ID

768

Descrizione

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

collegamento

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

Keywords

versioni (2)
  1. 26/08/12 26/08/12 -
  2. 20/03/14 20/03/14 - Martin Dugas
Caricato su

26 agosto 2012

DOI

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Licenza

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

Inglese

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 moduli  
Unnamed1
Descrizione

Unnamed1

CALGB Form
Descrizione

CALGBForm

Tipo di dati

text

CALGB Study No
Descrizione

CALGBStudyNo

Tipo di dati

text

CALGB Patient ID
Descrizione

CALGBPatientID

Tipo di dati

text

First date protocol therapy was given
Descrizione

TreatmentBeginDate

Tipo di dati

date

Last date protocol therapy was given (M)
Descrizione

TreatmentEndDate

Tipo di dati

date

Amended data?
Descrizione

AmendedDataInd

Tipo di dati

text

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

Unnamed2

Patient's Name
Descrizione

Patient'sName

Tipo di dati

text

Participating Group
Descrizione

ParticipatingGroup

Tipo di dati

text

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

PatientHospitalNumber

Tipo di dati

text

Participating Group Protocol No.
Descrizione

ParticipatingGroupProtocolNo.

Tipo di dati

text

Main Member Institution/Adjunct
Descrizione

AffiliateName

Tipo di dati

text

Participating Group Patient No.
Descrizione

ParticipatingGroupPatientID

Tipo di dati

text

Treatment Cycle Information
Descrizione

Treatment Cycle Information

Total Dose of Drugs for this Regimen (mg)
Descrizione

AgentTotalDose(percourse)

Tipo di dati

double

Agent Name
Descrizione

AgentName

Tipo di dati

text

Reason Treatment Ended (mark one with an X)
Descrizione

OffTreatmentReason

Tipo di dati

text

Other, specify (reason treatment ended)
Descrizione

OffTreatmentReason,Other

Tipo di dati

text

Treatment Schedule - Systemic Therapy
Descrizione

Treatment Schedule - Systemic Therapy

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

DoseModification(Change)

Tipo di dati

text

Treatment Schedule - Other Therapy
Descrizione

Treatment Schedule - Other Therapy

Were any optional protocol therapies given?
Descrizione

OptionalProtocolTherapyInd

Tipo di dati

text

optional protocol therapy name(s)
Descrizione

OptionalProtocolTherapyName

Tipo di dati

text

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

ConcurrentNon-ProtocolTherapyInd

Tipo di dati

text

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

indicatebelow(concurrentnon-protocoltherapygivenduringprotocoltreatment)

Tipo di dati

text

Comments
Descrizione

Comments

Comments
Descrizione

Comments

Tipo di dati

text

Unnamed5
Descrizione

Unnamed5

Completed By (Print or Type Name)
Descrizione

PersonCompletingForm,FirstName

Tipo di dati

text

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

FormCompletionDate,Original

Tipo di dati

date

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

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 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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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