ID

11032

Description

E4A08 Baseline Disease Assessment Form NCT01078454 Melphalan and Dexamethasone With or Without Bortezomib in Treating Patients With Previously Untreated Systemic Light-Chain Amyloidosis Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=7BCCA614-5186-15BB-E040-BB89AD4326D3

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=7BCCA614-5186-15BB-E040-BB89AD4326D3

Keywords

Versions (3)
  1. 9/19/12 9/19/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 6/16/15 6/16/15 -
Uploaded on

June 16, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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E4A08 Baseline Disease Assessment Form NCT01078454

English

No Instruction available.

1 forms  
  1. StudyEvent: E4A08 Baseline Disease Assessment Form
    1. No Instruction available.
Header
Description

Header

DCI Name
Description

Generic drug form

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C3242750
NCI Thesaurus Property
C19464
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus ObjectClass-2
C25452
Registration Step
Description

Registration Number

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1514821
NCI Thesaurus ObjectClass
C25646
UMLS CUI-2
C0237753
NCI Thesaurus Property
C16154
NCI Thesaurus ValueDomain-2
C16154
Reporting Period
Description

Clinical Trial Period

Data type

text

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

Patient Initials

Data type

text

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

Protocol Number ECOG

Data type

text

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

Protocol Number ECOG

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1512162
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25491
ECOG Patient ID
Description

Patient ID ECOG

Data type

text

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

Patient ID ECOG

Data type

text

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

Study Number Participating Group

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Participating Group Patient ID
Description

Trial subject ID Participating Group

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Institution/Affiliate
Description

Institution Name

Data type

text

Alias
NCI Thesaurus ObjectClass
C25454
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass-2
C21541
NCI Thesaurus Property
C25364
NCI Thesaurus ValueDomain
C25191
NCI Thesaurus ValueDomain-2
C21541
Data amendment
Description

Data amendment

Please mark an 'X' if data have been amended.
Description

Data amended

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Date data amended
Description

Data amended date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
UMLS CUI-2
C0011008
NCI Thesaurus Property
C25416
NCI Thesaurus ValueDomain-2
C25367
Protein Measurements
Description

Protein Measurements

Date of SPEP
Description

SerumProteinElectrophoresisDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C17126
UMLS 2011AA ObjectClass
C0036825
NCI Thesaurus Property
C16536
UMLS 2011AA Property
C0013855
Serum total protein (SPEP g/dl)
Description

Protein, Serum Total

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0036836
NCI Thesaurus Property
C25304
NCI Thesaurus Property-2
C20200
NCI Thesaurus Property-3
C17126
NCI Thesaurus ValueDomain
C25712
Serum M-protein spike (g/dl )
Description

LaboratoryProcedureSerumMProteinOutcomeUnspecifiedValue

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C13325
UMLS 2011AA Property
C0229671
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus Property-3
C17788
UMLS 2011AA Property-3
C0700271
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
If serum M-protein spike was left blank, please specify
Description

LaboratoryProcedureMProteinAbsentResultReason

Data type

text

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C48190
UMLS 2011AA Property
C0332197
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus Property-3
C17788
UMLS 2011AA Property-3
C0700271
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
Albumin LLN (g/dl)
Description

LaboratoryProcedureAlbuminResultLowerLimitofNormalValue

Data type

float

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

Albumin

Data type

float

Alias
NCI Thesaurus Property
C20200
UMLS CUI-1
C0201838
NCI Thesaurus Property-2
C214
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25712
Date of urine immunofixation (Urine immunofixation IFE leave blank if not done)
Description

SpecimenImmunofixationLabDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C37984
UMLS 2011AA Property
C0022877
NCI Thesaurus ObjectClass
C19157
UMLS 2011AA ObjectClass
C0370003
NCI Thesaurus Property-2
C54536
UMLS 2011AA Property-2
C0430292
Date of serum FLC assessment
Description

LaboratoryProcedureImmunoglobulinLightChainProteinResultDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C17021
UMLS 2011AA Property-2
C0033684
NCI Thesaurus Property-3
C16720
UMLS 2011AA Property-3
C0021038
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Kappa Free Light Chain (mg/dl)
Description

KappaFreeLightChainAssessmentUnspecifiedValue

Data type

float

Alias
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Metathesaurus ObjectClass
CL233214
NCI Thesaurus ObjectClass
C16718
UMLS 2011AA ObjectClass
C0021036
Mark an 'X' if not done
Description

Laboratory Procedure Not Performed

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0022885
NCI Thesaurus Property
C25594
UMLS CUI-2
C0445106
NCI Thesaurus Property-2
C38000
NCI Thesaurus ObjectClass
C25294
Mark an 'X' if not done
Description

Laboratory Procedure Not Performed

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0022885
NCI Thesaurus Property
C25594
UMLS CUI-2
C0445106
NCI Thesaurus Property-2
C38000
NCI Thesaurus ObjectClass
C25294
Lambda Free Light Chain (mg/dl)
Description

LambdaFreeLightChainAssessmentUnspecifiedValue

Data type

float

Alias
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Metathesaurus ObjectClass
CL233214
NCI Thesaurus ObjectClass
C16719
UMLS 2011AA ObjectClass
C0021037
Mark an 'X' if not done
Description

Laboratory Procedure Not Performed

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0022885
NCI Thesaurus Property
C25594
UMLS CUI-2
C0445106
NCI Thesaurus Property-2
C38000
NCI Thesaurus ObjectClass
C25294
Serum M-protein by immunofixation
Description

SerumProteinMonoclonalDetectedType

Data type

text

Alias
NCI Thesaurus ObjectClass
C13325
UMLS 2011AA ObjectClass
C0229671
NCI Thesaurus ObjectClass-2
C17021
UMLS 2011AA ObjectClass-2
C0033684
NCI Metathesaurus Property
C0746619
NCI Thesaurus Property
C25481
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Serum Heavy Chain (If positive:)
Description

LaboratoryProcedureImmunoglobulinHeavyChainOutcomeType

Data type

text

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C16717
UMLS 2011AA Property
C0021034
NCI Thesaurus Property-2
C13325
UMLS 2011AA Property-2
C0229671
NCI Thesaurus Property-3
C20200
UMLS 2011AA Property-3
C1274040
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Biclonal, specify
Description

LaboratoryProcedureSerumImmunoglobulinHeavyChainOutcomeSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C16717
UMLS 2011AA Property
C0021034
NCI Thesaurus Property-2
C13325
UMLS 2011AA Property-2
C0229671
NCI Thesaurus Property-3
C20200
UMLS 2011AA Property-3
C1274040
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Serum Light Chain
Description

LaboratoryProcedureImmunoglobulinLightChainProteinResultType

Data type

text

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C17021
UMLS 2011AA Property-2
C0033684
NCI Thesaurus Property-3
C16720
UMLS 2011AA Property-3
C0021038
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Urine Sample
Description

Urine Sample

Date of UPEP (Urine protein electrophoresis UPEP)
Description

UrineProteinElectrophoresisDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C13283
UMLS 2011AA ObjectClass
C0042036
NCI Thesaurus ObjectClass-2
C17021
UMLS 2011AA ObjectClass-2
C0033684
NCI Thesaurus Property
C16536
UMLS 2011AA Property
C0013855
Urine Total protein (UPEP mg/24 hr)
Description

LaboratoryProcedureTotalUrineProteinOutcomeUnspecifiedValue

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C25304
UMLS 2011AA Property
C0439810
NCI Thesaurus Property-2
C13283
UMLS 2011AA Property-2
C0042036
NCI Thesaurus Property-3
C20200
UMLS 2011AA Property-3
C1274040
NCI Thesaurus Property-4
C17021
UMLS 2011AA Property-4
C0033684
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
Urine M-protein measurement
Description

LaboratoryProcedureUrineMProteinOutcomeValue

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C13283
UMLS 2011AA Property
C0042036
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus Property-3
C17788
UMLS 2011AA Property-3
C0700271
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
If urine M-protein measurement was left blank, please specify
Description

LaboratoryProcedureUrineMProteinAbsentOutcomeReason

Data type

text

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C13283
UMLS 2011AA Property
C0042036
NCI Thesaurus Property-2
C48190
UMLS 2011AA Property-2
C0332197
NCI Thesaurus Property-3
C20200
UMLS 2011AA Property-3
C1274040
NCI Thesaurus Property-4
C17788
UMLS 2011AA Property-4
C0700271
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
Date of urine immunofixation (Urine immunofixation IFE leave blank if not done)
Description

SpecimenImmunofixationLabDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C37984
UMLS 2011AA Property
C0022877
NCI Thesaurus ObjectClass
C19157
UMLS 2011AA ObjectClass
C0370003
NCI Thesaurus Property-2
C54536
UMLS 2011AA Property-2
C0430292
Urine M-protein by immunofixation
Description

MonoclonalProteinUrineImmunofixationType

Data type

text

Alias
NCI Thesaurus ObjectClass
C17021
UMLS 2011AA ObjectClass
C0033684
NCI Metathesaurus ObjectClass
C0746619
NCI Thesaurus Property
C13283
UMLS 2011AA Property
C0042036
NCI Metathesaurus Property
CL201583
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Urine Light Chain (If positive:)
Description

UrineProteinLightChainAnalysisImmunofixationType

Data type

text

Alias
NCI Thesaurus ObjectClass
C13283
UMLS 2011AA ObjectClass
C0042036
NCI Thesaurus ObjectClass-2
C17021
UMLS 2011AA ObjectClass-2
C0033684
NCI Metathesaurus Property
CL201583
NCI Metathesaurus Property-2
CL105192
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Mark an 'X' if not done
Description

Laboratory Procedure Not Performed

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0022885
NCI Thesaurus Property
C25594
UMLS CUI-2
C0445106
NCI Thesaurus Property-2
C38000
NCI Thesaurus ObjectClass
C25294
Mark an 'X' if not done
Description

Laboratory Procedure Not Performed

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0022885
NCI Thesaurus Property
C25594
UMLS CUI-2
C0445106
NCI Thesaurus Property-2
C38000
NCI Thesaurus ObjectClass
C25294
Protein Measurements
Description

Protein Measurements

IgG (mg/dl)
Description

LaboratoryProcedureSerumImmunologicIgGResultUnspecifiedValue

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C568
UMLS 2011AA Property-2
C0020852
NCI Thesaurus Property-3
C25675
UMLS 2011AA Property-3
C1519267
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
IgG LLN (mg/dl)
Description

LaboratoryProcedureSerumImmunologicIgGResultLowerLimitofNormalValue

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C568
UMLS 2011AA Property-2
C0020852
NCI Thesaurus Property-3
C25675
UMLS 2011AA Property-3
C1519267
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25555
UMLS 2011AA ValueDomain-2
C1518030
IgG ULN (mg/dl)
Description

LaboratoryProcedureSerumImmunologicIgGResultUpperLimitofNormalValue

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C568
UMLS 2011AA Property-2
C0020852
NCI Thesaurus Property-3
C25675
UMLS 2011AA Property-3
C1519267
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25706
UMLS 2011AA ValueDomain-2
C1519815
IgA (mg/dl)
Description

LaboratoryProcedureSerumImmunologicIgAResultUnspecifiedValue

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C565
UMLS 2011AA Property-2
C0020835
NCI Thesaurus Property-3
C25675
UMLS 2011AA Property-3
C1519267
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
IgA LLN (mg/dl)
Description

LaboratoryProcedureSerumImmunologicIgAResultLowerLimitofNormalValue

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C565
UMLS 2011AA Property-2
C0020835
NCI Thesaurus Property-3
C25675
UMLS 2011AA Property-3
C1519267
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25555
UMLS 2011AA ValueDomain-2
C1518030
IgA ULN (mg/dl)
Description

LaboratoryProcedureSerumImmunologicIgAResultUpperLimitofNormalValue

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C565
UMLS 2011AA Property-2
C0020835
NCI Thesaurus Property-3
C25675
UMLS 2011AA Property-3
C1519267
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25706
UMLS 2011AA ValueDomain-2
C1519815
IgM (mg/dl)
Description

LaboratoryProcedureSerumImmunologicIgMResultUnspecifiedValue

Data type

float

Alias
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C569
UMLS 2011AA Property-2
C0020861
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus Property-3
C25675
UMLS 2011AA Property-3
C1519267
Date Hematology (Blood) Sample Obtained
Description

HematologySpecimenCollectedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C16673
UMLS 2011AA ObjectClass
C0018943
NCI Thesaurus ObjectClass-2
C19157
UMLS 2011AA ObjectClass-2
C0370003
NCI Thesaurus Property
C25452
IgM LLN (mg/dl)
Description

LaboratoryProcedureSerumImmunologicIgMResultLowerLimitofNormalValue

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C569
UMLS 2011AA Property-2
C0020861
NCI Thesaurus Property-3
C25675
UMLS 2011AA Property-3
C1519267
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25555
UMLS 2011AA ValueDomain-2
C1518030
Mark an 'X' if not done
Description

Laboratory Procedure Not Performed

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0022885
NCI Thesaurus Property
C25594
UMLS CUI-2
C0445106
NCI Thesaurus Property-2
C38000
NCI Thesaurus ObjectClass
C25294
IgM ULN (mg/dl)
Description

LaboratoryProcedureSerumImmunologicIgMResultUpperLimitofNormalValue

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C569
UMLS 2011AA Property-2
C0020861
NCI Thesaurus Property-3
C25675
UMLS 2011AA Property-3
C1519267
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25706
UMLS 2011AA ValueDomain-2
C1519815
Other Biopsy
Description

Other Biopsy

Organ biopsy results
Description

BiopsyAnatomicSitePerformedName

Data type

text

Alias
NCI Thesaurus Property
C13717
UMLS 2011AA Property
C1515974
NCI Thesaurus ObjectClass
C15189
UMLS 2011AA ObjectClass
C0005558
NCI Thesaurus Property-2
C38000
UMLS 2011AA Property-2
C0884358
NCI Thesaurus ValueDomain
C42614
UMLS 2011AA ValueDomain
C0027365
Specify other site
Description

BiopsyAnatomicSitePerformedSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C13717
UMLS 2011AA Property
C1515974
NCI Thesaurus ObjectClass
C15189
UMLS 2011AA ObjectClass
C0005558
NCI Thesaurus Property-2
C38000
UMLS 2011AA Property-2
C0884358
Biopsy done (Mark 'X' for all that apply)
Description

BiopsyPerformedText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C15189
UMLS 2011AA ObjectClass
C0005558
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
Positive congo red staining for amyloid
Description

LaboratoryProcedurePositiveFindingCongoRedStainingMethodAmyloidogenesisOutcomeIndicator

Data type

text

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C38758
UMLS 2011AA Property
C1514241
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus Property-3
C44955
UMLS 2011AA Property-3
C1706803
NCI Thesaurus Property-4
C23010
UMLS 2011AA Property-4
C0487602
NCI Thesaurus Property-5
C81102
UMLS 2011AA Property-5
C0009742
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Bone Marrow
Description

Bone Marrow

Was bone marrow biopsy done?
Description

BoneMarrowBiopsyInd

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus Property
C15189
UMLS 2011AA Property
C0005558
NCI Thesaurus ObjectClass
C12431
UMLS 2011AA ObjectClass
C0005953
Bone marrow biopsy date
Description

BoneMarrowBiopsyDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus Property
C15189
UMLS 2011AA Property
C0005558
NCI Thesaurus ObjectClass
C12431
UMLS 2011AA ObjectClass
C0005953
Plasma cells on biopsy (If yes:)
Description

BoneMarrowBiopsyPlasmaCellPercentageValue

Data type

float

Alias
NCI Thesaurus ObjectClass
C15189
UMLS 2011AA ObjectClass
C0005558
NCI Thesaurus ObjectClass-2
C12431
UMLS 2011AA ObjectClass-2
C0005953
NCI Thesaurus Property
C12486
UMLS 2011AA Property
C0032112
NCI Thesaurus ValueDomain
C25613
UMLS 2011AA ValueDomain
C0439165
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
If plasma cells on biopsy was left blank, please specify (%)
Description

TissueSpecimenBoneMarrowBiopsyPlasmaCellAbsentLaboratoryProcedureReason

Data type

text

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C15189
UMLS 2011AA Property
C0005558
NCI Thesaurus Property-2
C12431
UMLS 2011AA Property-2
C0005953
NCI Thesaurus Property-3
C48190
UMLS 2011AA Property-3
C0332197
NCI Thesaurus Property-4
C12486
UMLS 2011AA Property-4
C0032112
NCI Thesaurus Property-5
C25294
UMLS 2011AA Property-5
C0022885
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
Was bone marrow aspirate done?
Description

BoneMarrowAspirateInd

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C12431
UMLS 2011AA ObjectClass
C0005953
NCI Thesaurus Property
C13347
UMLS 2011AA Property
C0370199
Bone marrow aspirate date
Description

BoneMarrowAspirateDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C12431
UMLS 2011AA ObjectClass
C0005953
NCI Thesaurus Property
C13347
UMLS 2011AA Property
C0370199
Plasma Cells on Aspirate in Interpretation (%) (If yes:)
Description

AspirateBoneMarrowEstimatedPlasmaCellPercentageValue

Data type

float

Alias
NCI Thesaurus ObjectClass
C12431
UMLS 2011AA ObjectClass
C0005953
NCI Thesaurus ObjectClass-2
C25498
UMLS 2011AA ObjectClass-2
C0750572
NCI Thesaurus Property
C25498
UMLS 2011AA Property
C0750572
NCI Thesaurus Property-2
C12486
UMLS 2011AA Property-2
C0032112
NCI Thesaurus ValueDomain
C25613
UMLS 2011AA ValueDomain
C0439165
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
If plasma cells on aspirate was left blank, please specify
Description

LaboratoryProcedureBoneMarrowEstimatedPlasmaCellAbsentResultReason

Data type

text

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C12431
UMLS 2011AA Property
C0005953
NCI Thesaurus Property-2
C48190
UMLS 2011AA Property-2
C0332197
NCI Thesaurus Property-3
C25498
UMLS 2011AA Property-3
C0750572
NCI Thesaurus Property-4
C20200
UMLS 2011AA Property-4
C1274040
NCI Thesaurus Property-5
C12486
UMLS 2011AA Property-5
C0032112
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
Was plasma cell clonality done
Description

ClonalityPlasmaCellBoneMarrowTestInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C18304
UMLS 2011AA ObjectClass
C1704387
NCI Thesaurus ObjectClass-2
C12486
UMLS 2011AA ObjectClass-2
C0032112
NCI Thesaurus Property
C12431
UMLS 2011AA Property
C0005953
NCI Thesaurus Property-2
C25294
UMLS 2011AA Property-2
C0022885
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Plasma cell clonality test date (If Yes,)
Description

ClonalityPlasmaCellBoneMarrowTestDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C18304
UMLS 2011AA ObjectClass
C1704387
NCI Thesaurus ObjectClass-2
C12486
UMLS 2011AA ObjectClass-2
C0032112
NCI Thesaurus Property
C12431
UMLS 2011AA Property
C0005953
NCI Thesaurus Property-2
C25294
UMLS 2011AA Property-2
C0022885
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Clonality determination method
Description

CloneTestPlasmaCellType

Data type

text

Alias
NCI Thesaurus ObjectClass
C18304
UMLS 2011AA ObjectClass
C1704387
NCI Thesaurus ObjectClass-2
C12486
UMLS 2011AA ObjectClass-2
C0032112
NCI Thesaurus Property
C12431
UMLS 2011AA Property
C0005953
NCI Thesaurus Property-2
C25294
UMLS 2011AA Property-2
C0022885
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Other specify
Description

ClonalityPlasmaCellBoneMarrowTestSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C18304
UMLS 2011AA ObjectClass
C1704387
NCI Thesaurus ObjectClass-2
C12486
UMLS 2011AA ObjectClass-2
C0032112
NCI Thesaurus Property
C12431
UMLS 2011AA Property
C0005953
NCI Thesaurus Property-2
C25294
UMLS 2011AA Property-2
C0022885
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Result
Description

ClonalityPlasmaCellBoneMarrowAssessmentType

Data type

text

Alias
NCI Thesaurus ObjectClass
C18304
UMLS 2011AA ObjectClass
C1704387
NCI Thesaurus ObjectClass-2
C12486
UMLS 2011AA ObjectClass-2
C0032112
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus Property-2
C12431
UMLS 2011AA Property-2
C0005953
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Bone Involvement
Description

Bone Involvement

Were lytic bone lesions present at study entry
Description

LyticLesionPresentInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass-2
C27963
UMLS 2011AA ObjectClass-2
C0439680
Cardiac Assessment
Description

Cardiac Assessment

Does patient currently have cardiac involvement per the protocol criteria
Description

HeartInvolvedInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C12727
UMLS 2011AA ObjectClass
C0018787
NCI Thesaurus Property
C25547
Was an Echocardiogram (ECHO) performed (at baseline)
Description

HeartEchocardiogramTestInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C37945
UMLS 2011AA Property
C2243117
NCI Thesaurus ObjectClass
C12727
UMLS 2011AA ObjectClass
C0018787
NCI Thesaurus Property-2
C25294
UMLS 2011AA Property-2
C0022885
Date of echocardiogram
Description

EchocardiogramDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C37945
UMLS 2011AA ObjectClass
C2243117
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
Interventricular Septal Wall Thickness (mm)
Description

InterventricularSeptumWallofHeartMeasureSpecifiedValue

Data type

float

Measurement units
  • mm
Alias
NCI Thesaurus Property
C25209
UMLS 2011AA Property
C0242485
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ObjectClass
C32874
UMLS 2011AA ObjectClass
C0225870
NCI Metathesaurus Property
C0446990
mm
Left ventricular ejection fraction (%)
Description

HeartLeftVentricularEjectionFractionEchocardiogramAssessmentPercentageValue

Data type

float

Measurement units
  • %
Alias
NCI Thesaurus ObjectClass
C12727
UMLS 2011AA ObjectClass
C0018787
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus Property-2
C37945
UMLS 2011AA Property-2
C2243117
NCI Thesaurus Property-3
C37946
UMLS 2011AA Property-3
C2700377
NCI Thesaurus ValueDomain
C25613
UMLS 2011AA ValueDomain
C0439165
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
%
Troponin T ULN
Description

LaboratoryProcedureTroponinTOutcomeUpperLimitofNormalValue

Data type

float

Measurement units
  • ng/ml
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C38041
UMLS 2011AA Property-2
C0077404
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25706
UMLS 2011AA ValueDomain-2
C1519815
ng/ml
Troponin T
Description

LaboratoryProcedureTroponinTOutcomeValue

Data type

float

Measurement units
  • ng/ml
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
C38041
UMLS 2011AA Property-2
C0077404
ng/ml
Troponin I ULN
Description

LaboratoryProcedureTroponinIOutcomeUpperLimitofNormalValue

Data type

float

Measurement units
  • ng/ml
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C17343
UMLS 2011AA Property-2
C0077401
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25706
UMLS 2011AA ValueDomain-2
C1519815
ng/ml
Troponin I
Description

LaboratoryProcedureTroponinIOutcomeValue

Data type

float

Measurement units
  • ng/ml
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
C17343
UMLS 2011AA Property-2
C0077401
ng/ml
Date Hematology (Blood) Sample Obtained
Description

HematologySpecimenCollectedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C16673
UMLS 2011AA ObjectClass
C0018943
NCI Thesaurus ObjectClass-2
C19157
UMLS 2011AA ObjectClass-2
C0370003
NCI Thesaurus Property
C25452
Mark an 'X' if not done
Description

Laboratory Procedure Not Performed

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0022885
NCI Thesaurus Property
C25594
UMLS CUI-2
C0445106
NCI Thesaurus Property-2
C38000
NCI Thesaurus ObjectClass
C25294
New York Heart Association Classification
Description

CardiacPerformanceStatusAssessmentFunctionScale

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ObjectClass
C13306
UMLS 2011AA ObjectClass
C1522601
NCI Metathesaurus ObjectClass
CL092952
Liver Assessment
Description

Liver Assessment

Does patient currently have clinically evident liver involvement per the protocol criteria
Description

LiverInvolvedInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C12392
UMLS 2011AA ObjectClass
C0023884
NCI Thesaurus Property
C25547
Was a liver measurement done (at baseline)
Description

LiverMeasureInd-2

Data type

boolean

Alias
NCI Thesaurus Property
C25209
UMLS 2011AA Property
C0242485
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C12392
UMLS 2011AA ObjectClass
C0023884
Date of Liver Evaluation
Description

HepatomegalyAssessmentDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C3100
UMLS 2011AA ObjectClass
C0017924
Liver Measurement (cm)
Description

LiverSizeMeasurement

Data type

float

Alias
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
NCI Thesaurus ObjectClass
C12392
UMLS 2011AA ObjectClass
C0023884
NCI Thesaurus Property
C25681
UMLS 2011AA Property
C0456389
Method of liver evaluation
Description

LiverMeasureType

Data type

text

Alias
NCI Thesaurus Property
C25209
UMLS 2011AA Property
C0242485
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C12392
UMLS 2011AA ObjectClass
C0023884
Specify other method
Description

LiverMeasureSpecify

Data type

text

Alias
NCI Thesaurus Property
C25209
UMLS 2011AA Property
C0242485
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C12392
UMLS 2011AA ObjectClass
C0023884
Gi Tract Assessment
Description

Gi Tract Assessment

Does patient currently have clinically evident GI tract involvement per the protocol criteria
Description

GastrointestinalTractInvolvedInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25547
NCI Thesaurus ObjectClass
C34082
UMLS 2011AA ObjectClass
C0017189
Is there GI bleeding
Description

GastrointestinalHemorrhageAdverseEventPresentInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C13359
UMLS 2011AA ObjectClass
C0521362
NCI Thesaurus ObjectClass-2
C26791
UMLS 2011AA ObjectClass-2
C0019080
NCI Thesaurus ObjectClass-3
C41331
UMLS 2011AA ObjectClass-3
C0877248
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Is diarrhea present
Description

DiarrheaPresentInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C2987
UMLS 2011AA ObjectClass
C0011991
Number of stools per day
Description

BowelMovementObservedDailyCount

Data type

float

Alias
NCI Thesaurus ObjectClass
C12736
UMLS 2011AA ObjectClass
C0021853
NCI Thesaurus Property
C37994
UMLS 2011AA Property
C0026649
NCI Thesaurus Property-2
C25599
UMLS 2011AA Property-2
C1441672
NCI Thesaurus ValueDomain
C25473
UMLS 2011AA ValueDomain
C0332173
NCI Thesaurus ValueDomain-2
C25463
UMLS 2011AA ValueDomain-2
C0750480
Was a fecal fat excretion test done
Description

LaboratoryProcedureFecesLipidOutcomeInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C13234
UMLS 2011AA Property-2
C0015733
NCI Thesaurus Property-3
C616
UMLS 2011AA Property-3
C0023779
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
24-hour Fecal Fat Excretion (If Yes, - g)
Description

LaboratoryProcedureFecesLipidFirstDayOutcomeSpecifiedValue

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C25301
UMLS 2011AA Property
C0439228
NCI Thesaurus Property-2
C25509
UMLS 2011AA Property-2
C1279901
NCI Thesaurus Property-3
C20200
UMLS 2011AA Property-3
C1274040
NCI Thesaurus Property-4
C13234
UMLS 2011AA Property-4
C0015733
NCI Thesaurus Property-5
C616
UMLS 2011AA Property-5
C0023779
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
Date of fecal fat evaluation (start date)
Description

LaboratoryProcedureFecesLipidOutcomeDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C13234
UMLS 2011AA Property-2
C0015733
NCI Thesaurus Property-3
C616
UMLS 2011AA Property-3
C0023779
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Nerve Assessment
Description

Nerve Assessment

Does patient currently have clinically evident peripheral nerve involvement per the protocol criteria
Description

PeripheralNerveInvolvedInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25547
NCI Thesaurus ObjectClass
C12768
UMLS 2011AA ObjectClass
C0031119
Date of EMG/NCS
Description

ElectromyographyPerformedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass
C38056
UMLS 2011AA ObjectClass
C0013839
CMAP amplitude
Description

CompoundMuscleActionPotentialAmplitudeValue

Data type

float

Alias
NCI Thesaurus ObjectClass
C12435
UMLS 2011AA ObjectClass
C0026845
NCI Thesaurus ObjectClass-2
C43366
UMLS 2011AA ObjectClass-2
C1706082
NCI Thesaurus ObjectClass-3
C82324
UMLS 2011AA ObjectClass-3
C0025251
NCI Thesaurus Property
C70831
UMLS 2011AA Property
C2346753
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
Results of EMG
Description

ElectromyographyOutcome

Data type

text

Alias
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ValueDomain
C20200
UMLS 2011AA ValueDomain
C1274040
NCI Thesaurus ObjectClass
C38056
UMLS 2011AA ObjectClass
C0013839
Specify EMG result (If abnormal,)
Description

ElectromyographyOutcomeSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C38056
UMLS 2011AA ObjectClass
C0013839
Neuropathy Impairment Score
Description

NeuropathyImpairmentScoreAssessmentOutcome

Data type

text

Alias
NCI Thesaurus ObjectClass
C4731
UMLS 2011AA ObjectClass
C0031117
NCI Thesaurus Property
C25367
NCI Thesaurus Property-2
C21055
UMLS 2011AA Property
C0684336
NCI Thesaurus Property-3
C25338
UMLS 2011AA Property-2
C0449820
NCI Thesaurus ValueDomain
C20200
UMLS 2011AA ValueDomain
C1274040
Does patient have clinically evident autonomic nerve involvement per the protocol criteria
Description

AutonomicNervousSystemInvolvedInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25547
NCI Thesaurus ObjectClass
C12673
UMLS 2011AA ObjectClass
C0004388
Kidney Assessment
Description

Kidney Assessment

Does patient currently have clinically evident kidney involvement per the protocol criteria
Description

KidneyInvolvementInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C12415
UMLS 2011AA ObjectClass
C0022646
NCI Thesaurus Property
C25548
UMLS 2011AA Property
C1314939
Peripheral Blood Chemistry
Description

Peripheral Blood Chemistry

Beta-2 Microglobulin (ng/ml)
Description

LaboratoryProcedureBeta-2-MicroglobulinProteinOutcomeSpecifiedValue

Data type

float

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
C62657
UMLS 2011AA Property-2
C0005149
Beta-2 Microglobulin ULN (ng/ml)
Description

LaboratoryProcedureBeta-2-MicroglobulinProteinOutcomeSpecifiedUpperLimitofNormalValue

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C62657
UMLS 2011AA Property-2
C0005149
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25706
UMLS 2011AA ValueDomain-2
C1519815
Lactate dehydrogenase (LDH) (U/L)
Description

LDH

Data type

float

Measurement units
  • U/L
Alias
NCI Thesaurus Property
C20200
UMLS CUI-1
C0202113
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus Property-2
C25184
U/L
Lactate dehydrogenase ULN
Description

LDH ULN

Data type

float

Measurement units
  • U/L
Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0202113
NCI Thesaurus Property
C20200
UMLS CUI-2
C1519815
NCI Thesaurus Property-2
C25184
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C38024
NCI Thesaurus ValueDomain-3
C25706
U/L
Date Hematology (Blood) Sample Obtained
Description

HematologySpecimenCollectedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C16673
UMLS 2011AA ObjectClass
C0018943
NCI Thesaurus ObjectClass-2
C19157
UMLS 2011AA ObjectClass-2
C0370003
NCI Thesaurus Property
C25452
Mark an 'X' if not done
Description

Laboratory Procedure Not Performed

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0022885
NCI Thesaurus Property
C25594
UMLS CUI-2
C0445106
NCI Thesaurus Property-2
C38000
NCI Thesaurus ObjectClass
C25294
Mark an 'X' if not done
Description

Laboratory Procedure Not Performed

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0022885
NCI Thesaurus Property
C25594
UMLS CUI-2
C0445106
NCI Thesaurus Property-2
C38000
NCI Thesaurus ObjectClass
C25294
Comments
Description

Comments

Comments
Description

Research Comments

Data type

text

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

Investigator Signature Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2346576
NCI Thesaurus Property
C25678
UMLS CUI-2
C0011008
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C17089
Investigator Signature
Description

Investigator Signature

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C2346576
NCI Thesaurus Property
C25678
NCI Thesaurus ObjectClass
C17089
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  1. StudyEvent: E4A08 Baseline Disease Assessment Form
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
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 (Baseline)
C25213 (NCI Thesaurus)
C1442488 (UMLS 2011AA)
Patient Initials
Item
Patient Initials (Last, First)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Protocol Number ECOG
Item
ECOG Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
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
Data amendment
Data amended
Item
Please mark an 'X' if data have been amended.
text
C25704 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Data amended date
Item
Date data amended
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
Protein Measurements
SerumProteinElectrophoresisDate
Item
Date of SPEP
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C17126 (NCI Thesaurus ObjectClass)
C0036825 (UMLS 2011AA ObjectClass)
C16536 (NCI Thesaurus Property)
C0013855 (UMLS 2011AA Property)
Protein, Serum Total
Item
Serum total protein (SPEP g/dl)
float
C25294 (NCI Thesaurus ObjectClass)
C0036836 (UMLS CUI-1)
C25304 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C17126 (NCI Thesaurus Property-3)
C25712 (NCI Thesaurus ValueDomain)
LaboratoryProcedureSerumMProteinOutcomeUnspecifiedValue
Item
Serum M-protein spike (g/dl )
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C13325 (NCI Thesaurus Property)
C0229671 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C17788 (NCI Thesaurus Property-3)
C0700271 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
Item
If serum M-protein spike was left blank, please specify
text
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C48190 (NCI Thesaurus Property)
C0332197 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C17788 (NCI Thesaurus Property-3)
C0700271 (UMLS 2011AA Property-3)
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
CL.2
Code List
If serum M-protein spike was left blank, please specify
CL Item
Absent (Not present)
C48190 (NCI Thesaurus)
C0332197 (UMLS 2011AA)
CL Item
Present But Too Small To Quantify (Present but too small to quantify)
LaboratoryProcedureAlbuminResultLowerLimitofNormalValue
Item
Albumin LLN (g/dl)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C214 (NCI Thesaurus Property-2)
C0001924 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C1518030 (UMLS 2011AA ValueDomain-2)
Albumin
Item
Albumin (Value)
float
C20200 (NCI Thesaurus Property)
C0201838 (UMLS CUI-1)
C214 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
SpecimenImmunofixationLabDate
Item
Date of urine immunofixation (Urine immunofixation IFE leave blank if not done)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C37984 (NCI Thesaurus Property)
C0022877 (UMLS 2011AA Property)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C54536 (NCI Thesaurus Property-2)
C0430292 (UMLS 2011AA Property-2)
LaboratoryProcedureImmunoglobulinLightChainProteinResultDate
Item
Date of serum FLC assessment
date
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C17021 (NCI Thesaurus Property-2)
C0033684 (UMLS 2011AA Property-2)
C16720 (NCI Thesaurus Property-3)
C0021038 (UMLS 2011AA Property-3)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
KappaFreeLightChainAssessmentUnspecifiedValue
Item
Kappa Free Light Chain (mg/dl)
float
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
CL233214 (NCI Metathesaurus ObjectClass)
C16718 (NCI Thesaurus ObjectClass)
C0021036 (UMLS 2011AA ObjectClass)
Laboratory Procedure Not Performed
Item
Mark an 'X' if not done
text
C25704 (NCI Thesaurus ValueDomain)
C0022885 (UMLS CUI-1)
C25594 (NCI Thesaurus Property)
C0445106 (UMLS CUI-2)
C38000 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
Laboratory Procedure Not Performed
Item
Mark an 'X' if not done
text
C25704 (NCI Thesaurus ValueDomain)
C0022885 (UMLS CUI-1)
C25594 (NCI Thesaurus Property)
C0445106 (UMLS CUI-2)
C38000 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
LambdaFreeLightChainAssessmentUnspecifiedValue
Item
Lambda Free Light Chain (mg/dl)
float
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
CL233214 (NCI Metathesaurus ObjectClass)
C16719 (NCI Thesaurus ObjectClass)
C0021037 (UMLS 2011AA ObjectClass)
Laboratory Procedure Not Performed
Item
Mark an 'X' if not done
text
C25704 (NCI Thesaurus ValueDomain)
C0022885 (UMLS CUI-1)
C25594 (NCI Thesaurus Property)
C0445106 (UMLS CUI-2)
C38000 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
Item
Serum M-protein by immunofixation
text
C13325 (NCI Thesaurus ObjectClass)
C0229671 (UMLS 2011AA ObjectClass)
C17021 (NCI Thesaurus ObjectClass-2)
C0033684 (UMLS 2011AA ObjectClass-2)
C0746619 (NCI Metathesaurus Property)
C25481 (NCI Thesaurus Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.3
Code List
Serum M-protein by immunofixation
CL Item
Negative (negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Positive (positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
Item
Serum Heavy Chain (If positive:)
text
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C16717 (NCI Thesaurus Property)
C0021034 (UMLS 2011AA Property)
C13325 (NCI Thesaurus Property-2)
C0229671 (UMLS 2011AA Property-2)
C20200 (NCI Thesaurus Property-3)
C1274040 (UMLS 2011AA Property-3)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.4
Code List
Serum Heavy Chain (If positive:)
CL Item
G (G)
CL Item
A (A)
C14653 (NCI Thesaurus)
CL Item
M (M)
CL Item
D (D)
C25321 (NCI Thesaurus)
C0443203 (UMLS 2011AA)
CL Item
E (E)
CL Item
Biclonal (Biclonal)
CL Item
None (None)
C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
LaboratoryProcedureSerumImmunoglobulinHeavyChainOutcomeSpecify
Item
Biclonal, specify
text
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C16717 (NCI Thesaurus Property)
C0021034 (UMLS 2011AA Property)
C13325 (NCI Thesaurus Property-2)
C0229671 (UMLS 2011AA Property-2)
C20200 (NCI Thesaurus Property-3)
C1274040 (UMLS 2011AA Property-3)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Item
Serum Light Chain
text
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C17021 (NCI Thesaurus Property-2)
C0033684 (UMLS 2011AA Property-2)
C16720 (NCI Thesaurus Property-3)
C0021038 (UMLS 2011AA Property-3)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.5
Code List
Serum Light Chain
CL Item
Kappa (kappa)
CL Item
Lambda (lambda)
C0926407 (NCI Metathesaurus)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item Group
Urine Sample
UrineProteinElectrophoresisDate
Item
Date of UPEP (Urine protein electrophoresis UPEP)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C13283 (NCI Thesaurus ObjectClass)
C0042036 (UMLS 2011AA ObjectClass)
C17021 (NCI Thesaurus ObjectClass-2)
C0033684 (UMLS 2011AA ObjectClass-2)
C16536 (NCI Thesaurus Property)
C0013855 (UMLS 2011AA Property)
LaboratoryProcedureTotalUrineProteinOutcomeUnspecifiedValue
Item
Urine Total protein (UPEP mg/24 hr)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25304 (NCI Thesaurus Property)
C0439810 (UMLS 2011AA Property)
C13283 (NCI Thesaurus Property-2)
C0042036 (UMLS 2011AA Property-2)
C20200 (NCI Thesaurus Property-3)
C1274040 (UMLS 2011AA Property-3)
C17021 (NCI Thesaurus Property-4)
C0033684 (UMLS 2011AA Property-4)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureUrineMProteinOutcomeValue
Item
Urine M-protein measurement
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C13283 (NCI Thesaurus Property)
C0042036 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C17788 (NCI Thesaurus Property-3)
C0700271 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
Item
If urine M-protein measurement was left blank, please specify
text
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C13283 (NCI Thesaurus Property)
C0042036 (UMLS 2011AA Property)
C48190 (NCI Thesaurus Property-2)
C0332197 (UMLS 2011AA Property-2)
C20200 (NCI Thesaurus Property-3)
C1274040 (UMLS 2011AA Property-3)
C17788 (NCI Thesaurus Property-4)
C0700271 (UMLS 2011AA Property-4)
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
CL.6
Code List
If urine M-protein measurement was left blank, please specify
CL Item
Absent (Not present)
C48190 (NCI Thesaurus)
C0332197 (UMLS 2011AA)
CL Item
Present But Too Small To Quantify (Present but too small to quantify)
SpecimenImmunofixationLabDate
Item
Date of urine immunofixation (Urine immunofixation IFE leave blank if not done)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C37984 (NCI Thesaurus Property)
C0022877 (UMLS 2011AA Property)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C54536 (NCI Thesaurus Property-2)
C0430292 (UMLS 2011AA Property-2)
Item
Urine M-protein by immunofixation
text
C17021 (NCI Thesaurus ObjectClass)
C0033684 (UMLS 2011AA ObjectClass)
C0746619 (NCI Metathesaurus ObjectClass)
C13283 (NCI Thesaurus Property)
C0042036 (UMLS 2011AA Property)
CL201583 (NCI Metathesaurus Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.7
Code List
Urine M-protein by immunofixation
CL Item
Negative (negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Positive (positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
Item
Urine Light Chain (If positive:)
text
C13283 (NCI Thesaurus ObjectClass)
C0042036 (UMLS 2011AA ObjectClass)
C17021 (NCI Thesaurus ObjectClass-2)
C0033684 (UMLS 2011AA ObjectClass-2)
CL201583 (NCI Metathesaurus Property)
CL105192 (NCI Metathesaurus Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.8
Code List
Urine Light Chain (If positive:)
CL Item
Kappa (kappa)
CL Item
Lambda (lambda)
C0926407 (NCI Metathesaurus)
CL Item
Unknown (unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Laboratory Procedure Not Performed
Item
Mark an 'X' if not done
text
C25704 (NCI Thesaurus ValueDomain)
C0022885 (UMLS CUI-1)
C25594 (NCI Thesaurus Property)
C0445106 (UMLS CUI-2)
C38000 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
Laboratory Procedure Not Performed
Item
Mark an 'X' if not done
text
C25704 (NCI Thesaurus ValueDomain)
C0022885 (UMLS CUI-1)
C25594 (NCI Thesaurus Property)
C0445106 (UMLS CUI-2)
C38000 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
Item Group
Protein Measurements
LaboratoryProcedureSerumImmunologicIgGResultUnspecifiedValue
Item
IgG (mg/dl)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C568 (NCI Thesaurus Property-2)
C0020852 (UMLS 2011AA Property-2)
C25675 (NCI Thesaurus Property-3)
C1519267 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureSerumImmunologicIgGResultLowerLimitofNormalValue
Item
IgG LLN (mg/dl)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C568 (NCI Thesaurus Property-2)
C0020852 (UMLS 2011AA Property-2)
C25675 (NCI Thesaurus Property-3)
C1519267 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C1518030 (UMLS 2011AA ValueDomain-2)
LaboratoryProcedureSerumImmunologicIgGResultUpperLimitofNormalValue
Item
IgG ULN (mg/dl)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C568 (NCI Thesaurus Property-2)
C0020852 (UMLS 2011AA Property-2)
C25675 (NCI Thesaurus Property-3)
C1519267 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)
LaboratoryProcedureSerumImmunologicIgAResultUnspecifiedValue
Item
IgA (mg/dl)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C565 (NCI Thesaurus Property-2)
C0020835 (UMLS 2011AA Property-2)
C25675 (NCI Thesaurus Property-3)
C1519267 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureSerumImmunologicIgAResultLowerLimitofNormalValue
Item
IgA LLN (mg/dl)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C565 (NCI Thesaurus Property-2)
C0020835 (UMLS 2011AA Property-2)
C25675 (NCI Thesaurus Property-3)
C1519267 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C1518030 (UMLS 2011AA ValueDomain-2)
LaboratoryProcedureSerumImmunologicIgAResultUpperLimitofNormalValue
Item
IgA ULN (mg/dl)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C565 (NCI Thesaurus Property-2)
C0020835 (UMLS 2011AA Property-2)
C25675 (NCI Thesaurus Property-3)
C1519267 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)
LaboratoryProcedureSerumImmunologicIgMResultUnspecifiedValue
Item
IgM (mg/dl)
float
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C569 (NCI Thesaurus Property-2)
C0020861 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25675 (NCI Thesaurus Property-3)
C1519267 (UMLS 2011AA Property-3)
HematologySpecimenCollectedDate
Item
Date Hematology (Blood) Sample Obtained
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16673 (NCI Thesaurus ObjectClass)
C0018943 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
C25452 (NCI Thesaurus Property)
LaboratoryProcedureSerumImmunologicIgMResultLowerLimitofNormalValue
Item
IgM LLN (mg/dl)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C569 (NCI Thesaurus Property-2)
C0020861 (UMLS 2011AA Property-2)
C25675 (NCI Thesaurus Property-3)
C1519267 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C1518030 (UMLS 2011AA ValueDomain-2)
Laboratory Procedure Not Performed
Item
Mark an 'X' if not done
text
C25704 (NCI Thesaurus ValueDomain)
C0022885 (UMLS CUI-1)
C25594 (NCI Thesaurus Property)
C0445106 (UMLS CUI-2)
C38000 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
LaboratoryProcedureSerumImmunologicIgMResultUpperLimitofNormalValue
Item
IgM ULN (mg/dl)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C569 (NCI Thesaurus Property-2)
C0020861 (UMLS 2011AA Property-2)
C25675 (NCI Thesaurus Property-3)
C1519267 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)
Item Group
Other Biopsy
Item
Organ biopsy results
text
C13717 (NCI Thesaurus Property)
C1515974 (UMLS 2011AA Property)
C15189 (NCI Thesaurus ObjectClass)
C0005558 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property-2)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)
CL.9
Code List
Organ biopsy results
CL Item
Aspirate Adipocyte (Fat Aspirate)
C13347 (NCI Thesaurus)
C0370199 (UMLS 2011AA)
C12556 (NCI Thesaurus-3)
C0206131 (UMLS 2011AA-4)
CL Item
Fat Biopsy (Fat Biopsy)
CL Item
Gastrointestinal (Gastrointestinal)
C13359 (NCI Thesaurus)
C0521362 (UMLS 2011AA)
CL Item
Heart (Heart)
C12727 (NCI Thesaurus)
C0018787 (UMLS 2011AA)
CL Item
Kidney (Kidney)
C12415 (NCI Thesaurus)
C0022646 (UMLS 2011AA)
CL Item
Liver (Liver)
C12392 (NCI Thesaurus)
C0023884 (UMLS 2011AA)
CL Item
Other (Other)
CL Item
Nerve (Peripheral Nerve)
C12466 (NCI Thesaurus)
C0027740 (UMLS 2011AA)
BiopsyAnatomicSitePerformedSpecify
Item
Specify other site
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C13717 (NCI Thesaurus Property)
C1515974 (UMLS 2011AA Property)
C15189 (NCI Thesaurus ObjectClass)
C0005558 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property-2)
BiopsyPerformedText
Item
Biopsy done (Mark 'X' for all that apply)
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15189 (NCI Thesaurus ObjectClass)
C0005558 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
Item
Positive congo red staining for amyloid
text
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C38758 (NCI Thesaurus Property)
C1514241 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C44955 (NCI Thesaurus Property-3)
C1706803 (UMLS 2011AA Property-3)
C23010 (NCI Thesaurus Property-4)
C0487602 (UMLS 2011AA Property-4)
C81102 (NCI Thesaurus Property-5)
C0009742 (UMLS 2011AA Property-5)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.10
Code List
Positive congo red staining for amyloid
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Not Done (Not done)
CL281691 (NCI Metathesaurus)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Bone Marrow
Item
Was bone marrow biopsy done?
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C15189 (NCI Thesaurus Property)
C0005558 (UMLS 2011AA Property)
C12431 (NCI Thesaurus ObjectClass)
C0005953 (UMLS 2011AA ObjectClass)
CL.11
Code List
Was bone marrow biopsy done?
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Inadequate Sample (inadequate sample)
BoneMarrowBiopsyDate
Item
Bone marrow biopsy date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C15189 (NCI Thesaurus Property)
C0005558 (UMLS 2011AA Property)
C12431 (NCI Thesaurus ObjectClass)
C0005953 (UMLS 2011AA ObjectClass)
BoneMarrowBiopsyPlasmaCellPercentageValue
Item
Plasma cells on biopsy (If yes:)
float
C15189 (NCI Thesaurus ObjectClass)
C0005558 (UMLS 2011AA ObjectClass)
C12431 (NCI Thesaurus ObjectClass-2)
C0005953 (UMLS 2011AA ObjectClass-2)
C12486 (NCI Thesaurus Property)
C0032112 (UMLS 2011AA Property)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
Item
If plasma cells on biopsy was left blank, please specify (%)
text
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C15189 (NCI Thesaurus Property)
C0005558 (UMLS 2011AA Property)
C12431 (NCI Thesaurus Property-2)
C0005953 (UMLS 2011AA Property-2)
C48190 (NCI Thesaurus Property-3)
C0332197 (UMLS 2011AA Property-3)
C12486 (NCI Thesaurus Property-4)
C0032112 (UMLS 2011AA Property-4)
C25294 (NCI Thesaurus Property-5)
C0022885 (UMLS 2011AA Property-5)
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
CL.12
Code List
If plasma cells on biopsy was left blank, please specify (%)
CL Item
No Percentage Given (No percentage given)
CL Item
Present But Too Small To Quantify (Present but too small to quantify)
CL Item
Absent (Not present)
C48190 (NCI Thesaurus)
C0332197 (UMLS 2011AA)
Item
Was bone marrow aspirate done?
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C12431 (NCI Thesaurus ObjectClass)
C0005953 (UMLS 2011AA ObjectClass)
C13347 (NCI Thesaurus Property)
C0370199 (UMLS 2011AA Property)
CL.13
Code List
Was bone marrow aspirate done?
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Inadequate Sample (inadequate sample)
BoneMarrowAspirateDate
Item
Bone marrow aspirate date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C12431 (NCI Thesaurus ObjectClass)
C0005953 (UMLS 2011AA ObjectClass)
C13347 (NCI Thesaurus Property)
C0370199 (UMLS 2011AA Property)
AspirateBoneMarrowEstimatedPlasmaCellPercentageValue
Item
Plasma Cells on Aspirate in Interpretation (%) (If yes:)
float
C12431 (NCI Thesaurus ObjectClass)
C0005953 (UMLS 2011AA ObjectClass)
C25498 (NCI Thesaurus ObjectClass-2)
C0750572 (UMLS 2011AA ObjectClass-2)
C25498 (NCI Thesaurus Property)
C0750572 (UMLS 2011AA Property)
C12486 (NCI Thesaurus Property-2)
C0032112 (UMLS 2011AA Property-2)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
Item
If plasma cells on aspirate was left blank, please specify
text
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C12431 (NCI Thesaurus Property)
C0005953 (UMLS 2011AA Property)
C48190 (NCI Thesaurus Property-2)
C0332197 (UMLS 2011AA Property-2)
C25498 (NCI Thesaurus Property-3)
C0750572 (UMLS 2011AA Property-3)
C20200 (NCI Thesaurus Property-4)
C1274040 (UMLS 2011AA Property-4)
C12486 (NCI Thesaurus Property-5)
C0032112 (UMLS 2011AA Property-5)
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
CL.14
Code List
If plasma cells on aspirate was left blank, please specify
CL Item
No Percentage Given (No percentage given)
CL Item
Present But Too Small To Quantify (Present but too small to quantify)
CL Item
Absent (Not present)
C48190 (NCI Thesaurus)
C0332197 (UMLS 2011AA)
ClonalityPlasmaCellBoneMarrowTestInd-2
Item
Was plasma cell clonality done
boolean
C18304 (NCI Thesaurus ObjectClass)
C1704387 (UMLS 2011AA ObjectClass)
C12486 (NCI Thesaurus ObjectClass-2)
C0032112 (UMLS 2011AA ObjectClass-2)
C12431 (NCI Thesaurus Property)
C0005953 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property-2)
C0022885 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
ClonalityPlasmaCellBoneMarrowTestDate
Item
Plasma cell clonality test date (If Yes,)
date
C18304 (NCI Thesaurus ObjectClass)
C1704387 (UMLS 2011AA ObjectClass)
C12486 (NCI Thesaurus ObjectClass-2)
C0032112 (UMLS 2011AA ObjectClass-2)
C12431 (NCI Thesaurus Property)
C0005953 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property-2)
C0022885 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item
Clonality determination method
text
C18304 (NCI Thesaurus ObjectClass)
C1704387 (UMLS 2011AA ObjectClass)
C12486 (NCI Thesaurus ObjectClass-2)
C0032112 (UMLS 2011AA ObjectClass-2)
C12431 (NCI Thesaurus Property)
C0005953 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property-2)
C0022885 (UMLS 2011AA Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.16
Code List
Clonality determination method
CL Item
Flow Cytometry (flow cytometry)
C16585 (NCI Thesaurus)
C0016263 (UMLS 2011AA)
CL Item
Fluorescent Antibody Technique (Immunofluorescence)
C17370 (NCI Thesaurus)
C0016318 (UMLS 2011AA)
CL Item
Immunohistochemistry (Immunohistochemistry)
C16722 (NCI Thesaurus)
CL Item
Other (other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
ClonalityPlasmaCellBoneMarrowTestSpecify
Item
Other specify
text
C18304 (NCI Thesaurus ObjectClass)
C1704387 (UMLS 2011AA ObjectClass)
C12486 (NCI Thesaurus ObjectClass-2)
C0032112 (UMLS 2011AA ObjectClass-2)
C12431 (NCI Thesaurus Property)
C0005953 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property-2)
C0022885 (UMLS 2011AA Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Item
Result
text
C18304 (NCI Thesaurus ObjectClass)
C1704387 (UMLS 2011AA ObjectClass)
C12486 (NCI Thesaurus ObjectClass-2)
C0032112 (UMLS 2011AA ObjectClass-2)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C12431 (NCI Thesaurus Property-2)
C0005953 (UMLS 2011AA Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.17
Code List
Result
CL Item
Kappa (kappa)
CL Item
Lambda (lambda)
C0926407 (NCI Metathesaurus)
CL Item
Polyclonal (polyclonal)
Item Group
Bone Involvement
Item
Were lytic bone lesions present at study entry
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C27963 (NCI Thesaurus ObjectClass-2)
C0439680 (UMLS 2011AA ObjectClass-2)
CL.18
Code List
Were lytic bone lesions present at study entry
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)
Item Group
Cardiac Assessment
HeartInvolvedInd-3
Item
Does patient currently have cardiac involvement per the protocol criteria
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12727 (NCI Thesaurus ObjectClass)
C0018787 (UMLS 2011AA ObjectClass)
C25547 (NCI Thesaurus Property)
HeartEchocardiogramTestInd-3
Item
Was an Echocardiogram (ECHO) performed (at baseline)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C37945 (NCI Thesaurus Property)
C2243117 (UMLS 2011AA Property)
C12727 (NCI Thesaurus ObjectClass)
C0018787 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property-2)
C0022885 (UMLS 2011AA Property-2)
EchocardiogramDate
Item
Date of echocardiogram
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C37945 (NCI Thesaurus ObjectClass)
C2243117 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
InterventricularSeptumWallofHeartMeasureSpecifiedValue
Item
Interventricular Septal Wall Thickness (mm)
float
C25209 (NCI Thesaurus Property)
C0242485 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C32874 (NCI Thesaurus ObjectClass)
C0225870 (UMLS 2011AA ObjectClass)
C0446990 (NCI Metathesaurus Property)
HeartLeftVentricularEjectionFractionEchocardiogramAssessmentPercentageValue
Item
Left ventricular ejection fraction (%)
float
C12727 (NCI Thesaurus ObjectClass)
C0018787 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C37945 (NCI Thesaurus Property-2)
C2243117 (UMLS 2011AA Property-2)
C37946 (NCI Thesaurus Property-3)
C2700377 (UMLS 2011AA Property-3)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
LaboratoryProcedureTroponinTOutcomeUpperLimitofNormalValue
Item
Troponin T ULN
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C38041 (NCI Thesaurus Property-2)
C0077404 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)
LaboratoryProcedureTroponinTOutcomeValue
Item
Troponin T
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)
C38041 (NCI Thesaurus Property-2)
C0077404 (UMLS 2011AA Property-2)
LaboratoryProcedureTroponinIOutcomeUpperLimitofNormalValue
Item
Troponin I ULN
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C17343 (NCI Thesaurus Property-2)
C0077401 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)
LaboratoryProcedureTroponinIOutcomeValue
Item
Troponin I
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)
C17343 (NCI Thesaurus Property-2)
C0077401 (UMLS 2011AA Property-2)
HematologySpecimenCollectedDate
Item
Date Hematology (Blood) Sample Obtained
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16673 (NCI Thesaurus ObjectClass)
C0018943 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
C25452 (NCI Thesaurus Property)
Laboratory Procedure Not Performed
Item
Mark an 'X' if not done
text
C25704 (NCI Thesaurus ValueDomain)
C0022885 (UMLS CUI-1)
C25594 (NCI Thesaurus Property)
C0445106 (UMLS CUI-2)
C38000 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
Item
New York Heart Association Classification
text
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C13306 (NCI Thesaurus ObjectClass)
C1522601 (UMLS 2011AA ObjectClass)
CL092952 (NCI Metathesaurus ObjectClass)
CL.21
Code List
New York Heart Association Classification
CL Item
Patients With Cardiac Disease But Without Resulting Limitation Of Physical Activity. Ordinary Physical Activity Does Not Cause Undue Fatigue, Palpitation, Dyspnea Or Anginal Pain. (Class I)
CL Item
Patients With Cardiac Disease Resulting In Slight Limitation Of Physical Activity. They Are Comfortable At Rest. Ordinary Physical Activity Results In Fatigue, Palpitation, Dyspnea Or Anginal Pain. (Class II)
CL Item
Patients With Cardiac Disease Resulting In Marked Limitation Of Physical Activity. They Are Comfortable At Rest. Less Than Ordinary Activity Causes Fatigue, Palpitation, Dyspnea Or Anginal Pain. (Class III)
CL Item
Patients With Cardiac Disease Resulting In Inability To Carry On Any Physical Activity Without Discomfort. Symptoms Of Heart Failure Or The Anginal Syndrome May Be Present Even At Rest. If Any Physical Activity Is Undertaken, Discomfort Increases. (Class IV)
Item Group
Liver Assessment
LiverInvolvedInd-3
Item
Does patient currently have clinically evident liver involvement per the protocol criteria
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12392 (NCI Thesaurus ObjectClass)
C0023884 (UMLS 2011AA ObjectClass)
C25547 (NCI Thesaurus Property)
LiverMeasureInd-2
Item
Was a liver measurement done (at baseline)
boolean
C25209 (NCI Thesaurus Property)
C0242485 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C12392 (NCI Thesaurus ObjectClass)
C0023884 (UMLS 2011AA ObjectClass)
HepatomegalyAssessmentDate
Item
Date of Liver Evaluation
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain-2)
C3100 (NCI Thesaurus ObjectClass)
C0017924 (UMLS 2011AA ObjectClass)
LiverSizeMeasurement
Item
Liver Measurement (cm)
float
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C12392 (NCI Thesaurus ObjectClass)
C0023884 (UMLS 2011AA ObjectClass)
C25681 (NCI Thesaurus Property)
C0456389 (UMLS 2011AA Property)
Item
Method of liver evaluation
text
C25209 (NCI Thesaurus Property)
C0242485 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C12392 (NCI Thesaurus ObjectClass)
C0023884 (UMLS 2011AA ObjectClass)
CL.24
Code List
Method of liver evaluation
CL Item
Medical Examination (Clinical examination)
C25305 (NCI Thesaurus)
C0582103 (UMLS 2011AA)
CL Item
Computed Tomography (CT scan)
C17204 (NCI Thesaurus)
C0040405 (UMLS 2011AA)
CL Item
Radionuclide Imaging (Liver-spleen scan)
C62667 (NCI Thesaurus)
C0034606 (UMLS 2011AA)
CL Item
Other (Other)
CL Item
Ultrasound (Ultrasound)
C64384 (NCI Thesaurus)
C1456803 (UMLS 2011AA)
LiverMeasureSpecify
Item
Specify other method
text
C25209 (NCI Thesaurus Property)
C0242485 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C12392 (NCI Thesaurus ObjectClass)
C0023884 (UMLS 2011AA ObjectClass)
Item Group
Gi Tract Assessment
GastrointestinalTractInvolvedInd-2
Item
Does patient currently have clinically evident GI tract involvement per the protocol criteria
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25547 (NCI Thesaurus Property)
C34082 (NCI Thesaurus ObjectClass)
C0017189 (UMLS 2011AA ObjectClass)
GastrointestinalHemorrhageAdverseEventPresentInd-2
Item
Is there GI bleeding
boolean
C13359 (NCI Thesaurus ObjectClass)
C0521362 (UMLS 2011AA ObjectClass)
C26791 (NCI Thesaurus ObjectClass-2)
C0019080 (UMLS 2011AA ObjectClass-2)
C41331 (NCI Thesaurus ObjectClass-3)
C0877248 (UMLS 2011AA ObjectClass-3)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
DiarrheaPresentInd-2
Item
Is diarrhea present
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C2987 (NCI Thesaurus ObjectClass)
C0011991 (UMLS 2011AA ObjectClass)
BowelMovementObservedDailyCount
Item
Number of stools per day
float
C12736 (NCI Thesaurus ObjectClass)
C0021853 (UMLS 2011AA ObjectClass)
C37994 (NCI Thesaurus Property)
C0026649 (UMLS 2011AA Property)
C25599 (NCI Thesaurus Property-2)
C1441672 (UMLS 2011AA Property-2)
C25473 (NCI Thesaurus ValueDomain)
C0332173 (UMLS 2011AA ValueDomain)
C25463 (NCI Thesaurus ValueDomain-2)
C0750480 (UMLS 2011AA ValueDomain-2)
LaboratoryProcedureFecesLipidOutcomeInd-2
Item
Was a fecal fat excretion test done
boolean
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C13234 (NCI Thesaurus Property-2)
C0015733 (UMLS 2011AA Property-2)
C616 (NCI Thesaurus Property-3)
C0023779 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
LaboratoryProcedureFecesLipidFirstDayOutcomeSpecifiedValue
Item
24-hour Fecal Fat Excretion (If Yes, - g)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25301 (NCI Thesaurus Property)
C0439228 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property-2)
C1279901 (UMLS 2011AA Property-2)
C20200 (NCI Thesaurus Property-3)
C1274040 (UMLS 2011AA Property-3)
C13234 (NCI Thesaurus Property-4)
C0015733 (UMLS 2011AA Property-4)
C616 (NCI Thesaurus Property-5)
C0023779 (UMLS 2011AA Property-5)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureFecesLipidOutcomeDate
Item
Date of fecal fat evaluation (start date)
date
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C13234 (NCI Thesaurus Property-2)
C0015733 (UMLS 2011AA Property-2)
C616 (NCI Thesaurus Property-3)
C0023779 (UMLS 2011AA Property-3)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item Group
Nerve Assessment
PeripheralNerveInvolvedInd-2
Item
Does patient currently have clinically evident peripheral nerve involvement per the protocol criteria
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25547 (NCI Thesaurus Property)
C12768 (NCI Thesaurus ObjectClass)
C0031119 (UMLS 2011AA ObjectClass)
ElectromyographyPerformedDate
Item
Date of EMG/NCS
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C38056 (NCI Thesaurus ObjectClass)
C0013839 (UMLS 2011AA ObjectClass)
CompoundMuscleActionPotentialAmplitudeValue
Item
CMAP amplitude
float
C12435 (NCI Thesaurus ObjectClass)
C0026845 (UMLS 2011AA ObjectClass)
C43366 (NCI Thesaurus ObjectClass-2)
C1706082 (UMLS 2011AA ObjectClass-2)
C82324 (NCI Thesaurus ObjectClass-3)
C0025251 (UMLS 2011AA ObjectClass-3)
C70831 (NCI Thesaurus Property)
C2346753 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
Item
Results of EMG
text
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C20200 (NCI Thesaurus ValueDomain)
C1274040 (UMLS 2011AA ValueDomain)
C38056 (NCI Thesaurus ObjectClass)
C0013839 (UMLS 2011AA ObjectClass)
CL.30
Code List
Results of EMG
CL Item
Abnormal (Abnormal)
C25401 (NCI Thesaurus)
C0205161 (UMLS 2011AA)
CL Item
Normal (Normal)
C14165 (NCI Thesaurus)
C0205307 (UMLS 2011AA)
ElectromyographyOutcomeSpecify
Item
Specify EMG result (If abnormal,)
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C38056 (NCI Thesaurus ObjectClass)
C0013839 (UMLS 2011AA ObjectClass)
Item
Neuropathy Impairment Score
text
C4731 (NCI Thesaurus ObjectClass)
C0031117 (UMLS 2011AA ObjectClass)
C25367 (NCI Thesaurus Property)
C21055 (NCI Thesaurus Property-2)
C0684336 (UMLS 2011AA Property)
C25338 (NCI Thesaurus Property-3)
C0449820 (UMLS 2011AA Property-2)
C20200 (NCI Thesaurus ValueDomain)
C1274040 (UMLS 2011AA ValueDomain)
CL.31
Code List
Neuropathy Impairment Score
CL Item
25% (25%)
CL Item
50% (50%)
CL Item
75% Weak (75% weak)
CL Item
Normal (Normal)
C14165 (NCI Thesaurus)
C0205307 (UMLS 2011AA)
CL Item
Paralysis (Paralyzed)
C3310 (NCI Thesaurus)
C0522224 (UMLS 2011AA)
AutonomicNervousSystemInvolvedInd-2
Item
Does patient have clinically evident autonomic nerve involvement per the protocol criteria
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25547 (NCI Thesaurus Property)
C12673 (NCI Thesaurus ObjectClass)
C0004388 (UMLS 2011AA ObjectClass)
Item Group
Kidney Assessment
KidneyInvolvementInd-2
Item
Does patient currently have clinically evident kidney involvement per the protocol criteria
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C12415 (NCI Thesaurus ObjectClass)
C0022646 (UMLS 2011AA ObjectClass)
C25548 (NCI Thesaurus Property)
C1314939 (UMLS 2011AA Property)
Item Group
Peripheral Blood Chemistry
LaboratoryProcedureBeta-2-MicroglobulinProteinOutcomeSpecifiedValue
Item
Beta-2 Microglobulin (ng/ml)
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)
C62657 (NCI Thesaurus Property-2)
C0005149 (UMLS 2011AA Property-2)
LaboratoryProcedureBeta-2-MicroglobulinProteinOutcomeSpecifiedUpperLimitofNormalValue
Item
Beta-2 Microglobulin ULN (ng/ml)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C62657 (NCI Thesaurus Property-2)
C0005149 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)
LDH
Item
Lactate dehydrogenase (LDH) (U/L)
float
C20200 (NCI Thesaurus Property)
C0202113 (UMLS CUI-1)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C25184 (NCI Thesaurus Property-2)
LDH ULN
Item
Lactate dehydrogenase ULN
float
C25294 (NCI Thesaurus ObjectClass)
C0202113 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C1519815 (UMLS CUI-2)
C25184 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C38024 (NCI Thesaurus ValueDomain-2)
C25706 (NCI Thesaurus ValueDomain-3)
HematologySpecimenCollectedDate
Item
Date Hematology (Blood) Sample Obtained
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16673 (NCI Thesaurus ObjectClass)
C0018943 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
C25452 (NCI Thesaurus Property)
Laboratory Procedure Not Performed
Item
Mark an 'X' if not done
text
C25704 (NCI Thesaurus ValueDomain)
C0022885 (UMLS CUI-1)
C25594 (NCI Thesaurus Property)
C0445106 (UMLS CUI-2)
C38000 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
Laboratory Procedure Not Performed
Item
Mark an 'X' if not done
text
C25704 (NCI Thesaurus ValueDomain)
C0022885 (UMLS CUI-1)
C25594 (NCI Thesaurus Property)
C0445106 (UMLS CUI-2)
C38000 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
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 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)
Investigator Signature
Item
Investigator Signature
text
C25704 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
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