ID

9197

Description

CALGB: 10201 FOLLOW-UP 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=AD85E4FA-DE35-3551-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=AD85E4FA-DE35-3551-E034-0003BA12F5E7

Keywords

Versions (2)
  1. 9/19/12 9/19/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
Uploaded on

January 9, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Leukemia NCT00085124 Follow-Up - CALGB: 10201 FOLLOW-UP FORM - 2031846v3.0

English

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1 forms  
  1. StudyEvent: CALGB: 10201 FOLLOW-UP FORM
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Calgb Form
Description

Calgb Form

CALGB Study No.
Description

CALGBProtocolNumber

Data type

text

CALGB Patient ID
Description

CALGBPatientID

Data type

text

Reporting period Start Date
Description

IntervalReportFromDate

Data type

date

Reporting period End Date
Description

IntervalReportToDate

Data type

date

MM DD YYYY
Description

MMDDYYYY

Data type

text

Are data amended?
Description

AmendedDataInd

Data type

text

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

Patient Initials

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Participating Group
Description

ParticipatingGroup

Data type

text

Alias
NCI Thesaurus ObjectClass
C17005
UMLS 2011AA ObjectClass
C1257890
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Patient Hospital No.
Description

PatientHospitalNumber

Data type

text

Participating Group Protocol No.
Description

ParticipatingGroupProtocolNo.

Data type

text

Main Member Institution/Adjunct
Description

MainMemberInstitution/Affiliate

Data type

text

Participating Group Patient ID:
Description

ParticipatingGroupPatientID

Data type

text

Vital Status
Description

Vital Status

Patient's vital status
Description

Patient'sVitalStatus

Data type

text

Cause of Death (if dead)
Description

DeathReason

Data type

text

Describe Cause of Death
Description

DeathReason,Specify

Data type

text

Disease Follow-up Status
Description

Disease Follow-up Status

Has the patient had a documented clinical assessment for this cancer during this reporting period?
Description

CancerFollow-upStatusInd

Data type

text

Date of last clinical assessment (mm dd yyyy)
Description

CancerFollow-upStatusDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Did the patient achieve a complete response according to clinical/hematologic criteria during this reporting period?
Description

CompleteResponseInd,Hematologic

Data type

text

date of complete response
Description

CRFirstObservedDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C25755
UMLS 2011AA ObjectClass
C0871261
NCI Thesaurus Property
C15722
UMLS 2011AA Property
C0700325
Notice Of Progression
Description

Notice Of Progression

Has the patient developed a first progression or relapse that has not been previously reported?
Description

ProgressionInd

Data type

text

Date of bone marrow relapse (mm dd yyyy)
Description

DiseaseBoneMarrowRelapseDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C18265
NCI Thesaurus Property-2
C12431
UMLS 2011AA Property
C0005953
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
Date of non-marrow relapse (mm dd yyyy)
Description

DiseaseNonBoneMarrowRelapseDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property
C18265
NCI Thesaurus Property-2
C25594
UMLS 2011AA Property
C1518422
NCI Thesaurus Property-3
C12431
UMLS 2011AA Property-2
C0005953
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Type of non-marrow relapse (mark all that apply with an X)
Description

DiseaseNonBoneMarrowRelapseType

Data type

text

Alias
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property
C18265
NCI Thesaurus Property-2
C25594
UMLS 2011AA Property
C1518422
NCI Thesaurus Property-3
C12431
UMLS 2011AA Property-2
C0005953
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Other, specify (Type of non-marrow relapse)
Description

DiseaseNonBoneMarrowRelapseSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property
C18265
NCI Thesaurus Property-2
C25594
UMLS 2011AA Property
C1518422
NCI Thesaurus Property-3
C12431
UMLS 2011AA Property-2
C0005953
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Recovery
Description

Recovery

Was the patient hospitalized other than for chemotherapy administration? (If yes, )
Description

Wasthepatienthospitalizedotherthanforchemotherapyadministration?

Data type

boolean

number of extra days hospitalized
Description

PatientHospitalizationDayCount

Data type

float

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ValueDomain
C25301
UMLS 2011AA ValueDomain
C0439228
NCI Thesaurus ValueDomain-2
C25463
UMLS 2011AA ValueDomain-2
C0750480
NCI Thesaurus Property
C25179
UMLS 2011AA Property
C0019993
Did the patient require IV antibiotics/antifungals (in or out patient)?
Description

DidthepatientrequireIVantibiotics/antifungals(inoroutpatient)?

Data type

boolean

Number of days on IV antibiotics/antifungals
Description

IntravenousTreatmentInfectionDayCount

Data type

float

Alias
NCI Thesaurus ObjectClass
C13346
UMLS 2011AA ObjectClass
C0348016
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus Property
C26726
UMLS 2011AA Property
C0009450
NCI Thesaurus ValueDomain
C25301
UMLS 2011AA ValueDomain
C0439228
NCI Thesaurus ValueDomain-2
C25463
UMLS 2011AA ValueDomain-2
C0750480
Did the patient require platlet transfusions?
Description

PlateletTransfusionRequirementInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C15366
UMLS 2011AA ObjectClass
C0086818
NCI Thesaurus Property
C38015
Did the patient require red blood cell (RBC) transfusions? (If yes, )
Description

PackedRedBloodCellTransfusionRequirementInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C15409
UMLS 2011AA ObjectClass
C0199962
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
number of units given
Description

PackedRedBloodCellTransfusionReceivedUnitCount

Data type

float

Alias
NCI Thesaurus ValueDomain
C44278
UMLS 2011AA ValueDomain
C0439148
NCI Thesaurus Property
C25639
UMLS 2011AA Property
C1514756
NCI Thesaurus ValueDomain-2
C25463
UMLS 2011AA ValueDomain-2
C0750480
NCI Thesaurus ObjectClass
C15409
UMLS 2011AA ObjectClass
C0199962
First date of ANC dropped below 500 (mm dd yyyy)
Description

FirstdateofANCdroppedbelow500

Data type

text

First date of ANC recovery over 500 (mm dd yyyy)
Description

FirstdateofANCrecoveryover500

Data type

text

First date platelets dropped below 20,000 (mm dd yyyy)
Description

Firstdateplateletsdroppedbelow20,000

Data type

text

First date platelets recovery over 20,000 (non-transfused) (mm dd yyyy)
Description

Firstdateplateletsrecoveryover20,000(non-transfused)

Data type

text

Transplant Treatment Plan
Description

Transplant Treatment Plan

Did the patient receive a transplant?
Description

ProtocolTransplantInd

Data type

boolean

Date of first bone marrow or peripheral blood stem cell infusion (mm dd yyyy)
Description

BMSCTDate

Data type

date

Type of bone marrow or peripheral blood stem cell (PBSC) transplant (mark one with X)
Description

BMSCTType

Data type

text

Other, specify (type of bone marrow transplant)
Description

BMSCTType,Other

Data type

text

Ccrr Module For Calgb: 10201 Follow-up Form
Description

Ccrr Module For Calgb: 10201 Follow-up Form

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1 forms
  1. StudyEvent: CALGB: 10201 FOLLOW-UP FORM
    1. Continue to next page
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Calgb Form
CALGBProtocolNumber
Item
CALGB Study No.
text
CALGBPatientID
Item
CALGB Patient ID
text
IntervalReportFromDate
Item
Reporting period Start Date
date
IntervalReportToDate
Item
Reporting period End Date
date
MMDDYYYY
Item
MM DD YYYY
text
AmendedDataInd
Item
Are data amended?
text
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
Patient Initials
Item
Patient's Initials (Last, First, Middle)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus 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 No.
text
ParticipatingGroupProtocolNo.
Item
Participating Group Protocol No.
text
MainMemberInstitution/Affiliate
Item
Main Member Institution/Adjunct
text
ParticipatingGroupPatientID
Item
Participating Group Patient ID:
text
Item Group
Vital Status
Item
Patient's vital status
text
CL.1
Code List
Patient's vital status
CL Item
Alive (Alive)
CL Item
Dead (Dead)
Item
Cause of Death (if dead)
text
CL.2
Code List
Cause of Death (if dead)
CL Item
Due To This Disease (Due to this disease)
CL Item
Due To Protocol Treatment (Due to protocol treatment)
CL Item
Due To Other Cause (Due to other cause)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
DeathReason,Specify
Item
Describe Cause of Death
text
Item Group
Disease Follow-up Status
Item
Has the patient had a documented clinical assessment for this cancer during this reporting period?
text
CL.3
Code List
Has the patient had a documented clinical assessment for this cancer during this reporting period?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CancerFollow-upStatusDate
Item
Date of last clinical assessment (mm dd yyyy)
date
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Item
Did the patient achieve a complete response according to clinical/hematologic criteria during this reporting period?
text
CL.4
Code List
Did the patient achieve a complete response according to clinical/hematologic criteria during this reporting period?
CL Item
Null (No)
CL Item
Null (Yes)
CL Item
Null (Unknown)
CRFirstObservedDate
Item
date of complete response
date
C25755 (NCI Thesaurus ObjectClass)
C0871261 (UMLS 2011AA ObjectClass)
C15722 (NCI Thesaurus Property)
C0700325 (UMLS 2011AA Property)
Item Group
Notice Of Progression
Item
Has the patient developed a first progression or relapse that has not been previously reported?
text
CL.5
Code List
Has the patient developed a first progression or relapse that has not been previously reported?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Unknown (Uncertain)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
DiseaseBoneMarrowRelapseDate
Item
Date of bone marrow relapse (mm dd yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C18265 (NCI Thesaurus Property)
C12431 (NCI Thesaurus Property-2)
C0005953 (UMLS 2011AA Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
DiseaseNonBoneMarrowRelapseDate
Item
Date of non-marrow relapse (mm dd yyyy)
date
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C18265 (NCI Thesaurus Property)
C25594 (NCI Thesaurus Property-2)
C1518422 (UMLS 2011AA Property)
C12431 (NCI Thesaurus Property-3)
C0005953 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item
Type of non-marrow relapse (mark all that apply with an X)
text
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C18265 (NCI Thesaurus Property)
C25594 (NCI Thesaurus Property-2)
C1518422 (UMLS 2011AA Property)
C12431 (NCI Thesaurus Property-3)
C0005953 (UMLS 2011AA Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.6
Code List
Type of non-marrow relapse (mark all that apply with an X)
CL Item
Skin (Skin)
C12470 (NCI Thesaurus)
C1123023 (UMLS 2011AA)
CL Item
Peripheral Blood (Peripheral blood)
C0229664 (NCI Metathesaurus)
CL Item
Cns (CNS)
CL Item
Gonadal (Gonadal)
CL Item
Other, Specify (Other, specify)
DiseaseNonBoneMarrowRelapseSpecify
Item
Other, specify (Type of non-marrow relapse)
text
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C18265 (NCI Thesaurus Property)
C25594 (NCI Thesaurus Property-2)
C1518422 (UMLS 2011AA Property)
C12431 (NCI Thesaurus Property-3)
C0005953 (UMLS 2011AA Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Item Group
Recovery
Wasthepatienthospitalizedotherthanforchemotherapyadministration?
Item
Was the patient hospitalized other than for chemotherapy administration? (If yes, )
boolean
PatientHospitalizationDayCount
Item
number of extra days hospitalized
float
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25301 (NCI Thesaurus ValueDomain)
C0439228 (UMLS 2011AA ValueDomain)
C25463 (NCI Thesaurus ValueDomain-2)
C0750480 (UMLS 2011AA ValueDomain-2)
C25179 (NCI Thesaurus Property)
C0019993 (UMLS 2011AA Property)
DidthepatientrequireIVantibiotics/antifungals(inoroutpatient)?
Item
Did the patient require IV antibiotics/antifungals (in or out patient)?
boolean
IntravenousTreatmentInfectionDayCount
Item
Number of days on IV antibiotics/antifungals
float
C13346 (NCI Thesaurus ObjectClass)
C0348016 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C26726 (NCI Thesaurus Property)
C0009450 (UMLS 2011AA Property)
C25301 (NCI Thesaurus ValueDomain)
C0439228 (UMLS 2011AA ValueDomain)
C25463 (NCI Thesaurus ValueDomain-2)
C0750480 (UMLS 2011AA ValueDomain-2)
PlateletTransfusionRequirementInd-3
Item
Did the patient require platlet transfusions?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15366 (NCI Thesaurus ObjectClass)
C0086818 (UMLS 2011AA ObjectClass)
C38015 (NCI Thesaurus Property)
PackedRedBloodCellTransfusionRequirementInd-3
Item
Did the patient require red blood cell (RBC) transfusions? (If yes, )
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15409 (NCI Thesaurus ObjectClass)
C0199962 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
PackedRedBloodCellTransfusionReceivedUnitCount
Item
number of units given
float
C44278 (NCI Thesaurus ValueDomain)
C0439148 (UMLS 2011AA ValueDomain)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain-2)
C0750480 (UMLS 2011AA ValueDomain-2)
C15409 (NCI Thesaurus ObjectClass)
C0199962 (UMLS 2011AA ObjectClass)
FirstdateofANCdroppedbelow500
Item
First date of ANC dropped below 500 (mm dd yyyy)
text
FirstdateofANCrecoveryover500
Item
First date of ANC recovery over 500 (mm dd yyyy)
text
Firstdateplateletsdroppedbelow20,000
Item
First date platelets dropped below 20,000 (mm dd yyyy)
text
Firstdateplateletsrecoveryover20,000(non-transfused)
Item
First date platelets recovery over 20,000 (non-transfused) (mm dd yyyy)
text
Item Group
Transplant Treatment Plan
ProtocolTransplantInd
Item
Did the patient receive a transplant?
boolean
BMSCTDate
Item
Date of first bone marrow or peripheral blood stem cell infusion (mm dd yyyy)
date
Item
Type of bone marrow or peripheral blood stem cell (PBSC) transplant (mark one with X)
text
CL.12
Code List
Type of bone marrow or peripheral blood stem cell (PBSC) transplant (mark one with X)
CL Item
Bone Marrow Stem Cells Used For Transplant Obtained From Antigen-matched Sibling Or Family Member Of Recipient (Bone marrow from matched sibling)
CL Item
Peripheral Blood Stem Cells Used For Transplant Obtained From Antigen-matched Sibling Or Family Member Of Recipient (PBSC from matched sibling)
CL Item
Bone Marrow Stem Cells Used For Transplant Obtained From Antigen-matched Individual Unrelated To Recipient (Bone marrow from matched unrelated donor)
CL Item
Peripheral Blood Stem Cells Used For Transplant Obtained From Antigen-matched Individual Unrelated To Recipient (PBSC from matched unrelated donor)
CL Item
Bone Marrow Stem Cells Used For Transplant Obtained From Recipient Him/herself (Autologous bone marrow)
CL Item
Peripheral Blood Stem Cells Used For Transplant Obtained From Recipient Him/herself (Autologous PBSC)
CL Item
Specified Other Source, Type, And Form Of Transplanted Material (Other, specify)
BMSCTType,Other
Item
Other, specify (type of bone marrow transplant)
text
Item Group
Ccrr Module For Calgb: 10201 Follow-up Form
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