ID

4703

Beskrivning

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

Länk

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

Nyckelord

Versioner (2)
  1. 2012-08-26 2012-08-26 -
  2. 2014-03-20 2014-03-20 - Martin Dugas
Uppladdad den

20 mars 2014

DOI

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Licens

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

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. 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 Formulär  
Header
Beskrivning

Header

CALGB Form
Beskrivning

CALGBForm

Datatyp

text

CALGB Study No
Beskrivning

CALGBStudyNo

Datatyp

text

CALGB Patient ID
Beskrivning

CALGBPatientID

Datatyp

text

First date protocol therapy was given
Beskrivning

TreatmentBeginDate

Datatyp

date

Last date protocol therapy was given (M)
Beskrivning

TreatmentEndDate

Datatyp

date

Amended data?
Beskrivning

AmendedDataInd

Datatyp

text

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

IDs

Patient's Name
Beskrivning

Patient Name

Datatyp

string

Alias
UMLS CUI
C1299487
Participating Group
Beskrivning

ParticipatingGroup

Datatyp

text

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

PatientHospitalNumber

Datatyp

text

Participating Group Protocol No.
Beskrivning

ParticipatingGroupProtocolNo.

Datatyp

text

Main Member Institution/Adjunct
Beskrivning

AffiliateName

Datatyp

text

Participating Group Patient No.
Beskrivning

ParticipatingGroupPatientID

Datatyp

text

Treatment Cycle Information
Beskrivning

Treatment Cycle Information

Total Dose of Drugs for this Regimen [mg]
Beskrivning

Drug dose

Datatyp

float

Alias
UMLS CUI
C0678766
Agent Name
Beskrivning

Agent

Datatyp

string

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

OffTreatmentReason

Datatyp

string

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

OffTreatmentReason,Other

Datatyp

string

Alias
UMLS CUI
CL436968
Treatment Schedule - Systemic Therapy
Beskrivning

Treatment Schedule - Systemic Therapy

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

DoseModification(Change)

Datatyp

text

Treatment Schedule - Other Therapy
Beskrivning

Treatment Schedule - Other Therapy

Were any optional protocol therapies given?
Beskrivning

OptionalProtocolTherapyInd

Datatyp

string

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

OptionalProtocolTherapyName

Datatyp

string

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

ConcurrentNon-ProtocolTherapyInd

Datatyp

string

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

Concomitant Therapy

Datatyp

string

Alias
UMLS CUI
C1707479
Comments
Beskrivning

Comments

Comments
Beskrivning

Comments

Datatyp

string

Alias
UMLS CUI
C0947611
Signature
Beskrivning

Signature

Completed By (Print or Type Name)
Beskrivning

PersonCompletingForm,FirstName

Datatyp

text

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

FormCompletionDate,Original

Datatyp

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