ID

10614

Description

CALGB: Baseline Solid Tumor Evaluation Form 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=A73D1562-3BF3-473F-E034-0003BA0B1A09

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A73D1562-3BF3-473F-E034-0003BA0B1A09

Keywords

  1. 8/26/12 8/26/12 -
  2. 5/22/15 5/22/15 -
  3. 6/3/15 6/3/15 -
Uploaded on

June 3, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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CALGB: Baseline Solid Tumor Evaluation Form NCT00053339

INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. Do not leave any entries blank. Enter -1 to indicate that an answer in unknown, unobtainable, not applicable, or not done. Retain a copy for your records and submit ORIGINAL to the CALGB Data Management Center.

CALGB Information
Description

CALGB Information

CALGB Form
Description

CALGBForm

Data type

text

CALGB Study No
Description

CALGBStudyNo

Data type

text

CALGB Patient ID
Description

CALGBPatientID

Data type

text

Amended data?
Description

AmendedDataInd

Data type

text

Alias
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C25416
UMLS 2011AA Property
C1691222
Patient clinical trial data
Description

Patient clinical trial data

Patient's Name
Description

Patient'sName

Data type

text

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

AffiliateName

Data type

text

Participating Group Patient No.
Description

ParticipatingGroupPatientID

Data type

text

Target Lesion(s) Baseline Evaluation
Description

Target Lesion(s) Baseline Evaluation

Lesion Number (unnamed)
Description

Lesion,ReferenceNumber

Data type

double

Site
Description

Lesion,AnatomicSite,Target

Data type

text

Date of Evaluation
Description

AssessmentDate

Data type

date

Method of Evaluation
Description

AssessmentType

Data type

text

If other, specify (method of evaluation)
Description

AssessmentType,Specify

Data type

text

Longest Diameter (cm)
Description

Lesion,TumorDiameter

Data type

double

Alias
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
Sum of Longest Diameteres of All Target lesions (cm)
Description

Lesion,Diameter,LongestSum

Data type

double

Non-target Lesion(s) Baseline Evaluation
Description

Non-target Lesion(s) Baseline Evaluation

Are there any non-target lesions?
Description

NontargetLesionInd

Data type

text

Lesion Number (unnamed)
Description

Lesion,ReferenceNumber

Data type

double

Site
Description

Lesion,AnatomicSite,Nontarget

Data type

text

Date of Evaluation
Description

AssessmentDate

Data type

date

Method of Evaluation
Description

AssessmentType

Data type

text

If other, specify (method of evaluation)
Description

AssessmentType,Specify

Data type

text

Completed by
Description

PersonCompletingForm,FirstName

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Date completed
Description

FormCompletionDate,Original

Data type

date

Ccrr Module For Calgb: Baseline Solid Tumor Evaluation Form
Description

Ccrr Module For Calgb: Baseline Solid Tumor Evaluation Form

Similar models

INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. Do not leave any entries blank. Enter -1 to indicate that an answer in unknown, unobtainable, not applicable, or not done. Retain a copy for your records and submit ORIGINAL to the CALGB Data Management Center.

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
CALGB Information
CALGBForm
Item
CALGB Form
text
CALGBStudyNo
Item
CALGB Study No
text
CALGBPatientID
Item
CALGB Patient ID
text
Item
Amended data?
text
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
Code List
Amended data?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Patient clinical trial data
Patient'sName
Item
Patient's Name
text
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
AffiliateName
Item
Main Member Institution/Adjunct
text
ParticipatingGroupPatientID
Item
Participating Group Patient No.
text
Item Group
Target Lesion(s) Baseline Evaluation
Lesion,ReferenceNumber
Item
Lesion Number (unnamed)
double
Lesion,AnatomicSite,Target
Item
Site
text
AssessmentDate
Item
Date of Evaluation
date
Item
Method of Evaluation
text
Code List
Method of Evaluation
CL Item
Clinical Examination (clinical examination)
CL Item
Chest X-ray (chest x-ray)
CL Item
Ct Scan (CT scan)
CL Item
Spiral Ct Scan (Spiral CT scan)
CL Item
Mri (MRI (NMR))
CL Item
Ultrasound (Ultrasound)
C64384 (NCI Thesaurus)
C1456803 (UMLS 2011AA)
CL Item
Bone Scan (Bone scan)
C17646 (NCI Thesaurus)
C0203668 (UMLS 2011AA)
CL Item
Not Evaluated (not evaluated)
CL Item
Other (other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
AssessmentType,Specify
Item
If other, specify (method of evaluation)
text
Lesion,TumorDiameter
Item
Longest Diameter (cm)
double
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
Lesion,Diameter,LongestSum
Item
Sum of Longest Diameteres of All Target lesions (cm)
double
Item Group
Non-target Lesion(s) Baseline Evaluation
Item
Are there any non-target lesions?
text
Code List
Are there any non-target lesions?
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Lesion,ReferenceNumber
Item
Lesion Number (unnamed)
double
Lesion,AnatomicSite,Nontarget
Item
Site
text
AssessmentDate
Item
Date of Evaluation
date
Item
Method of Evaluation
text
Code List
Method of Evaluation
CL Item
Clinical Examination (clinical examination)
CL Item
Chest X-ray (chest x-ray)
CL Item
Ct Scan (CT scan)
CL Item
Spiral Ct Scan (Spiral CT scan)
CL Item
Mri (MRI (NMR))
CL Item
Ultrasound (Ultrasound)
C64384 (NCI Thesaurus)
C1456803 (UMLS 2011AA)
CL Item
Bone Scan (Bone scan)
C17646 (NCI Thesaurus)
C0203668 (UMLS 2011AA)
CL Item
Not Evaluated (not evaluated)
CL Item
Other (other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
AssessmentType,Specify
Item
If other, specify (method of evaluation)
text
PersonCompletingForm,FirstName
Item
Completed by
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
FormCompletionDate,Original
Item
Date completed
date
Item Group
Ccrr Module For Calgb: Baseline Solid Tumor Evaluation Form

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