ID

768

Description

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

Keywords

Versions (2)
  1. 8/26/12 8/26/12 -
  2. 3/20/14 3/20/14 - Martin Dugas
Uploaded on

August 26, 2012

DOI

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License

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

English

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 forms  
Unnamed1
Description

Unnamed1

CALGB Form
Description

CALGBForm

Data type

text

CALGB Study No
Description

CALGBStudyNo

Data type

text

CALGB Patient ID
Description

CALGBPatientID

Data type

text

First date protocol therapy was given
Description

TreatmentBeginDate

Data type

date

Last date protocol therapy was given (M)
Description

TreatmentEndDate

Data type

date

Amended data?
Description

AmendedDataInd

Data type

text

Alias
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C25416
UMLS 2011AA Property
C1691222
Unnamed2
Description

Unnamed2

Patient's Name
Description

Patient'sName

Data type

text

Participating Group
Description

ParticipatingGroup

Data type

text

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

PatientHospitalNumber

Data type

text

Participating Group Protocol No.
Description

ParticipatingGroupProtocolNo.

Data type

text

Main Member Institution/Adjunct
Description

AffiliateName

Data type

text

Participating Group Patient No.
Description

ParticipatingGroupPatientID

Data type

text

Treatment Cycle Information
Description

Treatment Cycle Information

Total Dose of Drugs for this Regimen (mg)
Description

AgentTotalDose(percourse)

Data type

double

Agent Name
Description

AgentName

Data type

text

Reason Treatment Ended (mark one with an X)
Description

OffTreatmentReason

Data type

text

Other, specify (reason treatment ended)
Description

OffTreatmentReason,Other

Data type

text

Treatment Schedule - Systemic Therapy
Description

Treatment Schedule - Systemic Therapy

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

DoseModification(Change)

Data type

text

Treatment Schedule - Other Therapy
Description

Treatment Schedule - Other Therapy

Were any optional protocol therapies given?
Description

OptionalProtocolTherapyInd

Data type

text

optional protocol therapy name(s)
Description

OptionalProtocolTherapyName

Data type

text

Was any concurrent non-protocol therapy given during protocol treatment?
Description

ConcurrentNon-ProtocolTherapyInd

Data type

text

indicate below (concurrent non-protocol therapy given during protocol treatment) (mark all that apply with an X)
Description

indicatebelow(concurrentnon-protocoltherapygivenduringprotocoltreatment)

Data type

text

Comments
Description

Comments

Comments
Description

Comments

Data type

text

Unnamed5
Description

Unnamed5

Completed By (Print or Type Name)
Description

PersonCompletingForm,FirstName

Data type

text

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

FormCompletionDate,Original

Data type

date

Ccrr Module For Calgb: 49903 Advanced Treatment Summary Form; All Patients
Description

Ccrr Module For Calgb: 49903 Advanced Treatment Summary Form; All Patients

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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 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Unnamed1
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
Unnamed2
Patient'sName
Item
Patient's Name
text
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
AgentTotalDose(percourse)
Item
Total Dose of Drugs for this Regimen (mg)
double
AgentName
Item
Agent Name
text
Item
Reason Treatment Ended (mark one with an X)
text
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)
text
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?
text
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)
text
Item
Was any concurrent non-protocol therapy given during protocol treatment?
text
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)
text
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
text
Item Group
Unnamed5
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
Item Group
Ccrr Module For Calgb: 49903 Advanced Treatment Summary Form; All Patients
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