ID

11037

Beschreibung

E4A03 Follow-up Disease Assessment Form - Form 2058 NCT00098475 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=DCEB2086-C366-716B-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=DCEB2086-C366-716B-E034-0003BA12F5E7

Stichworte

Klinische Studie [Dokumenttyp]

Plasmazellen-Tumoren

Multiples Myelom

Verlaufsstudien

Hochgeladen am

16. Juni 2015

DOI

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Lizenz

Creative Commons BY-NC 3.0 Legacy

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E4A03 Follow-up Disease Assessment Form - Form 2058 NCT00098475

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1 Formulare

StudyEvent: E4A03 Follow-up Disease Assessment Form - Form 2058
1. No Instruction available.

Name

Typ

Description | Question | Decode (Coded Value)

Datentyp

Alias

Header

Item Group

Header

Protocol Number ECOG

Item

ECOG Protocol Number

text

C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)

Patient ID ECOG

Item

ECOG Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)

Generic drug form

Item

DCI Name

text

C25191 (NCI Thesaurus ValueDomain)
C3242750 (UMLS CUI-1)
C19464 (NCI Thesaurus Property)
C25474 (NCI Thesaurus ObjectClass)
C25452 (NCI Thesaurus ObjectClass-2)

Registration Number

Item

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)

Patient Initials

Item

Patient Initials

text

C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)

Study Number Participating Group

Item

Participating Group Protocol Number

text

C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)

Trial subject ID Participating Group

Item

Participating Group Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)

Institution Name

Item

Institution/Affiliate

text

C25454 (NCI Thesaurus ObjectClass)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)

Data amended

Item

Are data amended (If this form covers an On Treatment Report Period:)

boolean

C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)

ON TREATMENT

Item Group

On Treatment

On Treatment Time Period

Item

On Treatment Time Period (Step 2: Arms C and D)

text

CL.3

Code List

On Treatment Time Period (Step 2: Arms C and D)

CL Item

Cycle 1 (Cycle 1 Step 2)

CL Item

Cycle 2 (Cycle 2 Step 2)

CL Item

Cycle 3 (Cycle 3 Step 2)

CL Item

Cycle 4 (Cycle 4 Step 2)

CL Item

Cycle 5 (Cycle 5 Step 2)

CL Item

Cycle 6 (Cycle 6 Step 2)

CL Item

Cycle 7 (Cycle 7 Step 2)

CL Item

Cycle 8 (Cycle 8 Step 2)

CL Item

Cycle 9 (Cycle 9 Step 2)

CL Item

Cycle 10 (Cycle 10 Step 2)

CL Item

Cycle 11 (Cycle 11 Step 2)

CL Item

Cycle 12 (Cycle 12 Step 2)

OFF TREATMENT

Item Group

Off Treatment

PersonOff-TreatmentTimePeriodType

Item

Off Treatment Report Period (since registration)

text

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25601 (NCI Thesaurus Property-2)
C1518544 (UMLS 2011AA Property-2)
C25207 (NCI Thesaurus Property-3)
C0040223 (UMLS 2011AA Property-3)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.4

Code List

Off Treatment Report Period (since registration)

CL Item

3 Months (3 Months Post Registration)

CL Item

6 Months (6 Months Post Registration)

CL Item

9 Months (9 Months Post Registration)

CL Item

12 Months (12 Months Post Registration)

CL Item

15 Months (15 Months Post Registration)

CL Item

18 Months (18 Months Post Registration)

CL Item

21 Months Post Registration (21 Months Post Registration)

CL Item

2 Years (24 Months Post Registration)

CL Item

30 Months (30 Months Post Registration)

CL Item

3 Years (36 Months Post Registration)

CL Item

42 Months (42 Months Post Registration)

CL Item

4 Years (48 Months Post Registration)

CL Item

54 Months (54 Months Post Registration)

CL Item

5 Years (60 Months Post Registration)

CL Item

6 Years (72 Months Post Registration)

CL Item

84 Months Post Registration (84 Months Post Registration)

Cycle Number

Item

Cycle Number

integer

C25337 (NCI Thesaurus ValueDomain)
C2045829 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25379 (NCI Thesaurus Property)

Protein Measurements

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)

SerumProteinMonoclonalPresentInd-3

Item

Is serum M-protein present but too small to quantify?

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C17021 (NCI Thesaurus ObjectClass)
C0033684 (UMLS 2011AA ObjectClass)

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)

SerumProteinImmunoelectrophoresisDate

Item

Date of serum immunoelectrophoresis (Serum immunoelectrophoresis leave blank if not done)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C17021 (NCI Thesaurus ObjectClass)
C0033684 (UMLS 2011AA ObjectClass)
C0020997 (NCI Metathesaurus Property)

SerumProteinMonoclonalImmunoelectrophoresisStatus

Item

Serum M-protein by immunoelectrophoresis

text

C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
C17021 (NCI Thesaurus ObjectClass)
C0033684 (UMLS 2011AA ObjectClass)
C0020997 (NCI Metathesaurus Property)

CL.6

Code List

Serum M-protein by immunoelectrophoresis

CL Item

Negative (negative)

C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)

CL Item

Positive (positive)

C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)

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)

SerumProteinMonoclonalDetectedType

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.7

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)

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)

UrineProteinMonoclonalPresentInd-3

Item

Is urine M-protein light chain excretion present but too small to quantify?

boolean

LaboratoryProcedureUrineMProteinImmunoglobulinLightChainOutcomeUnspecifiedValue

Item

Urine M-protein light chain excretion (mg/24 hr)

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)
C16720 (NCI Thesaurus Property-4)
C0021038 (UMLS 2011AA Property-4)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

UrineProteinImmunoelectrophoresisDate

Item

Date of urine immunoelectrophoresis (Urine immunoelectrophoresis leave blank if not done)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C17021 (NCI Thesaurus ObjectClass)
C0033684 (UMLS 2011AA ObjectClass)
C0020997 (NCI Metathesaurus Property)

UrineProteinMonoclonalImmunoelectrophoresisStatus

Item

Urine M-protein by immunoelectrophoresis

text

C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
C17021 (NCI Thesaurus ObjectClass)
C0033684 (UMLS 2011AA ObjectClass)
C0020997 (NCI Metathesaurus Property)

CL.9

Code List

Urine M-protein by immunoelectrophoresis

CL Item

Negative (negative)

C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)

CL Item

Positive (positive)

C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)

MonoclonalProteinUrineImmunofixationType

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.10

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)

Serum Quantitative Immunoglobulins

Item Group

Serum Quantitative Immunoglobulins

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)

LaboratoryProcedureSerumImmunologicIgGResultUnspecifiedValue

Item

IgG

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

float

LaboratoryProcedureSerumImmunologicIgGResultUpperLimitofNormalValue

Item

IgG ULN

float

LaboratoryProcedureSerumImmunologicIgAResultUnspecifiedValue

Item

IgA

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

float

LaboratoryProcedureSerumImmunologicIgAResultUpperLimitofNormalValue

Item

IgA ULN

float

LaboratoryProcedureSerumImmunologicIgMResultUnspecifiedValue

Item

IgM

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)

LaboratoryProcedureSerumImmunologicIgMResultLowerLimitofNormalValue

Item

IgM LLN

float

LaboratoryProcedureSerumImmunologicIgMResultUpperLimitofNormalValue

Item

IgM ULN

float

Bone Marrow

Item Group

Bone Marrow

BoneMarrowBiopsyInd

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)

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)

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)

BoneMarrowAspirateInd

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.12

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)

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)

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)

Soft Tissue Plasmacytoma

Item Group

Soft Tissue Plasmacytoma

SoftTissuePlasmacytomaPresentInd

Item

Soft tissue plasmacytoma?

text

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C12471 (NCI Thesaurus ObjectClass)
C0225317 (UMLS 2011AA ObjectClass)
C9349 (NCI Thesaurus ObjectClass-2)
C0032131 (UMLS 2011AA ObjectClass-2)

CL.13

Code List

Soft tissue plasmacytoma?

CL Item

No (no)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes, Previously Existing (yes, previously existing)

CL Item

Yes, New (yes, new)

CL Item

Yes, Both Previously Existing And New (yes, both previously existing and new)

CL Item

Unknown (unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

LesionNumber

Item

Lesion No.

float

C25337 (NCI Thesaurus Property)
C0237753 (UMLS 2011AA Property)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)

Lesion Site, Primary

Item

Site of lesion

text

C13717 (NCI Thesaurus ValueDomain)
C0449695 (UMLS CUI-1)
C3824 (NCI Thesaurus ObjectClass)
C25341 (NCI Thesaurus Property)

LesionAssessmentDate

Item

Date of Evaluation (Leave blank if not evaluated this report period)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain-2)

Evaluation method

Item

Method of evaluation

text

C25284 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C16847 (NCI Thesaurus Property)

CL.14

Code List

Method of evaluation

CL Item

Clinical (Clinical Examination)

C25398 (NCI Thesaurus)
C0205210 (UMLS 2011AA)

CL Item

Ct Scan (CT scan (non-spiral))

CL Item

Spiral Ct Scan (Spiral CT scan)

CL Item

Mri (MRI (NMR))

CL Item

Not Evaluated (Not evaluated)

CL Item

Other (Other (specify))

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

Evaluation method, specify

Item

Specify other assessment method

text

C25685 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C1521902 (UMLS CUI-2)
C16847 (NCI Thesaurus Property)

PlasmacytomaLongestDimensionMeasurement

Item

Size of Plasmacytoma (cm)

float

C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C25558 (NCI Thesaurus Property)
C1522425 (UMLS 2011AA Property)
C9349 (NCI Thesaurus ObjectClass)
C0032131 (UMLS 2011AA ObjectClass)
C25483 (NCI Thesaurus Property-2)
C0439534 (UMLS 2011AA Property-2)

New Plasmacytoma Longest Dimension Measurement

Item

New Plasmacytoma Longest Dimension Measurement

float

C25586 (NCI Thesaurus ObjectClass)
C9349 (NCI Thesaurus ObjectClass-2)
C25558 (NCI Thesaurus Property)
C25483 (NCI Thesaurus Property-2)
C25209 (NCI Thesaurus ValueDomain)
C0205314 (UMLS CUI-1)
C0032131 (UMLS CUI-2)
C1522425 (UMLS CUI-3)
C0439534 (UMLS CUI-4)
C0242485 (UMLS CUI-5)

PlasmacytomaFollow-UpStatusType

Item

Current status of plasmacytoma (*)

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C12471 (NCI Thesaurus ObjectClass)
C0225317 (UMLS 2011AA ObjectClass)
C9349 (NCI Thesaurus ObjectClass-2)
C0032131 (UMLS 2011AA ObjectClass-2)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)

CL.15

Code List

Current status of plasmacytoma (*)

CL Item

Increase (increase)

CL Item

Decrease (decrease)

CL Item

No Change (no change)

CL Item

New (new)

C25586 (NCI Thesaurus)
C0205314 (UMLS 2011AA)

Bone

Item Group

Bone

BoneAssessmentInd-3

Item

Was bone assessed this report period?

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C12366 (NCI Thesaurus ObjectClass)
C0262950 (UMLS 2011AA ObjectClass)

BoneAssessmentDate

Item

Date of bone assessment (If yes,)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C12366 (NCI Thesaurus ObjectClass)
C0262950 (UMLS 2011AA ObjectClass)

BoneCTScanInd-3

Item

CT scan

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C17204 (NCI Thesaurus ObjectClass)
C0040405 (UMLS 2011AA ObjectClass)
C17999 (NCI Thesaurus Property)
C0441633 (UMLS 2011AA Property)

BoneMRIScanInd-3

Item

MRI (NMR)

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C16809 (NCI Thesaurus ObjectClass)
C0024485 (UMLS 2011AA ObjectClass)
C17999 (NCI Thesaurus Property)
C0441633 (UMLS 2011AA Property)

BoneScanMedicalImagingAssessmentInd-3

Item

Bone scan

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C17646 (NCI Thesaurus ObjectClass)
C0203668 (UMLS 2011AA ObjectClass)
C16831 (NCI Thesaurus ObjectClass-2)

BoneTomogramScanInd-3

Item

Pet scan

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C17999 (NCI Thesaurus Property)
C0441633 (UMLS 2011AA Property)
C25221 (NCI Thesaurus ObjectClass)
C1522465 (UMLS 2011AA ObjectClass)

BoneScanDiagnosticImagingSkeletalSystemAssessmentInd-3

Item

Skeletal survey

boolean

C17646 (NCI Thesaurus ObjectClass)
C0203668 (UMLS 2011AA ObjectClass)
C16502 (NCI Thesaurus ObjectClass-2)
C0011923 (UMLS 2011AA ObjectClass-2)
C25367 (NCI Thesaurus Property)
C12788 (NCI Thesaurus Property-2)
C0037253 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

BoneOtherAssessmentInd-3

Item

Other

boolean

C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property-2)
C12366 (NCI Thesaurus ObjectClass)
C0262950 (UMLS 2011AA ObjectClass)

LyticLesionGrowthInd-3

Item

Was there distinct enlargement of existing lesions? (* Leave blank if no prior lesions.)

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C18825 (NCI Thesaurus Property)
C0018270 (UMLS 2011AA Property)
C27963 (NCI Thesaurus ObjectClass-2)
C0439680 (UMLS 2011AA ObjectClass-2)

CL.23

Code List

Was there distinct enlargement of existing lesions? (* Leave blank if no prior lesions.)

CL Item

No (no)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Unknown (unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

LyticLesionGrowthSpecify

Item

Explain results (If yes:)

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C18825 (NCI Thesaurus Property)
C0018270 (UMLS 2011AA Property)

BoneLesionAppearanceInd-3

Item

Was the appearance of any new lesions documented?

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25377 (NCI Thesaurus Property)
C0700364 (UMLS 2011AA Property)
C12366 (NCI Thesaurus ObjectClass-2)
C0262950 (UMLS 2011AA ObjectClass-2)

CL.24

Code List

Was the appearance of any new lesions documented?

CL Item

No (no)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Unknown (unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

Peripheral Blood Chemistry

Item Group

Peripheral Blood Chemistry

LaboratoryProcedureC-ReactiveProteinResultUpperLimitofNormalValue

Item

C-reactive protein ULN

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C60651 (NCI Thesaurus Property-2)
C0006560 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)

LaboratoryProcedureC-ReactiveProteinResultSpecifiedValue

Item

C-reactive protein (mg/dl)

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)
C60651 (NCI Thesaurus Property-2)
C0006560 (UMLS 2011AA Property-2)

LDH ULN

Item

Lactate dehydrogenase ULN (LDH)

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)

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)

LaboratoryProcedureBeta-2-MicroglobulinProteinOutcomeSpecifiedUpperLimitofNormalValue

Item

Beta-2 Microglobulin ULN

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)

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)

Objective Response

Item Group

Objective Response

ResponseChangeInd-2

Item

Since the previous evaluation, has the overall response changed?

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25755 (NCI Thesaurus ObjectClass)
C0871261 (UMLS 2011AA ObjectClass)
C25446 (NCI Thesaurus Property)
C0392747 (UMLS 2011AA Property)

MyelomaResponseType

Item

Objective status at this evaluation (confirmed)

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25755 (NCI Thesaurus Property)
C0871261 (UMLS 2011AA Property)
C3242 (NCI Thesaurus ObjectClass)
C0026764 (UMLS 2011AA ObjectClass)

CL.26

Code List

Objective status at this evaluation (confirmed)

CL Item

Complete Response (complete response (CR))

CL Item

Partial Response (partial response (PR))

C18212 (NCI Thesaurus)

CL Item

Minimal Response (minimal response (MR))

CL Item

No Response/stable Disease (no response/stable disease (NR, SD))

CL Item

Progressive Disease (progressive disease (PD))

C35571 (NCI Thesaurus)
C1335499 (UMLS 2011AA)

CL Item

Unevaluable (unevaluable)

C62222 (NCI Thesaurus)
C1883425 (UMLS 2011AA)

Complete Response First Observed Date

Item

Complete response (CR) first observed date

date

C25755 (NCI Thesaurus ObjectClass)
C0677874 (UMLS CUI-1)
C25250 (NCI Thesaurus ObjectClass-2)
C1115465 (UMLS CUI-2)
C25509 (NCI Thesaurus Property)
C25599 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)

BestPartialResponseFirstObservedDate

Item

Very good partial response first observed date (VGPR)

date

C18212 (NCI Thesaurus ObjectClass)
C25432 (NCI Thesaurus ObjectClass-2)
C1522427 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25599 (NCI Thesaurus Property-2)
C1441672 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)

Partial Response First Observed Date

Item

Partial response (PR) first observed date

date

C25755 (NCI Thesaurus ObjectClass)
C1521726 (UMLS CUI-1)
C25378 (NCI Thesaurus ObjectClass-2)
C1115465 (UMLS CUI-2)
C25509 (NCI Thesaurus Property)
C25599 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)

MinimalResponseFirstObservedDate

Item

Minimal response first observed date (MR)

date

C25755 (NCI Thesaurus ObjectClass)
C0871261 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25599 (NCI Thesaurus Property-2)
C1441672 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)

ProgressionFirstObservedDate

Item

Progressive disease first observed date (For PD: PD)

date

C25331 (NCI Thesaurus ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25599 (NCI Thesaurus Property-2)
C1441672 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)

StableDiseaseDate

Item

Date of disease plateau

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)

Comments

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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E4A03 Follow-up Disease Assessment Form - Form 2058 NCT00098475

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