ID

1990

Beschrijving

CALGB: 10201 ADVERSE EVENT FORM Daunorubicin and Cytarabine With or Without Oblimersen in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=AD846683-4685-2F05-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=AD846683-4685-2F05-E034-0003BA12F5E7

Trefwoorden

Versies (2)
  1. 19-09-12 19-09-12 -
  2. 09-01-15 09-01-15 - Martin Dugas
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19 september 2012

DOI

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Creative Commons BY-NC 3.0 Legacy
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Leukemia NCT00085124 Toxicity - CALGB: 10201 ADVERSE EVENT FORM - 2070578v3.0

Engels

Instructions: Complete and submit thie form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink. Mark an X in the appropriate box for fields with a choice. Print text in capital letters. Avoid contact with the edges of the boxes. Cirlce amended items and check "Amended data" box to teh right. If submitting by mail, retain a copy for your records and send the original form for mazimum clarity in transmission and fax to 919-416-4990. If submistting electronically, click the Send button when you have completed the PDF version of the form.

1 Formulieren  
Calgb Form
Beschrijving

Calgb Form

CALGB Study No.
Beschrijving

CALGBProtocolNumber

Datatype

text

CALGB Patient ID
Beschrijving

CALGBPatientID

Datatype

text

From
Beschrijving

CTCAdverseEventReportBeginDate

Datatype

date

To (MM DD YYYY)
Beschrijving

CTCAdverseEventReportEndDate

Datatype

date

Are data Amended?
Beschrijving

AmendedDataInd

Datatype

text

Alias
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C25416
UMLS 2011AA Property
C1691222
Patient's Initials (Last, First, Middle)
Beschrijving

PatientInitialsName

Datatype

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
Participating Group
Beschrijving

ParticipatingGroup

Datatype

text

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

PatientHospitalNumber

Datatype

text

Participating Group Protocol No.
Beschrijving

ParticipatingGroupProtocolNo.

Datatype

text

Main Member Institution/Adjunct
Beschrijving

MainMemberInstitution/Affiliate

Datatype

text

Participating Group Patient No.
Beschrijving

ParticipatingGroupPatientID

Datatype

text

Current Course/Cycle No.
Beschrijving

CurrentCourseNumber

Datatype

double

Treatment Phase
Beschrijving

TreatmentPhase

Datatype

text

Was an AER/ADR filed with Central Office based on an event reported below?
Beschrijving

WasanAER/ADRfiledwithCentralOfficebasedonaneventreportedbelow?

Datatype

text

Expected Adverse Events
Beschrijving

Expected Adverse Events

MedDRA Code
Beschrijving

MedDRACode

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Metathesaurus ObjectClass
CL104089
MedDRA Code
Beschrijving

MedDRACode

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Metathesaurus ObjectClass
CL104089
CTC Adverse Event Term
Beschrijving

CTCAdverseEventTerm

Datatype

text

CTC Adverse Event Term
Beschrijving

CTCAdverseEventTerm

Datatype

text

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

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

Datatype

text

CTC Grade
Beschrijving

CTCAdverseEventGrade

Datatype

double

CTC Grade
Beschrijving

CTCAdverseEventGrade

Datatype

double

Attribution
Beschrijving

CTCAdverseEventAttributionCode

Datatype

text

Attribution
Beschrijving

CTCAdverseEventAttributionCode

Datatype

text

Completed by (Print or Type Name)
Beschrijving

CompletedBy

Datatype

text

Date Completed (MM DD YYYY)
Beschrijving

DateCompleted

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Ccrr Module For Calgb: 10201 Adverse Event Form
Beschrijving

Ccrr Module For Calgb: 10201 Adverse Event Form

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Similar models

Instructions: Complete and submit thie form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink. Mark an X in the appropriate box for fields with a choice. Print text in capital letters. Avoid contact with the edges of the boxes. Cirlce amended items and check "Amended data" box to teh right. If submitting by mail, retain a copy for your records and send the original form for mazimum clarity in transmission and fax to 919-416-4990. If submistting electronically, click the Send button when you have completed the PDF version of the form.

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Calgb Form
CALGBProtocolNumber
Item
CALGB Study No.
text
CALGBPatientID
Item
CALGB Patient ID
text
CTCAdverseEventReportBeginDate
Item
From
date
CTCAdverseEventReportEndDate
Item
To (MM DD YYYY)
date
Item
Are data Amended?
text
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
CL.1
Code List
Are data Amended?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
PatientInitialsName
Item
Patient's Initials (Last, First, Middle)
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)
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/Affiliate
Item
Main Member Institution/Adjunct
text
ParticipatingGroupPatientID
Item
Participating Group Patient No.
text
CurrentCourseNumber
Item
Current Course/Cycle No.
double
Item
Treatment Phase
text
CL.2
Code List
Treatment Phase
CL Item
Current Phase Of Leukemia Treatment For Patient Is Induction (Induction)
CL Item
Current Phase Of Leukemia Treatment For Patient Is Consolidation (Consolidation)
CL Item
Current Phase Of Leukemia Treatment For Patient Is Specified Other Phase (Other, specify)
Item
Was an AER/ADR filed with Central Office based on an event reported below?
text
CL.3
Code List
Was an AER/ADR filed with Central Office based on an event reported below?
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
MedDRACode
Item
MedDRA Code
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
CL104089 (NCI Metathesaurus ObjectClass)
MedDRACode
Item
MedDRA Code
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
CL104089 (NCI Metathesaurus ObjectClass)
CTCAdverseEventTerm
Item
CTC Adverse Event Term
text
CTCAdverseEventTerm
Item
CTC Adverse Event Term
text
Item
Were there any other events (Hematologic grade 4-5 only or Non-Hematologic grade 3-5 only) noted during this time period?
text
CL.5
Code List
Were there 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 (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CTCAdverseEventGrade
Item
CTC Grade
double
CTCAdverseEventGrade
Item
CTC Grade
double
Item
Attribution
text
CL.6
Code List
Attribution
CL Item
Unrelated (unrelated to treatment)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
CL Item
Unlikely (unlikely to be related to treatment)
CL Item
Possible (possibly related to treatment)
C0332149 (NCI Metathesaurus)
CL Item
Probable (probably related to treatment)
C0332148 (NCI Metathesaurus)
CL Item
Definite (definitely related to treatment)
Item
Attribution
text
CL.6
Code List
Attribution
CL Item
Unrelated (unrelated to treatment)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
CL Item
Unlikely (unlikely to be related to treatment)
CL Item
Possible (possibly related to treatment)
C0332149 (NCI Metathesaurus)
CL Item
Probable (probably related to treatment)
C0332148 (NCI Metathesaurus)
CL Item
Definite (definitely related to treatment)
CompletedBy
Item
Completed by (Print or Type Name)
text
DateCompleted
Item
Date Completed (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item Group
Ccrr Module For Calgb: 10201 Adverse Event Form
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