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
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
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
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)
C3463824 (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)
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
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)
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
Item Group
Organ Involvement
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)
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)
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)
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)
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)
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)
Item Group
Current Symptoms
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)
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)
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
Item Group
Ccrr Module For Calgb: 10201on-study Form
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