ID

4703

Descripción

CALGB: 49903 ADVANCED TREATMENT SUMMARY FORM; All Patients 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=A73D1CA4-8ADF-4761-E034-0003BA0B1A09

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A73D1CA4-8ADF-4761-E034-0003BA0B1A09

Palabras clave

Versiones (2)
  1. 26/8/12 26/8/12 -
  2. 20/3/14 20/3/14 - Martin Dugas
Subido en

20 de marzo de 2014

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT00053339 Treatment - CALGB: 49903 ADVANCED TREATMENT SUMMARY FORM; All Patients - 2054479v3.0

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 Data Management Center. 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

CALGBForm

Tipo de datos

text

CALGB Study No
Descripción

CALGBStudyNo

Tipo de datos

text

CALGB Patient ID
Descripción

CALGBPatientID

Tipo de datos

text

First date protocol therapy was given
Descripción

TreatmentBeginDate

Tipo de datos

date

Last date protocol therapy was given (M)
Descripción

TreatmentEndDate

Tipo de datos

date

Amended data?
Descripción

AmendedDataInd

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C25416
UMLS 2011AA Property
C1691222
IDs
Descripción

IDs

Patient's Name
Descripción

Patient Name

Tipo de datos

string

Alias
UMLS CUI
C1299487
Participating Group
Descripción

ParticipatingGroup

Tipo de datos

text

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

PatientHospitalNumber

Tipo de datos

text

Participating Group Protocol No.
Descripción

ParticipatingGroupProtocolNo.

Tipo de datos

text

Main Member Institution/Adjunct
Descripción

AffiliateName

Tipo de datos

text

Participating Group Patient No.
Descripción

ParticipatingGroupPatientID

Tipo de datos

text

Treatment Cycle Information
Descripción

Treatment Cycle Information

Total Dose of Drugs for this Regimen [mg]
Descripción

Drug dose

Tipo de datos

float

Alias
UMLS CUI
C0678766
Agent Name
Descripción

Agent

Tipo de datos

string

Alias
UMLS CUI
C0450442
Reason Treatment Ended (mark one with an X)
Descripción

OffTreatmentReason

Tipo de datos

string

Alias
UMLS CUI
CL436968
Other, specify (reason treatment ended)
Descripción

OffTreatmentReason,Other

Tipo de datos

string

Alias
UMLS CUI
CL436968
Treatment Schedule - Systemic Therapy
Descripción

Treatment Schedule - Systemic Therapy

Were there any dose modifications or additions/ omissions to protocol treatment? (mark one with an X)
Descripción

DoseModification(Change)

Tipo de datos

text

Treatment Schedule - Other Therapy
Descripción

Treatment Schedule - Other Therapy

Were any optional protocol therapies given?
Descripción

OptionalProtocolTherapyInd

Tipo de datos

string

Alias
UMLS CUI
C1707479
optional protocol therapy name(s)
Descripción

OptionalProtocolTherapyName

Tipo de datos

string

Alias
UMLS CUI
C1707479
Was any concurrent non-protocol therapy given during protocol treatment?
Descripción

ConcurrentNon-ProtocolTherapyInd

Tipo de datos

string

Alias
UMLS CUI
C1707479
indicate below (concurrent non-protocol therapy given during protocol treatment) (mark all that apply with an X)
Descripción

Concomitant Therapy

Tipo de datos

string

Alias
UMLS CUI
C1707479
Comments
Descripción

Comments

Comments
Descripción

Comments

Tipo de datos

string

Alias
UMLS CUI
C0947611
Signature
Descripción

Signature

Completed By (Print or Type Name)
Descripción

PersonCompletingForm,FirstName

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Date Completed
Descripción

FormCompletionDate,Original

Tipo de datos

date

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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 Data Management Center. 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
CALGBForm
Item
CALGB Form
text
CALGBStudyNo
Item
CALGB Study No
text
CALGBPatientID
Item
CALGB Patient ID
text
TreatmentBeginDate
Item
First date protocol therapy was given
date
TreatmentEndDate
Item
Last date protocol therapy was given (M)
date
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
IDs
Patient Name
Item
Patient's Name
string
C1299487 (UMLS CUI)
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
Treatment Cycle Information
Drug dose
Item
Total Dose of Drugs for this Regimen [mg]
float
C0678766 (UMLS CUI)
Agent
Item
Agent Name
string
C0450442 (UMLS CUI)
Item
Reason Treatment Ended (mark one with an X)
string
CL436968 (UMLS CUI)
CL.2
Code List
Reason Treatment Ended (mark one with an X)
CL Item
Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
CL Item
Disease Progression, Relapse During Active Treatment (Disease progression, relapse during active treatment)
CL Item
Toxicity/side Effects/complications (Toxicity/side effects/complications)
CL Item
Death On Study (Death on study)
CL Item
Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient withdrawal or refusal after beginning protocol therapy)
CL Item
Patient Off-treatment For Other Complicating Disease (Other complicating disease)
CL Item
Alternative Therapy (Alternative therapy)
CL Item
Patient Withdrawal Or Refusal Prior To Beginning Protocol Therapy (Patient withdrawal or refusal prior to beginning protocol therapy)
CL Item
Other (Other, specify)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
OffTreatmentReason,Other
Item
Other, specify (reason treatment ended)
string
CL436968 (UMLS CUI)
Item Group
Treatment Schedule - Systemic Therapy
Item
Were there any dose modifications or additions/ omissions to protocol treatment? (mark one with an X)
text
CL.3
Code List
Were there any dose modifications or additions/ omissions to protocol treatment? (mark one with an X)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
(i.e., The Treatment Was Changed According To Protocol Guidelines) (Yes, planned)
CL Item
(i.e., The Treatment Change Was Not Part Of Protocol Guidelines) (Yes, unplanned)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item Group
Treatment Schedule - Other Therapy
Item
Were any optional protocol therapies given?
string
C1707479 (UMLS CUI)
CL.4
Code List
Were any optional protocol therapies given?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
OptionalProtocolTherapyName
Item
optional protocol therapy name(s)
string
C1707479 (UMLS CUI)
Item
Was any concurrent non-protocol therapy given during protocol treatment?
string
C1707479 (UMLS CUI)
CL.5
Code List
Was any concurrent non-protocol therapy given during protocol treatment?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
indicate below (concurrent non-protocol therapy given during protocol treatment) (mark all that apply with an X)
string
C1707479 (UMLS CUI)
CL.6
Code List
indicate below (concurrent non-protocol therapy given during protocol treatment) (mark all that apply with an X)
CL Item
Concurrent Non-protocol Chemotherapy (Concurrent non-protocol chemotherapy)
CL Item
Concurrent Non-protocol Hormonal Therapy (Concurrent non-protocol hormonal therapy)
CL Item
Concurrent Non-protocol Biologic Response Modifier Therapy (Concurrent non-protocol biologic response modifier therapy)
CL Item
Concurrent Non-protocol Radiation Therapy (Concurrent non-protocol radiation therapy)
CL Item
Concurrent Non-protocol High Dose Chemotherapy/autologous Stem Cell Transplant (Concurrent non-protocol high dose chemotherapy/ autologous stem cell transplant)
Item Group
Comments
Comments
Item
Comments
string
C0947611 (UMLS CUI)
Item Group
Signature
PersonCompletingForm,FirstName
Item
Completed By (Print or Type Name)
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
FormCompletionDate,Original
Item
Date Completed
date
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