ID

10615

Description

CALGB: 49903 Advanced Disease On-study 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=A73D2625-44FB-4784-E034-0003BA0B1A09

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A73D2625-44FB-4784-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 Disease On-study 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

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

Menopausal status (mark one with an X)
Description

MenopausalStatus

Data type

text

Advanced Disease Description
Description

Advanced Disease Description

ER status (mark one with an X)
Description

ERStatus

Data type

text

other, specify (timing of ER assay)
Description

ERTiming,Other

Data type

text

PgR status (mark one with an X)
Description

PgRStatus

Data type

text

Timing of ER assay
Description

ReceptorStatusTiming

Data type

text

Timing of ER assay
Description

ReceptorStatusTiming

Data type

text

other, specify (timing of ER assay)
Description

PgRTiming,Other

Data type

text

date of initial diagnosis of primary tumor
Description

FirstPositiveBiopsyDate

Data type

date

date progressive or metastatic disease first diagnosed
Description

RecurrenceDate

Data type

date

Sites Of Progression
Description

Sites Of Progression

Progression site(s) (mark all that apply with an X)
Description

ProgressionSite

Data type

text

other, specify (progression site)
Description

ProgressionSite,Other

Data type

text

Prior systemic therapy
Description

Priorsystemictherapy

Data type

text

Prior Treatment Regimen Name(s)
Description

PriorTreatmentRegimenName(s)

Data type

text

Prior Treatment Regimen Start Date
Description

PriorTreatmentRegimenBeginDate

Data type

date

Prior Treatment Regimen End Date
Description

PriorTreatmentRegimenEndDate

Data type

date

Prior Treatment Regimen Type (adjuvant/advanced)
Description

PriorTreatmentRegimenType

Data type

text

Laboratory
Description

Laboratory

Granulocytes
Description

Lab,Hematology,GranulocyteCount

Data type

double

Total bilirubin (mg/dl)
Description

Lab,Hepatic,Bilirubin

Data type

double

Creatinine (mg/dl)
Description

Lab,Renal,Creatinine

Data type

double

Platelet count
Description

Lab,Hematology,Platelets

Data type

double

Bilirubin upper limit of institutional laboratory normal (mg/dl)
Description

Bilirubin(mg/dl),ULN

Data type

double

Alias
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25706
UMLS 2011AA ValueDomain
C1519815
% LVEF
Description

Lab,Cardiovascular,LVEF

Data type

text

Alkaline phosphatase (U/mL)
Description

Lab,Hepatic,AlkalinePhosphatase

Data type

double

SGOT (U/mL)
Description

Lab,Hepatic,SGOT

Data type

double

SGPT (U/mL)
Description

Lab,Hepatic,SGPT

Data type

double

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

% Lower limit of institutional normal LVEF
Description

%LowerlimitofinstitutionalnormalLVEF

Data type

text

Ccrr Module For Calgb: 49903 Advanced Disease On-study Form
Description

Ccrr Module For Calgb: 49903 Advanced Disease On-study 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
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
Menopausal status (mark one with an X)
text
CL.2
Code List
Menopausal status (mark one with an X)
CL Item
Pre (<6 Mo Since Lmp And No Prior Bilateral Ovariectomy And Not On Estrogen Replacement) (Pre)
CL Item
Post (prior Bilateral Ovariectomy Or >12 Mo Since Lmp With No Prior Hysterectomy) (Post)
CL Item
Above Categories Not Applicable And Age < 50 (Above categories not applicable AND age < 50)
CL Item
Above Categories Not Applicable And Age => 50 (Above categories not applicable AND age >= 50)
Item Group
Advanced Disease Description
Item
ER status (mark one with an X)
text
CL.3
Code List
ER status (mark one with an X)
CL Item
Negative (negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Positive (positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
CL Item
Unknown (unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
ERTiming,Other
Item
other, specify (timing of ER assay)
text
Item
PgR status (mark one with an X)
text
CL.5
Code List
PgR status (mark one with an X)
CL Item
Negative (negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Positive (positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
CL Item
Unknown (unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Timing of ER assay
text
CL.6
Code List
Timing of ER assay
CL Item
Initial Diagnosis (initial diagnosis)
CL Item
At Recurrence (at recurrence)
CL Item
Other (other, specify)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
Item
Timing of ER assay
text
CL.6
Code List
Timing of ER assay
CL Item
Initial Diagnosis (initial diagnosis)
CL Item
At Recurrence (at recurrence)
CL Item
Other (other, specify)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
PgRTiming,Other
Item
other, specify (timing of ER assay)
text
FirstPositiveBiopsyDate
Item
date of initial diagnosis of primary tumor
date
RecurrenceDate
Item
date progressive or metastatic disease first diagnosed
date
Item Group
Sites Of Progression
Item
Progression site(s) (mark all that apply with an X)
text
CL.7
Code List
Progression site(s) (mark all that apply with an X)
CL Item
Local-regional (including Ipsilateral Breast; Chest Wall; Axillary, Internal Mammary, And Infraclavicular Nodes; Local-regional Skin And Subcutaneous Tissue) (local-regional)
CL Item
Ipsilateral Supraclavicular Nodes (ipsilateral supraclavicular nodes)
CL Item
Opposite Breast (opposite breast)
CL Item
Distant Nodes (distant nodes)
CL Item
Distant Skin/subcutaneous Tissue (distant skin/subcutaneous tissue)
CL Item
Bone (bone)
C12366 (NCI Thesaurus)
C0262950 (UMLS 2011AA)
CL Item
Bone Marrow (bone marrow)
C12431 (NCI Thesaurus)
C0005953 (UMLS 2011AA)
CL Item
Lung (lung)
C12468 (NCI Thesaurus)
C0024109 (UMLS 2011AA)
CL Item
Liver (liver)
C12392 (NCI Thesaurus)
C0023884 (UMLS 2011AA)
CL Item
Pleura (pleura)
CL Item
Central Nervous System/brain (brain)
CL Item
Other Cns (other CNS)
CL Item
First Other, Specify (other, specify)
ProgressionSite,Other
Item
other, specify (progression site)
text
Item
Prior systemic therapy
text
CL.8
Code List
Prior systemic therapy
CL Item
Prior Adjuvant Hormonal Therapy (prior adjuvant hormonal therapy)
C16156 (NCI Thesaurus)
CL Item
Prior Hormonal Therapy For Metastatis Or Recurrence (prior hormonal therapy for metastatis or recurrence)
CL Item
Prior Adjuvant Chemotherapy (prior adjuvant chemotherapy)
C15564 (NCI Thesaurus)
C0281265 (UMLS 2011AA)
CL Item
Prior Chemotherapy For Metastatis Or Recurrence (prior chemotherapy for metastatis or recurrence)
CL Item
Prior Adjuvant High Dose Chemotherapy/autologous Stem Cell Transplant (prior adjuvant high dose chemotherapy/autologous stem cell transplant)
CL Item
Prior Hdc/assct For Metastasis Or Recurrence (prior HDC/ASSCT for metastasis or recurrence)
CL Item
Prior Adjuvant Immunotherapy (prior adjuvant immunotherapy)
C16157 (NCI Thesaurus)
C1514455 (UMLS 2011AA)
CL Item
Prior Immunotherapy For Metastasis Or Recurrence (prior immunotherapy for metastasis or recurrence)
CL Item
Prior Adjuvant Other Therapy (prior adjuvant other therapy)
C16158 (NCI Thesaurus)
C1514456 (UMLS 2011AA)
CL Item
Prior Other Therapy For Metastasis Or Recurrence (prior other therapy for metastasis or recurrence)
PriorTreatmentRegimenName(s)
Item
Prior Treatment Regimen Name(s)
text
PriorTreatmentRegimenBeginDate
Item
Prior Treatment Regimen Start Date
date
PriorTreatmentRegimenEndDate
Item
Prior Treatment Regimen End Date
date
PriorTreatmentRegimenType
Item
Prior Treatment Regimen Type (adjuvant/advanced)
text
Item Group
Laboratory
Lab,Hematology,GranulocyteCount
Item
Granulocytes
double
Lab,Hepatic,Bilirubin
Item
Total bilirubin (mg/dl)
double
Lab,Renal,Creatinine
Item
Creatinine (mg/dl)
double
Lab,Hematology,Platelets
Item
Platelet count
double
Bilirubin(mg/dl),ULN
Item
Bilirubin upper limit of institutional laboratory normal (mg/dl)
double
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
Lab,Cardiovascular,LVEF
Item
% LVEF
text
Lab,Hepatic,AlkalinePhosphatase
Item
Alkaline phosphatase (U/mL)
double
Lab,Hepatic,SGOT
Item
SGOT (U/mL)
double
Lab,Hepatic,SGPT
Item
SGPT (U/mL)
double
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
%LowerlimitofinstitutionalnormalLVEF
Item
% Lower limit of institutional normal LVEF
text
Item Group
Ccrr Module For Calgb: 49903 Advanced Disease On-study Form
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