ID

43318

Beskrivning

E2905 Baseline Step 1 Disease Evaluation Form NCT00843882 Lenalidomide With or Without Epoetin Alfa in Treating Patients With Myelodysplastic Syndrome and Anemia Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=0EAB4E64-72BE-45B3-E044-0003BA3F9857

Länk

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=0EAB4E64-72BE-45B3-E044-0003BA3F9857

Nyckelord

Versioner (5)
  1. 2014-12-18 2014-12-18 - Martin Dugas
  2. 2015-01-08 2015-01-08 - Martin Dugas
  3. 2015-01-09 2015-01-09 - Martin Dugas
  4. 2015-06-16 2015-06-16 -
  5. 2021-09-20 2021-09-20 -
Uppladdad den

20 september 2021

DOI

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Licens

Creative Commons BY-NC 3.0 Legacy
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E2905 Baseline Step 1 Disease Evaluation Form NCT00843882

Engelsk

INSTRUCTIONS: Complete this form and submit original to the ECOG Coordinating Center within one week of registration. Keep a copy for your files

1 Formulär  
Header
Beskrivning

Header

ECOG Protocol Number
Beskrivning

Protocol Number ECOG

Datatyp

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
Beskrivning

Patient ID ECOG

Datatyp

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
DCI Name
Beskrivning

Generic drug form

Datatyp

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
Beskrivning

Registration Number

Datatyp

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
Report period
Beskrivning

Cycle number

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C2045829
NCI Thesaurus Property
C25214
NCI Thesaurus Property-2
C25616
NCI Thesaurus ObjectClass
C15368
Patient demographics
Beskrivning

Patient demographics

Patient Initials (Last, First)
Beskrivning

Patient Initials

Datatyp

text

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

Protocol Number ECOG

Datatyp

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
Beskrivning

Patient ID ECOG

Datatyp

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
Beskrivning

Study Number Participating Group

Datatyp

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
Beskrivning

Trial subject ID Participating Group

Datatyp

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
Beskrivning

Institution Name

Datatyp

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
Data amendment
Beskrivning

Data amendment

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

Data amended

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Date data amended (MM/DD/YYYY)
Beskrivning

Data amended date

Datatyp

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
Pre-registration Hematology/chemistry
Beskrivning

Pre-registration Hematology/chemistry

Hemoglobin (Hgb) (g/dl), LLN
Beskrivning

Hemoglobin LLN

Datatyp

float

Måttenheter
  • 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 (Hgbg/dl)
Beskrivning

LaboratoryProcedureHemoglobinResultSpecifiedValue

Datatyp

float

Måttenheter
  • g/dL
Alias
NCI Thesaurus Property
C16676
UMLS 2011AA Property
C0019046
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
g/dL
Date (MM/DD/YYYY)
Beskrivning

LaboratoryProcedureHemoglobinResultDate

Datatyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C16676
UMLS 2011AA Property
C0019046
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
Peripheral platelet count, LLN (/mm^3x1000)
Beskrivning

Platelets LLN

Datatyp

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
Peripheral Platelet Count (/mm^3x1000)
Beskrivning

Platelets

Datatyp

float

Måttenheter
  • 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
Date (MM/DD/YYYY)
Beskrivning

Platelets date

Datatyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0005821
NCI Thesaurus Property
C20200
UMLS CUI-2
C0011008
NCI Thesaurus Property-2
C12520
NCI Thesaurus ObjectClass
C25294
Peripheral Granulocytes Count LLN (AGC/ANC/mm^3)
Beskrivning

LaboratoryProcedureGranulocyteResultLowerLimitofNormalCount

Datatyp

float

Måttenheter
  • 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
Peripheral Granulocytes Count (AGC/ANC/mm^3 - Do not report % granulocytes: report absolute count without decimal.)
Beskrivning

Granulocyte count

Datatyp

float

Måttenheter
  • 1000/uL
Alias
NCI Thesaurus Property
C20200
UMLS CUI-1
C0857490
NCI Thesaurus Property-2
C12530
NCI Thesaurus ValueDomain
C25463
NCI Thesaurus ObjectClass
C25294
1000/uL
Date
Beskrivning

LaboratoryProcedureNeutrophilResultDate

Datatyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C12533
UMLS 2011AA Property
C0027950
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
Peripheral WBC Count (/mm^3 x 1000)
Beskrivning

LaboratoryProcedureLeukocyteResultSpecifiedValue

Datatyp

float

Måttenheter
  • 1000/uL
Alias
NCI Thesaurus Property
C12529
UMLS 2011AA Property
C0023516
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C38024
UMLS 2011AA ValueDomain-2
C0205369
1000/uL
Peripheral WBC count, LLN
Beskrivning

LaboratoryProcedureLeukocyteResultLowerLimitofNormalValue

Datatyp

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
Date
Beskrivning

LaboratoryProcedureLeukocyteResultDate

Datatyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C12529
UMLS 2011AA Property
C0023516
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
Creatinine
Beskrivning

Creatinine, Serum

Datatyp

float

Måttenheter
  • mg/dL
Alias
NCI Thesaurus Property
C20200
UMLS CUI-1
C0201976
NCI Thesaurus Property-2
C399
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25712
mg/dL
Creatinine ULN (mg/dl)
Beskrivning

Creatinine, serum ULN

Datatyp

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
Date
Beskrivning

Laboratory Procedure Date

Datatyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0022885
NCI Thesaurus Property
C25214
UMLS CUI-2
C0011008
NCI Thesaurus Property-2
C38000
NCI Thesaurus ObjectClass
C25294
Mean pre-transfusion hemoglobin
Beskrivning

LaboratoryProcedureHemoglobinPriorBloodTransfusionOutcomeUnspecifiedValue

Datatyp

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C16676
UMLS 2011AA Property
C0019046
NCI Thesaurus Property-2
C25629
UMLS 2011AA Property-2
C0332152
NCI Thesaurus Property-3
C20200
UMLS 2011AA Property-3
C1274040
NCI Thesaurus Property-4
C15192
UMLS 2011AA Property-4
C0005841
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
Leukemia Assessment
Beskrivning

Leukemia Assessment

MDS classification
Beskrivning

MyelodysplasticSyndromeWorldHealthOrganizationClassificationCategory

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25372
UMLS 2011AA ValueDomain
C0683312
NCI Thesaurus ObjectClass
C3247
UMLS 2011AA ObjectClass
C3463824
NCI Thesaurus Property
C25161
UMLS 2011AA Property
C0008902
NCI Thesaurus Property-2
C75419
UMLS 2011AA Property-2
C0043237
Date of Initial Pathologic Diagnosis
Beskrivning

CancerInitialDiagnosisDate

Datatyp

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
Date of Bone Marrow Biopsy (Aspirate)
Beskrivning

BoneMarrowBiopsyDate

Datatyp

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 (%) (Highest)
Beskrivning

Blasts, Bone Marrow

Datatyp

float

Måttenheter
  • %
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 (%)
Beskrivning

Bone Marrow Cellularity

Datatyp

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
Reason bone marrow cellularity was not recorded
Beskrivning

LaboratoryProcedureBoneMarrowCellularityNegationReportOutcomeReason

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C25594
UMLS 2011AA Property
C1518422
NCI Thesaurus Property-2
C12431
UMLS 2011AA Property-2
C0005953
NCI Thesaurus Property-3
C25375
UMLS 2011AA Property-3
C0684224
NCI Thesaurus Property-4
C20200
UMLS 2011AA Property-4
C1274040
NCI Thesaurus Property-5
C37923
UMLS 2011AA Property-5
C1516377
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
Dysplasia
Beskrivning

DysplasiaPresentInd-3

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C4086
UMLS 2011AA ObjectClass
C0334044
Specify type (mark all that apply)
Beskrivning

DysplasiaHistologyType

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C16681
UMLS 2011AA Property
C0019638
NCI Thesaurus ObjectClass
C4086
UMLS 2011AA ObjectClass
C0334044
Is cytogenetic abnormality present now
Beskrivning

CytogeneticAbnormalityPresentIndicator

Datatyp

text

Alias
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C2950
UMLS 2011AA ObjectClass
C0008625
NCI Metathesaurus ValueDomain
C0021212
Did the patient require packed red blood cell (PRBC) transfusions (in the last 8 weeks)
Beskrivning

PackedRedBloodCellTransfusionRequirementInd-3

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C15409
UMLS 2011AA ObjectClass
C0199962
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Total number of units PRBC (transfused in the last 8 weeks)
Beskrivning

PackedRedBloodCellTransfusionReceivedUnitCount

Datatyp

float

Alias
NCI Thesaurus ValueDomain
C44278
UMLS 2011AA ValueDomain
C0439148
NCI Thesaurus Property
C25639
UMLS 2011AA Property
C1514756
NCI Thesaurus ValueDomain-2
C25463
UMLS 2011AA ValueDomain-2
C0750480
NCI Thesaurus ObjectClass
C15409
UMLS 2011AA ObjectClass
C0199962
Date of First Transfusion (MM/DD/YYYY)
Beskrivning

PackedRedBloodCellTransfusionReceivedFirstDate

Datatyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25639
UMLS 2011AA Property
C1514756
NCI Thesaurus ValueDomain-2
C25509
UMLS 2011AA ValueDomain-2
C1279901
NCI Thesaurus ObjectClass
C15409
UMLS 2011AA ObjectClass
C0199962
Date of most recent PRBC transfusion (MM/DD/YYYY)
Beskrivning

PackedRedBloodCellTransfusionReceivedMostRecentDate

Datatyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25639
UMLS 2011AA Property
C1514756
NCI Thesaurus ObjectClass
C15409
UMLS 2011AA ObjectClass
C0199962
NCI Thesaurus ValueDomain-2
C25577
UMLS 2011AA ValueDomain-2
C1513491
International Prognostic Score (ipss)
Beskrivning

International Prognostic Score (ipss)

Marrow Blasts (%) (Highest)
Beskrivning

Blasts, Bone Marrow

Datatyp

float

Måttenheter
  • %
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 Blasts (%) (Highest)
Beskrivning

Blasts, Bone Marrow

Datatyp

float

Måttenheter
  • %
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
%
Date (Highest - Record earliest date of the values - MM/DD/YYYY)
Beskrivning

MyelodysplasticSyndromeInternationalPrognosticScoreSystemDate

Datatyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C3247
UMLS 2011AA ObjectClass
C3463824
NCI Thesaurus Property
C20118
UMLS 2011AA Property
C1512894
Date (Highest - Record earliest date of the values - MM/DD/YYYY)
Beskrivning

MyelodysplasticSyndromeInternationalPrognosticScoreSystemDate

Datatyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C3247
UMLS 2011AA ObjectClass
C3463824
NCI Thesaurus Property
C20118
UMLS 2011AA Property
C1512894
Karyotype (Highest)
Beskrivning

KaryotypeDescriptionType

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C25215
UMLS 2011AA ObjectClass
C1261273
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Karyotype (Highest)
Beskrivning

KaryotypeDescriptionType

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C25215
UMLS 2011AA ObjectClass
C1261273
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Number of Cytopenias (Highest - Red blood cells- Hemoglobin <10 g/dl 100 g/L - White blood cells- Absolute neutrophil count <1800/microliter - Platelets- Platelet count <100,000/ microliter)
Beskrivning

CytopeniaAssessmentCount

Datatyp

float

Alias
NCI Thesaurus Property
C25367
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
NCI Thesaurus ObjectClass
C2979
UMLS 2011AA ObjectClass
C0010828
Number of Cytopenias (Highest - Red blood cells- Hemoglobin <10 g/dl 100 g/L - White blood cells- Absolute neutrophil count <1800/microliter - Platelets- Platelet count <100,000/ microliter)
Beskrivning

CytopeniaAssessmentCount

Datatyp

float

Alias
NCI Thesaurus Property
C25367
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
NCI Thesaurus ObjectClass
C2979
UMLS 2011AA ObjectClass
C0010828
International Prognostic Score (IPSS) (Highest)
Beskrivning

MyelodysplasticSyndromeInternationalPrognosticScoreSystemScore

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C3247
UMLS 2011AA ObjectClass
C3463824
NCI Thesaurus Property
C20118
UMLS 2011AA Property
C1512894
NCI Thesaurus ValueDomain
C25338
UMLS 2011AA ValueDomain
C0449820
International Prognostic Score (IPSS) (Highest)
Beskrivning

MyelodysplasticSyndromeInternationalPrognosticScoreSystemScore

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C3247
UMLS 2011AA ObjectClass
C3463824
NCI Thesaurus Property
C20118
UMLS 2011AA Property
C1512894
NCI Thesaurus ValueDomain
C25338
UMLS 2011AA ValueDomain
C0449820
Baseline Abnormalities
Beskrivning

Baseline Abnormalities

CTC Adverse Event Term (Use CTCAE v4 terminology)
Beskrivning

AdverseEventCommonTerminologyforAdverseEventsVersion4TermName

Datatyp

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 (Use grade 1-4 per CTCAE v4)
Beskrivning

AdverseEventSeverityGrade

Datatyp

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
Beskrivning

Comments

Investigator Signature
Beskrivning

Investigator Signature

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C2346576
NCI Thesaurus Property
C25678
NCI Thesaurus ObjectClass
C17089
Investigator Signature Date
Beskrivning

Investigator Signature Date

Datatyp

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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Similar models

INSTRUCTIONS: Complete this form and submit original to the ECOG Coordinating Center within one week of registration. Keep a copy for your files

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Header
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)
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
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)
Item
Report period
text
C25284 (NCI Thesaurus ValueDomain)
C2045829 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C25616 (NCI Thesaurus Property-2)
C15368 (NCI Thesaurus ObjectClass)
CL.1
Code List
Report period
CL Item
Baseline Step 1 (Baseline Step 1)
Item Group
Patient demographics
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)
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
Data amendment
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 (MM/DD/YYYY)
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
Pre-registration Hematology/chemistry
Hemoglobin LLN
Item
Hemoglobin (Hgb) (g/dl), LLN
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)
LaboratoryProcedureHemoglobinResultSpecifiedValue
Item
Hemoglobin (Hgbg/dl)
float
C16676 (NCI Thesaurus Property)
C0019046 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureHemoglobinResultDate
Item
Date (MM/DD/YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16676 (NCI Thesaurus Property)
C0019046 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
Platelets LLN
Item
Peripheral platelet count, LLN (/mm^3x1000)
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
Peripheral Platelet Count (/mm^3x1000)
float
C20200 (NCI Thesaurus Property)
C0005821 (UMLS CUI-1)
C12520 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
Platelets date
Item
Date (MM/DD/YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0005821 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C12520 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
LaboratoryProcedureGranulocyteResultLowerLimitofNormalCount
Item
Peripheral Granulocytes Count LLN (AGC/ANC/mm^3)
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)
Granulocyte count
Item
Peripheral Granulocytes Count (AGC/ANC/mm^3 - Do not report % granulocytes: report absolute count without decimal.)
float
C20200 (NCI Thesaurus Property)
C0857490 (UMLS CUI-1)
C12530 (NCI Thesaurus Property-2)
C25463 (NCI Thesaurus ValueDomain)
C25294 (NCI Thesaurus ObjectClass)
LaboratoryProcedureNeutrophilResultDate
Item
Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C12533 (NCI Thesaurus Property)
C0027950 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
LaboratoryProcedureLeukocyteResultSpecifiedValue
Item
Peripheral WBC Count (/mm^3 x 1000)
float
C12529 (NCI Thesaurus Property)
C0023516 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C38024 (NCI Thesaurus ValueDomain-2)
C0205369 (UMLS 2011AA ValueDomain-2)
LaboratoryProcedureLeukocyteResultLowerLimitofNormalValue
Item
Peripheral WBC count, LLN
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)
LaboratoryProcedureLeukocyteResultDate
Item
Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C12529 (NCI Thesaurus Property)
C0023516 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
Creatinine, Serum
Item
Creatinine
float
C20200 (NCI Thesaurus Property)
C0201976 (UMLS CUI-1)
C399 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
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)
Laboratory Procedure Date
Item
Date
date
C25164 (NCI Thesaurus ValueDomain)
C0022885 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C38000 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
LaboratoryProcedureHemoglobinPriorBloodTransfusionOutcomeUnspecifiedValue
Item
Mean pre-transfusion hemoglobin
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C16676 (NCI Thesaurus Property)
C0019046 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C20200 (NCI Thesaurus Property-3)
C1274040 (UMLS 2011AA Property-3)
C15192 (NCI Thesaurus Property-4)
C0005841 (UMLS 2011AA Property-4)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
Item Group
Leukemia Assessment
Item
MDS classification
text
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C3247 (NCI Thesaurus ObjectClass)
C3463824 (UMLS 2011AA ObjectClass)
C25161 (NCI Thesaurus Property)
C0008902 (UMLS 2011AA Property)
C75419 (NCI Thesaurus Property-2)
C0043237 (UMLS 2011AA Property-2)
CL.2
Code List
MDS classification
CL Item
Chronic Myelomonocytic Leukemia (Chronic Myelomonocytic Leukemia)
C3178 (NCI Thesaurus)
C0023480 (UMLS 2011AA)
CL Item
Myelodysplastic Syndrome Associated With Isolated Del (5q) Chromosome Abnormality (MDS associated with isolated del(5q))
C6867 (NCI Thesaurus)
C1292779 (UMLS 2011AA)
CL Item
Myelodysplastic Syndrome, Unclassifiable (Myelodysplastic Syndrome, unclassified)
C8648 (NCI Thesaurus)
C0854809 (UMLS 2011AA)
CL Item
Refractory Anemia (Refractory Anemia)
C2872 (NCI Thesaurus)
C0002893 (UMLS 2011AA)
CL Item
Raeb-1 (Refractory anemia with excess blasts-1)
C7167 (NCI Thesaurus)
C1318550 (UMLS 2011AA)
CL Item
Raeb-2 (Refractory anemia with excess blasts-2)
C7168 (NCI Thesaurus)
C1318551 (UMLS 2011AA)
CL Item
Refractory Anemia With Ringed Sideroblasts (Refractory Anemia with Ringed Sideroblasts)
C4036 (NCI Thesaurus)
C1264195 (UMLS 2011AA)
CL Item
Refractory Cytopenia With Multilineage Dysplasia (Refractory Cytopenia with Multilineage Dysplasia)
C8574 (NCI Thesaurus)
C0796466 (UMLS 2011AA)
CL Item
Refractory Cytopenia With Multilineage Dysplasia And Ringed Sideroblasts (Refractory Cytopenia with Multilineage Dysplasia and Ringed Sideroblasts)
C27726 (NCI Thesaurus)
C1301356 (UMLS 2011AA)
CancerInitialDiagnosisDate
Item
Date of Initial Pathologic Diagnosis
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)
BoneMarrowBiopsyDate
Item
Date of Bone Marrow Biopsy (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 (%) (Highest)
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
Reason bone marrow cellularity was not recorded
text
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C12431 (NCI Thesaurus Property-2)
C0005953 (UMLS 2011AA Property-2)
C25375 (NCI Thesaurus Property-3)
C0684224 (UMLS 2011AA Property-3)
C20200 (NCI Thesaurus Property-4)
C1274040 (UMLS 2011AA Property-4)
C37923 (NCI Thesaurus Property-5)
C1516377 (UMLS 2011AA Property-5)
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
CL.3
Code List
Reason bone marrow cellularity was not recorded
CL Item
Cellularity Status Of Bone Marrow Unknown, Procedure Resulted In No Material To Analyze (Dry Tap or inaspirable)
CL Item
Local Pathologist Did Not Quantify Cellularity (Local pathologist did not quantify cellularity)
Item
Dysplasia
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C4086 (NCI Thesaurus ObjectClass)
C0334044 (UMLS 2011AA ObjectClass)
CL.4
Code List
Dysplasia
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Specify type (mark all that apply)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16681 (NCI Thesaurus Property)
C0019638 (UMLS 2011AA Property)
C4086 (NCI Thesaurus ObjectClass)
C0334044 (UMLS 2011AA ObjectClass)
CL.5
Code List
Specify type (mark all that apply)
CL Item
Erythroid (Erythroid)
C13805 (NCI Thesaurus)
C1516960 (UMLS 2011AA)
CL Item
Megakaryocyte (Megakaryocyte)
C12553 (NCI Thesaurus)
C0025166 (UMLS 2011AA)
CL Item
Myeloid (Myeloid)
C13349 (NCI Thesaurus)
C0439677 (UMLS 2011AA)
Item
Is cytogenetic abnormality present now
text
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C2950 (NCI Thesaurus ObjectClass)
C0008625 (UMLS 2011AA ObjectClass)
C0021212 (NCI Metathesaurus ValueDomain)
CL.6
Code List
Is cytogenetic abnormality present now
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Inevaluable (Inevaluable)
Item
Did the patient require packed red blood cell (PRBC) transfusions (in the last 8 weeks)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15409 (NCI Thesaurus ObjectClass)
C0199962 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
CL.7
Code List
Did the patient require packed red blood cell (PRBC) transfusions (in the last 8 weeks)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
PackedRedBloodCellTransfusionReceivedUnitCount
Item
Total number of units PRBC (transfused in the last 8 weeks)
float
C44278 (NCI Thesaurus ValueDomain)
C0439148 (UMLS 2011AA ValueDomain)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain-2)
C0750480 (UMLS 2011AA ValueDomain-2)
C15409 (NCI Thesaurus ObjectClass)
C0199962 (UMLS 2011AA ObjectClass)
PackedRedBloodCellTransfusionReceivedFirstDate
Item
Date of First Transfusion (MM/DD/YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C25509 (NCI Thesaurus ValueDomain-2)
C1279901 (UMLS 2011AA ValueDomain-2)
C15409 (NCI Thesaurus ObjectClass)
C0199962 (UMLS 2011AA ObjectClass)
PackedRedBloodCellTransfusionReceivedMostRecentDate
Item
Date of most recent PRBC transfusion (MM/DD/YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C15409 (NCI Thesaurus ObjectClass)
C0199962 (UMLS 2011AA ObjectClass)
C25577 (NCI Thesaurus ValueDomain-2)
C1513491 (UMLS 2011AA ValueDomain-2)
Item Group
International Prognostic Score (ipss)
Blasts, Bone Marrow
Item
Marrow Blasts (%) (Highest)
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)
Blasts, Bone Marrow
Item
Marrow Blasts (%) (Highest)
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)
MyelodysplasticSyndromeInternationalPrognosticScoreSystemDate
Item
Date (Highest - Record earliest date of the values - MM/DD/YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C3247 (NCI Thesaurus ObjectClass)
C3463824 (UMLS 2011AA ObjectClass)
C20118 (NCI Thesaurus Property)
C1512894 (UMLS 2011AA Property)
MyelodysplasticSyndromeInternationalPrognosticScoreSystemDate
Item
Date (Highest - Record earliest date of the values - MM/DD/YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C3247 (NCI Thesaurus ObjectClass)
C3463824 (UMLS 2011AA ObjectClass)
C20118 (NCI Thesaurus Property)
C1512894 (UMLS 2011AA Property)
Item
Karyotype (Highest)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25215 (NCI Thesaurus ObjectClass)
C1261273 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.10
Code List
Karyotype (Highest)
CL Item
Good (Good)
C0205170 (NCI Metathesaurus)
CL Item
Intermediate (Intermediate)
C0205103 (NCI Metathesaurus)
CL Item
Poor (POOR)
Item
Karyotype (Highest)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25215 (NCI Thesaurus ObjectClass)
C1261273 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.10
Code List
Karyotype (Highest)
CL Item
Good (Good)
C0205170 (NCI Metathesaurus)
CL Item
Intermediate (Intermediate)
C0205103 (NCI Metathesaurus)
CL Item
Poor (POOR)
CytopeniaAssessmentCount
Item
Number of Cytopenias (Highest - Red blood cells- Hemoglobin <10 g/dl 100 g/L - White blood cells- Absolute neutrophil count <1800/microliter - Platelets- Platelet count <100,000/ microliter)
float
C25367 (NCI Thesaurus Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C2979 (NCI Thesaurus ObjectClass)
C0010828 (UMLS 2011AA ObjectClass)
CytopeniaAssessmentCount
Item
Number of Cytopenias (Highest - Red blood cells- Hemoglobin <10 g/dl 100 g/L - White blood cells- Absolute neutrophil count <1800/microliter - Platelets- Platelet count <100,000/ microliter)
float
C25367 (NCI Thesaurus Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C2979 (NCI Thesaurus ObjectClass)
C0010828 (UMLS 2011AA ObjectClass)
MyelodysplasticSyndromeInternationalPrognosticScoreSystemScore
Item
International Prognostic Score (IPSS) (Highest)
text
C3247 (NCI Thesaurus ObjectClass)
C3463824 (UMLS 2011AA ObjectClass)
C20118 (NCI Thesaurus Property)
C1512894 (UMLS 2011AA Property)
C25338 (NCI Thesaurus ValueDomain)
C0449820 (UMLS 2011AA ValueDomain)
MyelodysplasticSyndromeInternationalPrognosticScoreSystemScore
Item
International Prognostic Score (IPSS) (Highest)
text
C3247 (NCI Thesaurus ObjectClass)
C3463824 (UMLS 2011AA ObjectClass)
C20118 (NCI Thesaurus Property)
C1512894 (UMLS 2011AA Property)
C25338 (NCI Thesaurus ValueDomain)
C0449820 (UMLS 2011AA ValueDomain)
Item Group
Baseline Abnormalities
AdverseEventCommonTerminologyforAdverseEventsVersion4TermName
Item
CTC Adverse Event Term (Use CTCAE v4 terminology)
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 (Use grade 1-4 per CTCAE v4)
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.12
Code List
CTC Adverse Event Grade (Use grade 1-4 per CTCAE v4)
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
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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