ID

10626

Beschreibung

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

Stichworte

Versionen (4)
  1. 26.08.12 26.08.12 -
  2. 22.05.15 22.05.15 -
  3. 03.06.15 03.06.15 -
  4. 03.06.15 03.06.15 -
Hochgeladen am

3. Juni 2015

DOI

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Lizenz

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

Englisch

No Instruction available.

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

CALGB clinical trial administrative data

CALGB Form
Beschreibung

CALGBForm

Datentyp

text

CALGB Study No
Beschreibung

CALGBProtocolNumber

Datentyp

text

CALGB Patient ID
Beschreibung

CALGBPatientID

Datentyp

text

From
Beschreibung

From

Datentyp

text

To
Beschreibung

To

Datentyp

text

Amended data?
Beschreibung

AmendedDataInd

Datentyp

text

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

Patient clinical trial data

Patient's Name
Beschreibung

Patient'sName

Datentyp

text

Participating Group
Beschreibung

ParticipatingGroup

Datentyp

text

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

PatientHospitalNumber

Datentyp

text

Participating Group Protocol No.
Beschreibung

ParticipatingGroupProtocolNo.

Datentyp

text

Main Member Institution/Adjunct
Beschreibung

MainMemberInstitution/Adjunct

Datentyp

text

Participating Group Patient No.
Beschreibung

ParticipatingGroupPatientNo.

Datentyp

text

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

WasanAER/ADRfiledwithCentralOfficebasedonaneventreportedbelow?

Datentyp

text

Expected Adverse Events
Beschreibung

Expected Adverse Events

IMT Code
Beschreibung

IMTCode

Datentyp

text

CTC Adverse Event Term
Beschreibung

CTCAdverseEventTerm

Datentyp

text

CTC Grade
Beschreibung

CTCGrade

Datentyp

text

Attribution
Beschreibung

Attribution

Datentyp

text

CTC Adverse Event Term, Specify
Beschreibung

CTCAdverseEventTerm,Specify

Datentyp

text

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

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

Datentyp

text

Completed By
Beschreibung

CompletedBy

Datentyp

text

Date Completed
Beschreibung

DateCompleted

Datentyp

date

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Ähnliche Modelle

No Instruction available.

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