ID

2288

Beskrivning

RTOG-0522 TF: Radiation Therapy Oncology Group Phase III Head and Neck Cancer Treatment Summary Form Radiation Therapy and Cisplatin With or Without Cetuximab in Treating Patients With Stage III or Stage IV Head and Neck Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=F62248A0-86B5-70AC-E034-0003BA3F9857

Länk

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=F62248A0-86B5-70AC-E034-0003BA3F9857

Nyckelord

  1. 2012-09-19 2012-09-19 -
  2. 2015-01-09 2015-01-09 - Martin Dugas
  3. 2015-01-09 2015-01-09 - Martin Dugas
  4. 2015-01-09 2015-01-09 - Martin Dugas
  5. 2015-07-08 2015-07-08 -
Uppladdad den

19 september 2012

DOI

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Licens

Creative Commons BY-NC 3.0 Legacy

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NCT00265941 Treatment - RTOG-0522 TF: Radiation Therapy Oncology Group Phase III Head and Neck Cancer Treatment Summary Form - 2309274v3.0

No Instruction available.

  1. StudyEvent: RTOG-0522 TF: Radiation Therapy Oncology Group Phase III Head and Neck Cancer Treatment Summary Form
    1. No Instruction available.
Unnamed Module 1
Beskrivning

Unnamed Module 1

RTOG Study No.
Beskrivning

ProtocolRTOGIdentifierNumber

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C19778
UMLS 2011AA Property
C1514695
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Case #
Beskrivning

RadiationTherapyOncologyGroupPatientCaseIdentifierNumber

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass
C19778
UMLS 2011AA ObjectClass
C1514695
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C49152
UMLS 2011AA Property
C1706256
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
Institution Name
Beskrivning

InstitutionName

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C21541
UMLS 2011AA ObjectClass
C0018704
NCI Thesaurus ValueDomain
C21541
UMLS 2011AA ValueDomain
C0018704
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Institution No.
Beskrivning

InstitutionIdentifierNumber

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C21541
UMLS 2011AA ObjectClass
C0018704
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Patient Initials
Beskrivning

PatientInitialsName

Datatyp

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
RTOG Patient ID
Beskrivning

PatientRadiationTherapyOncologyGroupIdentifierNumber

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C19778
UMLS 2011AA Property
C1514695
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Amended data
Beskrivning

DataAmendedInd-3

Datatyp

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
Summary Of Systemic Treatment
Beskrivning

Summary Of Systemic Treatment

Assigned Treatment Arm
Beskrivning

ProtocolTreatmentArmAssignmentType

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass
C42651
UMLS 2011AA ObjectClass
C0442711
NCI Thesaurus Property
C32141
UMLS 2011AA Property
C1140618
NCI Thesaurus Property
C25426
UMLS 2011AA Property
C1516050
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Patient Height (cm)
Beskrivning

PatientHeightMeasurement

Datatyp

double

Måttenheter
  • 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
Arm 2 Only
Beskrivning

Arm 2 Only

Patient Weight (kg)
Beskrivning

PatientWeightMeasurement

Datatyp

double

Måttenheter
  • 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
Body Surface Area (m^2)
Beskrivning

PatientBodySurfaceAreaMeasurement

Datatyp

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
Agent Name (pre-populated valid value -> C225)
Beskrivning

AgentName

Datatyp

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
Date Agent Administered
Beskrivning

AgentAdministeredDate

Datatyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Agent Total Dose (mg)
Beskrivning

AgentCourseTotalDose

Datatyp

double

Alias
NCI Thesaurus ValueDomain
C25304
UMLS 2011AA ValueDomain
C0439810
NCI Thesaurus Property
C25379
UMLS 2011AA Property
C0750729
NCI Thesaurus ValueDomain
C25488
UMLS 2011AA ValueDomain
C0178602
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
Dose per M2
Beskrivning

AgentAdministeredSquareMeterDose

Datatyp

double

Måttenheter
  • m2
Alias
NCI Thesaurus ValueDomain
C25488
UMLS 2011AA ValueDomain
C0178602
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ValueDomain
C42569
UMLS 2011AA ValueDomain
C0457242
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
m2
Reason for dose modification (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this must be a separate CDE; not limited to CDUS values)
Beskrivning

TreatmentModifiedDoseReason

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25256
UMLS 2011AA Property
C1265611
NCI Thesaurus Property
C25573
Reason Treatment Ended (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this CDE must use CDUS values only)
Beskrivning

Off-treatmentReason

Datatyp

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
Week 1 - Actual
Beskrivning

Week 1 - Actual

Patient Weight (kg)
Beskrivning

PatientWeightMeasurement

Datatyp

double

Måttenheter
  • 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
Body Surface Area (m^2)
Beskrivning

PatientBodySurfaceAreaMeasurement

Datatyp

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
If BSA >2.0, was cisplatin dose recalculated using ideal weight?
Beskrivning

Platinum-BasedAgentIdealBodyWeightCalculationInd

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ObjectClass
C25620
UMLS 2011AA ObjectClass
C1514162
NCI Metathesaurus Property
C1441506
NCI Metathesaurus Property
CL194347
NCI Metathesaurus ValueDomain
C0021212
Week 1
Beskrivning

Week 1

Patient Weight (kg)
Beskrivning

PatientWeightMeasurement

Datatyp

double

Måttenheter
  • 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
Body Surface Area (m^2)
Beskrivning

PatientBodySurfaceAreaMeasurement

Datatyp

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
Agent Name (pre-populated valid value -> C225)
Beskrivning

AgentName

Datatyp

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
Date Agent Administered
Beskrivning

AgentAdministeredDate

Datatyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Agent Total Dose (mg)
Beskrivning

AgentCourseTotalDose

Datatyp

double

Alias
NCI Thesaurus ValueDomain
C25304
UMLS 2011AA ValueDomain
C0439810
NCI Thesaurus Property
C25379
UMLS 2011AA Property
C0750729
NCI Thesaurus ValueDomain
C25488
UMLS 2011AA ValueDomain
C0178602
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
Dose per M2
Beskrivning

AgentAdministeredSquareMeterDose

Datatyp

double

Måttenheter
  • m2
Alias
NCI Thesaurus ValueDomain
C25488
UMLS 2011AA ValueDomain
C0178602
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ValueDomain
C42569
UMLS 2011AA ValueDomain
C0457242
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
m2
Reason for dose modification (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this must be a separate CDE; not limited to CDUS values)
Beskrivning

TreatmentModifiedDoseReason

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25256
UMLS 2011AA Property
C1265611
NCI Thesaurus Property
C25573
Reason Treatment Ended (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this CDE must use CDUS values only)
Beskrivning

Off-treatmentReason

Datatyp

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
Week 2
Beskrivning

Week 2

Patient Weight (kg)
Beskrivning

PatientWeightMeasurement

Datatyp

double

Måttenheter
  • 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
Body Surface Area (m^2)
Beskrivning

PatientBodySurfaceAreaMeasurement

Datatyp

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
Agent Name (pre-populated valid value -> C225)
Beskrivning

AgentName

Datatyp

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
Date Agent Administered
Beskrivning

AgentAdministeredDate

Datatyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Agent Total Dose (mg)
Beskrivning

AgentCourseTotalDose

Datatyp

double

Alias
NCI Thesaurus ValueDomain
C25304
UMLS 2011AA ValueDomain
C0439810
NCI Thesaurus Property
C25379
UMLS 2011AA Property
C0750729
NCI Thesaurus ValueDomain
C25488
UMLS 2011AA ValueDomain
C0178602
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
Dose per M2
Beskrivning

AgentAdministeredSquareMeterDose

Datatyp

double

Måttenheter
  • m2
Alias
NCI Thesaurus ValueDomain
C25488
UMLS 2011AA ValueDomain
C0178602
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ValueDomain
C42569
UMLS 2011AA ValueDomain
C0457242
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
m2
Reason for dose modification (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this must be a separate CDE; not limited to CDUS values)
Beskrivning

TreatmentModifiedDoseReason

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25256
UMLS 2011AA Property
C1265611
NCI Thesaurus Property
C25573
Reason Treatment Ended (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this CDE must use CDUS values only)
Beskrivning

Off-treatmentReason

Datatyp

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
Week 3
Beskrivning

Week 3

Patient Weight (kg)
Beskrivning

PatientWeightMeasurement

Datatyp

double

Måttenheter
  • 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
Body Surface Area (m^2)
Beskrivning

PatientBodySurfaceAreaMeasurement

Datatyp

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
Agent Name (pre-populated valid value -> C225)
Beskrivning

AgentName

Datatyp

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
Date Agent Administered
Beskrivning

AgentAdministeredDate

Datatyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Agent Total Dose (mg)
Beskrivning

AgentCourseTotalDose

Datatyp

double

Alias
NCI Thesaurus ValueDomain
C25304
UMLS 2011AA ValueDomain
C0439810
NCI Thesaurus Property
C25379
UMLS 2011AA Property
C0750729
NCI Thesaurus ValueDomain
C25488
UMLS 2011AA ValueDomain
C0178602
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
Dose per M2
Beskrivning

AgentAdministeredSquareMeterDose

Datatyp

double

Måttenheter
  • m2
Alias
NCI Thesaurus ValueDomain
C25488
UMLS 2011AA ValueDomain
C0178602
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ValueDomain
C42569
UMLS 2011AA ValueDomain
C0457242
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
m2
Reason for dose modification (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this must be a separate CDE; not limited to CDUS values)
Beskrivning

TreatmentModifiedDoseReason

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25256
UMLS 2011AA Property
C1265611
NCI Thesaurus Property
C25573
Reason Treatment Ended (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this CDE must use CDUS values only)
Beskrivning

Off-treatmentReason

Datatyp

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
Week 4 - Actual
Beskrivning

Week 4 - Actual

Patient Weight (kg)
Beskrivning

PatientWeightMeasurement

Datatyp

double

Måttenheter
  • 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
Body Surface Area (m^2)
Beskrivning

PatientBodySurfaceAreaMeasurement

Datatyp

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
If BSA >2.0, was cisplatin dose recalculated using ideal weight?
Beskrivning

Platinum-BasedAgentIdealBodyWeightCalculationInd

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ObjectClass
C25620
UMLS 2011AA ObjectClass
C1514162
NCI Metathesaurus Property
C1441506
NCI Metathesaurus Property
CL194347
NCI Metathesaurus ValueDomain
C0021212
Week 4
Beskrivning

Week 4

Patient Weight (kg)
Beskrivning

PatientWeightMeasurement

Datatyp

double

Måttenheter
  • 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
Body Surface Area (m^2)
Beskrivning

PatientBodySurfaceAreaMeasurement

Datatyp

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
Agent Name (pre-populated valid value -> C225)
Beskrivning

AgentName

Datatyp

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
Date Agent Administered
Beskrivning

AgentAdministeredDate

Datatyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Agent Total Dose (mg)
Beskrivning

AgentCourseTotalDose

Datatyp

double

Alias
NCI Thesaurus ValueDomain
C25304
UMLS 2011AA ValueDomain
C0439810
NCI Thesaurus Property
C25379
UMLS 2011AA Property
C0750729
NCI Thesaurus ValueDomain
C25488
UMLS 2011AA ValueDomain
C0178602
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
Dose per M2
Beskrivning

AgentAdministeredSquareMeterDose

Datatyp

double

Måttenheter
  • m2
Alias
NCI Thesaurus ValueDomain
C25488
UMLS 2011AA ValueDomain
C0178602
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ValueDomain
C42569
UMLS 2011AA ValueDomain
C0457242
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
m2
Reason for dose modification (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this must be a separate CDE; not limited to CDUS values)
Beskrivning

TreatmentModifiedDoseReason

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25256
UMLS 2011AA Property
C1265611
NCI Thesaurus Property
C25573
Reason Treatment Ended (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this CDE must use CDUS values only)
Beskrivning

Off-treatmentReason

Datatyp

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
Week 5
Beskrivning

Week 5

Patient Weight (kg)
Beskrivning

PatientWeightMeasurement

Datatyp

double

Måttenheter
  • 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
Body Surface Area (m^2)
Beskrivning

PatientBodySurfaceAreaMeasurement

Datatyp

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
Agent Name (pre-populated valid value -> C225)
Beskrivning

AgentName

Datatyp

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
Date Agent Administered
Beskrivning

AgentAdministeredDate

Datatyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Agent Total Dose (mg)
Beskrivning

AgentCourseTotalDose

Datatyp

double

Alias
NCI Thesaurus ValueDomain
C25304
UMLS 2011AA ValueDomain
C0439810
NCI Thesaurus Property
C25379
UMLS 2011AA Property
C0750729
NCI Thesaurus ValueDomain
C25488
UMLS 2011AA ValueDomain
C0178602
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
Dose per M2
Beskrivning

AgentAdministeredSquareMeterDose

Datatyp

double

Måttenheter
  • m2
Alias
NCI Thesaurus ValueDomain
C25488
UMLS 2011AA ValueDomain
C0178602
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ValueDomain
C42569
UMLS 2011AA ValueDomain
C0457242
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
m2
Reason for dose modification (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this must be a separate CDE; not limited to CDUS values)
Beskrivning

TreatmentModifiedDoseReason

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25256
UMLS 2011AA Property
C1265611
NCI Thesaurus Property
C25573
Reason Treatment Ended (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this CDE must use CDUS values only)
Beskrivning

Off-treatmentReason

Datatyp

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
Week 6
Beskrivning

Week 6

Patient Weight (kg)
Beskrivning

PatientWeightMeasurement

Datatyp

double

Måttenheter
  • 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
Body Surface Area (m^2)
Beskrivning

PatientBodySurfaceAreaMeasurement

Datatyp

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
Agent Name (pre-populated valid value -> C225)
Beskrivning

AgentName

Datatyp

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
Date Agent Administered
Beskrivning

AgentAdministeredDate

Datatyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Agent Total Dose (mg)
Beskrivning

AgentCourseTotalDose

Datatyp

double

Alias
NCI Thesaurus ValueDomain
C25304
UMLS 2011AA ValueDomain
C0439810
NCI Thesaurus Property
C25379
UMLS 2011AA Property
C0750729
NCI Thesaurus ValueDomain
C25488
UMLS 2011AA ValueDomain
C0178602
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
Dose per M2
Beskrivning

AgentAdministeredSquareMeterDose

Datatyp

double

Måttenheter
  • m2
Alias
NCI Thesaurus ValueDomain
C25488
UMLS 2011AA ValueDomain
C0178602
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ValueDomain
C42569
UMLS 2011AA ValueDomain
C0457242
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
m2
Reason for dose modification (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this must be a separate CDE; not limited to CDUS values)
Beskrivning

TreatmentModifiedDoseReason

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25256
UMLS 2011AA Property
C1265611
NCI Thesaurus Property
C25573
Reason Treatment Ended (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this CDE must use CDUS values only)
Beskrivning

Off-treatmentReason

Datatyp

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
Week 7
Beskrivning

Week 7

Patient Weight (kg)
Beskrivning

PatientWeightMeasurement

Datatyp

double

Måttenheter
  • 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
Body Surface Area (m^2)
Beskrivning

PatientBodySurfaceAreaMeasurement

Datatyp

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
Agent Name (pre-populated valid value -> C225)
Beskrivning

AgentName

Datatyp

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
Date Agent Administered
Beskrivning

AgentAdministeredDate

Datatyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Agent Total Dose (mg)
Beskrivning

AgentCourseTotalDose

Datatyp

double

Alias
NCI Thesaurus ValueDomain
C25304
UMLS 2011AA ValueDomain
C0439810
NCI Thesaurus Property
C25379
UMLS 2011AA Property
C0750729
NCI Thesaurus ValueDomain
C25488
UMLS 2011AA ValueDomain
C0178602
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
Dose per M2
Beskrivning

AgentAdministeredSquareMeterDose

Datatyp

double

Måttenheter
  • m2
Alias
NCI Thesaurus ValueDomain
C25488
UMLS 2011AA ValueDomain
C0178602
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ValueDomain
C42569
UMLS 2011AA ValueDomain
C0457242
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
m2
Reason for dose modification (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this must be a separate CDE; not limited to CDUS values)
Beskrivning

TreatmentModifiedDoseReason

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25256
UMLS 2011AA Property
C1265611
NCI Thesaurus Property
C25573
Reason Treatment Ended (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this CDE must use CDUS values only)
Beskrivning

Off-treatmentReason

Datatyp

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
Unnamed Module 3
Beskrivning

Unnamed Module 3

Non-Protocol Supportive Therapy (Was any non-protocol supportive therapy given during treatment?)
Beskrivning

Non-ProtocolSupportTherapyInd-3

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C15368
NCI Thesaurus ObjectClass
C25590
UMLS 2011AA ObjectClass
C1518384
NCI Thesaurus ObjectClass
C37902
UMLS 2011AA ObjectClass
C1521721
Type of Supportive Care Given (value for 0=None must be omitted not CDE Compliant)
Beskrivning

SupportTherapyAdministeredType

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass
C37902
UMLS 2011AA ObjectClass
C1521721
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Was the patient hospitalized for any treatment related complications in this report period?
Beskrivning

PatientTreatmentRelatedHospitalizationInd-3

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25648
UMLS 2011AA Property
C0439849
NCI Thesaurus Property
C15368
NCI Thesaurus Property
C25179
UMLS 2011AA Property
C0019993
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Protocol Specific Adverse Event Evaluation
Beskrivning

Protocol Specific Adverse Event Evaluation

CTC Adverse Event Term
Beskrivning

CommonToxicityCriteriaAdverseEventTermType

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C45559
UMLS 2011AA Property
C1705313
MedDRA Code
Beskrivning

MedDRACode

Datatyp

double

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Metathesaurus ObjectClass
CL104089
CTC AE Grade
Beskrivning

CommonToxicityCriteriaAdverseEventGrade

Datatyp

double

Alias
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus ValueDomain
C18000
UMLS 2011AA ValueDomain
C0919553
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
CTCAE Begin Date
Beskrivning

CTCAdverseEventReportBeginDate

Datatyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25375
UMLS 2011AA Property
C0684224
NCI Thesaurus ValueDomain
C25431
UMLS 2011AA ValueDomain
C0439659
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
CTC AE Attribution Code (A. Attribution to Protocol Treatment: See protocol sections 6&7 for definition of "protocol treatment" 1=unrelated; 2=unlikely; 3=possible; 4=probable; 5=definite)
Beskrivning

CTCAdverseEventAttributionScale

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C25358
UMLS 2011AA Property
C0596130
Serious adverse event report submitted (B. Adverse Event report submitted: 1=No; 2=Yes; 9=Unknown)
Beskrivning

SeriousAdverseEventReportInd-3

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25375
UMLS 2011AA Property
C0684224
NCI Thesaurus ObjectClass
C54035
UMLS 2011AA ObjectClass
C0205404
Comments
Beskrivning

AdverseEventAssessmentText

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
Protocol Specific Adverse Event Evaluation
Beskrivning

Protocol Specific Adverse Event Evaluation

New or continuing adverse events (Not reported in Q6)
Beskrivning

NewAdverseEventOccurrenceInd-3

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C25586
UMLS 2011AA ObjectClass
C0205314
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
CTC Adverse Event Term
Beskrivning

CommonToxicityCriteriaAdverseEventTermType

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C45559
UMLS 2011AA Property
C1705313
MedDRA Code
Beskrivning

MedDRACode

Datatyp

double

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Metathesaurus ObjectClass
CL104089
CTC AE Grade
Beskrivning

CommonToxicityCriteriaAdverseEventGrade

Datatyp

double

Alias
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus ValueDomain
C18000
UMLS 2011AA ValueDomain
C0919553
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
CTCAE Begin Date
Beskrivning

CTCAdverseEventReportBeginDate

Datatyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25375
UMLS 2011AA Property
C0684224
NCI Thesaurus ValueDomain
C25431
UMLS 2011AA ValueDomain
C0439659
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
CTC AE Attribution Code (A. Attribution to Protocol Treatment: See protocol sections 6&7 for definition of "protocol treatment" 1=unrelated; 2=unlikely; 3=possible; 4=probable; 5=definite)
Beskrivning

CTCAdverseEventAttributionScale

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C25358
UMLS 2011AA Property
C0596130
Serious adverse event report submitted (B. Adverse Event report submitted: 1=No; 2=Yes; 9=Unknown)
Beskrivning

SeriousAdverseEventReportInd-3

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25375
UMLS 2011AA Property
C0684224
NCI Thesaurus ObjectClass
C54035
UMLS 2011AA ObjectClass
C0205404
Comments
Beskrivning

AdverseEventAssessmentText

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
Lab Values Module
Beskrivning

Lab Values Module

Week 7
Beskrivning

Week 7

Patient Weight (kg)
Beskrivning

PatientWeightMeasurement

Datatyp

double

Måttenheter
  • 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
Body Surface Area (M^2)
Beskrivning

PersonBodySurfaceAreaValue

Datatyp

double

Måttenheter
  • m2
Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus Property
C25157
UMLS 2011AA Property
C0005902
m2
Agent Name (pre-populated valid value -> C225)
Beskrivning

AgentName

Datatyp

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
Date Agent Administered
Beskrivning

AgentAdministeredDate

Datatyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Agent Total Dose (mg)
Beskrivning

AgentCourseTotalDose

Datatyp

double

Alias
NCI Thesaurus ValueDomain
C25304
UMLS 2011AA ValueDomain
C0439810
NCI Thesaurus Property
C25379
UMLS 2011AA Property
C0750729
NCI Thesaurus ValueDomain
C25488
UMLS 2011AA ValueDomain
C0178602
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
Dose per M2
Beskrivning

AgentAdministeredSquareMeterDose

Datatyp

double

Måttenheter
  • m2
Alias
NCI Thesaurus ValueDomain
C25488
UMLS 2011AA ValueDomain
C0178602
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ValueDomain
C42569
UMLS 2011AA ValueDomain
C0457242
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
m2
Reason for dose modification (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this must be a separate CDE; not limited to CDUS values)
Beskrivning

TreatmentModifiedDoseReason

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25256
UMLS 2011AA Property
C1265611
NCI Thesaurus Property
C25573
Reason Treatment Ended (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this CDE must use CDUS values only)
Beskrivning

Off-treatmentReason

Datatyp

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
Unnamed Module 4
Beskrivning

Unnamed Module 4

Comments
Beskrivning

ResearchCommentsText

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
UMLS 2011AA Property
C0282411
Person completing this form
Beskrivning

ResponsiblePersonIdentifierType

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C25657
UMLS 2011AA ObjectClass
C1273518
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Form completion date
Beskrivning

FormCompleteDate

Datatyp

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

Similar models

No Instruction available.

  1. StudyEvent: RTOG-0522 TF: Radiation Therapy Oncology Group Phase III Head and Neck Cancer Treatment Summary Form
    1. No Instruction available.
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Unnamed Module 1
ProtocolRTOGIdentifierNumber
Item
RTOG Study No.
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C19778 (NCI Thesaurus Property)
C1514695 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
RadiationTherapyOncologyGroupPatientCaseIdentifierNumber
Item
Case #
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C19778 (NCI Thesaurus ObjectClass)
C1514695 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C49152 (NCI Thesaurus Property)
C1706256 (UMLS 2011AA Property)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
InstitutionName
Item
Institution Name
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C21541 (NCI Thesaurus ValueDomain)
C0018704 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
InstitutionIdentifierNumber
Item
Institution No.
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
PatientInitialsName
Item
Patient Initials
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)
PatientRadiationTherapyOncologyGroupIdentifierNumber
Item
RTOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C19778 (NCI Thesaurus Property)
C1514695 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
Item
Amended data
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)
Code List
Amended data
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Summary Of Systemic Treatment
Item
Assigned Treatment Arm
text
C15368 (NCI Thesaurus ObjectClass)
C42651 (NCI Thesaurus ObjectClass)
C0442711 (UMLS 2011AA ObjectClass)
C32141 (NCI Thesaurus Property)
C1140618 (UMLS 2011AA Property)
C25426 (NCI Thesaurus Property)
C1516050 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
Code List
Assigned Treatment Arm
CL Item
Arm 1 (Arm 1)
CL Item
Arm 2 (Arm 2)
PatientHeightMeasurement
Item
Patient 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)
Item Group
Arm 2 Only
PatientWeightMeasurement
Item
Patient 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
Body Surface Area (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)
AgentName
Item
Agent Name (pre-populated valid value -> C225)
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)
AgentAdministeredDate
Item
Date Agent Administered
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
AgentCourseTotalDose
Item
Agent Total Dose (mg)
double
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
AgentAdministeredSquareMeterDose
Item
Dose per M2
double
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C42569 (NCI Thesaurus ValueDomain)
C0457242 (UMLS 2011AA ValueDomain)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Item
Reason for dose modification (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this must be a separate CDE; not limited to CDUS values)
text
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25256 (NCI Thesaurus Property)
C1265611 (UMLS 2011AA Property)
C25573 (NCI Thesaurus Property)
Code List
Reason for dose modification (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this must be a separate CDE; not limited to CDUS values)
CL Item
Adverse Event/side Effects/complications (Adverse event/side effects/complications)
CL Item
Alternative Therapy (Alternative therapy)
CL Item
Death On Study (Death on study)
CL Item
Disease Progression, Relapse During Active Treatment (Disease progression, relapse during active treatment)
CL Item
None (None)
C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Other Complicating Disease (Other complicating disease)
CL Item
Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient withdrawal/refusal after beginning protocol therapy)
CL Item
Patient Withdrawal Or Refusal Prior To Beginning Protocol Therapy (Patient withdrawal/refusal prior to beginning protocol therapy)
CL Item
Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
Item
Reason Treatment Ended (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this CDE must use CDUS values only)
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)
Code List
Reason Treatment Ended (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this CDE must use CDUS values only)
CL Item
Adverse Event/side Effects/complications (Adverse Event/Side Effects/Complications)
CL Item
Alternative Therapy (Alternative therapy)
CL Item
Death On Study (Death on study)
CL Item
Disease Progression, Relapse During Active Treatment (Disease progression, relapse during active treatment)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Patient Off-treatment For Other Complicating Disease (Patient off-treatment for other complicating disease)
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
Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
Item Group
Week 1 - Actual
PatientWeightMeasurement
Item
Patient 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
Body Surface Area (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
If BSA >2.0, was cisplatin dose recalculated using ideal weight?
text
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25620 (NCI Thesaurus ObjectClass)
C1514162 (UMLS 2011AA ObjectClass)
C1441506 (NCI Metathesaurus Property)
CL194347 (NCI Metathesaurus Property)
C0021212 (NCI Metathesaurus ValueDomain)
Code List
If BSA >2.0, was cisplatin dose recalculated using ideal weight?
CL Item
Not Applicable (N/A)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Week 1
PatientWeightMeasurement
Item
Patient 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
Body Surface Area (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)
AgentName
Item
Agent Name (pre-populated valid value -> C225)
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)
AgentAdministeredDate
Item
Date Agent Administered
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
AgentCourseTotalDose
Item
Agent Total Dose (mg)
double
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
AgentAdministeredSquareMeterDose
Item
Dose per M2
double
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C42569 (NCI Thesaurus ValueDomain)
C0457242 (UMLS 2011AA ValueDomain)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Item
Reason for dose modification (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this must be a separate CDE; not limited to CDUS values)
text
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25256 (NCI Thesaurus Property)
C1265611 (UMLS 2011AA Property)
C25573 (NCI Thesaurus Property)
Code List
Reason for dose modification (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this must be a separate CDE; not limited to CDUS values)
CL Item
Adverse Event/side Effects/complications (Adverse event/side effects/complications)
CL Item
Alternative Therapy (Alternative therapy)
CL Item
Death On Study (Death on study)
CL Item
Disease Progression, Relapse During Active Treatment (Disease progression, relapse during active treatment)
CL Item
None (None)
C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Other Complicating Disease (Other complicating disease)
CL Item
Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient withdrawal/refusal after beginning protocol therapy)
CL Item
Patient Withdrawal Or Refusal Prior To Beginning Protocol Therapy (Patient withdrawal/refusal prior to beginning protocol therapy)
CL Item
Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
Item
Reason Treatment Ended (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this CDE must use CDUS values only)
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)
Code List
Reason Treatment Ended (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this CDE must use CDUS values only)
CL Item
Adverse Event/side Effects/complications (Adverse Event/Side Effects/Complications)
CL Item
Alternative Therapy (Alternative therapy)
CL Item
Death On Study (Death on study)
CL Item
Disease Progression, Relapse During Active Treatment (Disease progression, relapse during active treatment)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Patient Off-treatment For Other Complicating Disease (Patient off-treatment for other complicating disease)
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
Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
Item Group
Week 2
PatientWeightMeasurement
Item
Patient 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
Body Surface Area (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)
AgentName
Item
Agent Name (pre-populated valid value -> C225)
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)
AgentAdministeredDate
Item
Date Agent Administered
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
AgentCourseTotalDose
Item
Agent Total Dose (mg)
double
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
AgentAdministeredSquareMeterDose
Item
Dose per M2
double
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C42569 (NCI Thesaurus ValueDomain)
C0457242 (UMLS 2011AA ValueDomain)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Item
Reason for dose modification (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this must be a separate CDE; not limited to CDUS values)
text
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25256 (NCI Thesaurus Property)
C1265611 (UMLS 2011AA Property)
C25573 (NCI Thesaurus Property)
Code List
Reason for dose modification (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this must be a separate CDE; not limited to CDUS values)
CL Item
Adverse Event/side Effects/complications (Adverse event/side effects/complications)
CL Item
Alternative Therapy (Alternative therapy)
CL Item
Death On Study (Death on study)
CL Item
Disease Progression, Relapse During Active Treatment (Disease progression, relapse during active treatment)
CL Item
None (None)
C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Other Complicating Disease (Other complicating disease)
CL Item
Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient withdrawal/refusal after beginning protocol therapy)
CL Item
Patient Withdrawal Or Refusal Prior To Beginning Protocol Therapy (Patient withdrawal/refusal prior to beginning protocol therapy)
CL Item
Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
Item
Reason Treatment Ended (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this CDE must use CDUS values only)
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)
Code List
Reason Treatment Ended (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this CDE must use CDUS values only)
CL Item
Adverse Event/side Effects/complications (Adverse Event/Side Effects/Complications)
CL Item
Alternative Therapy (Alternative therapy)
CL Item
Death On Study (Death on study)
CL Item
Disease Progression, Relapse During Active Treatment (Disease progression, relapse during active treatment)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Patient Off-treatment For Other Complicating Disease (Patient off-treatment for other complicating disease)
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
Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
Item Group
Week 3
PatientWeightMeasurement
Item
Patient 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
Body Surface Area (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)
AgentName
Item
Agent Name (pre-populated valid value -> C225)
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)
AgentAdministeredDate
Item
Date Agent Administered
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
AgentCourseTotalDose
Item
Agent Total Dose (mg)
double
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
AgentAdministeredSquareMeterDose
Item
Dose per M2
double
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C42569 (NCI Thesaurus ValueDomain)
C0457242 (UMLS 2011AA ValueDomain)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Item
Reason for dose modification (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this must be a separate CDE; not limited to CDUS values)
text
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25256 (NCI Thesaurus Property)
C1265611 (UMLS 2011AA Property)
C25573 (NCI Thesaurus Property)
Code List
Reason for dose modification (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this must be a separate CDE; not limited to CDUS values)
CL Item
Adverse Event/side Effects/complications (Adverse event/side effects/complications)
CL Item
Alternative Therapy (Alternative therapy)
CL Item
Death On Study (Death on study)
CL Item
Disease Progression, Relapse During Active Treatment (Disease progression, relapse during active treatment)
CL Item
None (None)
C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Other Complicating Disease (Other complicating disease)
CL Item
Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient withdrawal/refusal after beginning protocol therapy)
CL Item
Patient Withdrawal Or Refusal Prior To Beginning Protocol Therapy (Patient withdrawal/refusal prior to beginning protocol therapy)
CL Item
Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
Item
Reason Treatment Ended (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this CDE must use CDUS values only)
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)
Code List
Reason Treatment Ended (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this CDE must use CDUS values only)
CL Item
Adverse Event/side Effects/complications (Adverse Event/Side Effects/Complications)
CL Item
Alternative Therapy (Alternative therapy)
CL Item
Death On Study (Death on study)
CL Item
Disease Progression, Relapse During Active Treatment (Disease progression, relapse during active treatment)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Patient Off-treatment For Other Complicating Disease (Patient off-treatment for other complicating disease)
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
Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
Item Group
Week 4 - Actual
PatientWeightMeasurement
Item
Patient 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
Body Surface Area (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
If BSA >2.0, was cisplatin dose recalculated using ideal weight?
text
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25620 (NCI Thesaurus ObjectClass)
C1514162 (UMLS 2011AA ObjectClass)
C1441506 (NCI Metathesaurus Property)
CL194347 (NCI Metathesaurus Property)
C0021212 (NCI Metathesaurus ValueDomain)
Code List
If BSA >2.0, was cisplatin dose recalculated using ideal weight?
CL Item
Not Applicable (N/A)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Week 4
PatientWeightMeasurement
Item
Patient 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
Body Surface Area (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)
AgentName
Item
Agent Name (pre-populated valid value -> C225)
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)
AgentAdministeredDate
Item
Date Agent Administered
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
AgentCourseTotalDose
Item
Agent Total Dose (mg)
double
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
AgentAdministeredSquareMeterDose
Item
Dose per M2
double
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C42569 (NCI Thesaurus ValueDomain)
C0457242 (UMLS 2011AA ValueDomain)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Item
Reason for dose modification (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this must be a separate CDE; not limited to CDUS values)
text
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25256 (NCI Thesaurus Property)
C1265611 (UMLS 2011AA Property)
C25573 (NCI Thesaurus Property)
Code List
Reason for dose modification (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this must be a separate CDE; not limited to CDUS values)
CL Item
Adverse Event/side Effects/complications (Adverse event/side effects/complications)
CL Item
Alternative Therapy (Alternative therapy)
CL Item
Death On Study (Death on study)
CL Item
Disease Progression, Relapse During Active Treatment (Disease progression, relapse during active treatment)
CL Item
None (None)
C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Other Complicating Disease (Other complicating disease)
CL Item
Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient withdrawal/refusal after beginning protocol therapy)
CL Item
Patient Withdrawal Or Refusal Prior To Beginning Protocol Therapy (Patient withdrawal/refusal prior to beginning protocol therapy)
CL Item
Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
Item
Reason Treatment Ended (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this CDE must use CDUS values only)
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)
Code List
Reason Treatment Ended (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this CDE must use CDUS values only)
CL Item
Adverse Event/side Effects/complications (Adverse Event/Side Effects/Complications)
CL Item
Alternative Therapy (Alternative therapy)
CL Item
Death On Study (Death on study)
CL Item
Disease Progression, Relapse During Active Treatment (Disease progression, relapse during active treatment)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Patient Off-treatment For Other Complicating Disease (Patient off-treatment for other complicating disease)
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
Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
Item Group
Week 5
PatientWeightMeasurement
Item
Patient 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
Body Surface Area (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)
AgentName
Item
Agent Name (pre-populated valid value -> C225)
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)
AgentAdministeredDate
Item
Date Agent Administered
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
AgentCourseTotalDose
Item
Agent Total Dose (mg)
double
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
AgentAdministeredSquareMeterDose
Item
Dose per M2
double
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C42569 (NCI Thesaurus ValueDomain)
C0457242 (UMLS 2011AA ValueDomain)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Item
Reason for dose modification (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this must be a separate CDE; not limited to CDUS values)
text
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25256 (NCI Thesaurus Property)
C1265611 (UMLS 2011AA Property)
C25573 (NCI Thesaurus Property)
Code List
Reason for dose modification (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this must be a separate CDE; not limited to CDUS values)
CL Item
Adverse Event/side Effects/complications (Adverse event/side effects/complications)
CL Item
Alternative Therapy (Alternative therapy)
CL Item
Death On Study (Death on study)
CL Item
Disease Progression, Relapse During Active Treatment (Disease progression, relapse during active treatment)
CL Item
None (None)
C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Other Complicating Disease (Other complicating disease)
CL Item
Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient withdrawal/refusal after beginning protocol therapy)
CL Item
Patient Withdrawal Or Refusal Prior To Beginning Protocol Therapy (Patient withdrawal/refusal prior to beginning protocol therapy)
CL Item
Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
Item
Reason Treatment Ended (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this CDE must use CDUS values only)
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)
Code List
Reason Treatment Ended (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this CDE must use CDUS values only)
CL Item
Adverse Event/side Effects/complications (Adverse Event/Side Effects/Complications)
CL Item
Alternative Therapy (Alternative therapy)
CL Item
Death On Study (Death on study)
CL Item
Disease Progression, Relapse During Active Treatment (Disease progression, relapse during active treatment)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Patient Off-treatment For Other Complicating Disease (Patient off-treatment for other complicating disease)
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
Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
Item Group
Week 6
PatientWeightMeasurement
Item
Patient 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
Body Surface Area (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)
AgentName
Item
Agent Name (pre-populated valid value -> C225)
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)
AgentAdministeredDate
Item
Date Agent Administered
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
AgentCourseTotalDose
Item
Agent Total Dose (mg)
double
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
AgentAdministeredSquareMeterDose
Item
Dose per M2
double
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C42569 (NCI Thesaurus ValueDomain)
C0457242 (UMLS 2011AA ValueDomain)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Item
Reason for dose modification (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this must be a separate CDE; not limited to CDUS values)
text
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25256 (NCI Thesaurus Property)
C1265611 (UMLS 2011AA Property)
C25573 (NCI Thesaurus Property)
Code List
Reason for dose modification (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this must be a separate CDE; not limited to CDUS values)
CL Item
Adverse Event/side Effects/complications (Adverse event/side effects/complications)
CL Item
Alternative Therapy (Alternative therapy)
CL Item
Death On Study (Death on study)
CL Item
Disease Progression, Relapse During Active Treatment (Disease progression, relapse during active treatment)
CL Item
None (None)
C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Other Complicating Disease (Other complicating disease)
CL Item
Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient withdrawal/refusal after beginning protocol therapy)
CL Item
Patient Withdrawal Or Refusal Prior To Beginning Protocol Therapy (Patient withdrawal/refusal prior to beginning protocol therapy)
CL Item
Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
Item
Reason Treatment Ended (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this CDE must use CDUS values only)
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)
Code List
Reason Treatment Ended (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this CDE must use CDUS values only)
CL Item
Adverse Event/side Effects/complications (Adverse Event/Side Effects/Complications)
CL Item
Alternative Therapy (Alternative therapy)
CL Item
Death On Study (Death on study)
CL Item
Disease Progression, Relapse During Active Treatment (Disease progression, relapse during active treatment)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Patient Off-treatment For Other Complicating Disease (Patient off-treatment for other complicating disease)
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
Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
Item Group
Week 7
PatientWeightMeasurement
Item
Patient 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
Body Surface Area (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)
AgentName
Item
Agent Name (pre-populated valid value -> C225)
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)
AgentAdministeredDate
Item
Date Agent Administered
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
AgentCourseTotalDose
Item
Agent Total Dose (mg)
double
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
AgentAdministeredSquareMeterDose
Item
Dose per M2
double
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C42569 (NCI Thesaurus ValueDomain)
C0457242 (UMLS 2011AA ValueDomain)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Item
Reason for dose modification (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this must be a separate CDE; not limited to CDUS values)
text
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25256 (NCI Thesaurus Property)
C1265611 (UMLS 2011AA Property)
C25573 (NCI Thesaurus Property)
Code List
Reason for dose modification (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this must be a separate CDE; not limited to CDUS values)
CL Item
Adverse Event/side Effects/complications (Adverse event/side effects/complications)
CL Item
Alternative Therapy (Alternative therapy)
CL Item
Death On Study (Death on study)
CL Item
Disease Progression, Relapse During Active Treatment (Disease progression, relapse during active treatment)
CL Item
None (None)
C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Other Complicating Disease (Other complicating disease)
CL Item
Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient withdrawal/refusal after beginning protocol therapy)
CL Item
Patient Withdrawal Or Refusal Prior To Beginning Protocol Therapy (Patient withdrawal/refusal prior to beginning protocol therapy)
CL Item
Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
Item
Reason Treatment Ended (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this CDE must use CDUS values only)
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)
Code List
Reason Treatment Ended (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this CDE must use CDUS values only)
CL Item
Adverse Event/side Effects/complications (Adverse Event/Side Effects/Complications)
CL Item
Alternative Therapy (Alternative therapy)
CL Item
Death On Study (Death on study)
CL Item
Disease Progression, Relapse During Active Treatment (Disease progression, relapse during active treatment)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Patient Off-treatment For Other Complicating Disease (Patient off-treatment for other complicating disease)
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
Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
Item Group
Unnamed Module 3
Item
Non-Protocol Supportive Therapy (Was any non-protocol supportive therapy given during treatment?)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus Property)
C25590 (NCI Thesaurus ObjectClass)
C1518384 (UMLS 2011AA ObjectClass)
C37902 (NCI Thesaurus ObjectClass)
C1521721 (UMLS 2011AA ObjectClass)
Code List
Non-Protocol Supportive Therapy (Was any non-protocol supportive therapy given during treatment?)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Type of Supportive Care Given (value for 0=None must be omitted not CDE Compliant)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C37902 (NCI Thesaurus ObjectClass)
C1521721 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Code List
Type of Supportive Care Given (value for 0=None must be omitted not CDE Compliant)
CL Item
Amifostine (Amifostine)
C488 (NCI Thesaurus)
C0015020 (UMLS 2011AA)
CL Item
Amifostine And Pilocarpine (Amifostine and Pilocarpine)
CL Item
Pilocarpine (Pilocarpine)
Item
Was the patient hospitalized for any treatment related complications in this report period?
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25648 (NCI Thesaurus Property)
C0439849 (UMLS 2011AA Property)
C15368 (NCI Thesaurus Property)
C25179 (NCI Thesaurus Property)
C0019993 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
Code List
Was the patient hospitalized for any treatment related complications in this report 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)
Item Group
Protocol Specific Adverse Event Evaluation
CommonToxicityCriteriaAdverseEventTermType
Item
CTC Adverse Event Term
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C45559 (NCI Thesaurus Property)
C1705313 (UMLS 2011AA Property)
MedDRACode
Item
MedDRA Code
double
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
CL104089 (NCI Metathesaurus ObjectClass)
Item
CTC AE Grade
double
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Code List
CTC AE Grade
CL Item
No Adverse Event Or Within Normal Limits (0)
CL Item
Mild Adverse Event (1)
C41338 (NCI Thesaurus)
C1513302 (UMLS 2011AA)
CL Item
Moderate Adverse Event (2)
C41339 (NCI Thesaurus)
C1513374 (UMLS 2011AA)
CL Item
Severe Adverse Event (3)
C41340 (NCI Thesaurus)
C1519275 (UMLS 2011AA)
CL Item
Life-threatening Or Disabling Adverse Event (4)
CL Item
Death Related To Adverse Event (5)
C48275 (NCI Thesaurus)
C1705232 (UMLS 2011AA)
CTCAdverseEventReportBeginDate
Item
CTCAE Begin Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25375 (NCI Thesaurus Property)
C0684224 (UMLS 2011AA Property)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
Item
CTC AE Attribution Code (A. Attribution to Protocol Treatment: See protocol sections 6&7 for definition of "protocol treatment" 1=unrelated; 2=unlikely; 3=possible; 4=probable; 5=definite)
text
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C25358 (NCI Thesaurus Property)
C0596130 (UMLS 2011AA Property)
Code List
CTC AE Attribution Code (A. Attribution to Protocol Treatment: See protocol sections 6&7 for definition of "protocol treatment" 1=unrelated; 2=unlikely; 3=possible; 4=probable; 5=definite)
CL Item
Definite (Definite)
CL209464 (NCI Metathesaurus)
CL Item
Possible (Possible)
C0332149 (NCI Metathesaurus)
CL Item
Probable (Probable)
C0332148 (NCI Metathesaurus)
CL Item
Unlikely (Unlikely)
CL Item
Unrelated (Unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
Item
Serious adverse event report submitted (B. Adverse Event report submitted: 1=No; 2=Yes; 9=Unknown)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25375 (NCI Thesaurus Property)
C0684224 (UMLS 2011AA Property)
C54035 (NCI Thesaurus ObjectClass)
C0205404 (UMLS 2011AA ObjectClass)
Code List
Serious adverse event report submitted (B. Adverse Event report submitted: 1=No; 2=Yes; 9=Unknown)
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)
AdverseEventAssessmentText
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
Item Group
Protocol Specific Adverse Event Evaluation
Item
New or continuing adverse events (Not reported in Q6)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
Code List
New or continuing adverse events (Not reported in Q6)
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)
CommonToxicityCriteriaAdverseEventTermType
Item
CTC Adverse Event Term
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C45559 (NCI Thesaurus Property)
C1705313 (UMLS 2011AA Property)
MedDRACode
Item
MedDRA Code
double
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
CL104089 (NCI Metathesaurus ObjectClass)
Item
CTC AE Grade
double
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Code List
CTC AE Grade
CL Item
No Adverse Event Or Within Normal Limits (0)
CL Item
Mild Adverse Event (1)
C41338 (NCI Thesaurus)
C1513302 (UMLS 2011AA)
CL Item
Moderate Adverse Event (2)
C41339 (NCI Thesaurus)
C1513374 (UMLS 2011AA)
CL Item
Severe Adverse Event (3)
C41340 (NCI Thesaurus)
C1519275 (UMLS 2011AA)
CL Item
Life-threatening Or Disabling Adverse Event (4)
CL Item
Death Related To Adverse Event (5)
C48275 (NCI Thesaurus)
C1705232 (UMLS 2011AA)
CTCAdverseEventReportBeginDate
Item
CTCAE Begin Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25375 (NCI Thesaurus Property)
C0684224 (UMLS 2011AA Property)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
Item
CTC AE Attribution Code (A. Attribution to Protocol Treatment: See protocol sections 6&7 for definition of "protocol treatment" 1=unrelated; 2=unlikely; 3=possible; 4=probable; 5=definite)
text
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C25358 (NCI Thesaurus Property)
C0596130 (UMLS 2011AA Property)
Code List
CTC AE Attribution Code (A. Attribution to Protocol Treatment: See protocol sections 6&7 for definition of "protocol treatment" 1=unrelated; 2=unlikely; 3=possible; 4=probable; 5=definite)
CL Item
Definite (Definite)
CL209464 (NCI Metathesaurus)
CL Item
Possible (Possible)
C0332149 (NCI Metathesaurus)
CL Item
Probable (Probable)
C0332148 (NCI Metathesaurus)
CL Item
Unlikely (Unlikely)
CL Item
Unrelated (Unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
Item
Serious adverse event report submitted (B. Adverse Event report submitted: 1=No; 2=Yes; 9=Unknown)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25375 (NCI Thesaurus Property)
C0684224 (UMLS 2011AA Property)
C54035 (NCI Thesaurus ObjectClass)
C0205404 (UMLS 2011AA ObjectClass)
Code List
Serious adverse event report submitted (B. Adverse Event report submitted: 1=No; 2=Yes; 9=Unknown)
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)
AdverseEventAssessmentText
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
Item Group
Lab Values Module
Item Group
Week 7
PatientWeightMeasurement
Item
Patient 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)
PersonBodySurfaceAreaValue
Item
Body Surface Area (M^2)
double
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25157 (NCI Thesaurus Property)
C0005902 (UMLS 2011AA Property)
AgentName
Item
Agent Name (pre-populated valid value -> C225)
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)
AgentAdministeredDate
Item
Date Agent Administered
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
AgentCourseTotalDose
Item
Agent Total Dose (mg)
double
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
AgentAdministeredSquareMeterDose
Item
Dose per M2
double
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C42569 (NCI Thesaurus ValueDomain)
C0457242 (UMLS 2011AA ValueDomain)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Item
Reason for dose modification (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this must be a separate CDE; not limited to CDUS values)
text
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25256 (NCI Thesaurus Property)
C1265611 (UMLS 2011AA Property)
C25573 (NCI Thesaurus Property)
Code List
Reason for dose modification (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this must be a separate CDE; not limited to CDUS values)
CL Item
Adverse Event/side Effects/complications (Adverse event/side effects/complications)
CL Item
Alternative Therapy (Alternative therapy)
CL Item
Death On Study (Death on study)
CL Item
Disease Progression, Relapse During Active Treatment (Disease progression, relapse during active treatment)
CL Item
None (None)
C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Other Complicating Disease (Other complicating disease)
CL Item
Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient withdrawal/refusal after beginning protocol therapy)
CL Item
Patient Withdrawal Or Refusal Prior To Beginning Protocol Therapy (Patient withdrawal/refusal prior to beginning protocol therapy)
CL Item
Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
Item
Reason Treatment Ended (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this CDE must use CDUS values only)
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)
Code List
Reason Treatment Ended (Table of values on Draft CRF for "Reason for Termination/Modification" combines values for 2Qs - this CDE must use CDUS values only)
CL Item
Adverse Event/side Effects/complications (Adverse Event/Side Effects/Complications)
CL Item
Alternative Therapy (Alternative therapy)
CL Item
Death On Study (Death on study)
CL Item
Disease Progression, Relapse During Active Treatment (Disease progression, relapse during active treatment)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Patient Off-treatment For Other Complicating Disease (Patient off-treatment for other complicating disease)
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
Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
Item Group
Unnamed Module 4
ResearchCommentsText
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS 2011AA Property)
Item
Person completing this form
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
Code List
Person completing this form
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Urologist Performing Surgery (urologist performing surgery)
FormCompleteDate
Item
Form completion date
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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