ID

7368

Beschrijving

E2906 Baseline Data Form - Step 1 (Induction) Clofarabine or Daunorubicin Hydrochloride and Cytarabine Followed By Decitabine or Observation in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=7585B205-CA04-8BDD-E040-BB89AD430415

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=7585B205-CA04-8BDD-E040-BB89AD430415

Trefwoorden

Versies (3)
  1. 19-09-12 19-09-12 -
  2. 09-01-15 09-01-15 - Martin Dugas
  3. 20-09-21 20-09-21 -
Geüploaded op

9 januari 2015

DOI

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Licentie

Creative Commons BY-NC 3.0 Legacy
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Leukemia NCT01041703 Treatment - E2906 Baseline Data Form - Step 1 (Induction) - 2951887v1.0

Engels

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

1 Formulieren  
Header
Beschrijving

Header

DCI Name
Beschrijving

Generic drug form

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C3242750
NCI Thesaurus Property
C19464
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus ObjectClass-2
C25452
Registration Step (Place ID Label Here)
Beschrijving

Registration Number

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1514821
NCI Thesaurus ObjectClass
C25646
UMLS CUI-2
C0237753
NCI Thesaurus Property
C16154
NCI Thesaurus ValueDomain-2
C16154
Patient Initials (Last, First)
Beschrijving

Patient Initials

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
ECOG Protocol Number
Beschrijving

Protocol Number ECOG

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1512162
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25491
ECOG Protocol Number
Beschrijving

Protocol Number ECOG

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1512162
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25491
ECOG Patient ID
Beschrijving

Patient ID ECOG

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1512162
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25491
ECOG Patient ID
Beschrijving

Patient ID ECOG

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1512162
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25491
Participating Group Protocol Number
Beschrijving

Study Number Participating Group

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Participating Group Patient ID
Beschrijving

Trial subject ID Participating Group

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Institution/Affiliate
Beschrijving

Institution Name

Datatype

text

Alias
NCI Thesaurus ObjectClass
C25454
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass-2
C21541
NCI Thesaurus Property
C25364
NCI Thesaurus ValueDomain
C25191
NCI Thesaurus ValueDomain-2
C21541
On Treatment
Beschrijving

On Treatment

Reporting Period
Beschrijving

Clinical Trial Period

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C2347804
NCI Thesaurus ObjectClass
C25214
NCI Thesaurus Property
C25616
NCI Thesaurus ObjectClass-2
C25651
Unnamed2
Beschrijving

Unnamed2

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

Data amended

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Date data amended (s M D Y)
Beschrijving

Data amended date

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
UMLS CUI-2
C0011008
NCI Thesaurus Property
C25416
NCI Thesaurus ValueDomain-2
C25367
Patient Information
Beschrijving

Patient Information

Patient Height (cm)
Beschrijving

Patient Height

Datatype

float

Maateenheden
  • cm
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0489786
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25347
cm
Performance Status
Beschrijving

ECOG Performance Status

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS CUI-1
C1520224
NCI Thesaurus Property
C25367
NCI Thesaurus ValueDomain-2
C25491
NCI Thesaurus ObjectClass
C20641
Leukemia Classification
Beschrijving

Leukemia Classification

Date of Initial Pathologic Diagnosis (M D Y)
Beschrijving

CancerInitialDiagnosisDate

Datatype

date

Alias
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C25509
UMLS 2011AA Property
C1279901
NCI Thesaurus Property-2
C15220
UMLS 2011AA Property-2
C0011900
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
Leukemia Classification (Choose one)
Beschrijving

LeukemiaFrench-American-BritishClassificationCategory

Datatype

text

Alias
NCI Thesaurus ObjectClass
C3161
UMLS 2011AA ObjectClass
C0023418
NCI Thesaurus Property
C43854
UMLS 2011AA Property
C1556084
NCI Thesaurus Property-2
C25161
UMLS 2011AA Property-2
C0008902
NCI Metathesaurus Property
C0596227
NCI Metathesaurus Property-2
C0596070
NCI Thesaurus ValueDomain
C25372
UMLS 2011AA ValueDomain
C0683312
Other specify
Beschrijving

LeukemiaFrench-American-BritishClassificationSpecify

Datatype

text

Alias
NCI Thesaurus ObjectClass
C3161
UMLS 2011AA ObjectClass
C0023418
NCI Thesaurus Property
C43854
UMLS 2011AA Property
C1556084
NCI Thesaurus Property-2
C25161
UMLS 2011AA Property-2
C0008902
NCI Metathesaurus Property
C0596227
NCI Metathesaurus Property-2
C0596070
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Extramedullary Disease Involvement
Beschrijving

DiseaseExtramedullaryInvolvementSite

Datatype

text

Alias
NCI Thesaurus ValueDomain
C13717
UMLS 2011AA ValueDomain
C1515974
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property
C25548
UMLS 2011AA Property
C1314939
NCI Thesaurus Property-2
C25503
UMLS 2011AA Property-2
C1517060
Other specify
Beschrijving

DiseaseExtramedullaryInvolvementOtherSite

Datatype

text

Alias
NCI Thesaurus ValueDomain
C13717
UMLS 2011AA ValueDomain
C1515974
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property
C25548
UMLS 2011AA Property
C1314939
NCI Thesaurus Property-2
C25503
UMLS 2011AA Property-2
C1517060
Bone Marrow
Beschrijving

Bone Marrow

Date of Bone Marrow Biopsy (M D Y /aspirate)
Beschrijving

BoneMarrowBiopsyDate

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus Property
C15189
UMLS 2011AA Property
C0005558
NCI Thesaurus ObjectClass
C12431
UMLS 2011AA ObjectClass
C0005953
Marrow Blasts (%)
Beschrijving

Blasts, Bone Marrow

Datatype

float

Maateenheden
  • %
Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C1982687
NCI Thesaurus Property
C12431
NCI Thesaurus Property-2
C20200
NCI Thesaurus Property-3
C12918
NCI Thesaurus ValueDomain
C25613
NCI Thesaurus ValueDomain-2
C25712
%
Marrow Cellularity (%)
Beschrijving

Bone Marrow Cellularity

Datatype

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C1561532
NCI Thesaurus Property
C12431
NCI Thesaurus Property-2
C20200
NCI Thesaurus Property-3
C37923
NCI Thesaurus ValueDomain
C25613
NCI Thesaurus ValueDomain-2
C25712
Cellularity
Beschrijving

LaboratoryProcedureBoneMarrowCellularityOutcomeStatus

Datatype

text

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C12431
UMLS 2011AA Property
C0005953
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus Property-3
C37923
UMLS 2011AA Property-3
C1516377
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
Clinical Onset of AML
Beschrijving

ClinicalEtiologyAcuteMyeloidLeukemiaDiagnosisType

Datatype

text

Alias
NCI Thesaurus ObjectClass
C25398
UMLS 2011AA ObjectClass
C0205210
NCI Thesaurus ObjectClass-2
C16390
UMLS 2011AA ObjectClass-2
C1524003
NCI Thesaurus Property
C3171
UMLS 2011AA Property
C0023467
NCI Thesaurus Property-2
C15220
UMLS 2011AA Property-2
C0011900
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
If secondary, choose one
Beschrijving

AcuteMyeloidLeukemiaDiseaseSecondaryDiagnosisType

Datatype

text

Alias
NCI Thesaurus ObjectClass
C3171
UMLS 2011AA ObjectClass
C0023467
NCI Thesaurus ObjectClass-2
C2991
UMLS 2011AA ObjectClass-2
C0012634
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
NCI Thesaurus Property-2
C25667
UMLS 2011AA Property-2
C0175668
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Specify
Beschrijving

AcuteMyeloidLeukemiaDiseaseSecondaryDiagnosisSpecify

Datatype

text

Alias
NCI Thesaurus ObjectClass
C3171
UMLS 2011AA ObjectClass
C0023467
NCI Thesaurus ObjectClass-2
C2991
UMLS 2011AA ObjectClass-2
C0012634
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
NCI Thesaurus Property-2
C25667
UMLS 2011AA Property-2
C0175668
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Specify malignancy
Beschrijving

PriorCancerDiagnosisSpecify

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
Prior Treatment For This Disease
Beschrijving

Prior Treatment For This Disease

Prior chemotherapy for other malignancy
Beschrijving

PriorChemotherapyOtherAdministeredInd-2

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Specify name of chemotherapy regimen (If yes ex: RCHOP)
Beschrijving

PriorChemotherapyRegimenSpecify

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus Property
C15697
UMLS 2011AA Property
C0040808
Date Chemotherapy Ended (M D Y)
Beschrijving

ChemotherapyAdministeredEndDate

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Prior Radiation Therapy for other malignancy
Beschrijving

RadiationTherapyPriorMalignantNeoplasmAdministeredInd-2

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C15313
UMLS 2011AA ObjectClass
C1522449
NCI Thesaurus Property
C9305
UMLS 2011AA Property
C0006826
NCI Thesaurus Property-2
C25629
UMLS 2011AA Property-2
C0332152
NCI Thesaurus Property-3
C25382
UMLS 2011AA Property-3
C1521801
Radiation Therapy Total Dose (If yes cGy)
Beschrijving

Radiation Therapy Total Dose

Datatype

float

Alias
NCI Thesaurus ValueDomain
C25304
UMLS CUI-1
C2169193
NCI Thesaurus ObjectClass
C15313
NCI Thesaurus ValueDomain-2
C25488
NCI Thesaurus Property
C25382
Mark an 'X' if unknown
Beschrijving

DataUnknownText

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C17998
UMLS 2011AA Property
C0439673
Date RT ended (M D Y)
Beschrijving

Radiation Therapy End Date

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1522449
NCI Thesaurus ObjectClass
C15313
UMLS CUI-2
C0806020
NCI Thesaurus Property
C25275
NCI Thesaurus Property-2
C25496
Has the patient received prior treatment for newly diagnosed AML
Beschrijving

PriorCancerTreatmentInd-2

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus Property
C49236
UMLS 2011AA Property
C0087111
Has the patient received the following (If yes)
Beschrijving

Non-ProtocolTherapyAdministeredType

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C25590
UMLS 2011AA ObjectClass
C1518384
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Hematology/chemistry
Beschrijving

Hematology/chemistry

Absolute granulocyte count LLN (AGC/ANC)
Beschrijving

LaboratoryProcedureGranulocyteResultLowerLimitofNormalCount

Datatype

float

Maateenheden
  • mm3
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C12530
UMLS 2011AA Property-2
C0018183
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
NCI Thesaurus ValueDomain-2
C25555
UMLS 2011AA ValueDomain-2
C1518030
mm3
Absolute Granulocyte Count (AGC/ANC)
Beschrijving

LaboratoryProcedureGranulocyteResultTotalValue

Datatype

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C12530
UMLS 2011AA Property-2
C0018183
NCI Thesaurus ValueDomain
C25304
UMLS 2011AA ValueDomain
C0439810
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
Alkaline Phosphatase ULN (U/L)
Beschrijving

Alkaline Phosphatase ULN

Datatype

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0151420
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C16276
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25706
Alkaline Phosphatase (U/L)
Beschrijving

Alkaline Phosphatase

Datatype

float

Alias
NCI Thesaurus Property
C20200
UMLS CUI-1
C0201850
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus Property-2
C16276
Creatinine ULN (mg/dl)
Beschrijving

Creatinine, serum ULN

Datatype

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0201976
NCI Thesaurus Property
C20200
UMLS CUI-2
C1519815
NCI Thesaurus Property-2
C399
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25706
Creatinine (mg/dl)
Beschrijving

Creatinine, Serum

Datatype

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0201976
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C399
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus ValueDomain-2
C25712
Creatinine Clearance (ml/min)
Beschrijving

Creatinine Clearance

Datatype

float

Alias
NCI Thesaurus Property
C20200
UMLS CUI-1
C0373595
NCI Thesaurus Property-2
C25747
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25712
Hematocrit LLN (%)
Beschrijving

LaboratoryProcedureErythrocyteResultPercentageLowerLimitofNormalValue

Datatype

text

Maateenheden
  • %
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C12521
UMLS 2011AA Property
C0014792
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus ValueDomain
C25613
UMLS 2011AA ValueDomain
C0439165
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
NCI Thesaurus ValueDomain-3
C25555
UMLS 2011AA ValueDomain-3
C1518030
%
Hematocrit (%)
Beschrijving

LaboratoryProcedureHematocritOutcomePercentageValue

Datatype

float

Maateenheden
  • %
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C64796
UMLS 2011AA Property-2
C0018935
NCI Thesaurus ValueDomain
C25613
UMLS 2011AA ValueDomain
C0439165
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
%
Hemoglobin (g/dl), LLN (g/dl)
Beschrijving

Hemoglobin LLN

Datatype

float

Maateenheden
  • g/dL
Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0019046
NCI Thesaurus Property
C16676
UMLS CUI-2
C1518030
NCI Thesaurus Property-2
C20200
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C38024
NCI Thesaurus ValueDomain-3
C25555
g/dL
Hemoglobin (g/dl)
Beschrijving

Hemoglobin

Datatype

float

Alias
NCI Thesaurus Property
C16676
UMLS CUI-1
C0019046
NCI Thesaurus Property-2
C20200
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25712
LDH ULN (U/L)
Beschrijving

LDH ULN

Datatype

float

Maateenheden
  • 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
LDH (U/L)
Beschrijving

LaboratoryProcedureLactateDehydrogenaseResultUnspecifiedValue

Datatype

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C25184
UMLS 2011AA Property-2
C0022917
NCI Thesaurus ValueDomain
C38046
UMLS 2011AA ValueDomain
C0205370
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
Peripheral Blasts (%)
Beschrijving

LaboratoryProcedureBlastCellOutcomePercentageValue

Datatype

float

Maateenheden
  • %
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C12918
UMLS 2011AA Property-2
C0368761
NCI Thesaurus ValueDomain
C25613
UMLS 2011AA ValueDomain
C0439165
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
%
Platelets LLN (x1000)
Beschrijving

Platelets LLN

Datatype

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0005821
NCI Thesaurus Property
C20200
UMLS CUI-2
C1518030
NCI Thesaurus Property-2
C12520
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25555
Platelets (x1000)
Beschrijving

Platelets

Datatype

float

Maateenheden
  • 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
SGOT (AST) ULN (U/L)
Beschrijving

LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedUpperLimitofNormalValue

Datatype

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C25202
UMLS 2011AA Property
C0242192
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25706
UMLS 2011AA ValueDomain-2
C1519815
SGOT (AST) (U/L)
Beschrijving

SGOT (AST)

Datatype

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0201899
NCI Thesaurus Property
C25202
NCI Thesaurus Property-2
C20200
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus ValueDomain-2
C25712
SGPT (ALT) ULN (U/L)
Beschrijving

LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultUpperLimitofNormalValue

Datatype

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C25293
UMLS 2011AA Property-2
C0376147
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25706
UMLS 2011AA ValueDomain-2
C1519815
SGPT (ALT) (U/L)
Beschrijving

SGPT (ALT)

Datatype

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0201836
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C25293
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus ValueDomain-2
C25712
Total bilirubin ULN (mg/dl)
Beschrijving

Bilirubin, Total ULN

Datatype

float

Maateenheden
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0201913
NCI Thesaurus Property
C20200
UMLS CUI-2
C1519815
NCI Thesaurus Property-2
C38037
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C38024
NCI Thesaurus ValueDomain-3
C25706
mg/dL
Total Bilirubin (mg/dl)
Beschrijving

Bilirubin, Total

Datatype

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0201913
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C38037
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus ValueDomain-2
C25712
Uric Acid ULN (mg/dl)
Beschrijving

LaboratoryProcedureUricAcidResultUnspecifiedUpperLimitofNormalValue

Datatype

float

Maateenheden
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C62652
UMLS 2011AA Property-2
C0041980
NCI Thesaurus ValueDomain
C38046
UMLS 2011AA ValueDomain
C0205370
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
NCI Thesaurus ValueDomain-3
C25706
UMLS 2011AA ValueDomain-3
C1519815
mg/dL
Uric acid (mg/dl)
Beschrijving

LaboratoryProcedureUricAcidResultUnspecifiedValue

Datatype

float

Maateenheden
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C62652
UMLS 2011AA Property-2
C0041980
NCI Thesaurus ValueDomain
C38046
UMLS 2011AA ValueDomain
C0205370
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
mg/dL
WBC count (x1000), LLN (x1000)
Beschrijving

LaboratoryProcedureLeukocyteResultLowerLimitofNormalValue

Datatype

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C12529
UMLS 2011AA Property
C0023516
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25555
UMLS 2011AA ValueDomain-2
C1518030
WBC Count (x1000)
Beschrijving

Leukocytes (WBC)

Datatype

float

Maateenheden
  • 1000/uL
Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0023508
NCI Thesaurus Property
C12529
NCI Thesaurus Property-2
C20200
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C38024
1000/uL
Date Obtained (M D Y)
Beschrijving

SpecimenCollectedDate

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C19157
UMLS 2011AA ObjectClass
C0370003
NCI Thesaurus Property
C25452
NCI Thesaurus Property-2
C25275
UMLS 2011AA Property
C2745955
Pre-registration Evaluation
Beschrijving

Pre-registration Evaluation

Method of Evaluation (cardiac test)
Beschrijving

Evaluation method

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C2911685
NCI Thesaurus ObjectClass
C20989
NCI Thesaurus Property
C16847
Date of Assessment (M D Y)
Beschrijving

Assessment Date

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2985720
NCI Thesaurus ObjectClass
C25367
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus Property
C38000
Resting ejection fraction (% See Section 3.0 of protocol for ejection fraction requirements)
Beschrijving

HeartLVEFTestPercentageValue

Datatype

float

Maateenheden
  • %
Alias
NCI Thesaurus ObjectClass
C12727
UMLS 2011AA ObjectClass
C0018787
NCI Thesaurus Property
C25294
UMLS 2011AA Property
C0022885
NCI Thesaurus Property-2
C37946
UMLS 2011AA Property-2
C2700377
NCI Thesaurus ValueDomain
C25613
UMLS 2011AA ValueDomain
C0439165
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
%
LLN (%)
Beschrijving

HeartLVEFTestPercentageLowerLimitofNormalValue

Datatype

float

Maateenheden
  • %
Alias
NCI Thesaurus ObjectClass
C12727
UMLS 2011AA ObjectClass
C0018787
NCI Thesaurus Property
C25294
UMLS 2011AA Property
C0022885
NCI Thesaurus Property-2
C37946
UMLS 2011AA Property-2
C2700377
NCI Thesaurus ValueDomain
C25613
UMLS 2011AA ValueDomain
C0439165
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
NCI Thesaurus ValueDomain-3
C25555
UMLS 2011AA ValueDomain-3
C1518030
%
Were there any clinically significant abnormalities
Beschrijving

AbnormalElectrocardiographyAdverseEventPresentInd-3

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C25401
UMLS 2011AA ObjectClass
C0205161
NCI Thesaurus ObjectClass-2
C41331
UMLS 2011AA ObjectClass-2
C0877248
NCI Thesaurus ObjectClass-3
C38053
UMLS 2011AA ObjectClass-3
C1623258
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Specify
Beschrijving

AbnormalElectrocardiographyAdverseEventPresentSpecify

Datatype

text

Alias
NCI Thesaurus ObjectClass
C25401
UMLS 2011AA ObjectClass
C0205161
NCI Thesaurus ObjectClass-2
C41331
UMLS 2011AA ObjectClass-2
C0877248
NCI Thesaurus ObjectClass-3
C38053
UMLS 2011AA ObjectClass-3
C1623258
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Does the patient have a history of cardiovascular disease
Beschrijving

CardiovascularDiseasePresentInd-2

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C25292
UMLS 2011AA ObjectClass
C0007226
NCI Thesaurus ObjectClass-2
C2991
UMLS 2011AA ObjectClass-2
C0012634
Comorbidities
Beschrijving

Comorbidities

Arrhythmia
Beschrijving

ArrhythmiaHistoryInd-3

Datatype

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C2881
UMLS 2011AA ObjectClass
C0003811
NCI Thesaurus Property
C18772
UMLS 2011AA Property
C0262926
Cardiac
Beschrijving

PatientCardiovascularAbnormalityPersonalMedicalHistoryInd-3

Datatype

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C9440
UMLS 2011AA Property
C1704258
NCI Thesaurus Property-2
C18772
UMLS 2011AA Property-2
C0262926
NCI Metathesaurus Property
C0374861
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Heart valve disease
Beschrijving

PersonValvularHeartDisorderPersonalMedicalHistoryInd-3

Datatype

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C18772
UMLS 2011AA Property
C0262926
NCI Thesaurus Property-2
C45525
UMLS 2011AA Property-2
C0018824
Inflammatory bowel disease
Beschrijving

PatientInflammatoryBowelDiseasePersonalMedicalHistoryInd-3

Datatype

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C3138
UMLS 2011AA Property
C0021390
NCI Thesaurus Property-2
C18772
UMLS 2011AA Property-2
C0262926
Peptic ulcer disease
Beschrijving

DiseaseStomachPresentInd-3

Datatype

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus Property-2
C12391
UMLS 2011AA Property-2
C0038351
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
Diabetes (without complications)
Beschrijving

DiabetesMellitusHistoryInd-3

Datatype

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C2985
UMLS 2011AA ObjectClass
C0011849
NCI Thesaurus Property
C18772
UMLS 2011AA Property
C0262926
Cerebrovascular disease
Beschrijving

PatientCerebrovascularAccidentHistoryInd-3

Datatype

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C3390
UMLS 2011AA Property
C0038454
NCI Thesaurus Property-2
C18772
UMLS 2011AA Property-2
C0262926
Psychiatric disturbance
Beschrijving

PersonPsychiatricDisorderPersonalMedicalHistoryInd-3

Datatype

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C2893
UMLS 2011AA Property
C0004936
NCI Thesaurus Property-2
C18772
UMLS 2011AA Property-2
C0262926
Obesity
Beschrijving

ObesityPresentInd-3

Datatype

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C3283
UMLS 2011AA ObjectClass
C0028754
Infection
Beschrijving

ChronicDiseaseInfectionInd-3

Datatype

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property
C26726
UMLS 2011AA Property
C0009450
NCI Thesaurus ObjectClass-2
C14141
UMLS 2011AA ObjectClass-2
C0205191
Rheumatologic
Beschrijving

PersonRheumatologicDisorderPersonalMedicalHistoryInd-3

Datatype

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C18772
UMLS 2011AA Property
C0262926
NCI Thesaurus Property-2
C27204
UMLS 2011AA Property-2
C0009326
Moderate/severe renal
Beschrijving

RenalAbnormalityInd-3

Datatype

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
Prior solid tumor
Beschrijving

PersonPriorSolidNeoplasmPersonalMedicalHistoryInd-3

Datatype

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C3262
UMLS 2011AA Property
C0027651
NCI Thesaurus Property-2
C25629
UMLS 2011AA Property-2
C0332152
NCI Thesaurus Property-3
C45300
UMLS 2011AA Property-3
C0205208
NCI Thesaurus Property-4
C18772
UMLS 2011AA Property-4
C0262926
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Moderate pulmonary
Beschrijving

LungInvolvedInd-3

Datatype

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C12468
UMLS 2011AA ObjectClass
C0024109
NCI Thesaurus Property
C25547
Severe pulmonary
Beschrijving

ChronicDiseasePulmonaryInd-3

Datatype

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus ObjectClass-2
C14141
UMLS 2011AA ObjectClass-2
C0205191
NCI Metathesaurus Property
CL317978
Hepatic, mild
Beschrijving

HepaticSymptomInd-3

Datatype

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C13308
UMLS 2011AA ObjectClass
C0205054
NCI Thesaurus Property
C4876
UMLS 2011AA Property
C1457887
Moderate/severe hepatic
Beschrijving

PatientHepaticDiseasePersonalMedicalHistoryInd-3

Datatype

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C13308
UMLS 2011AA Property
C0205054
NCI Thesaurus Property-2
C2991
UMLS 2011AA Property-2
C0012634
NCI Thesaurus Property-3
C18772
UMLS 2011AA Property-3
C0262926
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Pre-registration Evaluation1
Beschrijving

Pre-registration Evaluation1

Does the patient have any chronic disease
Beschrijving

ChronicDiseasePresentInd-3

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus ObjectClass-2
C14141
UMLS 2011AA ObjectClass-2
C0205191
Does the patient have any concurrent malignancies
Beschrijving

PreviousCancerIdentifiedInd-2

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C25737
UMLS 2011AA Property
C0205396
Specify concurrent malignancy (If yes,)
Beschrijving

PriorMalignantNeoplasmSpecify

Datatype

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus ObjectClass-3
C14143
UMLS 2011AA ObjectClass-3
C0205282
NCI Metathesaurus Property
CL111053
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Therapy Type
Beschrijving

TherapyNameType

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C15368
Lumbar puncture done
Beschrijving

CerebrospinalFluidCellInd-3

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C12692
UMLS 2011AA ObjectClass
C0007806
NCI Thesaurus Property
C12508
UMLS 2011AA Property
C0007634
Hla Typing
Beschrijving

Hla Typing

Number of living siblings (potentially eligable to donate stem cells)
Beschrijving

PatientRelativeDescriptionTotalNumber

Datatype

float

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C21480
UMLS 2011AA Property
C0080103
NCI Thesaurus Property-2
C25365
UMLS 2011AA Property-2
C0678257
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ValueDomain-2
C25304
UMLS 2011AA ValueDomain-2
C0439810
Was HLA typing performed (of siblings)
Beschrijving

HLATypingOutcomeIndicator

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C71329
UMLS 2011AA ObjectClass
C0242318
Number tested (If 'Yes, some')
Beschrijving

HLATypingOutcomeTotalNumber

Datatype

float

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ValueDomain-2
C25304
UMLS 2011AA ValueDomain-2
C0439810
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C71329
UMLS 2011AA ObjectClass
C0242318
Baseline Abnormalities
Beschrijving

Baseline Abnormalities

CTC Adverse Event Term (include subterm if applicable)
Beschrijving

CommonTerminologyCriteriaforAdverseEventsVersion4.0LowLevelTermName

Datatype

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C49704
UMLS 2011AA Property
C1516728
NCI Thesaurus Property-2
C45559
UMLS 2011AA Property-2
C1705313
NCI Thesaurus ValueDomain
C45255
UMLS 2011AA ValueDomain
C1708523
NCI Thesaurus ValueDomain-2
C49704
UMLS 2011AA ValueDomain-2
C1516728
NCI Thesaurus ValueDomain-3
C42614
UMLS 2011AA ValueDomain-3
C0027365
NCI Thesaurus ValueDomain-4
C45559
UMLS 2011AA ValueDomain-4
C1705313
NCI Thesaurus ValueDomain-5
C25714
UMLS 2011AA ValueDomain-5
C0333052
CTC Adverse Event Grade
Beschrijving

AdverseEventSeverityGrade

Datatype

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C48309
UMLS 2011AA Property
C0441800
NCI Thesaurus Property-2
C49705
UMLS 2011AA Property-2
C1710065
NCI Thesaurus Property-3
C25676
UMLS 2011AA Property-3
C0439793
NCI Thesaurus ValueDomain
C41331
UMLS 2011AA ValueDomain
C0877248
NCI Thesaurus ValueDomain-2
C48309
UMLS 2011AA ValueDomain-2
C0441800
NCI Thesaurus ValueDomain-3
C25676
UMLS 2011AA ValueDomain-3
C0439793
Comments
Beschrijving

Comments

Investigator Signature
Beschrijving

Investigator Signature

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C2346576
NCI Thesaurus Property
C25678
NCI Thesaurus ObjectClass
C17089
Investigator Signature Date (M D Y)
Beschrijving

Investigator Signature Date

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2346576
NCI Thesaurus Property
C25678
UMLS CUI-2
C0011008
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C17089
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INSTRUCTIONS: Complete this form and submit original to the ECOG Coordinating Center within one week of patient's entry on Induction. Keep a copy for your files

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Header
Generic drug form
Item
DCI Name
text
C25191 (NCI Thesaurus ValueDomain)
C3242750 (UMLS CUI-1)
C19464 (NCI Thesaurus Property)
C25474 (NCI Thesaurus ObjectClass)
C25452 (NCI Thesaurus ObjectClass-2)
Registration Number
Item
Registration Step (Place ID Label Here)
text
C25337 (NCI Thesaurus ValueDomain)
C1514821 (UMLS CUI-1)
C25646 (NCI Thesaurus ObjectClass)
C0237753 (UMLS CUI-2)
C16154 (NCI Thesaurus Property)
C16154 (NCI Thesaurus ValueDomain-2)
Patient Initials
Item
Patient Initials (Last, First)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Protocol Number ECOG
Item
ECOG Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Protocol Number ECOG
Item
ECOG Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Patient ID ECOG
Item
ECOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Patient ID ECOG
Item
ECOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Study Number Participating Group
Item
Participating Group Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Trial subject ID Participating Group
Item
Participating Group Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Institution Name
Item
Institution/Affiliate
text
C25454 (NCI Thesaurus ObjectClass)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)
Item Group
On Treatment
Item
Reporting Period
text
C25284 (NCI Thesaurus ValueDomain)
C2347804 (UMLS CUI-1)
C25214 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C25651 (NCI Thesaurus ObjectClass-2)
CL.1
Code List
Reporting Period
CL Item
Baseline Step 1 (Baseline step 1)
Item Group
Unnamed2
Data amended
Item
Please mark an 'X' if data have been amended. (Please circle amended items in red)
text
C25704 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Data amended date
Item
Date data amended (s M D Y)
date
C25164 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C0011008 (UMLS CUI-2)
C25416 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)
Item Group
Patient Information
Patient Height
Item
Patient Height (cm)
float
C25209 (NCI Thesaurus ValueDomain)
C0489786 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25347 (NCI Thesaurus Property)
Item
Performance Status
text
C25664 (NCI Thesaurus ValueDomain)
C1520224 (UMLS CUI-1)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain-2)
C20641 (NCI Thesaurus ObjectClass)
CL.2
Code List
Performance Status
CL Item
Fully Active, Able To Carry On All Pre-disease Performance Without Restriction. (0)
CL Item
Restricted In Physically Strenuous Activity But Ambulatory And Able To Carry Out Work Of A Light Or Sedentary Nature, E.g., Light Housework, Office Work. (1)
CL Item
Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities. Up And About More Than 50% Of Waking Hours. (2)
CL Item
Capable Of Only Limited Selfcare, Confined To Bed Or Chair More Than 50% Of Waking Hours. (3)
CL Item
Completely Disabled. Cannot Carry On Any Selfcare. Totally Confined To Bed Or Chair. (4)
Item Group
Leukemia Classification
CancerInitialDiagnosisDate
Item
Date of Initial Pathologic Diagnosis (M D Y)
date
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property-2)
C0011900 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Item
Leukemia Classification (Choose one)
text
C3161 (NCI Thesaurus ObjectClass)
C0023418 (UMLS 2011AA ObjectClass)
C43854 (NCI Thesaurus Property)
C1556084 (UMLS 2011AA Property)
C25161 (NCI Thesaurus Property-2)
C0008902 (UMLS 2011AA Property-2)
C0596227 (NCI Metathesaurus Property)
C0596070 (NCI Metathesaurus Property-2)
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
CL.3
Code List
Leukemia Classification (Choose one)
CL Item
Disease Classified As Undifferentiated Acute Myeloid Leukemia (fab M0) (Undifferentiated acute myeloid leukemia (FAB M0))
CL Item
Disease Classified As Acute Myeloid Leukemia W/o Maturation (fab M1) (Acute myeloid leukemia w/o maturation (FAB M1))
CL Item
Disease Classified As Acute Myeloid Leukemia W/ Maturation (fab M2) (Acute myeloid leukemia w/ maturation (FAB M2))
CL Item
Disease Classified As Acute Promyelocytic Leukemia (fab M3) (Acute promyelocytic leukemia (FAB M3))
CL Item
Disease Classified As Acute Myelomonocytic Leukemia (fab M4) (Acute myelomonocytic leukemia (FAB M4))
CL Item
Disease Classified As Acute Monocytic Leukemia (fab M5) (Acute monocytic leukemia (FAB M5))
CL Item
Disease Classified As Acute Erythroblastic Leukemia (fab M6) (Acute erythroblastic leukemia (FAB M6))
CL Item
Disease Classified As Acute Megakaryoblastic Leukemia (fab M7) (Acute megakaryoblastic leukemia (FAB M7))
CL Item
Disease Classified As Aml, Not Otherwise Specified (nos) (AML, not otherwise specified (NOS))
CL Item
Disease Is An Unclassifiable Acute Leukemia (Unclassifiable acute leukemia)
CL Item
Disease Classified As Acute Undifferentiated Leukemia (aul) (Acute undifferentiated leukemia (AUL))
CL Item
Disease Is A Mixed Lineage Acute Leukemia (Mixed lineage acute leukemia)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
LeukemiaFrench-American-BritishClassificationSpecify
Item
Other specify
text
C3161 (NCI Thesaurus ObjectClass)
C0023418 (UMLS 2011AA ObjectClass)
C43854 (NCI Thesaurus Property)
C1556084 (UMLS 2011AA Property)
C25161 (NCI Thesaurus Property-2)
C0008902 (UMLS 2011AA Property-2)
C0596227 (NCI Metathesaurus Property)
C0596070 (NCI Metathesaurus Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Item
Extramedullary Disease Involvement
text
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25548 (NCI Thesaurus Property)
C1314939 (UMLS 2011AA Property)
C25503 (NCI Thesaurus Property-2)
C1517060 (UMLS 2011AA Property-2)
CL.4
Code List
Extramedullary Disease Involvement
CL Item
Central Nervous System (Central nervous system)
C12438 (NCI Thesaurus)
C0927232 (UMLS 2011AA)
CL Item
Peripheral Nervous System (Peripheral nervous system)
C12465 (NCI Thesaurus)
C0206417 (UMLS 2011AA)
CL Item
Gingival Hypertrophy (Gingival hypertrophy)
CL Item
Mediastinal Mass (Mediastinal mass)
CL Item
Leukaemia Cutis (Skin (leukemia cutis))
CL049753 (NCI Metathesaurus)
CL Item
Other Specify (Other)
DiseaseExtramedullaryInvolvementOtherSite
Item
Other specify
text
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25548 (NCI Thesaurus Property)
C1314939 (UMLS 2011AA Property)
C25503 (NCI Thesaurus Property-2)
C1517060 (UMLS 2011AA Property-2)
BoneMarrowBiopsyDate
Item
Date of Bone Marrow Biopsy (M D Y /aspirate)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C15189 (NCI Thesaurus Property)
C0005558 (UMLS 2011AA Property)
C12431 (NCI Thesaurus ObjectClass)
C0005953 (UMLS 2011AA ObjectClass)
Blasts, Bone Marrow
Item
Marrow Blasts (%)
float
C25294 (NCI Thesaurus ObjectClass)
C1982687 (UMLS CUI-1)
C12431 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C12918 (NCI Thesaurus Property-3)
C25613 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
Bone Marrow Cellularity
Item
Marrow Cellularity (%)
float
C25294 (NCI Thesaurus ObjectClass)
C1561532 (UMLS CUI-1)
C12431 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C37923 (NCI Thesaurus Property-3)
C25613 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
Item
Cellularity
text
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C12431 (NCI Thesaurus Property)
C0005953 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C37923 (NCI Thesaurus Property-3)
C1516377 (UMLS 2011AA Property-3)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
CL.5
Code List
Cellularity
CL Item
Very Hypocellular (Very hypocellular)
CL Item
Moderately Hypocellular (Moderately hypocellular)
CL Item
Cellularity Status Of Bone Marrow Is Normocellular (Normocellular)
CL Item
Cellularity Status Of Bone Marrow Is Hypercellular (Hypercellular)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Clinical Onset of AML
text
C25398 (NCI Thesaurus ObjectClass)
C0205210 (UMLS 2011AA ObjectClass)
C16390 (NCI Thesaurus ObjectClass-2)
C1524003 (UMLS 2011AA ObjectClass-2)
C3171 (NCI Thesaurus Property)
C0023467 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property-2)
C0011900 (UMLS 2011AA Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.6
Code List
Clinical Onset of AML
CL Item
Aml Without Prior Clinical History Of Mds Or Potentially Leukemogenic Treatment (de novo)
CL Item
Secondary (Secondary)
C25667 (NCI Thesaurus)
C0175668 (UMLS 2011AA)
Item
If secondary, choose one
text
C3171 (NCI Thesaurus ObjectClass)
C0023467 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus ObjectClass-2)
C0012634 (UMLS 2011AA ObjectClass-2)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C25667 (NCI Thesaurus Property-2)
C0175668 (UMLS 2011AA Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.7
Code List
If secondary, choose one
CL Item
Prior Hematologic Disorder (mds) (Prior hematologic disorder (MDS))
CL Item
Prior Hematologic Disorder (myeloproliferative Disorders) (Prior hematologic disorder (myeloproliferative disorders))
CL Item
Unexplained Cytopenia (Unexplained cytopenia)
CL Item
Prior Treatment For Other Malignancy (Prior treatment for other malignancy)
AcuteMyeloidLeukemiaDiseaseSecondaryDiagnosisSpecify
Item
Specify
text
C3171 (NCI Thesaurus ObjectClass)
C0023467 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus ObjectClass-2)
C0012634 (UMLS 2011AA ObjectClass-2)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C25667 (NCI Thesaurus Property-2)
C0175668 (UMLS 2011AA Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
PriorCancerDiagnosisSpecify
Item
Specify malignancy
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
Item Group
Prior Treatment For This Disease
PriorChemotherapyOtherAdministeredInd-2
Item
Prior chemotherapy for other malignancy
boolean
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PriorChemotherapyRegimenSpecify
Item
Specify name of chemotherapy regimen (If yes ex: RCHOP)
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C15697 (NCI Thesaurus Property)
C0040808 (UMLS 2011AA Property)
ChemotherapyAdministeredEndDate
Item
Date Chemotherapy Ended (M D Y)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
RadiationTherapyPriorMalignantNeoplasmAdministeredInd-2
Item
Prior Radiation Therapy for other malignancy
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus Property)
C0006826 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C25382 (NCI Thesaurus Property-3)
C1521801 (UMLS 2011AA Property-3)
Radiation Therapy Total Dose
Item
Radiation Therapy Total Dose (If yes cGy)
float
C25304 (NCI Thesaurus ValueDomain)
C2169193 (UMLS CUI-1)
C15313 (NCI Thesaurus ObjectClass)
C25488 (NCI Thesaurus ValueDomain-2)
C25382 (NCI Thesaurus Property)
DataUnknownText
Item
Mark an 'X' if unknown
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C17998 (NCI Thesaurus Property)
C0439673 (UMLS 2011AA Property)
Radiation Therapy End Date
Item
Date RT ended (M D Y)
date
C25164 (NCI Thesaurus ValueDomain)
C1522449 (UMLS CUI-1)
C15313 (NCI Thesaurus ObjectClass)
C0806020 (UMLS CUI-2)
C25275 (NCI Thesaurus Property)
C25496 (NCI Thesaurus Property-2)
PriorCancerTreatmentInd-2
Item
Has the patient received prior treatment for newly diagnosed AML
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C49236 (NCI Thesaurus Property)
C0087111 (UMLS 2011AA Property)
Item
Has the patient received the following (If yes)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
CL.11
Code List
Has the patient received the following (If yes)
CL Item
Hydroxyurea (Hydroxyurea)
C560 (NCI Thesaurus)
C0020402 (UMLS 2011AA)
CL Item
Leukopheresis (Leukopheresis)
Item Group
Hematology/chemistry
LaboratoryProcedureGranulocyteResultLowerLimitofNormalCount
Item
Absolute granulocyte count LLN (AGC/ANC)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12530 (NCI Thesaurus Property-2)
C0018183 (UMLS 2011AA Property-2)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C1518030 (UMLS 2011AA ValueDomain-2)
LaboratoryProcedureGranulocyteResultTotalValue
Item
Absolute Granulocyte Count (AGC/ANC)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12530 (NCI Thesaurus Property-2)
C0018183 (UMLS 2011AA Property-2)
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
Alkaline Phosphatase ULN
Item
Alkaline Phosphatase ULN (U/L)
float
C25294 (NCI Thesaurus ObjectClass)
C0151420 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C16276 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
Alkaline Phosphatase
Item
Alkaline Phosphatase (U/L)
float
C20200 (NCI Thesaurus Property)
C0201850 (UMLS CUI-1)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C16276 (NCI Thesaurus Property-2)
Creatinine, serum ULN
Item
Creatinine ULN (mg/dl)
float
C25294 (NCI Thesaurus ObjectClass)
C0201976 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C1519815 (UMLS CUI-2)
C399 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
Creatinine, Serum
Item
Creatinine (mg/dl)
float
C25294 (NCI Thesaurus ObjectClass)
C0201976 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C399 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
Creatinine Clearance
Item
Creatinine Clearance (ml/min)
float
C20200 (NCI Thesaurus Property)
C0373595 (UMLS CUI-1)
C25747 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
LaboratoryProcedureErythrocyteResultPercentageLowerLimitofNormalValue
Item
Hematocrit LLN (%)
text
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C12521 (NCI Thesaurus Property)
C0014792 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
C25555 (NCI Thesaurus ValueDomain-3)
C1518030 (UMLS 2011AA ValueDomain-3)
LaboratoryProcedureHematocritOutcomePercentageValue
Item
Hematocrit (%)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C64796 (NCI Thesaurus Property-2)
C0018935 (UMLS 2011AA Property-2)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
Hemoglobin LLN
Item
Hemoglobin (g/dl), LLN (g/dl)
float
C25294 (NCI Thesaurus ObjectClass)
C0019046 (UMLS CUI-1)
C16676 (NCI Thesaurus Property)
C1518030 (UMLS CUI-2)
C20200 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C38024 (NCI Thesaurus ValueDomain-2)
C25555 (NCI Thesaurus ValueDomain-3)
Hemoglobin
Item
Hemoglobin (g/dl)
float
C16676 (NCI Thesaurus Property)
C0019046 (UMLS CUI-1)
C20200 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
LDH ULN
Item
LDH ULN (U/L)
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)
LaboratoryProcedureLactateDehydrogenaseResultUnspecifiedValue
Item
LDH (U/L)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25184 (NCI Thesaurus Property-2)
C0022917 (UMLS 2011AA Property-2)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
LaboratoryProcedureBlastCellOutcomePercentageValue
Item
Peripheral Blasts (%)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12918 (NCI Thesaurus Property-2)
C0368761 (UMLS 2011AA Property-2)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
Platelets LLN
Item
Platelets LLN (x1000)
float
C25294 (NCI Thesaurus ObjectClass)
C0005821 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C1518030 (UMLS CUI-2)
C12520 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
Platelets
Item
Platelets (x1000)
float
C20200 (NCI Thesaurus Property)
C0005821 (UMLS CUI-1)
C12520 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedUpperLimitofNormalValue
Item
SGOT (AST) ULN (U/L)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)
SGOT (AST)
Item
SGOT (AST) (U/L)
float
C25294 (NCI Thesaurus ObjectClass)
C0201899 (UMLS CUI-1)
C25202 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultUpperLimitofNormalValue
Item
SGPT (ALT) ULN (U/L)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25293 (NCI Thesaurus Property-2)
C0376147 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)
SGPT (ALT)
Item
SGPT (ALT) (U/L)
float
C25294 (NCI Thesaurus ObjectClass)
C0201836 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C25293 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
Bilirubin, Total ULN
Item
Total bilirubin ULN (mg/dl)
float
C25294 (NCI Thesaurus ObjectClass)
C0201913 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C1519815 (UMLS CUI-2)
C38037 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C38024 (NCI Thesaurus ValueDomain-2)
C25706 (NCI Thesaurus ValueDomain-3)
Bilirubin, Total
Item
Total Bilirubin (mg/dl)
float
C25294 (NCI Thesaurus ObjectClass)
C0201913 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C38037 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
LaboratoryProcedureUricAcidResultUnspecifiedUpperLimitofNormalValue
Item
Uric Acid ULN (mg/dl)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C62652 (NCI Thesaurus Property-2)
C0041980 (UMLS 2011AA Property-2)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
C25706 (NCI Thesaurus ValueDomain-3)
C1519815 (UMLS 2011AA ValueDomain-3)
LaboratoryProcedureUricAcidResultUnspecifiedValue
Item
Uric acid (mg/dl)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C62652 (NCI Thesaurus Property-2)
C0041980 (UMLS 2011AA Property-2)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
LaboratoryProcedureLeukocyteResultLowerLimitofNormalValue
Item
WBC count (x1000), LLN (x1000)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C12529 (NCI Thesaurus Property)
C0023516 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C1518030 (UMLS 2011AA ValueDomain-2)
Leukocytes (WBC)
Item
WBC Count (x1000)
float
C25294 (NCI Thesaurus ObjectClass)
C0023508 (UMLS CUI-1)
C12529 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C38024 (NCI Thesaurus ValueDomain-2)
SpecimenCollectedDate
Item
Date Obtained (M D Y)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C25452 (NCI Thesaurus Property)
C25275 (NCI Thesaurus Property-2)
C2745955 (UMLS 2011AA Property)
Item Group
Pre-registration Evaluation
Item
Method of Evaluation (cardiac test)
text
C25284 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C16847 (NCI Thesaurus Property)
CL.12
Code List
Method of Evaluation (cardiac test)
CL Item
Muga Scan (MUGA scan)
CL Item
Echocardiogram (Echocardiogram)
C37945 (NCI Thesaurus)
C2243117 (UMLS 2011AA)
Assessment Date
Item
Date of Assessment (M D Y)
date
C25164 (NCI Thesaurus ValueDomain)
C2985720 (UMLS CUI-1)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C38000 (NCI Thesaurus Property)
HeartLVEFTestPercentageValue
Item
Resting ejection fraction (% See Section 3.0 of protocol for ejection fraction requirements)
float
C12727 (NCI Thesaurus ObjectClass)
C0018787 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C37946 (NCI Thesaurus Property-2)
C2700377 (UMLS 2011AA Property-2)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
HeartLVEFTestPercentageLowerLimitofNormalValue
Item
LLN (%)
float
C12727 (NCI Thesaurus ObjectClass)
C0018787 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C37946 (NCI Thesaurus Property-2)
C2700377 (UMLS 2011AA Property-2)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
C25555 (NCI Thesaurus ValueDomain-3)
C1518030 (UMLS 2011AA ValueDomain-3)
AbnormalElectrocardiographyAdverseEventPresentInd-3
Item
Were there any clinically significant abnormalities
boolean
C25401 (NCI Thesaurus ObjectClass)
C0205161 (UMLS 2011AA ObjectClass)
C41331 (NCI Thesaurus ObjectClass-2)
C0877248 (UMLS 2011AA ObjectClass-2)
C38053 (NCI Thesaurus ObjectClass-3)
C1623258 (UMLS 2011AA ObjectClass-3)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
AbnormalElectrocardiographyAdverseEventPresentSpecify
Item
Specify
text
C25401 (NCI Thesaurus ObjectClass)
C0205161 (UMLS 2011AA ObjectClass)
C41331 (NCI Thesaurus ObjectClass-2)
C0877248 (UMLS 2011AA ObjectClass-2)
C38053 (NCI Thesaurus ObjectClass-3)
C1623258 (UMLS 2011AA ObjectClass-3)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
CardiovascularDiseasePresentInd-2
Item
Does the patient have a history of cardiovascular disease
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C25292 (NCI Thesaurus ObjectClass)
C0007226 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus ObjectClass-2)
C0012634 (UMLS 2011AA ObjectClass-2)
Item Group
Comorbidities
Item
Arrhythmia
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C2881 (NCI Thesaurus ObjectClass)
C0003811 (UMLS 2011AA ObjectClass)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
CL.15
Code List
Arrhythmia
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Cardiac
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C9440 (NCI Thesaurus Property)
C1704258 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property-2)
C0262926 (UMLS 2011AA Property-2)
C0374861 (NCI Metathesaurus Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.16
Code List
Cardiac
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Heart valve disease
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
C45525 (NCI Thesaurus Property-2)
C0018824 (UMLS 2011AA Property-2)
CL.17
Code List
Heart valve disease
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Inflammatory bowel disease
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3138 (NCI Thesaurus Property)
C0021390 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property-2)
C0262926 (UMLS 2011AA Property-2)
CL.18
Code List
Inflammatory bowel disease
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Peptic ulcer disease
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C12391 (NCI Thesaurus Property-2)
C0038351 (UMLS 2011AA Property-2)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
CL.19
Code List
Peptic ulcer disease
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Diabetes (without complications)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C2985 (NCI Thesaurus ObjectClass)
C0011849 (UMLS 2011AA ObjectClass)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
CL.20
Code List
Diabetes (without complications)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Cerebrovascular disease
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3390 (NCI Thesaurus Property)
C0038454 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property-2)
C0262926 (UMLS 2011AA Property-2)
CL.21
Code List
Cerebrovascular disease
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Psychiatric disturbance
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C2893 (NCI Thesaurus Property)
C0004936 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property-2)
C0262926 (UMLS 2011AA Property-2)
CL.22
Code List
Psychiatric disturbance
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Obesity
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C3283 (NCI Thesaurus ObjectClass)
C0028754 (UMLS 2011AA ObjectClass)
CL.23
Code List
Obesity
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Infection
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C26726 (NCI Thesaurus Property)
C0009450 (UMLS 2011AA Property)
C14141 (NCI Thesaurus ObjectClass-2)
C0205191 (UMLS 2011AA ObjectClass-2)
CL.24
Code List
Infection
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Rheumatologic
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
C27204 (NCI Thesaurus Property-2)
C0009326 (UMLS 2011AA Property-2)
CL.25
Code List
Rheumatologic
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Moderate/severe renal
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
Moderate/severe renal
CL Item
No (NO)
CL Item
Unknown (UNKNOWN)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Yes (YES)
Item
Prior solid tumor
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C3262 (NCI Thesaurus Property)
C0027651 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C45300 (NCI Thesaurus Property-3)
C0205208 (UMLS 2011AA Property-3)
C18772 (NCI Thesaurus Property-4)
C0262926 (UMLS 2011AA Property-4)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.27
Code List
Prior solid tumor
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Moderate pulmonary
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12468 (NCI Thesaurus ObjectClass)
C0024109 (UMLS 2011AA ObjectClass)
C25547 (NCI Thesaurus Property)
CL.28
Code List
Moderate pulmonary
CL Item
No (NO)
CL Item
Unknown (UNKNOWN)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Yes (YES)
Item
Severe pulmonary
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C14141 (NCI Thesaurus ObjectClass-2)
C0205191 (UMLS 2011AA ObjectClass-2)
CL317978 (NCI Metathesaurus Property)
CL.29
Code List
Severe pulmonary
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Hepatic, mild
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C13308 (NCI Thesaurus ObjectClass)
C0205054 (UMLS 2011AA ObjectClass)
C4876 (NCI Thesaurus Property)
C1457887 (UMLS 2011AA Property)
CL.30
Code List
Hepatic, mild
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Moderate/severe hepatic
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C13308 (NCI Thesaurus Property)
C0205054 (UMLS 2011AA Property)
C2991 (NCI Thesaurus Property-2)
C0012634 (UMLS 2011AA Property-2)
C18772 (NCI Thesaurus Property-3)
C0262926 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.31
Code List
Moderate/severe hepatic
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Pre-registration Evaluation1
ChronicDiseasePresentInd-3
Item
Does the patient have any chronic disease
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C14141 (NCI Thesaurus ObjectClass-2)
C0205191 (UMLS 2011AA ObjectClass-2)
PreviousCancerIdentifiedInd-2
Item
Does the patient have any concurrent malignancies
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25737 (NCI Thesaurus Property)
C0205396 (UMLS 2011AA Property)
PriorMalignantNeoplasmSpecify
Item
Specify concurrent malignancy (If yes,)
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C14143 (NCI Thesaurus ObjectClass-3)
C0205282 (UMLS 2011AA ObjectClass-3)
CL111053 (NCI Metathesaurus Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Item
Therapy Type
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C15368 (NCI Thesaurus ObjectClass)
CL.34
Code List
Therapy Type
CL Item
Chemotherapy (Chemotherapy)
C15632 (NCI Thesaurus)
C0392920 (UMLS 2011AA)
CL Item
Radiation Therapy (Radiation therapy)
C15313 (NCI Thesaurus)
C1522449 (UMLS 2011AA)
CL Item
Surgery (Surgery)
C17173 (NCI Thesaurus)
C0038894 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CerebrospinalFluidCellInd-3
Item
Lumbar puncture done
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12692 (NCI Thesaurus ObjectClass)
C0007806 (UMLS 2011AA ObjectClass)
C12508 (NCI Thesaurus Property)
C0007634 (UMLS 2011AA Property)
Item Group
Hla Typing
PatientRelativeDescriptionTotalNumber
Item
Number of living siblings (potentially eligable to donate stem cells)
float
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C21480 (NCI Thesaurus Property)
C0080103 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property-2)
C0678257 (UMLS 2011AA Property-2)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25304 (NCI Thesaurus ValueDomain-2)
C0439810 (UMLS 2011AA ValueDomain-2)
Item
Was HLA typing performed (of siblings)
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C71329 (NCI Thesaurus ObjectClass)
C0242318 (UMLS 2011AA ObjectClass)
CL.36
Code List
Was HLA typing performed (of siblings)
CL Item
No, None (No, none)
CL Item
Yes, All (Yes, all)
CL Item
Yes, Some (Yes, some)
HLATypingOutcomeTotalNumber
Item
Number tested (If 'Yes, some')
float
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25304 (NCI Thesaurus ValueDomain-2)
C0439810 (UMLS 2011AA ValueDomain-2)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C71329 (NCI Thesaurus ObjectClass)
C0242318 (UMLS 2011AA ObjectClass)
Item Group
Baseline Abnormalities
CommonTerminologyCriteriaforAdverseEventsVersion4.0LowLevelTermName
Item
CTC Adverse Event Term (include subterm if applicable)
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C49704 (NCI Thesaurus Property)
C1516728 (UMLS 2011AA Property)
C45559 (NCI Thesaurus Property-2)
C1705313 (UMLS 2011AA Property-2)
C45255 (NCI Thesaurus ValueDomain)
C1708523 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ValueDomain-2)
C1516728 (UMLS 2011AA ValueDomain-2)
C42614 (NCI Thesaurus ValueDomain-3)
C0027365 (UMLS 2011AA ValueDomain-3)
C45559 (NCI Thesaurus ValueDomain-4)
C1705313 (UMLS 2011AA ValueDomain-4)
C25714 (NCI Thesaurus ValueDomain-5)
C0333052 (UMLS 2011AA ValueDomain-5)
Item
CTC Adverse Event Grade
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C48309 (NCI Thesaurus Property)
C0441800 (UMLS 2011AA Property)
C49705 (NCI Thesaurus Property-2)
C1710065 (UMLS 2011AA Property-2)
C25676 (NCI Thesaurus Property-3)
C0439793 (UMLS 2011AA Property-3)
C41331 (NCI Thesaurus ValueDomain)
C0877248 (UMLS 2011AA ValueDomain)
C48309 (NCI Thesaurus ValueDomain-2)
C0441800 (UMLS 2011AA ValueDomain-2)
C25676 (NCI Thesaurus ValueDomain-3)
C0439793 (UMLS 2011AA ValueDomain-3)
CL.37
Code List
CTC Adverse Event Grade
CL Item
Mild Adverse Event (1)
C84263 (NCI Thesaurus)
C1513302 (UMLS 2011AA)
CL Item
Moderate Adverse Event (2)
C84264 (NCI Thesaurus)
C1513374 (UMLS 2011AA)
CL Item
Severe Adverse Event (3)
C84265 (NCI Thesaurus)
C2919019 (UMLS 2011AA)
CL Item
Life Threatening Adverse Event (4)
C84266 (NCI Thesaurus)
C1517874 (UMLS 2011AA)
Item Group
Comments
Investigator Signature
Item
Investigator Signature
text
C25704 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
Investigator Signature Date
Item
Investigator Signature Date (M D Y)
date
C25164 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C25367 (NCI Thesaurus ValueDomain-2)
C17089 (NCI Thesaurus ObjectClass)
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