ID

43140

Description

CALGB Randomization (CALGB 49903) NCT00053339 Trastuzumab With or Without Tamoxifen in Treating Women With Progressive Stage IV Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A73D2B92-2BAF-4794-E034-0003BA0B1A09

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A73D2B92-2BAF-4794-E034-0003BA0B1A09

Keywords

Versions (4)
  1. 12/18/14 12/18/14 - Martin Dugas
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 7/5/15 7/5/15 -
  4. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

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Creative Commons BY-NC 3.0 Legacy
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CALGB Randomization (CALGB 49903) NCT00053339

English

No Instruction available.

1 forms  
  1. StudyEvent: CALGB Randomization (CALGB 49903)
    1. No Instruction available.
Header
Description

Header

CALGB Patient ID
Description

CALGBPatientID

Data type

text

Affiliate/Treating Institution
Description

AffiliateName

Data type

text

Participating Group Patient No.
Description

ParticipatingGroupPatientID

Data type

text

Patient Hospital Record No.
Description

PatientMedicalRecordNumber

Data type

text

Participating Group Code
Description

ParticipatingGroupCode

Data type

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
Physician of Record
Description

RegisteredInvestigator

Data type

text

Fax
Description

FaxNumber

Data type

float

Phone
Description

PhoneNumber

Data type

float

Protocol Administration
Description

Protocol Administration

IRB Approval Date
Description

IRBApprovalDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C25425
UMLS 2011AA Property
C0205540
Consent Form Date
Description

InformedConsentDateSigned

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Projected Start Date
Description

ProjectedTreatmentBeginDate

Data type

date

Person Completing Form, Last Name
Description

PersonCompletingForm,LastName

Data type

text

Person Completing Form, first Name
Description

PersonCompletingForm,FirstName

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Person Phone
Description

PersonCompletingForm,Phone

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
Fax
Description

PersonCompletingForm,Fax

Data type

float

Patient Demographics / Pre-treatment Characteristics
Description

Patient Demographics / Pre-treatment Characteristics

Patient Name (l,f,m.i.)
Description

PatientName

Data type

text

Social Security # (USA Only)
Description

PatientSocialSecurityNumber

Data type

float

Patient Race/Ethnicity
Description

PatientRace

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C17049
UMLS 2011AA Property
C0034510
Sex
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
Birthdate (M)
Description

PatientBirthDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
Method of Payment
Description

PaymentMethod

Data type

text

Zip Code (USA Only)
Description

PatientAddress,PostalCode

Data type

float

Country of Residence (if not USA)
Description

PatientAddress,Country

Data type

text

Performance Status
Description

PerformanceStatus

Data type

text

Pt Height (cm)
Description

PatientHeight

Data type

float

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

PatientWeight

Data type

float

BSA
Description

BodySurfaceArea

Data type

float

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25157
UMLS 2011AA Property
C0005902
Certification Of Eligibility
Description

Certification Of Eligibility

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
Registration data
Description

Registration data

ASSIGNED TREATMENT ARM
Description

TreatmentArmNumber

Data type

text

Date of Registration
Description

RegistrationDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Registrar
Description

Registrar

Data type

text

Ccrr Module For Calgb Randomization (calgb 49903)
Description

Ccrr Module For Calgb Randomization (calgb 49903)

Participating Group Name
Description

ParticipatingGroup

Data type

text

Alias
NCI Thesaurus ObjectClass
C17005
UMLS 2011AA ObjectClass
C1257890
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
CALGB Patient ID
Description

CALGBPatientID

Data type

text

IRB Approval Date
Description

IRBApprovalDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C25425
UMLS 2011AA Property
C0205540
Affiliate/Treating Institution
Description

AffiliateName

Data type

text

Patient Initials
Description

Patient Initials

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Prior Chemotherapy
Description

PriorChemotherapyInd

Data type

text

Main Member Institution
Description

Institution

Data type

text

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
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Similar models

No Instruction available.

1 forms
  1. StudyEvent: CALGB Randomization (CALGB 49903)
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
CALGBPatientID
Item
CALGB Patient ID
text
AffiliateName
Item
Affiliate/Treating Institution
text
ParticipatingGroupPatientID
Item
Participating Group Patient No.
text
PatientMedicalRecordNumber
Item
Patient Hospital Record No.
text
ParticipatingGroupCode
Item
Participating Group Code
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
RegisteredInvestigator
Item
Physician of Record
text
FaxNumber
Item
Fax
float
PhoneNumber
Item
Phone
float
Item Group
Protocol Administration
IRBApprovalDate
Item
IRB Approval Date
date
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25425 (NCI Thesaurus Property)
C0205540 (UMLS 2011AA Property)
InformedConsentDateSigned
Item
Consent Form Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
ProjectedTreatmentBeginDate
Item
Projected Start Date
date
PersonCompletingForm,LastName
Item
Person Completing Form, Last Name
text
PersonCompletingForm,FirstName
Item
Person Completing Form, first Name
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
PersonCompletingForm,Phone
Item
Person Phone
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
PersonCompletingForm,Fax
Item
Fax
float
Item Group
Patient Demographics / Pre-treatment Characteristics
PatientName
Item
Patient Name (l,f,m.i.)
text
PatientSocialSecurityNumber
Item
Social Security # (USA Only)
float
Item
Patient Race/Ethnicity
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C17049 (NCI Thesaurus Property)
C0034510 (UMLS 2011AA Property)
CL.1
Code List
Patient Race/Ethnicity
CL Item
White_cdus (White)
CL Item
Hispanic (Hispanic)
CL Item
Black_cdus (Black)
CL Item
Asian_cdus (Oriental)
CL Item
Pacific_islander_cdus (Native Hawaiian)
CL Item
Native_american_cdus (Native American)
CL Item
Indian (Indian)
CL Item
Filipino (Filipino)
CL Item
Other (Other)
CL Item
Patient refusal (Patient refusal)
CL Item
Institution refusal (Institution refusal)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Sex
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.2
Code List
Sex
CL Item
Male (M)
C46109 (NCI Thesaurus)
C1706180 (UMLS 2011AA)
CL Item
Female (F)
C46110 (NCI Thesaurus)
C0086287 (UMLS 2011AA)
PatientBirthDate
Item
Birthdate (M)
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
Item
Method of Payment
text
CL.3
Code List
Method of Payment
CL Item
Private Insurance (Private Insurance)
CL Item
Medicare (Medicare)
CL Item
Medicare and Private Insurance (Medicare and Private Insurance)
CL Item
Medicaid (Medicaid)
CL Item
Medicaid and Medicare (Medicaid and Medicare)
CL Item
Military or Veterans Administration Sponsored (Military or Veterans Administration Sponsored)
CL Item
Self Pay (Self Pay)
CL Item
No means of payment (No means of payment)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
PatientAddress,PostalCode
Item
Zip Code (USA Only)
float
PatientAddress,Country
Item
Country of Residence (if not USA)
text
Item
Performance Status
text
CL.4
Code List
Performance Status
CL Item
0 (Fully active, able to carry on all pre-disease performance without restriction)
C0919414 (NCI Metathesaurus)
CL Item
1 (Restricted physically strenuous activity but ambulatory)
CL Item
2 (Ambulatory and capable of all selfcare but unable to carry out any work activities)
C66833 (NCI Thesaurus)
C0205448 (UMLS 2011AA)
CL Item
3 (Capable of limited selfcare, confined to bed or chair more than 50% of waking hours)
CL Item
4 (Completely disabled)
PatientHeight
Item
Pt Height (cm)
float
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25347 (NCI Thesaurus Property)
C0489786 (UMLS 2011AA Property)
PatientWeight
Item
Pt Weight (kg)
float
BodySurfaceArea
Item
BSA
float
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25157 (NCI Thesaurus Property)
C0005902 (UMLS 2011AA Property)
Item Group
Certification Of Eligibility
PatientEligibilityInd
Item
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
Registration data
Item
ASSIGNED TREATMENT ARM
text
CL.6
Code List
ASSIGNED TREATMENT ARM
CL Item
Arm 1 (Arm 1)
CL Item
Arm 2 (Arm 2)
RegistrationDate
Item
Date of Registration
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Registrar
Item
Registrar
text
Item Group
Ccrr Module For Calgb Randomization (calgb 49903)
ParticipatingGroup
Item
Participating Group Name
text
C17005 (NCI Thesaurus ObjectClass)
C1257890 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
CALGBPatientID
Item
CALGB Patient ID
text
IRBApprovalDate
Item
IRB Approval Date
date
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25425 (NCI Thesaurus Property)
C0205540 (UMLS 2011AA Property)
AffiliateName
Item
Affiliate/Treating Institution
text
Patient Initials
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
PriorChemotherapyInd
Item
Prior Chemotherapy
text
Institution
Item
Main Member Institution
text
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)
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