ID

10626

Beskrivning

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

Länk

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

Nyckelord

  1. 2012-08-26 2012-08-26 -
  2. 2015-05-22 2015-05-22 -
  3. 2015-06-03 2015-06-03 -
  4. 2015-06-03 2015-06-03 -
Uppladdad den

3 juni 2015

DOI

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Licens

Creative Commons BY-NC 3.0 Legacy

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CALGB: 49808 ADVERSE EVENT FORM DOXORUBICIN + CYCLOPHOSPHAMIDE + ZINECARD (AC+Z) NCT00016276

No Instruction available.

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

CALGB clinical trial administrative data

CALGB Form
Beskrivning

CALGBForm

Datatyp

text

CALGB Study No
Beskrivning

CALGBProtocolNumber

Datatyp

text

CALGB Patient ID
Beskrivning

CALGBPatientID

Datatyp

text

From
Beskrivning

From

Datatyp

text

To
Beskrivning

To

Datatyp

text

Amended data?
Beskrivning

AmendedDataInd

Datatyp

text

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

Patient clinical trial data

Patient's Name
Beskrivning

Patient'sName

Datatyp

text

Participating Group
Beskrivning

ParticipatingGroup

Datatyp

text

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

PatientHospitalNumber

Datatyp

text

Participating Group Protocol No.
Beskrivning

ParticipatingGroupProtocolNo.

Datatyp

text

Main Member Institution/Adjunct
Beskrivning

MainMemberInstitution/Adjunct

Datatyp

text

Participating Group Patient No.
Beskrivning

ParticipatingGroupPatientNo.

Datatyp

text

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

WasanAER/ADRfiledwithCentralOfficebasedonaneventreportedbelow?

Datatyp

text

Expected Adverse Events
Beskrivning

Expected Adverse Events

IMT Code
Beskrivning

IMTCode

Datatyp

text

CTC Adverse Event Term
Beskrivning

CTCAdverseEventTerm

Datatyp

text

CTC Grade
Beskrivning

CTCGrade

Datatyp

text

Attribution
Beskrivning

Attribution

Datatyp

text

CTC Adverse Event Term, Specify
Beskrivning

CTCAdverseEventTerm,Specify

Datatyp

text

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

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

Datatyp

text

Completed By
Beskrivning

CompletedBy

Datatyp

text

Date Completed
Beskrivning

DateCompleted

Datatyp

date

Similar models

No Instruction available.

  1. StudyEvent: CALGB: 49808 ADVERSE EVENT FORM DOXORUBICIN + CYCLOPHOSPHAMIDE + ZINECARD (AC+Z)
    1. No Instruction available.
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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)
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
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
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
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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