ID

2493

Beskrivning

CALGB-10501 Chronic Lymphocytic Leukemia (CLL) On-Study Form Early or Delayed Fludarabine and Rituximab in Treating Patients With Previously Untreated Chronic Lymphocytic Leukemia Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=3410113C-1559-25BC-E044-0003BA3F9857

Länk

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=3410113C-1559-25BC-E044-0003BA3F9857

Nyckelord

Uppladdad den

19 september 2012

DOI

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Creative Commons BY-NC 3.0 Legacy

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NCT00513747 On-Study - CALGB-10501 Chronic Lymphocytic Leukemia (CLL) On-Study Form - 2661520v1.0

model
Detaljer

INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink. Mark an X in the appropriate box for fields with a choice

1 Formulär

StudyEvent: CALGB-10501 Chronic Lymphocytic Leukemia (CLL) On-Study Form
1. INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink. Mark an X in the appropriate box for fields with a choice

Name

Typ

Description | Question | Decode (Coded Value)

Datatyp

Alias

Unnamed1

Item Group

Unnamed1

CALGBFormIdentifierNumber

Item

CALGB Form

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C19464 (NCI Thesaurus ObjectClass)
C0376315 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25442 (NCI Thesaurus ObjectClass)
C1516238 (UMLS 2011AA ObjectClass)

ProtocolCALGBIdentifierNumber

Item

CALGB Study No

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25442 (NCI Thesaurus Property)
C1516238 (UMLS 2011AA Property)

PatientCALGBIdentifierNumber

Item

CALGB Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25442 (NCI Thesaurus Property)
C1516238 (UMLS 2011AA Property)

DataAmendedInd-3

Item

Are data amended

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)

CL.1

Code List

Are data amended

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

Unnamed2

Item Group

Unnamed2

PatientInitialsName

Item

Patient Initials (Last, First Middle)

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)

PatientMedicalRecordNumber

Item

Patient Hospital No.

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25261 (NCI Thesaurus Property)
C0205476 (UMLS 2011AA Property)
C25198 (NCI Thesaurus Property)
C0034869 (UMLS 2011AA Property)

CombinedInstitutionName

Item

Institution/Affiliate

text

C25454 (NCI Thesaurus ObjectClass)
C0205195 (UMLS 2011AA ObjectClass)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ValueDomain)
C0018704 (UMLS 2011AA ValueDomain)

ParticipatingGroupName

Item

Participating Group

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25608 (NCI Thesaurus ObjectClass)
C0679823 (UMLS 2011AA ObjectClass)
C17005 (NCI Thesaurus ObjectClass)
C1257890 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

ProtocolParticipatingIdentifierNumber

Item

Participating Group Study No

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

PatientParticipatingIdentifierNumber

Item

Participating Group Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

Unnamed1

Item Group

Unnamed1

MedDRACode

Item

MedDRA Code

double

C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
CL104089 (NCI Metathesaurus ObjectClass)

CancerInitialDiagnosisDate

Item

Date of Initial Pathologic Diagnosis (MM DD YYYY)

date

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

PatientHeightMeasurement

Item

Height (cm)

double

C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25347 (NCI Thesaurus Property)
C0489786 (UMLS 2011AA Property)

PatientWeightMeasurement

Item

Weight (kg)

double

C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25208 (NCI Thesaurus Property)
C0043100 (UMLS 2011AA Property)

PersonBodySurfaceAreaValue

Item

BSA (m^2)

double

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25157 (NCI Thesaurus Property)
C0005902 (UMLS 2011AA Property)

RAI STAGE CLASSIFICATION

Item Group

Rai Stage Classification

CLLLeukemiaRAIStage

Item

Rai Stage Classification (Mark one with an X.)

text

C3161 (NCI Thesaurus ObjectClass)
C0023418 (UMLS 2011AA ObjectClass)
C3163 (NCI Thesaurus ObjectClass)
C0023434 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
C20115 (NCI Thesaurus Property)
C1514715 (UMLS 2011AA Property)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)

CL.2

Code List

Rai Stage Classification (Mark one with an X.)

CL Item

Lymphocytosis In Blood With Lymphocyte Count > 15,000/mcl And Bone Marrow Populated With Mature Lymphocytes Comprising >40% Of Nucleated Cells (Stage 0)

CL Item

Same As Stage 0 With Lymphadenopathy (Stage I)

BLOOD OR PLATELET TRANSFUSIONS

Item Group

Blood Or Platelet Transfusions

PackedRedBloodCellTransfusionReceivedUnitCount

Item

Total number of units PRBC (given during the three-month period prior to starting therapy)

double

C44278 (NCI Thesaurus ValueDomain)
C0439148 (UMLS 2011AA ValueDomain)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C15409 (NCI Thesaurus ObjectClass)
C0199962 (UMLS 2011AA ObjectClass)

PlateletTransfusionReceivedUnitCount

Item

Total number of units platelets (given during the three-month period prior to starting therapy)

double

C44278 (NCI Thesaurus ValueDomain)
C0439148 (UMLS 2011AA ValueDomain)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C15366 (NCI Thesaurus ObjectClass)
C0086818 (UMLS 2011AA ObjectClass)

ORGAN INVOLVEMENT

Item Group

Organ Involvement

SplenomegalyPalpationDocumentedInd

Item

Palpable splenomegaly

text

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C16950 (NCI Thesaurus Property)
C0030247 (UMLS 2011AA Property)
C3384 (NCI Thesaurus ObjectClass)
C0038002 (UMLS 2011AA ObjectClass)
C25356 (NCI Thesaurus ValueDomain)
C1301725 (UMLS 2011AA ValueDomain)

CL.3

Code List

Palpable splenomegaly

CL Item

Examination Performed And Splenomegaly Absent (No)

CL Item

Examination Of Spleen Not Performed (Not examined)

CL Item

Spleen Removed Via Prior Surgery (Surgically absent)

CL Item

Examination Performed And Splenomegaly Present (Yes)

SplenomegalyImageDocumentedInd

Item

Splenomegaly by scan (or X-ray)

text

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C3384 (NCI Thesaurus ObjectClass)
C0038002 (UMLS 2011AA ObjectClass)
C19477 (NCI Thesaurus Property)
C1704254 (UMLS 2011AA Property)
C25356 (NCI Thesaurus ValueDomain)
C1301725 (UMLS 2011AA ValueDomain)

CL.4

Code List

Splenomegaly by scan (or X-ray)

CL Item

Examination Performed And Splenomegaly Absent (No)

CL Item

Examination Of Spleen Not Performed (Not examined)

CL Item

Spleen Removed Via Prior Surgery (Surgically absent)

CL Item

Examination Performed And Splenomegaly Present (Yes)

PriorSplenectomyDate

Item

Date of Splenectomy (MM DD YYYY)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C15328 (NCI Thesaurus ObjectClass)
C0037995 (UMLS 2011AA ObjectClass)

HepatomegalyPalpationDocumentedInd

Item

Palpable hepatomegaly

text

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C16950 (NCI Thesaurus Property)
C0030247 (UMLS 2011AA Property)
C3100 (NCI Thesaurus ObjectClass)
C0017924 (UMLS 2011AA ObjectClass)
C25356 (NCI Thesaurus ValueDomain)
C1301725 (UMLS 2011AA ValueDomain)

CL.5

Code List

Palpable hepatomegaly

CL Item

Examination Performed And Hepatomegaly Absent (No)

CL Item

Examination Of Liver Not Performed (Not examined)

CL Item

Examination Performed And Hepatomegaly Present (Yes)

HepatomegalyImageDocumentedInd

Item

Hepatomegaly by scan (or X-ray)

text

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C3100 (NCI Thesaurus ObjectClass)
C0017924 (UMLS 2011AA ObjectClass)
C19477 (NCI Thesaurus Property)
C1704254 (UMLS 2011AA Property)
C25356 (NCI Thesaurus ValueDomain)
C1301725 (UMLS 2011AA ValueDomain)

CL.6

Code List

Hepatomegaly by scan (or X-ray)

CL Item

Examination Performed And Hepatomegaly Absent (No)

CL Item

Examination Of Liver Not Performed (Not examined)

CL Item

Examination Performed And Hepatomegaly Present (Yes)

LYMPH NODE INVOLVEMENT

Item Group

Lymph Node Involvement

LymphNodeInvolvementInd-3

Item

Is there lymph node involvement (If Yes, complete the following)

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25547 (NCI Thesaurus Property)

CL.7

Code List

Is there lymph node involvement (If Yes, complete the following)

CL Item

No (NO)

CL Item

Yes (YES)

LymphNodePositiveCount

Item

Number of Positive Lymph Nodes

double

C25246 (NCI Thesaurus Property)
C1446409 (UMLS 2011AA Property)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)

LymphomaLymphNodeLargeDiameterIndicator

Item

Any lymph node or aggregate with a diameter greater than 10 cm (if pediatric, >6 cm)

text

C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C3208 (NCI Thesaurus ObjectClass)
C0024299 (UMLS 2011AA ObjectClass)
C25285 (NCI Thesaurus Property)
C1301886 (UMLS 2011AA Property)
C49508 (NCI Thesaurus Property)
C0549177 (UMLS 2011AA Property)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)

CL.8

Code List

Any lymph node or aggregate with a diameter greater than 10 cm (if pediatric, >6 cm)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

LymphomaLymphNodeMediumDiameterInd-2

Item

Any lymph node or aggregate with a diameter greater than 5 cm

text

C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C3208 (NCI Thesaurus ObjectClass)
C0024299 (UMLS 2011AA ObjectClass)
C25285 (NCI Thesaurus Property)
C1301886 (UMLS 2011AA Property)
C49507 (NCI Thesaurus Property)
C0439536 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

CL.9

Code List

Any lymph node or aggregate with a diameter greater than 5 cm

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

LymphomaLymphNodeSmallMediumDiameterIndicator

Item

Any lymph node or aggregate with a diameter >2 cm

text

C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C3208 (NCI Thesaurus ObjectClass)
C0024299 (UMLS 2011AA ObjectClass)
C25285 (NCI Thesaurus Property)
C1301886 (UMLS 2011AA Property)
C49507 (NCI Thesaurus Property)
C0439536 (UMLS 2011AA Property)
C25376 (NCI Thesaurus Property)
C0700321 (UMLS 2011AA Property)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)

CL.10

Code List

Any lymph node or aggregate with a diameter >2 cm

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

LymphomaLymphNodeSmallDiameterIndicator

Item

Any lymph node or aggregate with a diameter >1 cm but <2 cm

text

C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C3208 (NCI Thesaurus ObjectClass)
C0024299 (UMLS 2011AA ObjectClass)
C25285 (NCI Thesaurus Property)
C1301886 (UMLS 2011AA Property)
C25376 (NCI Thesaurus Property)
C0700321 (UMLS 2011AA Property)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)

CL.11

Code List

Any lymph node or aggregate with a diameter >1 cm but <2 cm

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

LAB DATA/VALUES

Item Group

Lab Data/values

RenalCreatinineLabSpecifiedValue

Item

Creatinine (mg/dl)

double

C25225 (NCI Thesaurus ObjectClass)
C0022646 (UMLS 2011AA ObjectClass)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LaboratoryProcedureCreatinineResultUpperLimitNormalValue

Item

Creatinine ULN (mg/dl)

double

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)

LaboratoryProcedureLactateDehydrogenaseResultSpecifiedValue

Item

Lactate Dehydrogenase (LDH) (U/L)

double

C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25184 (NCI Thesaurus Property)
C0022917 (UMLS 2011AA Property)

LaboratoryProcedureLactateDehydrogenaseResultSpecifiedUpperLimitofNormalValue

Item

Lactate Dehydrogenase ULN (U/L)

double

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25184 (NCI Thesaurus Property)
C0022917 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C38024 (NCI Thesaurus ValueDomain)
C0205369 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)

LaboratoryProcedureBeta-2-MicroglobulinProteinOutcomeSpecifiedValue

Item

Beta-2 Microglobulin (mg/liter)

double

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)
C0005149 (UMLS 2011AA Property)

LaboratoryProcedureBeta-2-MicroglobulinProteinOutcomeSpecifiedUpperLimitofNormalValue

Item

Beta-2 Microglobulin ULN (mg/liter)

double

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C62657 (NCI Thesaurus Property)
C0005149 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)

LaboratoryProcedureAntibodyCytomegalovirusIgGResultStatus

Item

CMV IgG

text

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C14196 (NCI Thesaurus Property)
C0010825 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C568 (NCI Thesaurus Property)
C0020852 (UMLS 2011AA Property)
C16295 (NCI Thesaurus Property)
C0003241 (UMLS 2011AA Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)

CL.12

Code List

CMV IgG

CL Item

Negative (negative)

C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)

CL Item

Positive (positive)

C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)

LaboratoryProcedureAntibodyHumanHerpesvirus3IgGResultStatus

Item

Varicella IgG

text

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C568 (NCI Thesaurus Property)
C0020852 (UMLS 2011AA Property)
C16295 (NCI Thesaurus Property)
C0003241 (UMLS 2011AA Property)
C71091 (NCI Thesaurus Property)
C0042338 (UMLS 2011AA Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)

CL.13

Code List

Varicella IgG

CL Item

Negative (negative)

C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)

CL Item

Positive (positive)

C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)

LaboratoryProcedureAlbuminResultSpecifiedValue

Item

Albumin

double

C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C214 (NCI Thesaurus Property)
C0001924 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LaboratoryProcedureSerumImmunologicIgGResultUnspecifiedValue

Item

IgG (mg)

double

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C568 (NCI Thesaurus Property)
C0020852 (UMLS 2011AA Property)
C25675 (NCI Thesaurus Property)
C1519267 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LaboratoryProcedureSerumImmunologicIgAResultUnspecifiedValue

Item

IgA (mg)

double

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C565 (NCI Thesaurus Property)
C0020835 (UMLS 2011AA Property)
C25675 (NCI Thesaurus Property)
C1519267 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LaboratoryProcedureSerumImmunologicIgMResultUnspecifiedValue

Item

IgM (mg)

double

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C569 (NCI Thesaurus Property)
C0020861 (UMLS 2011AA Property)
C25675 (NCI Thesaurus Property)
C1519267 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

CoombsTestResultType

Item

Coomb's Test (Mark one with an X.)

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25163 (NCI Thesaurus ObjectClass)
C0009961 (UMLS 2011AA ObjectClass)
C0488535 (NCI Metathesaurus ObjectClass)

CL.14

Code List

Coomb's Test (Mark one with an X.)

CL Item

Coomb's Test Performed And Negative Result (Negative)

CL Item

Coomb's Test Performed And Positive Result (Positive)

IndirectCoombsTestResultType

Item

Coomb's Indirect Test

text

CL.15

Code List

Coomb's Indirect Test

CL Item

Coomb's Test Performed And Negative Result (Negative)

CL Item

Coomb's Test Performed And Positive Result (Positive)

CoombsTestPerformedDate

Item

Coomb's Test Date (MM DD YYYY)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25163 (NCI Thesaurus ObjectClass)
C0009961 (UMLS 2011AA ObjectClass)
C0488535 (NCI Metathesaurus ObjectClass)

LaboratoryProcedureCD56AntigenOutcomePercentageValue

Item

Peripheral CD56 Positive Cells (%)

double

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C17891 (NCI Thesaurus Property)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LaboratoryProcedureFc-GammaReceptorIIIResultPercentageValue

Item

Peripheral CD16 positive cells (%)

double

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C17487 (NCI Thesaurus Property)
C0108747 (UMLS 2011AA Property)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LaboratoryProcedureCD4-PositiveT-LymphocyteOutcomePercentageValue

Item

Peripheral CD4 positive cells (%)

double

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12537 (NCI Thesaurus Property)
C0039215 (UMLS 2011AA Property)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LaboratoryProcedureCD8+cellsOutcomePercentageValue

Item

Peripheral CD8 positive cells (%)

double

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12542 (NCI Thesaurus Property)
C0242629 (UMLS 2011AA Property)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LaboratoryProcedureCD19AntigenResultPercentageValue

Item

Peripheral CD19 positive cells (%)

double

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C38894 (NCI Thesaurus Property)
C0108748 (UMLS 2011AA Property)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

CHEST X-RAY OR THORACIC CT

Item Group

Chest X-ray Or Thoracic Ct

ComputedTomographyX-RayDiagnosticImagingChestThoracicAssessmentStatus

Item

Chest X-Ray Or Thoracic CT (Mark one with an X.)

text

C16502 (NCI Thesaurus ObjectClass)
C0011923 (UMLS 2011AA ObjectClass)
C17204 (NCI Thesaurus ObjectClass)
C0040405 (UMLS 2011AA ObjectClass)
C17261 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus Property)
C25389 (NCI Thesaurus Property)
C0817096 (UMLS 2011AA Property)
C13360 (NCI Thesaurus Property)
C0817096 (UMLS 2011AA Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)

CL.16

Code List

Chest X-Ray Or Thoracic CT (Mark one with an X.)

CL Item

Abnormal Mediastinal Enlargement (hilar/paratracheal) (Abnormal mediastinal enlargement (hilar/paratracheal))

CL Item

Abnormal, Interstitial Disease In Lung (Abnormal, interstitial disease in lung)

CL Item

Abnormal, Nodules In Lung Parenchyma (Abnormal, nodules in lung parenchyma)

CL Item

Abnormal, Other (Abnormal, other)

CL Item

Normal (Normal)

C14165 (NCI Thesaurus)
C0205307 (UMLS 2011AA)

ComputedTomographyX-RayDiagnosticImagingChestThoracicAssessmentSpecify

Item

Other, specify

text

C16502 (NCI Thesaurus ObjectClass)
C0011923 (UMLS 2011AA ObjectClass)
C17204 (NCI Thesaurus ObjectClass)
C0040405 (UMLS 2011AA ObjectClass)
C17261 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus Property)
C25389 (NCI Thesaurus Property)
C0817096 (UMLS 2011AA Property)
C13360 (NCI Thesaurus Property)
C0817096 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)

Unnamed2

Item Group

Unnamed3

AbdominalCavityComputedTomographyDiagnosticImagingPerformedInd-2

Item

Was an abdominal CT performed

text

C16502 (NCI Thesaurus ObjectClass)
C0011923 (UMLS 2011AA ObjectClass)
C17204 (NCI Thesaurus ObjectClass)
C0040405 (UMLS 2011AA ObjectClass)
C12664 (NCI Thesaurus ObjectClass)
C0230168 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

CL.17

Code List

Was an abdominal CT performed

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

LargestLymphNodeSizeStatus

Item

Size of Largest Lymph Node

text

C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
C25550 (NCI Thesaurus ObjectClass)
C0443228 (UMLS 2011AA ObjectClass)
C25681 (NCI Thesaurus Property)
C0456389 (UMLS 2011AA Property)

CL.18

Code List

Size of Largest Lymph Node

CL Item

> 1 Cm But < 2 Cm (> 1 cm but < 2 cm)

CL Item

>= 2 Cm But < 5 Cm (>= 2 cm but < 5 cm)

CL Item

>= 5 Cm (>= 5 cm)

PatientInsectHypersensitivityPersonalMedicalHistoryInd-2

Item

Does the patient have a history of bug bite hypersensitivity

text

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3114 (NCI Thesaurus Property)
C0020517 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
C14227 (NCI Thesaurus Property)
C0021585 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

CL.19

Code List

Does the patient have a history of bug bite hypersensitivity

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

PersonMilitaryServicePerformedType

Item

Military Service Type (Mark all that apply with an X.)

text

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C68638 (NCI Thesaurus Property)
C0026126 (UMLS 2011AA Property)
C47920 (NCI Thesaurus Property)
C0557854 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.20

Code List

Military Service Type (Mark all that apply with an X.)

CL Item

Iraq War 1990-1991 (IRAQ War 1990-1991)

CL Item

Iraq War 2001-present (IRAQ War 2001-present)

CL Item

Korean War (Korean War)

CL Item

No Military Service (No military service)

CL Item

Vietnam War (Vietnam War)

AntibioticAdministeredInd-3

Item

Has the patient taken antibiotics? (last year)

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C258 (NCI Thesaurus ObjectClass)
C0003232 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

CL.21

Code List

Has the patient taken antibiotics? (last year)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

PatientHospitalizationInd-2

Item

Did the patient require hospitalization (last year)

text

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25179 (NCI Thesaurus Property)
C0019993 (UMLS 2011AA Property)

CL.22

Code List

Did the patient require hospitalization (last year)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

PatientHerpesZosterPersonalMedicalHistoryInd-2

Item

Does the patient have a history of varicella zoster

text

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C0019360 (NCI Metathesaurus Property)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)

CL.23

Code List

Does the patient have a history of varicella zoster

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

Footer Module

Item Group

Overall Response

ResponsiblePersonName

Item

Completed by (print or type name)

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

FormCompleteDate

Item

Date Form Completed (MM DD YYYY)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C40988 (NCI Thesaurus ObjectClass)
C1516308 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain)

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NCT00513747 On-Study - CALGB-10501 Chronic Lymphocytic Leukemia (CLL) On-Study Form - 2661520v1.0

INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink. Mark an X in the appropriate box for fields with a choice

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