ID

43135

Description

CALGB 10201 REGISTRATION WORKSHEET 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=B228B8A4-E2DC-4D1A-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B228B8A4-E2DC-4D1A-E034-0003BA12F5E7

Keywords

Versions (3)
  1. 12/18/14 12/18/14 - Martin Dugas
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

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License

Creative Commons BY-NC 3.0 Legacy
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Leukemia NCT00085124 Registration - CALGB 10201 REGISTRATION WORKSHEET - 2076520v3.0

English

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

1 forms  
Protocol Administration
Description

Protocol Administration

IRB Approval Date (M M DD YYYY)
Description

IRBApprovalDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C25425
UMLS 2011AA Property
C0205540
Responsible Contact
Description

ContactPersonatInstitution

Data type

text

Alias
NCI Thesaurus ObjectClass
C21541
UMLS 2011AA ObjectClass
C0018704
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass-2
C25461
UMLS 2011AA ObjectClass-2
C0337611
Date Informed Consent Signed (M M DD YYYY)
Description

InformedConsentDateSigned

Data type

text

Phone
Description

PhoneNumber

Data type

float

Projected Treatment Start Date (M M DD YYYY)
Description

ProjectedTreatmentBeginDate

Data type

date

FAX
Description

FaxNumber

Data type

float

Patient Demographics/pre-treatment Characteristics
Description

Patient Demographics/pre-treatment Characteristics

Patient 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
Social Security Number
Description

PatientSocialSecurityNumber

Data type

float

Birth Date (M M DD YYYY)
Description

PatientBirthDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
Patient Hospital No.
Description

PatientHospitalNumber

Data type

text

Gender
Description

PatientGender

Data type

text

Alias
NCI Thesaurus ValueDomain
C25372
UMLS 2011AA ValueDomain
C0683312
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C17357
UMLS 2011AA Property
C0079399
Race (Mark all that apply)
Description

PatientRace

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C17049
UMLS 2011AA Property
C0034510
Ethnicity (Mark one)
Description

PatientEthnicity

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C17049
UMLS 2011AA Property
C0034510
Performance Status (ECOG/Zubrod scale)
Description

PerformanceStatus

Data type

text

Height (cm)
Description

PatientHeight

Data type

float

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25347
UMLS 2011AA Property
C0489786
Weight (kg)
Description

PatientWeight

Data type

float

Body Surface Area (2 m)
Description

BodySurfaceArea

Data type

float

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25157
UMLS 2011AA Property
C0005902
Method of Payment (USA only)
Description

PatientPaymentType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25371
UMLS 2011AA Property
C0680264
Patient's Zip Code
Description

PatientAddress,PostalCode

Data type

float

Country Of Residence (If not USA)
Description

PatientAddress,Country

Data type

text

Certification Of Eligibility
Description

Certification Of Eligibility

Is the patient eligible? (Stratification Factors)
Description

PatientEligibilityInd

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
Protocol Design
Description

Protocol Design

Type of AML
Description

TypeofAML

Data type

text

Assigned Treatment Arm
Description

TreatmentArmNumber

Data type

text

Initial Patient Consent For Specimen Use
Description

Initial Patient Consent For Specimen Use

Patient's Initial Consent given for Specimen use for research on the patient's cancer?
Description

PatientInitialConsent,Specimen,Patient'scancerresearchInd

Data type

boolean

Patient's Initial Consent given for specimen use for research unrelated to the patient's cancer?
Description

PatientInitialConsent,Specimen,Researchunrelatedtopatient'scancerInd

Data type

boolean

Patient's Initial Consent given for further contact regarding specimen?
Description

PatientInitialConsent,Specimen,ContactInd

Data type

boolean

Registration Information
Description

Registration Information

Assigned Participating Group Patient ID
Description

PatientStudyID,ParticipatingGroup

Data type

text

CALGB Patient ID
Description

CALGBPatientID

Data type

text

Registration Date (MM DD YYYY)
Description

RegistrationDate

Data type

text

Registrar's Signature
Description

SignatureofPersonCompletingThisForm

Data type

text

Ccrr Module For Calgb 10201 Registration Worksheet
Description

Ccrr Module For Calgb 10201 Registration Worksheet

Main Member Institution
Description

Institution Name

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass
C21541
NCI Thesaurus ValueDomain-2
C21541
NCI Thesaurus Property
C25364
Affiliate/Treating Institution
Description

AffiliateName

Data type

text

CALGB Patient ID
Description

CALGBPatientID

Data type

text

Physician of Record
Description

Investigator Name

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2826892
NCI Thesaurus Property
C25364
NCI Thesaurus ObjectClass
C17089
Participating Group Name
Description

ParticipatingGroupName

Data type

text

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Similar models

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

1 forms
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)
CL.1
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)
CL.2
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)
CL.3
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)
CL.4
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
CL.6
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
CL.7
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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