ID

10047

Descrição

ANHL01P1: Reporting Period Rituximab, Rasburicase, and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Advanced B-Cell Leukemia or Lymphoma NCT00057811 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

Palavras-chave

Versões (6)
  1. 27/08/2012 27/08/2012 -
  2. 08/01/2015 08/01/2015 - Martin Dugas
  3. 09/01/2015 09/01/2015 - Martin Dugas
  4. 09/01/2015 09/01/2015 - Martin Dugas
  5. 21/03/2015 21/03/2015 - Martin Dugas
  6. 20/09/2021 20/09/2021 -
Transferido a

21 de março de 2015

DOI

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Licença

Creative Commons BY-NC 3.0 Legacy
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Advanced B-Cell Leukemia or Lymphoma (NCT00057811)

Inglês

No Instruction available.

1 Formulários  
  1. StudyEvent: ANHL01P1: Reporting Period [reload]
    1. No Instruction available.
Header
Descrição

Header

Alias
UMLS CUI-1
C1320722
Institution
Descrição

Institution Name

Tipo de dados

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass
C21541
NCI Thesaurus ValueDomain-2
C21541
NCI Thesaurus Property
C25364
Study
Descrição

Protocol ID COG

Tipo de dados

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1516477
NCI Thesaurus Property
C25364
COG Number
Descrição

PatientCOGIdentifierNumber

Tipo de dados

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-2
C39353
UMLS 2011AA Property-2
C1516477
Patient Name
Descrição

Patient Name

Tipo de dados

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1299487
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25364
Today's date
Descrição

Form Completion Date

Tipo de dados

date

Alias
NCI Thesaurus ObjectClass
C19464
UMLS CUI-1
C1549507
NCI Thesaurus Property
C25250
NCI Thesaurus Property-2
C25604
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
Date entered into RDE
Descrição

DataEnteredDate

Tipo de dados

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

TreatmentReportingPeriodNumber

Tipo de dados

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-2
C25651
UMLS 2011AA Property-2
C0700287
Course Number
Descrição

TreatmentCurrentCourseNumber

Tipo de dados

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C15368
day number
Descrição

TreatmentDayCount

Tipo de dados

integer

Alias
NCI Thesaurus ValueDomain
C25301
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ValueDomain-2
C25463
UMLS CUI-1
C1547352
Reporting Period Start date (Required field)
Descrição

Reporting Period Start Date

Tipo de dados

date

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25616
UMLS CUI-1
C2361257
NCI Thesaurus Property-2
C25651
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25431
Reporting Period end date (Denote this field as "DT2")
Descrição

Reporting Period End Date

Tipo de dados

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2361259
NCI Thesaurus Property
C25616
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property-2
C25651
Patient characteristics
Descrição

Patient characteristics

Alias
UMLS CUI-1
C0815172
Patient's Height (in cm at beginning of Reporting Period)
Descrição

Patient's Height (in cm at beginning of Reporting Period)

Tipo de dados

float

Unidades de medida
  • cm
Alias
NCI Thesaurus ValueDomain
C25209
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25347
UMLS CUI-1
C0489786
cm
Patient's Weight (in kg at beginning of Reporting Period)
Descrição

Patient Weight

Tipo de dados

float

Unidades de medida
  • Kg
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0005910
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25208
Kg
Was the patient's disease status evaluated during this reporting period? (Required for reporting periods 1, 2, 3, 4)
Descrição

DiseaseExaminedDiseaseResponseInd-2

Tipo de dados

boolean

Alias
NCI Thesaurus ValueDomain
C38147
NCI Thesaurus Property
C25500
NCI Thesaurus ObjectClass
C2991
UMLS CUI-1
C1516048
COP Phase (Required only for Reduction Phase)
Descrição

LeukemiaDiseaseResponseType

Tipo de dados

text

Alias
NCI Thesaurus ValueDomain
C25284
NCI Thesaurus Property
C25755
NCI Thesaurus ObjectClass
C2991
NCI Thesaurus ObjectClass-2
C3161
UMLS CUI-1
C1704632
Did the patient have a bone marrow evaluation during this reporting period? (Required field)
Descrição

BoneMarrowEvaluationInd-3

Tipo de dados

boolean

Alias
NCI Thesaurus ValueDomain
C38148
NCI Thesaurus Property
C25214
NCI Thesaurus ObjectClass
C12431
UMLS CUI-1
C0005953
If bone marrow evaluation not done, specify reason (Required if above answer is not done)
Descrição

BoneMarrowNotEvaluationReason

Tipo de dados

text

Alias
NCI Thesaurus Property
C25214
NCI Thesaurus ObjectClass
C12431
what was the date of the exam? [bone marrow evaluation] (If yes,)
Descrição

BoneMarrowEvaluationDate

Tipo de dados

date

Alias
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus Property
C25214
NCI Thesaurus ObjectClass
C12431
UMLS CUI-1
C0005953
UMLS CUI-2
C0011008
does the patient have bone marrow involvement? (If yes,)
Descrição

BoneMarrowInvolvementInd-3

Tipo de dados

boolean

Alias
NCI Thesaurus ValueDomain
C38148
NCI Thesaurus ObjectClass
C12431
NCI Thesaurus Property
C25548
UMLS CUI-1
C1517677
percent (%) malignant blasts in bone marrow
Descrição

percent (%) malignant blasts in bone marrow

Tipo de dados

float

Unidades de medida
  • %
Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C12431
NCI Thesaurus Property-2
C20200
NCI Thesaurus Property-3
C12918
NCI Thesaurus ValueDomain
C25613
NCI Thesaurus ValueDomain-2
C25712
UMLS CUI-1
C1982687
%
CNS involvement
Descrição

CNS involvement

Alias
UMLS CUI-1
C0449389
Was patient's CNS status evaluated during this reporting period? (Required field)
Descrição

CNSEvaluationReportingInd-2

Tipo de dados

boolean

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')
Descrição

CNSInvolvedInd-3

Tipo de dados

boolean

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)
Descrição

CSFCellCountInd-3

Tipo de dados

boolean

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,)
Descrição

CSFCellCountDate

Tipo de dados

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)
Descrição

Leukocytes (WBC)

Tipo de dados

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0023508
NCI Thesaurus Property
C12529
NCI Thesaurus Property-2
C20200
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus ValueDomain-2
C25712
Number of red cells counted (Required if CNS involvement yes)
Descrição

LaboratoryProcedureErythrocyteResultSpecifiedValue

Tipo de dados

float

Unidades de medida
  • /ul
Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C12521
NCI Thesaurus Property-2
C20200
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C38024
UMLS CUI-1
C0014772
/ul
Blasts present in cytocentrifuge (Required if CNS involvement yes)
Descrição

HematologyBlastsLabValue

Tipo de dados

float

Alias
NCI Thesaurus Property
C20200
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0523113
total number of cells counted
Descrição

SpecimenCellCountTotalValue

Tipo de dados

float

Alias
NCI Thesaurus ObjectClass
C19157
NCI Thesaurus Property
C12508
NCI Thesaurus Property-2
C25256
NCI Thesaurus ValueDomain
C25304
NCI Thesaurus ValueDomain-2
C25712
UMLS CUI-1
C0427872
Diagnostics and treatment
Descrição

Diagnostics and treatment

was an Echocardiogram performed during this reporting period? (If Echocardiogram was not able to be performed prior to starting treatment,)
Descrição

EchocardiogramAssessmentPerformedReportingInd-2

Tipo de dados

boolean

Alias
NCI Thesaurus ValueDomain
C38147
NCI Thesaurus ObjectClass
C25367
NCI Thesaurus Property
C38000
UMLS CUI-1
C0013516
Imaging Studies Following Reporting Period (Required field)
Descrição

ReportingAssessmentMethodType

Tipo de dados

integer

Alias
NCI Thesaurus ObjectClass
C20989
NCI Thesaurus Property
C16847
UMLS CUI-1
C0011923
results of imaging studies
Descrição

AssessmentResultType

Tipo de dados

integer

Alias
NCI Thesaurus ValueDomain
C25284
NCI Thesaurus ObjectClass
C20989
NCI Thesaurus Property
C20200
UMLS CUI-1
C1287399
Is the patient off protocol therapy at the end of this reporting period? (Required field)
Descrição

PatientOff-treatmentInd-3

Tipo de dados

boolean

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,)
Descrição

Date Last Dose

Tipo de dados

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1762893
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25509
NCI Thesaurus Property-2
C25256
reason off protocol therapy (If yes,)
Descrição

Off Treatment Reason

Tipo de dados

text

Alias
NCI Thesaurus ObjectClass
C25601
UMLS CUI-1
C1518544
NCI Thesaurus Property
C25365
UMLS CUI-2
C0566251
was the patient switched to Sub-pilot Group C or pilot Group C, respectively? (If there was evidence of disease,)
Descrição

Treatment Modification

Tipo de dados

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C1299575
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25572
treatment assignment (If the treatment assignment is Group B Sub-Pilot or Group B Pilot)
Descrição

TreatmentAssignmentText

Tipo de dados

text

Alias
NCI Thesaurus ValueDomain
C25704
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25426
UMLS CUI-1
C1522541
Was there evidence of residual disease on diagnostic tests?
Descrição

ResidualDiseaseStatusType

Tipo de dados

integer

Alias
NCI Thesaurus ValueDomain
C25284
NCI Thesaurus ObjectClass
C2991
NCI Thesaurus ObjectClass-2
C37895
NCI Thesaurus Property
C25365
UMLS CUI-1
C0543478
was a biopsy performed? (If yes,)
Descrição

TumorBiopsyInd-3

Tipo de dados

boolean

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,)
Descrição

BiopsyResultType

Tipo de dados

text

Alias
NCI Thesaurus ObjectClass
C15189
NCI Thesaurus Property
C20200
UMLS CUI-1
C0005558
UMLS CUI-2
C1274040
Tumor lysis syndrome? (Required during reduction phase only)
Descrição

CTCAdverseEventLysisGrade

Tipo de dados

float

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Did renal dysfunction occur during the reduction phase? (Required for reduction phase only.)
Descrição

RenalAbnormalityInd-3

Tipo de dados

boolean

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
Maximal grade of renal dysfunction (Choose One)
Descrição

CTCAdverseEventRenalFailureGrade

Tipo de dados

float

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

RenalSupportAdministeredInd-2

Tipo de dados

boolean

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
type of renal support
Descrição

RenalSupportAdministeredType

Tipo de dados

integer

Alias
NCI Thesaurus ObjectClass
C37902
NCI Thesaurus Property
C25382
UMLS CUI-1
C0011946
please specify [type of renal support] (Text)
Descrição

RenalSupportAdministeredSpecify

Tipo de dados

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
agent name
Descrição

agent name

Tipo de dados

text

Alias
NCI Thesaurus Property
C25364
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus ValueDomain
C1708
NCI Thesaurus ValueDomain-2
C42614
UMLS CUI-1
C1521826
Was rasburicase utilized prior to Day 0 of the reduction phase? (Required only for Reduction Phase)
Descrição

AgentPriorAdministeredReportingInd-2

Tipo de dados

boolean

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,)
Descrição

number of days given prior to Day 0 (If yes,)

Tipo de dados

integer

Alias
NCI Thesaurus ValueDomain
C25301
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus Property
C25382
NCI Thesaurus ValueDomain-2
C25330
UMLS CUI-1
C0450442
UMLS CUI-2
C0449238
number of doses given prior to Day 0 (If yes,)
Descrição

AgentCourseCount

Tipo de dados

float

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
Did the patient receive rituximab in this cycle?
Descrição

Agent administered during reporting period

Tipo de dados

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS CUI-1
C0450442
NCI Thesaurus ObjectClass
C1708
UMLS CUI-2
C1521801
NCI Thesaurus Property
C25382
did the patient develop clinically significant Steven's Johnson syndrome? (If yes,)
Descrição

CTCAdverseEventStevens-JohnsonSyndromePresentInd-2

Tipo de dados

boolean

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)
Descrição

NewCancerDiagnosisInd-3

Tipo de dados

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C25586
UMLS 2011AA ObjectClass
C0205314
NCI Thesaurus ObjectClass-2
C9305
UMLS 2011AA ObjectClass-2
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.)
Descrição

NewCancerDiagnosisDate

Tipo de dados

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)
Descrição

Life status at end of this reporting period (Required field)

Tipo de dados

text

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus ValueDomain
C18003
NCI Thesaurus ValueDomain-2
C25688
NCI Thesaurus Property
C25365
UMLS CUI-1
C3846084
Was patient confirmed lost to follow-up at the end of this reporting period? (Required field)
Descrição

PatientLostFollow-upInd-2

Tipo de dados

boolean

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-2
C16033
UMLS 2011AA Property-2
C1522577
Was patient enrolled on another COG therapeutic study at the end of the reporting period? (Required field)
Descrição

PatientOtherEnrollmentInd-2

Tipo de dados

boolean

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.)
Descrição

PatientWithdrawFollow-upConsentInd-2

Tipo de dados

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C16033
UMLS 2011AA Property
C1522577
NCI Thesaurus Property-2
C25460
UMLS 2011AA Property-2
C1511481
NCI Thesaurus Property-3
C38061
UMLS 2011AA Property-3
C2349954
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Did the patient relapse or experience disease progression during the reporting period? (Required field)
Descrição

DiseaseProgressionInd-3

Tipo de dados

boolean

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,)
Descrição

DiseaseProgressionDate

Tipo de dados

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus Property
C25331
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
Lab values
Descrição

Lab values

Alias
UMLS CUI-1
C2346633
uric acid level, 4 Hours Post-Treatment
Descrição

RenalUricAcidLabSpecifiedValue

Tipo de dados

float

Unidades de medida
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25225
NCI Thesaurus Property
C37984
NCI Thesaurus ValueDomain
C25712
UMLS CUI-1
C0365228
mg/dL
Potassium
Descrição

LaboratoryProcedurePotassiumElectrolytesOutcomeSpecifiedValue

Tipo de dados

float

Unidades de medida
  • mmol/L
Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C464
NCI Thesaurus Property-3
C765
NCI Thesaurus ValueDomain
C25712
UMLS CUI-1
C0032821
mmol/L
Phosphate
Descrição

LaboratoryProcedurePhosphateMeasurementResultSpecifiedValue

Tipo de dados

float

Unidades de medida
  • mg/dL
Alias
NCI Thesaurus Property
C20200
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus Property-2
C64857
UMLS CUI-1
C0523826
mg/dL
Calcium
Descrição

ElectrolytesCalciumLabSpecifiedValue

Tipo de dados

float

Unidades de medida
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C331
NCI Thesaurus Property-2
C20200
NCI Thesaurus Property-3
C464
NCI Thesaurus ValueDomain
C25712
UMLS CUI-1
C0201925
mg/dL
BUN
Descrição

BUN

Tipo de dados

float

Unidades de medida
  • mg/dL
Alias
NCI Thesaurus Property
C20200
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property-2
C61019
NCI Thesaurus ValueDomain
C25712
UMLS CUI-1
C0005845
mg/dL
Creatinine
Descrição

RenalCreatinineLabSpecifiedValue

Tipo de dados

float

Unidades de medida
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25225
NCI Thesaurus Property
C399
NCI Thesaurus Property-2
C25294
NCI Thesaurus ValueDomain
C25712
UMLS CUI-1
C0201976
mg/dL
LDH (Required field)
Descrição

LDH

Tipo de dados

float

Unidades de medida
  • U/L
Alias
NCI Thesaurus Property
C20200
UMLS CUI-1
C0202113
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus Property-2
C25184
U/L
Institutional upper limits of normal for LDH (Required field)
Descrição

LDH ULN

Tipo de dados

float

Unidades de medida
  • U/L
Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0202113
NCI Thesaurus Property
C20200
UMLS CUI-2
C1519815
NCI Thesaurus Property-2
C25184
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C38024
NCI Thesaurus ValueDomain-3
C25706
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)
Descrição

ChemistryLDHLabElevatedValue

Tipo de dados

float

Alias
NCI Thesaurus Property
C37984
NCI Thesaurus ObjectClass
C16414
UMLS CUI-1
C0202113
UMLS CUI-2
C3163633
ANC
Descrição

LaboratoryProcedureNeutrophilResultSpecifiedValue

Tipo de dados

float

Unidades de medida
  • 1000/uL
Alias
NCI Thesaurus Property
C12533
NCI Thesaurus Property-2
C20200
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25712
UMLS CUI-1
C0948762
1000/uL
Platelets/uL (Required field)
Descrição

Platelets

Tipo de dados

float

Unidades de medida
  • 1000/uL
Alias
NCI Thesaurus Property
C20200
UMLS CUI-1
C0005821
NCI Thesaurus Property-2
C12520
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25712
1000/uL
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1 Formulários
  1. StudyEvent: ANHL01P1: Reporting Period [reload]
    1. No Instruction available.
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Header
C1320722 (UMLS CUI-1)
Institution Name
Item
Institution
text
C25191 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C21541 (NCI Thesaurus ValueDomain-2)
C25364 (NCI Thesaurus Property)
Protocol ID COG
Item
Study
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1516477 (UMLS CUI-2)
C25364 (NCI Thesaurus 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-2)
C1516477 (UMLS 2011AA Property-2)
Patient Name
Item
Patient Name
text
C25191 (NCI Thesaurus ValueDomain)
C1299487 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
Form Completion Date
Item
Today's date
date
C19464 (NCI Thesaurus ObjectClass)
C1549507 (UMLS CUI-1)
C25250 (NCI Thesaurus Property)
C25604 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
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
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-2)
C0700287 (UMLS 2011AA Property-2)
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)
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)
day number
Item
day number
integer
C25301 (NCI Thesaurus ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25463 (NCI Thesaurus ValueDomain-2)
C1547352 (UMLS CUI-1)
Reporting Period Start Date
Item
Reporting Period Start date (Required field)
date
C15368 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C2361257 (UMLS CUI-1)
C25651 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
Reporting Period End Date
Item
Reporting Period end date (Denote this field as "DT2")
date
C25164 (NCI Thesaurus ValueDomain)
C2361259 (UMLS CUI-1)
C25616 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)
C25651 (NCI Thesaurus Property-2)
Item Group
Patient characteristics
C0815172 (UMLS CUI-1)
Patient Height
Item
Patient's Height (in cm at beginning of Reporting Period)
float
C25209 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25347 (NCI Thesaurus Property)
C0489786 (UMLS CUI-1)
Patient Weight
Item
Patient's Weight (in kg at beginning of Reporting Period)
float
C25209 (NCI Thesaurus ValueDomain)
C0005910 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)
assessment
Item
Was the patient's disease status evaluated during this reporting period? (Required for reporting periods 1, 2, 3, 4)
boolean
C38147 (NCI Thesaurus ValueDomain)
C25500 (NCI Thesaurus Property)
C2991 (NCI Thesaurus ObjectClass)
C1516048 (UMLS CUI-1)
Item
COP Phase (Required only for Reduction Phase)
text
C25284 (NCI Thesaurus ValueDomain)
C25755 (NCI Thesaurus Property)
C2991 (NCI Thesaurus ObjectClass)
C3161 (NCI Thesaurus ObjectClass-2)
C1704632 (UMLS CUI-1)
CL.16
Code List
COP Phase (Required only for Reduction Phase)
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)
CL Item
20% tumor reduction (>)
Bone marrow
Item
Did the patient have a bone marrow evaluation during this reporting period? (Required field)
boolean
C38148 (NCI Thesaurus ValueDomain)
C25214 (NCI Thesaurus Property)
C12431 (NCI Thesaurus ObjectClass)
C0005953 (UMLS CUI-1)
Reason no bone marrow
Item
If bone marrow evaluation not done, specify reason (Required if above answer is not done)
text
C25214 (NCI Thesaurus Property)
C12431 (NCI Thesaurus ObjectClass)
Bone marrow date
Item
what was the date of the exam? [bone marrow evaluation] (If yes,)
date
C25164 (NCI Thesaurus ValueDomain)
C25214 (NCI Thesaurus Property)
C12431 (NCI Thesaurus ObjectClass)
C0005953 (UMLS CUI-1)
C0011008 (UMLS CUI-2)
Bone Marrow Involvement
Item
does the patient have bone marrow involvement? (If yes,)
boolean
C38148 (NCI Thesaurus ValueDomain)
C12431 (NCI Thesaurus ObjectClass)
C25548 (NCI Thesaurus Property)
C1517677 (UMLS CUI-1)
Blasts, Bone Marrow
Item
percent (%) malignant blasts in bone marrow
float
C25294 (NCI Thesaurus ObjectClass)
C12431 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C12918 (NCI Thesaurus Property-3)
C25613 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1982687 (UMLS CUI-1)
Item Group
CNS involvement
C0449389 (UMLS CUI-1)
CNSEvaluationReportingInd-2
Item
Was patient's CNS status evaluated during this reporting period? (Required field)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C12438 (NCI Thesaurus ObjectClass)
C0927232 (UMLS 2011AA ObjectClass)
CNSInvolvedInd-3
Item
Does patient have CNS involvement? (Required if above answer is 'yes')
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12438 (NCI Thesaurus ObjectClass)
C0927232 (UMLS 2011AA ObjectClass)
C25547 (NCI Thesaurus Property)
CSFCellCountInd-3
Item
Was cerebrospinal fluid cell count done? (Required if CNS involvement yes)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25256 (NCI Thesaurus Property)
C1265611 (UMLS 2011AA Property)
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)
Leukocytes (WBC)
Item
Number of white cells counted (Required if CNS involvement yes)
float
C25294 (NCI Thesaurus ObjectClass)
C0023508 (UMLS CUI-1)
C12529 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
Erythrocyte
Item
Number of red cells counted (Required if CNS involvement yes)
float
C25294 (NCI Thesaurus ObjectClass)
C12521 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C38024 (NCI Thesaurus ValueDomain-2)
C0014772 (UMLS CUI-1)
Blasts
Item
Blasts present in cytocentrifuge (Required if CNS involvement yes)
float
C20200 (NCI Thesaurus Property)
C25294 (NCI Thesaurus ObjectClass)
C0523113 (UMLS CUI-1)
Total number of cells
Item
total number of cells counted
float
C19157 (NCI Thesaurus ObjectClass)
C12508 (NCI Thesaurus Property)
C25256 (NCI Thesaurus Property-2)
C25304 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C0427872 (UMLS CUI-1)
Item Group
Diagnostics and treatment
Echocardiogram
Item
was an Echocardiogram performed during this reporting period? (If Echocardiogram was not able to be performed prior to starting treatment,)
boolean
C38147 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ObjectClass)
C38000 (NCI Thesaurus Property)
C0013516 (UMLS CUI-1)
Item
Imaging Studies Following Reporting Period (Required field)
integer
C20989 (NCI Thesaurus ObjectClass)
C16847 (NCI Thesaurus Property)
C0011923 (UMLS CUI-1)
CL.12
Code List
Imaging Studies Following Reporting Period (Required field)
CL Item
Chest X-ray (1)
C0039985 (UMLS CUI-1)
CL Item
Abdominal Ultrasound (2)
C2348813 (UMLS CUI-1)
CL Item
Abdominal CT or MRI (3)
CL Item
Bone Scan (4)
C0203668 (UMLS CUI-1)
CL Item
PET Scan (5)
C0032743 (UMLS CUI-1)
CL Item
Gallium Scan (6)
C0521316 (UMLS CUI-1)
CL Item
Head or spine CT or MRI (7)
CL Item
Testicular ultrasound (8)
Item
results of imaging studies
integer
C25284 (NCI Thesaurus ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C1287399 (UMLS CUI-1)
CL.13
Code List
results of imaging studies
CL Item
Evidence of disease (1)
C0332120 (UMLS CUI-1)
CL Item
No evidence of disease (2)
C1518340 (UMLS CUI-1)
CL Item
Equivocal (3)
C0332241 (UMLS CUI-1)
CL Item
Not done (4)
C1272696 (UMLS CUI-1)
PatientOff-treatmentInd-3
Item
Is the patient off protocol therapy at the end of this reporting period? (Required field)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25601 (NCI Thesaurus Property)
C1518544 (UMLS 2011AA Property)
Date Last Dose
Item
date last drug or other protocol defined treatment was received (If yes,)
date
C25164 (NCI Thesaurus ValueDomain)
C1762893 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25509 (NCI Thesaurus Property)
C25256 (NCI Thesaurus Property-2)
Item
reason off protocol therapy (If yes,)
text
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS CUI-1)
C25365 (NCI Thesaurus Property)
C0566251 (UMLS CUI-2)
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)
Treatment Modification
Item
was the patient switched to Sub-pilot Group C or pilot Group C, respectively? (If there was evidence of disease,)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1299575 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25572 (NCI Thesaurus Property)
Item
treatment assignment (If the treatment assignment is Group B Sub-Pilot or Group B Pilot)
text
C25704 (NCI Thesaurus ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25426 (NCI Thesaurus Property)
C1522541 (UMLS CUI-1)
CL.19
Code List
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?
integer
C25284 (NCI Thesaurus ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C37895 (NCI Thesaurus ObjectClass-2)
C25365 (NCI Thesaurus Property)
C0543478 (UMLS CUI-1)
CL.20
Code List
Was there evidence of residual disease on diagnostic tests?
CL Item
Yes (1)
C1705108 (UMLS CUI-1)
CL Item
No (2)
C1298908 (UMLS CUI-1)
CL Item
Gross Disease (3)
C0267604 (UMLS CUI-1)
CL Item
Microscopic Disease (4)
C0278939 (UMLS CUI-1)
CL Item
Unknown/not Documented (5)
C0439673 (UMLS CUI-1)
TumorBiopsyInd-3
Item
was a biopsy performed? (If yes,)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C15189 (NCI Thesaurus Property)
C0005558 (UMLS 2011AA Property)
Item
what were the results? (If yes,)
text
C15189 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C0005558 (UMLS CUI-1)
C1274040 (UMLS CUI-2)
CL.13
Code List
what were the results? (If yes,)
CL Item
Evidence of disease (1)
C0332120 (UMLS CUI-1)
CL Item
No evidence of disease (2)
C1518340 (UMLS CUI-1)
CL Item
Equivocal (3)
C0332241 (UMLS CUI-1)
CL Item
Not done (4)
C1272696 (UMLS CUI-1)
CTCAdverseEventLysisGrade
Item
Tumor lysis syndrome? (Required during reduction phase only)
float
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
RenalAbnormalityInd-3
Item
Did renal dysfunction occur during the reduction phase? (Required for reduction phase only.)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25225 (NCI Thesaurus ObjectClass)
C0022646 (UMLS 2011AA ObjectClass)
C9440 (NCI Thesaurus Property)
C1704258 (UMLS 2011AA Property)
CTCAdverseEventRenalFailureGrade
Item
Maximal grade of renal dysfunction (Choose One)
float
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
RenalSupportAdministeredInd-2
Item
Was there assisted renal support?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C37902 (NCI Thesaurus ObjectClass)
C1521721 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Item
type of renal support
integer
C37902 (NCI Thesaurus ObjectClass)
C25382 (NCI Thesaurus Property)
C0011946 (UMLS CUI-1)
CL.29
Code List
type of renal support
CL Item
Hemodialysis (1)
C0019004 (UMLS CUI-1)
CL Item
Peritoneal dialysis (2)
C0031139 (UMLS CUI-1)
CL Item
CVVH (3)
C0472684 (UMLS CUI-1)
CL Item
CVAH (4)
C0007474 (UMLS CUI-1)
CL Item
Other, Specify (5)
C3844311 (UMLS CUI-1)
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)
Agent
Item
agent name
text
C25364 (NCI Thesaurus Property)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
C1521826 (UMLS CUI-1)
AgentPriorAdministeredReportingInd-2
Item
Was rasburicase utilized prior to Day 0 of the reduction phase? (Required only for Reduction Phase)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
AgentAdministeredDayDuration
Item
number of days given prior to Day 0 (If yes,)
integer
C25301 (NCI Thesaurus ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C25382 (NCI Thesaurus Property)
C25330 (NCI Thesaurus ValueDomain-2)
C0450442 (UMLS CUI-1)
C0449238 (UMLS CUI-2)
AgentCourseCount
Item
number of doses given prior to Day 0 (If yes,)
float
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
Agent administered during reporting period
Item
Did the patient receive rituximab in this cycle?
boolean
C38147 (NCI Thesaurus ValueDomain)
C0450442 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1521801 (UMLS CUI-2)
C25382 (NCI Thesaurus Property)
CTCAdverseEventStevens-JohnsonSyndromePresentInd-2
Item
did the patient develop clinically significant Steven's Johnson syndrome? (If yes,)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
NewCancerDiagnosisInd-3
Item
Did a second malignant neoplasm (SMN) occur during this Reporting Period? (Required field)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
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)
C18003 (NCI Thesaurus ValueDomain)
C25688 (NCI Thesaurus ValueDomain-2)
C25365 (NCI Thesaurus Property)
C3846084 (UMLS CUI-1)
CL.35
Code List
Life status at end of this reporting period (Required field)
CL Item
Alive (Alive)
C2584946 (UMLS CUI-1)
CL Item
Dead (Dead)
C0011065 (UMLS CUI-1)
PatientLostFollow-upInd-2
Item
Was patient confirmed lost to follow-up at the end of this reporting period? (Required field)
boolean
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-2)
C1522577 (UMLS 2011AA Property-2)
PatientOtherEnrollmentInd-2
Item
Was patient enrolled on another COG therapeutic study at the end of the reporting period? (Required field)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
PatientWithdrawFollow-upConsentInd-2
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.)
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C16033 (NCI Thesaurus Property)
C1522577 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property-2)
C1511481 (UMLS 2011AA Property-2)
C38061 (NCI Thesaurus Property-3)
C2349954 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
DiseaseProgressionInd-3
Item
Did the patient relapse or experience disease progression during the reporting period? (Required field)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25331 (NCI Thesaurus Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
DiseaseProgressionDate
Item
date of relapse or progression (If yes,)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C25331 (NCI Thesaurus Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
Item Group
Lab values
C2346633 (UMLS CUI-1)
uric acid
Item
uric acid level, 4 Hours Post-Treatment
float
C25225 (NCI Thesaurus ObjectClass)
C37984 (NCI Thesaurus Property)
C25712 (NCI Thesaurus ValueDomain)
C0365228 (UMLS CUI-1)
Potassium
Item
Potassium
float
C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C464 (NCI Thesaurus Property-2)
C765 (NCI Thesaurus Property-3)
C25712 (NCI Thesaurus ValueDomain)
C0032821 (UMLS CUI-1)
Phosphate
Item
Phosphate
float
C20200 (NCI Thesaurus Property)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C64857 (NCI Thesaurus Property-2)
C0523826 (UMLS CUI-1)
Calcium
Item
Calcium
float
C25294 (NCI Thesaurus ObjectClass)
C331 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C464 (NCI Thesaurus Property-3)
C25712 (NCI Thesaurus ValueDomain)
C0201925 (UMLS CUI-1)
Blood Urea Nitrogen
Item
BUN
float
C20200 (NCI Thesaurus Property)
C25294 (NCI Thesaurus ObjectClass)
C61019 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C0005845 (UMLS CUI-1)
Creatinine
Item
Creatinine
float
C25225 (NCI Thesaurus ObjectClass)
C399 (NCI Thesaurus Property)
C25294 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C0201976 (UMLS CUI-1)
LDH
Item
LDH (Required field)
float
C20200 (NCI Thesaurus Property)
C0202113 (UMLS CUI-1)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C25184 (NCI Thesaurus Property-2)
LDH ULN
Item
Institutional upper limits of normal for LDH (Required field)
float
C25294 (NCI Thesaurus ObjectClass)
C0202113 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C1519815 (UMLS CUI-2)
C25184 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C38024 (NCI Thesaurus ValueDomain-2)
C25706 (NCI Thesaurus ValueDomain-3)
LDH elevated
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)
float
C37984 (NCI Thesaurus Property)
C16414 (NCI Thesaurus ObjectClass)
C0202113 (UMLS CUI-1)
C3163633 (UMLS CUI-2)
ANC
Item
ANC
float
C12533 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C0948762 (UMLS CUI-1)
Platelets
Item
Platelets/uL (Required field)
float
C20200 (NCI Thesaurus Property)
C0005821 (UMLS CUI-1)
C12520 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
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