Instructions: Complete and submit thie 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. Print text in capital letters. Avoid contact with the edges of the boxes. Cirlce amended items and check "Amended data" box to teh right. If submitting by mail, retain a copy for your records and send the original form for mazimum clarity in transmission and fax to 919-416-4990. If submistting electronically, click the Send button when you have completed the PDF version of the form.

1 forms

StudyEvent: CALGB: 10201On-Study Form
1. Instructions: Complete and submit thie 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. Print text in capital letters. Avoid contact with the edges of the boxes. Cirlce amended items and check "Amended data" box to teh right. If submitting by mail, retain a copy for your records and send the original form for mazimum clarity in transmission and fax to 919-416-4990. If submistting electronically, click the Send button when you have completed the PDF version of the form.

Name

Type

Description | Question | Decode (Coded Value)

Data type

Alias

CALGB Form

Item Group

Calgb Form

CALGBProtocolNumber

Item

CALGB Study No.

text

CALGBPatientID

Item

CALGB Patient ID

text

AmendedDataInd

Item

Are data amended?

text

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

Patient Initials

Item

Patient's Initials (Last, First, Middle)

text

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

ParticipatingGroup

Item

Participating Group

text

C17005 (NCI Thesaurus ObjectClass)
C1257890 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

PatientHospitalNumber

Item

Patient Hospital Number

text

ParticipatingGroupProtocolNo.

Item

Participating Group Protocol No.

text

MainMemberInstitution/Affiliate

Item

Main Member Institution/Adjunct

text

ParticipatingGroupPatientID

Item

Participating Group Patient No.

text

Patient Description

Item Group

Patient Description

InitialDiagnosisDate

Item

Date of initial Pathologic Diagnosis (Enter test date for first diagnosis of AML)

date

FirstAbnormalBoneMarrowPriorMyelodysplasticSyndromeFindingDate

Item

Date of first abnormal bone marrow for antecedent myelodysplasia (MM DD YYYY)

date

C25401 (NCI Thesaurus ObjectClass)
C0205161 (UMLS 2011AA ObjectClass)
C12431 (NCI Thesaurus ObjectClass-2)
C0005953 (UMLS 2011AA ObjectClass-2)
C25509 (NCI Thesaurus ObjectClass-3)
C1279901 (UMLS 2011AA ObjectClass-3)
C3247 (NCI Thesaurus Property)
C0026986 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C61036 (NCI Thesaurus Property-3)
C0243095 (UMLS 2011AA Property-3)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

Leukemia/MDSClassification

Item

Leukemia

text

C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C3161 (NCI Thesaurus ObjectClass)
C0023418 (UMLS 2011AA ObjectClass)
C25161 (NCI Thesaurus Property)
C0008902 (UMLS 2011AA Property)

CL.1

Code List

Leukemia

CL Item

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

CL Item

Disease Classified As Acute Myeloid Leukemia W/o Maturation (fab M1) (Acute meyloid leukemia without maturation)

CL Item

Disease Classified As Acute Promyelocytic Leukemia (fab M3) (Acute promyelocytic leukemia)

CL Item

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

CL Item

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

CL Item

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

CL Item

Acute megakaryoblastic leukemia (Acute megakaryoblastic leukemia)

CL Item

Disease Classified As Aml, Not Otherwise Specified (nos) (AML, not otherwise specified)

CL Item

Disease Is An Unclassifiable Acute Leukemia (Unclassifiable acute leukemia)

CL Item

Disease Classified As Acute Undifferentiated Leukemia (aul) (Acute undifferentiated leukemia)

CL Item

Disease Is A Mixed Lineage Acute Leukemia (Mixed lineage acute leukemia)

CL Item

Disease Classified As Specified Other Leukemia (Other, specify)

LeukemiaClassification,Other

Item

Other, specify (leukemia)

text

Onset,AML

Item

Clinical Onset of AML

text

CL.2

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 (Therapy related)

CL Item

Aml Related To/associated With Prior Clinical History Of Mds (Following primary MDS)

ExtramedullaryDisease

Item

Extramedullary Disease Involvement (mark all that apply)

text

CL.3

Code List

Extramedullary Disease Involvement (mark all that apply)

CL Item

Pathology Or Disease Involving The Central Nervous System Present (Central Nervous System)

CL Item

Pathology Or Disease Involving The Peripheral Nervous System Present (Peripheral Nervous System)

CL Item

Gingival Hypertrophy Present (Gingival Hypertrophy)

CL Item

Mediastinal Mass Present (Mediastinal Mass)

CL Item

Skin (Skin)

CL Item

Other (Other)

DiseaseInvolvementSite,Other

Item

Other, specify

text

BoneMarrowAuerrods

Item

Are Auer Rods present?

boolean

Organ Involvement

Item Group

Organ Involvement

Splenomegaly,Palpation

Item

Palpable Splenomegaly

text

C16950 (NCI Thesaurus Property)
C0030247 (UMLS 2011AA Property)
C3384 (NCI Thesaurus ObjectClass)
C0038002 (UMLS 2011AA ObjectClass)

CL.5

Code List

Palpable Splenomegaly

CL Item

Palpation Performed And Splenomegaly Absent (No)

CL Item

Palpation Performed And Splenomegaly Present (Yes)

CL Item

Palpation Of Spleen Not Performed (Not examined)

CL Item

Surgically absent (Surgically absent)

Splenomegaly,Imaging

Item

Splenomegaly by scan or x-ray

text

C3384 (NCI Thesaurus ObjectClass)
C0038002 (UMLS 2011AA ObjectClass)
C19477 (NCI Thesaurus Property)
C1704254 (UMLS 2011AA Property)

CL.6

Code List

Splenomegaly by scan or x-ray

CL Item

Imaging Performed And Splenomegaly Absent (No)

CL Item

Imaging Performed And Splenomegaly Present (Yes)

CL Item

Imaging Of Spleen Not Performed (Not examined)

CL Item

Spleen Removed Via Prior Surgery (Surgically absent)

Hepatomegaly,Palpation

Item

Palpable Heptomegaly

text

C16950 (NCI Thesaurus Property)
C0030247 (UMLS 2011AA Property)
C3100 (NCI Thesaurus ObjectClass)
C0017924 (UMLS 2011AA ObjectClass)

CL.7

Code List

Palpable Heptomegaly

CL Item

No (No)

CL Item

Yes (Yes)

CL Item

Not examined (Not examined)

Hepatomegaly,Imaging

Item

Hepatomegaly by scan or x-ray

text

C3100 (NCI Thesaurus ObjectClass)
C0017924 (UMLS 2011AA ObjectClass)
C19477 (NCI Thesaurus Property)
C1704254 (UMLS 2011AA Property)

CL.8

Code List

Hepatomegaly by scan or x-ray

CL Item

No (No)

CL Item

Yes (Yes)

CL Item

Not examined (Not examined)

Lymphadenopathy,Palpation

Item

Palpable Lymphadenopathy

text

C16950 (NCI Thesaurus Property)
C0030247 (UMLS 2011AA Property)
C3206 (NCI Thesaurus ObjectClass)
C0024228 (UMLS 2011AA ObjectClass)

CL.9

Code List

Palpable Lymphadenopathy

CL Item

No (No)

CL Item

Yes (Yes)

CL Item

Not examined (Not examined)

Lymphadenopathy,Imaging

Item

Lymphadenopathy by scan or x-ray

text

C3206 (NCI Thesaurus ObjectClass)
C0024228 (UMLS 2011AA ObjectClass)
C19477 (NCI Thesaurus Property)
C1704254 (UMLS 2011AA Property)

CL.10

Code List

Lymphadenopathy by scan or x-ray

CL Item

No (No)

CL Item

Yes (Yes)

CL Item

Not examined (Not examined)

Current Symptoms

Item Group

Current Symptoms

CurrentInfection

Item

Current Infection (mark one with an X)

text

CL.11

Code List

Current Infection (mark one with an X)

CL Item

None (None)

C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)

CL Item

Mild (Mild)

C70666 (NCI Thesaurus)
C2945599 (UMLS 2011AA)

CL Item

Moderate (Moderate)

CL Item

Severe (Severe)

CL Item

Life-threatening (Life-threatening)

AdverseEventHemorrhageSymptomStatus

Item

Bleeding/Hemorrage (mark one with an X)

text

C26791 (NCI Thesaurus Property)
C0019080 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C4876 (NCI Thesaurus Property-2)
C1457887 (UMLS 2011AA Property-2)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)

CL.12

Code List

Bleeding/Hemorrage (mark one with an X)

CL Item

None (None)

C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)

CL Item

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

CL Item

Active, Requiring Transfusion (Active, requiring transfusion)

Lab data at Study Entry

Item Group

Lab Data At Study Entry

Lab,Renal,Creatinine

Item

Creatinine

float

Lab,Hepatic,Bilirubin

Item

Bilirubin

float

Lab,Chemistry,LactateDehydrogenase

Item

Lacate Dehyrogenase (LDH)

float

Lab,Chemistry,LactateDehydrogenase,ULN

Item

Upper Limit of Normal (LDH)

float

Lab,Hepatic,SGOT

Item

SGOT

float

SGOTLabUpperLimitNormalValue

Item

Upper Limit of Normal (SGOT)

float

C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)

Lab,Hepatic,SGPT

Item

SGPT

float

SGPTLabUpperLimitNormalValue

Item

Upper Limit of Normal (SGPT)

float

C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)

Lab,Hepatic,AlkalinePhosphatase

Item

Alkaline Phosphatase

float

Alkaline Phosphatase ULN

Item

Upper Limit of Normal (Alkaline Phosphatase)

float

C25294 (NCI Thesaurus ObjectClass)
C0151420 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C16276 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)

%LVEFbyMUGA

Item

%LVEF by MUGA

text

CompletedBy

Item

Completed by (Print or Type name)

text

DateCompleted

Item

Date completed (MM DD YYYY)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

%LVEFbyECHO

Item

% LVEF by ECHO

text

CCRR MODULE

Item Group

Ccrr Module For Calgb: 10201on-study Form

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