A Phase III Study of Daunorubicin and Cytarabine +/- G3139 (Genasense) in Previously Untreated Patients with Acute Myeloid Leukemia

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Protocol Administration
IRBApprovalDate
Item
IRB Approval Date (M M DD YYYY)
date
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25425 (NCI Thesaurus Property)
C0205540 (UMLS 2011AA Property)
ContactPersonatInstitution
Item
Responsible Contact
text
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25461 (NCI Thesaurus ObjectClass-2)
C0337611 (UMLS 2011AA ObjectClass-2)
InformedConsentDateSigned
Item
Date Informed Consent Signed (M M DD YYYY)
text
PhoneNumber
Item
Phone
float
ProjectedTreatmentBeginDate
Item
Projected Treatment Start Date (M M DD YYYY)
date
FaxNumber
Item
FAX
float
Item Group
Patient Demographics/pre-treatment Characteristics
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)
PatientSocialSecurityNumber
Item
Social Security Number
float
PatientBirthDate
Item
Birth Date (M M DD YYYY)
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
PatientHospitalNumber
Item
Patient Hospital No.
text
Item
Gender
text
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C17357 (NCI Thesaurus Property)
C0079399 (UMLS 2011AA Property)
Code List
Gender
CL Item
Male (Male)
C46109 (NCI Thesaurus)
C1706180 (UMLS 2011AA)
CL Item
Female (Female)
C46110 (NCI Thesaurus)
C0086287 (UMLS 2011AA)
Item
Race (Mark all that apply)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C17049 (NCI Thesaurus Property)
C0034510 (UMLS 2011AA Property)
Code List
Race (Mark all that apply)
CL Item
American Indian or Alaskan Native (American Indian or Alaskan Native)
CL Item
Pacific_islander_cdus (Native Hawaiian or Other Pacific Islander)
CL Item
Asian_cdus (Asian)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Black_cdus (Black or African American)
CL Item
White_cdus (White)
Item
Ethnicity (Mark one)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C17049 (NCI Thesaurus Property)
C0034510 (UMLS 2011AA Property)
Code List
Ethnicity (Mark one)
CL Item
Hispanic_or_latino (Hispanic or Latino)
CL Item
Non_hispanic (Non-Hispanic)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
PerformanceStatus
Item
Performance Status (ECOG/Zubrod scale)
text
PatientHeight
Item
Height (cm)
float
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25347 (NCI Thesaurus Property)
C0489786 (UMLS 2011AA Property)
PatientWeight
Item
Weight (kg)
float
BodySurfaceArea
Item
Body Surface Area (2 m)
float
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25157 (NCI Thesaurus Property)
C0005902 (UMLS 2011AA Property)
Item
Method of Payment (USA only)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25371 (NCI Thesaurus Property)
C0680264 (UMLS 2011AA Property)
Code List
Method of Payment (USA only)
CL Item
Medicaid (Medicaid)
C0025071 (NCI Metathesaurus)
CL Item
Medicare And Private Insurance (Medicare and Private Insurance)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Self Pay (no Insurance) (Self Pay)
CL Item
Medicaid And Medicare (Medicaid and Medicare)
CL Item
Military Sponsored (including Champus & Tricare) (Military)
CL Item
Private Insurance (Private Insurance)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Medicare (Medicare)
C16665 (NCI Thesaurus)
C0018717 (UMLS 2011AA)
CL Item
No Means Of Payment (no Insurance) (No means of payment)
CL Item
Military Or Veterans Sponsored Nos (Veterans Administration Sponsored)
PatientAddress,PostalCode
Item
Patient's Zip Code
float
PatientAddress,Country
Item
Country Of Residence (If not USA)
text
Item Group
Certification Of Eligibility
PatientEligibilityInd
Item
Is the patient eligible? (Stratification Factors)
boolean
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
Item Group
Protocol Design
Item
Type of AML
text
Code List
Type of AML
CL Item
De Novo Aml (de novo AML)
CL Item
Aml With Antecedent Mds (AML with antecedent MDS)
Item
Assigned Treatment Arm
text
Code List
Assigned Treatment Arm
CL Item
G3139 and Cytarabine and Daunorubicin (G3139 and Cytarabine and Daunorubicin)
CL Item
Cytarabine and Daunorubicin (Cytarabine and Daunorubicin)
Item Group
Initial Patient Consent For Specimen Use
PatientInitialConsent,Specimen,Patient'scancerresearchInd
Item
Patient's Initial Consent given for Specimen use for research on the patient's cancer?
boolean
PatientInitialConsent,Specimen,Researchunrelatedtopatient'scancerInd
Item
Patient's Initial Consent given for specimen use for research unrelated to the patient's cancer?
boolean
PatientInitialConsent,Specimen,ContactInd
Item
Patient's Initial Consent given for further contact regarding specimen?
boolean
Item Group
Registration Information
PatientStudyID,ParticipatingGroup
Item
Assigned Participating Group Patient ID
text
CALGBPatientID
Item
CALGB Patient ID
text
RegistrationDate
Item
Registration Date (MM DD YYYY)
text
SignatureofPersonCompletingThisForm
Item
Registrar's Signature
text
Item Group
Ccrr Module For Calgb 10201 Registration Worksheet
Institution Name
Item
Main Member Institution
text
C25191 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C21541 (NCI Thesaurus ValueDomain-2)
C25364 (NCI Thesaurus Property)
AffiliateName
Item
Affiliate/Treating Institution
text
CALGBPatientID
Item
CALGB Patient ID
text
Investigator Name
Item
Physician of Record
text
C25191 (NCI Thesaurus ValueDomain)
C2826892 (UMLS CUI-1)
C25364 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
ParticipatingGroupName
Item
Participating Group Name
text

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