ID

8576

Beschrijving

Waldenstrom's Macroglobulinemia - On-Study Form Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=D6795205-A4D9-0CD9-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=D6795205-A4D9-0CD9-E034-0003BA12F5E7

Trefwoorden

D008258

Clinical Trial

On-Study Form

Geüploaded op

9 januari 2015

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0 Legacy

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On-Study - Waldenstroms Macroglobulinemia - On-Study Form - 2273908v3.0

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StudyEvent: Waldenstroms Macroglobulinemia - On-Study Form
1. No Instruction available.

Name

Type

Description | Question | Decode (Coded Value)

Datatype

Alias

CRF Header

Item Group

Crf Header

Protocol ID Coordinating Group

Item

Coordinating Group Protocol No.

text

C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1711341 (UMLS CUI-2)
C25462 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)

Coordinating Group Code

Item

Coordinating Group Code

text

C25162 (NCI Thesaurus ValueDomain)
C1711341 (UMLS CUI-1)
C17005 (NCI Thesaurus ObjectClass)
C0805701 (UMLS CUI-2)
C25462 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)

Protocol Title

Item

Protocol Title

text

C25191 (NCI Thesaurus ValueDomain)
C2986303 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C42774 (NCI Thesaurus Property)

Patient Study ID

Item

Patient Study ID

text

C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25462 (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)

Trial subject ID Participating Group

Item

Other 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)

ParticipatingGroupIdentifierCode

Item

Participating Group Code

text

C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25608 (NCI Thesaurus ObjectClass)
C0679823 (UMLS 2011AA ObjectClass)
C17005 (NCI Thesaurus ObjectClass-2)
C1257890 (UMLS 2011AA ObjectClass-2)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

Patient Name

Item

Patient Name (initials acceptable)

text

C25191 (NCI Thesaurus ValueDomain)
C1299487 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)

Waldenstrom's: Form Administration

Item Group

Waldenstrom's: Form Administration

Person Completing Form

Item

Person Completing Form

text

C25191 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)

Data amended

Item

Are data amended (If data are amended, please circle in red when using paper form)

boolean

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

Waldenstrom's: Disease Description

Item Group

Waldenstrom's: Disease Description

CancerInitialDiagnosisDate

Item

Date of Initial Pathologic Diagnosis

date

C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property-2)
C0011900 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)

DiseaseRegisteringStatusType

Item

Disease Status at Registration (For advanced or recurrent studies,)

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25645 (NCI Thesaurus Property)
C25688 (NCI Thesaurus Property-2)
C0449438 (UMLS 2011AA Property)

CL.2

Code List

Disease Status at Registration (For advanced or recurrent studies,)

CL Item

Initial Diagnosis (Initial Diagnosis)

CL Item

Relapsed (Relapsed)

CL Item

Refractory (Refractory)

C38014 (NCI Thesaurus)
C0205269 (UMLS 2011AA)

DiseaseDiagnosisHematopoieticType

Item

Hematopoietic Diagnosis (WHO)

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C13324 (NCI Thesaurus ValueDomain-2)
C0229601 (UMLS 2011AA ValueDomain-2)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)

CL.3

Code List

Hematopoietic Diagnosis (WHO)

CL Item

Lymphoplasmacytic Lymphoma (waldenstrom Macroglobulinemia) (Lymphoplasmacytic lymphoma)

CL Item

Other Specify (Other)

DiseaseDiagnosisHematopoieticSpecify

Item

Other specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C13324 (NCI Thesaurus ValueDomain-2)
C0229601 (UMLS 2011AA ValueDomain-2)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)

MyelomaSymptomType

Item

Disease Symptoms Present (current check all that apply)

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C3242 (NCI Thesaurus ObjectClass)
C0026764 (UMLS 2011AA ObjectClass)
C4876 (NCI Thesaurus Property)
C1457887 (UMLS 2011AA Property)

CL.4

Code List

Disease Symptoms Present (current check all that apply)

CL Item

Dizziness (Dizziness)

CL Item

Fatigue (Fatigue)

C3036 (NCI Thesaurus)
C0015672 (UMLS 2011AA)

CL Item

Visual Disturbance (Visual disturbance)

CL Item

Dyspnea (Dyspnea)

C2998 (NCI Thesaurus)
C0013404 (UMLS 2011AA)

CL Item

Paresthesias Or Painful/numb Feet (Paresthesias or painful/numb feet)

CL Item

Retinal Hemorrhage (Retinal hemorrhage)

CL Item

Any Other Bleeding (Any other bleeding)

CL Item

Weakness (Weakness)

CL Item

Headaches (Headaches)

CL Item

Epistaxis (Epistaxis)

C26766 (NCI Thesaurus)
C0014591 (UMLS 2011AA)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

MyelomaSymptomSpecify

Item

Other specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C3242 (NCI Thesaurus ObjectClass)
C0026764 (UMLS 2011AA ObjectClass)
C4876 (NCI Thesaurus Property)
C1457887 (UMLS 2011AA Property)

MyelomaHemorrhageSymptomOtherSpecify

Item

Any other bleeding specify

text

C3242 (NCI Thesaurus ObjectClass)
C0026764 (UMLS 2011AA ObjectClass)
C26791 (NCI Thesaurus Property)
C0019080 (UMLS 2011AA Property)
C4876 (NCI Thesaurus Property-2)
C1457887 (UMLS 2011AA Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus ValueDomain-2)
C0205394 (UMLS 2011AA ValueDomain-2)

LymphomaBSymptomIndicator

Item

Are B-symptoms present

boolean

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C3208 (NCI Thesaurus ObjectClass)
C0024299 (UMLS 2011AA ObjectClass)
C43283 (NCI Thesaurus Property)
C1706867 (UMLS 2011AA Property)

LymphomaB-SymptomsFirstDate

Item

Date of First Symptoms (If yes,)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C3208 (NCI Thesaurus ObjectClass)
C0024299 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus ValueDomain-2)
C1279901 (UMLS 2011AA ValueDomain-2)
C43283 (NCI Thesaurus Property)
C1706867 (UMLS 2011AA Property)

LymphomaFeverSymptomInd-3

Item

Unexplained, persistent fever >38 degrees C (or >100 degrees F) in the previous month

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C3208 (NCI Thesaurus ObjectClass)
C0024299 (UMLS 2011AA ObjectClass)
C4876 (NCI Thesaurus Property)
C1457887 (UMLS 2011AA Property)
C3038 (NCI Thesaurus Property-2)
C0015967 (UMLS 2011AA Property-2)

LymphomaSweatingSymptomInd-3

Item

Recurring, drenching night sweats during the previous month

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C3208 (NCI Thesaurus ObjectClass)
C0024299 (UMLS 2011AA ObjectClass)
C4876 (NCI Thesaurus Property)
C1457887 (UMLS 2011AA Property)
C36172 (NCI Thesaurus Property-2)
C0038990 (UMLS 2011AA Property-2)

LymphomaWeightLossInd-3

Item

Unexplained weight loss >10% of body weight in the previous 6 months

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C3445 (NCI Thesaurus Property)
C0043096 (UMLS 2011AA Property)
C3208 (NCI Thesaurus ObjectClass)
C0024299 (UMLS 2011AA ObjectClass)

ExtramedullaryLymphoplasmacyticLymphomaPresentInd-3

Item

Was extramedullary immunocytoma present at baseline

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C25503 (NCI Thesaurus ObjectClass)
C1517060 (UMLS 2011AA ObjectClass)
C0024419 (NCI Metathesaurus ObjectClass)

CL.9

Code List

Was extramedullary immunocytoma present at baseline

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)

DiseaseInvolvementSite

Item

Site of Involvement (If yes, s)

text

C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25548 (NCI Thesaurus Property)
C1314939 (UMLS 2011AA Property)

CL.10

Code List

Site of Involvement (If yes, s)

CL Item

Liver (Liver)

C12392 (NCI Thesaurus)
C0023884 (UMLS 2011AA)

CL Item

Lung (Lung)

C12468 (NCI Thesaurus)
C0024109 (UMLS 2011AA)

CL Item

Pleura (Pleura)

C12469 (NCI Thesaurus)
C0032225 (UMLS 2011AA)

CL Item

Brain (Brain)

C12439 (NCI Thesaurus)
C0006104 (UMLS 2011AA)

CL Item

Bone (Bone)

C12366 (NCI Thesaurus)
C0262950 (UMLS 2011AA)

CL Item

Bone Marrow (Bone Marrow)

C12431 (NCI Thesaurus)
C0005953 (UMLS 2011AA)

CL Item

Kidney (Kidney)

C12415 (NCI Thesaurus)
C0022646 (UMLS 2011AA)

CL Item

Gastrointestinal Tract (GI Tract)

C34082 (NCI Thesaurus)
C0017189 (UMLS 2011AA)

CL Item

Skin (Skin (cutaneous))

C12470 (NCI Thesaurus)
C1123023 (UMLS 2011AA)

CL Item

Spleen (Spleen)

C12432 (NCI Thesaurus)
C0037993 (UMLS 2011AA)

CL Item

Lymph Nodes (Lymph nodes)

CL Item

Other Specify (Other)

DiseaseInvolvementSiteOtherSpecify

Item

Other specify

text

C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25547 (NCI Thesaurus Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus ValueDomain-2)
C0205394 (UMLS 2011AA 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.11

Code List

Method of Evaluation

CL Item

Clinical Examination (pe) (Clinical examination)

CL Item

Ct Scan (CT Scan)

CL Item

Mri (MRI (NMR))

CL Item

Ultrasound (Ultrasound)

C64384 (NCI Thesaurus)
C1456803 (UMLS 2011AA)

CL Item

Biopsy (Biopsy)

C15189 (NCI Thesaurus)
C0005558 (UMLS 2011AA)
C15189 (NCI Thesaurus-3)
C0005558 (UMLS 2011AA-4)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

Evaluation method, specify

Item

Other specify

text

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

TransfusionLastAdministeredMonthInd-3

Item

Did patient receive a transfusion in the previous 4 weeks

text

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C15366 (NCI Thesaurus ObjectClass)
C0086818 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

CL.12

Code List

Did patient receive a transfusion in the previous 4 weeks

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)

ErythropoietinAgentLastAdministeredMonthInd-3

Item

Did patient receive erythropoietin-type agents (e.g., Epogen, Procrit or Aranesp) within the previous 4 weeks

text

C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C20429 (NCI Thesaurus ObjectClass-2)
C0014822 (UMLS 2011AA ObjectClass-2)
C25551 (NCI Thesaurus Property)
C1517741 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C29846 (NCI Thesaurus ValueDomain-2)
C0439231 (UMLS 2011AA ValueDomain-2)

CL.13

Code List

Did patient receive erythropoietin-type agents (e.g., Epogen, Procrit or Aranesp) within the previous 4 weeks

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)

Waldenstrom's: Prior Treatment

Item Group

Waldenstrom's: Prior Treatment

CancerPriorTreatmentInd-3

Item

Prior Treatment? (If yes, respond to treatment-specific questions below.)

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C15368 (NCI Thesaurus Property-2)

PriorTreatmentPlannedRegimenCount

Item

No. of Planned Regimens (If yes, Note: Multiple drug/staged regimens count as 1)

float

C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C25619 (NCI Thesaurus Property)
C1301732 (UMLS 2011AA Property)
C15697 (NCI Thesaurus Property-2)
C0040808 (UMLS 2011AA Property-2)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)

MyelomaTreatmentPriorRegimenType

Item

Prior Treatment Regimen Name(s) (* Prior Treatment Regimen Name)

text

C3242 (NCI Thesaurus ObjectClass)
C0026764 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C15697 (NCI Thesaurus Property-2)
C0040808 (UMLS 2011AA Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.15

Code List

Prior Treatment Regimen Name(s) (* Prior Treatment Regimen Name)

CL Item

Anti-cd20 Antibody (Anti-CD20 antibody)

CL Item

Bexxar ([131]-i-anti-cd20) (Bexxar ([131]-I-anti-CD20))

CL Item

Chlorambucil (Chlorambucil)

C362 (NCI Thesaurus)
C0008163 (UMLS 2011AA)

CL Item

Chlorambucil/prednisone (Chlorambucil/prednisone)

CL Item

Chop (CHOP)

C1140700 (NCI Metathesaurus)

CL Item

R-chop (R-CHOP)

CL Item

Cyclophosphamide (Cyclophosphamide)

C405 (NCI Thesaurus)
C0010583 (UMLS 2011AA)

CL Item

Cyclophosphamide/prednisone (Cyclophosphamide/prednisone)

CL Item

Cvp (CVP)

CL Item

Etoposide (vp16) (Etoposide (VP16))

CL Item

Fludarabine (Fludarabine)

C1094 (NCI Thesaurus)
C0059985 (UMLS 2011AA)

CL Item

Fludara/ctx (Fludara/CTX)

CL Item

Fludara/ctx/rituxan (fcr) (Fludara/CTX/Rituxan (FCR))

CL Item

Fludara/rituxan (Fludara/Rituxan)

CL Item

Prednisone (Prednisone)

C770 (NCI Thesaurus)
C0032952 (UMLS 2011AA)

CL Item

Rituxan (Rituxan)

CL Item

Zevalin (yttrium-90-anti-cd20) (Zevalin (Yttrium-90-anti-CD20))

CL Item

2-chloro-deoxy-adenosine (2-cda) (2-chloro-deoxy-adenosine (2-CDA))

CL Item

2-cda/rituxan (2-CDA/Rituxan)

CL Item

Transplant (Transplant)

C0040733 (NCI Metathesaurus)

CL Item

Corticosteroids (Corticosteroids)

CL Item

Interferon (Interferon)

C20493 (NCI Thesaurus)
C0733470 (UMLS 2011AA)

CL Item

Interleukin-2 (Interleukin-2)

C20507 (NCI Thesaurus)
C0021756 (UMLS 2011AA)

CL Item

Thalidomide (Thalidomide)

C870 (NCI Thesaurus)
C0039736 (UMLS 2011AA)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

PriorTreatmentRegimenSpecify

Item

Other Prior Regimen Name (** If Other specify)

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C15697 (NCI Thesaurus Property)
C0040808 (UMLS 2011AA Property)

PriorTreatmentRegimenBeginDate

Item

Prior Treatment Regimen Start Date

date

C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C15697 (NCI Thesaurus Property)
C0040808 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)

PriorTreatmentRegimenEndDate

Item

Prior Treatment Regimen End Date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C15697 (NCI Thesaurus Property)
C0040808 (UMLS 2011AA Property)

PriorTreatmentMaintenanceRegimenInd-2

Item

Maintenance Only

boolean

C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C15697 (NCI Thesaurus Property)
C0040808 (UMLS 2011AA Property)
C53297 (NCI Thesaurus Property-2)
C0024501 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PriorTreatmentDiscontinuedReason

Item

Reason Stopped (? Reason Stopped)

text

C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C25484 (NCI Thesaurus Property)
C1444662 (UMLS 2011AA Property)

CL.17

Code List

Reason Stopped (? Reason Stopped)

CL Item

Completed Treatment (Completed treatment)

CL Item

Alternative Treatment (Alternative treatment)

CL Item

Patient Refusal (Patient refusal)

CL Item

Toxicity (Toxicity)

C27990 (NCI Thesaurus)
C0600688 (UMLS 2011AA)

CL Item

Progression (Progression/Relapse)

C25331 (NCI Thesaurus)
C25331 (NCI Thesaurus-2)

CL Item

Maintenance Only (Maintenance only)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

MyelomaTreatmentPriorResponseType

Item

Best Response (Best Response)

text

C3242 (NCI Thesaurus ObjectClass)
C0026764 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C25755 (NCI Thesaurus Property)
C0871261 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.18

Code List

Best Response (Best Response)

CL Item

Response/improvement (Response/Improvement)

CL Item

Progression (Progression)

C25331 (NCI Thesaurus)

CL Item

Plateau/stable (Plateau/Stable)

CL Item

Inevaluable (Inevaluable)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

PriorBMSCTAdministeredInd-3

Item

Prior Bone Marrow or Peripheral Blood Stem Cell Transplant?

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C25437 (NCI Thesaurus ObjectClass-2)
C0842093 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

PriorTransplantAdministeredType

Item

Prior Transplant Type (If yes,)

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C12981 (NCI Thesaurus ObjectClass-2)
C0332835 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

CL.20

Code List

Prior Transplant Type (If yes,)

CL Item

Autologous (Autologous)

C28000 (NCI Thesaurus)
C0439859 (UMLS 2011AA)

CL Item

Allogeneic (Allogeneic)

AutologousTransplantPriorAdministeredCount

Item

Number of autologous transplants

float

C12981 (NCI Thesaurus ObjectClass)
C0332835 (UMLS 2011AA ObjectClass)
C28000 (NCI Thesaurus ObjectClass-2)
C0439859 (UMLS 2011AA ObjectClass-2)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)

PriorTransplantLastDate

Item

Date of Last Transplant

date

C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C12981 (NCI Thesaurus ObjectClass-2)
C0332835 (UMLS 2011AA ObjectClass-2)
C25551 (NCI Thesaurus Property)
C1517741 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property-2)
C2745955 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25551 (NCI Thesaurus ValueDomain-2)
C1517741 (UMLS 2011AA ValueDomain-2)

AllogeneicTransplantPriorAdministeredCount

Item

Number of allogeneic transplants

float

C12981 (NCI Thesaurus ObjectClass)
C0332835 (UMLS 2011AA ObjectClass)
C28343 (NCI Thesaurus ObjectClass-2)
C1515895 (UMLS 2011AA ObjectClass-2)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)

PriorTransplantAllogenicAdministeredType

Item

Allogeneic Transplant Type

text

C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C12981 (NCI Thesaurus ObjectClass-2)
C0332835 (UMLS 2011AA ObjectClass-2)
C28343 (NCI Thesaurus Property)
C1515895 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.21

Code List

Allogeneic Transplant Type

CL Item

Mini (non-myeloablative) (Mini (non-myeloablative))

CL Item

Myeloablative (Myeloablative)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

PriorTransplantDate

Item

Date of Transplant

date

C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C12981 (NCI Thesaurus ObjectClass-2)
C0332835 (UMLS 2011AA ObjectClass-2)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)

PriorTransplantLymphocyteInfusionInd-2

Item

DLI

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15388 (NCI Thesaurus Property)
C0574032 (UMLS 2011AA Property)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C12981 (NCI Thesaurus ObjectClass-2)
C0332835 (UMLS 2011AA ObjectClass-2)
C12535 (NCI Thesaurus Property-2)
C0024264 (UMLS 2011AA Property-2)

PriorTransplantLymphocyteInfusionLastDate

Item

Date of Last DLI (If yes,)

date

C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C12981 (NCI Thesaurus ObjectClass-2)
C0332835 (UMLS 2011AA ObjectClass-2)
C15388 (NCI Thesaurus Property)
C0574032 (UMLS 2011AA Property)
C12535 (NCI Thesaurus Property-2)
C0024264 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25551 (NCI Thesaurus ValueDomain-2)
C1517741 (UMLS 2011AA ValueDomain-2)

PriorRTTotal-BodyIrradiationAdministeredInd-3

Item

Total body irradiation

text

C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C15350 (NCI Thesaurus Property)
C0043162 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

CL.23

Code List

Total body irradiation

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)

RadiolabeledImmunotherapyPriorAdministeredInd-3

Item

Prior Immuno-radiolabeled therapy (as transplant conditioning)

boolean

C15262 (NCI Thesaurus ObjectClass)
C0021083 (UMLS 2011AA ObjectClass)
C18138 (NCI Thesaurus ObjectClass-2)
C1527121 (UMLS 2011AA ObjectClass-2)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

Prior Surgery

Item

Prior Surgery

boolean

C38148 (NCI Thesaurus ValueDomain)
C0744961 (UMLS CUI-1)
C38000 (NCI Thesaurus Property)
C15329 (NCI Thesaurus ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)

PriorSurgeryPerformedText

Item

Prior Surgery Type (If yes,)

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)

Waldenstrom's: Relapsed Disease

Item Group

Waldenstrom's: Relapsed Disease

HematopoieticDiseaseStatusType

Item

Disease Status (current)

text

C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C13324 (NCI Thesaurus ObjectClass-2)
C0229601 (UMLS 2011AA ObjectClass-2)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)

CL.26

Code List

Disease Status (current)

CL Item

First Relapse (Relapse: 1st)

CL Item

Second Relapse (Relapse: 2nd)

CL Item

Third Or Greater Relapse (Relapse: 3rd+)

CL Item

Relapse (Relapse NOS)

C18265 (NCI Thesaurus)

CL Item

Refractory To First Induction (Refractory to 1st induction)

CL Item

Refractory To Reinduction After Complete Response (Refractory to reinduction after CR)

CL Item

Refractory (Refractory NOS)

C38014 (NCI Thesaurus)
C0205269 (UMLS 2011AA)

CL Item

Other, Specify (Other)

DiseaseStatusSpecify

Item

Other (specify)

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)

LymphomaInitialResponseBestType

Item

Best Response to Initial Therapy

text

C3208 (NCI Thesaurus ObjectClass)
C0024299 (UMLS 2011AA ObjectClass)
C25755 (NCI Thesaurus Property)
C0871261 (UMLS 2011AA Property)
C25536 (NCI Thesaurus Property-2)
C1555582 (UMLS 2011AA Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25432 (NCI Thesaurus ValueDomain-2)
C1522427 (UMLS 2011AA ValueDomain-2)

CL.27

Code List

Best Response to Initial Therapy

CL Item

Cr (CR)

CL Item

Pr (PR)

CL Item

Mr (MR)

CL Item

Sd (SD)

CL Item

Pd (PD)

LymphomaInitialResponseDate

Item

Date of Initial Response to Therapy

date

C3208 (NCI Thesaurus ObjectClass)
C0024299 (UMLS 2011AA ObjectClass)
C25755 (NCI Thesaurus Property)
C0871261 (UMLS 2011AA Property)
C25536 (NCI Thesaurus Property-2)
C1555582 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)

LymphomaFirstRelapseDate

Item

Date of First Relapse

date

C3208 (NCI Thesaurus ObjectClass)
C0024299 (UMLS 2011AA ObjectClass)
C18265 (NCI Thesaurus Property)
C25509 (NCI Thesaurus Property-2)
C1279901 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)

ECOG Performance Status

Item

Performance Status (at Time of Treatment Failure For CDUS reporting, please convert Karnofsky and Lansky scores to this Zubrod Score)

text

C25664 (NCI Thesaurus ValueDomain)
C1520224 (UMLS CUI-1)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain-2)
C20641 (NCI Thesaurus ObjectClass)

CL.28

Code List

Performance Status (at Time of Treatment Failure For CDUS reporting, please convert Karnofsky and Lansky scores to this Zubrod Score)

CL Item

Fully Active, Able To Carry On All Pre-disease Performance Without Restriction. (0)

CL Item

Restricted In Physically Strenuous Activity But Ambulatory And Able To Carry Out Work Of A Light Or Sedentary Nature, E.g., Light Housework, Office Work. (1)

CL Item

Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities. Up And About More Than 50% Of Waking Hours. (2)

CL Item

Capable Of Only Limited Selfcare, Confined To Bed Or Chair More Than 50% Of Waking Hours. (3)

CL Item

Completely Disabled. Cannot Carry On Any Selfcare. Totally Confined To Bed Or Chair. (4)

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On-Study - Waldenstroms Macroglobulinemia - On-Study Form - 2273908v3.0

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