ID

7394

Beschreibung

E4A03 Multiple Myeloma On-Study Form - Form 2055 Lenalidomide and Dexamethasone With or Without Thalidomide in Treating Patients With Multiple Myeloma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=DD003264-3C16-26D3-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=DD003264-3C16-26D3-E034-0003BA12F5E7

Stichworte

Versionen (3)
  1. 19.09.12 19.09.12 -
  2. 09.01.15 09.01.15 - Martin Dugas
  3. 09.06.15 09.06.15 -
Hochgeladen am

9. Januar 2015

DOI

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Lizenz

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Multiple Myeloma and Plasma Cell Neoplasm NCT00098475 On-Study - E4A03 Multiple Myeloma On-Study Form - Form 2055 - 2284999v3.0

Englisch

No Instruction available.

1 Formulare  
  1. StudyEvent: E4A03 Multiple Myeloma On-Study Form - Form 2055
    1. No Instruction available.
Header
Beschreibung

Header

DCI Name
Beschreibung

Generic drug form

Datentyp

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
Beschreibung

Registration Number

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1514821
NCI Thesaurus ObjectClass
C25646
UMLS CUI-2
C0237753
NCI Thesaurus Property
C16154
NCI Thesaurus ValueDomain-2
C16154
Report Period (Place ID Label Here)
Beschreibung

ReportingPeriod

Datentyp

text

Patient Initials
Beschreibung

Patient Initials

Datentyp

text

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

Protocol Number ECOG

Datentyp

text

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

Protocol Number ECOG

Datentyp

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
Beschreibung

Patient ID ECOG

Datentyp

text

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

Patient ID ECOG

Datentyp

text

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

Study Number Participating Group

Datentyp

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
Beschreibung

Trial subject ID Participating Group

Datentyp

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
Beschreibung

Institution Name

Datentyp

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
Unnamed2
Beschreibung

Unnamed2

Are data amended
Beschreibung

Data amended

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Disease Description - Initial Diagnosis
Beschreibung

Disease Description - Initial Diagnosis

Date of Initial Pathologic Diagnosis
Beschreibung

CancerInitialDiagnosisDate

Datentyp

date

Alias
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C25509
UMLS 2011AA Property
C1279901
NCI Thesaurus Property-2
C15220
UMLS 2011AA Property-2
C0011900
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
Durie-Salmon Stage (at initial diagnosis - see attached)
Beschreibung

MyelomaDiagnosisStage

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C3242
UMLS 2011AA ObjectClass
C0026764
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
NCI Thesaurus ValueDomain
C16899
UMLS 2011AA ValueDomain
C1300072
Durie-Salmon Sub-Stage (at initial diagnosis - see attached)
Beschreibung

MyelomaDiagnosisRenalStage

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25225
UMLS 2011AA ValueDomain
C0022646
NCI Thesaurus ObjectClass
C3242
UMLS 2011AA ObjectClass
C0026764
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
NCI Thesaurus ValueDomain-2
C16899
UMLS 2011AA ValueDomain-2
C1300072
Pre-registration Hematology/chemistry
Beschreibung

Pre-registration Hematology/chemistry

Peripheral WBC Count LLN (/mm3 x1000)
Beschreibung

LaboratoryProcedureLeukocyteResultLowerLimitofNormalValue

Datentyp

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C12529
UMLS 2011AA Property
C0023516
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25555
UMLS 2011AA ValueDomain-2
C1518030
Peripheral WBC Count
Beschreibung

Leukocytes (WBC)

Datentyp

float

Maßeinheiten
  • 1000/uL
Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0023508
NCI Thesaurus Property
C12529
NCI Thesaurus Property-2
C20200
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C38024
1000/uL
Peripheral Granulocytes Count LLN (AGC.ANC /mm3)
Beschreibung

LaboratoryProcedureGranulocyteResultLowerLimitofNormalCount

Datentyp

float

Maßeinheiten
  • mm3
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C12530
UMLS 2011AA Property-2
C0018183
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
NCI Thesaurus ValueDomain-2
C25555
UMLS 2011AA ValueDomain-2
C1518030
mm3
Peripheral Granulocytes Count
Beschreibung

Granulocyte count

Datentyp

float

Maßeinheiten
  • 1000/uL
Alias
NCI Thesaurus Property
C20200
UMLS CUI-1
C0857490
NCI Thesaurus Property-2
C12530
NCI Thesaurus ValueDomain
C25463
NCI Thesaurus ObjectClass
C25294
1000/uL
Peripheral platelet count LLN (/mm3 x1000)
Beschreibung

Platelets LLN

Datentyp

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0005821
NCI Thesaurus Property
C20200
UMLS CUI-2
C1518030
NCI Thesaurus Property-2
C12520
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25555
Peripheral platelet count
Beschreibung

Platelets

Datentyp

float

Maßeinheiten
  • 1000/uL
Alias
NCI Thesaurus Property
C20200
UMLS CUI-1
C0005821
NCI Thesaurus Property-2
C12520
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25712
1000/uL
Alkaline Phosphatase ULN (U/L)
Beschreibung

Alkaline Phosphatase ULN

Datentyp

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0151420
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C16276
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25706
Patient Initials
Beschreibung

Patient Initials

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Alkaline Phosphatase
Beschreibung

HepaticAlkalinePhosphataseLabValue

Datentyp

float

Alias
NCI Thesaurus ObjectClass
C13308
UMLS 2011AA ObjectClass
C0205054
NCI Thesaurus Property
C37984
UMLS 2011AA Property
C0022877
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus Property-2
C16276
UMLS 2011AA Property-2
C0002059
Bilirubin ULN (mg/dl)
Beschreibung

HepaticBilirubinLabUpperLimitNormalValue

Datentyp

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C305
UMLS 2011AA Property-2
C0005437
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25706
UMLS 2011AA ValueDomain-2
C1519815
ECOG Patient ID
Beschreibung

Patient ID ECOG

Datentyp

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
Bilirubin
Beschreibung

HepaticBilirubinLabValue

Datentyp

float

Maßeinheiten
  • mg/dL
Alias
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C305
UMLS 2011AA Property-2
C0005437
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
mg/dL
Creatinine ULN (mg/dl)
Beschreibung

Creatinine, serum ULN

Datentyp

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0201976
NCI Thesaurus Property
C20200
UMLS CUI-2
C1519815
NCI Thesaurus Property-2
C399
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25706
Creatinine
Beschreibung

RenalCreatinineLabSpecifiedValue

Datentyp

float

Maßeinheiten
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25225
UMLS 2011AA ObjectClass
C0022646
NCI Thesaurus Property
C399
UMLS 2011AA Property
C0010294
NCI Thesaurus Property-2
C25294
UMLS 2011AA Property-2
C0022885
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
mg/dL
Hemoglobin (Hgb), LLN (g/dl)
Beschreibung

Hemoglobin LLN

Datentyp

float

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

LaboratoryProcedureHemoglobinResultSpecifiedValue

Datentyp

float

Maßeinheiten
  • g/dL
Alias
NCI Thesaurus Property
C16676
UMLS 2011AA Property
C0019046
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
g/dL
SGOT (AST) ULN
Beschreibung

LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedUpperLimitofNormalValue

Datentyp

float

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

HepaticSGOT(AST)LabUnspecifiedValue

Datentyp

float

Alias
NCI Thesaurus ObjectClass
C13308
UMLS 2011AA ObjectClass
C0205054
NCI Thesaurus Property
C25202
UMLS 2011AA Property
C0242192
NCI Thesaurus Property-2
C37984
UMLS 2011AA Property-2
C0022877
NCI Thesaurus ValueDomain
C38046
UMLS 2011AA ValueDomain
C0205370
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
SGPT (ALT) ULN
Beschreibung

LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultUpperLimitofNormalValue

Datentyp

float

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

HepaticSGPT(ALT)LabUnspecifiedValue

Datentyp

float

Alias
NCI Thesaurus ObjectClass
C13308
UMLS 2011AA ObjectClass
C0205054
NCI Thesaurus Property
C37984
UMLS 2011AA Property
C0022877
NCI Thesaurus Property-2
C25293
UMLS 2011AA Property-2
C0376147
NCI Thesaurus ValueDomain
C38046
UMLS 2011AA ValueDomain
C0205370
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
Albumin LLN (g/dl)
Beschreibung

LaboratoryProcedureAlbuminResultLowerLimitofNormalValue

Datentyp

float

Alias
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C214
UMLS 2011AA Property-2
C0001924
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25555
UMLS 2011AA ValueDomain-2
C1518030
Albumin
Beschreibung

LaboratoryProcedureAlbuminResultUnspecifiedValue

Datentyp

float

Alias
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C214
UMLS 2011AA Property-2
C0001924
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
Calcium LLN (Ca mg/dl)
Beschreibung

LaboratoryProcedureCalciumElectrolytesOutcomeLowerLimitofNormalValue

Datentyp

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C331
UMLS 2011AA Property
C0006675
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus Property-3
C464
UMLS 2011AA Property-3
C0013832
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25555
UMLS 2011AA ValueDomain-2
C1518030
Calcium ULN
Beschreibung

LaboratoryProcedureCalciumElectrolytesOutcomeUpperLimitofNormalValue

Datentyp

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C331
UMLS 2011AA Property
C0006675
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus Property-3
C464
UMLS 2011AA Property-3
C0013832
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25706
UMLS 2011AA ValueDomain-2
C1519815
Calcium
Beschreibung

ElectrolytesCalciumLabSpecifiedValue

Datentyp

float

Maßeinheiten
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C331
UMLS 2011AA Property
C0006675
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus Property-3
C464
UMLS 2011AA Property-3
C0013832
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
mg/dL
Glucose LLN (mg/dl)
Beschreibung

LaboratoryProcedureGlucoseElectrolytesOutcomeLowerLimitofNormalValue

Datentyp

float

Maßeinheiten
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C2831
UMLS 2011AA Property-2
C0017725
NCI Thesaurus Property-3
C464
UMLS 2011AA Property-3
C0013832
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25555
UMLS 2011AA ValueDomain-2
C1518030
mg/dL
Glucose ULN
Beschreibung

LaboratoryProcedureGlucoseElectrolytesOutcomeUpperLimitNormalValue

Datentyp

float

Maßeinheiten
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C2831
UMLS 2011AA Property-2
C0017725
NCI Thesaurus Property-3
C464
UMLS 2011AA Property-3
C0013832
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25706
UMLS 2011AA ValueDomain-2
C1519815
mg/dL
Glucose
Beschreibung

LaboratoryProcedureGlucoseElectrolytesOutcomeUnspecifiedValue

Datentyp

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C2831
UMLS 2011AA Property-2
C0017725
NCI Thesaurus Property-3
C464
UMLS 2011AA Property-3
C0013832
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
Potassium LLN (K mmol/L)
Beschreibung

LaboratoryProcedurePotassiumElectrolytesOutcomeLowerLimitNormalValue

Datentyp

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C464
UMLS 2011AA Property-2
C0013832
NCI Thesaurus Property-3
C765
UMLS 2011AA Property-3
C0032821
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25555
UMLS 2011AA ValueDomain-2
C1518030
Potassium ULN
Beschreibung

LaboratoryProcedurePotassiumElectrolytesOutcomeUpperLimitNormalValue

Datentyp

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C464
UMLS 2011AA Property-2
C0013832
NCI Thesaurus Property-3
C765
UMLS 2011AA Property-3
C0032821
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25706
UMLS 2011AA ValueDomain-2
C1519815
Potassium
Beschreibung

LaboratoryProcedurePotassiumElectrolytesOutcomeSpecifiedValue

Datentyp

float

Maßeinheiten
  • mmol/L
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C464
UMLS 2011AA Property-2
C0013832
NCI Thesaurus Property-3
C765
UMLS 2011AA Property-3
C0032821
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
mmol/L
Sodium LLN (Na mmol/L)
Beschreibung

LaboratoryProcedureSodiumElectrolytesOutcomeLowerLimitofNormalValue

Datentyp

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C830
UMLS 2011AA Property-2
C0037473
NCI Thesaurus Property-3
C464
UMLS 2011AA Property-3
C0013832
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25555
UMLS 2011AA ValueDomain-2
C1518030
Sodium ULN
Beschreibung

LaboratoryProcedureSodiumElectrolytesOutcomeUpperLimitofNormalValue

Datentyp

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C830
UMLS 2011AA Property-2
C0037473
NCI Thesaurus Property-3
C464
UMLS 2011AA Property-3
C0013832
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25706
UMLS 2011AA ValueDomain-2
C1519815
Sodium
Beschreibung

LaboratoryProcedureSodiumElectrolytesOutcomeSpecifiedValue

Datentyp

float

Maßeinheiten
  • mmol/L
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C830
UMLS 2011AA Property-2
C0037473
NCI Thesaurus Property-3
C464
UMLS 2011AA Property-3
C0013832
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
mmol/L
Uric acid LLN (mg/dl)
Beschreibung

LaboratoryProcedureUricAcidResultSpecifiedLowerLimitofNormalValue

Datentyp

float

Maßeinheiten
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C62652
UMLS 2011AA Property-2
C0041980
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C38024
UMLS 2011AA ValueDomain-2
C0205369
NCI Thesaurus ValueDomain-3
C25555
UMLS 2011AA ValueDomain-3
C1518030
mg/dL
Uric acid ULN
Beschreibung

LaboratoryProcedureUricAcidResultUpperLimitofNormalValue

Datentyp

float

Maßeinheiten
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C62652
UMLS 2011AA Property-2
C0041980
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25706
UMLS 2011AA ValueDomain-2
C1519815
mg/dL
Uric acid
Beschreibung

LaboratoryProcedureUricAcidResultSpecifiedValue

Datentyp

float

Maßeinheiten
  • mg/dL
Alias
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus Property-2
C62652
UMLS 2011AA Property-2
C0041980
mg/dL
Date Hematology (Blood) Sample Obtained
Beschreibung

HematologyLabCollectedDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus ValueDomain-2
C25452
Current Infections (last 6 Months)
Beschreibung

Current Infections (last 6 Months)

CTC Adverse Event Term Type (Specify site for each event)
Beschreibung

CommonToxicityCriteriaAdverseEventShortNameType

Datentyp

text

Alias
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Metathesaurus ValueDomain
C0332307
NCI Thesaurus Property-2
C25249
UMLS 2011AA Property-2
C1806781
Specify site
Beschreibung

CTCAdverseEventSiteSpecify

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
CTC Adverse Event Grade (Use grade 1-4 per CTCAE v3)
Beschreibung

CommonToxicityCriteriaAdverseEventGrade

Datentyp

float

Alias
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus ValueDomain
C18000
UMLS 2011AA ValueDomain
C0919553
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Current Clinical Date
Beschreibung

Current Clinical Date

Performance status
Beschreibung

PerformanceStatusScale

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
NCI Thesaurus ObjectClass
C25361
UMLS 2011AA ObjectClass
C0597198
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Serum pregnancy test result
Beschreibung

TestPregnancyInd

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus Property
C25742
UMLS 2011AA Property
C0032961
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
Date of serum pregnancy test
Beschreibung

PatientMostRecentPregnancyTestDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Metathesaurus Property
C0032976
NCI Thesaurus Property
C25577
UMLS 2011AA Property
C1513491
Bone pain on entry to study
Beschreibung

PainBoneSymptomType

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C3303
UMLS 2011AA ObjectClass
C0030193
NCI Thesaurus ObjectClass-2
C12366
UMLS 2011AA ObjectClass-2
C0262950
NCI Thesaurus Property
C4876
UMLS 2011AA Property
C1457887
Is severe osteoporosis present?
Beschreibung

DiseaseSevereOsteoporosisDiagnosisInd-3

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property
C3298
UMLS 2011AA Property
C0029456
NCI Thesaurus Property-2
C70667
UMLS 2011AA Property-2
C0205082
NCI Thesaurus Property-3
C15220
UMLS 2011AA Property-3
C0011900
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Number of bones with lytic lesions present
Beschreibung

LyticLesionBoneDetectedType

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus ObjectClass-2
C27963
UMLS 2011AA ObjectClass-2
C0439680
NCI Thesaurus Property
C12366
UMLS 2011AA Property
C0262950
NCI Thesaurus Property-2
C25481
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Number of lytic lesions > 2 cm in diameter
Beschreibung

LyticLesionMediumDetectedType

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus ObjectClass-2
C27963
UMLS 2011AA ObjectClass-2
C0439680
NCI Thesaurus Property
C49507
UMLS 2011AA Property
C0439536
NCI Thesaurus Property-2
C25481
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Patient Initials
Beschreibung

Patient Initials

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Pathologic fracture during previous 1 month (including compression and rib fractures)
Beschreibung

BonePathologicFractureInd-3

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25610
UMLS 2011AA Property
C1521733
NCI Thesaurus ObjectClass
C12366
UMLS 2011AA ObjectClass
C0262950
NCI Thesaurus Property-2
C3046
UMLS 2011AA Property-2
C0016658
ECOG Patient ID
Beschreibung

Patient ID ECOG

Datentyp

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
Is patient on anti-coagulation therapy?
Beschreibung

Anticoagulation therapy daily

Datentyp

boolean

Alias
NCI Thesaurus ObjectClass
C263
UMLS CUI-1
C0003280
NCI Thesaurus Property
C25473
UMLS CUI-2
C0332173
NCI Thesaurus Property-2
C25629
NCI Thesaurus Property-3
C25409
NCI Thesaurus ValueDomain
C38148
Prior Therapy
Beschreibung

Prior Therapy

Prior corticosteroids?
Beschreibung

CorticosteroidPriorAdministeredInd-3

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus ObjectClass
C2322
UMLS 2011AA ObjectClass
C0001617
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
Specify (If yes,)
Beschreibung

PriorCorticosteroidAdministeredSpecify

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus ObjectClass
C2322
UMLS 2011AA ObjectClass
C0001617
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
Prior bisphosphanate therapy?
Beschreibung

Bisphosphonates

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0012544
NCI Thesaurus ObjectClass
C443
NCI Thesaurus ObjectClass-2
C37902
NCI Thesaurus Property
C25382
Bisphosphanate type(s) received (If yes,)
Beschreibung

Bisphosphonates type

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C0012544
NCI Thesaurus ObjectClass
C443
UMLS CUI-2
C0683312
NCI Thesaurus ObjectClass-2
C37902
NCI Thesaurus Property
C25382
Prior radiation therapy?
Beschreibung

Prior Radiation Therapy

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C1522449
NCI Thesaurus ObjectClass
C15313
UMLS CUI-2
C0332152
NCI Thesaurus ObjectClass-2
C25629
NCI Thesaurus Property
C25382
Sites of prior RT (If yes,)
Beschreibung

SitesofpriorRT

Datentyp

text

Date prior RT ended (Record any symptoms, complaints or diagnostic test abnormalities that were present at the time of registration for which a CTCAE term exists.)
Beschreibung

RTPriorEndDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C15313
UMLS 2011AA ObjectClass
C1522449
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
Baseline Abnormalities
Beschreibung

Baseline Abnormalities

CTC Adverse Event Term Type (include subterm if applicable Use CTCAE v3 terminology)
Beschreibung

CommonToxicityCriteriaAdverseEventTermType

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C45559
UMLS 2011AA Property
C1705313
CTC Adverse Event Grade (Use grade 1-4 per CTCAE v3)
Beschreibung

CommonToxicityCriteriaAdverseEventGrade

Datentyp

float

Alias
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus ValueDomain
C18000
UMLS 2011AA ValueDomain
C0919553
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Comments
Beschreibung

Comments

Comments
Beschreibung

Research Comments

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
Investigator Signature
Beschreibung

Investigator Signature

Datentyp

text

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

Investigator Signature Date

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2346576
NCI Thesaurus Property
C25678
UMLS CUI-2
C0011008
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C17089
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1 Formulare
  1. StudyEvent: E4A03 Multiple Myeloma On-Study Form - Form 2055
    1. No Instruction available.
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Header
Generic drug form
Item
DCI Name
text
C25191 (NCI Thesaurus ValueDomain)
C3242750 (UMLS CUI-1)
C19464 (NCI Thesaurus Property)
C25474 (NCI Thesaurus ObjectClass)
C25452 (NCI Thesaurus ObjectClass-2)
Registration Number
Item
Registration Step
text
C25337 (NCI Thesaurus ValueDomain)
C1514821 (UMLS CUI-1)
C25646 (NCI Thesaurus ObjectClass)
C0237753 (UMLS CUI-2)
C16154 (NCI Thesaurus Property)
C16154 (NCI Thesaurus ValueDomain-2)
Item
Report Period (Place ID Label Here)
text
CL.1
Code List
Report Period (Place ID Label Here)
CL Item
Baseline Step 1 (Baseline Step 1)
Patient Initials
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Protocol Number ECOG
Item
ECOG Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Protocol Number ECOG
Item
ECOG Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Patient ID ECOG
Item
ECOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Patient ID ECOG
Item
ECOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Study Number Participating Group
Item
Participating Group Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Trial subject ID Participating Group
Item
Participating Group Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Institution Name
Item
Institution/Affiliate
text
C25454 (NCI Thesaurus ObjectClass)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)
Item Group
Unnamed2
Data amended
Item
Are data amended
boolean
C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Item Group
Disease Description - Initial Diagnosis
CancerInitialDiagnosisDate
Item
Date of Initial Pathologic Diagnosis
date
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property-2)
C0011900 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Item
Durie-Salmon Stage (at initial diagnosis - see attached)
text
C3242 (NCI Thesaurus ObjectClass)
C0026764 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
CL.3
Code List
Durie-Salmon Stage (at initial diagnosis - see attached)
CL Item
I - All Of The Following Must Be Present (hemoglobin >10 G/dl; Serum Calcium <12 Mg/dl; Urine Light Chains <4 G/24 Hrs; Normal Bones On Radiograph Or Solitary Plasmacytoma; Igg <5 G/dl; Iga <3 G/dl) (I)
CL Item
Ii - Fitting Neither Stage I Or Stage Iii (II)
CL Item
Iii - One Of The Following Must Be Present (hemoglobin <8.5 G/dl; Serum Calcium >12 Mg/dl; Urine Light Chains >12 G/24 Hrs; Advanced Lytic Bone Lesions (>3 Lytic Lesions); Igg >7 G/dl; Iga >5 G/dl) (III)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Durie-Salmon Sub-Stage (at initial diagnosis - see attached)
text
C25225 (NCI Thesaurus ValueDomain)
C0022646 (UMLS 2011AA ValueDomain)
C3242 (NCI Thesaurus ObjectClass)
C0026764 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C16899 (NCI Thesaurus ValueDomain-2)
C1300072 (UMLS 2011AA ValueDomain-2)
CL.4
Code List
Durie-Salmon Sub-Stage (at initial diagnosis - see attached)
CL Item
A (relatively Normal Renal Function - Serum Creatinine <2.0 Mg/dl) (A)
CL Item
B (abnormal Renal Function - Serum Creatinine >= 2.0 Mg/dl) (B)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item Group
Pre-registration Hematology/chemistry
LaboratoryProcedureLeukocyteResultLowerLimitofNormalValue
Item
Peripheral WBC Count LLN (/mm3 x1000)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C12529 (NCI Thesaurus Property)
C0023516 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C1518030 (UMLS 2011AA ValueDomain-2)
Leukocytes (WBC)
Item
Peripheral WBC Count
float
C25294 (NCI Thesaurus ObjectClass)
C0023508 (UMLS CUI-1)
C12529 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C38024 (NCI Thesaurus ValueDomain-2)
LaboratoryProcedureGranulocyteResultLowerLimitofNormalCount
Item
Peripheral Granulocytes Count LLN (AGC.ANC /mm3)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12530 (NCI Thesaurus Property-2)
C0018183 (UMLS 2011AA Property-2)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C1518030 (UMLS 2011AA ValueDomain-2)
Granulocyte count
Item
Peripheral Granulocytes Count
float
C20200 (NCI Thesaurus Property)
C0857490 (UMLS CUI-1)
C12530 (NCI Thesaurus Property-2)
C25463 (NCI Thesaurus ValueDomain)
C25294 (NCI Thesaurus ObjectClass)
Platelets LLN
Item
Peripheral platelet count LLN (/mm3 x1000)
float
C25294 (NCI Thesaurus ObjectClass)
C0005821 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C1518030 (UMLS CUI-2)
C12520 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
Platelets
Item
Peripheral platelet count
float
C20200 (NCI Thesaurus Property)
C0005821 (UMLS CUI-1)
C12520 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
Alkaline Phosphatase ULN
Item
Alkaline Phosphatase ULN (U/L)
float
C25294 (NCI Thesaurus ObjectClass)
C0151420 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C16276 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
Patient Initials
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
HepaticAlkalinePhosphataseLabValue
Item
Alkaline Phosphatase
float
C13308 (NCI Thesaurus ObjectClass)
C0205054 (UMLS 2011AA ObjectClass)
C37984 (NCI Thesaurus Property)
C0022877 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C16276 (NCI Thesaurus Property-2)
C0002059 (UMLS 2011AA Property-2)
HepaticBilirubinLabUpperLimitNormalValue
Item
Bilirubin ULN (mg/dl)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C305 (NCI Thesaurus Property-2)
C0005437 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-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)
HepaticBilirubinLabValue
Item
Bilirubin
float
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C305 (NCI Thesaurus Property-2)
C0005437 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
Creatinine, serum ULN
Item
Creatinine ULN (mg/dl)
float
C25294 (NCI Thesaurus ObjectClass)
C0201976 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C1519815 (UMLS CUI-2)
C399 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
RenalCreatinineLabSpecifiedValue
Item
Creatinine
float
C25225 (NCI Thesaurus ObjectClass)
C0022646 (UMLS 2011AA ObjectClass)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property-2)
C0022885 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
Hemoglobin LLN
Item
Hemoglobin (Hgb), LLN (g/dl)
float
C25294 (NCI Thesaurus ObjectClass)
C0019046 (UMLS CUI-1)
C16676 (NCI Thesaurus Property)
C1518030 (UMLS CUI-2)
C20200 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C38024 (NCI Thesaurus ValueDomain-2)
C25555 (NCI Thesaurus ValueDomain-3)
LaboratoryProcedureHemoglobinResultSpecifiedValue
Item
Hemoglobin (Hgb)
float
C16676 (NCI Thesaurus Property)
C0019046 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedUpperLimitofNormalValue
Item
SGOT (AST) ULN
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)
HepaticSGOT(AST)LabUnspecifiedValue
Item
SGOT (AST)
float
C13308 (NCI Thesaurus ObjectClass)
C0205054 (UMLS 2011AA ObjectClass)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C37984 (NCI Thesaurus Property-2)
C0022877 (UMLS 2011AA Property-2)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultUpperLimitofNormalValue
Item
SGPT (ALT) ULN
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25293 (NCI Thesaurus Property-2)
C0376147 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)
HepaticSGPT(ALT)LabUnspecifiedValue
Item
SGPT (ALT)
float
C13308 (NCI Thesaurus ObjectClass)
C0205054 (UMLS 2011AA ObjectClass)
C37984 (NCI Thesaurus Property)
C0022877 (UMLS 2011AA Property)
C25293 (NCI Thesaurus Property-2)
C0376147 (UMLS 2011AA Property-2)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
LaboratoryProcedureAlbuminResultLowerLimitofNormalValue
Item
Albumin LLN (g/dl)
float
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C214 (NCI Thesaurus Property-2)
C0001924 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C1518030 (UMLS 2011AA ValueDomain-2)
LaboratoryProcedureAlbuminResultUnspecifiedValue
Item
Albumin
float
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C214 (NCI Thesaurus Property-2)
C0001924 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureCalciumElectrolytesOutcomeLowerLimitofNormalValue
Item
Calcium LLN (Ca mg/dl)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C331 (NCI Thesaurus Property)
C0006675 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C464 (NCI Thesaurus Property-3)
C0013832 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C1518030 (UMLS 2011AA ValueDomain-2)
LaboratoryProcedureCalciumElectrolytesOutcomeUpperLimitofNormalValue
Item
Calcium ULN
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C331 (NCI Thesaurus Property)
C0006675 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C464 (NCI Thesaurus Property-3)
C0013832 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)
ElectrolytesCalciumLabSpecifiedValue
Item
Calcium
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C331 (NCI Thesaurus Property)
C0006675 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C464 (NCI Thesaurus Property-3)
C0013832 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureGlucoseElectrolytesOutcomeLowerLimitofNormalValue
Item
Glucose LLN (mg/dl)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C2831 (NCI Thesaurus Property-2)
C0017725 (UMLS 2011AA Property-2)
C464 (NCI Thesaurus Property-3)
C0013832 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C1518030 (UMLS 2011AA ValueDomain-2)
LaboratoryProcedureGlucoseElectrolytesOutcomeUpperLimitNormalValue
Item
Glucose ULN
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C2831 (NCI Thesaurus Property-2)
C0017725 (UMLS 2011AA Property-2)
C464 (NCI Thesaurus Property-3)
C0013832 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)
LaboratoryProcedureGlucoseElectrolytesOutcomeUnspecifiedValue
Item
Glucose
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C2831 (NCI Thesaurus Property-2)
C0017725 (UMLS 2011AA Property-2)
C464 (NCI Thesaurus Property-3)
C0013832 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedurePotassiumElectrolytesOutcomeLowerLimitNormalValue
Item
Potassium LLN (K mmol/L)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C464 (NCI Thesaurus Property-2)
C0013832 (UMLS 2011AA Property-2)
C765 (NCI Thesaurus Property-3)
C0032821 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C1518030 (UMLS 2011AA ValueDomain-2)
LaboratoryProcedurePotassiumElectrolytesOutcomeUpperLimitNormalValue
Item
Potassium ULN
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C464 (NCI Thesaurus Property-2)
C0013832 (UMLS 2011AA Property-2)
C765 (NCI Thesaurus Property-3)
C0032821 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)
LaboratoryProcedurePotassiumElectrolytesOutcomeSpecifiedValue
Item
Potassium
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C464 (NCI Thesaurus Property-2)
C0013832 (UMLS 2011AA Property-2)
C765 (NCI Thesaurus Property-3)
C0032821 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureSodiumElectrolytesOutcomeLowerLimitofNormalValue
Item
Sodium LLN (Na mmol/L)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C830 (NCI Thesaurus Property-2)
C0037473 (UMLS 2011AA Property-2)
C464 (NCI Thesaurus Property-3)
C0013832 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C1518030 (UMLS 2011AA ValueDomain-2)
LaboratoryProcedureSodiumElectrolytesOutcomeUpperLimitofNormalValue
Item
Sodium ULN
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C830 (NCI Thesaurus Property-2)
C0037473 (UMLS 2011AA Property-2)
C464 (NCI Thesaurus Property-3)
C0013832 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)
LaboratoryProcedureSodiumElectrolytesOutcomeSpecifiedValue
Item
Sodium
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C830 (NCI Thesaurus Property-2)
C0037473 (UMLS 2011AA Property-2)
C464 (NCI Thesaurus Property-3)
C0013832 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureUricAcidResultSpecifiedLowerLimitofNormalValue
Item
Uric acid LLN (mg/dl)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C62652 (NCI Thesaurus Property-2)
C0041980 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C38024 (NCI Thesaurus ValueDomain-2)
C0205369 (UMLS 2011AA ValueDomain-2)
C25555 (NCI Thesaurus ValueDomain-3)
C1518030 (UMLS 2011AA ValueDomain-3)
LaboratoryProcedureUricAcidResultUpperLimitofNormalValue
Item
Uric acid ULN
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C62652 (NCI Thesaurus Property-2)
C0041980 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)
LaboratoryProcedureUricAcidResultSpecifiedValue
Item
Uric acid
float
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C62652 (NCI Thesaurus Property-2)
C0041980 (UMLS 2011AA Property-2)
HematologyLabCollectedDate
Item
Date Hematology (Blood) Sample Obtained
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25452 (NCI Thesaurus ValueDomain-2)
Item Group
Current Infections (last 6 Months)
Item
CTC Adverse Event Term Type (Specify site for each event)
text
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C0332307 (NCI Metathesaurus ValueDomain)
C25249 (NCI Thesaurus Property-2)
C1806781 (UMLS 2011AA Property-2)
CL.5
Code List
CTC Adverse Event Term Type (Specify site for each event)
CL Item
Infection (documented Clinically Or Microbiologically) With Grade 3 Or 4 Neutrophils (anc <1.0 X 10^9/l) (Infection with Grade 3 or 4 neutrophils)
CL Item
Infection With Normal Anc Or Grade 1 Or 2 Neutrophils (Infection with normal ANC or Grade 1 or 2 neutrophils)
CL Item
Infection With Unknown Anc (Infection with unknown ANC)
CTCAdverseEventSiteSpecify
Item
Specify site
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
CommonToxicityCriteriaAdverseEventGrade
Item
CTC Adverse Event Grade (Use grade 1-4 per CTCAE v3)
float
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Item Group
Current Clinical Date
Item
Performance status
text
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C25361 (NCI Thesaurus ObjectClass)
C0597198 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.6
Code List
Performance status
CL Item
Fully Active, Able To Carry On All Pre-disease Performance Without Restriction (karnofsky 90 - 100) (ecog - 0 Asymptomatic) (0)
CL Item
Restricted In Physically Strenuous Activity But Ambulatory (k70 - 80) (ecog - 1 Symptomatic - Fully Ambulatory) (1)
CL Item
Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities (k 50 - 60) (ecog - 2 Symptomatic; In Bed , 50% Of The Day) (2)
CL Item
Capable Of Limited Selfcare, Confined To Bed Or Chair More Than 50% Of Waking Hours. (k 30 - 40) (ecog - 3 Symptomatic; In Bed > 50% Of The Day But Not Bedridden) (3)
CL Item
Completely Disabled (k10 - 20) (ecog - 4 Bedridden) (4)
Item
Serum pregnancy test result
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C25742 (NCI Thesaurus Property)
C0032961 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
CL.7
Code List
Serum pregnancy test result
CL Item
Negative (negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Positive (positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
CL Item
Unknown (not done)
CL Item
Not Applicable, Not Female Of Child-bearing Potential (not applicable, patient not female of child-bearing potential)
PatientMostRecentPregnancyTestDate
Item
Date of serum pregnancy test
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C0032976 (NCI Metathesaurus Property)
C25577 (NCI Thesaurus Property)
C1513491 (UMLS 2011AA Property)
Item
Bone pain on entry to study
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C3303 (NCI Thesaurus ObjectClass)
C0030193 (UMLS 2011AA ObjectClass)
C12366 (NCI Thesaurus ObjectClass-2)
C0262950 (UMLS 2011AA ObjectClass-2)
C4876 (NCI Thesaurus Property)
C1457887 (UMLS 2011AA Property)
CL.8
Code List
Bone pain on entry to study
CL Item
None (none)
C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)
CL Item
Mild Requires Only Non-narcotic Medication (mild, requires use of non-narcotic pain relief)
CL Item
Requires Occasional Narcotics (requires occasional narcotics)
CL Item
Requires Per Os Narcotics (requires p.o. narcotics)
CL Item
Requires Parenteral Narcotics Or Patch (requires parenteral narcotics, or patch)
CL Item
Uncontrollable Pain (uncontrollable pain)
CL Item
Unknown (unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Is severe osteoporosis present?
text
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C3298 (NCI Thesaurus Property)
C0029456 (UMLS 2011AA Property)
C70667 (NCI Thesaurus Property-2)
C0205082 (UMLS 2011AA Property-2)
C15220 (NCI Thesaurus Property-3)
C0011900 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.9
Code List
Is severe osteoporosis present?
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Number of bones with lytic lesions present
text
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C27963 (NCI Thesaurus ObjectClass-2)
C0439680 (UMLS 2011AA ObjectClass-2)
C12366 (NCI Thesaurus Property)
C0262950 (UMLS 2011AA Property)
C25481 (NCI Thesaurus Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.10
Code List
Number of bones with lytic lesions present
CL Item
None (none)
C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)
CL Item
1-3 Bones (1-3 bones)
CL Item
More Than 3 Bones (more than 3 bones)
CL Item
Unknown (unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Number of lytic lesions > 2 cm in diameter
text
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C27963 (NCI Thesaurus ObjectClass-2)
C0439680 (UMLS 2011AA ObjectClass-2)
C49507 (NCI Thesaurus Property)
C0439536 (UMLS 2011AA Property)
C25481 (NCI Thesaurus Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.11
Code List
Number of lytic lesions > 2 cm in diameter
CL Item
None (none)
C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)
CL Item
1-3 Lesions (1-3 bones)
CL Item
More Than 3 Lesions (more than 3 bones)
CL Item
Unknown (unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Patient Initials
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Item
Pathologic fracture during previous 1 month (including compression and rib fractures)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25610 (NCI Thesaurus Property)
C1521733 (UMLS 2011AA Property)
C12366 (NCI Thesaurus ObjectClass)
C0262950 (UMLS 2011AA ObjectClass)
C3046 (NCI Thesaurus Property-2)
C0016658 (UMLS 2011AA Property-2)
CL.12
Code List
Pathologic fracture during previous 1 month (including compression and rib fractures)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
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)
Anticoagulation therapy daily
Item
Is patient on anti-coagulation therapy?
boolean
C263 (NCI Thesaurus ObjectClass)
C0003280 (UMLS CUI-1)
C25473 (NCI Thesaurus Property)
C0332173 (UMLS CUI-2)
C25629 (NCI Thesaurus Property-2)
C25409 (NCI Thesaurus Property-3)
C38148 (NCI Thesaurus ValueDomain)
Item Group
Prior Therapy
CorticosteroidPriorAdministeredInd-3
Item
Prior corticosteroids?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C2322 (NCI Thesaurus ObjectClass)
C0001617 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
PriorCorticosteroidAdministeredSpecify
Item
Specify (If yes,)
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C2322 (NCI Thesaurus ObjectClass)
C0001617 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
Bisphosphonates
Item
Prior bisphosphanate therapy?
boolean
C38148 (NCI Thesaurus ValueDomain)
C0012544 (UMLS CUI-1)
C443 (NCI Thesaurus ObjectClass)
C37902 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property)
Item
Bisphosphanate type(s) received (If yes,)
text
C25284 (NCI Thesaurus ValueDomain)
C0012544 (UMLS CUI-1)
C443 (NCI Thesaurus ObjectClass)
C0683312 (UMLS CUI-2)
C37902 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property)
CL.16
Code List
Bisphosphanate type(s) received (If yes,)
CL Item
Pamidronate (pamidronate)
CL Item
Zoledronic Acid (zoledronic acid)
CL Item
Both Pamidronate And Zoledronic Acid (both pamidronate and zoledronic acid)
Prior Radiation Therapy
Item
Prior radiation therapy?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1522449 (UMLS CUI-1)
C15313 (NCI Thesaurus ObjectClass)
C0332152 (UMLS CUI-2)
C25629 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property)
SitesofpriorRT
Item
Sites of prior RT (If yes,)
text
RTPriorEndDate
Item
Date prior RT ended (Record any symptoms, complaints or diagnostic test abnormalities that were present at the time of registration for which a CTCAE term exists.)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
Item Group
Baseline Abnormalities
Item
CTC Adverse Event Term Type (include subterm if applicable Use CTCAE v3 terminology)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C45559 (NCI Thesaurus Property)
C1705313 (UMLS 2011AA Property)
CL.18
Code List
CTC Adverse Event Term Type (include subterm if applicable Use CTCAE v3 terminology)
CL Item
Thrombosis Nos (Thrombosis/thrombus/embolism)
CL Item
Peripheral Sensory Neuropathy (Neuropathy - sensory)
C3501 (NCI Thesaurus)
C0151313 (UMLS 2011AA)
CommonToxicityCriteriaAdverseEventGrade
Item
CTC Adverse Event Grade (Use grade 1-4 per CTCAE v3)
float
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Item Group
Comments
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
Investigator Signature
Item
Investigator Signature
text
C25704 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
Investigator Signature Date
Item
Investigator Signature Date
date
C25164 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C25367 (NCI Thesaurus ValueDomain-2)
C17089 (NCI Thesaurus ObjectClass)
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