ID

11332

Descripción

CALGB: TRASTUZUMAB MONITORING FORM NCT00024102 Comparison of Combination Chemotherapy Regimens in Treating Older Women Who Have Undergone Surgery for Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=0DF41E5E-5CC3-5A4A-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=0DF41E5E-5CC3-5A4A-E044-0003BA3F9857

Palabras clave

Versiones (3)
  1. 26/8/12 26/8/12 -
  2. 9/1/15 9/1/15 - Martin Dugas
  3. 3/7/15 3/7/15 -
Subido en

3 de julio de 2015

DOI

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Licencia

Creative Commons BY-NC 3.0 Legacy
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CALGB: TRASTUZUMAB MONITORING FORM NCT00024102

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. For optimal accuracy use black ink. Mark an X in the appropriate box for fields with a choice. Print text in capital letters. Avoid contact with the edges of the boxes. Circle amended items and check "Amended data" box to the right. If submitting by mail, retain a copy for your records and send the original to the CALGB Statistical Center, Data Operations. If faxing, use an original form for maximum clarity in transmission and fax to 919-416-4990. If submitting electronically, click the Send button when you have completed the PDF version of the form.

1 formularios  
Header
Descripción

Header

CALGB Form
Descripción

CALGB Form

Tipo de datos

text

Alias
UMLS CUI-1
C3262252
UMLS CUI-2
C1516238
CALGB Study No
Descripción

CALGBStudyNo

Tipo de datos

text

CALGB Patient ID
Descripción

CALGBPatientID

Tipo de datos

text

Amended data?
Descripción

Amendeddata?

Tipo de datos

text

Patient demographics
Descripción

Patient demographics

Patient Initials (Last, First Middle)
Descripción

Patient Initials

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Participating Group
Descripción

Participating Group

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2347449
NCI Thesaurus ObjectClass
C25608
NCI Thesaurus ObjectClass-2
C17005
NCI Thesaurus Property
C25364
Patient Hospital No.
Descripción

Medical Record Number

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1301894
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25261
NCI Thesaurus Property-2
C25198
Participating Group Study No.
Descripción

Study Number Participating Group

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Institution/Affiliate
Descripción

Institution Name

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C25454
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass-2
C21541
NCI Thesaurus Property
C25364
NCI Thesaurus ValueDomain
C25191
NCI Thesaurus ValueDomain-2
C21541
Participating Group Patient ID
Descripción

Trial subject ID Participating Group

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Testing Results
Descripción

Testing Results

Did the patient receive any Herceptin treatment?
Descripción

ImmunotherapyTrastuzumabReceivedInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C1647
UMLS 2011AA Property
C0338204
NCI Thesaurus ObjectClass
C15262
UMLS 2011AA ObjectClass
C0021083
NCI Thesaurus Property-2
C25639
UMLS 2011AA Property-2
C1514756
No, specify reason
Descripción

TrastuzumabAgentNotAdministrationSpecify

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C1647
UMLS 2011AA ObjectClass
C0338204
NCI Thesaurus Property
C25594
UMLS 2011AA Property
C1518422
NCI Thesaurus ObjectClass-2
C1708
UMLS 2011AA ObjectClass-2
C0450442
NCI Thesaurus Property-2
C25409
UMLS 2011AA Property-2
C1533734
Date trastuzumab started (mm/dd/yyyy)
Descripción

TrastuzumabAgentAdministrationBeginDate

Tipo de datos

date

Alias
NCI Thesaurus ObjectClass
C1647
UMLS 2011AA ObjectClass
C0338204
NCI Thesaurus ObjectClass-2
C1708
UMLS 2011AA ObjectClass-2
C0450442
NCI Thesaurus Property
C25409
UMLS 2011AA Property
C1533734
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25431
UMLS 2011AA ValueDomain-2
C0439659
Date trastuzumab discontinued (mm/dd/yyyy)
Descripción

TrastuzumabAgentAdministrationEndDate

Tipo de datos

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C1647
UMLS 2011AA ObjectClass
C0338204
NCI Thesaurus ObjectClass-2
C1708
UMLS 2011AA ObjectClass-2
C0450442
NCI Thesaurus Property
C25409
UMLS 2011AA Property
C1533734
Reason for ending trastuzumab treatment (Mark one with an X)
Descripción

TrastuzumabAgentAdministrationDiscontinuedReason

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C1647
UMLS 2011AA ObjectClass
C0338204
NCI Thesaurus ObjectClass-2
C1708
UMLS 2011AA ObjectClass-2
C0450442
NCI Thesaurus Property
C25409
UMLS 2011AA Property
C1533734
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
NCI Thesaurus ValueDomain-2
C25484
UMLS 2011AA ValueDomain-2
C1444662
Other, specify
Descripción

TrastuzumabAgentAdministrationDiscontinuedSpecify

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C1647
UMLS 2011AA ObjectClass
C0338204
NCI Thesaurus ObjectClass-2
C1708
UMLS 2011AA ObjectClass-2
C0450442
NCI Thesaurus Property
C25409
UMLS 2011AA Property
C1533734
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ValueDomain-2
C25484
UMLS 2011AA ValueDomain-2
C1444662
Form completed by
Descripción

Form completed by

Completed by
Descripción

Responsible Person Signature

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass
C25190
NCI Thesaurus ObjectClass-2
C25657
NCI Thesaurus Property
C25678
Date Form Completed
Descripción

Date Form Completed

Tipo de datos

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1115437
NCI Thesaurus ObjectClass
C40988
NCI Thesaurus Property
C25250
NCI Thesaurus ValueDomain-2
C25367
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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. For optimal accuracy use black ink. Mark an X in the appropriate box for fields with a choice. Print text in capital letters. Avoid contact with the edges of the boxes. Circle amended items and check "Amended data" box to the right. If submitting by mail, retain a copy for your records and send the original to the CALGB Statistical Center, Data Operations. If faxing, use an original form for maximum clarity in transmission and fax to 919-416-4990. If submitting electronically, click the Send button when you have completed the PDF version of the form.

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Header
CALGB Form
Item
CALGB Form
text
C3262252 (UMLS CUI-1)
C1516238 (UMLS CUI-2)
CALGBStudyNo
Item
CALGB Study No
text
CALGBPatientID
Item
CALGB Patient ID
text
Item
Amended data?
text
CL.1
Code List
Amended data?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Patient demographics
Patient Initials
Item
Patient Initials (Last, First Middle)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Participating Group
Item
Participating Group
text
C25191 (NCI Thesaurus ValueDomain)
C2347449 (UMLS CUI-1)
C25608 (NCI Thesaurus ObjectClass)
C17005 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
Medical Record Number
Item
Patient Hospital No.
text
C25337 (NCI Thesaurus ValueDomain)
C1301894 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25261 (NCI Thesaurus Property)
C25198 (NCI Thesaurus Property-2)
Study Number Participating Group
Item
Participating Group Study No.
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Institution Name
Item
Institution/Affiliate
text
C25454 (NCI Thesaurus ObjectClass)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)
Trial subject ID Participating Group
Item
Participating Group Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Item Group
Testing Results
ImmunotherapyTrastuzumabReceivedInd-2
Item
Did the patient receive any Herceptin treatment?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C1647 (NCI Thesaurus Property)
C0338204 (UMLS 2011AA Property)
C15262 (NCI Thesaurus ObjectClass)
C0021083 (UMLS 2011AA ObjectClass)
C25639 (NCI Thesaurus Property-2)
C1514756 (UMLS 2011AA Property-2)
TrastuzumabAgentNotAdministrationSpecify
Item
No, specify reason
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C1647 (NCI Thesaurus ObjectClass)
C0338204 (UMLS 2011AA ObjectClass)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C25409 (NCI Thesaurus Property-2)
C1533734 (UMLS 2011AA Property-2)
TrastuzumabAgentAdministrationBeginDate
Item
Date trastuzumab started (mm/dd/yyyy)
date
C1647 (NCI Thesaurus ObjectClass)
C0338204 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)
TrastuzumabAgentAdministrationEndDate
Item
Date trastuzumab discontinued (mm/dd/yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C1647 (NCI Thesaurus ObjectClass)
C0338204 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
Item
Reason for ending trastuzumab treatment (Mark one with an X)
text
C1647 (NCI Thesaurus ObjectClass)
C0338204 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C25484 (NCI Thesaurus ValueDomain-2)
C1444662 (UMLS 2011AA ValueDomain-2)
CL.3
Code List
Reason for ending trastuzumab treatment (Mark one with an X)
CL Item
Completed Per Protocol Criteria (Completed per protocol criteria)
CL Item
Cardiac Adverse Event (Cardiac adverse event)
CL Item
Other Cardiac Adverse Event (Other cardiac adverse event)
CL Item
Non-cardiac Adverse Event (Non-cardiac adverse event)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
TrastuzumabAgentAdministrationDiscontinuedSpecify
Item
Other, specify
text
C1647 (NCI Thesaurus ObjectClass)
C0338204 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25484 (NCI Thesaurus ValueDomain-2)
C1444662 (UMLS 2011AA ValueDomain-2)
Item Group
Form completed by
Responsible Person Signature
Item
Completed by
text
C25704 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25190 (NCI Thesaurus ObjectClass)
C25657 (NCI Thesaurus ObjectClass-2)
C25678 (NCI Thesaurus Property)
Date Form Completed
Item
Date Form Completed
date
C25164 (NCI Thesaurus ValueDomain)
C1115437 (UMLS CUI-1)
C40988 (NCI Thesaurus ObjectClass)
C25250 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)
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