ID

2069

Description

E2906 Baseline Data Form - Maintenance - Arm E and Arm F Clofarabine or Daunorubicin Hydrochloride and Cytarabine Followed By Decitabine or Observation in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=7585B205-CA52-8BDD-E040-BB89AD430415

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=7585B205-CA52-8BDD-E040-BB89AD430415

Keywords

  1. 9/19/12 9/19/12 -
  2. 1/8/15 1/8/15 - Martin Dugas
  3. 1/9/15 1/9/15 - Martin Dugas
Uploaded on

September 19, 2012

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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Leukemia NCT01041703 Treatment - E2906 Baseline Data Form - Maintenance - Arm E and Arm F - 2951934v1.0

INSTRUCTIONS: Complete this form and submit original to the ECOG Coordinating Center within one week of patient's entry on Consolidation. Keep a copy for your files

Unnamed1
Description

Unnamed1

DCI Name
Description

CollectedDataFormName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus Property
C19464
UMLS 2011AA Property
C0376315
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus ObjectClass
C25452
Registration Step (Place ID Label Here)
Description

RegistrationStepNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25646
UMLS 2011AA ObjectClass
C1514821
NCI Thesaurus Property
C16154
UMLS 2011AA Property
C1704379
NCI Thesaurus ValueDomain
C16154
UMLS 2011AA ValueDomain
C1704379
Patient Initials (Last, First)
Description

PatientInitialsName

Data type

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
ECOG Protocol Number
Description

ProtocolECOGIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C25491
UMLS 2011AA Property
C1512162
ECOG Protocol Number
Description

ProtocolECOGIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C25491
UMLS 2011AA Property
C1512162
ECOG Patient ID
Description

PatientECOGIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C25491
UMLS 2011AA Property
C1512162
ECOG Patient ID
Description

PatientECOGIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C25491
UMLS 2011AA Property
C1512162
Participating Group Protocol Number
Description

ProtocolParticipatingIdentifierNumber

Data type

text

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

PatientParticipatingIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25608
UMLS 2011AA Property
C0679823
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Institution/Affiliate
Description

CombinedInstitutionName

Data type

text

Alias
NCI Thesaurus ObjectClass
C25454
UMLS 2011AA ObjectClass
C0205195
NCI Thesaurus ObjectClass
C21541
UMLS 2011AA ObjectClass
C0018704
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ValueDomain
C21541
UMLS 2011AA ValueDomain
C0018704
On Treatment
Description

On Treatment

On Treatment Report Period
Description

TreatmentEvaluationPeriodType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C25214
UMLS 2011AA Property
C0220825
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus ObjectClass
C15368
Unnamed2
Description

Unnamed2

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

DataAmendedText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C25416
UMLS 2011AA Property
C1691222
Date data amended (s M D Y)
Description

DataAmendedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C25416
UMLS 2011AA Property
C1691222
NCI Thesaurus ValueDomain
C25367
Pre-registration Evaluation
Description

Pre-registration Evaluation

ECOG Performance Status
Description

PerformanceStatusAssessmentEasternCooperativeOncologyGroupScale

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
NCI Thesaurus Property
C25367
NCI Thesaurus ValueDomain
C25491
UMLS 2011AA ValueDomain
C1512162
NCI Thesaurus ObjectClass
C20641
UMLS 2011AA ObjectClass
C1518965
Does patient have bacterial or fungal infectious complications (related to the treatment on the prior protocol step)
Description

AdverseEventInfectionInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C26726
UMLS 2011AA Property
C0009450
Does the patient have any congestive heart failure medical complications (related to the treatment on the prior protocol step)
Description

CongestiveHeartFailureHistoryInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C3080
UMLS 2011AA ObjectClass
C0018802
NCI Thesaurus Property
C18772
UMLS 2011AA Property
C0262926
Assessment Type (cardiac)
Description

AssessmentMethodType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus Property
C16847
UMLS 2011AA Property
C0449851
Date of Assessment (M D Y)
Description

AssessmentPerformedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25367
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
Resting ejection fraction (% See Section 3.0 of protocol for ejection fraction requirements)
Description

HeartLVEFTestPercentageValue

Data type

double

Measurement units
  • %
Alias
NCI Thesaurus ObjectClass
C12727
UMLS 2011AA ObjectClass
C0018787
NCI Thesaurus Property
C25294
UMLS 2011AA Property
C0022885
NCI Thesaurus Property
C37946
UMLS 2011AA Property
C2700377
NCI Thesaurus ValueDomain
C25613
UMLS 2011AA ValueDomain
C0439165
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
%
Was an EKG done
Description

ElectrocardiographyDiagnosticProcedureAssessmentInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ObjectClass
C38053
UMLS 2011AA ObjectClass
C1623258
NCI Thesaurus ObjectClass
C18020
UMLS 2011AA ObjectClass
C0430022
Date of EKG (M D Y)
Description

DiagnosticElectrocardiogramPerformedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass
C25482
UMLS 2011AA ObjectClass
C0348026
NCI Metathesaurus ObjectClass
C0013798
Are there any clinically significant abnormalities
Description

AbnormalElectrocardiographyAdverseEventPresentInd-3

Data type

text

Alias
NCI Thesaurus ObjectClass
C25401
UMLS 2011AA ObjectClass
C0205161
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus ObjectClass
C38053
UMLS 2011AA ObjectClass
C1623258
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Specify
Description

AbnormalElectrocardiographyAdverseEventPresentSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C25401
UMLS 2011AA ObjectClass
C0205161
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus ObjectClass
C38053
UMLS 2011AA ObjectClass
C1623258
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Has patient received transfusion support
Description

TransfusionAdministeredInd

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C15366
UMLS 2011AA ObjectClass
C0086818
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Bone Marrow
Description

Bone Marrow

Date of Bone Marrow Biopsy (M D Y or Aspirate NOTE: Also submit biopsy/aspirate report)
Description

BoneMarrowBiopsyDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus Property
C15189
UMLS 2011AA Property
C0005558
NCI Thesaurus ObjectClass
C12431
UMLS 2011AA ObjectClass
C0005953
Marrow Blasts (%)
Description

LaboratoryProcedureBoneMarrowBlastCellOutcomePercentageValue

Data type

double

Measurement units
  • %
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C12431
UMLS 2011AA Property
C0005953
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C12918
UMLS 2011AA Property
C0368761
NCI Thesaurus ValueDomain
C25613
UMLS 2011AA ValueDomain
C0439165
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
%
Marrow Cellularity (%)
Description

LaboratoryProcedureBoneMarrowCellularityOutcomePercentageValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C12431
UMLS 2011AA Property
C0005953
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C37923
UMLS 2011AA Property
C1516377
NCI Thesaurus ValueDomain
C25613
UMLS 2011AA ValueDomain
C0439165
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
Hematology/chemistry
Description

Hematology/chemistry

WBC count (x1000), LLN (x1000)
Description

LaboratoryProcedureLeukocyteResultLowerLimitofNormalValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C12529
UMLS 2011AA Property
C0023516
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25555
UMLS 2011AA ValueDomain
C1518030
WBC Count (x1000)
Description

LaboratoryProcedureLeukocyteResultSpecifiedValue

Data type

double

Measurement units
  • 1000/uL
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C12529
UMLS 2011AA Property
C0023516
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C38024
UMLS 2011AA ValueDomain
C0205369
1000/uL
Peripheral Blasts (%)
Description

LaboratoryProcedureBlastCellOutcomePercentageValue

Data type

double

Measurement units
  • %
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C12918
UMLS 2011AA Property
C0368761
NCI Thesaurus ValueDomain
C25613
UMLS 2011AA ValueDomain
C0439165
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
%
Absolute Granulocyte Count (AGC/ANC)
Description

LaboratoryProcedureGranulocyteResultTotalValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C12530
UMLS 2011AA Property
C0018183
NCI Thesaurus ValueDomain
C25304
UMLS 2011AA ValueDomain
C0439810
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
Platelets LLN (x1000)
Description

LaboratoryProcedurePlateletResultLowerLimitofNormalValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C12520
UMLS 2011AA Property
C0005821
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25555
UMLS 2011AA ValueDomain
C1518030
Platelets (PLT) (x1000)
Description

LaboratoryProcedurePlateletResultSpecifiedValue

Data type

double

Measurement units
  • 1000/uL
Alias
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C12520
UMLS 2011AA Property
C0005821
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
1000/uL
Hemoglobin (Hgb) (g/dl), LLN (g/dl)
Description

LaboratoryProcedureHemoglobinResultSpecifiedLowerLimitofNormalValue

Data type

double

Measurement units
  • g/dL
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C16676
UMLS 2011AA Property
C0019046
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C38024
UMLS 2011AA ValueDomain
C0205369
NCI Thesaurus ValueDomain
C25555
UMLS 2011AA ValueDomain
C1518030
g/dL
Hemoglobin (g/dl)
Description

LaboratoryProcedureHemoglobinResultUnspecifiedValue

Data type

double

Alias
NCI Thesaurus Property
C16676
UMLS 2011AA Property
C0019046
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
Hematocrit LLN (%)
Description

LaboratoryProcedureErythrocyteResultPercentageLowerLimitofNormalValue

Data type

text

Measurement units
  • %
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C12521
UMLS 2011AA Property
C0014792
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ValueDomain
C25613
UMLS 2011AA ValueDomain
C0439165
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25555
UMLS 2011AA ValueDomain
C1518030
%
Hematocrit (%)
Description

LaboratoryProcedureHematocritOutcomePercentageValue

Data type

double

Measurement units
  • %
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C64796
UMLS 2011AA Property
C0018935
NCI Thesaurus ValueDomain
C25613
UMLS 2011AA ValueDomain
C0439165
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
%
Creatinine ULN (mg/dl)
Description

LaboratoryProcedureCreatinineResultUpperLimitNormalValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C399
UMLS 2011AA Property
C0010294
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25706
UMLS 2011AA ValueDomain
C1519815
Creatinine (mg/dl)
Description

LaboratoryProcedureCreatinineResultUnspecifiedValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C399
UMLS 2011AA Property
C0010294
NCI Thesaurus ValueDomain
C38046
UMLS 2011AA ValueDomain
C0205370
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
Total bilirubin (mg/dl), ULN (mg/dl)
Description

LaboratoryProcedureTotalBilirubinResultSpecifiedUpperLimitofNormalValue

Data type

double

Measurement units
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C38037
UMLS 2011AA Property
C0201913
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C38024
UMLS 2011AA ValueDomain
C0205369
NCI Thesaurus ValueDomain
C25706
UMLS 2011AA ValueDomain
C1519815
mg/dL
Total Bilirubin (mg/dl)
Description

LaboratoryProcedureTotalBilirubinResultUnspecifiedValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C38037
UMLS 2011AA Property
C0201913
NCI Thesaurus ValueDomain
C38046
UMLS 2011AA ValueDomain
C0205370
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
Alkaline Phosphatase ULN (U/L)
Description

LaboratoryProcedureAlkalinePhosphataseResultUpperLimitNormalValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C16276
UMLS 2011AA Property
C0002059
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25706
UMLS 2011AA ValueDomain
C1519815
Alkaline Phosphatase (U/L)
Description

LaboratoryProcedureAlkalinePhosphataseResultValue

Data type

double

Alias
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus Property
C16276
UMLS 2011AA Property
C0002059
SGOT (AST) ULN (U/L)
Description

LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedUpperLimitofNormalValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C25202
UMLS 2011AA Property
C0242192
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25706
UMLS 2011AA ValueDomain
C1519815
SGOT (AST) (U/L)
Description

LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C25202
UMLS 2011AA Property
C0242192
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ValueDomain
C38046
UMLS 2011AA ValueDomain
C0205370
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
SGPT (ALT) ULN (U/L)
Description

LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultUpperLimitofNormalValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C25293
UMLS 2011AA Property
C0376147
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25706
UMLS 2011AA ValueDomain
C1519815
SGPT (ALT) (U/L)
Description

LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultUnspecifiedValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C25293
UMLS 2011AA Property
C0376147
NCI Thesaurus ValueDomain
C38046
UMLS 2011AA ValueDomain
C0205370
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
Uric Acid ULN (mg/dl)
Description

LaboratoryProcedureUricAcidResultUnspecifiedUpperLimitofNormalValue

Data type

double

Measurement units
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C62652
UMLS 2011AA Property
C0041980
NCI Thesaurus ValueDomain
C38046
UMLS 2011AA ValueDomain
C0205370
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25706
UMLS 2011AA ValueDomain
C1519815
mg/dL
Uric acid (mg/dl)
Description

LaboratoryProcedureUricAcidResultUnspecifiedValue

Data type

double

Measurement units
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C62652
UMLS 2011AA Property
C0041980
NCI Thesaurus ValueDomain
C38046
UMLS 2011AA ValueDomain
C0205370
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
mg/dL
LDH ULN (U/L)
Description

LaboratoryProcedureLactateDehydrogenaseResultSpecifiedUpperLimitofNormalValue

Data type

double

Measurement units
  • U/L
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C25184
UMLS 2011AA Property
C0022917
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C38024
UMLS 2011AA ValueDomain
C0205369
NCI Thesaurus ValueDomain
C25706
UMLS 2011AA ValueDomain
C1519815
U/L
LDH (U/L)
Description

LaboratoryProcedureLactateDehydrogenaseResultUnspecifiedValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C25184
UMLS 2011AA Property
C0022917
NCI Thesaurus ValueDomain
C38046
UMLS 2011AA ValueDomain
C0205370
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
Magnesium, LLN (mg/dl)
Description

LaboratoryProcedureMagnesiumResultUnspecifiedLowerLimitofNormalValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C29239
UMLS 2011AA Property
C0024467
NCI Thesaurus ValueDomain
C38046
UMLS 2011AA ValueDomain
C0205370
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25555
UMLS 2011AA ValueDomain
C1518030
Magnesium (mg/dl)
Description

LaboratoryProcedureMagnesiumResultUnspecifiedValue

Data type

double

Measurement units
  • mmol/L
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C29239
UMLS 2011AA Property
C0024467
NCI Thesaurus ValueDomain
C38046
UMLS 2011AA ValueDomain
C0205370
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
mmol/L
Date Obtained (M D Y)
Description

SpecimenCollectedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C19157
UMLS 2011AA ObjectClass
C0370003
NCI Thesaurus Property
C25452
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
Baseline Abnormalities
Description

Baseline Abnormalities

CTC Adverse Event Term
Description

AdverseEventCommonTerminologyforAdverseEventsVersion4TermName

Data type

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C49704
UMLS 2011AA Property
C1516728
NCI Thesaurus Property
C45559
UMLS 2011AA Property
C1705313
NCI Thesaurus ValueDomain
C45255
UMLS 2011AA ValueDomain
C1708523
NCI Thesaurus ValueDomain
C49704
UMLS 2011AA ValueDomain
C1516728
NCI Thesaurus ValueDomain
C42614
UMLS 2011AA ValueDomain
C0027365
NCI Thesaurus ValueDomain
C45559
UMLS 2011AA ValueDomain
C1705313
NCI Thesaurus ValueDomain
C25714
UMLS 2011AA ValueDomain
C0333052
CTC Adverse Event Grade
Description

AdverseEventSeverityGrade

Data type

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C48309
UMLS 2011AA Property
C0441800
NCI Thesaurus Property
C49705
UMLS 2011AA Property
C1710065
NCI Thesaurus Property
C25676
UMLS 2011AA Property
C0439793
NCI Thesaurus ValueDomain
C41331
UMLS 2011AA ValueDomain
C0877248
NCI Thesaurus ValueDomain
C48309
UMLS 2011AA ValueDomain
C0441800
NCI Thesaurus ValueDomain
C25676
UMLS 2011AA ValueDomain
C0439793
Comments
Description

Comments

Investigator Signature
Description

InvestigatorSignatureText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus Property
C25678
UMLS 2011AA Property
C1519316
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173
Investigator Signature Date (MM DD YYYY)
Description

InvestigatorSignatureDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25678
UMLS 2011AA Property
C1519316
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173

Similar models

INSTRUCTIONS: Complete this form and submit original to the ECOG Coordinating Center within one week of patient's entry on Consolidation. Keep a copy for your files

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Unnamed1
CollectedDataFormName
Item
DCI Name
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C19464 (NCI Thesaurus Property)
C0376315 (UMLS 2011AA Property)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25452 (NCI Thesaurus ObjectClass)
RegistrationStepNumber
Item
Registration Step (Place ID Label Here)
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25646 (NCI Thesaurus ObjectClass)
C1514821 (UMLS 2011AA ObjectClass)
C16154 (NCI Thesaurus Property)
C1704379 (UMLS 2011AA Property)
C16154 (NCI Thesaurus ValueDomain)
C1704379 (UMLS 2011AA ValueDomain)
PatientInitialsName
Item
Patient Initials (Last, First)
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)
ProtocolECOGIdentifierNumber
Item
ECOG Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25491 (NCI Thesaurus Property)
C1512162 (UMLS 2011AA Property)
ProtocolECOGIdentifierNumber
Item
ECOG Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25491 (NCI Thesaurus Property)
C1512162 (UMLS 2011AA Property)
PatientECOGIdentifierNumber
Item
ECOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25491 (NCI Thesaurus Property)
C1512162 (UMLS 2011AA Property)
PatientECOGIdentifierNumber
Item
ECOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25491 (NCI Thesaurus Property)
C1512162 (UMLS 2011AA Property)
ProtocolParticipatingIdentifierNumber
Item
Participating Group Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
PatientParticipatingIdentifierNumber
Item
Participating Group Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
CombinedInstitutionName
Item
Institution/Affiliate
text
C25454 (NCI Thesaurus ObjectClass)
C0205195 (UMLS 2011AA ObjectClass)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ValueDomain)
C0018704 (UMLS 2011AA ValueDomain)
Item Group
On Treatment
Item
On Treatment Report Period
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C15368 (NCI Thesaurus ObjectClass)
Code List
On Treatment Report Period
CL Item
Baseline Step 3 (Baseline Step 3)
Item Group
Unnamed2
DataAmendedText
Item
Please mark an 'X' if data have been amended. (Please circle amended items in red)
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
DataAmendedDate
Item
Date data amended (s M D Y)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain)
Item Group
Pre-registration Evaluation
Item
ECOG Performance Status
text
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain)
C1512162 (UMLS 2011AA ValueDomain)
C20641 (NCI Thesaurus ObjectClass)
C1518965 (UMLS 2011AA ObjectClass)
Code List
ECOG Performance Status
CL Item
Fully Active, Able To Carry On All Pre-disease Performance Without Restriction. (0)
CL Item
Restricted In Physically Strenuous Activity But Ambulatory And Able To Carry Out Work Of A Light Or Sedentary Nature, E.g., Light Housework, Office Work. (1)
CL Item
Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities. Up And About More Than 50% Of Waking Hours. (2)
CL Item
Capable Of Only Limited Selfcare, Confined To Bed Or Chair More Than 50% Of Waking Hours. (3)
CL Item
Completely Disabled. Cannot Carry On Any Selfcare. Totally Confined To Bed Or Chair. (4)
Item
Does patient have bacterial or fungal infectious complications (related to the treatment on the prior protocol step)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C26726 (NCI Thesaurus Property)
C0009450 (UMLS 2011AA Property)
Code List
Does patient have bacterial or fungal infectious complications (related to the treatment on the prior protocol step)
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
Does the patient have any congestive heart failure medical complications (related to the treatment on the prior protocol step)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C3080 (NCI Thesaurus ObjectClass)
C0018802 (UMLS 2011AA ObjectClass)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
Code List
Does the patient have any congestive heart failure medical complications (related to the treatment on the prior protocol step)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Assessment Type (cardiac)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
Code List
Assessment Type (cardiac)
CL Item
Muga Scan (MUGA scan)
CL Item
Echocardiogram (Echocardiogram)
C37945 (NCI Thesaurus)
C2243117 (UMLS 2011AA)
AssessmentPerformedDate
Item
Date of Assessment (M D Y)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
HeartLVEFTestPercentageValue
Item
Resting ejection fraction (% See Section 3.0 of protocol for ejection fraction requirements)
double
C12727 (NCI Thesaurus ObjectClass)
C0018787 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C37946 (NCI Thesaurus Property)
C2700377 (UMLS 2011AA Property)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
Item
Was an EKG done
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C38053 (NCI Thesaurus ObjectClass)
C1623258 (UMLS 2011AA ObjectClass)
C18020 (NCI Thesaurus ObjectClass)
C0430022 (UMLS 2011AA ObjectClass)
Code List
Was an EKG done
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
DiagnosticElectrocardiogramPerformedDate
Item
Date of EKG (M D Y)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25482 (NCI Thesaurus ObjectClass)
C0348026 (UMLS 2011AA ObjectClass)
C0013798 (NCI Metathesaurus ObjectClass)
Item
Are there any clinically significant abnormalities
text
C25401 (NCI Thesaurus ObjectClass)
C0205161 (UMLS 2011AA ObjectClass)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C38053 (NCI Thesaurus ObjectClass)
C1623258 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
Code List
Are there any clinically significant abnormalities
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
AbnormalElectrocardiographyAdverseEventPresentSpecify
Item
Specify
text
C25401 (NCI Thesaurus ObjectClass)
C0205161 (UMLS 2011AA ObjectClass)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C38053 (NCI Thesaurus ObjectClass)
C1623258 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Item
Has patient received transfusion support
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C15366 (NCI Thesaurus ObjectClass)
C0086818 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Code List
Has patient received transfusion support
CL Item
No Transfusion (No)
CL Item
Yes, Prbc (packed Red Blood Cells) (yes, PRBC (packed red blood cells))
CL Item
Transfusion With Platelets (Yes, platelets)
Item Group
Bone Marrow
BoneMarrowBiopsyDate
Item
Date of Bone Marrow Biopsy (M D Y or Aspirate NOTE: Also submit biopsy/aspirate report)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C15189 (NCI Thesaurus Property)
C0005558 (UMLS 2011AA Property)
C12431 (NCI Thesaurus ObjectClass)
C0005953 (UMLS 2011AA ObjectClass)
LaboratoryProcedureBoneMarrowBlastCellOutcomePercentageValue
Item
Marrow Blasts (%)
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C12431 (NCI Thesaurus Property)
C0005953 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12918 (NCI Thesaurus Property)
C0368761 (UMLS 2011AA Property)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureBoneMarrowCellularityOutcomePercentageValue
Item
Marrow Cellularity (%)
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C12431 (NCI Thesaurus Property)
C0005953 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C37923 (NCI Thesaurus Property)
C1516377 (UMLS 2011AA Property)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
Item Group
Hematology/chemistry
LaboratoryProcedureLeukocyteResultLowerLimitofNormalValue
Item
WBC count (x1000), LLN (x1000)
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C12529 (NCI Thesaurus Property)
C0023516 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain)
C1518030 (UMLS 2011AA ValueDomain)
LaboratoryProcedureLeukocyteResultSpecifiedValue
Item
WBC Count (x1000)
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C12529 (NCI Thesaurus Property)
C0023516 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C38024 (NCI Thesaurus ValueDomain)
C0205369 (UMLS 2011AA ValueDomain)
LaboratoryProcedureBlastCellOutcomePercentageValue
Item
Peripheral Blasts (%)
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12918 (NCI Thesaurus Property)
C0368761 (UMLS 2011AA Property)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureGranulocyteResultTotalValue
Item
Absolute Granulocyte Count (AGC/ANC)
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12530 (NCI Thesaurus Property)
C0018183 (UMLS 2011AA Property)
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedurePlateletResultLowerLimitofNormalValue
Item
Platelets LLN (x1000)
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12520 (NCI Thesaurus Property)
C0005821 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain)
C1518030 (UMLS 2011AA ValueDomain)
LaboratoryProcedurePlateletResultSpecifiedValue
Item
Platelets (PLT) (x1000)
double
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12520 (NCI Thesaurus Property)
C0005821 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureHemoglobinResultSpecifiedLowerLimitofNormalValue
Item
Hemoglobin (Hgb) (g/dl), LLN (g/dl)
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C16676 (NCI Thesaurus Property)
C0019046 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C38024 (NCI Thesaurus ValueDomain)
C0205369 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain)
C1518030 (UMLS 2011AA ValueDomain)
LaboratoryProcedureHemoglobinResultUnspecifiedValue
Item
Hemoglobin (g/dl)
double
C16676 (NCI Thesaurus Property)
C0019046 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureErythrocyteResultPercentageLowerLimitofNormalValue
Item
Hematocrit LLN (%)
text
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C12521 (NCI Thesaurus Property)
C0014792 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain)
C1518030 (UMLS 2011AA ValueDomain)
LaboratoryProcedureHematocritOutcomePercentageValue
Item
Hematocrit (%)
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C64796 (NCI Thesaurus Property)
C0018935 (UMLS 2011AA Property)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureCreatinineResultUpperLimitNormalValue
Item
Creatinine ULN (mg/dl)
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
LaboratoryProcedureCreatinineResultUnspecifiedValue
Item
Creatinine (mg/dl)
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureTotalBilirubinResultSpecifiedUpperLimitofNormalValue
Item
Total bilirubin (mg/dl), ULN (mg/dl)
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C38037 (NCI Thesaurus Property)
C0201913 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C38024 (NCI Thesaurus ValueDomain)
C0205369 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
LaboratoryProcedureTotalBilirubinResultUnspecifiedValue
Item
Total Bilirubin (mg/dl)
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C38037 (NCI Thesaurus Property)
C0201913 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureAlkalinePhosphataseResultUpperLimitNormalValue
Item
Alkaline Phosphatase ULN (U/L)
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C16276 (NCI Thesaurus Property)
C0002059 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
LaboratoryProcedureAlkalinePhosphataseResultValue
Item
Alkaline Phosphatase (U/L)
double
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C16276 (NCI Thesaurus Property)
C0002059 (UMLS 2011AA Property)
LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedUpperLimitofNormalValue
Item
SGOT (AST) ULN (U/L)
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedValue
Item
SGOT (AST) (U/L)
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultUpperLimitofNormalValue
Item
SGPT (ALT) ULN (U/L)
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25293 (NCI Thesaurus Property)
C0376147 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultUnspecifiedValue
Item
SGPT (ALT) (U/L)
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25293 (NCI Thesaurus Property)
C0376147 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureUricAcidResultUnspecifiedUpperLimitofNormalValue
Item
Uric Acid ULN (mg/dl)
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C62652 (NCI Thesaurus Property)
C0041980 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
LaboratoryProcedureUricAcidResultUnspecifiedValue
Item
Uric acid (mg/dl)
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C62652 (NCI Thesaurus Property)
C0041980 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureLactateDehydrogenaseResultSpecifiedUpperLimitofNormalValue
Item
LDH ULN (U/L)
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25184 (NCI Thesaurus Property)
C0022917 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C38024 (NCI Thesaurus ValueDomain)
C0205369 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
LaboratoryProcedureLactateDehydrogenaseResultUnspecifiedValue
Item
LDH (U/L)
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25184 (NCI Thesaurus Property)
C0022917 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureMagnesiumResultUnspecifiedLowerLimitofNormalValue
Item
Magnesium, LLN (mg/dl)
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C29239 (NCI Thesaurus Property)
C0024467 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain)
C1518030 (UMLS 2011AA ValueDomain)
LaboratoryProcedureMagnesiumResultUnspecifiedValue
Item
Magnesium (mg/dl)
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C29239 (NCI Thesaurus Property)
C0024467 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
SpecimenCollectedDate
Item
Date Obtained (M D Y)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C25452 (NCI Thesaurus Property)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
Item Group
Baseline Abnormalities
AdverseEventCommonTerminologyforAdverseEventsVersion4TermName
Item
CTC Adverse Event Term
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C49704 (NCI Thesaurus Property)
C1516728 (UMLS 2011AA Property)
C45559 (NCI Thesaurus Property)
C1705313 (UMLS 2011AA Property)
C45255 (NCI Thesaurus ValueDomain)
C1708523 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ValueDomain)
C1516728 (UMLS 2011AA ValueDomain)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)
C45559 (NCI Thesaurus ValueDomain)
C1705313 (UMLS 2011AA ValueDomain)
C25714 (NCI Thesaurus ValueDomain)
C0333052 (UMLS 2011AA ValueDomain)
Item
CTC Adverse Event Grade
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C48309 (NCI Thesaurus Property)
C0441800 (UMLS 2011AA Property)
C49705 (NCI Thesaurus Property)
C1710065 (UMLS 2011AA Property)
C25676 (NCI Thesaurus Property)
C0439793 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ValueDomain)
C0877248 (UMLS 2011AA ValueDomain)
C48309 (NCI Thesaurus ValueDomain)
C0441800 (UMLS 2011AA ValueDomain)
C25676 (NCI Thesaurus ValueDomain)
C0439793 (UMLS 2011AA ValueDomain)
Code List
CTC Adverse Event Grade
CL Item
Mild Adverse Event (1)
C84263 (NCI Thesaurus)
C1513302 (UMLS 2011AA)
CL Item
Moderate Adverse Event (2)
C84264 (NCI Thesaurus)
C1513374 (UMLS 2011AA)
CL Item
Severe Adverse Event (3)
C84265 (NCI Thesaurus)
C2919019 (UMLS 2011AA)
CL Item
Life Threatening Adverse Event (4)
C84266 (NCI Thesaurus)
C1517874 (UMLS 2011AA)
Item Group
Comments
InvestigatorSignatureText
Item
Investigator Signature
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
InvestigatorSignatureDate
Item
Investigator Signature Date (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)

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