ID

3274

Beschrijving

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

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

19 september 2012

DOI

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Licentie

Creative Commons BY-NC 3.0 Legacy
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Prostate Cancer NCT00430183 Treatment - CALGB 90203: Chemohormonal Treatment Form - 2525831v1.0

Engels

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 Formulieren  
Unnamed1
Beschrijving

Unnamed1

CALGB Form (C-1241)
Beschrijving

CALGBFormIdentifierNumber

Datatype

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.
Beschrijving

ProtocolCALGBIdentifierNumber

Datatype

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
Beschrijving

PatientCALGBIdentifierNumber

Datatype

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)
Beschrijving

TreatmentCourseBeginDate

Datatype

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)
Beschrijving

TreatmentCourseEndDate

Datatype

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
Beschrijving

DataAmendedInd-3

Datatype

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
Beschrijving

Unnamed2

Patient Initials (Last, First Middle)
Beschrijving

PatientInitialsName

Datatype

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.
Beschrijving

PatientMedicalRecordNumber

Datatype

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
Beschrijving

CombinedInstitutionName

Datatype

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
Beschrijving

ParticipatingGroupName

Datatype

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.
Beschrijving

ProtocolParticipatingIdentifierNumber

Datatype

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
Beschrijving

PatientParticipatingIdentifierNumber

Datatype

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
Beschrijving

Additional Instructions

Cycle Number
Beschrijving

TherapyCourseNumber

Datatype

double

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

PatientHeightMeasurement

Datatype

double

Maateenheden
  • 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)
Beschrijving

PatientWeightMeasurement

Datatype

double

Maateenheden
  • 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)
Beschrijving

PatientBodySurfaceAreaMeasurement

Datatype

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
Beschrijving

Unnamed3

Agent Name (Docetaxel #628503)
Beschrijving

AgentName

Datatype

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)
Beschrijving

AgentAdministeredDose

Datatype

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)
Beschrijving

DoseModificationStatus

Datatype

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.)
Beschrijving

DoseModificationReason

Datatype

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
Beschrijving

DoseModificationReasonSpecify

Datatype

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.)
Beschrijving

ConcomitantAgentAdministeredType

Datatype

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
Beschrijving

ConcomitantAgentAdministeredSpecify

Datatype

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)
Beschrijving

ProtocolChemotherapyContinueAdministrationInd-2

Datatype

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)
Beschrijving

ChemotherapyAdministeredEndDate

Datatype

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
Beschrijving

ChemotherapyTotalCycleCompleteCount

Datatype

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.)
Beschrijving

Off-treatmentReason

Datatype

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,)
Beschrijving

Off-treatmentReasonSpecify

Datatype

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
Beschrijving

Unnamed2

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

HormoneTherapyLuteinizingHormone-releasingHormoneAgonistAdministrationInd-3

Datatype

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.)
Beschrijving

HormoneTherapyLuteinizingHormone-releasingHormoneAgonistAdministrationName

Datatype

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
Beschrijving

HormoneTherapyLuteinizingHormone-releasingHormoneAgonistAdministrationSpecify

Datatype

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)
Beschrijving

HormoneTherapyLuteinizingHormone-releasingHormoneAgonistAdministrationBeginDate

Datatype

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)
Beschrijving

HormoneTherapyLuteinizingHormone-releasingHormoneAgonistAdministrationEndDate

Datatype

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)
Beschrijving

CumulativeAgentTotalDose

Datatype

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)
Beschrijving

NonsteroidalAntiandrogenTherapyAdministeredInd-2

Datatype

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.)
Beschrijving

OralAntiandrogenTherapyAgentAdministeredName

Datatype

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.)
Beschrijving

Off-treatmentReason

Datatype

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
Beschrijving

OralAntiandrogenTherapyAgentAdministeredSpecify

Datatype

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,)
Beschrijving

Off-treatmentReasonSpecify

Datatype

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)
Beschrijving

OralAntiandrogenTherapyAgentAdministeredBeginDate

Datatype

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)
Beschrijving

OralAntiandrogenTherapyAgentAdministeredEndDate

Datatype

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
Beschrijving

PatientWithdrawFollow-upConsentInd-2

Datatype

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")
Beschrijving

PatientWithdrawnConsentClinicalInd-2

Datatype

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
Beschrijving

PatientWithdrawnConsentSurvivalInd-2

Datatype

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)
Beschrijving

PatientWithdrawConsentDate

Datatype

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
Beschrijving

Ccrr Module For Calgb: 90202 Adverse Event Form

Completed by (Last name, First name)
Beschrijving

ResponsiblePersonName

Datatype

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)
Beschrijving

FormCompleteDate

Datatype

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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Similar models

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 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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