ID

11126

Beschreibung

CALGB-10501 Chronic Lymphocytic Leukemia (CLL) On-Study Form NCT00513747 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

Link

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

Stichworte

Klinische Studie [Dokumenttyp]

On-Study Form

Leukämie

Hochgeladen am

21. Juni 2015

DOI

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Lizenz

Creative Commons BY-NC 3.0 Legacy

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CALGB-10501 Chronic Lymphocytic Leukemia (CLL) On-Study Form NCT00513747

Modell
Details

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 Formulare

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)

Datentyp

Alias

Header

Item Group

Header

Form ID CALGB

Item

CALGB Form

text

C25337 (NCI Thesaurus ValueDomain)
C3262252 (UMLS CUI-1)
C19464 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus ObjectClass-2)

Protocol ID CALGB

Item

CALGB Study No

text

C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus Property-2)

Trial subject ID CALGB

Item

CALGB Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus Property-2)

Data amended

Item

Are data amended

boolean

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

Patient demographics

Item Group

Patient demographics

Patient Initials

Item

Patient Initials (Last, First Middle)

text

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

Medical Record Number

Item

Patient Hospital No.

text

C25337 (NCI Thesaurus ValueDomain)
C1301894 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25261 (NCI Thesaurus Property)
C25198 (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)

Participating Group

Item

Participating Group

text

C25191 (NCI Thesaurus ValueDomain)
C2347449 (UMLS CUI-1)
C25608 (NCI Thesaurus ObjectClass)
C17005 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)

Study Number Participating Group

Item

Participating Group Study No

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)

Patient status assessment

Item Group

Patient status assessment

MedDRACode

Item

MedDRA Code

float

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-2)
C0011900 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)

Patient Height

Item

Height (cm)

float

C25209 (NCI Thesaurus ValueDomain)
C0489786 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25347 (NCI Thesaurus Property)

Patient Weight

Item

Weight (kg)

float

C25209 (NCI Thesaurus ValueDomain)
C0005910 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)

Body Surface Area

Item

BSA (m^2)

float

C25190 (NCI Thesaurus ObjectClass)
C0005902 (UMLS CUI-1)
C25712 (NCI Thesaurus ValueDomain)
C25157 (NCI Thesaurus Property)

AbdominalCavityComputedTomographyDiagnosticImagingPerformedInd-2

Item

Was an abdominal CT performed

boolean

C16502 (NCI Thesaurus ObjectClass)
C0011923 (UMLS 2011AA ObjectClass)
C17204 (NCI Thesaurus ObjectClass-2)
C0040405 (UMLS 2011AA ObjectClass-2)
C12664 (NCI Thesaurus ObjectClass-3)
C0230168 (UMLS 2011AA ObjectClass-3)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

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-2)
C0443228 (UMLS 2011AA ObjectClass-2)
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

boolean

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3114 (NCI Thesaurus Property)
C0020517 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property-2)
C0262926 (UMLS 2011AA Property-2)
C14227 (NCI Thesaurus Property-3)
C0021585 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

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-2)
C0026126 (UMLS 2011AA Property-2)
C47920 (NCI Thesaurus Property-3)
C0557854 (UMLS 2011AA Property-3)
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)

boolean

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

PatientHospitalizationInd-2

Item

Did the patient require hospitalization (last year)

boolean

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

PatientHerpesZosterPersonalMedicalHistoryInd-2

Item

Does the patient have a history of varicella zoster

boolean

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)

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-2)
C0023434 (UMLS 2011AA ObjectClass-2)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
C20115 (NCI Thesaurus Property-2)
C1514715 (UMLS 2011AA Property-2)
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)

float

C44278 (NCI Thesaurus ValueDomain)
C0439148 (UMLS 2011AA ValueDomain)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain-2)
C0750480 (UMLS 2011AA ValueDomain-2)
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)

float

C44278 (NCI Thesaurus ValueDomain)
C0439148 (UMLS 2011AA ValueDomain)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain-2)
C0750480 (UMLS 2011AA ValueDomain-2)
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-2)
C1301725 (UMLS 2011AA ValueDomain-2)

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-2)
C1301725 (UMLS 2011AA ValueDomain-2)

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-2)
C0037995 (UMLS 2011AA ObjectClass-2)

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-2)
C1301725 (UMLS 2011AA ValueDomain-2)

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-2)
C1301725 (UMLS 2011AA ValueDomain-2)

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)

boolean

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

LymphNodePositiveCount

Item

Number of Positive Lymph Nodes

float

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)

boolean

C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C3208 (NCI Thesaurus ObjectClass-2)
C0024299 (UMLS 2011AA ObjectClass-2)
C25285 (NCI Thesaurus Property)
C1301886 (UMLS 2011AA Property)
C49508 (NCI Thesaurus Property-2)
C0549177 (UMLS 2011AA Property-2)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)

LymphomaLymphNodeMediumDiameterInd-2

Item

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

boolean

C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C3208 (NCI Thesaurus ObjectClass-2)
C0024299 (UMLS 2011AA ObjectClass-2)
C25285 (NCI Thesaurus Property)
C1301886 (UMLS 2011AA Property)
C49507 (NCI Thesaurus Property-2)
C0439536 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

LymphomaLymphNodeSmallMediumDiameterIndicator

Item

Any lymph node or aggregate with a diameter >2 cm

boolean

C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C3208 (NCI Thesaurus ObjectClass-2)
C0024299 (UMLS 2011AA ObjectClass-2)
C25285 (NCI Thesaurus Property)
C1301886 (UMLS 2011AA Property)
C49507 (NCI Thesaurus Property-2)
C0439536 (UMLS 2011AA Property-2)
C25376 (NCI Thesaurus Property-3)
C0700321 (UMLS 2011AA Property-3)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)

LymphomaLymphNodeSmallDiameterIndicator

Item

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

boolean

C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C3208 (NCI Thesaurus ObjectClass-2)
C0024299 (UMLS 2011AA ObjectClass-2)
C25285 (NCI Thesaurus Property)
C1301886 (UMLS 2011AA Property)
C25376 (NCI Thesaurus Property-2)
C0700321 (UMLS 2011AA Property-2)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)

LAB DATA/VALUES

Item Group

Lab Data/values

RenalCreatinineLabSpecifiedValue

Item

Creatinine (mg/dl)

float

C25225 (NCI Thesaurus ObjectClass)
C0022646 (UMLS 2011AA ObjectClass)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property-2)
C0022885 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

Creatinine, serum ULN

Item

Creatinine ULN (mg/dl)

float

C25294 (NCI Thesaurus ObjectClass)
C0201976 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C1519815 (UMLS CUI-2)
C399 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)

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 (U/L)

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)

LaboratoryProcedureBeta-2-MicroglobulinProteinOutcomeSpecifiedValue

Item

Beta-2 Microglobulin (mg/liter)

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 (mg/liter)

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)

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-2)
C1274040 (UMLS 2011AA Property-2)
C568 (NCI Thesaurus Property-3)
C0020852 (UMLS 2011AA Property-3)
C16295 (NCI Thesaurus Property-4)
C0003241 (UMLS 2011AA Property-4)
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-2)
C0020852 (UMLS 2011AA Property-2)
C16295 (NCI Thesaurus Property-3)
C0003241 (UMLS 2011AA Property-3)
C71091 (NCI Thesaurus Property-4)
C0042338 (UMLS 2011AA Property-4)
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)

Albumin

Item

Albumin

float

C20200 (NCI Thesaurus Property)
C0201838 (UMLS CUI-1)
C214 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)

LaboratoryProcedureSerumImmunologicIgGResultUnspecifiedValue

Item

IgG (mg)

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)

LaboratoryProcedureSerumImmunologicIgAResultUnspecifiedValue

Item

IgA (mg)

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)

LaboratoryProcedureSerumImmunologicIgMResultUnspecifiedValue

Item

IgM (mg)

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)

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 (%)

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C17891 (NCI Thesaurus Property-2)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)

LaboratoryProcedureFc-GammaReceptorIIIResultPercentageValue

Item

Peripheral CD16 positive cells (%)

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C17487 (NCI Thesaurus Property-2)
C0108747 (UMLS 2011AA Property-2)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)

LaboratoryProcedureCD4-PositiveT-LymphocyteOutcomePercentageValue

Item

Peripheral CD4 positive cells (%)

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12537 (NCI Thesaurus Property-2)
C0039215 (UMLS 2011AA Property-2)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)

LaboratoryProcedureCD8+cellsOutcomePercentageValue

Item

Peripheral CD8 positive cells (%)

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12542 (NCI Thesaurus Property-2)
C0242629 (UMLS 2011AA Property-2)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)

LaboratoryProcedureCD19AntigenResultPercentageValue

Item

Peripheral CD19 positive cells (%)

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C38894 (NCI Thesaurus Property-2)
C0108748 (UMLS 2011AA Property-2)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)

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-2)
C0040405 (UMLS 2011AA ObjectClass-2)
C17261 (NCI Thesaurus ObjectClass-3)
C25367 (NCI Thesaurus Property)
C25389 (NCI Thesaurus Property-2)
C0817096 (UMLS 2011AA Property)
C13360 (NCI Thesaurus Property-3)
C0817096 (UMLS 2011AA Property-2)
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-2)
C0040405 (UMLS 2011AA ObjectClass-2)
C17261 (NCI Thesaurus ObjectClass-3)
C25367 (NCI Thesaurus Property)
C25389 (NCI Thesaurus Property-2)
C0817096 (UMLS 2011AA Property)
C13360 (NCI Thesaurus Property-3)
C0817096 (UMLS 2011AA Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)

Footer Module

Item Group

Footer module

Person Completing Form

Item

Completed by (print or type name)

text

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

Date Form Completed

Item

Date Form Completed (MM DD YYYY)

date

C25164 (NCI Thesaurus ValueDomain)
C1115437 (UMLS CUI-1)
C40988 (NCI Thesaurus ObjectClass)
C25250 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)

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CALGB-10501 Chronic Lymphocytic Leukemia (CLL) On-Study Form NCT00513747

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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