ID

2065

Beskrivning

CALGB: 10603 On-Study Form Daunorubicin, Cytarabine, and Midostaurin in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=437820BA-0A20-2BB7-E044-0003BA3F9857

Länk

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=437820BA-0A20-2BB7-E044-0003BA3F9857

Nyckelord

Uppladdad den

19 september 2012

DOI

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Licens

Creative Commons BY-NC 3.0 Legacy

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Leukemia NCT00651261 On-Study - CALGB: 10603 On-Study Form - 2719613v1.0

model
Detaljer

No Instruction available.

1 Formulär

StudyEvent: CALGB: 10603 On-Study Form
1. No Instruction available.

Name

Typ

Description | Question | Decode (Coded Value)

Datatyp

Alias

Unnamed1

Item Group

Unnamed1

CALGBFormIdentifierNumber

Item

CALGB Form (C-1619)

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)

Header Module

Item Group

Ccrr Module For Calgb 90202: Prostate Specific Antigen Form

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 (Country Name for International site:)

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 Protocol Number

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)

Patient Description

Item Group

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

MedDRACode

Item

MedDRA disease code

double

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

FirstAbnormalBoneMarrowPriorMyelodysplasticSyndromeFindingDate

Item

Date of first abnormal bone marrow for antecedent myelodysplasia

date

C25401 (NCI Thesaurus ObjectClass)
C0205161 (UMLS 2011AA ObjectClass)
C12431 (NCI Thesaurus ObjectClass)
C0005953 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus ObjectClass)
C1279901 (UMLS 2011AA ObjectClass)
C3247 (NCI Thesaurus Property)
C0026986 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C61036 (NCI Thesaurus Property)
C0243095 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

PatientAgeValue

Item

Patient/Participant Age

double

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25150 (NCI Thesaurus Property)
C0001779 (UMLS 2011AA Property)

Leukemia Classification (WHO/FAB)

Item Group

Leukemia Classification (who/fab)

DiseaseDiagnosisHematopoieticType

Item

WHO Diagnosis

text

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

CL.2

Code List

WHO Diagnosis

CL Item

Acute Basophilic Leukemia (Acute basophilic leukemia)

C3164 (NCI Thesaurus)
C0023437 (UMLS 2011AA)

CL Item

Acute Erythroid Leukemia (Acute erythroid leukemia)

C8923 (NCI Thesaurus)
C0023440 (UMLS 2011AA)

CL Item

Acute Megakaryoblastic Leukemia (Acute megakaryoblastic leukemia)

C3170 (NCI Thesaurus)
C0023462 (UMLS 2011AA)

CL Item

Acute Myelomonocytic Leukemia (Acute myelomonocytic leukemia)

C7463 (NCI Thesaurus)
C0023479 (UMLS 2011AA)

CL Item

Acute Panmyelosis With Myelofibrosis (Acute panmyelosis with myelofibrosis)

C4344 (NCI Thesaurus)
C0334674 (UMLS 2011AA)

CL Item

Acute Myeloid Leukemia With 11q23 (mll) Abnormalities (AML with 11q23 (MLL) abnormalities)

C6924 (NCI Thesaurus)
C2825116 (UMLS 2011AA)

CL Item

Acute Myeloid Leukemia With Inv(16)(p13q22) Or T(16;16)(p13;q22), (cbf-beta/myh11) (AML with inv(16)(p13q22) or t(16;16)(p13;q22))

CL Item

Acute Myeloid Leukemia With Maturation (AML with maturation)

C3250 (NCI Thesaurus)
C0473527 (UMLS 2011AA)

CL Item

Acute Myeloid Leukemia With Multilineage Dysplasia Without Prior Myelodysplastic Syndrome (AML with multilineage dysplasia w/o prior MDS)

CL Item

Acute Myeloid Leukemia With Multilineage Dysplasia With Prior Myelodysplastic Syndrome (AML with multilineage dysplasia with prior MDS)

CL Item

Acute Myeloid Leukemia With T(8;21)(q22;q22), (aml1/eto) (AML with t(8;21)(q22;q22))

CL Item

Acute Myeloid Leukemia Without Maturation (AML without maturation)

C3249 (NCI Thesaurus)
C0026998 (UMLS 2011AA)

CL Item

Acute Myeloid Leukemia, Minimally Differentiated (AML, minimally differentiated)

C8460 (NCI Thesaurus)
C0522631 (UMLS 2011AA)

CL Item

Myeloid Sarcoma (Myeloid sarcoma)

C3520 (NCI Thesaurus)
C0151714 (UMLS 2011AA)

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)
C0229601 (UMLS 2011AA ValueDomain)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)

LeukemiaFrench-American-BritishClassificationCategory

Item

Leukemia Classification (FAB)

text

C3161 (NCI Thesaurus ObjectClass)
C0023418 (UMLS 2011AA ObjectClass)
C43854 (NCI Thesaurus Property)
C1556084 (UMLS 2011AA Property)
C25161 (NCI Thesaurus Property)
C0008902 (UMLS 2011AA Property)
C0596227 (NCI Metathesaurus Property)
C0596070 (NCI Metathesaurus Property)
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)

CL.3

Code List

Leukemia Classification (FAB)

CL Item

Disease Classified As Acute Erythroblastic Leukemia (fab M6) (Acute erythroblastic leukemia (FAB M6))

CL Item

Disease Classified As Acute Megakaryoblastic Leukemia (fab M7) (Acute megakaryoblastic leukemia (FAB M7))

CL Item

Disease Classified As Acute Monocytic Leukemia (fab M5) (Acute monocytic leukemia (FAB M5))

CL Item

Disease Classified As Acute Myeloid Leukemia W/ Maturation (fab M2) (Acute myeloid leukemia w/ maturation (FAB M2))

CL Item

Disease Classified As Acute Myeloid Leukemia W/o Maturation (fab M1) (Acute myeloid leukemia w/o maturation (FAB M1))

CL Item

Disease Classified As Acute Myelomonocytic Leukemia (fab M4) (Acute myelomonocytic leukemia (FAB M4))

CL Item

Other Specify (Other specify)

CL Item

Disease Classified As Undifferentiated Acute Myeloid Leukemia (fab M0) (Undifferentiated acute myeloid leukemia (FAB M0))

LeukemiaFrench-American-BritishClassificationSpecify

Item

Other specify

text

C3161 (NCI Thesaurus ObjectClass)
C0023418 (UMLS 2011AA ObjectClass)
C43854 (NCI Thesaurus Property)
C1556084 (UMLS 2011AA Property)
C25161 (NCI Thesaurus Property)
C0008902 (UMLS 2011AA Property)
C0596227 (NCI Metathesaurus Property)
C0596070 (NCI Metathesaurus Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)

Clinical Onset of AML

Item Group

Clinical Onset Of Aml

ClinicalEtiologyAcuteMyeloidLeukemiaDiagnosisType

Item

Clinical Onset of AML

text

C25398 (NCI Thesaurus ObjectClass)
C0205210 (UMLS 2011AA ObjectClass)
C16390 (NCI Thesaurus ObjectClass)
C1524003 (UMLS 2011AA ObjectClass)
C3171 (NCI Thesaurus Property)
C0023467 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.4

Code List

Clinical Onset of AML

CL Item

Aml Without Prior Clinical History Of Mds Or Potentially Leukemogenic Treatment (de novo)

CL Item

Aml Related To/associated With Prior Clinical History Of Potentially Leukemogenic Treatment (Treatment related)

CL Item

Aml Related To/associated With Prior Clinical History Of Mds (MDS-related)

PriorTherapyMDSLeukemiaAdministeredInd-2

Item

Prior treatment for leukemia or myelodysplasia

text

C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass)
C3247 (NCI Thesaurus Property)
C0026986 (UMLS 2011AA Property)
C3161 (NCI Thesaurus Property)
C0023418 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

CL.5

Code List

Prior treatment for leukemia or myelodysplasia

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

PriorChemotherapyMyelodysplasticSyndromeAdministeredInd-2

Item

Did the patient receive cytotoxic treatment for the MDS (If the patient had antecedent MDS,)

text

C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C3247 (NCI Thesaurus Property)
C0026986 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

CL.6

Code List

Did the patient receive cytotoxic treatment for the MDS (If the patient had antecedent MDS,)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

HydroxyureaAgentAdministeredDayCount

Item

Number of days hydroxyurea received

double

C560 (NCI Thesaurus ObjectClass)
C0020402 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25301 (NCI Thesaurus ValueDomain)
C0439228 (UMLS 2011AA ValueDomain)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)

Extramedullary Disease Involvement

Item Group

Extramedullary Disease Involvement

DiseaseExtramedullaryInvolvementSite

Item

Extramedullary Disease Involvement

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)
C25503 (NCI Thesaurus Property)
C1517060 (UMLS 2011AA Property)

CL.7

Code List

Extramedullary Disease Involvement

CL Item

Central Nervous System (Central nervous system)

C12438 (NCI Thesaurus)
C0927232 (UMLS 2011AA)

CL Item

Peripheral Nervous System (Peripheral nervous system)

C12465 (NCI Thesaurus)
C0206417 (UMLS 2011AA)

CL Item

Gingival Hypertrophy (Gingival hypertrophy)

CL Item

Mediastinal Mass (Mediastinal mass)

CL Item

Leukaemia Cutis (Skin (leukemia cutis))

CL049753 (NCI Metathesaurus)

CL Item

Other Specify (Other)

DiseaseExtramedullaryInvolvementOtherSite

Item

Other specify

text

LaboratoryProcedureAuerRodsOutcomeStatus

Item

Are auer rods present?

text

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C12431 (NCI Thesaurus Property)
C0005953 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25287 (NCI Thesaurus Property)
C0333828 (UMLS 2011AA Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)

CL.8

Code List

Are auer rods present?

CL Item

Auer Rods Absent From Bone Marrow (Absent)

CL Item

Auer Rods Present In Bone Marrow (Present)

AssessmentMethodText

Item

Not done

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)

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.9

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.10

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)

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.11

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.12

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)

LymphadenopathyPalpationDocumentedInd

Item

Palpable lymphadenopathy

text

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C16950 (NCI Thesaurus Property)
C0030247 (UMLS 2011AA Property)
C3206 (NCI Thesaurus ObjectClass)
C0024228 (UMLS 2011AA ObjectClass)
C25356 (NCI Thesaurus ValueDomain)
C1301725 (UMLS 2011AA ValueDomain)

CL.13

Code List

Palpable lymphadenopathy

CL Item

Examination Performed And Lymphadenopathy Absent (No)

CL Item

Examination Of Lymph Nodes Not Performed (Not examined)

CL Item

Examination Performed And Lymphadenopathy Present (Yes)

LymphadenopathyImageDocumentedInd

Item

Lymphadenopathy by scan

text

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C3206 (NCI Thesaurus ObjectClass)
C0024228 (UMLS 2011AA ObjectClass)
C19477 (NCI Thesaurus Property)
C1704254 (UMLS 2011AA Property)
C25356 (NCI Thesaurus ValueDomain)
C1301725 (UMLS 2011AA ValueDomain)

CL.14

Code List

Lymphadenopathy by scan

CL Item

Examination Performed And Lymphadenopathy Absent (No)

CL Item

Examination Of Lymph Nodes Not Performed (Not examined)

CL Item

Examination Performed And Lymphadenopathy Present (Yes)

Current Symptoms

Item Group

Current Symptoms

InfectionSeverityType

Item

Current Infection

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C26726 (NCI Thesaurus ObjectClass)
C0009450 (UMLS 2011AA ObjectClass)
C25676 (NCI Thesaurus Property)
C0439793 (UMLS 2011AA Property)

CL.15

Code List

Current Infection

CL Item

None (None)

C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)

CL Item

Life Threatening Or Disabling Adverse Event (Life-threatening)

C41337 (NCI Thesaurus)
C1517874 (UMLS 2011AA)

CL Item

Moderate Adverse Event (Moderate)

C41339 (NCI Thesaurus)
C1513374 (UMLS 2011AA)

CL Item

Severe Adverse Event (Severe)

C41340 (NCI Thesaurus)
C1519275 (UMLS 2011AA)

AdverseEventHemorrhageSymptomStatus

Item

Bleeding/Hemorrage

text

C26791 (NCI Thesaurus Property)
C0019080 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C4876 (NCI Thesaurus Property)
C1457887 (UMLS 2011AA Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)

CL.16

Code List

Bleeding/Hemorrage

CL Item

Active, Requiring Transfusion (Active, requiring transfusion)

CL Item

Mild, Not Requiring Transfusion (Mild, not requiring transfusion)

CL Item

None (None)

C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)

Lab Data at Study Entry

Item Group

Lab Data At Study Entry

ChestX-RayResultType

Item

Chest X-Ray Result

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25389 (NCI Thesaurus ObjectClass)
C0817096 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C17261 (NCI Thesaurus ObjectClass)

CL.17

Code List

Chest X-Ray Result

CL Item

Normal (Normal)

C14165 (NCI Thesaurus)
C0205307 (UMLS 2011AA)

CL Item

Abnormal (Abnormal)

C25401 (NCI Thesaurus)
C0205161 (UMLS 2011AA)

ChestX-rayResultAbnormalSpecify

Item

Abnormal, specify

text

C25389 (NCI Thesaurus ObjectClass)
C0817096 (UMLS 2011AA ObjectClass)
C17261 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25401 (NCI Thesaurus ValueDomain)
C0205161 (UMLS 2011AA ValueDomain)

ChestX-RayAssessmentDate

Item

Date of Chest X-ray

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25389 (NCI Thesaurus ObjectClass)
C0817096 (UMLS 2011AA ObjectClass)
C17261 (NCI Thesaurus ObjectClass)

HepaticBilirubinLabValue

Item

Bilirubin

double

C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C305 (NCI Thesaurus Property)
C0005437 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

HepaticBilirubinLabUpperLimitNormalValue

Item

Bilirubin ULN

double

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C305 (NCI Thesaurus Property)
C0005437 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)

CardiacEvaluationDiagnosticProcedure

Item

EKG result

text

C25214 (NCI Thesaurus ObjectClass)
C0220825 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)
C25218 (NCI Thesaurus ValueDomain)
C1948041 (UMLS 2011AA ValueDomain)

CL.18

Code List

EKG result

CL Item

Normal (Normal)

C14165 (NCI Thesaurus)
C0205307 (UMLS 2011AA)

CL Item

Abnormal (Abnormal)

C25401 (NCI Thesaurus)
C0205161 (UMLS 2011AA)

CL Item

Not Done (Not done)

CL281691 (NCI Metathesaurus)

AbnormalElectrocardiographyAdverseEventPresentSpecify

Item

Specify nature of abnormalities

text

C25401 (NCI Thesaurus ObjectClass)
C0205161 (UMLS 2011AA ObjectClass)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C38053 (NCI Thesaurus ObjectClass)
C1623258 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)

DiagnosticElectrocardiogramPerformedDate

Item

Date of EKG

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25482 (NCI Thesaurus ObjectClass)
C0348026 (UMLS 2011AA ObjectClass)
C0013798 (NCI Metathesaurus ObjectClass)

HeartLVEFTestPercentageValue

Item

LVEF (%)

double

C12727 (NCI Thesaurus ObjectClass)
C0018787 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C37946 (NCI Thesaurus Property)
C2700377 (UMLS 2011AA Property)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LeftVentricularEjectionFractionAssessmentType

Item

Method to determine ejection fraction

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C37946 (NCI Thesaurus ObjectClass)
C2700377 (UMLS 2011AA ObjectClass)

CL.19

Code List

Method to determine ejection fraction

CL Item

Echocardiogram (Echocardiogram)

C37945 (NCI Thesaurus)
C2243117 (UMLS 2011AA)

CL Item

Radionuclide Ventriculogram Scan (Multiple Gated Acquisition (MUGA))

C38073 (NCI Thesaurus)
C0521317 (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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Itemgroup-kommentar för :

Item-kommentar för :

Leukemia NCT00651261 On-Study - CALGB: 10603 On-Study Form - 2719613v1.0

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