ID

11625

Beskrivning

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

Länk

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

Nyckelord

Versioner (3)
  1. 2012-08-26 2012-08-26 -
  2. 2015-07-08 2015-07-08 -
  3. 2015-07-08 2015-07-08 -
Uppladdad den

8 juli 2015

DOI

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Licens

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

Engelsk

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 Formulär  
CALGB clinical trial administrative data
Beskrivning

CALGB clinical trial administrative data

CALGB Form
Beskrivning

CALGB Form

Datatyp

text

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

CALGB Study No

Datatyp

text

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

CALGB Patient ID

Datatyp

text

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

Amended data?

Datatyp

text

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

From

Datatyp

date

Alias
UMLS CUI-1
C0580096
To
Beskrivning

To

Datatyp

date

Alias
UMLS CUI-1
C0806020
Patient demographics
Beskrivning

Patient demographics

Alias
UMLS CUI-1
C1955348
Patient Name
Beskrivning

Patient Name

Datatyp

text

Alias
UMLS CUI-1
C1299487
Participating Group
Beskrivning

Participating Group

Datatyp

float

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

Patient Hospital Number

Datatyp

text

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

Participating Group Protocol No.

Datatyp

text

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

Main Member Institution/Adjunct

Datatyp

float

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

Participating Group Patient No.

Datatyp

text

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

Target Lesion(s) Follow-up Evaluation

Lesion Number
Beskrivning

Lesion Number

Datatyp

integer

Alias
UMLS CUI-1
C0449791
Site
Beskrivning

Site

Datatyp

float

Alias
UMLS CUI-1
C0449685
Date of Evaluation
Beskrivning

Date of Evaluation

Datatyp

date

Alias
UMLS CUI-1
C2985720
Method of Evaluation
Beskrivning

Method of Evaluation

Datatyp

text

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

If other, specify (method of evaluation)

Datatyp

text

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

Longest Diameter (cm)

Datatyp

integer

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

Sum of Longest Diameteres of All Target lesions (cm)

Datatyp

integer

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

Response Status at this assessment (Target Lesion)

Datatyp

text

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

Non-target Lesion(s) Follow-up Evaluation

Are there any non-target lesions?
Beskrivning

Are there any non-target lesions?

Datatyp

boolean

Alias
UMLS CUI-1
C2986547
Site
Beskrivning

Site

Datatyp

text

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

New Lesion(s) At Follow-up Evaluation

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

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

Datatyp

boolean

Alias
UMLS CUI-1
C2986548
Completed by
Beskrivning

Completed by

Datatyp

text

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

Date completed

Datatyp

date

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

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 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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