ID

781

Beschreibung

CALGB: Follow-up Solid Tumor Evaluation Form 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=A73D1896-B650-4751-E034-0003BA0B1A09

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A73D1896-B650-4751-E034-0003BA0B1A09

Stichworte

Versionen (3)
  1. 26.08.12 26.08.12 -
  2. 08.07.15 08.07.15 -
  3. 08.07.15 08.07.15 -
Hochgeladen am

26. August 2012

DOI

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Lizenz

Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT00053339 Response - CALGB: Follow-up Solid Tumor Evaluation Form - 2054391v3.0

Englisch

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.

1 Formulare  
Unnamed1
Beschreibung

Unnamed1

CALGB Form
Beschreibung

CALGBForm

Datentyp

text

CALGB Study No
Beschreibung

CALGBStudyNo

Datentyp

text

CALGB Patient ID
Beschreibung

CALGBPatientID

Datentyp

text

Amended data?
Beschreibung

AmendedDataInd

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C25416
UMLS 2011AA Property
C1691222
Unnamed2
Beschreibung

Unnamed2

Patient's Name
Beschreibung

Patient'sName

Datentyp

text

Participating Group
Beschreibung

ParticipatingGroup

Datentyp

text

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

PatientHospitalNumber

Datentyp

text

Participating Group Protocol No.
Beschreibung

ParticipatingGroupProtocolNo.

Datentyp

text

Main Member Institution/Adjunct
Beschreibung

AffiliateName

Datentyp

text

Participating Group Patient No.
Beschreibung

ParticipatingGroupPatientID

Datentyp

text

Reporting Period
Beschreibung

Reporting Period

From
Beschreibung

IntervalReportFromDate

Datentyp

date

To
Beschreibung

IntervalReportToDate

Datentyp

date

Target Lesion(s) Follow-up Evaluation
Beschreibung

Target Lesion(s) Follow-up Evaluation

Lesion Number (unnamed)
Beschreibung

Lesion,ReferenceNumber

Datentyp

double

Site
Beschreibung

Lesion,AnatomicSite,New

Datentyp

text

Date of Evaluation
Beschreibung

AssessmentDate

Datentyp

date

Method of Evaluation
Beschreibung

AssessmentType

Datentyp

text

If other, specify (method of evaluation)
Beschreibung

AssessmentType,Specify

Datentyp

text

Longest Diameter (cm)
Beschreibung

Lesion,TumorDiameter

Datentyp

double

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

Lesion,Diameter,LongestSum

Datentyp

double

Response Status at this assessment (Target Lesion)
Beschreibung

ResponseCriteria

Datentyp

text

Non-target Lesion(s) Follow-up Evaluation
Beschreibung

Non-target Lesion(s) Follow-up Evaluation

Are there any non-target lesions?
Beschreibung

NontargetLesionInd

Datentyp

text

Lesion Number (unnamed)
Beschreibung

Lesion,ReferenceNumber

Datentyp

double

Site
Beschreibung

Lesion,AnatomicSite,Nontarget

Datentyp

text

Date of Evaluation
Beschreibung

AssessmentDate

Datentyp

date

Method of Evaluation
Beschreibung

AssessmentType

Datentyp

text

If other, specify (method of evaluation)
Beschreibung

AssessmentType,Specify

Datentyp

text

Response Status at this assessment (Target Lesion)
Beschreibung

ResponseCriteria

Datentyp

text

New Lesion(s) At Follow-up Evaluation
Beschreibung

New Lesion(s) At Follow-up Evaluation

Was the appearance of any new lesions documented since the baseline evaluation?
Beschreibung

NewLesionInd

Datentyp

text

Lesion Number (unnamed)
Beschreibung

Lesion,ReferenceNumber

Datentyp

double

Site
Beschreibung

Lesion,AnatomicSite,New

Datentyp

text

Date of Evaluation
Beschreibung

AssessmentDate

Datentyp

date

Method of Evaluation
Beschreibung

AssessmentType

Datentyp

text

If other, specify (method of evaluation)
Beschreibung

AssessmentType,Specify

Datentyp

text

Completed by
Beschreibung

PersonCompletingForm,FirstName

Datentyp

text

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

FormCompletionDate,Original

Datentyp

date

Ccrr Module For Calgb: Follow-up Solid Tumor Evaluation Form
Beschreibung

Ccrr Module For Calgb: Follow-up Solid Tumor Evaluation Form

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Ähnliche Modelle

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.

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Unnamed1
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)
CL.1
Code List
Amended data?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Unnamed2
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
Reporting Period
IntervalReportFromDate
Item
From
date
IntervalReportToDate
Item
To
date
Item Group
Target Lesion(s) Follow-up Evaluation
Lesion,ReferenceNumber
Item
Lesion Number (unnamed)
double
Lesion,AnatomicSite,New
Item
Site
text
AssessmentDate
Item
Date of Evaluation
date
Item
Method of Evaluation
text
CL.9
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)
Item
If other, specify (method of evaluation)
text
CL.10
Code List
If other, specify (method of evaluation)
CL Item
complete response (CR) (complete response (CR))
CL Item
partial response (PR) (partial response (PR))
CL Item
stable disease (SD) (stable disease (SD))
CL Item
progressive disease (PD) (progressive disease (PD))
CL Item
insufficient evaluation to determine response status (insufficient evaluation to determine response status)
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
Response Status at this assessment (Target Lesion)
text
CL.7
Code List
Response Status at this assessment (Target Lesion)
CL Item
Complete Response (complete response (CR))
CL Item
Partial Response (partial response (PR))
C18212 (NCI Thesaurus)
CL Item
Incomplete Response Or Stable Disesase (stable disease (SD))
CL Item
Partial Response; At Least A 30% Decrease In The Sum Of Ld Of Target Lesions Taking As Reference The Baseline Sum Ld (progressive disease (PD))
CL Item
Insufficient Evaluation (insufficient evaluation to determine response status)
Item Group
Non-target Lesion(s) Follow-up Evaluation
Item
Are there any non-target lesions?
text
CL.4
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
CL.9
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)
Item
If other, specify (method of evaluation)
text
CL.10
Code List
If other, specify (method of evaluation)
CL Item
complete response (CR) (complete response (CR))
CL Item
partial response (PR) (partial response (PR))
CL Item
stable disease (SD) (stable disease (SD))
CL Item
progressive disease (PD) (progressive disease (PD))
CL Item
insufficient evaluation to determine response status (insufficient evaluation to determine response status)
Item
Response Status at this assessment (Target Lesion)
text
CL.7
Code List
Response Status at this assessment (Target Lesion)
CL Item
Complete Response (complete response (CR))
CL Item
Partial Response (partial response (PR))
C18212 (NCI Thesaurus)
CL Item
Incomplete Response Or Stable Disesase (stable disease (SD))
CL Item
Partial Response; At Least A 30% Decrease In The Sum Of Ld Of Target Lesions Taking As Reference The Baseline Sum Ld (progressive disease (PD))
CL Item
Insufficient Evaluation (insufficient evaluation to determine response status)
Item Group
New Lesion(s) At Follow-up Evaluation
Item
Was the appearance of any new lesions documented since the baseline evaluation?
text
CL.8
Code List
Was the appearance of any new lesions documented since the baseline evaluation?
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,New
Item
Site
text
AssessmentDate
Item
Date of Evaluation
date
Item
Method of Evaluation
text
CL.9
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)
Item
If other, specify (method of evaluation)
text
CL.10
Code List
If other, specify (method of evaluation)
CL Item
complete response (CR) (complete response (CR))
CL Item
partial response (PR) (partial response (PR))
CL Item
stable disease (SD) (stable disease (SD))
CL Item
progressive disease (PD) (progressive disease (PD))
CL Item
insufficient evaluation to determine response status (insufficient evaluation to determine response status)
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: Follow-up Solid Tumor Evaluation Form
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