ID

10721

Description

CALGB: 10603 Follow-Up Form NCT00651261 Daunorubicin, Cytarabine, and Midostaurin in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=43C5D677-EB7A-6D45-E044-0003BA3F9857

Lien

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=43C5D677-EB7A-6D45-E044-0003BA3F9857

Mots-clés

Versions (3)
  1. 19-09-12 19-09-12 -
  2. 08-01-15 08-01-15 - Martin Dugas
  3. 08-06-15 08-06-15 -
Téléchargé le

8 juni 2015

DOI

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Licence

Creative Commons BY-NC 3.0 Legacy
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CALGB: 10603 Follow-Up Form DRKS00003845 NCT00651261

Anglais

INSTRUCTIONS: Complete and submit this 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

1 Formulaires  
Header
Description

Header

CALGB Form (C-1623)
Description

Form ID CALGB

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3262252
NCI Thesaurus ObjectClass
C19464
UMLS CUI-2
C1516238
NCI Thesaurus Property
C25364
NCI Thesaurus ObjectClass-2
C25442
CALGB Study No.
Description

Protocol ID CALGB

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1516238
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25442
CALGB Patient ID
Description

Trial subject ID CALGB

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1516238
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25442
Reporting Period Start Date
Description

Reporting Period Start Date

Type de données

date

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25616
UMLS CUI-1
C2361257
NCI Thesaurus Property-2
C25651
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25431
Reporting Period End Date
Description

Reporting Period End Date

Type de données

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2361259
NCI Thesaurus Property
C25616
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property-2
C25651
Are data amended
Description

Data amended

Type de données

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Patient demographics
Description

Patient demographics

Patient Initials (Last, First Middle)
Description

Patient Initials

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Patient Hospital No.
Description

Medical Record Number

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1301894
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25261
NCI Thesaurus Property-2
C25198
Institution/Affiliate
Description

Institution Name

Type de données

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
Participating Group
Description

Participating Group

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2347449
NCI Thesaurus ObjectClass
C25608
NCI Thesaurus ObjectClass-2
C17005
NCI Thesaurus Property
C25364
Participating Group Study No.
Description

Study Number Participating Group

Type de données

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
Description

Trial subject ID Participating Group

Type de données

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
Treatment Phase Information
Description

Treatment Phase Information

Treatment Phase
Description

ProtocolTherapyPhaseType

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C42651
UMLS 2011AA ObjectClass
C0442711
NCI Thesaurus Property
C25257
UMLS 2011AA Property
C0205390
Aml/all/apl: Vital Status
Description

Aml/all/apl: Vital Status

Patient's Vital Status (Mark one with an X)
Description

Patient Status

Type de données

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS CUI-1
C3846084
NCI Thesaurus ValueDomain
C18003
NCI Thesaurus ValueDomain-2
C25688
NCI Thesaurus Property
C25717
Date of Last Contact or Death (mm dd yyyy)
Description

Date last contact

Type de données

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS CUI-1
C0805839
NCI Thesaurus Property
C25461
NCI Thesaurus Property-2
C25551
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
Primary Cause of Death (Mark one with an X)
Description

Primary Cause of Death

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS CUI-1
C0007465
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C28554
NCI Thesaurus ValueDomain-2
C25251
Describe cause of death
Description

Cause of Death, specify

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C0007465
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1521902
NCI Thesaurus Property
C28554
Aml/all/apl: Disease Follow-up Status
Description

Aml/all/apl: Disease Follow-up Status

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

Documented clinical assessment for this cancer

Type de données

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C1522577
NCI Thesaurus Property
C16033
UMLS CUI-2
C0006826
NCI Thesaurus ObjectClass
C9305
NCI Thesaurus Property-2
C25365
Date of Last Clinical Assessment (mm dd yyyy only provide date if assessment during this reporting period)
Description

Follow-Up Date

Type de données

date

Alias
NCI Thesaurus ObjectClass
C9305
UMLS CUI-1
C3694716
NCI Thesaurus Property
C16033
NCI Thesaurus Property-2
C25365
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
Did the patient achieve a complete response according to clinical/ hematologic criteria (during this reporting period)
Description

HematologyCompleteResponseInd-3

Type de données

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C16673
UMLS 2011AA ObjectClass
C0018943
NCI Metathesaurus Property
C0677874
Complete Response (CR) First Observed Date
Description

Complete Response First Observed Date

Type de données

date

Alias
NCI Thesaurus ObjectClass
C25755
UMLS CUI-1
C0677874
NCI Thesaurus ObjectClass-2
C25250
UMLS CUI-2
C1115465
NCI Thesaurus Property
C25509
NCI Thesaurus Property-2
C25599
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
Did the patient achieve a partial response according to clinical/ hematologic criteria
Description

HematologyPartialRemissionInd-3

Type de données

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C16673
UMLS 2011AA ObjectClass
C0018943
NCI Thesaurus Property
C18058
UMLS 2011AA Property
C1521726
Partial Response (PR) First Observed Date
Description

Partial Response First Observed Date

Type de données

date

Alias
NCI Thesaurus ObjectClass
C25755
UMLS CUI-1
C1521726
NCI Thesaurus ObjectClass-2
C25378
UMLS CUI-2
C1115465
NCI Thesaurus Property
C25509
NCI Thesaurus Property-2
C25599
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
Cll: Notice Of Progression
Description

Cll: Notice Of Progression

Has the patient developed a first progression (or relapse) that has not been previously reported? (Mark one with an X.)
Description

DiseaseProgressionInd-3

Type de données

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25331
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
Date of bone marrow relapse
Description

DiseaseBoneMarrowRelapseDate

Type de données

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
Description

DiseaseNonBoneMarrowRelapseDate

Type de données

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
Description

DiseaseNonBoneMarrowRelapseType

Type de données

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

Type de données

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

Did the patient require hospitalization (other than for chemotherapy administration)
Description

PatientHospitalizationInd-2

Type de données

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25179
UMLS 2011AA Property
C0019993
Number of extra days hospitalized
Description

PatientHospitalizationDayCount

Type de données

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 or antifungals
Description

IntravenousTreatmentInfectionInd-3

Type de données

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C13346
UMLS 2011AA ObjectClass
C0348016
NCI Thesaurus Property
C26726
UMLS 2011AA Property
C0009450
NCI Thesaurus ObjectClass-2
C15368
Number of days on IV antibiotics/antifungals
Description

IntravenousTreatmentInfectionDayCount

Type de données

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 platelet transfusion
Description

PlateletTransfusionRequirementInd-3

Type de données

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C15366
UMLS 2011AA ObjectClass
C0086818
NCI Thesaurus Property
C38015
Number of days platelet transfusion(s) given (If yes,)
Description

PlateletTransfusionRequirementDayCount

Type de données

float

Alias
NCI Thesaurus ValueDomain
C25301
UMLS 2011AA ValueDomain
C0439228
NCI Thesaurus ValueDomain-2
C25463
UMLS 2011AA ValueDomain-2
C0750480
NCI Thesaurus ObjectClass
C15366
UMLS 2011AA ObjectClass
C0086818
NCI Thesaurus Property
C38015
Type of platelet transfusion
Description

PlateletTransfusionAdministeredType

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C15366
UMLS 2011AA ObjectClass
C0086818
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Other specify
Description

PlateletTransfusionAdministeredSpecify

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C15366
UMLS 2011AA ObjectClass
C0086818
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Did the patient require red blood cell (RBC) transfusions?
Description

PackedRedBloodCellTransfusionRequirementInd-3

Type de données

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 of RBC transfusions (If yes, )
Description

RedCellTransfusionUnitsSpecify

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C15408
NCI Metathesaurus Property
CL110548
NCI Metathesaurus ObjectClass
CL285914
First date ANC (Absolute Neutrophil Count) dropped below 500/ul
Description

AbsoluteNeutrophilCountDecliningDate

Type de données

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C63321
UMLS 2011AA ObjectClass
C0948762
NCI Thesaurus Property
C25475
UMLS 2011AA Property
C1511741
First date of ANC (Absolute Neutrophil Count) recovery over 500/ul
Description

AbsoluteNeutrophilCountRecoveryPostDecliningDate

Type de données

date

Alias
NCI Thesaurus ObjectClass
C63321
UMLS 2011AA ObjectClass
C0948762
NCI Thesaurus Property
C38008
UMLS 2011AA Property
C0687676
NCI Thesaurus Property-2
C25746
UMLS 2011AA Property-2
C2004454
NCI Thesaurus Property-3
C25475
UMLS 2011AA Property-3
C1511741
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
First date platelets dropped below 20,000/ul
Description

LastPlateletCountAssessmentLaboratoryProcedureDate

Type de données

date

Alias
NCI Thesaurus ObjectClass
C51951
UMLS 2011AA ObjectClass
C0032181
NCI Thesaurus ObjectClass-2
C25551
UMLS 2011AA ObjectClass-2
C1517741
NCI Thesaurus Property
C25217
UMLS 2011AA Property
C1516048
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25294
UMLS 2011AA ValueDomain-2
C0022885
First date platelets recovered over 20,000/ul (non-transfused)
Description

PostTransplantPlateletRecoveryAssessmentDate

Type de données

date

Alias
NCI Thesaurus ObjectClass
C38008
UMLS 2011AA ObjectClass
C0687676
NCI Thesaurus ObjectClass-2
C12981
UMLS 2011AA ObjectClass-2
C0332835
NCI Thesaurus ObjectClass-3
C12520
UMLS 2011AA ObjectClass-3
C0005821
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus Property-2
C25746
UMLS 2011AA Property-2
C2004454
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Notice Of Progression2
Description

Notice Of Progression2

Date of First Bone Marrow or Peripheral Blood Stem Cell (PBSC) Infusion
Description

BMSCTAdministeredDate

Type de données

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25437
UMLS 2011AA ObjectClass
C0842093
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Type of Bone Marrow or Peripheral Blood Stem Cell (PBSC) Transplant
Description

BMSCTType

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C25437
UMLS 2011AA ObjectClass
C0842093
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Other specify
Description

TransplantProcedureSpecify

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C12981
UMLS 2011AA ObjectClass
C0332835
NCI Thesaurus Property
C15368
Notice Of New Primary
Description

Notice Of New Primary

Has a new primary cancer or MDS been diagnosed that has not been previously reported?
Description

NewCancerDiagnosisInd-3

Type de données

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C25586
UMLS 2011AA ObjectClass
C0205314
NCI Thesaurus ObjectClass-2
C9305
UMLS 2011AA ObjectClass-2
C0006826
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
New Primary Diagnosis
Description

NewCancerDiagnosisText

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C25586
UMLS 2011AA ObjectClass
C0205314
NCI Thesaurus ObjectClass-2
C9305
UMLS 2011AA ObjectClass-2
C0006826
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
Date of diagnosis
Description

NewCancerDiagnosisDate

Type de données

date

Alias
NCI Thesaurus ObjectClass
C25586
UMLS 2011AA ObjectClass
C0205314
NCI Thesaurus ObjectClass-2
C9305
UMLS 2011AA ObjectClass-2
C0006826
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
Site of New Primary (s)
Description

NewCancerSiteText

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C25586
UMLS 2011AA ObjectClass
C0205314
NCI Thesaurus Property
C25341
UMLS 2011AA Property
C0450429
NCI Thesaurus ObjectClass-2
C9305
UMLS 2011AA ObjectClass-2
C0006826
Comments
Description

Comments

Completed by (Last name, First name)
Description

Person Completing Form

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass
C25657
NCI Thesaurus Property
C25364
Date Form Completed
Description

Date Form Completed

Type de données

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1115437
NCI Thesaurus ObjectClass
C40988
NCI Thesaurus Property
C25250
NCI Thesaurus ValueDomain-2
C25367
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Similar models

INSTRUCTIONS: Complete and submit this 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

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Header
Form ID CALGB
Item
CALGB Form (C-1623)
text
C25337 (NCI Thesaurus ValueDomain)
C3262252 (UMLS CUI-1)
C19464 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus ObjectClass-2)
Protocol ID CALGB
Item
CALGB Study No.
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus Property-2)
Trial subject ID CALGB
Item
CALGB Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus Property-2)
Reporting Period Start Date
Item
Reporting Period Start Date
date
C15368 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C2361257 (UMLS CUI-1)
C25651 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
Reporting Period End Date
Item
Reporting Period End Date
date
C25164 (NCI Thesaurus ValueDomain)
C2361259 (UMLS CUI-1)
C25616 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)
C25651 (NCI Thesaurus Property-2)
Data amended
Item
Are data amended
boolean
C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Item Group
Patient demographics
Patient Initials
Item
Patient Initials (Last, First Middle)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Medical Record Number
Item
Patient Hospital No.
text
C25337 (NCI Thesaurus ValueDomain)
C1301894 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25261 (NCI Thesaurus Property)
C25198 (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)
Participating Group
Item
Participating Group
text
C25191 (NCI Thesaurus ValueDomain)
C2347449 (UMLS CUI-1)
C25608 (NCI Thesaurus ObjectClass)
C17005 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
Study Number Participating Group
Item
Participating Group Study No.
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)
Item Group
Treatment Phase Information
Item
Treatment Phase
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C42651 (NCI Thesaurus ObjectClass-2)
C0442711 (UMLS 2011AA ObjectClass)
C25257 (NCI Thesaurus Property)
C0205390 (UMLS 2011AA Property)
CL.2
Code List
Treatment Phase
CL Item
Induction #1 (Induction #1)
CL Item
Induction #2 (Induction #2)
CL Item
Consolidation #1 (Consolidation #1)
CL Item
Consolidation #2 (Consolidation #2)
CL Item
Consolidation #3 (Consolidation #3)
CL Item
Consolidation #4 (Consolidation #4)
CL Item
Continuation (Continuation)
CL Item
Post-therapy (Post-therapy follow-up)
C54735 (NCI Thesaurus)
C1882428 (UMLS 2011AA)
Item Group
Aml/all/apl: Vital Status
Item
Patient's Vital Status (Mark one with an X)
text
C16960 (NCI Thesaurus ObjectClass)
C3846084 (UMLS CUI-1)
C18003 (NCI Thesaurus ValueDomain)
C25688 (NCI Thesaurus ValueDomain-2)
C25717 (NCI Thesaurus Property)
CL.3
Code List
Patient's Vital Status (Mark one with an X)
CL Item
Alive (Alive)
CL Item
Dead (Dead)
Date last contact
Item
Date of Last Contact or Death (mm dd yyyy)
date
C16960 (NCI Thesaurus ObjectClass)
C0805839 (UMLS CUI-1)
C25461 (NCI Thesaurus Property)
C25551 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Item
Primary Cause of Death (Mark one with an X)
text
C25638 (NCI Thesaurus ValueDomain)
C0007465 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C28554 (NCI Thesaurus Property)
C25251 (NCI Thesaurus ValueDomain-2)
CL.4
Code List
Primary Cause of Death (Mark one with an X)
CL Item
Due To Other Cause (Due to other cause)
CL Item
Due To Protocol Treatment (Due to protocol treatment)
CL Item
Due To This Disease (Due to this disease)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Cause of Death, specify
Item
Describe cause of death
text
C25685 (NCI Thesaurus ValueDomain)
C0007465 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1521902 (UMLS CUI-2)
C28554 (NCI Thesaurus Property)
Item Group
Aml/all/apl: Disease Follow-up Status
Item
Has the patient had a documented clinical assessment for this cancer? (during this reporting period)
text
C38148 (NCI Thesaurus ValueDomain)
C1522577 (UMLS CUI-1)
C16033 (NCI Thesaurus Property)
C0006826 (UMLS CUI-2)
C9305 (NCI Thesaurus ObjectClass)
C25365 (NCI Thesaurus Property-2)
CL.5
Code List
Has the patient had a documented clinical assessment for this cancer? (during this reporting period)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Follow-Up Date
Item
Date of Last Clinical Assessment (mm dd yyyy only provide date if assessment during this reporting period)
date
C9305 (NCI Thesaurus ObjectClass)
C3694716 (UMLS CUI-1)
C16033 (NCI Thesaurus Property)
C25365 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Item
Did the patient achieve a complete response according to clinical/ hematologic criteria (during this reporting period)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C16673 (NCI Thesaurus ObjectClass)
C0018943 (UMLS 2011AA ObjectClass)
C0677874 (NCI Metathesaurus Property)
CL.6
Code List
Did the patient achieve a complete response according to clinical/ hematologic criteria (during this reporting period)
CL Item
No (NO)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C49487 (NCI Thesaurus-3)
C1298908 (UMLS 2011AA-4)
CL Item
Yes (YES)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus-3)
C1705108 (UMLS 2011AA-4)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Complete Response First Observed Date
Item
Complete Response (CR) First Observed Date
date
C25755 (NCI Thesaurus ObjectClass)
C0677874 (UMLS CUI-1)
C25250 (NCI Thesaurus ObjectClass-2)
C1115465 (UMLS CUI-2)
C25509 (NCI Thesaurus Property)
C25599 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Item
Did the patient achieve a partial response according to clinical/ hematologic criteria
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C16673 (NCI Thesaurus ObjectClass)
C0018943 (UMLS 2011AA ObjectClass)
C18058 (NCI Thesaurus Property)
C1521726 (UMLS 2011AA Property)
CL.7
Code List
Did the patient achieve a partial response according to clinical/ hematologic criteria
CL Item
No (NO)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C49487 (NCI Thesaurus-3)
C1298908 (UMLS 2011AA-4)
CL Item
Yes (YES)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus-3)
C1705108 (UMLS 2011AA-4)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Partial Response First Observed Date
Item
Partial Response (PR) First Observed Date
date
C25755 (NCI Thesaurus ObjectClass)
C1521726 (UMLS CUI-1)
C25378 (NCI Thesaurus ObjectClass-2)
C1115465 (UMLS CUI-2)
C25509 (NCI Thesaurus Property)
C25599 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Item Group
Cll: Notice Of Progression
Item
Has the patient developed a first progression (or relapse) that has not been previously reported? (Mark one with an X.)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25331 (NCI Thesaurus Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
CL.8
Code List
Has the patient developed a first progression (or relapse) that has not been previously reported? (Mark one with an X.)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
DiseaseBoneMarrowRelapseDate
Item
Date of bone marrow relapse
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
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
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.9
Code List
Type of non-marrow relapse
CL Item
Cns (CNS)
CL Item
Gonadal (Gonadal)
CL Item
Other, Specify (Other, specify)
CL Item
Peripheral Blood (Peripheral blood)
C0229664 (NCI Metathesaurus)
CL Item
Skin (Skin)
C12470 (NCI Thesaurus)
C1123023 (UMLS 2011AA)
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
PatientHospitalizationInd-2
Item
Did the patient require hospitalization (other than for chemotherapy administration)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25179 (NCI Thesaurus Property)
C0019993 (UMLS 2011AA Property)
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)
IntravenousTreatmentInfectionInd-3
Item
Did the patient require IV antibiotics or antifungals
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C13346 (NCI Thesaurus ObjectClass)
C0348016 (UMLS 2011AA ObjectClass)
C26726 (NCI Thesaurus Property)
C0009450 (UMLS 2011AA Property)
C15368 (NCI Thesaurus ObjectClass-2)
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 platelet transfusion
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15366 (NCI Thesaurus ObjectClass)
C0086818 (UMLS 2011AA ObjectClass)
C38015 (NCI Thesaurus Property)
PlateletTransfusionRequirementDayCount
Item
Number of days platelet transfusion(s) given (If yes,)
float
C25301 (NCI Thesaurus ValueDomain)
C0439228 (UMLS 2011AA ValueDomain)
C25463 (NCI Thesaurus ValueDomain-2)
C0750480 (UMLS 2011AA ValueDomain-2)
C15366 (NCI Thesaurus ObjectClass)
C0086818 (UMLS 2011AA ObjectClass)
C38015 (NCI Thesaurus Property)
Item
Type of platelet transfusion
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15366 (NCI Thesaurus ObjectClass)
C0086818 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
CL.13
Code List
Type of platelet transfusion
CL Item
Random Donor (Random donor)
CL Item
Single Donor (Single donor)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
PlateletTransfusionAdministeredSpecify
Item
Other specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C15366 (NCI Thesaurus ObjectClass)
C0086818 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
PackedRedBloodCellTransfusionRequirementInd-3
Item
Did the patient require red blood cell (RBC) transfusions?
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)
RedCellTransfusionUnitsSpecify
Item
Number of units of RBC transfusions (If yes, )
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C15408 (NCI Thesaurus ObjectClass)
CL110548 (NCI Metathesaurus Property)
CL285914 (NCI Metathesaurus ObjectClass)
AbsoluteNeutrophilCountDecliningDate
Item
First date ANC (Absolute Neutrophil Count) dropped below 500/ul
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C63321 (NCI Thesaurus ObjectClass)
C0948762 (UMLS 2011AA ObjectClass)
C25475 (NCI Thesaurus Property)
C1511741 (UMLS 2011AA Property)
AbsoluteNeutrophilCountRecoveryPostDecliningDate
Item
First date of ANC (Absolute Neutrophil Count) recovery over 500/ul
date
C63321 (NCI Thesaurus ObjectClass)
C0948762 (UMLS 2011AA ObjectClass)
C38008 (NCI Thesaurus Property)
C0687676 (UMLS 2011AA Property)
C25746 (NCI Thesaurus Property-2)
C2004454 (UMLS 2011AA Property-2)
C25475 (NCI Thesaurus Property-3)
C1511741 (UMLS 2011AA Property-3)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
LastPlateletCountAssessmentLaboratoryProcedureDate
Item
First date platelets dropped below 20,000/ul
date
C51951 (NCI Thesaurus ObjectClass)
C0032181 (UMLS 2011AA ObjectClass)
C25551 (NCI Thesaurus ObjectClass-2)
C1517741 (UMLS 2011AA ObjectClass-2)
C25217 (NCI Thesaurus Property)
C1516048 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25294 (NCI Thesaurus ValueDomain-2)
C0022885 (UMLS 2011AA ValueDomain-2)
PostTransplantPlateletRecoveryAssessmentDate
Item
First date platelets recovered over 20,000/ul (non-transfused)
date
C38008 (NCI Thesaurus ObjectClass)
C0687676 (UMLS 2011AA ObjectClass)
C12981 (NCI Thesaurus ObjectClass-2)
C0332835 (UMLS 2011AA ObjectClass-2)
C12520 (NCI Thesaurus ObjectClass-3)
C0005821 (UMLS 2011AA ObjectClass-3)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25746 (NCI Thesaurus Property-2)
C2004454 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item Group
Notice Of Progression2
BMSCTAdministeredDate
Item
Date of First Bone Marrow or Peripheral Blood Stem Cell (PBSC) Infusion
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25437 (NCI Thesaurus ObjectClass)
C0842093 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Item
Type of Bone Marrow or Peripheral Blood Stem Cell (PBSC) Transplant
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25437 (NCI Thesaurus ObjectClass)
C0842093 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.15
Code List
Type of Bone Marrow or Peripheral Blood Stem Cell (PBSC) Transplant
CL Item
Bone Marrow Stem Cells Used For Transplant Obtained From Antigen-matched Sibling Or Family Member Of Recipient (Bone marrow from matched sibling or family member)
CL Item
Peripheral Blood Stem Cells Used For Transplant Obtained From Antigen-matched Sibling Or Family Member Of Recipient (PBSC from matched sibling or family member)
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
Cord Blood (Cord blood)
CL Item
Other Specify (Other)
TransplantProcedureSpecify
Item
Other specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C12981 (NCI Thesaurus ObjectClass)
C0332835 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)
Item Group
Notice Of New Primary
NewCancerDiagnosisInd-3
Item
Has a new primary cancer or MDS been diagnosed that has not been previously reported?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
NewCancerDiagnosisText
Item
New Primary Diagnosis
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
NewCancerDiagnosisDate
Item
Date of diagnosis
date
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
NewCancerSiteText
Item
Site of New Primary (s)
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
Item Group
Comments
Person Completing Form
Item
Completed by (Last name, First name)
text
C25191 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
Date Form Completed
Item
Date Form Completed
date
C25164 (NCI Thesaurus ValueDomain)
C1115437 (UMLS CUI-1)
C40988 (NCI Thesaurus ObjectClass)
C25250 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)
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