ID

10626

Descripción

CALGB: 49808 ADVERSE EVENT FORM DOXORUBICIN + CYCLOPHOSPHAMIDE + ZINECARD (AC+Z) NCT00016276 Combination Chemotherapy, Surgery, and Radiation Therapy With or Without Dexrazoxane and Trastuzumab in Treating Women With Stage III or Stage IV Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9E35395C-8D28-227A-E034-080020C9C0E0

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9E35395C-8D28-227A-E034-080020C9C0E0

Palabras clave

Versiones (4)
  1. 26/8/12 26/8/12 -
  2. 22/5/15 22/5/15 -
  3. 3/6/15 3/6/15 -
  4. 3/6/15 3/6/15 -
Subido en

3 de junio de 2015

DOI

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Licencia

Creative Commons BY-NC 3.0 Legacy
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CALGB: 49808 ADVERSE EVENT FORM DOXORUBICIN + CYCLOPHOSPHAMIDE + ZINECARD (AC+Z) NCT00016276

Inglés

No Instruction available.

1 formularios  
  1. StudyEvent: CALGB: 49808 ADVERSE EVENT FORM DOXORUBICIN + CYCLOPHOSPHAMIDE + ZINECARD (AC+Z)
    1. No Instruction available.
CALGB clinical trial administrative data
Descripción

CALGB clinical trial administrative data

CALGB Form
Descripción

CALGBForm

Tipo de datos

text

CALGB Study No
Descripción

CALGBProtocolNumber

Tipo de datos

text

CALGB Patient ID
Descripción

CALGBPatientID

Tipo de datos

text

From
Descripción

From

Tipo de datos

text

To
Descripción

To

Tipo de datos

text

Amended data?
Descripción

AmendedDataInd

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C25416
UMLS 2011AA Property
C1691222
Patient clinical trial data
Descripción

Patient clinical trial data

Patient's Name
Descripción

Patient'sName

Tipo de datos

text

Participating Group
Descripción

ParticipatingGroup

Tipo de datos

text

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

PatientHospitalNumber

Tipo de datos

text

Participating Group Protocol No.
Descripción

ParticipatingGroupProtocolNo.

Tipo de datos

text

Main Member Institution/Adjunct
Descripción

MainMemberInstitution/Adjunct

Tipo de datos

text

Participating Group Patient No.
Descripción

ParticipatingGroupPatientNo.

Tipo de datos

text

Was an AER/ADR filed with Central Office based on an event reported below? (see section 16.0 of the protocol)
Descripción

WasanAER/ADRfiledwithCentralOfficebasedonaneventreportedbelow?

Tipo de datos

text

Expected Adverse Events
Descripción

Expected Adverse Events

IMT Code
Descripción

IMTCode

Tipo de datos

text

CTC Adverse Event Term
Descripción

CTCAdverseEventTerm

Tipo de datos

text

CTC Grade
Descripción

CTCGrade

Tipo de datos

text

Attribution
Descripción

Attribution

Tipo de datos

text

CTC Adverse Event Term, Specify
Descripción

CTCAdverseEventTerm,Specify

Tipo de datos

text

Were any other events (Hematologic grade 4-5 only or Non-Hematologic grade 3-5 only) noted during this time period?
Descripción

Wereanyotherevents(Hematologicgrade4-5onlyorNon-Hematologicgrade3-5only)notedduringthistimeperiod?

Tipo de datos

text

Completed By
Descripción

CompletedBy

Tipo de datos

text

Date Completed
Descripción

DateCompleted

Tipo de datos

date

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Similar models

No Instruction available.

1 formularios
  1. StudyEvent: CALGB: 49808 ADVERSE EVENT FORM DOXORUBICIN + CYCLOPHOSPHAMIDE + ZINECARD (AC+Z)
    1. No Instruction available.
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
CALGB clinical trial administrative data
CALGBForm
Item
CALGB Form
text
CALGBProtocolNumber
Item
CALGB Study No
text
CALGBPatientID
Item
CALGB Patient ID
text
From
Item
From
text
To
Item
To
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
MainMemberInstitution/Adjunct
Item
Main Member Institution/Adjunct
text
ParticipatingGroupPatientNo.
Item
Participating Group Patient No.
text
Item
Was an AER/ADR filed with Central Office based on an event reported below? (see section 16.0 of the protocol)
text
CL.2
Code List
Was an AER/ADR filed with Central Office based on an event reported below? (see section 16.0 of the protocol)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Expected Adverse Events
IMTCode
Item
IMT Code
text
CTCAdverseEventTerm
Item
CTC Adverse Event Term
text
CTCGrade
Item
CTC Grade
text
Item
Attribution
text
CL.3
Code List
Attribution
CL Item
Unrelated To Treatment (unrelated to treatment)
CL Item
Unlikely To Be Related To Treatment (unlikely to be related to treatment)
CL Item
Possibly Related To Treatment (possibly related to treatment)
CL Item
Probably Related To Treatment (probably related to treatment)
CL Item
Definitely Related To Treatment (definitely related to treatment)
CTCAdverseEventTerm,Specify
Item
CTC Adverse Event Term, Specify
text
Item
Were any other events (Hematologic grade 4-5 only or Non-Hematologic grade 3-5 only) noted during this time period?
text
CL.4
Code List
Were any other events (Hematologic grade 4-5 only or Non-Hematologic grade 3-5 only) noted during this time period?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes, Document Below (Yes, document below)
CompletedBy
Item
Completed By
text
DateCompleted
Item
Date Completed
date
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