ID

10616

Description

CALGB: 49903 ADVANCED FOLLOW-UP FORM NCT00053339 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=A73D2007-5070-476F-E034-0003BA0B1A09

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A73D2007-5070-476F-E034-0003BA0B1A09

Keywords

Versions (3)
  1. 8/26/12 8/26/12 -
  2. 5/22/15 5/22/15 -
  3. 6/3/15 6/3/15 -
Uploaded on

June 3, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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CALGB: 49903 ADVANCED FOLLOW-UP FORM NCT00053339

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  
CALGB Information
Description

CALGB Information

CALGB Form
Description

CALGBForm

Data type

text

CALGB Study No
Description

CALGBStudyNo

Data type

text

CALGB Patient ID
Description

CALGBPatientID

Data type

text

From
Description

IntervalReportFromDate

Data type

date

To (M)
Description

IntervalReportToDate

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
Patient clinical trial data
Description

Patient clinical trial data

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

Cancer follow up
Description

Cancer follow up

Vital Status (mark one with an X)
Description

Patient'sVitalStatus

Data type

text

cause of death (mark one with an X)
Description

DeathReason

Data type

text

Date of last contact or death (M)
Description

DeathDate/LastContactDate

Data type

date

Has patient had a documented clinical assessment for this cancer since submission of the previous follow-up form?
Description

CancerFollow-upStatusInd

Data type

text

Date of last clinical assessment (only provide date if assessment since submission of previous follow-up form)
Description

CancerFollow-upStatusDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Has the patient achieved a response? (mark one with an X)
Description

OverallTumorResponse

Data type

text

date response first documented (Notice of Progression)
Description

ResponseDurationBeginDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C25755
UMLS 2011AA ObjectClass
C0871261
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
Did the patient develop a first progression (or relapse) that has not been previously reported?
Description

ProgressionInd

Data type

text

Date of progression (M)
Description

ProgressionDate

Data type

date

Non-protocol Therapy
Description

Non-protocol Therapy

Is the patient receiving any non-protocol cancer therapy not previously reported?
Description

Non-ProtocolTherapyInd

Data type

text

Non-protocol therapy
Description

Non-ProtocolHormonalTherapyInd

Data type

text

other non-protocol therapy, specify name
Description

OtherNon-ProtocolTherapyName

Data type

text

Date of first non-protocol therapy
Description

Non-ProtocolTherapyDate,First

Data type

date

Date tamoxifen discontinued
Description

AgentEndDate

Data type

date

Comments
Description

Comments

Data type

text

Completed by
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 Follow-up Form
Description

Ccrr Module For Calgb: 49903 Advanced Follow-up Form

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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
CALGB Information
CALGBForm
Item
CALGB Form
text
CALGBStudyNo
Item
CALGB Study No
text
CALGBPatientID
Item
CALGB Patient ID
text
IntervalReportFromDate
Item
From
date
IntervalReportToDate
Item
To (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
Patient clinical trial data
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
Cancer follow up
Item
Vital Status (mark one with an X)
text
CL.2
Code List
Vital Status (mark one with an X)
CL Item
Alive (Alive)
CL Item
Dead (If dead)
CL Item
Lost (Lost)
Item
cause of death (mark one with an X)
text
CL.3
Code List
cause of death (mark one with an X)
CL Item
Due To This Disease (Due to this disease)
CL Item
Due To Protocol Treatment (Due to this protocol treatment)
CL Item
Due To Other Cause, Specify (Due to other cause)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
DeathDate/LastContactDate
Item
Date of last contact or death (M)
date
Item
Has patient had a documented clinical assessment for this cancer since submission of the previous follow-up form?
text
CL.4
Code List
Has patient had a documented clinical assessment for this cancer since submission of the previous follow-up form?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CancerFollow-upStatusDate
Item
Date of last clinical assessment (only provide date if assessment since submission of previous follow-up form)
date
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Item
Has the patient achieved a response? (mark one with an X)
text
CL.5
Code List
Has the patient achieved a response? (mark one with an X)
CL Item
Complete Response (complete response (CR))
CL Item
Partial Response (partial response (PR))
C18212 (NCI Thesaurus)
CL Item
Stable Disease (stable disease (SD))
C18213 (NCI Thesaurus)
C0677946 (UMLS 2011AA)
CL Item
Partial Response (progressive disease (PD))
C18212 (NCI Thesaurus)
CL Item
Insufficient Evaluation (insufficient evaluation to determine response status)
ResponseDurationBeginDate
Item
date response first documented (Notice of Progression)
date
C25755 (NCI Thesaurus ObjectClass)
C0871261 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
Item
Did the patient develop a first progression (or relapse) that has not been previously reported?
text
CL.6
Code List
Did the patient develop a first progression (or relapse) that has not been previously reported?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
ProgressionDate
Item
Date of progression (M)
date
Item Group
Non-protocol Therapy
Item
Is the patient receiving any non-protocol cancer therapy not previously reported?
text
CL.7
Code List
Is the patient receiving any non-protocol cancer therapy not previously reported?
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Non-protocol therapy
text
CL.8
Code List
Non-protocol therapy
CL Item
non-protocol hormonal therapy (non-protocol hormonal therapy)
CL Item
non-protocol surgery (non-protocol surgery)
CL Item
non-protocol radiation therapy (non-protocol radiation therapy)
CL Item
other non-protocol therapy (other non-protocol therapy)
OtherNon-ProtocolTherapyName
Item
other non-protocol therapy, specify name
text
Non-ProtocolTherapyDate,First
Item
Date of first non-protocol therapy
date
AgentEndDate
Item
Date tamoxifen discontinued
date
Comments
Item
Comments
text
PersonCompletingForm,FirstName
Item
Completed by
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 Follow-up Form
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