ID

43363

Description

E2905 On-Study 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=0EA9BECA-9DE5-1273-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=0EA9BECA-9DE5-1273-E044-0003BA3F9857

Keywords

Versions (4)
  1. 12/18/14 12/18/14 - Martin Dugas
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 6/16/15 6/16/15 -
  4. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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E2905 On-Study Form NCT00843882

English

Complete this form and submit original to the ECOG Coordinating Center within one week of registration. Keep a copy for your files. NOTE: Submit bone marrow and cytogenics reports

1 forms  
Header
Description

Header

ECOG Protocol Number
Description

Protocol Number ECOG

Data type

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
Description

Patient ID ECOG

Data type

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
Description

Generic drug form

Data type

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
Description

Registration Number

Data type

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
Reporting Period
Description

Clinical Trial Period

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C2347804
NCI Thesaurus ObjectClass
C25214
NCI Thesaurus Property
C25616
NCI Thesaurus ObjectClass-2
C25651
Patient Initials (Last, First)
Description

Patient Initials

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Participating Group Protocol Number
Description

Study Number Participating Group

Data type

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
Description

Trial subject ID Participating Group

Data type

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
Description

Institution Name

Data type

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
Description

Data amendment

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

Data amended

Data type

text

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

Data amended date

Data type

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
Current Performance Status
Description

Current Performance Status

ECOG Performance Status
Description

ECOG Performance Status

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS CUI-1
C1520224
NCI Thesaurus Property
C25367
NCI Thesaurus ValueDomain-2
C25491
NCI Thesaurus ObjectClass
C20641
Weight
Description

Patient Weight

Data type

float

Measurement units
  • Kg
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0005910
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25208
Kg
Height
Description

Patient Height

Data type

float

Measurement units
  • cm
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0489786
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25347
cm
Is bone marrow iron stain available for patient
Description

IronStainingMethodLaboratoryProcedureInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus ObjectClass-2
C23016
UMLS 2011AA ObjectClass-2
C1522279
Transferrin saturation
Description

TransferrinSaturationPercentageValue

Data type

float

Alias
NCI Thesaurus ValueDomain
C25613
UMLS 2011AA ValueDomain
C0439165
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
NCI Thesaurus ObjectClass
C17211
UMLS 2011AA ObjectClass
C0040679
NCI Thesaurus Property
C61427
UMLS 2011AA Property
C0522534
Serum ferritin
Description

SerumFerritinLaboratoryProcedureOutcomeValue

Data type

text

Measurement units
  • ng/ml
Alias
NCI Thesaurus ObjectClass
C13325
UMLS 2011AA ObjectClass
C0229671
NCI Thesaurus ObjectClass-2
C25294
UMLS 2011AA ObjectClass-2
C0022885
NCI Thesaurus ObjectClass-3
C16577
UMLS 2011AA ObjectClass-3
C0015879
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
ng/ml
Does the patient have a history of thromboembolic events
Description

PersonThromboembolismPersonalMedicalHistoryInd-3

Data type

boolean

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 Metathesaurus Property
C0040038
Does the patient have any history of the following (If yes,)
Description

PersonThromboembolismPersonalMedicalHistoryType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C18772
UMLS 2011AA Property
C0262926
NCI Metathesaurus Property
C0040038
Did it occur in the last 3 years (If yes,)
Description

PersonThromboembolismPriorThreeYearPersonalMedicalHistoryInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property-2
C29848
UMLS 2011AA Property-2
C0439234
NCI Thesaurus Property-3
C18772
UMLS 2011AA Property-3
C0262926
NCI Metathesaurus Property
C0040038
NCI Thesaurus Property-4
C66834
UMLS 2011AA Property-4
C0205449
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Baseline Abnormalities
Description

Baseline Abnormalities

Radiotherapy
Description

RadiationTherapyAdministeredInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C15313
UMLS 2011AA ObjectClass
C1522449
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Chemotherapy
Description

ChemotherapyAdministeredInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Immunotherapy
Description

PriorImmunotherapyAdministeredInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C15262
UMLS 2011AA ObjectClass
C0021083
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Leukocyte Growth Factor
Description

LeukocyteGrowthFactorTherapyAdministeredInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C20424
UMLS 2011AA ObjectClass
C0018284
NCI Thesaurus ObjectClass-2
C12529
UMLS 2011AA ObjectClass-2
C0023516
NCI Thesaurus ObjectClass-3
C15368
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Year last given (If yes,)
Description

TherapeuticProcedurePriorMalignantNeoplasmAdministrationYearDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C49236
UMLS 2011AA ObjectClass
C0087111
NCI Thesaurus Property
C9305
UMLS 2011AA Property
C0006826
NCI Thesaurus Property-2
C25629
UMLS 2011AA Property-2
C0332152
NCI Thesaurus Property-3
C25409
UMLS 2011AA Property-3
C1533734
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C29848
UMLS 2011AA ValueDomain-2
C0439234
Was this disease MDS secondary due to treatment
Description

MyelodysplasticSyndromeSecondaryDiseaseorDisorderTreatmentAssessmentInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C3247
UMLS 2011AA ObjectClass
C3463824
NCI Thesaurus Property
C25367
NCI Thesaurus Property-2
C2991
UMLS 2011AA Property
C0012634
NCI Thesaurus Property-3
C15368
NCI Thesaurus Property-4
C25667
UMLS 2011AA Property-2
C0175668
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Cytarabine
Description

ChemotherapyPriorCytarabineAdministeredInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property-2
C408
UMLS 2011AA Property-2
C0010711
NCI Thesaurus Property-3
C25382
UMLS 2011AA Property-3
C1521801
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Azacitidine
Description

ChemotherapyAzacitidinePriorAdministrationInd-3

Data type

text

Alias
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property-2
C25409
UMLS 2011AA Property-2
C1533734
NCI Thesaurus Property-3
C288
UMLS 2011AA Property-3
C0004475
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Decitabine
Description

ChemotherapyDecitabinePriorAdministrationInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property-2
C25409
UMLS 2011AA Property-2
C1533734
NCI Thesaurus Property-3
C981
UMLS 2011AA Property-3
C0049065
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Cyclosporin
Description

ImmunotherapyCyclosporinePriorAdministrationInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C15262
UMLS 2011AA ObjectClass
C0021083
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property-2
C406
UMLS 2011AA Property-2
C0010592
NCI Thesaurus Property-3
C25409
UMLS 2011AA Property-3
C1533734
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
ATG (anti-thymocyte globulin)
Description

ImmunotherapyAnti-ThymocyteGlobulinPriorAdministrationInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C15262
UMLS 2011AA ObjectClass
C0021083
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property-2
C278
UMLS 2011AA Property-2
C0003442
NCI Thesaurus Property-3
C25409
UMLS 2011AA Property-3
C1533734
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Thalidomide
Description

ChemotherapyThalidomidePriorAdministrationInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property-2
C870
UMLS 2011AA Property-2
C0039736
NCI Thesaurus Property-3
C25409
UMLS 2011AA Property-3
C1533734
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Year last given (If yes,)
Description

TherapeuticProcedurePriorMyelodysplasticSyndromeAdministrationYearDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C49236
UMLS 2011AA ObjectClass
C0087111
NCI Thesaurus Property
C3247
UMLS 2011AA Property
C3463824
NCI Thesaurus Property-2
C25629
UMLS 2011AA Property-2
C0332152
NCI Thesaurus Property-3
C25409
UMLS 2011AA Property-3
C1533734
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C29848
UMLS 2011AA ValueDomain-2
C0439234
Prior Darpoietin Alpha (DA)
Description

ImmunotherapyErythropoietinPriorAdministeredInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C15262
UMLS 2011AA ObjectClass
C0021083
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property-2
C20429
UMLS 2011AA Property-2
C0014822
NCI Thesaurus Property-3
C25382
UMLS 2011AA Property-3
C1521801
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Date (DA first administered)
Description

ImmunotherapyErythropoietinPriorAdministeredFirstDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C15262
UMLS 2011AA ObjectClass
C0021083
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property-2
C20429
UMLS 2011AA Property-2
C0014822
NCI Thesaurus Property-3
C25382
UMLS 2011AA Property-3
C1521801
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25509
UMLS 2011AA ValueDomain-2
C1279901
Date (DA last administered)
Description

ImmunotherapyErythropoietinPriorAdministeredMostRecentDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C15262
UMLS 2011AA ObjectClass
C0021083
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property-2
C20429
UMLS 2011AA Property-2
C0014822
NCI Thesaurus Property-3
C25382
UMLS 2011AA Property-3
C1521801
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25577
UMLS 2011AA ValueDomain-2
C1513491
Prior Epoetin Alpha
Description

ImmunotherapyEpoetinAlfaPriorAdministrationInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C15262
UMLS 2011AA ObjectClass
C0021083
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property-2
C2695
UMLS 2011AA Property-2
C0357126
NCI Thesaurus Property-3
C25382
UMLS 2011AA Property-3
C1521801
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Date (If yes, - EPO last administered)
Description

ErythropoietinAgentLastAdministeredDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ObjectClass-2
C20429
UMLS 2011AA ObjectClass-2
C0014822
NCI Thesaurus Property
C25551
UMLS 2011AA Property
C1517741
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Did patient have prior EPO failure
Description

ImmunotherapyEpoetinAlfaPriorFailureInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C15262
UMLS 2011AA ObjectClass
C0021083
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property-2
C25745
UMLS 2011AA Property-2
C0231174
NCI Thesaurus Property-3
C2695
UMLS 2011AA Property-3
C0357126
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Low EPO response profile (If no,)
Description

ImmunotherapyEpoetinAlfaPriorLowResponseIND-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C15262
UMLS 2011AA ObjectClass
C0021083
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property-2
C54722
UMLS 2011AA Property-2
C0205251
NCI Thesaurus Property-3
C2695
UMLS 2011AA Property-3
C0357126
NCI Thesaurus Property-4
C50995
UMLS 2011AA Property-4
C1704632
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Serum EPO Level (at study entry)
Description

SerumErythropoietinLevelAmount

Data type

text

Alias
NCI Thesaurus ObjectClass
C13325
UMLS 2011AA ObjectClass
C0229671
NCI Thesaurus Property
C20429
UMLS 2011AA Property
C0014822
NCI Thesaurus ValueDomain
C25417
NCI Thesaurus Property-2
C25554
UMLS 2011AA Property-2
C0441889
Date (EPO level done)
Description

SerumErythropoietinLevelDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C13325
UMLS 2011AA ObjectClass
C0229671
NCI Thesaurus Property
C20429
UMLS 2011AA Property
C0014822
NCI Thesaurus Property-2
C25554
UMLS 2011AA Property-2
C0441889
Other prior erythropoietic growth factor (other than rhu-EPO and Darbepoetin Alfa)
Description

OtherErythropoietinAgentAdministeredInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C17649
UMLS 2011AA ObjectClass
C0205394
NCI Thesaurus ObjectClass-2
C1708
UMLS 2011AA ObjectClass-2
C0450442
NCI Thesaurus ObjectClass-3
C20429
UMLS 2011AA ObjectClass-3
C0014822
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Date agent ended (erythropoietic growth factor)
Description

OtherErythropoietinAgentAdministeredEndDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C17649
UMLS 2011AA ObjectClass
C0205394
NCI Thesaurus ObjectClass-2
C1708
UMLS 2011AA ObjectClass-2
C0450442
NCI Thesaurus ObjectClass-3
C20429
UMLS 2011AA ObjectClass-3
C0014822
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Comments
Description

Comments

Investigator Signature
Description

Investigator Signature

Data type

text

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

Investigator Signature Date

Data type

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
Comments
Description

Comments

Data type

text

Alias
UMLS CUI-1
C0947611
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Similar models

Complete this form and submit original to the ECOG Coordinating Center within one week of registration. Keep a copy for your files. NOTE: Submit bone marrow and cytogenics reports

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
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)
Patient Initials
Item
Patient Initials (Last, First)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
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 (s - 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
Current Performance Status
Item
ECOG 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
ECOG 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)
Patient Weight
Item
Weight
float
C25209 (NCI Thesaurus ValueDomain)
C0005910 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)
Patient Height
Item
Height
float
C25209 (NCI Thesaurus ValueDomain)
C0489786 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25347 (NCI Thesaurus Property)
IronStainingMethodLaboratoryProcedureInd-2
Item
Is bone marrow iron stain available for patient
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C23016 (NCI Thesaurus ObjectClass-2)
C1522279 (UMLS 2011AA ObjectClass-2)
TransferrinSaturationPercentageValue
Item
Transferrin saturation
float
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
C17211 (NCI Thesaurus ObjectClass)
C0040679 (UMLS 2011AA ObjectClass)
C61427 (NCI Thesaurus Property)
C0522534 (UMLS 2011AA Property)
SerumFerritinLaboratoryProcedureOutcomeValue
Item
Serum ferritin
text
C13325 (NCI Thesaurus ObjectClass)
C0229671 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus ObjectClass-2)
C0022885 (UMLS 2011AA ObjectClass-2)
C16577 (NCI Thesaurus ObjectClass-3)
C0015879 (UMLS 2011AA ObjectClass-3)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
PersonThromboembolismPersonalMedicalHistoryInd-3
Item
Does the patient have a history of thromboembolic events
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
C0040038 (NCI Metathesaurus Property)
Item
Does the patient have any history of the following (If yes,)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
C0040038 (NCI Metathesaurus Property)
CL.5
Code List
Does the patient have any history of the following (If yes,)
CL Item
Blood Clot (Clot)
C27083 (NCI Thesaurus)
C0302148 (UMLS 2011AA)
CL Item
Coronary Thrombosis (Coronary thrombosis)
CL Item
Deep Vein Thrombosis (Deep Vein Thrombosis)
CL Item
Pulmonary Embolism (Pulmonary Embolism)
C50713 (NCI Thesaurus)
C0034065 (UMLS 2011AA)
PersonThromboembolismPriorThreeYearPersonalMedicalHistoryInd-3
Item
Did it occur in the last 3 years (If yes,)
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C29848 (NCI Thesaurus Property-2)
C0439234 (UMLS 2011AA Property-2)
C18772 (NCI Thesaurus Property-3)
C0262926 (UMLS 2011AA Property-3)
C0040038 (NCI Metathesaurus Property)
C66834 (NCI Thesaurus Property-4)
C0205449 (UMLS 2011AA Property-4)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
Item Group
Baseline Abnormalities
RadiationTherapyAdministeredInd-2
Item
Radiotherapy
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
ChemotherapyAdministeredInd-2
Item
Chemotherapy
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
PriorImmunotherapyAdministeredInd-3
Item
Immunotherapy
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15262 (NCI Thesaurus ObjectClass)
C0021083 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
LeukocyteGrowthFactorTherapyAdministeredInd-2
Item
Leukocyte Growth Factor
boolean
C20424 (NCI Thesaurus ObjectClass)
C0018284 (UMLS 2011AA ObjectClass)
C12529 (NCI Thesaurus ObjectClass-2)
C0023516 (UMLS 2011AA ObjectClass-2)
C15368 (NCI Thesaurus ObjectClass-3)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
TherapeuticProcedurePriorMalignantNeoplasmAdministrationYearDate
Item
Year last given (If yes,)
date
C49236 (NCI Thesaurus ObjectClass)
C0087111 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus Property)
C0006826 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C25409 (NCI Thesaurus Property-3)
C1533734 (UMLS 2011AA Property-3)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C29848 (NCI Thesaurus ValueDomain-2)
C0439234 (UMLS 2011AA ValueDomain-2)
MyelodysplasticSyndromeSecondaryDiseaseorDisorderTreatmentAssessmentInd-2
Item
Was this disease MDS secondary due to treatment
boolean
C3247 (NCI Thesaurus ObjectClass)
C3463824 (UMLS 2011AA ObjectClass)
C25367 (NCI Thesaurus Property)
C2991 (NCI Thesaurus Property-2)
C0012634 (UMLS 2011AA Property)
C15368 (NCI Thesaurus Property-3)
C25667 (NCI Thesaurus Property-4)
C0175668 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
ChemotherapyPriorCytarabineAdministeredInd-2
Item
Cytarabine
boolean
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C408 (NCI Thesaurus Property-2)
C0010711 (UMLS 2011AA Property-2)
C25382 (NCI Thesaurus Property-3)
C1521801 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item
Azacitidine
text
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C25409 (NCI Thesaurus Property-2)
C1533734 (UMLS 2011AA Property-2)
C288 (NCI Thesaurus Property-3)
C0004475 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.13
Code List
Azacitidine
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)
ChemotherapyDecitabinePriorAdministrationInd-3
Item
Decitabine
boolean
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C25409 (NCI Thesaurus Property-2)
C1533734 (UMLS 2011AA Property-2)
C981 (NCI Thesaurus Property-3)
C0049065 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
ImmunotherapyCyclosporinePriorAdministrationInd-3
Item
Cyclosporin
boolean
C15262 (NCI Thesaurus ObjectClass)
C0021083 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C406 (NCI Thesaurus Property-2)
C0010592 (UMLS 2011AA Property-2)
C25409 (NCI Thesaurus Property-3)
C1533734 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
ImmunotherapyAnti-ThymocyteGlobulinPriorAdministrationInd-3
Item
ATG (anti-thymocyte globulin)
boolean
C15262 (NCI Thesaurus ObjectClass)
C0021083 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C278 (NCI Thesaurus Property-2)
C0003442 (UMLS 2011AA Property-2)
C25409 (NCI Thesaurus Property-3)
C1533734 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
ChemotherapyThalidomidePriorAdministrationInd-3
Item
Thalidomide
boolean
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C870 (NCI Thesaurus Property-2)
C0039736 (UMLS 2011AA Property-2)
C25409 (NCI Thesaurus Property-3)
C1533734 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
TherapeuticProcedurePriorMyelodysplasticSyndromeAdministrationYearDate
Item
Year last given (If yes,)
date
C49236 (NCI Thesaurus ObjectClass)
C0087111 (UMLS 2011AA ObjectClass)
C3247 (NCI Thesaurus Property)
C3463824 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C25409 (NCI Thesaurus Property-3)
C1533734 (UMLS 2011AA Property-3)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C29848 (NCI Thesaurus ValueDomain-2)
C0439234 (UMLS 2011AA ValueDomain-2)
ImmunotherapyErythropoietinPriorAdministeredInd-2
Item
Prior Darpoietin Alpha (DA)
boolean
C15262 (NCI Thesaurus ObjectClass)
C0021083 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C20429 (NCI Thesaurus Property-2)
C0014822 (UMLS 2011AA Property-2)
C25382 (NCI Thesaurus Property-3)
C1521801 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
ImmunotherapyErythropoietinPriorAdministeredFirstDate
Item
Date (DA first administered)
date
C15262 (NCI Thesaurus ObjectClass)
C0021083 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C20429 (NCI Thesaurus Property-2)
C0014822 (UMLS 2011AA Property-2)
C25382 (NCI Thesaurus Property-3)
C1521801 (UMLS 2011AA Property-3)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25509 (NCI Thesaurus ValueDomain-2)
C1279901 (UMLS 2011AA ValueDomain-2)
ImmunotherapyErythropoietinPriorAdministeredMostRecentDate
Item
Date (DA last administered)
date
C15262 (NCI Thesaurus ObjectClass)
C0021083 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C20429 (NCI Thesaurus Property-2)
C0014822 (UMLS 2011AA Property-2)
C25382 (NCI Thesaurus Property-3)
C1521801 (UMLS 2011AA Property-3)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25577 (NCI Thesaurus ValueDomain-2)
C1513491 (UMLS 2011AA ValueDomain-2)
ImmunotherapyEpoetinAlfaPriorAdministrationInd-2
Item
Prior Epoetin Alpha
boolean
C15262 (NCI Thesaurus ObjectClass)
C0021083 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C2695 (NCI Thesaurus Property-2)
C0357126 (UMLS 2011AA Property-2)
C25382 (NCI Thesaurus Property-3)
C1521801 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
ErythropoietinAgentLastAdministeredDate
Item
Date (If yes, - EPO last administered)
date
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C20429 (NCI Thesaurus ObjectClass-2)
C0014822 (UMLS 2011AA ObjectClass-2)
C25551 (NCI Thesaurus Property)
C1517741 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
ImmunotherapyEpoetinAlfaPriorFailureInd-2
Item
Did patient have prior EPO failure
boolean
C15262 (NCI Thesaurus ObjectClass)
C0021083 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C25745 (NCI Thesaurus Property-2)
C0231174 (UMLS 2011AA Property-2)
C2695 (NCI Thesaurus Property-3)
C0357126 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
ImmunotherapyEpoetinAlfaPriorLowResponseIND-2
Item
Low EPO response profile (If no,)
boolean
C15262 (NCI Thesaurus ObjectClass)
C0021083 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C54722 (NCI Thesaurus Property-2)
C0205251 (UMLS 2011AA Property-2)
C2695 (NCI Thesaurus Property-3)
C0357126 (UMLS 2011AA Property-3)
C50995 (NCI Thesaurus Property-4)
C1704632 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
SerumErythropoietinLevelAmount
Item
Serum EPO Level (at study entry)
text
C13325 (NCI Thesaurus ObjectClass)
C0229671 (UMLS 2011AA ObjectClass)
C20429 (NCI Thesaurus Property)
C0014822 (UMLS 2011AA Property)
C25417 (NCI Thesaurus ValueDomain)
C25554 (NCI Thesaurus Property-2)
C0441889 (UMLS 2011AA Property-2)
SerumErythropoietinLevelDate
Item
Date (EPO level done)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C13325 (NCI Thesaurus ObjectClass)
C0229671 (UMLS 2011AA ObjectClass)
C20429 (NCI Thesaurus Property)
C0014822 (UMLS 2011AA Property)
C25554 (NCI Thesaurus Property-2)
C0441889 (UMLS 2011AA Property-2)
OtherErythropoietinAgentAdministeredInd-2
Item
Other prior erythropoietic growth factor (other than rhu-EPO and Darbepoetin Alfa)
boolean
C17649 (NCI Thesaurus ObjectClass)
C0205394 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C20429 (NCI Thesaurus ObjectClass-3)
C0014822 (UMLS 2011AA ObjectClass-3)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
OtherErythropoietinAgentAdministeredEndDate
Item
Date agent ended (erythropoietic growth factor)
date
C17649 (NCI Thesaurus ObjectClass)
C0205394 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C20429 (NCI Thesaurus ObjectClass-3)
C0014822 (UMLS 2011AA ObjectClass-3)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
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)
Comments
Item
Comments
text
C0947611 (UMLS CUI-1)
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