ID

817

Beskrivning

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

Länk

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

Nyckelord

Versioner (2)
  1. 2012-08-26 2012-08-26 -
  2. 2015-01-09 2015-01-09 - Martin Dugas
Uppladdad den

26 augusti 2012

DOI

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Licens

Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT00090974 Off Treatment - OFF TREATMENT FORM (OPT) - 2058934v3.0

Engelsk

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 Formulär  
Patient Information
Beskrivning

Patient Information

Patient Study ID, Coordinating Group
Beskrivning

PatientStudyID,CoordinatingGroup

Datatyp

text

Patient Initials (first - middle - last)
Beskrivning

PatientInitialsName

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
Patient Medical Record Number
Beskrivning

PatientMedicalRecordNumber

Datatyp

text

Investigator Name
Beskrivning

InvestigatorName

Datatyp

text

Institution Name
Beskrivning

InstitutionName

Datatyp

text

Registered Investigator (NCI Investigator #)
Beskrivning

RegisteredInvestigator

Datatyp

text

Off Protocol Therapy
Beskrivning

Off Protocol Therapy

Treatment End Date (yyyy mmm dd)
Beskrivning

TreatmentEndDate

Datatyp

date

Reason treatment ended (both components of study)
Beskrivning

OffTreatmentReason

Datatyp

text

Other specify (Reason treatment ended)
Beskrivning

OffTreatmentReason,Other

Datatyp

text

CTC Adverse Event Term
Beskrivning

CTCAdverseEventTerm

Datatyp

text

CTC Adverse Event Category
Beskrivning

CTCAdverseEventCategory

Datatyp

text

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

CTCAdverseEventGrade

Datatyp

text

CTC Adverse Event Attribution Code
Beskrivning

CTCAdverseEventAttributionCode

Datatyp

text

Unblinding
Beskrivning

Unblinding

Was study treatment unblinded?
Beskrivning

TreatmentUnblindingIndicator

Datatyp

text

Date study treatment unblinded (yyyy mmm dd)
Beskrivning

TreatmentUnblindedDate

Datatyp

text

Unnamed1
Beskrivning

Unnamed1

Patient Study ID, Coordinating Group
Beskrivning

PatientStudyID,CoordinatingGroup

Datatyp

text

Patient Initials (first - middle - last)
Beskrivning

PatientInitialsName

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
Comments
Beskrivning

Comments

COMMENTS
Beskrivning

Comments

Datatyp

text

Investigator Signature
Beskrivning

Investigator Signature

Investigator Signature
Beskrivning

InvestigatorSignature

Datatyp

text

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

PersonCompletingForm,LastName

Datatyp

text

Person Completing Form, First Name
Beskrivning

PersonCompletingForm,FirstName

Datatyp

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)
Beskrivning

FormCompletionDate,Original

Datatyp

date

Ccrr Module For Off Treatment Form (opt)
Beskrivning

Ccrr Module For Off Treatment Form (opt)

Tillbaka till toppen

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 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Patient Information
PatientStudyID,CoordinatingGroup
Item
Patient Study ID, Coordinating Group
text
PatientInitialsName
Item
Patient Initials (first - middle - last)
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA 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
Item
Was study treatment unblinded?
text
CL.3
Code List
Was study treatment unblinded?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
TreatmentUnblindedDate
Item
Date study treatment unblinded (yyyy mmm dd)
text
Item Group
Unnamed1
PatientStudyID,CoordinatingGroup
Item
Patient Study ID, Coordinating Group
text
PatientInitialsName
Item
Patient Initials (first - middle - last)
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA 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)
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