ID

43363

Descrizione

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

collegamento

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

Keywords

versioni (4)
  1. 18/12/14 18/12/14 - Martin Dugas
  2. 09/01/15 09/01/15 - Martin Dugas
  3. 16/06/15 16/06/15 -
  4. 20/09/21 20/09/21 -
Caricato su

20 settembre 2021

DOI

Per favore, per richiedere un accesso.

Licenza

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

Inglese

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 moduli  
Header
Descrizione

Header

ECOG Protocol Number
Descrizione

Protocol Number ECOG

Tipo di dati

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
Descrizione

Patient ID ECOG

Tipo di dati

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
Descrizione

Generic drug form

Tipo di dati

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
Descrizione

Registration Number

Tipo di dati

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
Descrizione

Clinical Trial Period

Tipo di dati

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)
Descrizione

Patient Initials

Tipo di dati

text

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

Study Number Participating Group

Tipo di dati

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
Descrizione

Trial subject ID Participating Group

Tipo di dati

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
Descrizione

Institution Name

Tipo di dati

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
Descrizione

Data amendment

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

Data amended

Tipo di dati

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)
Descrizione

Data amended date

Tipo di dati

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
Descrizione

Current Performance Status

ECOG Performance Status
Descrizione

ECOG Performance Status

Tipo di dati

text

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

Patient Weight

Tipo di dati

float

Unità di misura
  • Kg
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0005910
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25208
Kg
Height
Descrizione

Patient Height

Tipo di dati

float

Unità di misura
  • 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
Descrizione

IronStainingMethodLaboratoryProcedureInd-2

Tipo di dati

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
Descrizione

TransferrinSaturationPercentageValue

Tipo di dati

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
Descrizione

SerumFerritinLaboratoryProcedureOutcomeValue

Tipo di dati

text

Unità di misura
  • 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
Descrizione

PersonThromboembolismPersonalMedicalHistoryInd-3

Tipo di dati

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,)
Descrizione

PersonThromboembolismPersonalMedicalHistoryType

Tipo di dati

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,)
Descrizione

PersonThromboembolismPriorThreeYearPersonalMedicalHistoryInd-3

Tipo di dati

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
Descrizione

Baseline Abnormalities

Radiotherapy
Descrizione

RadiationTherapyAdministeredInd-2

Tipo di dati

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
Descrizione

ChemotherapyAdministeredInd-2

Tipo di dati

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
Descrizione

PriorImmunotherapyAdministeredInd-3

Tipo di dati

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
Descrizione

LeukocyteGrowthFactorTherapyAdministeredInd-2

Tipo di dati

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,)
Descrizione

TherapeuticProcedurePriorMalignantNeoplasmAdministrationYearDate

Tipo di dati

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
Descrizione

MyelodysplasticSyndromeSecondaryDiseaseorDisorderTreatmentAssessmentInd-2

Tipo di dati

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
Descrizione

ChemotherapyPriorCytarabineAdministeredInd-2

Tipo di dati

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
Descrizione

ChemotherapyAzacitidinePriorAdministrationInd-3

Tipo di dati

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
Descrizione

ChemotherapyDecitabinePriorAdministrationInd-3

Tipo di dati

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
Descrizione

ImmunotherapyCyclosporinePriorAdministrationInd-3

Tipo di dati

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)
Descrizione

ImmunotherapyAnti-ThymocyteGlobulinPriorAdministrationInd-3

Tipo di dati

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
Descrizione

ChemotherapyThalidomidePriorAdministrationInd-3

Tipo di dati

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,)
Descrizione

TherapeuticProcedurePriorMyelodysplasticSyndromeAdministrationYearDate

Tipo di dati

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)
Descrizione

ImmunotherapyErythropoietinPriorAdministeredInd-2

Tipo di dati

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)
Descrizione

ImmunotherapyErythropoietinPriorAdministeredFirstDate

Tipo di dati

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)
Descrizione

ImmunotherapyErythropoietinPriorAdministeredMostRecentDate

Tipo di dati

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
Descrizione

ImmunotherapyEpoetinAlfaPriorAdministrationInd-2

Tipo di dati

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)
Descrizione

ErythropoietinAgentLastAdministeredDate

Tipo di dati

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
Descrizione

ImmunotherapyEpoetinAlfaPriorFailureInd-2

Tipo di dati

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,)
Descrizione

ImmunotherapyEpoetinAlfaPriorLowResponseIND-2

Tipo di dati

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)
Descrizione

SerumErythropoietinLevelAmount

Tipo di dati

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)
Descrizione

SerumErythropoietinLevelDate

Tipo di dati

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)
Descrizione

OtherErythropoietinAgentAdministeredInd-2

Tipo di dati

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)
Descrizione

OtherErythropoietinAgentAdministeredEndDate

Tipo di dati

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
Descrizione

Comments

Investigator Signature
Descrizione

Investigator Signature

Tipo di dati

text

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

Investigator Signature Date

Tipo di dati

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
Descrizione

Comments

Tipo di dati

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 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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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