ID

6988

Beskrivning

E2906 Acute Leukemia Disease Assessment Form Clofarabine or Daunorubicin Hydrochloride and Cytarabine Followed By Decitabine or Observation in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=7585B205-C98E-8BDD-E040-BB89AD430415

Länk

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=7585B205-C98E-8BDD-E040-BB89AD430415

Nyckelord

Versioner (2)
  1. 2012-09-19 2012-09-19 -
  2. 2015-01-08 2015-01-08 - Martin Dugas
Uppladdad den

8 januari 2015

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0 Legacy
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NCT01041703 Response - E2906 Acute Leukemia Disease Assessment Form - 2951828v1.0

Engelsk

INSTRUCTIONS: Complete this form and submit original to the ECOG Coordinating Center. Keep a copy for your files. If disease was assessed on more than one date, submit additional forms

1 Formulär  
Header
Beskrivning

Header

DCI Name
Beskrivning

Generic drug form

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C3242750
NCI Thesaurus Property
C19464
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus ObjectClass-2
C25452
Registration Step (Place ID Label Here)
Beskrivning

Registration Number

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1514821
NCI Thesaurus ObjectClass
C25646
UMLS CUI-2
C0237753
NCI Thesaurus Property
C16154
NCI Thesaurus ValueDomain-2
C16154
Patient Initials (Last, First)
Beskrivning

Patient Initials

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
ECOG Protocol Number
Beskrivning

Protocol Number ECOG

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1512162
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25491
ECOG Protocol Number
Beskrivning

Protocol Number ECOG

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1512162
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25491
ECOG Patient ID
Beskrivning

Patient ID ECOG

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1512162
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25491
ECOG Patient ID
Beskrivning

Patient ID ECOG

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1512162
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25491
Participating Group Protocol Number
Beskrivning

Study Number Participating Group

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Participating Group Patient ID
Beskrivning

Trial subject ID Participating Group

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Institution/Affiliate
Beskrivning

Institution Name

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C25454
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass-2
C21541
NCI Thesaurus Property
C25364
NCI Thesaurus ValueDomain
C25191
NCI Thesaurus ValueDomain-2
C21541
On Treatment
Beskrivning

On Treatment

On Treatment Report Period
Beskrivning

Cycle number

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C2045829
NCI Thesaurus Property
C25214
NCI Thesaurus Property-2
C25616
NCI Thesaurus ObjectClass
C15368
Off Treatment
Beskrivning

Off Treatment

Off Treatment Report Period (since registration to Step 1 If this form covers an Off Treatment Report Period Choose one)
Beskrivning

PersonOff-TreatmentTimePeriodType

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property-2
C25601
UMLS 2011AA Property-2
C1518544
NCI Thesaurus Property-3
C25207
UMLS 2011AA Property-3
C0040223
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Unnamed2
Beskrivning

Unnamed2

Please mark an 'X' if data have been amended. (Please circle amended items in red)
Beskrivning

Data amended

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Date data amended (s M D Y)
Beskrivning

Data amended date

Datatyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
UMLS CUI-2
C0011008
NCI Thesaurus Property
C25416
NCI Thesaurus ValueDomain-2
C25367
Bone Marrow Biopsy Information
Beskrivning

Bone Marrow Biopsy Information

Was bone marrow biopsy done (/aspirate obtained for this reporting period)
Beskrivning

BoneMarrowBiopsyInd

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus Property
C15189
UMLS 2011AA Property
C0005558
NCI Thesaurus ObjectClass
C12431
UMLS 2011AA ObjectClass
C0005953
Date of Bone Marrow Biopsy (second /aspirate if done M D Y Submit copy of bone marrow report with E2906 Source Document Tracking Coversheet attached)
Beskrivning

BoneMarrowBiopsyDate

Datatyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus Property
C15189
UMLS 2011AA Property
C0005558
NCI Thesaurus ObjectClass
C12431
UMLS 2011AA ObjectClass
C0005953
Date of Bone Marrow Biopsy (second /aspirate if done M D Y Submit copy of bone marrow report with E2906 Source Document Tracking Coversheet attached)
Beskrivning

BoneMarrowBiopsyDate

Datatyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus Property
C15189
UMLS 2011AA Property
C0005558
NCI Thesaurus ObjectClass
C12431
UMLS 2011AA ObjectClass
C0005953
Mark an 'X' if not done (second bone marrow biopsy/aspirate)
Beskrivning

DataUnknownText

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C17998
UMLS 2011AA Property
C0439673
Marrow Cellularity (%)
Beskrivning

LaboratoryProcedureBoneMarrowCellularityOutcomePercentageValue

Datatyp

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C12431
UMLS 2011AA Property
C0005953
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus Property-3
C37923
UMLS 2011AA Property-3
C1516377
NCI Thesaurus ValueDomain
C25613
UMLS 2011AA ValueDomain
C0439165
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
Are all cell lines maturing
Beskrivning

LaboratoryProcedureCytogeneticAnalysisCellLineOutcomeInd-2

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C18280
UMLS 2011AA Property
C0752095
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus Property-3
C16403
UMLS 2011AA Property-3
C0007600
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Marrow Blasts (%)
Beskrivning

LaboratoryProcedureBoneMarrowBlastCellOutcomePercentageValue

Datatyp

float

Måttenheter
  • %
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C12431
UMLS 2011AA Property
C0005953
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus Property-3
C12918
UMLS 2011AA Property-3
C0368761
NCI Thesaurus ValueDomain
C25613
UMLS 2011AA ValueDomain
C0439165
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
%
Are auer rods present?
Beskrivning

LaboratoryProcedureAuerRodsOutcomeStatus

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C12431
UMLS 2011AA Property
C0005953
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus Property-3
C25287
UMLS 2011AA Property-3
C0333828
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
Was there evidence of persistence of leukemia associated phenotype by flow cytometry
Beskrivning

PersistentLeukemiaPhenotypeFlowCytometryFindingInd-2

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C3161
UMLS 2011AA ObjectClass
C0023418
NCI Thesaurus ObjectClass-2
C43623
UMLS 2011AA ObjectClass-2
C0205322
NCI Thesaurus ObjectClass-3
C16977
UMLS 2011AA ObjectClass-3
C0031437
NCI Thesaurus Property
C16585
UMLS 2011AA Property
C0016263
NCI Thesaurus Property-2
C3367
UMLS 2011AA Property-2
C0037088
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Were there circulating blasts in peripheral blood
Beskrivning

PeripheralBloodBlastCellPresentInd-2

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C12434
UMLS 2011AA ObjectClass
C0229664
NCI Thesaurus ObjectClass-2
C25233
UMLS 2011AA ObjectClass-2
C0205100
NCI Thesaurus ObjectClass-3
C12918
UMLS 2011AA ObjectClass-3
C0368761
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Did the patient achieve morphologic leukemia-free state
Beskrivning

MorphologicFindingDisease-FreeSurvivalLeukemiaDiagnosisInd-2

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C3161
UMLS 2011AA ObjectClass
C0023418
NCI Thesaurus ObjectClass-2
C17751
UMLS 2011AA ObjectClass-2
C0242793
NCI Thesaurus ObjectClass-3
C35867
UMLS 2011AA ObjectClass-3
C0700329
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Date patient achieved morphologic leukemia-free state
Beskrivning

MorphologicFindingDisease-FreeSurvivalLeukemiaDiagnosisDate

Datatyp

date

Alias
NCI Thesaurus ObjectClass
C3161
UMLS 2011AA ObjectClass
C0023418
NCI Thesaurus ObjectClass-2
C17751
UMLS 2011AA ObjectClass-2
C0242793
NCI Thesaurus ObjectClass-3
C35867
UMLS 2011AA ObjectClass-3
C0700329
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Did patient achieve PR
Beskrivning

PartialResponseFirstObservedInd-2

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C25755
UMLS 2011AA ObjectClass
C0871261
NCI Thesaurus ObjectClass-2
C25378
UMLS 2011AA ObjectClass-2
C0728938
NCI Thesaurus Property
C25509
UMLS 2011AA Property
C1279901
NCI Thesaurus Property-2
C25599
UMLS 2011AA Property-2
C1441672
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Date of PR (M D Y)
Beskrivning

PartialResponseConfirmedDate

Datatyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25755
UMLS 2011AA ObjectClass
C0871261
NCI Thesaurus Property
C25458
UMLS 2011AA Property
C0750484
NCI Thesaurus ObjectClass-2
C25378
UMLS 2011AA ObjectClass-2
C0728938
Did patient achieve CR
Beskrivning

CompleteResponseObservedInd-2

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C25755
UMLS 2011AA ObjectClass
C0871261
NCI Thesaurus ObjectClass-2
C25250
UMLS 2011AA ObjectClass-2
C0205197
NCI Thesaurus Property
C25599
UMLS 2011AA Property
C1441672
Date of CR (M D Y)
Beskrivning

CompleteResponseOccurrenceDate

Datatyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25755
UMLS 2011AA ObjectClass
C0871261
NCI Thesaurus ObjectClass-2
C25250
UMLS 2011AA ObjectClass-2
C0205197
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
Was Complete Remission incomplete (CRi) achieved (If no CR)
Beskrivning

IncompleteBloodCellCountRecoveryCellularMorphologyCompleteRemissionFirstObservedInd-2

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C49160
UMLS 2011AA ObjectClass
C0205257
NCI Thesaurus ObjectClass-2
C4870
UMLS 2011AA ObjectClass-2
C0677874
NCI Thesaurus ObjectClass-3
C17768
UMLS 2011AA ObjectClass-3
C2700385
NCI Thesaurus ObjectClass-4
C70827
UMLS 2011AA ObjectClass-4
C0237820
NCI Thesaurus ObjectClass-5
C28133
UMLS 2011AA ObjectClass-5
C0009555
NCI Thesaurus Property
C25509
UMLS 2011AA Property
C1279901
NCI Thesaurus Property-2
C25599
UMLS 2011AA Property-2
C1441672
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Date of CRi (M D Y)
Beskrivning

IncompleteBloodCellCountRecoveryCellularMorphologyCompleteRemissionFirstObservedDate

Datatyp

date

Alias
NCI Thesaurus ObjectClass
C49160
UMLS 2011AA ObjectClass
C0205257
NCI Thesaurus ObjectClass-2
C4870
UMLS 2011AA ObjectClass-2
C0677874
NCI Thesaurus ObjectClass-3
C17768
UMLS 2011AA ObjectClass-3
C2700385
NCI Thesaurus ObjectClass-4
C70827
UMLS 2011AA ObjectClass-4
C0237820
NCI Thesaurus ObjectClass-5
C28133
UMLS 2011AA ObjectClass-5
C0009555
NCI Thesaurus Property
C25509
UMLS 2011AA Property
C1279901
NCI Thesaurus Property-2
C25599
UMLS 2011AA Property-2
C1441672
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Is there any extramedullary disease
Beskrivning

PatientExtramedullaryDiseaseAssessmentInd-3

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus Property-2
C2991
UMLS 2011AA Property-2
C0012634
NCI Thesaurus Property-3
C25503
UMLS 2011AA Property-3
C1517060
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Specify sites
Beskrivning

DiseaseInvolvedSiteSpecify

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C25341
UMLS 2011AA Property
C0450429
NCI Thesaurus Property-2
C25547
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
Comments
Beskrivning

Comments

Investigator Signature
Beskrivning

Investigator Signature

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C2346576
NCI Thesaurus Property
C25678
NCI Thesaurus ObjectClass
C17089
Investigator Signature Date (MM DD YYYY)
Beskrivning

Investigator Signature Date

Datatyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2346576
NCI Thesaurus Property
C25678
UMLS CUI-2
C0011008
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C17089
Tillbaka till toppen

Similar models

INSTRUCTIONS: Complete this form and submit original to the ECOG Coordinating Center. Keep a copy for your files. If disease was assessed on more than one date, submit additional forms

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Header
Generic drug form
Item
DCI Name
text
C25191 (NCI Thesaurus ValueDomain)
C3242750 (UMLS CUI-1)
C19464 (NCI Thesaurus Property)
C25474 (NCI Thesaurus ObjectClass)
C25452 (NCI Thesaurus ObjectClass-2)
Registration Number
Item
Registration Step (Place ID Label Here)
text
C25337 (NCI Thesaurus ValueDomain)
C1514821 (UMLS CUI-1)
C25646 (NCI Thesaurus ObjectClass)
C0237753 (UMLS CUI-2)
C16154 (NCI Thesaurus Property)
C16154 (NCI Thesaurus ValueDomain-2)
Patient Initials
Item
Patient Initials (Last, First)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Protocol Number ECOG
Item
ECOG Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Protocol Number ECOG
Item
ECOG Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Patient ID ECOG
Item
ECOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Patient ID ECOG
Item
ECOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Study Number Participating Group
Item
Participating Group Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Trial subject ID Participating Group
Item
Participating Group Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Institution Name
Item
Institution/Affiliate
text
C25454 (NCI Thesaurus ObjectClass)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)
Item Group
On Treatment
Item
On Treatment Report Period
text
C25284 (NCI Thesaurus ValueDomain)
C2045829 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C25616 (NCI Thesaurus Property-2)
C15368 (NCI Thesaurus ObjectClass)
CL.1
Code List
On Treatment Report Period
CL Item
Cycle 1 - Induction (Cycle 1 - Induction)
CL Item
Cycle 2 - Induction (Cycle 2 - Induction)
CL Item
Cycle 1 - Consolidation (Cycle 1 - Consolidation)
CL Item
Cycle 2 - Consolidation (Cycle 2 - Consolidation)
CL Item
Cycle 1 - Step 3 (Cycle 1 - Step 3)
CL Item
Cycle 2 - Step 3 (Cycle 2 - Step 3)
CL Item
Cycle 3 - Step 3 (Cycle 3 - Step 3)
CL Item
Cycle 4 - Step 3 (Cycle 4 - Step 3)
CL Item
Cycle 5 - Step 3 (Cycle 5 - Step 3)
CL Item
Cycle 6 - Step 3 (Cycle 6 - Step 3)
CL Item
Cycle 7 - Step 3 (Cycle 7 - Step 3)
CL Item
Cycle 8 - Step 3 (Cycle 8 - Step 3)
CL Item
Cycle 9 - Step 3 (Cycle 9 - Step 3)
CL Item
Cycle 10 - Step 3 (Cycle 10 - Step 3)
CL Item
Cycle 11 - Step 3 (Cycle 11 - Step 3)
CL Item
Cycle 12 - Step 3 (Cycle 12 - Step 3)
CL Item
Cycle 13 - Step 3 (Cycle 13 - Step 3)
CL Item
At Transplant (At Transplant)
Item Group
Off Treatment
Item
Off Treatment Report Period (since registration to Step 1 If this form covers an Off Treatment Report Period Choose one)
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25601 (NCI Thesaurus Property-2)
C1518544 (UMLS 2011AA Property-2)
C25207 (NCI Thesaurus Property-3)
C0040223 (UMLS 2011AA Property-3)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.2
Code List
Off Treatment Report Period (since registration to Step 1 If this form covers an Off Treatment Report Period Choose one)
CL Item
3 Months (3 Months Post Registration)
CL Item
6 Months (6 Months Post Registration)
CL Item
9 Months (9 Months Post Registration)
CL Item
12 Months (12 Months Post Registration)
CL Item
15 Months (15 Months Post Registration)
CL Item
18 Months (18 Months Post Registration)
CL Item
21 Months Post Registration (21 Months Post Registration)
CL Item
2 Years (24 Months Post Registration)
CL Item
30 Months (30 Months Post Registration)
CL Item
3 Years (36 Months Post Registration)
CL Item
42 Months (42 Months Post Registration)
CL Item
4 Years (48 Months Post Registration)
CL Item
54 Months (54 Months Post Registration)
CL Item
5 Years (60 Months Post Registration)
Item Group
Unnamed2
Data amended
Item
Please mark an 'X' if data have been amended. (Please circle amended items in red)
text
C25704 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Data amended date
Item
Date data amended (s M D Y)
date
C25164 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C0011008 (UMLS CUI-2)
C25416 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)
Item Group
Bone Marrow Biopsy Information
Item
Was bone marrow biopsy done (/aspirate obtained for this reporting period)
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C15189 (NCI Thesaurus Property)
C0005558 (UMLS 2011AA Property)
C12431 (NCI Thesaurus ObjectClass)
C0005953 (UMLS 2011AA ObjectClass)
CL.3
Code List
Was bone marrow biopsy done (/aspirate obtained for this reporting period)
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
BoneMarrowBiopsyDate
Item
Date of Bone Marrow Biopsy (second /aspirate if done M D Y Submit copy of bone marrow report with E2906 Source Document Tracking Coversheet attached)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C15189 (NCI Thesaurus Property)
C0005558 (UMLS 2011AA Property)
C12431 (NCI Thesaurus ObjectClass)
C0005953 (UMLS 2011AA ObjectClass)
BoneMarrowBiopsyDate
Item
Date of Bone Marrow Biopsy (second /aspirate if done M D Y Submit copy of bone marrow report with E2906 Source Document Tracking Coversheet attached)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C15189 (NCI Thesaurus Property)
C0005558 (UMLS 2011AA Property)
C12431 (NCI Thesaurus ObjectClass)
C0005953 (UMLS 2011AA ObjectClass)
DataUnknownText
Item
Mark an 'X' if not done (second bone marrow biopsy/aspirate)
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C17998 (NCI Thesaurus Property)
C0439673 (UMLS 2011AA Property)
LaboratoryProcedureBoneMarrowCellularityOutcomePercentageValue
Item
Marrow Cellularity (%)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C12431 (NCI Thesaurus Property)
C0005953 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C37923 (NCI Thesaurus Property-3)
C1516377 (UMLS 2011AA Property-3)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
LaboratoryProcedureCytogeneticAnalysisCellLineOutcomeInd-2
Item
Are all cell lines maturing
boolean
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C18280 (NCI Thesaurus Property)
C0752095 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C16403 (NCI Thesaurus Property-3)
C0007600 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
LaboratoryProcedureBoneMarrowBlastCellOutcomePercentageValue
Item
Marrow Blasts (%)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C12431 (NCI Thesaurus Property)
C0005953 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C12918 (NCI Thesaurus Property-3)
C0368761 (UMLS 2011AA Property-3)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
Item
Are auer rods present?
text
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C12431 (NCI Thesaurus Property)
C0005953 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25287 (NCI Thesaurus Property-3)
C0333828 (UMLS 2011AA Property-3)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
CL.5
Code List
Are auer rods present?
CL Item
Auer Rods Absent From Bone Marrow (Absent)
CL Item
Auer Rods Present In Bone Marrow (Present)
PersistentLeukemiaPhenotypeFlowCytometryFindingInd-2
Item
Was there evidence of persistence of leukemia associated phenotype by flow cytometry
boolean
C3161 (NCI Thesaurus ObjectClass)
C0023418 (UMLS 2011AA ObjectClass)
C43623 (NCI Thesaurus ObjectClass-2)
C0205322 (UMLS 2011AA ObjectClass-2)
C16977 (NCI Thesaurus ObjectClass-3)
C0031437 (UMLS 2011AA ObjectClass-3)
C16585 (NCI Thesaurus Property)
C0016263 (UMLS 2011AA Property)
C3367 (NCI Thesaurus Property-2)
C0037088 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PeripheralBloodBlastCellPresentInd-2
Item
Were there circulating blasts in peripheral blood
boolean
C12434 (NCI Thesaurus ObjectClass)
C0229664 (UMLS 2011AA ObjectClass)
C25233 (NCI Thesaurus ObjectClass-2)
C0205100 (UMLS 2011AA ObjectClass-2)
C12918 (NCI Thesaurus ObjectClass-3)
C0368761 (UMLS 2011AA ObjectClass-3)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
MorphologicFindingDisease-FreeSurvivalLeukemiaDiagnosisInd-2
Item
Did the patient achieve morphologic leukemia-free state
boolean
C3161 (NCI Thesaurus ObjectClass)
C0023418 (UMLS 2011AA ObjectClass)
C17751 (NCI Thesaurus ObjectClass-2)
C0242793 (UMLS 2011AA ObjectClass-2)
C35867 (NCI Thesaurus ObjectClass-3)
C0700329 (UMLS 2011AA ObjectClass-3)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
MorphologicFindingDisease-FreeSurvivalLeukemiaDiagnosisDate
Item
Date patient achieved morphologic leukemia-free state
date
C3161 (NCI Thesaurus ObjectClass)
C0023418 (UMLS 2011AA ObjectClass)
C17751 (NCI Thesaurus ObjectClass-2)
C0242793 (UMLS 2011AA ObjectClass-2)
C35867 (NCI Thesaurus ObjectClass-3)
C0700329 (UMLS 2011AA ObjectClass-3)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
PartialResponseFirstObservedInd-2
Item
Did patient achieve PR
boolean
C25755 (NCI Thesaurus ObjectClass)
C0871261 (UMLS 2011AA ObjectClass)
C25378 (NCI Thesaurus ObjectClass-2)
C0728938 (UMLS 2011AA ObjectClass-2)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25599 (NCI Thesaurus Property-2)
C1441672 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PartialResponseConfirmedDate
Item
Date of PR (M D Y)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25755 (NCI Thesaurus ObjectClass)
C0871261 (UMLS 2011AA ObjectClass)
C25458 (NCI Thesaurus Property)
C0750484 (UMLS 2011AA Property)
C25378 (NCI Thesaurus ObjectClass-2)
C0728938 (UMLS 2011AA ObjectClass-2)
CompleteResponseObservedInd-2
Item
Did patient achieve CR
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25755 (NCI Thesaurus ObjectClass)
C0871261 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus ObjectClass-2)
C0205197 (UMLS 2011AA ObjectClass-2)
C25599 (NCI Thesaurus Property)
C1441672 (UMLS 2011AA Property)
CompleteResponseOccurrenceDate
Item
Date of CR (M D Y)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25755 (NCI Thesaurus ObjectClass)
C0871261 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus ObjectClass-2)
C0205197 (UMLS 2011AA ObjectClass-2)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
IncompleteBloodCellCountRecoveryCellularMorphologyCompleteRemissionFirstObservedInd-2
Item
Was Complete Remission incomplete (CRi) achieved (If no CR)
boolean
C49160 (NCI Thesaurus ObjectClass)
C0205257 (UMLS 2011AA ObjectClass)
C4870 (NCI Thesaurus ObjectClass-2)
C0677874 (UMLS 2011AA ObjectClass-2)
C17768 (NCI Thesaurus ObjectClass-3)
C2700385 (UMLS 2011AA ObjectClass-3)
C70827 (NCI Thesaurus ObjectClass-4)
C0237820 (UMLS 2011AA ObjectClass-4)
C28133 (NCI Thesaurus ObjectClass-5)
C0009555 (UMLS 2011AA ObjectClass-5)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25599 (NCI Thesaurus Property-2)
C1441672 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
IncompleteBloodCellCountRecoveryCellularMorphologyCompleteRemissionFirstObservedDate
Item
Date of CRi (M D Y)
date
C49160 (NCI Thesaurus ObjectClass)
C0205257 (UMLS 2011AA ObjectClass)
C4870 (NCI Thesaurus ObjectClass-2)
C0677874 (UMLS 2011AA ObjectClass-2)
C17768 (NCI Thesaurus ObjectClass-3)
C2700385 (UMLS 2011AA ObjectClass-3)
C70827 (NCI Thesaurus ObjectClass-4)
C0237820 (UMLS 2011AA ObjectClass-4)
C28133 (NCI Thesaurus ObjectClass-5)
C0009555 (UMLS 2011AA ObjectClass-5)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25599 (NCI Thesaurus Property-2)
C1441672 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
PatientExtramedullaryDiseaseAssessmentInd-3
Item
Is there any extramedullary disease
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C2991 (NCI Thesaurus Property-2)
C0012634 (UMLS 2011AA Property-2)
C25503 (NCI Thesaurus Property-3)
C1517060 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
DiseaseInvolvedSiteSpecify
Item
Specify sites
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25547 (NCI Thesaurus Property-2)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
Item Group
Comments
Investigator Signature
Item
Investigator Signature
text
C25704 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
Investigator Signature Date
Item
Investigator Signature Date (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C25367 (NCI Thesaurus ValueDomain-2)
C17089 (NCI Thesaurus ObjectClass)
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