ID

11625

Descripción

CALGB: Follow-up 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=A73D1896-B650-4751-E034-0003BA0B1A09

Link

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

Palabras clave

Versiones (3)
  1. 26/8/12 26/8/12 -
  2. 8/7/15 8/7/15 -
  3. 8/7/15 8/7/15 -
Subido en

8 de julio de 2015

DOI

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Licencia

Creative Commons BY-NC 3.0 Legacy
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CALGB: Follow-up Solid Tumor Evaluation Form NCT00053339

Inglés

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 formularios  
CALGB clinical trial administrative data
Descripción

CALGB clinical trial administrative data

CALGB Form
Descripción

CALGB Form

Tipo de datos

text

Alias
UMLS CUI-1
C1516238
UMLS CUI-2
C0348078
CALGB Study No
Descripción

CALGB Study No

Tipo de datos

text

Alias
UMLS CUI-1
C1516238
UMLS CUI-2
C2826693
CALGB Patient ID
Descripción

CALGB Patient ID

Tipo de datos

text

Alias
UMLS CUI-1
C1516238
UMLS CUI-2
C1549734
Amended data?
Descripción

Amended data?

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
UMLS CUI-1
C1511726
UMLS CUI-2
C1691222
From
Descripción

From

Tipo de datos

date

Alias
UMLS CUI-1
C0580096
To
Descripción

To

Tipo de datos

date

Alias
UMLS CUI-1
C0806020
Patient demographics
Descripción

Patient demographics

Alias
UMLS CUI-1
C1955348
Patient Name
Descripción

Patient Name

Tipo de datos

text

Alias
UMLS CUI-1
C1299487
Participating Group
Descripción

Participating Group

Tipo de datos

float

Alias
NCI Thesaurus ObjectClass
C17005
NCI Thesaurus Property
C25364
UMLS CUI-1
C1257890
UMLS CUI-2
C0600091
Patient Hospital Number
Descripción

Patient Hospital Number

Tipo de datos

text

Alias
UMLS CUI-1
C0421459
Participating Group Protocol No.
Descripción

Participating Group Protocol No.

Tipo de datos

text

Alias
UMLS CUI-1
C2826263
Main Member Institution/Adjunct
Descripción

Main Member Institution/Adjunct

Tipo de datos

float

Alias
UMLS CUI-1
C2698041
Participating Group Patient No.
Descripción

Participating Group Patient No.

Tipo de datos

text

Alias
UMLS CUI-1
C0441833
UMLS CUI-2
C1830427
Target Lesion(s) Follow-up Evaluation
Descripción

Target Lesion(s) Follow-up Evaluation

Lesion Number
Descripción

Lesion Number

Tipo de datos

integer

Alias
UMLS CUI-1
C0449791
Site
Descripción

Site

Tipo de datos

float

Alias
UMLS CUI-1
C0449685
Date of Evaluation
Descripción

Date of Evaluation

Tipo de datos

date

Alias
UMLS CUI-1
C2985720
Method of Evaluation
Descripción

Method of Evaluation

Tipo de datos

text

Alias
UMLS CUI-1
C2911685
If other, specify (method of evaluation)
Descripción

If other, specify (method of evaluation)

Tipo de datos

text

Alias
UMLS CUI-1
C0846619
UMLS CUI-2
C3845569
Longest Diameter (cm)
Descripción

Longest Diameter (cm)

Tipo de datos

integer

Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0242485
UMLS CUI-2
C1301886
Sum of Longest Diameteres of All Target lesions (cm)
Descripción

Sum of Longest Diameteres of All Target lesions (cm)

Tipo de datos

integer

Alias
UMLS CUI-1
C3272915
UMLS CUI-2
C2986546
Response Status at this assessment (Target Lesion)
Descripción

Response Status at this assessment (Target Lesion)

Tipo de datos

text

Alias
UMLS CUI-1
C1704632
UMLS CUI-2
C0449438
Non-target Lesion(s) Follow-up Evaluation
Descripción

Non-target Lesion(s) Follow-up Evaluation

Are there any non-target lesions?
Descripción

Are there any non-target lesions?

Tipo de datos

boolean

Alias
UMLS CUI-1
C2986547
Site
Descripción

Site

Tipo de datos

text

Alias
UMLS CUI-1
C0449685
New Lesion(s) At Follow-up Evaluation
Descripción

New Lesion(s) At Follow-up Evaluation

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

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

Tipo de datos

boolean

Alias
UMLS CUI-1
C2986548
Completed by
Descripción

Completed by

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C25190
NCI Thesaurus Property
C25364
UMLS CUI-1
C3258039
Date completed
Descripción

Date completed

Tipo de datos

date

Alias
UMLS CUI-1
C1115437
Ccrr Module For Calgb: Follow-up Solid Tumor Evaluation Form
Descripción

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

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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.

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
CALGB clinical trial administrative data
CALGBForm
Item
CALGB Form
text
C1516238 (UMLS CUI-1)
C0348078 (UMLS CUI-2)
CALGBStudyNo
Item
CALGB Study No
text
C1516238 (UMLS CUI-1)
C2826693 (UMLS CUI-2)
CALGBPatientID
Item
CALGB Patient ID
text
C1516238 (UMLS CUI-1)
C1549734 (UMLS CUI-2)
Item
Amended data?
text
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
C1511726 (UMLS CUI-1)
C1691222 (UMLS CUI-2)
CL.1
Code List
Amended data?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
IntervalReportFromDate
Item
From
date
C0580096 (UMLS CUI-1)
IntervalReportToDate
Item
To
date
C0806020 (UMLS CUI-1)
Item Group
Patient demographics
C1955348 (UMLS CUI-1)
Patient'sName
Item
Patient Name
text
C1299487 (UMLS CUI-1)
ParticipatingGroup
Item
Participating Group
float
C17005 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
C1257890 (UMLS CUI-1)
C0600091 (UMLS CUI-2)
PatientHospitalNumber
Item
Patient Hospital Number
text
C0421459 (UMLS CUI-1)
ParticipatingGroupProtocolNo.
Item
Participating Group Protocol No.
text
C2826263 (UMLS CUI-1)
AffiliateName
Item
Main Member Institution/Adjunct
float
C2698041 (UMLS CUI-1)
ParticipatingGroupPatientID
Item
Participating Group Patient No.
text
C0441833 (UMLS CUI-1)
C1830427 (UMLS CUI-2)
Item Group
Target Lesion(s) Follow-up Evaluation
Lesion,ReferenceNumber
Item
Lesion Number
integer
C0449791 (UMLS CUI-1)
Lesion,AnatomicSite,New
Item
Site
float
C0449685 (UMLS CUI-1)
AssessmentDate
Item
Date of Evaluation
date
C2985720 (UMLS CUI-1)
Item
Method of Evaluation
text
C2911685 (UMLS CUI-1)
CL.9
Code List
Method of Evaluation
CL Item
Clinical Examination (clinical examination)
C1456356 (UMLS CUI-1)
CL Item
Chest X-ray (chest x-ray)
C0039985 (UMLS CUI-1)
CL Item
Ct Scan (CT scan)
C0040405 (UMLS CUI-1)
CL Item
Spiral Ct Scan (Spiral CT scan)
C0860888 (UMLS CUI-1)
CL Item
Mri (MRI (NMR))
C0024485 (UMLS CUI-1)
CL Item
Ultrasound (Ultrasound)
C64384 (NCI Thesaurus)
C1456803 (UMLS CUI-1)
CL Item
Bone Scan (Bone scan)
C17646 (NCI Thesaurus)
C0203668 (UMLS CUI-1)
CL Item
Not Evaluated (not evaluated)
C3846720 (UMLS CUI-1)
CL Item
Other (other)
C17649 (NCI Thesaurus)
C0205394 (UMLS CUI-1)
Item
If other, specify (method of evaluation)
text
C0846619 (UMLS CUI-1)
C3845569 (UMLS CUI-2)
CL.10
Code List
If other, specify (method of evaluation)
CL Item
complete response (CR) (complete response (CR))
C0677874 (UMLS CUI-1)
CL Item
partial response (PR) (partial response (PR))
C1521726 (UMLS CUI-1)
CL Item
stable disease (SD) (stable disease (SD))
C0677946 (UMLS CUI-1)
CL Item
progressive disease (PD) (progressive disease (PD))
C1335499 (UMLS CUI-1)
CL Item
insufficient evaluation to determine response status (insufficient evaluation to determine response status)
C0205412 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
Lesion,TumorDiameter
Item
Longest Diameter (cm)
integer
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS CUI-1)
C1301886 (UMLS CUI-2)
Lesion,Diameter,LongestSum
Item
Sum of Longest Diameteres of All Target lesions (cm)
integer
C3272915 (UMLS CUI-1)
C2986546 (UMLS CUI-2)
Item
Response Status at this assessment (Target Lesion)
text
C1704632 (UMLS CUI-1)
C0449438 (UMLS CUI-2)
CL.7
Code List
Response Status at this assessment (Target Lesion)
CL Item
Complete Response (complete response (CR))
C0677874 (UMLS CUI-1)
CL Item
Partial Response (partial response (PR))
C18212 (NCI Thesaurus)
C1521726 (UMLS CUI-1)
CL Item
Incomplete Response Or Stable Disesase (stable disease (SD))
C0205257 (UMLS CUI-1)
C1704632 (UMLS CUI-2)
C0677946 (UMLS CUI-3)
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))
C1521726 (UMLS CUI-1)
C0547047 (UMLS CUI-2)
C3828606 (UMLS CUI-3)
CL Item
Insufficient Evaluation (insufficient evaluation to determine response status)
C0231180 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
Item Group
Non-target Lesion(s) Follow-up Evaluation
NontargetLesionInd
Item
Are there any non-target lesions?
boolean
C2986547 (UMLS CUI-1)
Lesion,AnatomicSite,Nontarget
Item
Site
text
C0449685 (UMLS CUI-1)
Item Group
New Lesion(s) At Follow-up Evaluation
NewLesionInd
Item
Was the appearance of any new lesions documented since the baseline evaluation?
boolean
C2986548 (UMLS CUI-1)
PersonCompletingForm,FirstName
Item
Completed by
text
C25190 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
C3258039 (UMLS CUI-1)
FormCompletionDate,Original
Item
Date completed
date
C1115437 (UMLS CUI-1)
Item Group
Ccrr Module For Calgb: Follow-up Solid Tumor Evaluation Form
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