ID

11665

Description

SOUTHWEST ONCOLOGY GROUP Previously Untreated Acute Promyelocytic Leukemia Prestudy Form (S0521) 2412866v1.0 Combination Chemotherapy With or Without Gemtuzumab Followed By Tretinoin, Mercaptopurine, and Methotrexate or Observation in Treating Patients With Acute Promyelocytic Leukemia Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=01FDEB64-5CFB-0063-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=01FDEB64-5CFB-0063-E044-0003BA3F9857

Keywords

Versions (3)
  1. 9/19/12 9/19/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 7/25/15 7/25/15 - Martin Dugas
Uploaded on

July 25, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Prestudy Form Acute Promyelocytic Leukemia NCT00492856

English

No Instruction available.

1 forms  
  1. StudyEvent: SOUTHWEST ONCOLOGY GROUP Previously Untreated Acute Promyelocytic Leukemia Prestudy Form (S0521)
    1. No Instruction available.
Header
Description

Header

SWOG Patient ID
Description

Trial subject ID SWOG

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1519429
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25699
SWOG Study No.
Description

Protocol ID SWOG

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1519429
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25699
Registration Step
Description

Registration Number

Data type

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 (L, F M)
Description

Patient Initials

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Institution/Affiliate
Description

Institution Name

Data type

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
Physician (Participating Group:)
Description

Investigator Name

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2826892
NCI Thesaurus Property
C25364
NCI Thesaurus ObjectClass
C17089
NCI Thesaurus ObjectClass-2
C25644
Participating Group Name
Description

Participating Group

Data type

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

Data type

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 (Instructions: All dates are MONTH, DAY, YEAR. Explain any blank fields or blank dates in the Comments section. Place an X in appropriate boxes. Circle AMENDED items in red and write AMENDED across the top of the form.)
Description

Trial subject ID Participating Group

Data type

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
Patient Characteristics
Description

Patient Characteristics

Performance Status
Description

ECOG Performance Status

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS CUI-1
C1520224
NCI Thesaurus Property
C25367
NCI Thesaurus ValueDomain-2
C25491
NCI Thesaurus ObjectClass
C20641
Risk classification at first registration
Description

PatientFirstProtocolRegistrationDiseaseRiskCategory

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25320
NCI Thesaurus Property-2
C25646
NCI Thesaurus Property-3
C25509
NCI Thesaurus ValueDomain
C25372
NCI Thesaurus ValueDomain-2
C2991
NCI Thesaurus ValueDomain-3
C17102
UMLS CUI-1
C0086930
Specimen for RT-PCR (Pretreatment)
Description

RT-PCRSpecimenCollectionSource

Data type

text

Alias
NCI Thesaurus ObjectClass
C18136
UMLS 2011AA ObjectClass
C0599161
NCI Thesaurus Property
C25453
UMLS 2011AA Property
C1516698
NCI Thesaurus ValueDomain
C25683
UMLS 2011AA ValueDomain
C0449416
NCI Thesaurus ObjectClass-2
C19157
UMLS 2011AA ObjectClass-2
C0370003
Date of marrow specimen collection
Description

BoneMarrowSpecimenCollectionDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C12431
UMLS 2011AA ObjectClass
C0005953
NCI Thesaurus Property
C25453
UMLS 2011AA Property
C1516698
NCI Thesaurus ObjectClass-2
C19157
UMLS 2011AA ObjectClass-2
C0370003
Date of blood specimen collection
Description

BloodSpecimenCollectionDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C12434
UMLS 2011AA ObjectClass
C0229664
NCI Thesaurus ObjectClass-2
C19157
UMLS 2011AA ObjectClass-2
C0370003
NCI Thesaurus Property
C25452
Did the patient receive ATRA prior to registration
Description

ATRAAgentPriorClinicalTrialRegistrationAdministeredInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ObjectClass-2
C900
UMLS 2011AA ObjectClass-2
C0040845
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
NCI Thesaurus Property-2
C25629
UMLS 2011AA Property-2
C0332152
NCI Thesaurus Property-3
C15207
NCI Thesaurus Property-4
C25382
UMLS 2011AA Property-3
C1521801
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Date ATRA first given
Description

ATRAAgentPriorClinicalTrialRegistrationAdministeredBeginDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ObjectClass-2
C900
UMLS 2011AA ObjectClass-2
C0040845
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
NCI Thesaurus Property-2
C25629
UMLS 2011AA Property-2
C0332152
NCI Thesaurus Property-3
C15207
NCI Thesaurus Property-4
C25382
UMLS 2011AA Property-3
C1521801
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25431
UMLS 2011AA ValueDomain-2
C0439659
Number of days of ATRA before registration
Description

ATRAAgentPriorClinicalTrialRegistrationAdministeredDayCount

Data type

float

Alias
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ObjectClass-2
C900
UMLS 2011AA ObjectClass-2
C0040845
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
NCI Thesaurus Property-2
C25629
UMLS 2011AA Property-2
C0332152
NCI Thesaurus Property-3
C15207
NCI Thesaurus Property-4
C25382
UMLS 2011AA Property-3
C1521801
NCI Thesaurus ValueDomain
C25301
UMLS 2011AA ValueDomain
C0439228
NCI Thesaurus ValueDomain-2
C25463
UMLS 2011AA ValueDomain-2
C0750480
Maximum dose of ATRA before registration
Description

ATRAAgentPriorClinicalTrialRegistrationAdministeredMaximumDose

Data type

float

Measurement units
  • mg/m^2/day
Alias
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus ObjectClass-2
C900
NCI Thesaurus Property
C25646
NCI Thesaurus Property-2
C25629
NCI Thesaurus Property-3
C15207
NCI Thesaurus Property-4
C25382
NCI Thesaurus ValueDomain
C25564
NCI Thesaurus ValueDomain-2
C25488
UMLS CUI-1
C0040845
UMLS CUI-2
C0806909
UMLS CUI-3
C0178602
mg/m^2/day
Is patient a woman of childbearing potential (indicator NO for males)
Description

FemalePatientPotentialPregnancyInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus ObjectClass-2
C16576
NCI Thesaurus Property
C25742
NCI Metathesaurus Property
C0237399
NCI Thesaurus ValueDomain
C38147
UMLS CUI-1
C3831118
Has a negative pregnancy test been performed
Description

PatientNegativePregnancyTestInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25247
NCI Metathesaurus Property
C0032976
UMLS CUI-1
C0427780
Date of pregnancy test
Description

PatientMostRecentPregnancyTestDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ObjectClass
C16960
NCI Metathesaurus Property
C0032976
NCI Thesaurus Property
C25577
UMLS CUI-1
C0032976
UMLS CUI-2
C0011008
Patient And Disease Description
Description

Patient And Disease Description

Height
Description

Height

Data type

float

Measurement units
  • cm
Alias
NCI Thesaurus ValueDomain
C25209
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25347
UMLS CUI-1
C0005890
cm
Date of Initial Pathologic Diagnosis
Description

CancerInitialDiagnosisDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C9305
NCI Thesaurus Property
C25509
NCI Thesaurus Property-2
C15220
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
UMLS CUI-1
C0006826
UMLS CUI-2
C2316983
Patient Disseminated Intravascular Coagulation Personal Medical History Indicator
Description

PatientDisseminatedIntravascularCoagulationPersonalMedicalHistoryIndicator

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C2992
UMLS 2011AA Property
C0012739
NCI Thesaurus Property-2
C18772
UMLS 2011AA Property-2
C0262926
Current Laboratory Values
Description

Current Laboratory Values

Date Hematology (Blood) Sample Obtained
Description

HematologyLabCollectedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus ValueDomain-2
C25452
Time hematology sample obtained
Description

HematologySpecimenCollectedTime

Data type

time

Alias
NCI Thesaurus ObjectClass
C16673
UMLS 2011AA ObjectClass
C0018943
NCI Thesaurus ValueDomain
C25207
UMLS 2011AA ValueDomain
C0040223
NCI Thesaurus ObjectClass-2
C19157
UMLS 2011AA ObjectClass-2
C0370003
NCI Thesaurus Property
C25452
Hemoglobin
Description

Hemoglobin

Data type

float

Alias
NCI Thesaurus Property
C16676
UMLS CUI-1
C0019046
NCI Thesaurus Property-2
C20200
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25712
Peripheral Platelet Count
Description

Platelets

Data type

float

Measurement units
  • 1000/uL
Alias
NCI Thesaurus Property
C20200
UMLS CUI-1
C0005821
NCI Thesaurus Property-2
C12520
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25712
1000/uL
Peripheral Blasts
Description

LaboratoryProcedureBlastCellOutcomePercentageValue

Data type

float

Measurement units
  • %
Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C12918
NCI Thesaurus ValueDomain
C25613
NCI Thesaurus ValueDomain-2
C25712
UMLS CUI-1
C0368761
%
Peripheral WBC Count
Description

Leukocytes (WBC)

Data type

float

Measurement units
  • 1000/uL
Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0023508
NCI Thesaurus Property
C12529
NCI Thesaurus Property-2
C20200
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C38024
1000/uL
Peripheral Promyelocytes
Description

LaboratoryProcedurePromyelocyteResultPercentageValue

Data type

float

Measurement units
  • %
Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C13114
NCI Thesaurus ValueDomain
C25613
NCI Thesaurus ValueDomain-2
C25712
UMLS CUI-1
C0455279
%
Peripheral Neutrophils (%)
Description

Neutrophil percentage

Data type

float

Measurement units
  • %
Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C1171400
NCI Thesaurus Property
C12533
NCI Thesaurus Property-2
C20200
NCI Thesaurus ValueDomain
C25613
NCI Thesaurus ValueDomain-2
C25712
%
Bone Marrow Biopsy Date
Description

BoneMarrowBiopsyDate

Data type

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
Marrow Blasts (%)
Description

Blasts, Bone Marrow

Data type

float

Measurement units
  • %
Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C1982687
NCI Thesaurus Property
C12431
NCI Thesaurus Property-2
C20200
NCI Thesaurus Property-3
C12918
NCI Thesaurus ValueDomain
C25613
NCI Thesaurus ValueDomain-2
C25712
%
Marrow Cellularity (%)
Description

Marrow Cellularity (%)

Data type

float

Measurement units
  • %
Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C12431
NCI Thesaurus Property-2
C20200
NCI Thesaurus Property-3
C37923
NCI Thesaurus ValueDomain
C25613
NCI Thesaurus ValueDomain-2
C25712
UMLS CUI-1
C1561532
%
Marrow Promyelocytes (%)
Description

LaboratoryProcedureBoneMarrowPromyelocyteResultPercentageValue

Data type

float

Measurement units
  • %
Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C12431
NCI Thesaurus Property-2
C20200
NCI Thesaurus Property-3
C13114
NCI Thesaurus ValueDomain
C25613
NCI Thesaurus ValueDomain-2
C25712
UMLS CUI-1
C0005953
UMLS CUI-2
C0033416
%
Marrow Cellularity Status
Description

LaboratoryProcedureBoneMarrowCellularityOutcomeStatus

Data type

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
C37923
UMLS 2011AA Property-3
C1516377
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
Date of Examination for Extramedullary Disease
Description

PatientExtramedullaryDiseaseAssessmentDate

Data type

date

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
C25164
UMLS 2011AA ValueDomain
C0011008
Extramedullary Disease Involvement
Description

DiseaseExtramedullaryInvolvementSite

Data type

text

Alias
NCI Thesaurus ValueDomain
C13717
UMLS 2011AA ValueDomain
C1515974
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property
C25548
UMLS 2011AA Property
C1314939
NCI Thesaurus Property-2
C25503
UMLS 2011AA Property-2
C1517060
Other, specify
Description

DiseaseExtramedullaryInvolvementOtherSite

Data type

text

Alias
NCI Thesaurus ValueDomain
C13717
UMLS 2011AA ValueDomain
C1515974
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property
C25548
UMLS 2011AA Property
C1314939
NCI Thesaurus Property-2
C25503
UMLS 2011AA Property-2
C1517060
Comments
Description

Comments

Comments
Description

Research Comments

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
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1 forms
  1. StudyEvent: SOUTHWEST ONCOLOGY GROUP Previously Untreated Acute Promyelocytic Leukemia Prestudy Form (S0521)
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
Trial subject ID SWOG
Item
SWOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1519429 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25699 (NCI Thesaurus Property-2)
Protocol ID SWOG
Item
SWOG Study No.
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1519429 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25699 (NCI Thesaurus Property-2)
Registration Number
Item
Registration Step
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 (L, F M)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
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)
Investigator Name
Item
Physician (Participating Group:)
text
C25191 (NCI Thesaurus ValueDomain)
C2826892 (UMLS CUI-1)
C25364 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
C25644 (NCI Thesaurus ObjectClass-2)
Item
Participating Group Name
text
C25191 (NCI Thesaurus ValueDomain)
C2347449 (UMLS CUI-1)
C25608 (NCI Thesaurus ObjectClass)
C17005 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
CL.1
Code List
Participating Group Name
CL Item
American College Of Surgeons Oncology Group (ACOSOG)
C19712 (NCI Thesaurus)
C1515944 (UMLS 2011AA)
CL Item
American College Of Radiology Oncologic Imaging Network (ACRIN)
CL Item
Aids-associated Malignancies Clinical Trials Consortium (AMC)
CL Item
Cancer And Leukemia Group B (CALGB)
C25442 (NCI Thesaurus)
C1516238 (UMLS 2011AA)
CL Item
Children's Oncology Group (COG)
C39353 (NCI Thesaurus)
C1516477 (UMLS 2011AA)
CL Item
Eastern Cooperative Oncology Group (ECOG)
C25491 (NCI Thesaurus)
C1512162 (UMLS 2011AA)
CL Item
European Organization For Research And Treatment Of Cancer (EORTC)
C19741 (NCI Thesaurus)
C1516985 (UMLS 2011AA)
CL Item
Gynecologic Oncology Group (GOG)
C25521 (NCI Thesaurus)
C1512288 (UMLS 2011AA)
CL Item
International Breast Cancer Study Group (IBCSG)
C25530 (NCI Thesaurus)
C1512890 (UMLS 2011AA)
CL Item
North American Brain Tumor Consortium (NABTC)
C37995 (NCI Thesaurus)
C1518418 (UMLS 2011AA)
CL Item
Nabtt Brain Tumor Consortium (NABTT)
CL Item
North Central Cancer Treatment Group (NCCTG)
C25581 (NCI Thesaurus)
C1518419 (UMLS 2011AA)
CL Item
National Cancer Institute Of Canada Clinical Trials Group (NCIC)
C39467 (NCI Thesaurus)
C1513885 (UMLS 2011AA)
CL Item
National Surgical Adjuvant Breast And Bowel Project (NSABP)
C15818 (NCI Thesaurus)
C1513905 (UMLS 2011AA)
CL Item
Radiation Therapy Oncology Group (RTOG)
C19778 (NCI Thesaurus)
C1514695 (UMLS 2011AA)
CL Item
Southwest Oncology Group (SWOG)
C25699 (NCI Thesaurus)
C1519429 (UMLS 2011AA)
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 (Instructions: All dates are MONTH, DAY, YEAR. Explain any blank fields or blank dates in the Comments section. Place an X in appropriate boxes. Circle AMENDED items in red and write AMENDED across the top of the form.)
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
Patient Characteristics
Item
Performance Status
text
C25664 (NCI Thesaurus ValueDomain)
C1520224 (UMLS CUI-1)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain-2)
C20641 (NCI Thesaurus ObjectClass)
CL.2
Code List
Performance Status
CL Item
Fully Active, Able To Carry On All Pre-disease Performance Without Restriction. (0)
CL Item
Restricted In Physically Strenuous Activity But Ambulatory And Able To Carry Out Work Of A Light Or Sedentary Nature, E.g., Light Housework, Office Work. (1)
CL Item
Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities. Up And About More Than 50% Of Waking Hours. (2)
CL Item
Capable Of Only Limited Selfcare, Confined To Bed Or Chair More Than 50% Of Waking Hours. (3)
CL Item
Completely Disabled. Cannot Carry On Any Selfcare. Totally Confined To Bed Or Chair. (4)
CL Item
Dead (5)
Item
Risk classification at first registration
text
C16960 (NCI Thesaurus ObjectClass)
C25320 (NCI Thesaurus Property)
C25646 (NCI Thesaurus Property-2)
C25509 (NCI Thesaurus Property-3)
C25372 (NCI Thesaurus ValueDomain)
C2991 (NCI Thesaurus ValueDomain-2)
C17102 (NCI Thesaurus ValueDomain-3)
C0086930 (UMLS CUI-1)
CL.3
Code List
Risk classification at first registration
CL Item
Intermediate Risk (intermediate)
C3640764 (UMLS CUI-1)
CL Item
Low Risk (low)
C3538919 (UMLS CUI-1)
Item
Specimen for RT-PCR (Pretreatment)
text
C18136 (NCI Thesaurus ObjectClass)
C0599161 (UMLS 2011AA ObjectClass)
C25453 (NCI Thesaurus Property)
C1516698 (UMLS 2011AA Property)
C25683 (NCI Thesaurus ValueDomain)
C0449416 (UMLS 2011AA ValueDomain)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
CL.4
Code List
Specimen for RT-PCR (Pretreatment)
CL Item
Bone Marrow (bone marrow)
C12431 (NCI Thesaurus)
C0005953 (UMLS 2011AA)
CL Item
Peripheral Blood (peripheral blood)
C0229664 (NCI Metathesaurus)
BoneMarrowSpecimenCollectionDate
Item
Date of marrow specimen collection
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C12431 (NCI Thesaurus ObjectClass)
C0005953 (UMLS 2011AA ObjectClass)
C25453 (NCI Thesaurus Property)
C1516698 (UMLS 2011AA Property)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
BloodSpecimenCollectionDate
Item
Date of blood specimen collection
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C12434 (NCI Thesaurus ObjectClass)
C0229664 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
C25452 (NCI Thesaurus Property)
ATRAAgentPriorClinicalTrialRegistrationAdministeredInd-2
Item
Did the patient receive ATRA prior to registration
boolean
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C900 (NCI Thesaurus ObjectClass-2)
C0040845 (UMLS 2011AA ObjectClass-2)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C15207 (NCI Thesaurus Property-3)
C25382 (NCI Thesaurus Property-4)
C1521801 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
ATRAAgentPriorClinicalTrialRegistrationAdministeredBeginDate
Item
Date ATRA first given
date
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C900 (NCI Thesaurus ObjectClass-2)
C0040845 (UMLS 2011AA ObjectClass-2)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C15207 (NCI Thesaurus Property-3)
C25382 (NCI Thesaurus Property-4)
C1521801 (UMLS 2011AA Property-3)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)
ATRAAgentPriorClinicalTrialRegistrationAdministeredDayCount
Item
Number of days of ATRA before registration
float
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C900 (NCI Thesaurus ObjectClass-2)
C0040845 (UMLS 2011AA ObjectClass-2)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C15207 (NCI Thesaurus Property-3)
C25382 (NCI Thesaurus Property-4)
C1521801 (UMLS 2011AA Property-3)
C25301 (NCI Thesaurus ValueDomain)
C0439228 (UMLS 2011AA ValueDomain)
C25463 (NCI Thesaurus ValueDomain-2)
C0750480 (UMLS 2011AA ValueDomain-2)
Maximum ATRA dose
Item
Maximum dose of ATRA before registration
float
C1708 (NCI Thesaurus ObjectClass)
C900 (NCI Thesaurus ObjectClass-2)
C25646 (NCI Thesaurus Property)
C25629 (NCI Thesaurus Property-2)
C15207 (NCI Thesaurus Property-3)
C25382 (NCI Thesaurus Property-4)
C25564 (NCI Thesaurus ValueDomain)
C25488 (NCI Thesaurus ValueDomain-2)
C0040845 (UMLS CUI-1)
C0806909 (UMLS CUI-2)
C0178602 (UMLS CUI-3)
Woman with childbearing potential
Item
Is patient a woman of childbearing potential (indicator NO for males)
boolean
C16960 (NCI Thesaurus ObjectClass)
C16576 (NCI Thesaurus ObjectClass-2)
C25742 (NCI Thesaurus Property)
C0237399 (NCI Metathesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C3831118 (UMLS CUI-1)
Pregnancy test negative
Item
Has a negative pregnancy test been performed
boolean
C38147 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25247 (NCI Thesaurus Property)
C0032976 (NCI Metathesaurus Property)
C0427780 (UMLS CUI-1)
Pregnancy test date
Item
Date of pregnancy test
date
C25164 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0032976 (NCI Metathesaurus Property)
C25577 (NCI Thesaurus Property)
C0032976 (UMLS CUI-1)
C0011008 (UMLS CUI-2)
Item Group
Patient And Disease Description
Height
Item
Height
float
C25209 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25347 (NCI Thesaurus Property)
C0005890 (UMLS CUI-1)
Tumor diagnosis date
Item
Date of Initial Pathologic Diagnosis
date
C9305 (NCI Thesaurus ObjectClass)
C25509 (NCI Thesaurus Property)
C15220 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C0006826 (UMLS CUI-1)
C2316983 (UMLS CUI-2)
Item
Patient Disseminated Intravascular Coagulation Personal Medical History Indicator
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C2992 (NCI Thesaurus Property)
C0012739 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property-2)
C0262926 (UMLS 2011AA Property-2)
CL.8
Code List
Patient Disseminated Intravascular Coagulation Personal Medical History Indicator
CL Item
No: C0028423 (No)
C0028423 (NCI Metathesaurus)
CL Item
Yes, With Bleeding (Yes, with bleeding)
CL Item
Yes, Without Bleeding (Yes, without bleeding)
Item Group
Current Laboratory Values
HematologyLabCollectedDate
Item
Date Hematology (Blood) Sample Obtained
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25452 (NCI Thesaurus ValueDomain-2)
HematologySpecimenCollectedTime
Item
Time hematology sample obtained
time
C16673 (NCI Thesaurus ObjectClass)
C0018943 (UMLS 2011AA ObjectClass)
C25207 (NCI Thesaurus ValueDomain)
C0040223 (UMLS 2011AA ValueDomain)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
C25452 (NCI Thesaurus Property)
Hemoglobin
Item
Hemoglobin
float
C16676 (NCI Thesaurus Property)
C0019046 (UMLS CUI-1)
C20200 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
Platelets
Item
Peripheral Platelet Count
float
C20200 (NCI Thesaurus Property)
C0005821 (UMLS CUI-1)
C12520 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
Blasts
Item
Peripheral Blasts
float
C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C12918 (NCI Thesaurus Property-2)
C25613 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C0368761 (UMLS CUI-1)
Leukocytes (WBC)
Item
Peripheral WBC Count
float
C25294 (NCI Thesaurus ObjectClass)
C0023508 (UMLS CUI-1)
C12529 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C38024 (NCI Thesaurus ValueDomain-2)
Promyelocytes
Item
Peripheral Promyelocytes
float
C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C13114 (NCI Thesaurus Property-2)
C25613 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C0455279 (UMLS CUI-1)
Neutrophil percentage
Item
Peripheral Neutrophils (%)
float
C25294 (NCI Thesaurus ObjectClass)
C1171400 (UMLS CUI-1)
C12533 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C25613 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
BoneMarrowBiopsyDate
Item
Bone Marrow Biopsy Date
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)
Blasts, Bone Marrow
Item
Marrow Blasts (%)
float
C25294 (NCI Thesaurus ObjectClass)
C1982687 (UMLS CUI-1)
C12431 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C12918 (NCI Thesaurus Property-3)
C25613 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
Bone Marrow Cellularity
Item
Marrow Cellularity (%)
float
C25294 (NCI Thesaurus ObjectClass)
C12431 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C37923 (NCI Thesaurus Property-3)
C25613 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1561532 (UMLS CUI-1)
Marrow Promyelocytes
Item
Marrow Promyelocytes (%)
float
C25294 (NCI Thesaurus ObjectClass)
C12431 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C13114 (NCI Thesaurus Property-3)
C25613 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C0005953 (UMLS CUI-1)
C0033416 (UMLS CUI-2)
Item
Marrow Cellularity Status
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)
C37923 (NCI Thesaurus Property-3)
C1516377 (UMLS 2011AA Property-3)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
CL.9
Code List
Marrow Cellularity Status
CL Item
Cellularity Status Of Bone Marrow Is Aplasitc (severely Hypocellular) (Aplastic (severely hypocellular))
CL Item
Cellularity Status Of Bone Marrow Unknown, Procedure Resulted In No Material To Analyze (Dry tap or inaspirable)
CL Item
Cellularity Status Of Bone Marrow Is Hypercellular (Hypercellular)
CL Item
Cellularity Status Of Bone Marrow Is Hypocellular (Hypocellular)
CL Item
Cellularity Status Of Bone Marrow Is Normocellular (Normocellular)
CL Item
Cellularity Status Of Bone Marrow Is Packed (intensely Hypercellular) (Packed (intensely hypercellular))
PatientExtramedullaryDiseaseAssessmentDate
Item
Date of Examination for Extramedullary Disease
date
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)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item
Extramedullary Disease Involvement
text
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25548 (NCI Thesaurus Property)
C1314939 (UMLS 2011AA Property)
C25503 (NCI Thesaurus Property-2)
C1517060 (UMLS 2011AA Property-2)
CL.10
Code List
Extramedullary Disease Involvement
CL Item
Gingival Hypertrophy (Gingival hypertrophy)
CL Item
Mediastinal Mass (Mediastinal mass)
CL Item
Peripheral Nervous System (Peripheral nervous system)
C12465 (NCI Thesaurus)
C0206417 (UMLS 2011AA)
CL Item
Skin (Skin (cutaneous))
C12470 (NCI Thesaurus)
C1123023 (UMLS 2011AA)
CL Item
Other Specify (Other)
DiseaseExtramedullaryInvolvementOtherSite
Item
Other, specify
text
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25548 (NCI Thesaurus Property)
C1314939 (UMLS 2011AA Property)
C25503 (NCI Thesaurus Property-2)
C1517060 (UMLS 2011AA Property-2)
Item Group
Comments
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
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