ID

6289

Description

E2905 Follow Up Disease Evaluation Form 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=0F12A9EE-8D74-6165-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=0F12A9EE-8D74-6165-E044-0003BA3F9857

Keywords

Versions (4)
  1. 12/18/14 12/18/14 - Martin Dugas
  2. 1/8/15 1/8/15 - Martin Dugas
  3. 1/23/15 1/23/15 - Martin Dugas
  4. 9/20/21 9/20/21 -
Uploaded on

December 18, 2014

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Leukemia NCT00843882 On-Study - E2905 Follow Up Disease Evaluation Form - 2459288v1.0

English

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

1 forms  
Unnamed1
Description

Unnamed1

ECOG Protocol Number
Description

ProtocolECOGIdentifierNumber

Data type

text

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

PatientECOGIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C25491
UMLS 2011AA Property
C1512162
DCI Name
Description

CollectedDataFormName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus Property
C19464
UMLS 2011AA Property
C0376315
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus ObjectClass
C25452
Registration Step
Description

RegistrationStepNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25646
UMLS 2011AA ObjectClass
C1514821
NCI Thesaurus Property
C16154
UMLS 2011AA Property
C1704379
NCI Thesaurus ValueDomain
C16154
UMLS 2011AA ValueDomain
C1704379
Unnamed2
Description

Unnamed2

Patient Initials (Last, First)
Description

PatientInitialsName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
ECOG Protocol Number
Description

ProtocolECOGIdentifierNumber

Data type

text

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

PatientECOGIdentifierNumber

Data type

text

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

ProtocolParticipatingIdentifierNumber

Data type

text

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

PatientParticipatingIdentifierNumber

Data type

text

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

CombinedInstitutionName

Data type

text

Alias
NCI Thesaurus ObjectClass
C25454
UMLS 2011AA ObjectClass
C0205195
NCI Thesaurus ObjectClass
C21541
UMLS 2011AA ObjectClass
C0018704
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ValueDomain
C21541
UMLS 2011AA ValueDomain
C0018704
Unnamed3
Description

Unnamed3

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

DataAmendedText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C25416
UMLS 2011AA Property
C1691222
Date data amended (MM/DD/YYYY)
Description

DataAmendedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C25416
UMLS 2011AA Property
C1691222
NCI Thesaurus ValueDomain
C25367
On Treatment
Description

On Treatment

On Treatment Report Period (Step 2 - Choose one x)
Description

TreatmentEvaluationPeriodType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C25214
UMLS 2011AA Property
C0220825
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus ObjectClass
C15368
On Treatment Report Period (Step 2 - Choose one x)
Description

TreatmentEvaluationPeriodType

Data type

text

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

TreatmentEvaluationPeriodCycleSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25214
UMLS 2011AA Property
C0220825
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ValueDomain
C25472
UMLS 2011AA ValueDomain
C1511572
NCI Thesaurus ValueDomain
C25275
UMLS 2011AA ValueDomain
C2745955
Specify Cycle
Description

TreatmentEvaluationPeriodCycleSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25214
UMLS 2011AA Property
C0220825
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ValueDomain
C25472
UMLS 2011AA ValueDomain
C1511572
NCI Thesaurus ValueDomain
C25275
UMLS 2011AA ValueDomain
C2745955
Off Treatment
Description

Off Treatment

Off Treatment Report Period (since registration - Choose one x)
Description

PersonOff-TreatmentTimePeriodType

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property
C25601
UMLS 2011AA Property
C1518544
NCI Thesaurus Property
C25207
UMLS 2011AA Property
C0040223
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Unnamed5
Description

Unnamed5

MDS classification
Description

MyelodysplasticSyndromeWorldHealthOrganizationClassificationCategory

Data type

text

Alias
NCI Thesaurus ValueDomain
C25372
UMLS 2011AA ValueDomain
C0683312
NCI Thesaurus ObjectClass
C3247
UMLS 2011AA ObjectClass
C0026986
NCI Thesaurus Property
C25161
UMLS 2011AA Property
C0008902
NCI Thesaurus Property
C75419
UMLS 2011AA Property
C0043237
Was bone marrow biopsy done
Description

BoneMarrowBiopsyInd

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus Property
C15189
UMLS 2011AA Property
C0005558
NCI Thesaurus ObjectClass
C12431
UMLS 2011AA ObjectClass
C0005953
Date of Bone Marrow Biopsy (Aspirate)
Description

BoneMarrowBiopsyDate

Data type

date

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

LaboratoryProcedureBoneMarrowBlastCellOutcomePercentageValue

Data type

double

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

LaboratoryProcedureBoneMarrowCellularityOutcomePercentageValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C12431
UMLS 2011AA Property
C0005953
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C37923
UMLS 2011AA Property
C1516377
NCI Thesaurus ValueDomain
C25613
UMLS 2011AA ValueDomain
C0439165
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
Reason bone marrow cellularity was not recorded
Description

LaboratoryProcedureBoneMarrowCellularityNegationReportOutcomeReason

Data type

text

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C25594
UMLS 2011AA Property
C1518422
NCI Thesaurus Property
C12431
UMLS 2011AA Property
C0005953
NCI Thesaurus Property
C25375
UMLS 2011AA Property
C0684224
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C37923
UMLS 2011AA Property
C1516377
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
Dysplasia
Description

DysplasiaPresentInd-3

Data type

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
Description

DysplasiaHistologyType

Data type

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
Description

CytogeneticAbnormalityPresentIndicator

Data type

text

Alias
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C2950
UMLS 2011AA ObjectClass
C0008625
NCI Metathesaurus ValueDomain
C0021212
Section Ii
Description

Section Ii

Did the patient require packed red blood cell (PRBC) transfusions (in the last 8 weeks)
Description

PackedRedBloodCellTransfusionRequirementInd-3

Data type

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)
Description

PackedRedBloodCellTransfusionReceivedUnitCount

Data type

double

Alias
NCI Thesaurus ValueDomain
C44278
UMLS 2011AA ValueDomain
C0439148
NCI Thesaurus Property
C25639
UMLS 2011AA Property
C1514756
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
NCI Thesaurus ObjectClass
C15409
UMLS 2011AA ObjectClass
C0199962
Date of First Transfusion (in the last 8 weeks)
Description

PackedRedBloodCellTransfusionReceivedFirstDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25639
UMLS 2011AA Property
C1514756
NCI Thesaurus ValueDomain
C25509
UMLS 2011AA ValueDomain
C1279901
NCI Thesaurus ObjectClass
C15409
UMLS 2011AA ObjectClass
C0199962
Date of most recent PRBC transfusion
Description

PackedRedBloodCellTransfusionReceivedMostRecentDate

Data type

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
C25577
UMLS 2011AA ValueDomain
C1513491
Mds Response
Description

Mds Response

Best response to date
Description

MyelodysplasticSyndromeResponseType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C25755
UMLS 2011AA Property
C0871261
NCI Thesaurus ObjectClass
C3247
UMLS 2011AA ObjectClass
C0026986
First observed date
Description

MyelodysplasticSyndromeResponseFirstDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25755
UMLS 2011AA Property
C0871261
NCI Thesaurus ObjectClass
C3247
UMLS 2011AA ObjectClass
C0026986
NCI Thesaurus ValueDomain
C25509
UMLS 2011AA ValueDomain
C1279901
First Confirmed Date
Description

MyelodysplasticSyndromeResponseDiagnosisDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25755
UMLS 2011AA Property
C0871261
NCI Thesaurus ObjectClass
C3247
UMLS 2011AA ObjectClass
C0026986
NCI Thesaurus ValueDomain
C15220
UMLS 2011AA ValueDomain
C0011900
Relapse
Description

DiseaseRelapseInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C18265
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
Date of relapse
Description

DiseaseRelapseDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C18265
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
If Hematologic improvement
Description

DiseaseMyelodysplasticSyndromeHematologyResponseType

Data type

text

Alias
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property
C3247
UMLS 2011AA Property
C0026986
NCI Thesaurus Property
C16673
UMLS 2011AA Property
C0018943
NCI Thesaurus Property
C50995
UMLS 2011AA Property
C1704632
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
First observed date (HI)
Description

DiseaseMyelodysplasticSyndromeHematologyResponseFirstDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property
C3247
UMLS 2011AA Property
C0026986
NCI Thesaurus Property
C16673
UMLS 2011AA Property
C0018943
NCI Thesaurus Property
C50995
UMLS 2011AA Property
C1704632
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25509
UMLS 2011AA ValueDomain
C1279901
First confirmed date (HI)
Description

DiseaseMyelodysplasticSyndromeHematologyResponseDiagnosisDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property
C3247
UMLS 2011AA Property
C0026986
NCI Thesaurus Property
C16673
UMLS 2011AA Property
C0018943
NCI Thesaurus Property
C50995
UMLS 2011AA Property
C1704632
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C15220
UMLS 2011AA ValueDomain
C0011900
Cytogenetic Response
Description

Cytogenetic Response

Cytogenetic Response
Description

CytogeneticResponseType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C50995
UMLS 2011AA Property
C1704632
NCI Thesaurus ObjectClass
C17938
UMLS 2011AA ObjectClass
C0314603
Comments
Description

Comments

Investigator Signature
Description

InvestigatorSignatureText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus Property
C25678
UMLS 2011AA Property
C1519316
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173
Investigator Signature Date
Description

InvestigatorSignatureDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25678
UMLS 2011AA Property
C1519316
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173
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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 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Unnamed1
ProtocolECOGIdentifierNumber
Item
ECOG Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25491 (NCI Thesaurus Property)
C1512162 (UMLS 2011AA Property)
PatientECOGIdentifierNumber
Item
ECOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25491 (NCI Thesaurus Property)
C1512162 (UMLS 2011AA Property)
CollectedDataFormName
Item
DCI Name
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C19464 (NCI Thesaurus Property)
C0376315 (UMLS 2011AA Property)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25452 (NCI Thesaurus ObjectClass)
RegistrationStepNumber
Item
Registration Step
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25646 (NCI Thesaurus ObjectClass)
C1514821 (UMLS 2011AA ObjectClass)
C16154 (NCI Thesaurus Property)
C1704379 (UMLS 2011AA Property)
C16154 (NCI Thesaurus ValueDomain)
C1704379 (UMLS 2011AA ValueDomain)
Item Group
Unnamed2
PatientInitialsName
Item
Patient Initials (Last, First)
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
ProtocolECOGIdentifierNumber
Item
ECOG Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25491 (NCI Thesaurus Property)
C1512162 (UMLS 2011AA Property)
PatientECOGIdentifierNumber
Item
ECOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25491 (NCI Thesaurus Property)
C1512162 (UMLS 2011AA Property)
ProtocolParticipatingIdentifierNumber
Item
Participating Group Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
PatientParticipatingIdentifierNumber
Item
Participating Group Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
CombinedInstitutionName
Item
Institution/Affiliate
text
C25454 (NCI Thesaurus ObjectClass)
C0205195 (UMLS 2011AA ObjectClass)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ValueDomain)
C0018704 (UMLS 2011AA ValueDomain)
Item Group
Unnamed3
DataAmendedText
Item
Please mark an 'X' if data have been amended. (Please circle amended items in red)
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
DataAmendedDate
Item
Date data amended (MM/DD/YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain)
Item Group
On Treatment
Item
On Treatment Report Period (Step 2 - Choose one x)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C15368 (NCI Thesaurus ObjectClass)
CL.2
Code List
On Treatment Report Period (Step 2 - Choose one x)
CL Item
Cycle 1 Step 2 (Cycle 1 Step 2)
CL Item
Cycle 2 Step 2 (Cycle 2 Step 2)
CL Item
Cycle 3 Step 2 (Cycle 3 Step 2)
CL Item
Cycle 4 Step 2 (Cycle 4 Step 2)
CL Item
Cycle 5 Step 2 (Cycle 5 Step 2)
CL Item
Cycle 6 Step 2 (Cycle 6 Step 2)
CL Item
Cycle 7 Step 2 (Cycle 7 Step 2)
CL Item
Cycle 8 Step 2 (Cycle 8 Step 2)
CL Item
Cycle 9 Step 2 (Cycle 9 Step 2)
CL Item
Cycle 10 Step 2 (Cycle 10 Step 2)
CL Item
Cycle 11 Step 2 (Cycle 11 Step 2)
CL Item
Cycle 12 Step 2 (Cycle 12 Step 2)
CL Item
Cycle 13-step 2 (Cycle 13-Step 2)
CL Item
>cycle 13-step 2 (>Cycle 13-Step 2)
Item
On Treatment Report Period (Step 2 - Choose one x)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C15368 (NCI Thesaurus ObjectClass)
CL.2
Code List
On Treatment Report Period (Step 2 - Choose one x)
CL Item
Cycle 1 Step 2 (Cycle 1 Step 2)
CL Item
Cycle 2 Step 2 (Cycle 2 Step 2)
CL Item
Cycle 3 Step 2 (Cycle 3 Step 2)
CL Item
Cycle 4 Step 2 (Cycle 4 Step 2)
CL Item
Cycle 5 Step 2 (Cycle 5 Step 2)
CL Item
Cycle 6 Step 2 (Cycle 6 Step 2)
CL Item
Cycle 7 Step 2 (Cycle 7 Step 2)
CL Item
Cycle 8 Step 2 (Cycle 8 Step 2)
CL Item
Cycle 9 Step 2 (Cycle 9 Step 2)
CL Item
Cycle 10 Step 2 (Cycle 10 Step 2)
CL Item
Cycle 11 Step 2 (Cycle 11 Step 2)
CL Item
Cycle 12 Step 2 (Cycle 12 Step 2)
CL Item
Cycle 13-step 2 (Cycle 13-Step 2)
CL Item
>cycle 13-step 2 (>Cycle 13-Step 2)
TreatmentEvaluationPeriodCycleSpecify
Item
Specify Cycle
text
C15368 (NCI Thesaurus ObjectClass)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25472 (NCI Thesaurus ValueDomain)
C1511572 (UMLS 2011AA ValueDomain)
C25275 (NCI Thesaurus ValueDomain)
C2745955 (UMLS 2011AA ValueDomain)
TreatmentEvaluationPeriodCycleSpecify
Item
Specify Cycle
text
C15368 (NCI Thesaurus ObjectClass)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25472 (NCI Thesaurus ValueDomain)
C1511572 (UMLS 2011AA ValueDomain)
C25275 (NCI Thesaurus ValueDomain)
C2745955 (UMLS 2011AA ValueDomain)
Item Group
Off Treatment
Item
Off Treatment Report Period (since registration - Choose one x)
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25601 (NCI Thesaurus Property)
C1518544 (UMLS 2011AA Property)
C25207 (NCI Thesaurus Property)
C0040223 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.3
Code List
Off Treatment Report Period (since registration - Choose one x)
CL Item
3 Months Post End Of Treatment (3 months post end of treatment)
CL Item
6 Months Post End Of Treatment (6 months post end of treatment)
Item Group
Unnamed5
Item
MDS classification
text
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C3247 (NCI Thesaurus ObjectClass)
C0026986 (UMLS 2011AA ObjectClass)
C25161 (NCI Thesaurus Property)
C0008902 (UMLS 2011AA Property)
C75419 (NCI Thesaurus Property)
C0043237 (UMLS 2011AA Property)
CL.4
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
No Evidence Of Disease (No evidence of disease)
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)
Item
Was bone marrow biopsy done
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C15189 (NCI Thesaurus Property)
C0005558 (UMLS 2011AA Property)
C12431 (NCI Thesaurus ObjectClass)
C0005953 (UMLS 2011AA ObjectClass)
CL.5
Code List
Was bone marrow biopsy done
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
BoneMarrowBiopsyDate
Item
Date of Bone Marrow Biopsy (Aspirate)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C15189 (NCI Thesaurus Property)
C0005558 (UMLS 2011AA Property)
C12431 (NCI Thesaurus ObjectClass)
C0005953 (UMLS 2011AA ObjectClass)
LaboratoryProcedureBoneMarrowBlastCellOutcomePercentageValue
Item
Marrow Blasts (%)
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C12431 (NCI Thesaurus Property)
C0005953 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12918 (NCI Thesaurus Property)
C0368761 (UMLS 2011AA Property)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureBoneMarrowCellularityOutcomePercentageValue
Item
Marrow Cellularity (%)
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C12431 (NCI Thesaurus Property)
C0005953 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C37923 (NCI Thesaurus Property)
C1516377 (UMLS 2011AA Property)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
Item
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)
C0005953 (UMLS 2011AA Property)
C25375 (NCI Thesaurus Property)
C0684224 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C37923 (NCI Thesaurus Property)
C1516377 (UMLS 2011AA Property)
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
CL.6
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.7
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
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.8
Code List
Specify type
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.9
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 Group
Section Ii
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.10
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
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
PackedRedBloodCellTransfusionReceivedUnitCount
Item
Total number of units PRBC (transfused in the last 8 weeks)
double
C44278 (NCI Thesaurus ValueDomain)
C0439148 (UMLS 2011AA ValueDomain)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C15409 (NCI Thesaurus ObjectClass)
C0199962 (UMLS 2011AA ObjectClass)
PackedRedBloodCellTransfusionReceivedFirstDate
Item
Date of First Transfusion (in the last 8 weeks)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C25509 (NCI Thesaurus ValueDomain)
C1279901 (UMLS 2011AA ValueDomain)
C15409 (NCI Thesaurus ObjectClass)
C0199962 (UMLS 2011AA ObjectClass)
PackedRedBloodCellTransfusionReceivedMostRecentDate
Item
Date of most recent PRBC transfusion
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)
C1513491 (UMLS 2011AA ValueDomain)
Item Group
Mds Response
Item
Best response to date
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25755 (NCI Thesaurus Property)
C0871261 (UMLS 2011AA Property)
C3247 (NCI Thesaurus ObjectClass)
C0026986 (UMLS 2011AA ObjectClass)
CL.11
Code List
Best response to date
CL Item
Complete Remission (CR)
C4870 (NCI Thesaurus)
C0677874 (UMLS 2011AA)
CL Item
Partial Remission (PR)
C18058 (NCI Thesaurus)
C1521726 (UMLS 2011AA)
CL Item
Stable Disease (SD)
C18213 (NCI Thesaurus)
C0677946 (UMLS 2011AA)
CL Item
Better Hematologic (HI)
C62780 (NCI Thesaurus)
C0205488 (UMLS 2011AA)
C71685 (NCI Thesaurus)
C0332272 (UMLS 2011AA)
CL Item
Progressive Disease (PD)
C35571 (NCI Thesaurus)
C1335499 (UMLS 2011AA)
CL Item
Transformation To Aml (Transformation to AML)
MyelodysplasticSyndromeResponseFirstDate
Item
First observed date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25755 (NCI Thesaurus Property)
C0871261 (UMLS 2011AA Property)
C3247 (NCI Thesaurus ObjectClass)
C0026986 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus ValueDomain)
C1279901 (UMLS 2011AA ValueDomain)
MyelodysplasticSyndromeResponseDiagnosisDate
Item
First Confirmed Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25755 (NCI Thesaurus Property)
C0871261 (UMLS 2011AA Property)
C3247 (NCI Thesaurus ObjectClass)
C0026986 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus ValueDomain)
C0011900 (UMLS 2011AA ValueDomain)
Item
Relapse
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C18265 (NCI Thesaurus Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
CL.12
Code List
Relapse
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
DiseaseRelapseDate
Item
Date of relapse
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C18265 (NCI Thesaurus Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
Item
If Hematologic improvement
text
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C3247 (NCI Thesaurus Property)
C0026986 (UMLS 2011AA Property)
C16673 (NCI Thesaurus Property)
C0018943 (UMLS 2011AA Property)
C50995 (NCI Thesaurus Property)
C1704632 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.13
Code List
If Hematologic improvement
CL Item
Major Erythroid Response (Major erythroid response)
CL Item
Minor Erythroid Response (Minor erythroid response)
CL Item
Relapse Major Erythroid Response (Relaspe MER)
DiseaseMyelodysplasticSyndromeHematologyResponseFirstDate
Item
First observed date (HI)
date
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C3247 (NCI Thesaurus Property)
C0026986 (UMLS 2011AA Property)
C16673 (NCI Thesaurus Property)
C0018943 (UMLS 2011AA Property)
C50995 (NCI Thesaurus Property)
C1704632 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25509 (NCI Thesaurus ValueDomain)
C1279901 (UMLS 2011AA ValueDomain)
DiseaseMyelodysplasticSyndromeHematologyResponseDiagnosisDate
Item
First confirmed date (HI)
date
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C3247 (NCI Thesaurus Property)
C0026986 (UMLS 2011AA Property)
C16673 (NCI Thesaurus Property)
C0018943 (UMLS 2011AA Property)
C50995 (NCI Thesaurus Property)
C1704632 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15220 (NCI Thesaurus ValueDomain)
C0011900 (UMLS 2011AA ValueDomain)
Item Group
Cytogenetic Response
Item
Cytogenetic Response
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C50995 (NCI Thesaurus Property)
C1704632 (UMLS 2011AA Property)
C17938 (NCI Thesaurus ObjectClass)
C0314603 (UMLS 2011AA ObjectClass)
CL.14
Code List
Cytogenetic Response
CL Item
Complete Cytogenetic Response (Complete Cytogenetic Response)
CL Item
Partial Cytogenetic Response (Partial Cytogenetic Response)
Item Group
Comments
InvestigatorSignatureText
Item
Investigator Signature
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
InvestigatorSignatureDate
Item
Investigator Signature Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
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