ID

44676

Description

CALGB: 10201On-Study Form Daunorubicin and Cytarabine With or Without Oblimersen in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=AD838530-D422-2F4D-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=AD838530-D422-2F4D-E034-0003BA12F5E7

Keywords

Versions (3)
  1. 9/19/12 9/19/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 9/27/21 9/27/21 -
Uploaded on

September 27, 2021

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Creative Commons BY-NC 3.0 Legacy
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Leukemia NCT00085124 On-Study - CALGB: 10201On-Study Form - 2057573v3.0

English

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  
Calgb Form
Description

Calgb Form

CALGB Study No.
Description

CALGBProtocolNumber

Data type

text

CALGB Patient ID
Description

CALGBPatientID

Data type

text

Are data amended?
Description

AmendedDataInd

Data type

text

Alias
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C25416
UMLS 2011AA Property
C1691222
Patient's Initials (Last, First, Middle)
Description

Patient Initials

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Participating Group
Description

ParticipatingGroup

Data type

text

Alias
NCI Thesaurus ObjectClass
C17005
UMLS 2011AA ObjectClass
C1257890
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Patient Hospital Number
Description

PatientHospitalNumber

Data type

text

Participating Group Protocol No.
Description

ParticipatingGroupProtocolNo.

Data type

text

Main Member Institution/Adjunct
Description

MainMemberInstitution/Affiliate

Data type

text

Participating Group Patient No.
Description

ParticipatingGroupPatientID

Data type

text

Patient Description
Description

Patient Description

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

InitialDiagnosisDate

Data type

date

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

FirstAbnormalBoneMarrowPriorMyelodysplasticSyndromeFindingDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C25401
UMLS 2011AA ObjectClass
C0205161
NCI Thesaurus ObjectClass-2
C12431
UMLS 2011AA ObjectClass-2
C0005953
NCI Thesaurus ObjectClass-3
C25509
UMLS 2011AA ObjectClass-3
C1279901
NCI Thesaurus Property
C3247
UMLS 2011AA Property
C3463824
NCI Thesaurus Property-2
C25629
UMLS 2011AA Property-2
C0332152
NCI Thesaurus Property-3
C61036
UMLS 2011AA Property-3
C0243095
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Leukemia
Description

Leukemia/MDSClassification

Data type

text

Alias
NCI Thesaurus ValueDomain
C25372
UMLS 2011AA ValueDomain
C0683312
NCI Thesaurus ObjectClass
C3161
UMLS 2011AA ObjectClass
C0023418
NCI Thesaurus Property
C25161
UMLS 2011AA Property
C0008902
Other, specify (leukemia)
Description

LeukemiaClassification,Other

Data type

text

Clinical Onset of AML
Description

Onset,AML

Data type

text

Extramedullary Disease Involvement (mark all that apply)
Description

ExtramedullaryDisease

Data type

text

Other, specify
Description

DiseaseInvolvementSite,Other

Data type

text

Are Auer Rods present?
Description

BoneMarrowAuerrods

Data type

boolean

Organ Involvement
Description

Organ Involvement

Palpable Splenomegaly
Description

Splenomegaly,Palpation

Data type

text

Alias
NCI Thesaurus Property
C16950
UMLS 2011AA Property
C0030247
NCI Thesaurus ObjectClass
C3384
UMLS 2011AA ObjectClass
C0038002
Splenomegaly by scan or x-ray
Description

Splenomegaly,Imaging

Data type

text

Alias
NCI Thesaurus ObjectClass
C3384
UMLS 2011AA ObjectClass
C0038002
NCI Thesaurus Property
C19477
UMLS 2011AA Property
C1704254
Palpable Heptomegaly
Description

Hepatomegaly,Palpation

Data type

text

Alias
NCI Thesaurus Property
C16950
UMLS 2011AA Property
C0030247
NCI Thesaurus ObjectClass
C3100
UMLS 2011AA ObjectClass
C0017924
Hepatomegaly by scan or x-ray
Description

Hepatomegaly,Imaging

Data type

text

Alias
NCI Thesaurus ObjectClass
C3100
UMLS 2011AA ObjectClass
C0017924
NCI Thesaurus Property
C19477
UMLS 2011AA Property
C1704254
Palpable Lymphadenopathy
Description

Lymphadenopathy,Palpation

Data type

text

Alias
NCI Thesaurus Property
C16950
UMLS 2011AA Property
C0030247
NCI Thesaurus ObjectClass
C3206
UMLS 2011AA ObjectClass
C0024228
Lymphadenopathy by scan or x-ray
Description

Lymphadenopathy,Imaging

Data type

text

Alias
NCI Thesaurus ObjectClass
C3206
UMLS 2011AA ObjectClass
C0024228
NCI Thesaurus Property
C19477
UMLS 2011AA Property
C1704254
Current Symptoms
Description

Current Symptoms

Current Infection (mark one with an X)
Description

CurrentInfection

Data type

text

Bleeding/Hemorrage (mark one with an X)
Description

AdverseEventHemorrhageSymptomStatus

Data type

text

Alias
NCI Thesaurus Property
C26791
UMLS 2011AA Property
C0019080
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property-2
C4876
UMLS 2011AA Property-2
C1457887
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
Lab Data At Study Entry
Description

Lab Data At Study Entry

Creatinine
Description

Lab,Renal,Creatinine

Data type

float

Bilirubin
Description

Lab,Hepatic,Bilirubin

Data type

float

Lacate Dehyrogenase (LDH)
Description

Lab,Chemistry,LactateDehydrogenase

Data type

float

Upper Limit of Normal (LDH)
Description

Lab,Chemistry,LactateDehydrogenase,ULN

Data type

float

SGOT
Description

Lab,Hepatic,SGOT

Data type

float

Upper Limit of Normal (SGOT)
Description

SGOTLabUpperLimitNormalValue

Data type

float

Alias
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25706
UMLS 2011AA ValueDomain-2
C1519815
SGPT
Description

Lab,Hepatic,SGPT

Data type

float

Upper Limit of Normal (SGPT)
Description

SGPTLabUpperLimitNormalValue

Data type

float

Alias
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25706
UMLS 2011AA ValueDomain-2
C1519815
Alkaline Phosphatase
Description

Lab,Hepatic,AlkalinePhosphatase

Data type

float

Upper Limit of Normal (Alkaline Phosphatase)
Description

Alkaline Phosphatase ULN

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0151420
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C16276
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25706
%LVEF by MUGA
Description

%LVEFbyMUGA

Data type

text

Completed by (Print or Type name)
Description

CompletedBy

Data type

text

Date completed (MM DD YYYY)
Description

DateCompleted

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
% LVEF by ECHO
Description

%LVEFbyECHO

Data type

text

Ccrr Module For Calgb: 10201on-study Form
Description

Ccrr Module For Calgb: 10201on-study Form

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Similar models

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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