ID

9402

Description

OFF TREATMENT FORM (OPT) Quality Of Life Companion Study For JMA27 (NCIC-MA.27): A Randomized Phase III Trial Of Exemestane Versus Anastrozole With Or Without Celecoxib In Postmenopausal Women With Receptor Positive Primary Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=ABE19FE8-ADA4-53BD-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=ABE19FE8-ADA4-53BD-E034-0003BA12F5E7

Keywords

Versions (2)
  1. 8/26/12 8/26/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
Uploaded on

January 9, 2015

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0 Legacy
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Breast Cancer NCT00090974 Off Treatment - OFF TREATMENT FORM (OPT) - 2058934v3.0

English

Canadian Centres: When completed please mail to: National Cancer Institute of Canada, Clinical Trials Group, Queen's University, 82-84 Barrie Street, Kingston, Ontario, K7L 3N6

1 forms  
Patient Information
Description

Patient Information

Patient Study ID, Coordinating Group
Description

PatientStudyID,CoordinatingGroup

Data type

text

Patient Initials (first - middle - last)
Description

Patient Initials

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Patient Medical Record Number
Description

PatientMedicalRecordNumber

Data type

text

Investigator Name
Description

InvestigatorName

Data type

text

Institution Name
Description

InstitutionName

Data type

text

Registered Investigator (NCI Investigator #)
Description

RegisteredInvestigator

Data type

text

Off Protocol Therapy
Description

Off Protocol Therapy

Treatment End Date (yyyy mmm dd)
Description

TreatmentEndDate

Data type

date

Reason treatment ended (both components of study)
Description

OffTreatmentReason

Data type

text

Other specify (Reason treatment ended)
Description

OffTreatmentReason,Other

Data type

text

CTC Adverse Event Term
Description

CTCAdverseEventTerm

Data type

text

CTC Adverse Event Category
Description

CTCAdverseEventCategory

Data type

text

CTC Adverse Event Grade (Grade according to NCI Common Toxicity Criteria, Version 2.0)
Description

CTCAdverseEventGrade

Data type

text

CTC Adverse Event Attribution Code
Description

CTCAdverseEventAttributionCode

Data type

text

Unblinding
Description

Unblinding

Was study treatment unblinded?
Description

TreatmentUnblindingIndicator

Data type

boolean

Date study treatment unblinded (yyyy mmm dd)
Description

TreatmentUnblindedDate

Data type

text

Header
Description

Header

Patient Study ID, Coordinating Group
Description

PatientStudyID,CoordinatingGroup

Data type

text

Patient Initials (first - middle - last)
Description

Patient Initials

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Comments
Description

Comments

COMMENTS
Description

Comments

Data type

text

Investigator Signature
Description

Investigator Signature

Investigator Signature
Description

InvestigatorSignature

Data type

text

Alias
NCI Thesaurus Property
C25678
UMLS 2011AA Property
C1519316
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173
Person Completing Form, Last Name
Description

PersonCompletingForm,LastName

Data type

text

Person Completing Form, First Name
Description

PersonCompletingForm,FirstName

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Form Completion Date, Original (yyyy mmm dd)
Description

FormCompletionDate,Original

Data type

date

Ccrr Module For Off Treatment Form (opt)
Description

Ccrr Module For Off Treatment Form (opt)

Back to the top of the page

Similar models

Canadian Centres: When completed please mail to: National Cancer Institute of Canada, Clinical Trials Group, Queen's University, 82-84 Barrie Street, Kingston, Ontario, K7L 3N6

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Patient Information
PatientStudyID,CoordinatingGroup
Item
Patient Study ID, Coordinating Group
text
Patient Initials
Item
Patient Initials (first - middle - last)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
PatientMedicalRecordNumber
Item
Patient Medical Record Number
text
InvestigatorName
Item
Investigator Name
text
InstitutionName
Item
Institution Name
text
RegisteredInvestigator
Item
Registered Investigator (NCI Investigator #)
text
Item Group
Off Protocol Therapy
TreatmentEndDate
Item
Treatment End Date (yyyy mmm dd)
date
Item
Reason treatment ended (both components of study)
text
CL.1
Code List
Reason treatment ended (both components of study)
CL Item
Disease Progression, Relapse During Active Treatment (Disease progression, relapse during active treatment)
CL Item
Patient Off-treatment For Other Complicating Disease (Patient off treatment for other complicating disease)
CL Item
Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
CL Item
Toxicity/side Effects/complications (Toxicity/side effects/complications)
CL Item
Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient withdrawal or refusal after beginning protocol therapy)
CL Item
Patient Withdrawal Or Refusal Prior To Beginning Protocol Therapy (Patient withdrawal or refusal prior to beginning protocol therapy)
CL Item
Death On Study (Death on-study)
CL Item
Other, Specify (Other specify)
OffTreatmentReason,Other
Item
Other specify (Reason treatment ended)
text
CTCAdverseEventTerm
Item
CTC Adverse Event Term
text
CTCAdverseEventCategory
Item
CTC Adverse Event Category
text
CTCAdverseEventGrade
Item
CTC Adverse Event Grade (Grade according to NCI Common Toxicity Criteria, Version 2.0)
text
Item
CTC Adverse Event Attribution Code
text
CL.2
Code List
CTC Adverse Event Attribution Code
CL Item
Unrelated (unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
CL Item
Unlikely (unlikely)
CL Item
Possibly (possible)
CL Item
Probably (probable)
CL Item
Definitely (definite)
Item Group
Unblinding
TreatmentUnblindingIndicator
Item
Was study treatment unblinded?
boolean
TreatmentUnblindedDate
Item
Date study treatment unblinded (yyyy mmm dd)
text
Item Group
Header
PatientStudyID,CoordinatingGroup
Item
Patient Study ID, Coordinating Group
text
Patient Initials
Item
Patient Initials (first - middle - last)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Item Group
Comments
Comments
Item
COMMENTS
text
Item Group
Investigator Signature
InvestigatorSignature
Item
Investigator Signature
text
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
PersonCompletingForm,LastName
Item
Person Completing Form, Last Name
text
PersonCompletingForm,FirstName
Item
Person Completing Form, First Name
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
FormCompletionDate,Original
Item
Form Completion Date, Original (yyyy mmm dd)
date
Item Group
Ccrr Module For Off Treatment Form (opt)
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial