ID

6831

Beschreibung

SOUTHWEST ONCOLOGY GROUP Consolidation #1 And #2 Treatment Summary Form (S0521) 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=02DB2B73-5A1C-5C81-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=02DB2B73-5A1C-5C81-E044-0003BA3F9857

Stichworte

Versionen (2)
  1. 18/12/2014 18/12/2014 - Martin Dugas
  2. 08/01/2015 08/01/2015 - Martin Dugas
Hochgeladen am

8 de janeiro de 2015

DOI

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Lizenz

Creative Commons BY-NC 3.0 Legacy
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Leukemia NCT00492856 Treatment - SOUTHWEST ONCOLOGY GROUP Consolidation #1 And #2 Treatment Summary Form (S0521) - 2415788v1.0

Englisch

No Instruction available.

1 Formulare  
  1. StudyEvent: SOUTHWEST ONCOLOGY GROUP Consolidation #1 And #2 Treatment Summary Form (S0521)
    1. No Instruction available.
Header
Beschreibung

Header

SWOG Patient ID
Beschreibung

Trial subject ID SWOG

Datentyp

float

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.
Beschreibung

Protocol ID SWOG

Datentyp

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
Beschreibung

Registration Number

Datentyp

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
Cycle completed
Beschreibung

TreatmentCycleCompleteName

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Thesaurus ObjectClass
C25472
UMLS 2011AA ObjectClass
C1511572
NCI Thesaurus ObjectClass-2
C15368
Patient Initials (L, F M)
Beschreibung

Patient Initials

Datentyp

text

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

Institution Name

Datentyp

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:)
Beschreibung

Investigator Name

Datentyp

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
Beschreibung

Participating Group

Datentyp

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.
Beschreibung

Study Number Participating Group

Datentyp

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
Beschreibung

Trial subject ID Participating Group

Datentyp

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
Reporting Period
Beschreibung

Reporting Period

Reporting Period Start Date
Beschreibung

Reporting Period Start Date

Datentyp

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
Beschreibung

Reporting Period End Date

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2361259
NCI Thesaurus Property
C25616
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property-2
C25651
Patient And Disease Description
Beschreibung

Patient And Disease Description

Date of Last Contact or Death
Beschreibung

Date last contact

Datentyp

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
Vital Status
Beschreibung

Patient Status

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS CUI-1
C3846084
NCI Thesaurus ValueDomain
C18003
NCI Thesaurus ValueDomain-2
C25688
NCI Thesaurus Property
C25717
Physical
Beschreibung

Physical

Weight
Beschreibung

Patient Weight

Datentyp

float

Maßeinheiten
  • Kg
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0005910
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25208
Kg
BSA (Note: Enter values used to calculate doses.)
Beschreibung

Body Surface Area

Datentyp

float

Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0005902
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25157
Treatment: Atra
Beschreibung

Treatment: Atra

Did the patient receive arsenic trioxide during this reporting period?
Beschreibung

ArsenicTrioxideAgentCurrentReportPeriodAdministeredInd-2

Datentyp

boolean

Alias
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ObjectClass-2
C1005
UMLS 2011AA ObjectClass-2
C0052416
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property-2
C25471
UMLS 2011AA Property-2
C0521116
NCI Thesaurus Property-3
C25375
UMLS 2011AA Property-3
C0684224
NCI Thesaurus Property-4
C25382
UMLS 2011AA Property-4
C1521801
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Total dose of arsenic trioxide in this reporting period? (If yes, - mg)
Beschreibung

ArsenicTrioxideAgentCurrentReportPeriodAdminsteredTotalDose

Datentyp

float

Alias
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ObjectClass-2
C1005
UMLS 2011AA ObjectClass-2
C0052416
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property-2
C25471
UMLS 2011AA Property-2
C0521116
NCI Thesaurus Property-3
C25375
UMLS 2011AA Property-3
C0684224
NCI Thesaurus Property-4
C25382
UMLS 2011AA Property-4
C1521801
NCI Thesaurus ValueDomain
C25304
UMLS 2011AA ValueDomain
C0439810
NCI Thesaurus ValueDomain-2
C25488
UMLS 2011AA ValueDomain-2
C0178602
Start date of arsenic trioxide during this reporting period?
Beschreibung

ArsenicTrioxideAgentCurrentReportPeriodAdminsteredBeginDate

Datentyp

date

Alias
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ObjectClass-2
C1005
UMLS 2011AA ObjectClass-2
C0052416
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property-2
C25471
UMLS 2011AA Property-2
C0521116
NCI Thesaurus Property-3
C25375
UMLS 2011AA Property-3
C0684224
NCI Thesaurus Property-4
C25382
UMLS 2011AA Property-4
C1521801
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25431
UMLS 2011AA ValueDomain-2
C0439659
End date of arsenic trioxide during this reporting period?
Beschreibung

ArsenicTrioxideAgentCurrentReportPeriodAdminsteredEndDate

Datentyp

date

Alias
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ObjectClass-2
C1005
UMLS 2011AA ObjectClass-2
C0052416
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property-2
C25471
UMLS 2011AA Property-2
C0521116
NCI Thesaurus Property-3
C25375
UMLS 2011AA Property-3
C0684224
NCI Thesaurus Property-4
C25382
UMLS 2011AA Property-4
C1521801
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Treatment: Growth Factors
Beschreibung

Treatment: Growth Factors

If yes,
Beschreibung

GrowthFactorAgentCurrentReportPeriodAdministeredType

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C20424
UMLS 2011AA ObjectClass
C0018284
NCI Thesaurus ObjectClass-2
C1708
UMLS 2011AA ObjectClass-2
C0450442
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property-2
C25471
UMLS 2011AA Property-2
C0521116
NCI Thesaurus Property-3
C25375
UMLS 2011AA Property-3
C0684224
NCI Thesaurus Property-4
C25382
UMLS 2011AA Property-4
C1521801
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Other, specify
Beschreibung

GrowthFactorAgentCurrentReportPeriodAdministeredSpecify

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C20424
UMLS 2011AA ObjectClass
C0018284
NCI Thesaurus ObjectClass-2
C1708
UMLS 2011AA ObjectClass-2
C0450442
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property-2
C25471
UMLS 2011AA Property-2
C0521116
NCI Thesaurus Property-3
C25375
UMLS 2011AA Property-3
C0684224
NCI Thesaurus Property-4
C25382
UMLS 2011AA Property-4
C1521801
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Total dose of growth factor in this reporting period? (mcg)
Beschreibung

GrowthFactorAgentCurrentReportPeriodAdministeredTotalDose

Datentyp

float

Alias
NCI Thesaurus ObjectClass
C20424
UMLS 2011AA ObjectClass
C0018284
NCI Thesaurus ObjectClass-2
C1708
UMLS 2011AA ObjectClass-2
C0450442
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property-2
C25471
UMLS 2011AA Property-2
C0521116
NCI Thesaurus Property-3
C25375
UMLS 2011AA Property-3
C0684224
NCI Thesaurus Property-4
C25382
UMLS 2011AA Property-4
C1521801
NCI Thesaurus ValueDomain
C25304
UMLS 2011AA ValueDomain
C0439810
NCI Thesaurus ValueDomain-2
C25488
UMLS 2011AA ValueDomain-2
C0178602
Start date of growth factor during this reporting period?
Beschreibung

GrowthFactorAgentCurrentReportPeriodAdministeredBeginDate

Datentyp

date

Alias
NCI Thesaurus ObjectClass
C20424
UMLS 2011AA ObjectClass
C0018284
NCI Thesaurus ObjectClass-2
C1708
UMLS 2011AA ObjectClass-2
C0450442
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property-2
C25471
UMLS 2011AA Property-2
C0521116
NCI Thesaurus Property-3
C25375
UMLS 2011AA Property-3
C0684224
NCI Thesaurus Property-4
C25382
UMLS 2011AA Property-4
C1521801
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25431
UMLS 2011AA ValueDomain-2
C0439659
End date of growth factor during this reporting period?
Beschreibung

GrowthFactorAgentCurrentReportPeriodAdministeredEndDate

Datentyp

date

Alias
NCI Thesaurus ObjectClass
C20424
UMLS 2011AA ObjectClass
C0018284
NCI Thesaurus ObjectClass-2
C1708
UMLS 2011AA ObjectClass-2
C0450442
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property-2
C25471
UMLS 2011AA Property-2
C0521116
NCI Thesaurus Property-3
C25375
UMLS 2011AA Property-3
C0684224
NCI Thesaurus Property-4
C25382
UMLS 2011AA Property-4
C1521801
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Was growth factor permanently discontined during this reporting period?
Beschreibung

GrowthFactorAgentCurrentReportPeriodDiscontinuedInd-2

Datentyp

boolean

Alias
NCI Thesaurus ObjectClass
C20424
UMLS 2011AA ObjectClass
C0018284
NCI Thesaurus ObjectClass-2
C1708
UMLS 2011AA ObjectClass-2
C0450442
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property-2
C25471
UMLS 2011AA Property-2
C0521116
NCI Thesaurus Property-3
C25375
UMLS 2011AA Property-3
C0684224
NCI Thesaurus Property-4
C25484
UMLS 2011AA Property-4
C1444662
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Was growth factor permanently discontined during this reporting period?
Beschreibung

GrowthFactorAgentCurrentReportPeriodDiscontinuedInd-2

Datentyp

boolean

Alias
NCI Thesaurus ObjectClass
C20424
UMLS 2011AA ObjectClass
C0018284
NCI Thesaurus ObjectClass-2
C1708
UMLS 2011AA ObjectClass-2
C0450442
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property-2
C25471
UMLS 2011AA Property-2
C0521116
NCI Thesaurus Property-3
C25375
UMLS 2011AA Property-3
C0684224
NCI Thesaurus Property-4
C25484
UMLS 2011AA Property-4
C1444662
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Date of discontinuation (If yes,)
Beschreibung

GrowthFactorAgentCurrentReportPeriodDiscontinuedDate

Datentyp

date

Alias
NCI Thesaurus ObjectClass
C20424
UMLS 2011AA ObjectClass
C0018284
NCI Thesaurus ObjectClass-2
C1708
UMLS 2011AA ObjectClass-2
C0450442
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property-2
C25471
UMLS 2011AA Property-2
C0521116
NCI Thesaurus Property-3
C25375
UMLS 2011AA Property-3
C0684224
NCI Thesaurus Property-4
C25484
UMLS 2011AA Property-4
C1444662
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Treatment: Other Therapy
Beschreibung

Treatment: Other Therapy

Did the patient receive other therapy during this reporting period? (If yes, give start and end dates and describe the other therapy in the Comments section.)
Beschreibung

UnspecifiedAgentCurrentReportPeriodAdministeredInd-2

Datentyp

boolean

Alias
NCI Thesaurus ObjectClass
C38046
UMLS 2011AA ObjectClass
C0205370
NCI Thesaurus ObjectClass-2
C1708
UMLS 2011AA ObjectClass-2
C0450442
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property-2
C25471
UMLS 2011AA Property-2
C0521116
NCI Thesaurus Property-3
C25375
UMLS 2011AA Property-3
C0684224
NCI Thesaurus Property-4
C25382
UMLS 2011AA Property-4
C1521801
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Specify agent
Beschreibung

UnspecifiedAgentCurrentReportPeriodAdministeredSpecify

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C38046
UMLS 2011AA ObjectClass
C0205370
NCI Thesaurus ObjectClass-2
C1708
UMLS 2011AA ObjectClass-2
C0450442
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property-2
C25471
UMLS 2011AA Property-2
C0521116
NCI Thesaurus Property-3
C25375
UMLS 2011AA Property-3
C0684224
NCI Thesaurus Property-4
C25382
UMLS 2011AA Property-4
C1521801
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Dose Modifications
Beschreibung

Dose Modifications

Were there any dose modifications or additions/omissions to protocol treatment?
Beschreibung

Dose Modification

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS CUI-1
C1707811
NCI Thesaurus ObjectClass
C25256
NCI Thesaurus Property
C25572
NCI Thesaurus ValueDomain-2
C25572
Plans For Consildation #3 And #4
Beschreibung

Plans For Consildation #3 And #4

Is this patient expected to receive consolidation #3 and #4? (see NOTE in protocol section 7.3)
Beschreibung

ThirdCycleConsolidationTherapyAdministeredInd-2

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C25472
UMLS 2011AA ObjectClass
C1511572
NCI Thesaurus ObjectClass-2
C25260
UMLS 2011AA ObjectClass-2
C0205437
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ObjectClass-3
C15679
UMLS 2011AA ObjectClass-3
C1511484
Ejection fraction
Beschreibung

LeftVentricularEjectionFractionAssessmentType

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ObjectClass
C37946
UMLS 2011AA ObjectClass
C2700377
LVEF
Beschreibung

HeartLVEFTestPercentageValue

Datentyp

float

Maßeinheiten
  • %
Alias
NCI Thesaurus ObjectClass
C12727
UMLS 2011AA ObjectClass
C0018787
NCI Thesaurus Property
C25294
UMLS 2011AA Property
C0022885
NCI Thesaurus Property-2
C37946
UMLS 2011AA Property-2
C2700377
NCI Thesaurus ValueDomain
C25613
UMLS 2011AA ValueDomain
C0439165
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
%
Collection Date
Beschreibung

SpecimenCollectedDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C19157
UMLS 2011AA ObjectClass
C0370003
NCI Thesaurus Property
C25452
NCI Thesaurus Property-2
C25275
UMLS 2011AA Property
C2745955
Other evidence of inadequate LV function
Beschreibung

HeartLeftVentricularEjectionFractionReducedFunctionSpecify

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C12727
UMLS 2011AA ObjectClass
C0018787
NCI Thesaurus Property
C25640
UMLS 2011AA Property
C0392756
NCI Thesaurus Property-2
C25518
UMLS 2011AA Property-2
C0542341
NCI Thesaurus Property-3
C37946
UMLS 2011AA Property-3
C2700377
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Other reason, specify
Beschreibung

ThirdCycleConsolidationTherapyOffTreatmentSpecify

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C25472
UMLS 2011AA ObjectClass
C1511572
NCI Thesaurus ObjectClass-2
C25260
UMLS 2011AA ObjectClass-2
C0205437
NCI Thesaurus ObjectClass-3
C15679
UMLS 2011AA ObjectClass-3
C1511484
NCI Thesaurus Property
C25601
UMLS 2011AA Property
C1518544
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Comments
Beschreibung

Comments

Comments
Beschreibung

Research Comments

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
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1 Formulare
  1. StudyEvent: SOUTHWEST ONCOLOGY GROUP Consolidation #1 And #2 Treatment Summary Form (S0521)
    1. No Instruction available.
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Header
Trial subject ID SWOG
Item
SWOG Patient ID
float
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)
Item
Cycle completed
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25472 (NCI Thesaurus ObjectClass)
C1511572 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
CL.1
Code List
Cycle completed
CL Item
First Arsenic Consolidation (First arsenic consolidation)
CL Item
Second Arsenic Consolidation (Second arsenic consolidation)
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.2
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
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
Reporting Period
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)
Item Group
Patient And Disease Description
Date last contact
Item
Date of Last Contact or Death
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
Vital Status
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
Vital Status
CL Item
Alive (Alive)
CL Item
Dead (Dead)
Item Group
Physical
Patient Weight
Item
Weight
float
C25209 (NCI Thesaurus ValueDomain)
C0005910 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)
Body Surface Area
Item
BSA (Note: Enter values used to calculate doses.)
float
C25209 (NCI Thesaurus ValueDomain)
C0005902 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25157 (NCI Thesaurus Property)
Item Group
Treatment: Atra
ArsenicTrioxideAgentCurrentReportPeriodAdministeredInd-2
Item
Did the patient receive arsenic trioxide during this reporting period?
boolean
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C1005 (NCI Thesaurus ObjectClass-2)
C0052416 (UMLS 2011AA ObjectClass-2)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25471 (NCI Thesaurus Property-2)
C0521116 (UMLS 2011AA Property-2)
C25375 (NCI Thesaurus Property-3)
C0684224 (UMLS 2011AA Property-3)
C25382 (NCI Thesaurus Property-4)
C1521801 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
ArsenicTrioxideAgentCurrentReportPeriodAdminsteredTotalDose
Item
Total dose of arsenic trioxide in this reporting period? (If yes, - mg)
float
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C1005 (NCI Thesaurus ObjectClass-2)
C0052416 (UMLS 2011AA ObjectClass-2)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25471 (NCI Thesaurus Property-2)
C0521116 (UMLS 2011AA Property-2)
C25375 (NCI Thesaurus Property-3)
C0684224 (UMLS 2011AA Property-3)
C25382 (NCI Thesaurus Property-4)
C1521801 (UMLS 2011AA Property-4)
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25488 (NCI Thesaurus ValueDomain-2)
C0178602 (UMLS 2011AA ValueDomain-2)
ArsenicTrioxideAgentCurrentReportPeriodAdminsteredBeginDate
Item
Start date of arsenic trioxide during this reporting period?
date
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C1005 (NCI Thesaurus ObjectClass-2)
C0052416 (UMLS 2011AA ObjectClass-2)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25471 (NCI Thesaurus Property-2)
C0521116 (UMLS 2011AA Property-2)
C25375 (NCI Thesaurus Property-3)
C0684224 (UMLS 2011AA Property-3)
C25382 (NCI Thesaurus Property-4)
C1521801 (UMLS 2011AA Property-4)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)
ArsenicTrioxideAgentCurrentReportPeriodAdminsteredEndDate
Item
End date of arsenic trioxide during this reporting period?
date
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C1005 (NCI Thesaurus ObjectClass-2)
C0052416 (UMLS 2011AA ObjectClass-2)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25471 (NCI Thesaurus Property-2)
C0521116 (UMLS 2011AA Property-2)
C25375 (NCI Thesaurus Property-3)
C0684224 (UMLS 2011AA Property-3)
C25382 (NCI Thesaurus Property-4)
C1521801 (UMLS 2011AA Property-4)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item Group
Treatment: Growth Factors
Item
If yes,
text
C20424 (NCI Thesaurus ObjectClass)
C0018284 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25471 (NCI Thesaurus Property-2)
C0521116 (UMLS 2011AA Property-2)
C25375 (NCI Thesaurus Property-3)
C0684224 (UMLS 2011AA Property-3)
C25382 (NCI Thesaurus Property-4)
C1521801 (UMLS 2011AA Property-4)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.6
Code List
If yes,
CL Item
Granulocyte-macrophage Colony-stimulating Factor (G-CSF)
CL Item
Recombinant Granulocyte-macrophage Colony-stimulating Factor (rhGM_CSF)
C1288 (NCI Thesaurus)
C0376563 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
GrowthFactorAgentCurrentReportPeriodAdministeredSpecify
Item
Other, specify
text
C20424 (NCI Thesaurus ObjectClass)
C0018284 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25471 (NCI Thesaurus Property-2)
C0521116 (UMLS 2011AA Property-2)
C25375 (NCI Thesaurus Property-3)
C0684224 (UMLS 2011AA Property-3)
C25382 (NCI Thesaurus Property-4)
C1521801 (UMLS 2011AA Property-4)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
GrowthFactorAgentCurrentReportPeriodAdministeredTotalDose
Item
Total dose of growth factor in this reporting period? (mcg)
float
C20424 (NCI Thesaurus ObjectClass)
C0018284 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25471 (NCI Thesaurus Property-2)
C0521116 (UMLS 2011AA Property-2)
C25375 (NCI Thesaurus Property-3)
C0684224 (UMLS 2011AA Property-3)
C25382 (NCI Thesaurus Property-4)
C1521801 (UMLS 2011AA Property-4)
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25488 (NCI Thesaurus ValueDomain-2)
C0178602 (UMLS 2011AA ValueDomain-2)
GrowthFactorAgentCurrentReportPeriodAdministeredBeginDate
Item
Start date of growth factor during this reporting period?
date
C20424 (NCI Thesaurus ObjectClass)
C0018284 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25471 (NCI Thesaurus Property-2)
C0521116 (UMLS 2011AA Property-2)
C25375 (NCI Thesaurus Property-3)
C0684224 (UMLS 2011AA Property-3)
C25382 (NCI Thesaurus Property-4)
C1521801 (UMLS 2011AA Property-4)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)
GrowthFactorAgentCurrentReportPeriodAdministeredEndDate
Item
End date of growth factor during this reporting period?
date
C20424 (NCI Thesaurus ObjectClass)
C0018284 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25471 (NCI Thesaurus Property-2)
C0521116 (UMLS 2011AA Property-2)
C25375 (NCI Thesaurus Property-3)
C0684224 (UMLS 2011AA Property-3)
C25382 (NCI Thesaurus Property-4)
C1521801 (UMLS 2011AA Property-4)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
GrowthFactorAgentCurrentReportPeriodDiscontinuedInd-2
Item
Was growth factor permanently discontined during this reporting period?
boolean
C20424 (NCI Thesaurus ObjectClass)
C0018284 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25471 (NCI Thesaurus Property-2)
C0521116 (UMLS 2011AA Property-2)
C25375 (NCI Thesaurus Property-3)
C0684224 (UMLS 2011AA Property-3)
C25484 (NCI Thesaurus Property-4)
C1444662 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
GrowthFactorAgentCurrentReportPeriodDiscontinuedInd-2
Item
Was growth factor permanently discontined during this reporting period?
boolean
C20424 (NCI Thesaurus ObjectClass)
C0018284 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25471 (NCI Thesaurus Property-2)
C0521116 (UMLS 2011AA Property-2)
C25375 (NCI Thesaurus Property-3)
C0684224 (UMLS 2011AA Property-3)
C25484 (NCI Thesaurus Property-4)
C1444662 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
GrowthFactorAgentCurrentReportPeriodDiscontinuedDate
Item
Date of discontinuation (If yes,)
date
C20424 (NCI Thesaurus ObjectClass)
C0018284 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25471 (NCI Thesaurus Property-2)
C0521116 (UMLS 2011AA Property-2)
C25375 (NCI Thesaurus Property-3)
C0684224 (UMLS 2011AA Property-3)
C25484 (NCI Thesaurus Property-4)
C1444662 (UMLS 2011AA Property-4)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item Group
Treatment: Other Therapy
UnspecifiedAgentCurrentReportPeriodAdministeredInd-2
Item
Did the patient receive other therapy during this reporting period? (If yes, give start and end dates and describe the other therapy in the Comments section.)
boolean
C38046 (NCI Thesaurus ObjectClass)
C0205370 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25471 (NCI Thesaurus Property-2)
C0521116 (UMLS 2011AA Property-2)
C25375 (NCI Thesaurus Property-3)
C0684224 (UMLS 2011AA Property-3)
C25382 (NCI Thesaurus Property-4)
C1521801 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
UnspecifiedAgentCurrentReportPeriodAdministeredSpecify
Item
Specify agent
text
C38046 (NCI Thesaurus ObjectClass)
C0205370 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25471 (NCI Thesaurus Property-2)
C0521116 (UMLS 2011AA Property-2)
C25375 (NCI Thesaurus Property-3)
C0684224 (UMLS 2011AA Property-3)
C25382 (NCI Thesaurus Property-4)
C1521801 (UMLS 2011AA Property-4)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Item Group
Dose Modifications
Item
Were there any dose modifications or additions/omissions to protocol treatment?
text
C25180 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25256 (NCI Thesaurus ObjectClass)
C25572 (NCI Thesaurus Property)
C25572 (NCI Thesaurus ValueDomain-2)
CL.9
Code List
Were there any dose modifications or additions/omissions to protocol treatment?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes, Planned (i.e., The Treatment Was Changed According To Protocol Guidelines) (Yes, planned)
CL Item
Yes, Unplanned (i.e., The Treatment Change Was Not Part Of Protocol Guidelines) (Yes, unplanned)
Item Group
Plans For Consildation #3 And #4
ThirdCycleConsolidationTherapyAdministeredInd-2
Item
Is this patient expected to receive consolidation #3 and #4? (see NOTE in protocol section 7.3)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25472 (NCI Thesaurus ObjectClass)
C1511572 (UMLS 2011AA ObjectClass)
C25260 (NCI Thesaurus ObjectClass-2)
C0205437 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C15679 (NCI Thesaurus ObjectClass-3)
C1511484 (UMLS 2011AA ObjectClass-3)
Item
Ejection fraction
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C37946 (NCI Thesaurus ObjectClass)
C2700377 (UMLS 2011AA ObjectClass)
CL.11
Code List
Ejection fraction
CL Item
Echocardiogram (Echocardiogram)
C37945 (NCI Thesaurus)
C2243117 (UMLS 2011AA)
CL Item
Radionuclide Ventriculogram Scan (Multiple Gated Acquisition (MUGA))
C38073 (NCI Thesaurus)
C0521317 (UMLS 2011AA)
HeartLVEFTestPercentageValue
Item
LVEF
float
C12727 (NCI Thesaurus ObjectClass)
C0018787 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C37946 (NCI Thesaurus Property-2)
C2700377 (UMLS 2011AA Property-2)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
SpecimenCollectedDate
Item
Collection Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C25452 (NCI Thesaurus Property)
C25275 (NCI Thesaurus Property-2)
C2745955 (UMLS 2011AA Property)
HeartLeftVentricularEjectionFractionReducedFunctionSpecify
Item
Other evidence of inadequate LV function
text
C12727 (NCI Thesaurus ObjectClass)
C0018787 (UMLS 2011AA ObjectClass)
C25640 (NCI Thesaurus Property)
C0392756 (UMLS 2011AA Property)
C25518 (NCI Thesaurus Property-2)
C0542341 (UMLS 2011AA Property-2)
C37946 (NCI Thesaurus Property-3)
C2700377 (UMLS 2011AA Property-3)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
ThirdCycleConsolidationTherapyOffTreatmentSpecify
Item
Other reason, specify
text
C25472 (NCI Thesaurus ObjectClass)
C1511572 (UMLS 2011AA ObjectClass)
C25260 (NCI Thesaurus ObjectClass-2)
C0205437 (UMLS 2011AA ObjectClass-2)
C15679 (NCI Thesaurus ObjectClass-3)
C1511484 (UMLS 2011AA ObjectClass-3)
C25601 (NCI Thesaurus Property)
C1518544 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
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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