UMLS 2011AA ObjectClass
C0178602
NCI Thesaurus Property
C25572
Concomitant medications administered during this cycle (Mark all that apply with an X.)
Beschreibung

ConcomitantAgentAdministeredType

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ObjectClass
C25730
UMLS 2011AA ObjectClass
C0521115
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Other specify
Beschreibung

ConcomitantAgentAdministeredSpecify

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ObjectClass
C25730
UMLS 2011AA ObjectClass
C0521115
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Is protocol chemotherapy continuing? (after this cycle)
Beschreibung

ProtocolChemotherapyContinueAdministrationInd-2

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus ObjectClass
C42651
UMLS 2011AA ObjectClass
C0442711
NCI Thesaurus Property
C53279
UMLS 2011AA Property
C0549178
NCI Thesaurus Property
C25409
UMLS 2011AA Property
C1533734
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Date Chemotherapy Ended (mm dd yyyy)
Beschreibung

ChemotherapyAdministeredEndDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Total number of chemotherapy cycles completed
Beschreibung

ChemotherapyTotalCycleCompleteCount

Datentyp

double

Alias
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Thesaurus Property
C25304
UMLS 2011AA Property
C0439810
NCI Thesaurus Property
C25472
UMLS 2011AA Property
C1511572
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
Reason Treatment Ended (Recommended Term for CRF text "Reason LHRH Agonist treatment ended" - 2 Reason treatment ended codes: 18=Treatment completed per protocol criteria; 19=Disease progression, relapse during active treatment; 20=Adverse event/side effects/... 27=Other.)
Beschreibung

Off-treatmentReason

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
NCI Thesaurus ObjectClass
C25601
UMLS 2011AA ObjectClass
C1518544
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Specify (If reason LHRH agonist treatment ended = 24-27,)
Beschreibung

Off-treatmentReasonSpecify

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C25601
UMLS 2011AA ObjectClass
C1518544
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Unnamed2
Beschreibung

Unnamed2

Is patient receiving on-going LH-RH agonist therapy (Add NEW CDE for lead question... "Is patient receiving ongoing LHRH agonist therapy")
Beschreibung

HormoneTherapyLuteinizingHormone-releasingHormoneAgonistAdministrationInd-3

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property
C25409
UMLS 2011AA Property
C1533734
NCI Thesaurus Property
C1910
UMLS 2011AA Property
C1518041
LHRH agonist therapy (Mark all that apply with an X.)
Beschreibung

HormoneTherapyLuteinizingHormone-releasingHormoneAgonistAdministrationName

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property
C25409
UMLS 2011AA Property
C1533734
NCI Thesaurus ValueDomain
C42614
UMLS 2011AA ValueDomain
C0027365
NCI Thesaurus Property
C1910
UMLS 2011AA Property
C1518041
Other specify
Beschreibung

HormoneTherapyLuteinizingHormone-releasingHormoneAgonistAdministrationSpecify

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property
C25409
UMLS 2011AA Property
C1533734
NCI Thesaurus Property
C1910
UMLS 2011AA Property
C1518041
LHRH agonist start date (mm dd yyyy)
Beschreibung

HormoneTherapyLuteinizingHormone-releasingHormoneAgonistAdministrationBeginDate

Datentyp

date

Alias
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property
C25409
UMLS 2011AA Property
C1533734
NCI Thesaurus Property
C1910
UMLS 2011AA Property
C1518041
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25431
UMLS 2011AA ValueDomain
C0439659
LHRH agonist last administered date (mm dd yyyy)
Beschreibung

HormoneTherapyLuteinizingHormone-releasingHormoneAgonistAdministrationEndDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property
C25409
UMLS 2011AA Property
C1533734
NCI Thesaurus Property
C1910
UMLS 2011AA Property
C1518041
Agent Total Cumulative Dose (Recommended Term for CRF Text "LHRH Agonist Total Dose to Date" mg)
Beschreibung

CumulativeAgentTotalDose

Datentyp

double

Alias
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ObjectClass
C25470
UMLS 2011AA ObjectClass
C1511559
NCI Thesaurus Property
C25304
UMLS 2011AA Property
C0439810
NCI Thesaurus Property
C25256
UMLS 2011AA Property
C1265611
NCI Thesaurus ValueDomain
C25304
UMLS 2011AA ValueDomain
C0439810
NCI Thesaurus ValueDomain
C25488
UMLS 2011AA ValueDomain
C0178602
Did patient take oral antiandrogen(s) (Recommended Term for CRF Text "Did patient take oral antiandrogens during this period" Allowed, but not recommended by protocol)
Beschreibung

NonsteroidalAntiandrogenTherapyAdministeredInd-2

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Metathesaurus ObjectClass
CL316360
Oral antiandrogen therapy (Mark all that apply with an X.)
Beschreibung

OralAntiandrogenTherapyAgentAdministeredName

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ObjectClass
C25311
UMLS 2011AA ObjectClass
C0442027
NCI Thesaurus ObjectClass
C15481
UMLS 2011AA ObjectClass
C0279492
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
Reason Treatment Ended (Recommended Term for CRF text "Reason LHRH Agonist treatment ended" - 2 Reason treatment ended codes: 18=Treatment completed per protocol criteria; 19=Disease progression, relapse during active treatment; 20=Adverse event/side effects/... 27=Other.)
Beschreibung

Off-treatmentReason

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
NCI Thesaurus ObjectClass
C25601
UMLS 2011AA ObjectClass
C1518544
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Other specify
Beschreibung

OralAntiandrogenTherapyAgentAdministeredSpecify

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ObjectClass
C25311
UMLS 2011AA ObjectClass
C0442027
NCI Thesaurus ObjectClass
C15481
UMLS 2011AA ObjectClass
C0279492
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Specify (If reason LHRH agonist treatment ended = 24-27,)
Beschreibung

Off-treatmentReasonSpecify

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C25601
UMLS 2011AA ObjectClass
C1518544
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Oral Antiandrogen Start Date (Most recent. mm dd yyyy)
Beschreibung

OralAntiandrogenTherapyAgentAdministeredBeginDate

Datentyp

date

Alias
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ObjectClass
C25311
UMLS 2011AA ObjectClass
C0442027
NCI Thesaurus ObjectClass
C15481
UMLS 2011AA ObjectClass
C0279492
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25431
UMLS 2011AA ValueDomain
C0439659
Oral antiandrogen last administered date (mm dd yyyy)
Beschreibung

OralAntiandrogenTherapyAgentAdministeredEndDate

Datentyp

date

Alias
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ObjectClass
C25311
UMLS 2011AA ObjectClass
C0442027
NCI Thesaurus ObjectClass
C15481
UMLS 2011AA ObjectClass
C0279492
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Has patient refused further protocol therapy or withdrawn from study
Beschreibung

PatientWithdrawFollow-upConsentInd-2

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C16033
UMLS 2011AA Property
C1522577
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
NCI Thesaurus Property
C38061
UMLS 2011AA Property
C2349954
Patient has withdrawn consent for clinical follow-up (Recommended Term to replace "Clinical follow-up withdrawn consent date")
Beschreibung

PatientWithdrawnConsentClinicalInd-2

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
NCI Thesaurus Property
C38061
UMLS 2011AA Property
C2349954
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ValueDomain
C25398
UMLS 2011AA ValueDomain
C0205210
Patient has withdrawn consent for survival follow-up
Beschreibung

PatientWithdrawnConsentSurvivalInd-2

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
NCI Thesaurus Property
C38061
UMLS 2011AA Property
C2349954
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ValueDomain
C17177
UMLS 2011AA ValueDomain
C0038952
Withdrawn consent date (mm dd yyyy)
Beschreibung

PatientWithdrawConsentDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
NCI Thesaurus Property
C38061
UMLS 2011AA Property
C2349954
Ccrr Module For Calgb: 90202 Adverse Event Form
Beschreibung

Ccrr Module For Calgb: 90202 Adverse Event Form

Completed by (Last name, First name)
Beschreibung

ResponsiblePersonName

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C25657
UMLS 2011AA ObjectClass
C1273518
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Date Form Completed (mm dd yyyy)
Beschreibung

FormCompleteDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C40988
UMLS 2011AA ObjectClass
C1516308
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Thesaurus ValueDomain
C25367
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Ähnliche Modelle

Instructions: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink. Mark an X in the appropriate box for fields with a choice...

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Unnamed1
CALGBFormIdentifierNumber
Item
CALGB Form (C-1241)
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C19464 (NCI Thesaurus ObjectClass)
C0376315 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25442 (NCI Thesaurus ObjectClass)
C1516238 (UMLS 2011AA ObjectClass)
ProtocolCALGBIdentifierNumber
Item
CALGB Study No.
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25442 (NCI Thesaurus Property)
C1516238 (UMLS 2011AA Property)
PatientCALGBIdentifierNumber
Item
CALGB Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25442 (NCI Thesaurus Property)
C1516238 (UMLS 2011AA Property)
TreatmentCourseBeginDate
Item
Cycle Start Date (mm dd yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
TreatmentCourseEndDate
Item
Cycle end date (mm dd yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
Item
Are data amended
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
CL.1
Code List
Are data amended
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Unnamed2
PatientInitialsName
Item
Patient Initials (Last, First Middle)
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
PatientMedicalRecordNumber
Item
Patient Hospital No.
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25261 (NCI Thesaurus Property)
C0205476 (UMLS 2011AA Property)
C25198 (NCI Thesaurus Property)
C0034869 (UMLS 2011AA Property)
CombinedInstitutionName
Item
Institution/Affiliate
text
C25454 (NCI Thesaurus ObjectClass)
C0205195 (UMLS 2011AA ObjectClass)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ValueDomain)
C0018704 (UMLS 2011AA ValueDomain)
ParticipatingGroupName
Item
Participating Group
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25608 (NCI Thesaurus ObjectClass)
C0679823 (UMLS 2011AA ObjectClass)
C17005 (NCI Thesaurus ObjectClass)
C1257890 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
ProtocolParticipatingIdentifierNumber
Item
Participating Group Study No.
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
PatientParticipatingIdentifierNumber
Item
Participating Group Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
Item Group
Additional Instructions
TherapyCourseNumber
Item
Cycle Number
double
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
PatientHeightMeasurement
Item
Height (cm)
double
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25347 (NCI Thesaurus Property)
C0489786 (UMLS 2011AA Property)
PatientWeightMeasurement
Item
Weight (kg)
double
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25208 (NCI Thesaurus Property)
C0043100 (UMLS 2011AA Property)
PatientBodySurfaceAreaMeasurement
Item
BSA (m^2)
double
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25157 (NCI Thesaurus Property)
C0005902 (UMLS 2011AA Property)
Item Group
Unnamed3
AgentName
Item
Agent Name (Docetaxel #628503)
text
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C0450442 (UMLS 2011AA ValueDomain)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)
AgentAdministeredDose
Item
Agent Dose (mg)
double
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C0450442 (UMLS 2011AA ValueDomain)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Item
Dose modification (1 Dose Modification codes: 0=No dose modification; 1=Dose held not given; 2=Dose delayed; 3=Dose reduced; 4=Dose delayed and reduced; 5=Dose discontinued; 6=Dosing error)
text
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
C25572 (NCI Thesaurus Property)
CL.2
Code List
Dose modification (1 Dose Modification codes: 0=No dose modification; 1=Dose held not given; 2=Dose delayed; 3=Dose reduced; 4=Dose delayed and reduced; 5=Dose discontinued; 6=Dosing error)
CL Item
No Dose Modification (No dose modification)
CL Item
Dose Held (Dose held)
CL Item
Dose Delayed (Dose delayed)
CL Item
Dose Reduced (Dose reduced)
C49505 (NCI Thesaurus)
C1707814 (UMLS 2011AA)
C49505 (NCI Thesaurus)
C1707814 (UMLS 2011AA)
CL Item
Dose Delayed And Reduced (Dose delayed and reduced)
CL Item
Drug Discontinued (Drug discontinued)
CL Item
Dosing Error (Dosing error)
Item
Dose Modification Reason (2 Dose modification reason codes: 1=Adverse event; 2=Hypersensitiv... 99=Other. Do not report a dose modification reason for subsequent weeks or cycles that continue the same dose modification. Dose changes due to BSA do not constitute dose modifications.)
text
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
C25572 (NCI Thesaurus Property)
CL.3
Code List
Dose Modification Reason (2 Dose modification reason codes: 1=Adverse event; 2=Hypersensitiv... 99=Other. Do not report a dose modification reason for subsequent weeks or cycles that continue the same dose modification. Dose changes due to BSA do not constitute dose modifications.)
CL Item
Adverse Event (Adverse event)
C41331 (NCI Thesaurus)
C0877248 (UMLS 2011AA)
CL Item
Hypersensitivity (Hypersensitivity)
C3114 (NCI Thesaurus)
C0020517 (UMLS 2011AA)
CL Item
Patient Refusal/noncompliance (Patient refusal/noncompliance)
CL Item
Scheduling (Scheduling)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
DoseModificationReasonSpecify
Item
If dose modification reason = 99, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
C25572 (NCI Thesaurus Property)
Item
Concomitant medications administered during this cycle (Mark all that apply with an X.)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25730 (NCI Thesaurus ObjectClass)
C0521115 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
CL.4
Code List
Concomitant medications administered during this cycle (Mark all that apply with an X.)
CL Item
Darbepoetin Alfa (Darbepoetin alfa)
C1878 (NCI Thesaurus)
C0937950 (UMLS 2011AA)
CL Item
Dexamethasone (Dexamethasone)
C422 (NCI Thesaurus)
C0011777 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
ConcomitantAgentAdministeredSpecify
Item
Other specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25730 (NCI Thesaurus ObjectClass)
C0521115 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Item
Is protocol chemotherapy continuing? (after this cycle)
text
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C42651 (NCI Thesaurus ObjectClass)
C0442711 (UMLS 2011AA ObjectClass)
C53279 (NCI Thesaurus Property)
C0549178 (UMLS 2011AA Property)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.5
Code List
Is protocol chemotherapy continuing? (after this cycle)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
ChemotherapyAdministeredEndDate
Item
Date Chemotherapy Ended (mm dd yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
ChemotherapyTotalCycleCompleteCount
Item
Total number of chemotherapy cycles completed
double
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25304 (NCI Thesaurus Property)
C0439810 (UMLS 2011AA Property)
C25472 (NCI Thesaurus Property)
C1511572 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
Item
Reason Treatment Ended (Recommended Term for CRF text "Reason LHRH Agonist treatment ended" - 2 Reason treatment ended codes: 18=Treatment completed per protocol criteria; 19=Disease progression, relapse during active treatment; 20=Adverse event/side effects/... 27=Other.)
text
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.9
Code List
Reason Treatment Ended (Recommended Term for CRF text "Reason LHRH Agonist treatment ended" - 2 Reason treatment ended codes: 18=Treatment completed per protocol criteria; 19=Disease progression, relapse during active treatment; 20=Adverse event/side effects/... 27=Other.)
CL Item
Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
CL Item
Disease Progression, Relapse During Active Treatment (Disease progression, relapse during active treatment)
CL Item
Adverse Event/side Effects/complications (Adverse Event/Side Effects/Complications)
CL Item
Death On Study (Death on study)
CL Item
Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient withdrawal/refusal after beginning protocol therapy)
CL Item
Patient Withdrawal Or Refusal Before Beginning Protocol Therapy (Patient withdrawal/refusal prior to beginning protocol therapy)
CL Item
Alternative Therapy (Alternative therapy)
CL Item
Patient Off-treatment For Other Complicating Disease (Patient off-treatment for other complicating disease)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
Off-treatmentReasonSpecify
Item
Specify (If reason LHRH agonist treatment ended = 24-27,)
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Item
Is patient receiving on-going LH-RH agonist therapy (Add NEW CDE for lead question... "Is patient receiving ongoing LHRH agonist therapy")
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C1910 (NCI Thesaurus Property)
C1518041 (UMLS 2011AA Property)
CL.7
Code List
Is patient receiving on-going LH-RH agonist therapy (Add NEW CDE for lead question... "Is patient receiving ongoing LHRH agonist therapy")
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
LHRH agonist therapy (Mark all that apply with an X.)
text
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)
C1910 (NCI Thesaurus Property)
C1518041 (UMLS 2011AA Property)
CL.8
Code List
LHRH agonist therapy (Mark all that apply with an X.)
CL Item
Goserelin (Goserelin (Zoladex))
C1374 (NCI Thesaurus)
C0120107 (UMLS 2011AA)
CL Item
Leuprolide Acetate (Leuprolide (Lupron))
C1319 (NCI Thesaurus)
C0085272 (UMLS 2011AA)
C1319 (NCI Thesaurus)
C0085272 (UMLS 2011AA)
CL Item
Leuprolide Acetate (Leuprolide (Eligard))
C1319 (NCI Thesaurus)
C0085272 (UMLS 2011AA)
C1319 (NCI Thesaurus)
C0085272 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
HormoneTherapyLuteinizingHormone-releasingHormoneAgonistAdministrationSpecify
Item
Other specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C1910 (NCI Thesaurus Property)
C1518041 (UMLS 2011AA Property)
HormoneTherapyLuteinizingHormone-releasingHormoneAgonistAdministrationBeginDate
Item
LHRH agonist start date (mm dd yyyy)
date
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C1910 (NCI Thesaurus Property)
C1518041 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)
HormoneTherapyLuteinizingHormone-releasingHormoneAgonistAdministrationEndDate
Item
LHRH agonist last administered date (mm dd yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C1910 (NCI Thesaurus Property)
C1518041 (UMLS 2011AA Property)
CumulativeAgentTotalDose
Item
Agent Total Cumulative Dose (Recommended Term for CRF Text "LHRH Agonist Total Dose to Date" mg)
double
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25470 (NCI Thesaurus ObjectClass)
C1511559 (UMLS 2011AA ObjectClass)
C25304 (NCI Thesaurus Property)
C0439810 (UMLS 2011AA Property)
C25256 (NCI Thesaurus Property)
C1265611 (UMLS 2011AA Property)
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
Item
Did patient take oral antiandrogen(s) (Recommended Term for CRF Text "Did patient take oral antiandrogens during this period" Allowed, but not recommended by protocol)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
CL316360 (NCI Metathesaurus ObjectClass)
CL.10
Code List
Did patient take oral antiandrogen(s) (Recommended Term for CRF Text "Did patient take oral antiandrogens during this period" Allowed, but not recommended by protocol)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Oral antiandrogen therapy (Mark all that apply with an X.)
text
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25311 (NCI Thesaurus ObjectClass)
C0442027 (UMLS 2011AA ObjectClass)
C15481 (NCI Thesaurus ObjectClass)
C0279492 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
CL.11
Code List
Oral antiandrogen therapy (Mark all that apply with an X.)
CL Item
Bicalutamide (Bicalutamide (Casodex))
C1599 (NCI Thesaurus)
C0285590 (UMLS 2011AA)
CL Item
Flutamide (Flutamide (Eulexin))
C509 (NCI Thesaurus)
C0016384 (UMLS 2011AA)
CL Item
Nilutamide (Nilutamide (Nilandron))
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
Item
Reason Treatment Ended (Recommended Term for CRF text "Reason LHRH Agonist treatment ended" - 2 Reason treatment ended codes: 18=Treatment completed per protocol criteria; 19=Disease progression, relapse during active treatment; 20=Adverse event/side effects/... 27=Other.)
text
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.9
Code List
Reason Treatment Ended (Recommended Term for CRF text "Reason LHRH Agonist treatment ended" - 2 Reason treatment ended codes: 18=Treatment completed per protocol criteria; 19=Disease progression, relapse during active treatment; 20=Adverse event/side effects/... 27=Other.)
CL Item
Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
CL Item
Disease Progression, Relapse During Active Treatment (Disease progression, relapse during active treatment)
CL Item
Adverse Event/side Effects/complications (Adverse Event/Side Effects/Complications)
CL Item
Death On Study (Death on study)
CL Item
Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient withdrawal/refusal after beginning protocol therapy)
CL Item
Patient Withdrawal Or Refusal Before Beginning Protocol Therapy (Patient withdrawal/refusal prior to beginning protocol therapy)
CL Item
Alternative Therapy (Alternative therapy)
CL Item
Patient Off-treatment For Other Complicating Disease (Patient off-treatment for other complicating disease)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
OralAntiandrogenTherapyAgentAdministeredSpecify
Item
Other specify
text
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25311 (NCI Thesaurus ObjectClass)
C0442027 (UMLS 2011AA ObjectClass)
C15481 (NCI Thesaurus ObjectClass)
C0279492 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Off-treatmentReasonSpecify
Item
Specify (If reason LHRH agonist treatment ended = 24-27,)
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
OralAntiandrogenTherapyAgentAdministeredBeginDate
Item
Oral Antiandrogen Start Date (Most recent. mm dd yyyy)
date
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25311 (NCI Thesaurus ObjectClass)
C0442027 (UMLS 2011AA ObjectClass)
C15481 (NCI Thesaurus ObjectClass)
C0279492 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)
OralAntiandrogenTherapyAgentAdministeredEndDate
Item
Oral antiandrogen last administered date (mm dd yyyy)
date
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25311 (NCI Thesaurus ObjectClass)
C0442027 (UMLS 2011AA ObjectClass)
C15481 (NCI Thesaurus ObjectClass)
C0279492 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item
Has patient refused further protocol therapy or withdrawn from study
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C16033 (NCI Thesaurus Property)
C1522577 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C38061 (NCI Thesaurus Property)
C2349954 (UMLS 2011AA Property)
CL.12
Code List
Has patient refused further protocol therapy or withdrawn from study
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Patient has withdrawn consent for clinical follow-up (Recommended Term to replace "Clinical follow-up withdrawn consent date")
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C38061 (NCI Thesaurus Property)
C2349954 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25398 (NCI Thesaurus ValueDomain)
C0205210 (UMLS 2011AA ValueDomain)
CL.13
Code List
Patient has withdrawn consent for clinical follow-up (Recommended Term to replace "Clinical follow-up withdrawn consent date")
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Patient has withdrawn consent for survival follow-up
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C38061 (NCI Thesaurus Property)
C2349954 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C17177 (NCI Thesaurus ValueDomain)
C0038952 (UMLS 2011AA ValueDomain)
CL.14
Code List
Patient has withdrawn consent for survival follow-up
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
PatientWithdrawConsentDate
Item
Withdrawn consent date (mm dd yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C38061 (NCI Thesaurus Property)
C2349954 (UMLS 2011AA Property)
Item Group
Ccrr Module For Calgb: 90202 Adverse Event Form
ResponsiblePersonName
Item
Completed by (Last name, First name)
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
FormCompleteDate
Item
Date Form Completed (mm dd yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C40988 (NCI Thesaurus ObjectClass)
C1516308 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain)
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