ID

1549

Descripción

ANHL01P1: Reporting Period [reload] Rituximab, Rasburicase, and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Advanced B-Cell Leukemia or Lymphoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=BA568824-31F6-08D7-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=BA568824-31F6-08D7-E034-0003BA12F5E7

Palabras clave

Versiones (6)
  1. 27/8/12 27/8/12 -
  2. 8/1/15 8/1/15 - Martin Dugas
  3. 9/1/15 9/1/15 - Martin Dugas
  4. 9/1/15 9/1/15 - Martin Dugas
  5. 21/3/15 21/3/15 - Martin Dugas
  6. 20/9/21 20/9/21 -
Subido en

27 de agosto de 2012

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0 Legacy
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Drug/Agent Toxicity by Tissue/Organ NCT00057811 Treatment - ANHL01P1: Reporting Period [reload] - 2091659v3.0

Inglés

No Instruction available.

1 formularios  
  1. StudyEvent: ANHL01P1: Reporting Period [reload]
    1. No Instruction available.
Unnamed1
Descripción

Unnamed1

Institution
Descripción

InstitutionName

Tipo de datos

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
Descripción

InstitutionName

Tipo de datos

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
Study
Descripción

ProtocolCOGIdentifierNumber

Tipo de datos

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
Patient Name
Descripción

PatientName

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
COG Number
Descripción

PatientCOGIdentifierNumber

Tipo de datos

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
C39353
UMLS 2011AA Property
C1516477
Today's date
Descripción

FormOriginalCompleteDate

Tipo de datos

date

Alias
NCI Thesaurus ObjectClass
C19464
UMLS 2011AA ObjectClass
C0376315
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Thesaurus Property
C25604
UMLS 2011AA Property
C0205313
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
Date entered into RDE
Descripción

DataEnteredDate

Tipo de datos

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C37949
UMLS 2011AA Property
C1521975
Unnamed2
Descripción

Unnamed2

Reporting Period (Institution will choose which course their patient is on.)
Descripción

TreatmentReportingPeriodNumber

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25651
UMLS 2011AA Property
C0700287
Reporting Period Start date (Required field)
Descripción

TreatmentReportingPeriodBeginDate

Tipo de datos

date

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property
C25651
UMLS 2011AA Property
C0700287
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25431
UMLS 2011AA ValueDomain
C0439659
Reporting Period end date (Denote this field as "DT2")
Descripción

TreatmentReportingPeriodEndDate

Tipo de datos

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25651
UMLS 2011AA Property
C0700287
Patient's Height (in cm at beginning of Reporting Period)
Descripción

PatientHeightMeasurement

Tipo de datos

double

Unidades de medida
  • 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
Patient's Weight (in kg at beginning of Reporting Period)
Descripción

PatientWeightMeasurement

Tipo de datos

double

Unidades de medida
  • 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
Unnamed3
Descripción

Unnamed3

Institution
Descripción

InstitutionName

Tipo de datos

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
Study
Descripción

ProtocolCOGIdentifierNumber

Tipo de datos

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
Patient Name
Descripción

PatientName

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
COG Number
Descripción

PatientCOGIdentifierNumber

Tipo de datos

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
C39353
UMLS 2011AA Property
C1516477
Course Number
Descripción

TreatmentCurrentCourseNumber

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C15368
Date entered into RDE
Descripción

DataEnteredDate

Tipo de datos

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C37949
UMLS 2011AA Property
C1521975
Unnamed4
Descripción

Unnamed4

Was the patient's disease status evaluated during this reporting period? (Required for reporting periods 1, 2, 3, 4)
Descripción

DiseaseExaminedDiseaseResponseInd-2

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25500
UMLS 2011AA Property
C0332128
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
COP Phase (Required only for Reduction Phase)
Descripción

LeukemiaDiseaseResponseType

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C25755
UMLS 2011AA Property
C0871261
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus ObjectClass
C3161
UMLS 2011AA ObjectClass
C0023418
Did the patient have a bone marrow evaluation during this reporting period? (Required field)
Descripción

BoneMarrowEvaluationInd-3

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25214
UMLS 2011AA Property
C0220825
NCI Thesaurus ObjectClass
C12431
UMLS 2011AA ObjectClass
C0005953
If bone marrow evaluation not done, specify reason (Required if above answer is not done)
Descripción

BoneMarrowNotEvaluationReason

Tipo de datos

text

Alias
NCI Thesaurus Property
C25214
UMLS 2011AA Property
C0220825
NCI Thesaurus ObjectClass
C12431
UMLS 2011AA ObjectClass
C0005953
what was the date of the exam? [bone marrow evaluation] (If yes,)
Descripción

BoneMarrowEvaluationDate

Tipo de datos

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25214
UMLS 2011AA Property
C0220825
NCI Thesaurus ObjectClass
C12431
UMLS 2011AA ObjectClass
C0005953
does the patient have bone marrow involvement? (If yes,)
Descripción

BoneMarrowInvolvementInd-3

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C12431
UMLS 2011AA ObjectClass
C0005953
NCI Thesaurus Property
C25548
UMLS 2011AA Property
C1314939
percent (%) malignant blasts in bone marrow (Required field)
Descripción

LaboratoryProcedureBoneMarrowBlastCellOutcomePercentageValue

Tipo de datos

double

Unidades de medida
  • %
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
%
Unnamed5
Descripción

Unnamed5

Was patient's CNS status evaluated during this reporting period? (Required field)
Descripción

CNSEvaluationReportingInd-2

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25214
UMLS 2011AA Property
C0220825
NCI Thesaurus ObjectClass
C12438
UMLS 2011AA ObjectClass
C0927232
Does patient have CNS involvement? (Required if above answer is 'yes')
Descripción

CNSInvolvedInd-3

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C12438
UMLS 2011AA ObjectClass
C0927232
NCI Thesaurus Property
C25547
Was cerebrospinal fluid cell count done? (Required if CNS involvement yes)
Descripción

CSFCellCountInd-3

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25256
UMLS 2011AA Property
C1265611
date CSF fluid cell count was done (If yes,)
Descripción

CSFCellCountDate

Tipo de datos

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25256
UMLS 2011AA Property
C1265611
Number of white cells counted (Required if CNS involvement yes)
Descripción

LaboratoryProcedureLeukocyteResultUnspecifiedValue

Tipo de datos

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
C38046
UMLS 2011AA ValueDomain
C0205370
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
Number of red cells counted (Required if CNS involvement yes)
Descripción

LaboratoryProcedureErythrocyteResultSpecifiedValue

Tipo de datos

double

Unidades de medida
  • ul
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
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C38024
UMLS 2011AA ValueDomain
C0205369
ul
Blasts present in cytocentrifuge (Required if CNS involvement yes)
Descripción

HematologyBlastsLabValue

Tipo de datos

text

Alias
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
Were total number of cells counted in the cytocentrifuge? (Required if CNS involvement yes)
Descripción

SpecimenCellCountInd-3

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C19157
UMLS 2011AA ObjectClass
C0370003
NCI Thesaurus Property
C25256
UMLS 2011AA Property
C1265611
total number of cells counted (If yes,)
Descripción

SpecimenCellCountTotalValue

Tipo de datos

double

Alias
NCI Thesaurus ObjectClass
C19157
UMLS 2011AA ObjectClass
C0370003
NCI Thesaurus Property
C12508
UMLS 2011AA Property
C0007634
NCI Thesaurus Property
C25256
UMLS 2011AA Property
C1265611
NCI Thesaurus ValueDomain
C25304
UMLS 2011AA ValueDomain
C0439810
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
was an Echocardiogram performed during this reporting period? (If Echocardiogram was not able to be performed prior to starting treatment,)
Descripción

EchocardiogramAssessmentPerformedReportingInd-2

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C25367
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
Unnamed6
Descripción

Unnamed6

Imaging Studies Following Reporting Period (Required field)
Descripción

ReportingAssessmentMethodType

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus Property
C16847
UMLS 2011AA Property
C0449851
Unnamed question [results of imaging studies]
Descripción

AssessmentResultType

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
COP Phase (Required only for Reduction Phase)
Descripción

LeukemiaDiseaseResponseType

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C25755
UMLS 2011AA Property
C0871261
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus ObjectClass
C3161
UMLS 2011AA ObjectClass
C0023418
Is the patient off protocol therapy at the end of this reporting period? (Required field)
Descripción

PatientOff-treatmentInd-3

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25601
UMLS 2011AA Property
C1518544
date last drug or other protocol defined treatment was received (If yes,)
Descripción

TreatmentLastDoseEndDate

Tipo de datos

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25509
UMLS 2011AA Property
C1279901
NCI Thesaurus Property
C25256
UMLS 2011AA Property
C1265611
reason off protocol therapy (If yes,)
Descripción

Off-treatmentReason

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C25601
UMLS 2011AA ObjectClass
C1518544
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
LDH (Required field)
Descripción

LaboratoryProcedureLactateDehydrogenaseResultSpecifiedValue

Tipo de datos

double

Unidades de medida
  • U/L
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
C25184
UMLS 2011AA Property
C0022917
U/L
Institutional upper limits of normal for LDH (Required field)
Descripción

LaboratoryProcedureLactateDehydrogenaseResultSpecifiedUpperLimitofNormalValue

Tipo de datos

double

Unidades de medida
  • 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
If LDH level was elevate above institutional upper limits of normal,: ____ fold increase (Required only if LDH was elevated above institutional upper limits of normal)
Descripción

ChemistryLDHLabElevatedValue

Tipo de datos

double

Alias
NCI Thesaurus Property
C37984
UMLS 2011AA Property
C0022877
NCI Thesaurus ObjectClass
C16414
UMLS 2011AA ObjectClass
C0007996
ANC (uL)
Descripción

LaboratoryProcedureNeutrophilResultSpecifiedValue

Tipo de datos

double

Unidades de medida
  • 1000/uL
Alias
NCI Thesaurus Property
C12533
UMLS 2011AA Property
C0027950
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
1000/uL
Platelets/uL (Required field)
Descripción

LaboratoryProcedurePlateletResultSpecifiedValue

Tipo de datos

double

Unidades de medida
  • 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
was the patient switched to Sub-pilot Group C or pilot Group C, respectively? (If there was evidence of disease,)
Descripción

TreatmentModifiedInd-3

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25572
was the patient switched to Sub-pilot Group C or pilot Group C, respectively? (If there was evidence of disease,)
Descripción

TreatmentModifiedInd-3

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25572
was the patient switched to Sub-pilot Group C or pilot Group C, respectively? (If there was evidence of disease,)
Descripción

TreatmentModifiedInd-3

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25572
Unnamed question [treatment assignment] (If the treatment assignment is Group B Sub-Pilot or Group B Pilot)
Descripción

TreatmentAssignmentText

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25426
UMLS 2011AA Property
C1516050
Was there evidence of residual disease on diagnostic tests?
Descripción

ResidualDiseaseStatusType

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus ObjectClass
C37895
UMLS 2011AA ObjectClass
C1609982
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
was a biopsy performed? (If yes,)
Descripción

TumorBiopsyInd-3

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus Property
C15189
UMLS 2011AA Property
C0005558
what were the results? (If yes,)
Descripción

BiopsyResultType

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C15189
UMLS 2011AA ObjectClass
C0005558
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
Tumor lysis syndrome? (Required during reduction phase only)
Descripción

CTCAdverseEventLysisGrade

Tipo de datos

double

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Unnamed7
Descripción

Unnamed7

Unnamed question [day number]
Descripción

TreatmentDayCount

Tipo de datos

double

Alias
NCI Thesaurus ValueDomain
C25301
UMLS 2011AA ValueDomain
C0439228
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
4 Hours Post-Treatment [uric acid level]
Descripción

RenalUricAcidLabSpecifiedValue

Tipo de datos

double

Unidades de medida
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25225
UMLS 2011AA ObjectClass
C0022646
NCI Thesaurus Property
C37984
UMLS 2011AA Property
C0022877
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
mg/dL
Potassium (mEq/L)
Descripción

LaboratoryProcedurePotassiumElectrolytesOutcomeSpecifiedValue

Tipo de datos

double

Unidades de medida
  • mmol/L
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C464
UMLS 2011AA Property
C0013832
NCI Thesaurus Property
C765
UMLS 2011AA Property
C0032821
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
mmol/L
Phosphate (mg/dL)
Descripción

LaboratoryProcedurePhosphateMeasurementResultSpecifiedValue

Tipo de datos

double

Unidades de medida
  • mg/dL
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
C64857
UMLS 2011AA Property
C0523826
mg/dL
Calcium (mg/dL)
Descripción

ElectrolytesCalciumLabSpecifiedValue

Tipo de datos

double

Unidades de medida
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C331
UMLS 2011AA Property
C0006675
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C464
UMLS 2011AA Property
C0013832
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
mg/dL
BUN (mg/dL)
Descripción

LaboratoryProcedureBloodUreaNitrogenResultUnspecifiedValue

Tipo de datos

double

Alias
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C61019
UMLS 2011AA Property
C0005845
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
Creatinine (mg/dL)
Descripción

RenalCreatinineLabSpecifiedValue

Tipo de datos

double

Unidades de medida
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25225
UMLS 2011AA ObjectClass
C0022646
NCI Thesaurus Property
C399
UMLS 2011AA Property
C0010294
NCI Thesaurus Property
C25294
UMLS 2011AA Property
C0022885
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
mg/dL
Unnamed8
Descripción

Unnamed8

Did renal dysfunction occur during the reduction phase? (Required for reduction phase only.)
Descripción

RenalAbnormalityInd-3

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C25225
UMLS 2011AA ObjectClass
C0022646
NCI Thesaurus Property
C9440
UMLS 2011AA Property
C1704258
Unnamed question [agent name]
Descripción

AgentName

Tipo de datos

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
Unnamed question [agent name]
Descripción

AgentName

Tipo de datos

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
Unnamed question [agent name]
Descripción

AgentName

Tipo de datos

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
Maximal grade of renal dysfunction (Choose One)
Descripción

CTCAdverseEventRenalFailureGrade

Tipo de datos

double

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Was there assisted renal support?
Descripción

RenalSupportAdministeredInd-2

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C37902
UMLS 2011AA ObjectClass
C1521721
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Unnamed question [type of renal support] (If yes for assisted renal support)
Descripción

RenalSupportAdministeredType

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C37902
UMLS 2011AA ObjectClass
C1521721
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
please specify [type of renal support] (Text)
Descripción

RenalSupportAdministeredSpecify

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C37902
UMLS 2011AA ObjectClass
C1521721
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Was rasburicase utilized prior to Day 0 of the reduction phase? (Required only for Reduction Phase)
Descripción

AgentPriorAdministeredReportingInd-2

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
number of days given prior to Day 0 (If yes,)
Descripción

AgentAdministeredDayDuration

Tipo de datos

double

Alias
NCI Thesaurus ValueDomain
C25301
UMLS 2011AA ValueDomain
C0439228
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C25330
UMLS 2011AA ValueDomain
C0449238
number of doses given prior to Day 0 (If yes,)
Descripción

AgentCourseCount

Tipo de datos

double

Alias
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
NCI Thesaurus Property
C25379
UMLS 2011AA Property
C0750729
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
Unnamed9
Descripción

Unnamed9

Unnamed question [day number]
Descripción

TreatmentDayCount

Tipo de datos

double

Alias
NCI Thesaurus ValueDomain
C25301
UMLS 2011AA ValueDomain
C0439228
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
4 Hours Post-Treatment [uric acid level]
Descripción

RenalUricAcidLabSpecifiedValue

Tipo de datos

double

Unidades de medida
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25225
UMLS 2011AA ObjectClass
C0022646
NCI Thesaurus Property
C37984
UMLS 2011AA Property
C0022877
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
mg/dL
4 Hours Post-Treatment [uric acid level]
Descripción

RenalUricAcidLabSpecifiedValue

Tipo de datos

double

Unidades de medida
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25225
UMLS 2011AA ObjectClass
C0022646
NCI Thesaurus Property
C37984
UMLS 2011AA Property
C0022877
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
mg/dL
Unnamed10
Descripción

Unnamed10

Unnamed question [agent name]
Descripción

AgentName

Tipo de datos

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
Did the patient receive rituximab in this cycle?
Descripción

AgentAdministeredInd-2

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
did the patient develop clinically significant Steven's Johnson syndrome? (If yes,)
Descripción

CTCAdverseEventStevens-JohnsonSyndromePresentInd-2

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
Did a second malignant neoplasm (SMN) occur during this Reporting Period? (Required field)
Descripción

NewCancerDiagnosisInd-3

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C25586
UMLS 2011AA ObjectClass
C0205314
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
Date SMN diagnosed (If the answer to SMN is yes this field must be supplied. The date must be between the start and end date of this reporting period.)
Descripción

NewCancerDiagnosisDate

Tipo de datos

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
Life status at end of this reporting period (Required field)
Descripción

PatientVitalStatus

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ValueDomain
C18003
UMLS 2011AA ValueDomain
C0442732
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Was patient confirmed lost to follow-up at the end of this reporting period? (Required field)
Descripción

PatientLostFollow-upInd-2

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25560
UMLS 2011AA Property
C0745777
NCI Thesaurus Property
C16033
UMLS 2011AA Property
C1522577
Was patient enrolled on another COG therapeutic study at the end of the reporting period? (Required field)
Descripción

PatientOtherEnrollmentInd-2

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
Did the patient withdraw consent for follow-up at the end of the reporting period? (Note: Withdrawal of consent is to be coded only when the patient no longer wants to participate in the study and asks that data no longer be submitted.)
Descripción

PatientWithdrawFollow-upConsentInd-2

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C16033
UMLS 2011AA Property
C1522577
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
NCI Thesaurus Property
C38061
UMLS 2011AA Property
C2349954
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Did the patient relapse or experience disease progression during the reporting period? (Required field)
Descripción

DiseaseProgressionInd-3

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25331
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
date of relapse or progression (If yes,)
Descripción

DiseaseProgressionDate

Tipo de datos

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus Property
C25331
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
Ccrr Module For Anhl01p1: Reporting Period [reload]
Descripción

Ccrr Module For Anhl01p1: Reporting Period [reload]

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  1. StudyEvent: ANHL01P1: Reporting Period [reload]
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Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Unnamed1
InstitutionName
Item
Institution
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)
InstitutionName
Item
Institution
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)
ProtocolCOGIdentifierNumber
Item
Study
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)
PatientName
Item
Patient Name
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
PatientCOGIdentifierNumber
Item
COG Number
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)
C39353 (NCI Thesaurus Property)
C1516477 (UMLS 2011AA Property)
FormOriginalCompleteDate
Item
Today's date
date
C19464 (NCI Thesaurus ObjectClass)
C0376315 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25604 (NCI Thesaurus Property)
C0205313 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
DataEnteredDate
Item
Date entered into RDE
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C37949 (NCI Thesaurus Property)
C1521975 (UMLS 2011AA Property)
Item Group
Unnamed2
Item
Reporting Period (Institution will choose which course their patient is on.)
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C15368 (NCI Thesaurus ObjectClass)
C25651 (NCI Thesaurus Property)
C0700287 (UMLS 2011AA Property)
CL.1
Code List
Reporting Period (Institution will choose which course their patient is on.)
CL Item
Reduction Phase (Reduction Phase)
CL Item
Induction, 1st Cycle (Induction, 1st Cycle)
CL Item
Induction, 2nd cycle (Induction, 2nd cycle)
CL Item
Consolidation, 1st course (CYM-RM1) (Consolidation, 1st course (CYM-RM1))
CL Item
Consolidation, other than CYM-RM1 (Consolidation, other than CYM-RM1)
CL Item
Maintenance, Course 1 (Maintenance, Course 1)
CL Item
Maintenance, Course 2 (Maintenance, Course 2)
CL Item
Maintenance, Course 3 (Maintenance, Course 3)
CL Item
Maintenance, Course 4 (Maintenance, Course 4)
TreatmentReportingPeriodBeginDate
Item
Reporting Period Start date (Required field)
date
C15368 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25651 (NCI Thesaurus Property)
C0700287 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)
TreatmentReportingPeriodEndDate
Item
Reporting Period end date (Denote this field as "DT2")
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C15368 (NCI Thesaurus ObjectClass)
C25651 (NCI Thesaurus Property)
C0700287 (UMLS 2011AA Property)
PatientHeightMeasurement
Item
Patient's Height (in cm at beginning of Reporting Period)
double
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25347 (NCI Thesaurus Property)
C0489786 (UMLS 2011AA Property)
PatientWeightMeasurement
Item
Patient's Weight (in kg at beginning of Reporting Period)
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)
Item Group
Unnamed3
InstitutionName
Item
Institution
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)
ProtocolCOGIdentifierNumber
Item
Study
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)
PatientName
Item
Patient Name
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
PatientCOGIdentifierNumber
Item
COG Number
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)
C39353 (NCI Thesaurus Property)
C1516477 (UMLS 2011AA Property)
TreatmentCurrentCourseNumber
Item
Course Number
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C15368 (NCI Thesaurus ObjectClass)
DataEnteredDate
Item
Date entered into RDE
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C37949 (NCI Thesaurus Property)
C1521975 (UMLS 2011AA Property)
Item Group
Unnamed4
Item
Was the patient's disease status evaluated during this reporting period? (Required for reporting periods 1, 2, 3, 4)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25500 (NCI Thesaurus Property)
C0332128 (UMLS 2011AA Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
CL.2
Code List
Was the patient's disease status evaluated during this reporting period? (Required for reporting periods 1, 2, 3, 4)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
No (Not Done)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
COP Phase (Required only for Reduction Phase)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25755 (NCI Thesaurus Property)
C0871261 (UMLS 2011AA Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C3161 (NCI Thesaurus ObjectClass)
C0023418 (UMLS 2011AA ObjectClass)
CL.16
Code List
COP Phase (Required only for Reduction Phase)
CL Item
>=20% tumor reduction (>=20% tumor reduction)
CL Item
<20% tumor reduction (<20% tumor reduction)
CL Item
Equivocal (Equivocal)
CL Item
Not done (Not done)
CL Item
Sub-Pilot B or Pilot B <20% reduction (Sub-Pilot B or Pilot B <20% reduction)
CL Item
Complete Response (CR)
CL Item
Incomplete Response Or Stable Disesase (Incomplete response/SD)
CL Item
Insufficient Evaluation (Insufficient evaluation to determine response status)
CL Item
Progression; At Least A 20% Increase In The Sum Of Ld Of Target Lesions Taking As References The Smallest Sum Ld Recorded Since The Treatment Started Or The Appearance Of One Or More New Lesions (PD)
CL Item
Partial Response (PR)
C18212 (NCI Thesaurus)
CL Item
Stable Disease (SD)
C18213 (NCI Thesaurus)
C0677946 (UMLS 2011AA)
Item
Did the patient have a bone marrow evaluation during this reporting period? (Required field)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C12431 (NCI Thesaurus ObjectClass)
C0005953 (UMLS 2011AA ObjectClass)
CL.4
Code List
Did the patient have a bone marrow evaluation during this reporting period? (Required field)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
BoneMarrowNotEvaluationReason
Item
If bone marrow evaluation not done, specify reason (Required if above answer is not done)
text
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C12431 (NCI Thesaurus ObjectClass)
C0005953 (UMLS 2011AA ObjectClass)
Item
what was the date of the exam? [bone marrow evaluation] (If yes,)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C12431 (NCI Thesaurus ObjectClass)
C0005953 (UMLS 2011AA ObjectClass)
CL.5
Code List
what was the date of the exam? [bone marrow evaluation] (If yes,)
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
N/A, not done (N/A, not done)
Item
does the patient have bone marrow involvement? (If yes,)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12431 (NCI Thesaurus ObjectClass)
C0005953 (UMLS 2011AA ObjectClass)
C25548 (NCI Thesaurus Property)
C1314939 (UMLS 2011AA Property)
CL.6
Code List
does the patient have bone marrow involvement? (If yes,)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
LaboratoryProcedureBoneMarrowBlastCellOutcomePercentageValue
Item
percent (%) malignant blasts in bone marrow (Required field)
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)
Item Group
Unnamed5
Item
Was patient's CNS status evaluated during this reporting period? (Required field)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C12438 (NCI Thesaurus ObjectClass)
C0927232 (UMLS 2011AA ObjectClass)
CL.7
Code List
Was patient's CNS status evaluated during this reporting period? (Required field)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Does patient have CNS involvement? (Required if above answer is 'yes')
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12438 (NCI Thesaurus ObjectClass)
C0927232 (UMLS 2011AA ObjectClass)
C25547 (NCI Thesaurus Property)
CL.8
Code List
Does patient have CNS involvement? (Required if above answer is 'yes')
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Was cerebrospinal fluid cell count done? (Required if CNS involvement yes)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25256 (NCI Thesaurus Property)
C1265611 (UMLS 2011AA Property)
CL.9
Code List
Was cerebrospinal fluid cell count done? (Required if CNS involvement yes)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CSFCellCountDate
Item
date CSF fluid cell count was done (If yes,)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25256 (NCI Thesaurus Property)
C1265611 (UMLS 2011AA Property)
LaboratoryProcedureLeukocyteResultUnspecifiedValue
Item
Number of white cells counted (Required if CNS involvement yes)
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)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureErythrocyteResultSpecifiedValue
Item
Number of red cells counted (Required if CNS involvement yes)
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C12521 (NCI Thesaurus Property)
C0014792 (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)
HematologyBlastsLabValue
Item
Blasts present in cytocentrifuge (Required if CNS involvement yes)
text
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
Item
Were total number of cells counted in the cytocentrifuge? (Required if CNS involvement yes)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C25256 (NCI Thesaurus Property)
C1265611 (UMLS 2011AA Property)
CL.10
Code List
Were total number of cells counted in the cytocentrifuge? (Required if CNS involvement yes)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
SpecimenCellCountTotalValue
Item
total number of cells counted (If yes,)
double
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C12508 (NCI Thesaurus Property)
C0007634 (UMLS 2011AA Property)
C25256 (NCI Thesaurus Property)
C1265611 (UMLS 2011AA Property)
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
Item
was an Echocardiogram performed during this reporting period? (If Echocardiogram was not able to be performed prior to starting treatment,)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
CL.11
Code List
was an Echocardiogram performed during this reporting period? (If Echocardiogram was not able to be performed prior to starting treatment,)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
No (Not Done)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item Group
Unnamed6
Item
Imaging Studies Following Reporting Period (Required field)
text
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
CL.12
Code List
Imaging Studies Following Reporting Period (Required field)
CL Item
Chest X-ray, Pa And Lateral (Chest x-ray)
CL Item
Abdominal Ultrasound (Abdominal Ultrasound)
CL Item
Abdominal Ct Or Mri (Abdominal CT or MRI)
CL Item
Bone Scan (Bone Scan)
C17646 (NCI Thesaurus)
C0203668 (UMLS 2011AA)
CL Item
Pet Scan (PET Scan)
CL Item
Gallium Scan (Gallium Scan)
C38087 (NCI Thesaurus)
C0521316 (UMLS 2011AA)
CL Item
Head Or Spine Ct Or Mri (Head or spine CT or MRI)
CL Item
Testicular Ultrasound (Testicular ultrasound)
Item
Unnamed question [results of imaging studies]
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
CL.13
Code List
Unnamed question [results of imaging studies]
CL Item
Evidence Of Disease (Evidence of disease)
CL Item
No Evidence Of Disease (No evidence of disease)
C40413 (NCI Thesaurus)
C1518340 (UMLS 2011AA)
CL Item
Equivocal (Equivocal)
C86071 (NCI Thesaurus)
C0332241 (UMLS 2011AA)
CL Item
Not Done (Not done)
CL281691 (NCI Metathesaurus)
Item
COP Phase (Required only for Reduction Phase)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25755 (NCI Thesaurus Property)
C0871261 (UMLS 2011AA Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C3161 (NCI Thesaurus ObjectClass)
C0023418 (UMLS 2011AA ObjectClass)
CL.16
Code List
COP Phase (Required only for Reduction Phase)
CL Item
>=20% tumor reduction (>=20% tumor reduction)
CL Item
<20% tumor reduction (<20% tumor reduction)
CL Item
Equivocal (Equivocal)
CL Item
Not done (Not done)
CL Item
Sub-Pilot B or Pilot B <20% reduction (Sub-Pilot B or Pilot B <20% reduction)
CL Item
Complete Response (CR)
CL Item
Incomplete Response Or Stable Disesase (Incomplete response/SD)
CL Item
Insufficient Evaluation (Insufficient evaluation to determine response status)
CL Item
Progression; At Least A 20% Increase In The Sum Of Ld Of Target Lesions Taking As References The Smallest Sum Ld Recorded Since The Treatment Started Or The Appearance Of One Or More New Lesions (PD)
CL Item
Partial Response (PR)
C18212 (NCI Thesaurus)
CL Item
Stable Disease (SD)
C18213 (NCI Thesaurus)
C0677946 (UMLS 2011AA)
Item
Is the patient off protocol therapy at the end of this reporting period? (Required field)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25601 (NCI Thesaurus Property)
C1518544 (UMLS 2011AA Property)
CL.14
Code List
Is the patient off protocol therapy at the end of this reporting period? (Required field)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
TreatmentLastDoseEndDate
Item
date last drug or other protocol defined treatment was received (If yes,)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25256 (NCI Thesaurus Property)
C1265611 (UMLS 2011AA Property)
Item
reason off protocol therapy (If yes,)
text
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.15
Code List
reason off protocol therapy (If yes,)
CL Item
Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
CL Item
Disease Progression Before Active Treatment (Disease progression/relapse during active treatment)
CL Item
Disease Progression, Relapse During Active Treatment (Group C patients who have biopsy proven residual disease after induction (COPADM2))
CL Item
Adverse Event/side Effects/complications (Toxicity/Side Effects/Complications)
CL Item
Death On Study (Death)
CL Item
Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient withdrawal or refusal after beginning protocol therapy)
CL Item
Patient Withdrawal Or Refusal Before Beginning Protocol Therapy (Patient withdrawal or refusal prior to beginning a protocol therapy)
CL Item
Alternative Therapy (Alternative therapy)
CL Item
Patient Off-treatment For Other Complicating Disease (Patient off-treatment for other complicating disease)
CL Item
Cytogenetic Resistance (Cytogenetic resistance)
CL Item
Disease Progression Before Active Treatment (Disease progression before active treatment)
CL Item
Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient declared ineligible)
CL Item
Lost To Follow-up (Lost to follow-up)
CL310949 (NCI Metathesaurus)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
LaboratoryProcedureLactateDehydrogenaseResultSpecifiedValue
Item
LDH (Required field)
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)
C25184 (NCI Thesaurus Property)
C0022917 (UMLS 2011AA Property)
LaboratoryProcedureLactateDehydrogenaseResultSpecifiedUpperLimitofNormalValue
Item
Institutional upper limits of normal for LDH (Required field)
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)
ChemistryLDHLabElevatedValue
Item
If LDH level was elevate above institutional upper limits of normal,: ____ fold increase (Required only if LDH was elevated above institutional upper limits of normal)
double
C37984 (NCI Thesaurus Property)
C0022877 (UMLS 2011AA Property)
C16414 (NCI Thesaurus ObjectClass)
C0007996 (UMLS 2011AA ObjectClass)
LaboratoryProcedureNeutrophilResultSpecifiedValue
Item
ANC (uL)
double
C12533 (NCI Thesaurus Property)
C0027950 (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)
LaboratoryProcedurePlateletResultSpecifiedValue
Item
Platelets/uL (Required field)
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)
Item
was the patient switched to Sub-pilot Group C or pilot Group C, respectively? (If there was evidence of disease,)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25572 (NCI Thesaurus Property)
CL.23
Code List
was the patient switched to Sub-pilot Group C or pilot Group C, respectively? (If there was evidence of disease,)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
was the patient switched to Sub-pilot Group C or pilot Group C, respectively? (If there was evidence of disease,)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25572 (NCI Thesaurus Property)
CL.23
Code List
was the patient switched to Sub-pilot Group C or pilot Group C, respectively? (If there was evidence of disease,)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
was the patient switched to Sub-pilot Group C or pilot Group C, respectively? (If there was evidence of disease,)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25572 (NCI Thesaurus Property)
CL.23
Code List
was the patient switched to Sub-pilot Group C or pilot Group C, respectively? (If there was evidence of disease,)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Unnamed question [treatment assignment] (If the treatment assignment is Group B Sub-Pilot or Group B Pilot)
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25426 (NCI Thesaurus Property)
C1516050 (UMLS 2011AA Property)
CL.19
Code List
Unnamed question [treatment assignment] (If the treatment assignment is Group B Sub-Pilot or Group B Pilot)
CL Item
CYM-RM1 (CYM-RM1)
CL Item
CYM-RM2 (CYM-RM2)
Item
Was there evidence of residual disease on diagnostic tests?
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C37895 (NCI Thesaurus ObjectClass)
C1609982 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.20
Code List
Was there evidence of residual disease on diagnostic tests?
CL Item
Yes (Yes)
CL Item
No Evidence Of Disease (No)
C40413 (NCI Thesaurus)
C1518340 (UMLS 2011AA)
CL Item
Gross Disease (gross disease)
CL Item
Microscopic Disease (microscopic disease)
CL Item
Unknown/not Documented (unknown/not documented)
Item
was a biopsy performed? (If yes,)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C15189 (NCI Thesaurus Property)
C0005558 (UMLS 2011AA Property)
CL.21
Code List
was a biopsy performed? (If yes,)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
what were the results? (If yes,)
text
C15189 (NCI Thesaurus ObjectClass)
C0005558 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
CL.22
Code List
what were the results? (If yes,)
CL Item
Evidence Of Disease (Evidence of disease)
CL Item
No Evidence Of Disease (No evidence of disease)
C40413 (NCI Thesaurus)
C1518340 (UMLS 2011AA)
CL Item
Equivocal (Equivocal)
C86071 (NCI Thesaurus)
C0332241 (UMLS 2011AA)
Item
Tumor lysis syndrome? (Required during reduction phase only)
double
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.24
Code List
Tumor lysis syndrome? (Required during reduction phase only)
CL Item
Yes (Yes)
CL Item
Absent (No)
CL Item
Death Related To Toxicity (5)
CL Item
Present (3)
C25626 (NCI Thesaurus)
C0150312 (UMLS 2011AA)
Item Group
Unnamed7
Item
Unnamed question [day number]
double
C25301 (NCI Thesaurus ValueDomain)
C0439228 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
CL.31
Code List
Unnamed question [day number]
CL Item
-3 (-3)
CL Item
-2 (-2)
CL Item
-1 (-1)
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
RenalUricAcidLabSpecifiedValue
Item
4 Hours Post-Treatment [uric acid level]
double
C25225 (NCI Thesaurus ObjectClass)
C0022646 (UMLS 2011AA ObjectClass)
C37984 (NCI Thesaurus Property)
C0022877 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedurePotassiumElectrolytesOutcomeSpecifiedValue
Item
Potassium (mEq/L)
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C464 (NCI Thesaurus Property)
C0013832 (UMLS 2011AA Property)
C765 (NCI Thesaurus Property)
C0032821 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedurePhosphateMeasurementResultSpecifiedValue
Item
Phosphate (mg/dL)
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)
C64857 (NCI Thesaurus Property)
C0523826 (UMLS 2011AA Property)
ElectrolytesCalciumLabSpecifiedValue
Item
Calcium (mg/dL)
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C331 (NCI Thesaurus Property)
C0006675 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C464 (NCI Thesaurus Property)
C0013832 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureBloodUreaNitrogenResultUnspecifiedValue
Item
BUN (mg/dL)
double
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C61019 (NCI Thesaurus Property)
C0005845 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
RenalCreatinineLabSpecifiedValue
Item
Creatinine (mg/dL)
double
C25225 (NCI Thesaurus ObjectClass)
C0022646 (UMLS 2011AA ObjectClass)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
Item Group
Unnamed8
Item
Did renal dysfunction occur during the reduction phase? (Required for reduction phase only.)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25225 (NCI Thesaurus ObjectClass)
C0022646 (UMLS 2011AA ObjectClass)
C9440 (NCI Thesaurus Property)
C1704258 (UMLS 2011AA Property)
CL.26
Code List
Did renal dysfunction occur during the reduction phase? (Required for reduction phase only.)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
AgentName
Item
Unnamed question [agent name]
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)
AgentName
Item
Unnamed question [agent name]
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)
AgentName
Item
Unnamed question [agent name]
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)
Item
Maximal grade of renal dysfunction (Choose One)
double
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.27
Code List
Maximal grade of renal dysfunction (Choose One)
CL Item
Mild (Mild)
CL Item
Moderate (Moderate)
CL Item
Requiring Dialysis, But Reversible (Severe)
CL Item
Requiring Dialysis And Irreversible (Life-threatening)
CL Item
Death Related To Toxicity (Death)
CL Item
Unknown (Unknown)
CL Item
None (0)
C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)
Item
Was there assisted renal support?
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C37902 (NCI Thesaurus ObjectClass)
C1521721 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
CL.28
Code List
Was there assisted renal support?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Unnamed question [type of renal support] (If yes for assisted renal support)
text
C37902 (NCI Thesaurus ObjectClass)
C1521721 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
CL.29
Code List
Unnamed question [type of renal support] (If yes for assisted renal support)
CL Item
Hemodialysis (Hemodialysis)
C15248 (NCI Thesaurus)
C0019004 (UMLS 2011AA)
CL Item
Peritoneal Dialysis (Peritoneal dialysis)
C15297 (NCI Thesaurus)
C0031139 (UMLS 2011AA)
CL Item
Cvvh (CVVH)
CL Item
Cvah (CVAH)
CL Item
Other, Specify (Other (please specify below))
RenalSupportAdministeredSpecify
Item
please specify [type of renal support] (Text)
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C37902 (NCI Thesaurus ObjectClass)
C1521721 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Item
Was rasburicase utilized prior to Day 0 of the reduction phase? (Required only for Reduction Phase)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
CL.30
Code List
Was rasburicase utilized prior to Day 0 of the reduction phase? (Required only for Reduction Phase)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
AgentAdministeredDayDuration
Item
number of days given prior to Day 0 (If yes,)
double
C25301 (NCI Thesaurus ValueDomain)
C0439228 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25330 (NCI Thesaurus ValueDomain)
C0449238 (UMLS 2011AA ValueDomain)
AgentCourseCount
Item
number of doses given prior to Day 0 (If yes,)
double
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
Item Group
Unnamed9
Item
Unnamed question [day number]
double
C25301 (NCI Thesaurus ValueDomain)
C0439228 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
CL.31
Code List
Unnamed question [day number]
CL Item
-3 (-3)
CL Item
-2 (-2)
CL Item
-1 (-1)
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
RenalUricAcidLabSpecifiedValue
Item
4 Hours Post-Treatment [uric acid level]
double
C25225 (NCI Thesaurus ObjectClass)
C0022646 (UMLS 2011AA ObjectClass)
C37984 (NCI Thesaurus Property)
C0022877 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
RenalUricAcidLabSpecifiedValue
Item
4 Hours Post-Treatment [uric acid level]
double
C25225 (NCI Thesaurus ObjectClass)
C0022646 (UMLS 2011AA ObjectClass)
C37984 (NCI Thesaurus Property)
C0022877 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
Item Group
Unnamed10
AgentName
Item
Unnamed question [agent name]
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)
Item
Did the patient receive rituximab in this cycle?
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
CL.32
Code List
Did the patient receive rituximab in this cycle?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
did the patient develop clinically significant Steven's Johnson syndrome? (If yes,)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
CL.33
Code List
did the patient develop clinically significant Steven's Johnson syndrome? (If yes,)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Did a second malignant neoplasm (SMN) occur during this Reporting Period? (Required field)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
CL.34
Code List
Did a second malignant neoplasm (SMN) occur during this Reporting Period? (Required field)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
NewCancerDiagnosisDate
Item
Date SMN diagnosed (If the answer to SMN is yes this field must be supplied. The date must be between the start and end date of this reporting period.)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
Item
Life status at end of this reporting period (Required field)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C18003 (NCI Thesaurus ValueDomain)
C0442732 (UMLS 2011AA ValueDomain)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.35
Code List
Life status at end of this reporting period (Required field)
CL Item
Alive (Alive)
CL Item
Dead (Dead)
Item
Was patient confirmed lost to follow-up at the end of this reporting period? (Required field)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25560 (NCI Thesaurus Property)
C0745777 (UMLS 2011AA Property)
C16033 (NCI Thesaurus Property)
C1522577 (UMLS 2011AA Property)
CL.36
Code List
Was patient confirmed lost to follow-up at the end of this reporting period? (Required field)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Was patient enrolled on another COG therapeutic study at the end of the reporting period? (Required field)
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
CL.37
Code List
Was patient enrolled on another COG therapeutic study at the end of the reporting period? (Required field)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Did the patient withdraw consent for follow-up at the end of the reporting period? (Note: Withdrawal of consent is to be coded only when the patient no longer wants to participate in the study and asks that data no longer be submitted.)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C16033 (NCI Thesaurus Property)
C1522577 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C38061 (NCI Thesaurus Property)
C2349954 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.38
Code List
Did the patient withdraw consent for follow-up at the end of the reporting period? (Note: Withdrawal of consent is to be coded only when the patient no longer wants to participate in the study and asks that data no longer be submitted.)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Did the patient relapse or experience disease progression during the reporting period? (Required field)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25331 (NCI Thesaurus Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
CL.39
Code List
Did the patient relapse or experience disease progression during the reporting period? (Required field)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
DiseaseProgressionDate
Item
date of relapse or progression (If yes,)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C25331 (NCI Thesaurus Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
Item Group
Ccrr Module For Anhl01p1: Reporting Period [reload]
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