ID

43030

Descripción

GOG-0229K: Fast Fact Sheet for Protocol 0229-K (Endometrium) BIBF 1120 in Treating Patients With Recurrent or Persistent Endometrial Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=99D51BE9-A450-39B5-E040-BB89AD43255D

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=99D51BE9-A450-39B5-E040-BB89AD43255D

Palabras clave

Versiones (3)
  1. 18/12/14 18/12/14 - Martin Dugas
  2. 9/1/15 9/1/15 - Martin Dugas
  3. 17/9/21 17/9/21 -
Subido en

17 de septiembre de 2021

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0 Legacy
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Endometrial Cancer NCT01225887 Pre-Study - GOG-0229K: Fast Fact Sheet for Protocol 0229-K (Endometrium) - 3183206v1.0

Inglés

No Instruction available.

1 formularios  
  1. StudyEvent: GOG-0229K: Fast Fact Sheet for Protocol 0229-K (Endometrium)
    1. No Instruction available.
Tracking Information
Descripción

Tracking Information

GOG Institution Code
Descripción

InstitutionGynecologicOncologyGroupIdentifierCode

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus ObjectClass
C21541
UMLS 2011AA ObjectClass
C0018704
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property-2
C25521
UMLS 2011AA Property-2
C1512288
GOG Affiliate Code
Descripción

AffiliatedInstitutionGynecologicOncologyGroupIdentifierCode

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C21541
UMLS 2011AA ObjectClass
C0018704
NCI Thesaurus ObjectClass-2
C25413
UMLS 2011AA ObjectClass-2
C1510826
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property-2
C25521
UMLS 2011AA Property-2
C1512288
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
Previous GOG #
Descripción

PriorClinicalStudyProtocolGynecologicOncologyGroupIdentifierNumber

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property-2
C25521
UMLS 2011AA Property-2
C1512288
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
Treating physician
Descripción

TreatingPhysicianName

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C25741
UMLS 2011AA ObjectClass
C0031831
NCI Thesaurus ObjectClass-2
C25705
UMLS 2011AA ObjectClass-2
C1522326
Other Physician
Descripción

PhysicianPersonVerificationIdentifierName

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus ObjectClass-2
C25741
UMLS 2011AA ObjectClass-2
C0031831
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property-2
C45513
UMLS 2011AA Property-2
C1711411
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
Patient Hospital No.
Descripción

Medical Record Number

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1301894
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25261
NCI Thesaurus Property-2
C25198
Date of Birth
Descripción

PersonBirthDate

Tipo de datos

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25155
UMLS 2011AA Property
C0005615
Patient Last Name
Descripción

Last Name

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1301584
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25551
Patient First Name
Descripción

First Name

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1443235
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25509
Patient Middle Name
Descripción

PatientMiddleName

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property-2
C25569
UMLS 2011AA Property-2
C0444598
Header
Descripción

Header

Did the patient sign an approved informed consent
Descripción

InformedConsentFormSignedInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16468
UMLS 2011AA ObjectClass
C0009797
NCI Thesaurus Property
C25679
Is the SGOT less than or equal to 3 X ULN (regardless of the presence of liver metastases)
Descripción

LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseUpperLimitofNormalResultInd-2

Tipo de datos

boolean

Has HIPAA authorization been obtained
Descripción

HealthInsurancePortabilityandAccountabilityActAuthorizationIndicator

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C62504
UMLS 2011AA ObjectClass
C0600593
NCI Thesaurus Property
C41192
UMLS 2011AA Property
C1524004
Is the patient eligible for a higher priority GOG protocol
Descripción

PersonPriorityGynecologicOncologyGroupClinicalTrialEligibilityCriteriaInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25521
UMLS 2011AA Property
C1512288
NCI Thesaurus Property-2
C16112
UMLS 2011AA Property-2
C1516637
NCI Thesaurus Property-3
C48911
UMLS 2011AA Property-3
C0549179
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
What is the site of the disease
Descripción

GynecologicMalignantNeoplasmPrimarySite

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus ObjectClass-2
C28016
UMLS 2011AA ObjectClass-2
C0205480
NCI Thesaurus Property
C25341
UMLS 2011AA Property
C0450429
NCI Thesaurus Property-2
C25251
UMLS 2011AA Property-2
C0205225
NCI Thesaurus ValueDomain
C13717
UMLS 2011AA ValueDomain
C1515974
What is the cell type?
Descripción

PersonMalignantNeoplasmPathologyClinicalTrialEligibilityCriteriaMalignantNeoplasmPathologyType

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C9305
UMLS 2011AA Property
C0006826
NCI Thesaurus Property-2
C18189
UMLS 2011AA Property-2
C0030664
NCI Thesaurus Property-3
C16112
UMLS 2011AA Property-3
C1516637
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Date of initial histologic diagnosis of malignancy
Descripción

MalignantNeoplasmInitialHistologicDiagnosisDate

Tipo de datos

date

Alias
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
NCI Thesaurus Property-2
C25526
UMLS 2011AA Property-2
C0205462
NCI Thesaurus Property-3
C15220
UMLS 2011AA Property-3
C0011900
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
What was the grade of the primary tumor
Descripción

GynecologicTumorHistologicGrade

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C28016
UMLS 2011AA ObjectClass-2
C0205480
NCI Thesaurus Property
C25526
UMLS 2011AA Property
C0205462
NCI Thesaurus Property-2
C25365
UMLS 2011AA Property-2
C0678257
NCI Thesaurus ValueDomain
C25526
UMLS 2011AA ValueDomain
C0205462
NCI Thesaurus ValueDomain-2
C18000
UMLS 2011AA ValueDomain-2
C0919553
Is the disease recurrent or persistent with documented progression? Which one?
Descripción

PersonMalignantNeoplasmRecurrentDiseaseDiseaseProgressionClinicalTrialEligibilityCriteriaStatus

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C38155
UMLS 2011AA Property
C0277556
NCI Thesaurus Property-2
C9305
UMLS 2011AA Property-2
C0006826
NCI Thesaurus Property-3
C17747
UMLS 2011AA Property-3
C0242656
NCI Thesaurus Property-4
C16112
UMLS 2011AA Property-4
C1516637
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
Is the cancer refractory to curative therapy or established treatment?
Descripción

DiseaseTreatmentRefractoryInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property
C15368
How was it established to be recurrent or persistent?
Descripción

PersonMalignantNeoplasmRecurrentDiseaseDiseaseProgressionDiagnosisType

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C38155
UMLS 2011AA Property
C0277556
NCI Thesaurus Property-2
C9305
UMLS 2011AA Property-2
C0006826
NCI Thesaurus Property-3
C17747
UMLS 2011AA Property-3
C0242656
NCI Thesaurus Property-4
C15220
UMLS 2011AA Property-4
C0011900
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Date recurrence or persistence documented? (NOTE: This should be the date of the most recent progression or persistence that made the patient eligible for this study.)
Descripción

PersonMalignantNeoplasmRecurrentDiseaseDiseaseProgressionDiagnosisDate

Tipo de datos

date

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C38155
UMLS 2011AA Property
C0277556
NCI Thesaurus Property-2
C9305
UMLS 2011AA Property-2
C0006826
NCI Thesaurus Property-3
C17747
UMLS 2011AA Property-3
C0242656
NCI Thesaurus Property-4
C15220
UMLS 2011AA Property-4
C0011900
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Does patient have measurable disease defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded) using RECIST 1.1 criteria?
Descripción

PersonMalignantNeoplasmMeasurableDiseasePresentClinicalTrialEligibilityCriteriaIndicator

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus Property-2
C9305
UMLS 2011AA Property-2
C0006826
NCI Thesaurus Property-3
C8507
UMLS 2011AA Property-3
C1513041
NCI Thesaurus Property-4
C16112
UMLS 2011AA Property-4
C1516637
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
What method of evaluation is used to obtain tumor measurements?
Descripción

MalignantNeoplasmMeasurableDiseaseEvaluationMethodClinicalTrialEligibilityCriteriaType

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25214
UMLS 2011AA Property
C0220825
NCI Thesaurus Property-2
C9305
UMLS 2011AA Property-2
C0006826
NCI Thesaurus Property-3
C8507
UMLS 2011AA Property-3
C1513041
NCI Thesaurus Property-4
C71460
UMLS 2011AA Property-4
C0025663
NCI Thesaurus Property-5
C16112
UMLS 2011AA Property-5
C1516637
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Is the measurable disease > or = 10 mm when measured by CT, MRI or caliper measurement by clinical exam; or > or = 20 mm when measured by chest x-ray or lymph nodes > or = 15 mm in short axis when measured by CT or MRI?
Descripción

PersonMalignantNeoplasmMeasurableDiseaseSizePresentClinicalTrialEligibilityCriteriaIndicator

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus Property-2
C9305
UMLS 2011AA Property-2
C0006826
NCI Thesaurus Property-3
C8507
UMLS 2011AA Property-3
C1513041
NCI Thesaurus Property-4
C16112
UMLS 2011AA Property-4
C1516637
NCI Thesaurus Property-5
C25681
UMLS 2011AA Property-5
C0456389
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Does the patient have at least one target lesion to be used to assess response on this protocol as defined by RECIST 1.1?
Descripción

PersonMalignantNeoplasmMeasurableDiseaseResponseEvaluationCriteriainSolidTumorsClinicalTrialEligibilityCriteriaIndicator

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C9305
UMLS 2011AA Property
C0006826
NCI Thesaurus Property-2
C8507
UMLS 2011AA Property-2
C1513041
NCI Thesaurus Property-3
C16112
UMLS 2011AA Property-3
C1516637
NCI Thesaurus Property-4
C49164
UMLS 2011AA Property-4
C1709926
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Is the measurable disease in a previously irradiated field?
Descripción

PersonMalignantNeoplasmMeasurableDiseaseRadiationFieldClinicalTrialEligibilityCriteriaIndicator

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C9305
UMLS 2011AA Property
C0006826
NCI Thesaurus Property-2
C8507
UMLS 2011AA Property-2
C1513041
NCI Thesaurus Property-3
C54648
UMLS 2011AA Property-3
C1882536
NCI Thesaurus Property-4
C16112
UMLS 2011AA Property-4
C1516637
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
If yes, does the patient have disease in an irradiated field as the only site of measurable disease and has progression been documented or a biopsy obtained to confirm persistent disease at least 90 days following completion of radiation treatment?
Descripción

PersonMalignantNeoplasmMeasurableDiseaseRadiationFieldClinicalTrialEligibilityCriteriaInd-3b

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C9305
UMLS 2011AA Property
C0006826
NCI Thesaurus Property-2
C8507
UMLS 2011AA Property-2
C1513041
NCI Thesaurus Property-3
C54648
UMLS 2011AA Property-3
C1882536
NCI Thesaurus Property-4
C16112
UMLS 2011AA Property-4
C1516637
NCI Thesaurus ValueDomain
C49797
UMLS 2011AA ValueDomain
C1708496
Performance Status
Descripción

ECOG Performance Status

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS CUI-1
C1520224
NCI Thesaurus Property
C25367
NCI Thesaurus ValueDomain-2
C25491
NCI Thesaurus ObjectClass
C20641
Does the patient have normal thyroid function?
Descripción

PersonThyroidGlandFunctionClinicalTrialEligibilityCriteriaInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C12400
UMLS 2011AA Property
C0040132
NCI Thesaurus Property-2
C25518
UMLS 2011AA Property-2
C0542341
NCI Thesaurus Property-3
C16112
UMLS 2011AA Property-3
C1516637
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Has the patient recovered from the effects of recent surgery, radiotherapy or chemotherapy?
Descripción

PersonLastTherapeuticProcedureRecoveryClinicalTrialEligibilityCriteriaInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C49236
UMLS 2011AA Property
C0087111
NCI Thesaurus Property-2
C25746
UMLS 2011AA Property-2
C2004454
NCI Thesaurus Property-3
C25551
UMLS 2011AA Property-3
C1517741
NCI Thesaurus Property-4
C16112
UMLS 2011AA Property-4
C1516637
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Is the patient free of active infection requiring antibiotics with the exception of uncomplicated urinary tract infection (UTI)?
Descripción

PersonNoInfectionRequiredAntibioticClinicalTrialEligibilityCriteriaInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C49487
UMLS 2011AA Property
C1298908
NCI Thesaurus Property-2
C26726
UMLS 2011AA Property-2
C0009450
NCI Thesaurus Property-3
C258
UMLS 2011AA Property-3
C0003232
NCI Thesaurus Property-4
C25652
UMLS 2011AA Property-4
C1514873
NCI Thesaurus Property-5
C16112
UMLS 2011AA Property-5
C1516637
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Has any hormonal therapy directed at the malignant tumor been discontinued at least one week prior to registration?
Descripción

PersonMalignantNeoplasmEndocrineTherapyClinicalTrialEligibilityCriteriaInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C9305
UMLS 2011AA Property
C0006826
NCI Thesaurus Property-2
C15445
UMLS 2011AA Property-2
C0279025
NCI Thesaurus Property-3
C16112
UMLS 2011AA Property-3
C1516637
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Has all prior therapy directed at the malignant tumor, including immunologic agents, been discontinued for at least three weeks prior to registration?
Descripción

PersonTherapeuticProcedureDiscontinuedPriorRegistrationClinicalTrialEligibilityCriteriaInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
NCI Thesaurus Property-2
C25629
UMLS 2011AA Property-2
C0332152
NCI Thesaurus Property-3
C49236
UMLS 2011AA Property-3
C0087111
NCI Thesaurus Property-4
C25484
UMLS 2011AA Property-4
C1444662
NCI Thesaurus Property-5
C16112
UMLS 2011AA Property-5
C1516637
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Has the patient received one prior chemotherapeutic regimen for management of endometrial carcinoma?
Descripción

PriorCytotoxicChemotherapyUterineEndometrialCarcinomaAdministeredInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus ObjectClass-2
C15681
UMLS 2011AA ObjectClass-2
C0677881
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus Property-2
C7558
UMLS 2011AA Property-2
C0476089
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Drug Regimen 1:
Descripción

ChemotherapyRegimenOneReceiveName

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C12218
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus Property
C25639
UMLS 2011AA Property
C1514756
NCI Thesaurus Property-2
C66832
UMLS 2011AA Property-2
C0205447
NCI Thesaurus ValueDomain
C1708
UMLS 2011AA ValueDomain
C0450442
NCI Thesaurus ValueDomain-2
C42614
UMLS 2011AA ValueDomain-2
C0027365
Start date for Regimen 1:
Descripción

ChemotherapyRegimenOneReceiveBeginDate

Tipo de datos

date

Alias
NCI Thesaurus ObjectClass
C12218
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus Property
C25639
UMLS 2011AA Property
C1514756
NCI Thesaurus Property-2
C66832
UMLS 2011AA Property-2
C0205447
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25431
UMLS 2011AA ValueDomain-2
C0439659
End date for Regimen 1:
Descripción

ChemotherapyRegimenOneReceiveEndDate

Tipo de datos

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25639
UMLS 2011AA Property
C1514756
NCI Thesaurus Property-2
C66832
UMLS 2011AA Property-2
C0205447
NCI Thesaurus ObjectClass
C12218
UMLS 2011AA ObjectClass
C0392920
How many prior cytotoxic chemotherapy regimens has the patient received?
Descripción

ChemotherapyRegimenReceiveChemotherapyRegimenReceiveType

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C25639
UMLS 2011AA Property
C1514756
NCI Thesaurus ObjectClass
C12218
UMLS 2011AA ObjectClass
C0392920
Drug Regimen 2:
Descripción

ChemotherapyRegimenTwoReceiveName

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C12218
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus Property
C66833
UMLS 2011AA Property
C0205448
NCI Thesaurus Property-2
C25639
UMLS 2011AA Property-2
C1514756
NCI Thesaurus ValueDomain
C1708
UMLS 2011AA ValueDomain
C0450442
NCI Thesaurus ValueDomain-2
C42614
UMLS 2011AA ValueDomain-2
C0027365
Start date for Regimen 2:
Descripción

ChemotherapyRegimenTwoReceiveBeginDate

Tipo de datos

date

Alias
NCI Thesaurus ObjectClass
C12218
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus Property
C66833
UMLS 2011AA Property
C0205448
NCI Thesaurus Property-2
C25639
UMLS 2011AA Property-2
C1514756
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25431
UMLS 2011AA ValueDomain-2
C0439659
End date for Regimen 2:
Descripción

ChemotherapyRegimenTwoReceiveEndDate

Tipo de datos

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C66833
UMLS 2011AA Property
C0205448
NCI Thesaurus Property-2
C25639
UMLS 2011AA Property-2
C1514756
NCI Thesaurus ObjectClass
C12218
UMLS 2011AA ObjectClass
C0392920
Has the patient received any non-cytotoxic chemotherapy for management of recurrent or persistent disease
Descripción

PersonMalignantNeoplasmRecurrentDiseaseDiseaseProgressionTherapeuticProcedureReceiveInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C38155
UMLS 2011AA Property
C0277556
NCI Thesaurus Property-2
C9305
UMLS 2011AA Property-2
C0006826
NCI Thesaurus Property-3
C17747
UMLS 2011AA Property-3
C0242656
NCI Thesaurus Property-4
C25639
UMLS 2011AA Property-4
C1514756
NCI Thesaurus Property-5
C49236
UMLS 2011AA Property-5
C0087111
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Date of Results (if more than one, enter earliest:)
Descripción

LaboratoryProcedureEvaluationOutcomeDate

Tipo de datos

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25214
UMLS 2011AA Property
C0220825
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
Platelets greater than or equal to 100,000/mcl?
Descripción

LaboratoryProcedurePlateletCountEligibilityDeterminationInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C51951
UMLS 2011AA Property
C0032181
NCI Thesaurus Property-2
C25171
UMLS 2011AA Property-2
C0013893
ANC greater than or equal to 1,500/mcl?
Descripción

LaboratoryProcedureAbsoluteNeutrophilCountEligibilityDeterminationInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C63321
UMLS 2011AA Property
C0948762
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property-2
C25171
UMLS 2011AA Property-2
C0013893
Is the creatinine less than or equal to 1.5 X ULN
Descripción

LaboratoryProcedureCreatinineUpperLimitofNormalOutcomeInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C399
UMLS 2011AA Property-2
C0010294
NCI Thesaurus Property-3
C25706
UMLS 2011AA Property-3
C1519815
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Is the bilirubin less than or equal to 1.5 x ULN (regardless of the presence of liver metastases)
Descripción

PatientElevatedBilirubinPersonalMedicalHistoryInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C27088
UMLS 2011AA Property
C0311468
NCI Thesaurus Property-2
C18772
UMLS 2011AA Property-2
C0262926
Is SGPT (ALT) less than or equal to 3.0 X Upper Limits of Normal
Descripción

SerumGlutamicPyruvateTransaminasesHepaticWithinProtocolUpperLimitofNormalLabInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C13308
UMLS 2011AA ObjectClass
C0205054
NCI Thesaurus ObjectClass-2
C25293
UMLS 2011AA ObjectClass-2
C0376147
NCI Thesaurus Property
C25320
UMLS 2011AA Property
C1507394
NCI Thesaurus Property-2
C37984
UMLS 2011AA Property-2
C0022877
NCI Thesaurus Property-3
C25282
UMLS 2011AA Property-3
C0332285
NCI Thesaurus Property-4
C25706
UMLS 2011AA Property-4
C1519815
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Is the alkaline phosphatase less than or equal to 2.5 x ULN? (regardless of the presence of liver metastases)
Descripción

LaboratoryProcedureAlkalinePhosphataseEligibilityDeterminationInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
NCI Thesaurus Property-2
C16276
UMLS 2011AA Property-2
C0002059
Is her urine protein creatinine (UPC) ratio less than 1 (or urinary protein less than 1.0g/24 hours)
Descripción

PersonCreatinineUrineProteinMeasurementClinicalTrialEligibilityCriteriaInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C399
UMLS 2011AA Property
C0010294
NCI Thesaurus Property-2
C16112
UMLS 2011AA Property-2
C1516637
NCI Thesaurus Property-3
C74760
UMLS 2011AA Property-3
C0262923
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Is the Prothrombin Time (PT) such that the International Normalized Ratio (INR) is:
Descripción

LaboratoryProcedureProthrombinTimeResultProthrombinTimeType

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C62656
UMLS 2011AA Property-2
C0033707
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
Is the PTT less than or equal to 1.5 times the institutional upper limit of normal?
Descripción

LaboratoryProcedurePartialThromboplastinTimeResultInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property-2
C38462
UMLS 2011AA Property-2
C0030605
Has the patient had a baseline electrocardiogram completed within 28 days prior to study entry and was the QTc found to be less than or equal to 450 msec? (ventricular tachycardia must be less than 3 beats in a row or ventricular fibrillation)
Descripción

ElectrocardiographyDiagnosticProcedureQTcIntervalAssessmentInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C38053
UMLS 2011AA ObjectClass
C1623258
NCI Thesaurus ObjectClass-2
C18020
UMLS 2011AA ObjectClass-2
C0430022
NCI Thesaurus Property
C25367
NCI Metathesaurus Property
C0489625
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Has the patient met the pre-entry requirements as specified in section 7.0
Descripción

PatientEligibilityInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
If the patient has childbearing potential, has she had a negative serum pregnancy test within 14 days prior to initiation protocol therapy
Descripción

PatientNegativePregnancyTestInd-4

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25247
UMLS 2011AA Property
C0205160
NCI Metathesaurus Property
C0032976
NCI Thesaurus ValueDomain
C49486
UMLS 2011AA ValueDomain
C1704854
If patient has the capacity to become pregnant, has she agreed to use adequate contraception (two barrier methods of birth control) prior to study entry and for the duration of the study and up to three months after the final dose of BIBF1120?
Descripción

ContraceptionAgreementInd

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C37932
UMLS 2011AA ObjectClass
C0700589
NCI Thesaurus Property
C25369
UMLS 2011AA Property
C0680240
Has the patient received prior therapy with BIBF1120?
Descripción

PersonPriorAntiangiogenesisTherapyClinicalTrialEligibilityCriteriaInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property-2
C16112
UMLS 2011AA Property-2
C1516637
NCI Thesaurus Property-3
C15568
UMLS 2011AA Property-3
C0281318
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Has the patient had another invasive malignancy other than non-melanoma of the skin, localized cancer of the breast, head and neck or skin diagnosed, present or recur within the past 3 years?
Descripción

PatientNeoplasmPersonalMedicalHistoryIndicator

Tipo de datos

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C3262
UMLS 2011AA Property
C0027651
NCI Thesaurus Property-2
C18772
UMLS 2011AA Property-2
C0262926
Has the patient received prior radiotherapy to any portion of the abdominal cavity or pelvis other than for the treatment of endometrial cancer within the last three years?
Descripción

PersonPriorRadiationTherapyAbdominalCavityPelvisClinicalTrialEligibilityCriteriaInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C15313
UMLS 2011AA Property
C1522449
NCI Thesaurus Property-2
C12664
UMLS 2011AA Property-2
C0230168
NCI Thesaurus Property-3
C12767
UMLS 2011AA Property-3
C0030797
NCI Thesaurus Property-4
C25629
UMLS 2011AA Property-4
C0332152
NCI Thesaurus Property-5
C16112
UMLS 2011AA Property-5
C1516637
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Has the patient received prior radiation for localized cancer of the breast, head and neck or skin?
Descripción

PersonPriorRadiationTherapyBreastHeadandNeckSkinClinicalTrialEligibilityCriteriaInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C15313
UMLS 2011AA Property
C1522449
NCI Thesaurus Property-2
C12470
UMLS 2011AA Property-2
C1123023
NCI Thesaurus Property-3
C12971
UMLS 2011AA Property-3
C0006141
NCI Thesaurus Property-4
C12418
UMLS 2011AA Property-4
C0460004
NCI Thesaurus Property-5
C25629
UMLS 2011AA Property-5
C0332152
NCI Thesaurus Property-6
C16112
UMLS 2011AA Property-6
C1516637
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Was the prior radiation for localized cancer of the breast, head and neck or skin completed more than 3 years prior to registration and does the patient remain free of recurrent or metastatic disease?
Descripción

PersonPriorRadiationTherapyBreastHeadandNeckSkinNoCancerProgressionClinicalTrialEligibilityCriteriaInd-4

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C49487
UMLS 2011AA Property
C1298908
NCI Thesaurus Property-2
C15313
UMLS 2011AA Property-2
C1522449
NCI Thesaurus Property-3
C12470
UMLS 2011AA Property-3
C1123023
NCI Thesaurus Property-4
C12971
UMLS 2011AA Property-4
C0006141
NCI Thesaurus Property-5
C12418
UMLS 2011AA Property-5
C0460004
NCI Thesaurus Property-6
C25629
UMLS 2011AA Property-6
C0332152
NCI Thesaurus Property-7
C19987
UMLS 2011AA Property-7
C0242656
NCI Thesaurus Property-8
C16112
UMLS 2011AA Property-8
C1516637
NCI Thesaurus ValueDomain
C49486
UMLS 2011AA ValueDomain
C1704854
Has the patient received prior chemotherapy for any abdominal or pelvic tumor other than for the treatment of endometrial cancer within the last three years?
Descripción

PriorGynecologicChemotherapyAdministeredInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus ObjectClass-3
C28016
UMLS 2011AA ObjectClass-3
C0205480
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Has the patient received prior adjuvant chemotherapy for localized breast cancer?
Descripción

PersonPriorAdjuvantChemotherapyClinicalTrialEligibilityCriteriaInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C15360
UMLS 2011AA Property
C0085533
NCI Thesaurus Property-2
C25629
UMLS 2011AA Property-2
C0332152
NCI Thesaurus Property-3
C16112
UMLS 2011AA Property-3
C1516637
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Was the prior adjuvant chemotherapy for localized cancer of the breast completed more than 3 years prior to registration and does the patient remain free of recurrent or metastatic disease?
Descripción

PersonPriorAdjuvantChemotherapyNoCancerProgressionClinicalTrialEligibilityCriteriaInd-4

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C49487
UMLS 2011AA Property
C1298908
NCI Thesaurus Property-2
C15360
UMLS 2011AA Property-2
C0085533
NCI Thesaurus Property-3
C25629
UMLS 2011AA Property-3
C0332152
NCI Thesaurus Property-4
C19987
UMLS 2011AA Property-4
C0242656
NCI Thesaurus Property-5
C16112
UMLS 2011AA Property-5
C1516637
NCI Thesaurus ValueDomain
C49486
UMLS 2011AA ValueDomain
C1704854
Is the treatment of previous cancer a contraindication to the current protocol therapy?
Descripción

ReceivedTherapyProtocolContraindicatedInd-3

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C25639
UMLS 2011AA ObjectClass
C1514756
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus Property
C25320
UMLS 2011AA Property
C1507394
NCI Thesaurus Property-2
C37933
UMLS 2011AA Property-2
C1444657
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Does the patient have a serious non-healing wound, ulcer or bone fracture?
Descripción

PatientWoundComplicationPersonalMedicalHistoryInd-3b

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C3671
UMLS 2011AA Property
C0043250
NCI Thesaurus Property-2
C2959
UMLS 2011AA Property-2
C0009566
NCI Thesaurus Property-3
C18772
UMLS 2011AA Property-3
C0262926
NCI Thesaurus ValueDomain
C49797
UMLS 2011AA ValueDomain
C1708496
Does the patient have a history of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess within 28 days prior to first day of study therapy or an underlying lesion(s) that caused the fistula or perforation in the past that have not been corrected?
Descripción

PersonAbdominalCavityFistulaPerforationAbscessClinicalTrialEligibilityCriteriaInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C12664
UMLS 2011AA Property
C0230168
NCI Thesaurus Property-2
C26686
UMLS 2011AA Property-2
C0549483
NCI Thesaurus Property-3
C16112
UMLS 2011AA Property-3
C1516637
NCI Thesaurus Property-4
C4080
UMLS 2011AA Property-4
C0549099
NCI Thesaurus Property-5
C3045
UMLS 2011AA Property-5
C0016169
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Does the patient have active bleeding or pathologic conditions that carry high risk of bleeding such as known bleeding disorder, coagulopathy or tumor involving major vessels?
Descripción

PatientHemorrhagePre-ExistingConditionInd-3b

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C26791
UMLS 2011AA Property
C0019080
NCI Metathesaurus Property
CL232826
NCI Thesaurus ValueDomain
C49797
UMLS 2011AA ValueDomain
C1708496
Does the patient have a history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study
Descripción

PatientCentralNervousSystemDiseaseorDisorderEligibilityDeterminationInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C12438
UMLS 2011AA Property
C3714787
NCI Thesaurus Property-2
C2991
UMLS 2011AA Property-2
C0012634
NCI Thesaurus Property-3
C25171
UMLS 2011AA Property-3
C0013893
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Does the patient have a history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study
Descripción

PatientCentralNervousSystemDiseaseorDisorderEligibilityDeterminationInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C12438
UMLS 2011AA Property
C3714787
NCI Thesaurus Property-2
C2991
UMLS 2011AA Property-2
C0012634
NCI Thesaurus Property-3
C25171
UMLS 2011AA Property-3
C0013893
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Has the patient had clinically significant cardiovascular disease
Descripción

CardiovascularDiseasePresentInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C25292
UMLS 2011AA ObjectClass
C0007226
NCI Thesaurus ObjectClass-2
C2991
UMLS 2011AA ObjectClass-2
C0012634
Does the patient have uncontrolled hypertension defined as systolic greater than 140 mm Hg or diastolic greater than 90 mm Hg despite anti-hypertensive therapy?
Descripción

PatientInadequateControlHypertensionExclusionCriteriaInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C3117
UMLS 2011AA Property
C0020538
NCI Thesaurus Property-2
C61299
UMLS 2011AA Property-2
C2587213
NCI Thesaurus Property-3
C25370
UMLS 2011AA Property-3
C0680251
NCI Thesaurus Property-4
C69177
UMLS 2011AA Property-4
C0205412
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Has the patient had a myocardial infarction or unstable angina within 6 months of the first date of study therapy?
Descripción

MyocardialInfarctionPatientPreviousYearPersonalMedicalHistoryInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C27996
UMLS 2011AA ObjectClass
C0027051
NCI Metathesaurus ObjectClass
C0030705
NCI Thesaurus Property
C25627
UMLS 2011AA Property
C0205156
NCI Thesaurus Property-2
C29848
UMLS 2011AA Property-2
C0439234
NCI Thesaurus Property-3
C18772
UMLS 2011AA Property-3
C0262926
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Using the New York Heart Association (NYHA) guideline, does the patient have Class II or greater congestive heart failure?
Descripción

PersonNewYorkHeartAssociationClassIIClinicalTrialEligibilityCriteriaInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C16112
UMLS 2011AA Property
C1516637
NCI Thesaurus Property-2
C66905
UMLS 2011AA Property-2
C1882085
Does the patient have an ejection fraction of less than institutional LLN?
Descripción

PersonEjectionFractionLowerLimitofNormalClinicalTrialEligibilityCriteriaInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C37946
UMLS 2011AA Property
C2700377
NCI Thesaurus Property-2
C16112
UMLS 2011AA Property-2
C1516637
NCI Thesaurus Property-3
C25555
UMLS 2011AA Property-3
C1518030
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Does the patient have a history of serious ventricular arrhythmia (ventricular tachycardia or ventricular fibrillation) or arrhythmias requiring anti-arrhythmic medications (except for atrial fibrillation that is well controlled with anti-arrhythmic medication)?
Descripción

PersonVentricularArrhythmiaArrhythmiaMedicationClinicalTrialEligibilityCriteriaInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C2881
UMLS 2011AA Property
C0003811
NCI Thesaurus Property-2
C459
UMLS 2011AA Property-2
C0013227
CTCAE Property
E10230
NCI Thesaurus Property-3
C16112
UMLS 2011AA Property-3
C1516637
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Does the patient have valvular heart disease greater than or equal to Grade 2?
Descripción

CardiacDiseasePresentInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
Has the patient undergone a major surgical procedure, open biopsy or incurred a significant traumatic injury within 28 days prior to the first date of study therapy?
Descripción

PersonSurgicalProcedureInjuryEligibilityDeterminationInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C15329
UMLS 2011AA Property
C0543467
NCI Thesaurus Property-2
C3671
UMLS 2011AA Property-2
C0043250
NCI Thesaurus Property-3
C25171
UMLS 2011AA Property-3
C0013893
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Is a major surgical procedure anticipated for this patient during the course of this study
Descripción

GynecologicOncologyGroupMajorSurgeryInd-3b

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C25521
UMLS 2011AA ObjectClass
C1512288
NCI Metathesaurus Property
C0679637
NCI Thesaurus ValueDomain
C49797
UMLS 2011AA ValueDomain
C1708496
Has the patient had any minor surgical procedures, fine needle aspirates or core biopsies within 7 days prior to the first date of study therapy?
Descripción

PatientCoreBiopsyMinorSurgicalProcedureExclusionCriteriaInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C15680
UMLS 2011AA Property
C1318309
NCI Thesaurus Property-2
C15329
UMLS 2011AA Property-2
C0543467
NCI Thesaurus Property-3
C45367
UMLS 2011AA Property-3
C0205165
NCI Thesaurus Property-4
C25370
UMLS 2011AA Property-4
C0680251
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Is the patient under age 18?
Descripción

PersonLegalAdolescentClinicalTrialEligibilityCriteriaInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C16112
UMLS 2011AA Property
C1516637
NCI Thesaurus Property-2
C27954
UMLS 2011AA Property-2
C0205653
NCI Thesaurus Property-3
C54074
UMLS 2011AA Property-3
C1301860
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Is the patient pregnant or nursing?
Descripción

PatientPregnancyInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25742
UMLS 2011AA Property
C0032961
Does the patient have a history of major thromboembolic event defined as: symptomatic pulmonary embolism (PE), recurrent asymptomatic PE, or recurrent deep vein thrombosis?
Descripción

PersonThromboembolismPersonalMedicalHistoryInd-3

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C18772
UMLS 2011AA Property
C0262926
NCI Metathesaurus Property
C0040038
Has the patient had prior thrombosis or thromboembolic event due to a known inherited coagulopathy? (ie, antithrombin-III deficiency, Protein C or Protein S deficiency, Factor V Leiden mutation presence, prothrombin G20210A mutation )
Descripción

PersonPriorThromboemboliceventInheritedCoagulationDisorderClinicalTrialEligibilityCriteriaInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
CTCAE Property
E13825
NCI Thesaurus Property-2
C16112
UMLS 2011AA Property-2
C1516637
NCI Thesaurus Property-3
C2902
UMLS 2011AA Property-3
C0005779
NCI Thesaurus Property-4
C28018
UMLS 2011AA Property-4
C0439660
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Has the patient had serious infections requiring systemic antibiotics or antiviral therapy including: known active Hepatitis B or C infection; known HIV infection?
Descripción

PatientPriorDiseaseorDisorderSystemicAntibioticAntiviralTherapyEligibilityDeterminationInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C13310
UMLS 2011AA Property
C0205373
NCI Thesaurus Property-2
C25629
UMLS 2011AA Property-2
C0332152
NCI Thesaurus Property-3
C2991
UMLS 2011AA Property-3
C0012634
NCI Thesaurus Property-4
C258
UMLS 2011AA Property-4
C0003232
NCI Thesaurus Property-5
C25171
UMLS 2011AA Property-5
C0013893
NCI Thesaurus Property-6
C16119
UMLS 2011AA Property-6
C0280274
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Has the patient been treated with immune modulators such as systemic cyclosporine or tacrolimus within 30 days prior to enrollment?
Descripción

PersonPriorImmunomodulatingAgentClinicalTrialEligibilityCriteriaInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property-2
C16112
UMLS 2011AA Property-2
C1516637
NCI Thesaurus Property-3
C308
UMLS 2011AA Property-3
C0005525
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Does the patient have a history of photosensitivity or must she take agents which increase photosensitivity?
Descripción

PersonPriorPhotosensitivityClinicalTrialEligibilityCriteriaInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property-2
C16112
UMLS 2011AA Property-2
C1516637
CTCAE Property
E13680
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Does the patient have the ability to swallow oral medication
Descripción

PatientSwallowingAssessmentInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus Property-2
C38028
UMLS 2011AA Property-2
C0011167
Anticipated date treatment will start
Descripción

TreatmentPlannedDate

Tipo de datos

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25619
UMLS 2011AA Property
C1301732
Comments
Descripción

Comments

Provide comments about this Fast Fact Sheet
Descripción

ClinicalTrialEligibilityCriteriaWorksheetCommentText

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus Property
C25393
UMLS 2011AA Property
C0282411
NCI Thesaurus ObjectClass
C16112
UMLS 2011AA ObjectClass
C1516637
NCI Thesaurus Property-2
C73541
UMLS 2011AA Property-2
C2349155
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  1. StudyEvent: GOG-0229K: Fast Fact Sheet for Protocol 0229-K (Endometrium)
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Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Tracking Information
InstitutionGynecologicOncologyGroupIdentifierCode
Item
GOG Institution Code
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25521 (NCI Thesaurus Property-2)
C1512288 (UMLS 2011AA Property-2)
AffiliatedInstitutionGynecologicOncologyGroupIdentifierCode
Item
GOG Affiliate Code
text
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25413 (NCI Thesaurus ObjectClass-2)
C1510826 (UMLS 2011AA ObjectClass-2)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25521 (NCI Thesaurus Property-2)
C1512288 (UMLS 2011AA Property-2)
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
PriorClinicalStudyProtocolGynecologicOncologyGroupIdentifierNumber
Item
Previous GOG #
text
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25521 (NCI Thesaurus Property-2)
C1512288 (UMLS 2011AA Property-2)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
TreatingPhysicianName
Item
Treating physician
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25741 (NCI Thesaurus ObjectClass)
C0031831 (UMLS 2011AA ObjectClass)
C25705 (NCI Thesaurus ObjectClass-2)
C1522326 (UMLS 2011AA ObjectClass-2)
PhysicianPersonVerificationIdentifierName
Item
Other Physician
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25741 (NCI Thesaurus ObjectClass-2)
C0031831 (UMLS 2011AA ObjectClass-2)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C45513 (NCI Thesaurus Property-2)
C1711411 (UMLS 2011AA Property-2)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
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)
PersonBirthDate
Item
Date of Birth
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25155 (NCI Thesaurus Property)
C0005615 (UMLS 2011AA Property)
Last Name
Item
Patient Last Name
text
C25191 (NCI Thesaurus ValueDomain)
C1301584 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
C25551 (NCI Thesaurus Property-2)
First Name
Item
Patient First Name
text
C25191 (NCI Thesaurus ValueDomain)
C1443235 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
C25509 (NCI Thesaurus Property-2)
PatientMiddleName
Item
Patient Middle Name
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25569 (NCI Thesaurus Property-2)
C0444598 (UMLS 2011AA Property-2)
Item Group
Header
InformedConsentFormSignedInd-2
Item
Did the patient sign an approved informed consent
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseUpperLimitofNormalResultInd-2
Item
Is the SGOT less than or equal to 3 X ULN (regardless of the presence of liver metastases)
boolean
Item
Has HIPAA authorization been obtained
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C62504 (NCI Thesaurus ObjectClass)
C0600593 (UMLS 2011AA ObjectClass)
C41192 (NCI Thesaurus Property)
C1524004 (UMLS 2011AA Property)
CL.2
Code List
Has HIPAA authorization been obtained
CL Item
Yes: C49488 (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Exempt - Non-usa Participant (Exempt - non-USA participant)
PersonPriorityGynecologicOncologyGroupClinicalTrialEligibilityCriteriaInd-2
Item
Is the patient eligible for a higher priority GOG protocol
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25521 (NCI Thesaurus Property)
C1512288 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property-2)
C1516637 (UMLS 2011AA Property-2)
C48911 (NCI Thesaurus Property-3)
C0549179 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item
What is the site of the disease
text
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C28016 (NCI Thesaurus ObjectClass-2)
C0205480 (UMLS 2011AA ObjectClass-2)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25251 (NCI Thesaurus Property-2)
C0205225 (UMLS 2011AA Property-2)
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
CL.4
Code List
What is the site of the disease
CL Item
Endometrium (Endometrium)
C12313 (NCI Thesaurus)
C0014180 (UMLS 2011AA)
Item
What is the cell type?
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus Property)
C0006826 (UMLS 2011AA Property)
C18189 (NCI Thesaurus Property-2)
C0030664 (UMLS 2011AA Property-2)
C16112 (NCI Thesaurus Property-3)
C1516637 (UMLS 2011AA Property-3)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.5
Code List
What is the cell type?
CL Item
Unspecified Adenocarcinoma (Adenocarcinoma, Unspecified)
C2852 (NCI Thesaurus)
C0001418 (UMLS 2011AA)
C38046 (NCI Thesaurus-3)
C0205370 (UMLS 2011AA-4)
CL Item
Clear Cell Carcinoma (Clear cell carcinoma)
CL Item
Endometrioid Adenocarcinoma (Endometrioid Adenocarcinoma)
C3769 (NCI Thesaurus)
C0206687 (UMLS 2011AA)
CL Item
Mixed Epithelial Carcinoma (Mixed Epithelial Carcinoma)
CL Item
Mucinous Adenocarcinoma (Mucinous Adenocarcinoma)
C26712 (NCI Thesaurus)
C0007130 (UMLS 2011AA)
CL Item
Serous Adenocarcinoma (Serous Adenocarcinoma)
C40101 (NCI Thesaurus)
C0206701 (UMLS 2011AA)
CL Item
Squamous Cell Carcinoma (Squamous Cell Carcinoma)
C2929 (NCI Thesaurus)
C0007137 (UMLS 2011AA)
CL Item
Transitional Cell Carcinoma (Transitional Cell Carcinoma)
C2930 (NCI Thesaurus)
C0007138 (UMLS 2011AA)
CL Item
Undifferentiated Carcinoma (Undifferentiated Carcinoma)
C3692 (NCI Thesaurus)
C0205698 (UMLS 2011AA)
MalignantNeoplasmInitialHistologicDiagnosisDate
Item
Date of initial histologic diagnosis of malignancy
date
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
C25526 (NCI Thesaurus Property-2)
C0205462 (UMLS 2011AA Property-2)
C15220 (NCI Thesaurus Property-3)
C0011900 (UMLS 2011AA Property-3)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item
What was the grade of the primary tumor
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C28016 (NCI Thesaurus ObjectClass-2)
C0205480 (UMLS 2011AA ObjectClass-2)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property-2)
C0678257 (UMLS 2011AA Property-2)
C25526 (NCI Thesaurus ValueDomain)
C0205462 (UMLS 2011AA ValueDomain)
C18000 (NCI Thesaurus ValueDomain-2)
C0919553 (UMLS 2011AA ValueDomain-2)
CL.6
Code List
What was the grade of the primary tumor
CL Item
Grade 1-well Differentiated (1)
CL Item
Grade 2-moderately Differentiated (2)
CL Item
Grade 3-poorly Differentiated (3)
Item
Is the disease recurrent or persistent with documented progression? Which one?
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C38155 (NCI Thesaurus Property)
C0277556 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property-2)
C0006826 (UMLS 2011AA Property-2)
C17747 (NCI Thesaurus Property-3)
C0242656 (UMLS 2011AA Property-3)
C16112 (NCI Thesaurus Property-4)
C1516637 (UMLS 2011AA Property-4)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
CL.7
Code List
Is the disease recurrent or persistent with documented progression? Which one?
CL Item
Recurrent Disease (Recurrent)
C38155 (NCI Thesaurus)
C0277556 (UMLS 2011AA)
CL Item
Persistent Disease (Persistent)
C90169 (NCI Thesaurus)
DiseaseTreatmentRefractoryInd-2
Item
Is the cancer refractory to curative therapy or established treatment?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)
Item
How was it established to be recurrent or persistent?
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C38155 (NCI Thesaurus Property)
C0277556 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property-2)
C0006826 (UMLS 2011AA Property-2)
C17747 (NCI Thesaurus Property-3)
C0242656 (UMLS 2011AA Property-3)
C15220 (NCI Thesaurus Property-4)
C0011900 (UMLS 2011AA Property-4)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.9
Code List
How was it established to be recurrent or persistent?
CL Item
Surgical Procedure (Surgery)
C15329 (NCI Thesaurus)
C0543467 (UMLS 2011AA)
CL Item
Biopsy (Biopsy)
C15189 (NCI Thesaurus)
C0005558 (UMLS 2011AA)
CL Item
Non-histologic Evaluation (Non-Histologic)
PersonMalignantNeoplasmRecurrentDiseaseDiseaseProgressionDiagnosisDate
Item
Date recurrence or persistence documented? (NOTE: This should be the date of the most recent progression or persistence that made the patient eligible for this study.)
date
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C38155 (NCI Thesaurus Property)
C0277556 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property-2)
C0006826 (UMLS 2011AA Property-2)
C17747 (NCI Thesaurus Property-3)
C0242656 (UMLS 2011AA Property-3)
C15220 (NCI Thesaurus Property-4)
C0011900 (UMLS 2011AA Property-4)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
PersonMalignantNeoplasmMeasurableDiseasePresentClinicalTrialEligibilityCriteriaIndicator
Item
Does patient have measurable disease defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded) using RECIST 1.1 criteria?
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property-2)
C0006826 (UMLS 2011AA Property-2)
C8507 (NCI Thesaurus Property-3)
C1513041 (UMLS 2011AA Property-3)
C16112 (NCI Thesaurus Property-4)
C1516637 (UMLS 2011AA Property-4)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
Item
What method of evaluation is used to obtain tumor measurements?
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property-2)
C0006826 (UMLS 2011AA Property-2)
C8507 (NCI Thesaurus Property-3)
C1513041 (UMLS 2011AA Property-3)
C71460 (NCI Thesaurus Property-4)
C0025663 (UMLS 2011AA Property-4)
C16112 (NCI Thesaurus Property-5)
C1516637 (UMLS 2011AA Property-5)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.11
Code List
What method of evaluation is used to obtain tumor measurements?
CL Item
Computed Tomography (CT)
C17204 (NCI Thesaurus)
C0040405 (UMLS 2011AA)
CL Item
Magnetic Resonance Imaging (MRI)
C16809 (NCI Thesaurus)
C0024485 (UMLS 2011AA)
CL Item
Caliper Measurement By Clinical Exam (Caliper measurement by clinical exam)
CL Item
Chest Radiography (Chest X-ray)
C38103 (NCI Thesaurus)
C0039985 (UMLS 2011AA)
PersonMalignantNeoplasmMeasurableDiseaseSizePresentClinicalTrialEligibilityCriteriaIndicator
Item
Is the measurable disease > or = 10 mm when measured by CT, MRI or caliper measurement by clinical exam; or > or = 20 mm when measured by chest x-ray or lymph nodes > or = 15 mm in short axis when measured by CT or MRI?
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property-2)
C0006826 (UMLS 2011AA Property-2)
C8507 (NCI Thesaurus Property-3)
C1513041 (UMLS 2011AA Property-3)
C16112 (NCI Thesaurus Property-4)
C1516637 (UMLS 2011AA Property-4)
C25681 (NCI Thesaurus Property-5)
C0456389 (UMLS 2011AA Property-5)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
PersonMalignantNeoplasmMeasurableDiseaseResponseEvaluationCriteriainSolidTumorsClinicalTrialEligibilityCriteriaIndicator
Item
Does the patient have at least one target lesion to be used to assess response on this protocol as defined by RECIST 1.1?
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus Property)
C0006826 (UMLS 2011AA Property)
C8507 (NCI Thesaurus Property-2)
C1513041 (UMLS 2011AA Property-2)
C16112 (NCI Thesaurus Property-3)
C1516637 (UMLS 2011AA Property-3)
C49164 (NCI Thesaurus Property-4)
C1709926 (UMLS 2011AA Property-4)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
PersonMalignantNeoplasmMeasurableDiseaseRadiationFieldClinicalTrialEligibilityCriteriaIndicator
Item
Is the measurable disease in a previously irradiated field?
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus Property)
C0006826 (UMLS 2011AA Property)
C8507 (NCI Thesaurus Property-2)
C1513041 (UMLS 2011AA Property-2)
C54648 (NCI Thesaurus Property-3)
C1882536 (UMLS 2011AA Property-3)
C16112 (NCI Thesaurus Property-4)
C1516637 (UMLS 2011AA Property-4)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
Item
If yes, does the patient have disease in an irradiated field as the only site of measurable disease and has progression been documented or a biopsy obtained to confirm persistent disease at least 90 days following completion of radiation treatment?
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus Property)
C0006826 (UMLS 2011AA Property)
C8507 (NCI Thesaurus Property-2)
C1513041 (UMLS 2011AA Property-2)
C54648 (NCI Thesaurus Property-3)
C1882536 (UMLS 2011AA Property-3)
C16112 (NCI Thesaurus Property-4)
C1516637 (UMLS 2011AA Property-4)
C49797 (NCI Thesaurus ValueDomain)
C1708496 (UMLS 2011AA ValueDomain)
CL.15
Code List
If yes, does the patient have disease in an irradiated field as the only site of measurable disease and has progression been documented or a biopsy obtained to confirm persistent disease at least 90 days following completion of radiation treatment?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Not Applicable (Not Applicable)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
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.16
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)
PersonThyroidGlandFunctionClinicalTrialEligibilityCriteriaInd-2
Item
Does the patient have normal thyroid function?
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C12400 (NCI Thesaurus Property)
C0040132 (UMLS 2011AA Property)
C25518 (NCI Thesaurus Property-2)
C0542341 (UMLS 2011AA Property-2)
C16112 (NCI Thesaurus Property-3)
C1516637 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PersonLastTherapeuticProcedureRecoveryClinicalTrialEligibilityCriteriaInd-2
Item
Has the patient recovered from the effects of recent surgery, radiotherapy or chemotherapy?
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C49236 (NCI Thesaurus Property)
C0087111 (UMLS 2011AA Property)
C25746 (NCI Thesaurus Property-2)
C2004454 (UMLS 2011AA Property-2)
C25551 (NCI Thesaurus Property-3)
C1517741 (UMLS 2011AA Property-3)
C16112 (NCI Thesaurus Property-4)
C1516637 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PersonNoInfectionRequiredAntibioticClinicalTrialEligibilityCriteriaInd-2
Item
Is the patient free of active infection requiring antibiotics with the exception of uncomplicated urinary tract infection (UTI)?
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C49487 (NCI Thesaurus Property)
C1298908 (UMLS 2011AA Property)
C26726 (NCI Thesaurus Property-2)
C0009450 (UMLS 2011AA Property-2)
C258 (NCI Thesaurus Property-3)
C0003232 (UMLS 2011AA Property-3)
C25652 (NCI Thesaurus Property-4)
C1514873 (UMLS 2011AA Property-4)
C16112 (NCI Thesaurus Property-5)
C1516637 (UMLS 2011AA Property-5)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PersonMalignantNeoplasmEndocrineTherapyClinicalTrialEligibilityCriteriaInd-2
Item
Has any hormonal therapy directed at the malignant tumor been discontinued at least one week prior to registration?
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus Property)
C0006826 (UMLS 2011AA Property)
C15445 (NCI Thesaurus Property-2)
C0279025 (UMLS 2011AA Property-2)
C16112 (NCI Thesaurus Property-3)
C1516637 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PersonTherapeuticProcedureDiscontinuedPriorRegistrationClinicalTrialEligibilityCriteriaInd-2
Item
Has all prior therapy directed at the malignant tumor, including immunologic agents, been discontinued for at least three weeks prior to registration?
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C49236 (NCI Thesaurus Property-3)
C0087111 (UMLS 2011AA Property-3)
C25484 (NCI Thesaurus Property-4)
C1444662 (UMLS 2011AA Property-4)
C16112 (NCI Thesaurus Property-5)
C1516637 (UMLS 2011AA Property-5)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PriorCytotoxicChemotherapyUterineEndometrialCarcinomaAdministeredInd-2
Item
Has the patient received one prior chemotherapeutic regimen for management of endometrial carcinoma?
boolean
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15681 (NCI Thesaurus ObjectClass-2)
C0677881 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C7558 (NCI Thesaurus Property-2)
C0476089 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
ChemotherapyRegimenOneReceiveName
Item
Drug Regimen 1:
text
C12218 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C66832 (NCI Thesaurus Property-2)
C0205447 (UMLS 2011AA Property-2)
C1708 (NCI Thesaurus ValueDomain)
C0450442 (UMLS 2011AA ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
C0027365 (UMLS 2011AA ValueDomain-2)
ChemotherapyRegimenOneReceiveBeginDate
Item
Start date for Regimen 1:
date
C12218 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C66832 (NCI Thesaurus Property-2)
C0205447 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)
ChemotherapyRegimenOneReceiveEndDate
Item
End date for Regimen 1:
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C66832 (NCI Thesaurus Property-2)
C0205447 (UMLS 2011AA Property-2)
C12218 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
Item
How many prior cytotoxic chemotherapy regimens has the patient received?
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C12218 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
CL.23
Code List
How many prior cytotoxic chemotherapy regimens has the patient received?
CL Item
No Chemotherapy Regimens (0 Regimens)
CL Item
One Chemotherapy Regimen (1 Regimen)
CL Item
Two Or More Chemotherapy Regimens (2 or more Regimens)
ChemotherapyRegimenTwoReceiveName
Item
Drug Regimen 2:
text
C12218 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C66833 (NCI Thesaurus Property)
C0205448 (UMLS 2011AA Property)
C25639 (NCI Thesaurus Property-2)
C1514756 (UMLS 2011AA Property-2)
C1708 (NCI Thesaurus ValueDomain)
C0450442 (UMLS 2011AA ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
C0027365 (UMLS 2011AA ValueDomain-2)
ChemotherapyRegimenTwoReceiveBeginDate
Item
Start date for Regimen 2:
date
C12218 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C66833 (NCI Thesaurus Property)
C0205448 (UMLS 2011AA Property)
C25639 (NCI Thesaurus Property-2)
C1514756 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)
ChemotherapyRegimenTwoReceiveEndDate
Item
End date for Regimen 2:
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C66833 (NCI Thesaurus Property)
C0205448 (UMLS 2011AA Property)
C25639 (NCI Thesaurus Property-2)
C1514756 (UMLS 2011AA Property-2)
C12218 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
PersonMalignantNeoplasmRecurrentDiseaseDiseaseProgressionTherapeuticProcedureReceiveInd-2
Item
Has the patient received any non-cytotoxic chemotherapy for management of recurrent or persistent disease
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C38155 (NCI Thesaurus Property)
C0277556 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property-2)
C0006826 (UMLS 2011AA Property-2)
C17747 (NCI Thesaurus Property-3)
C0242656 (UMLS 2011AA Property-3)
C25639 (NCI Thesaurus Property-4)
C1514756 (UMLS 2011AA Property-4)
C49236 (NCI Thesaurus Property-5)
C0087111 (UMLS 2011AA Property-5)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
LaboratoryProcedureEvaluationOutcomeDate
Item
Date of Results (if more than one, enter earliest:)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
LaboratoryProcedurePlateletCountEligibilityDeterminationInd-2
Item
Platelets greater than or equal to 100,000/mcl?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C51951 (NCI Thesaurus Property)
C0032181 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
LaboratoryProcedureAbsoluteNeutrophilCountEligibilityDeterminationInd-2
Item
ANC greater than or equal to 1,500/mcl?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C63321 (NCI Thesaurus Property)
C0948762 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
LaboratoryProcedureCreatinineUpperLimitofNormalOutcomeInd-2
Item
Is the creatinine less than or equal to 1.5 X ULN
boolean
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C399 (NCI Thesaurus Property-2)
C0010294 (UMLS 2011AA Property-2)
C25706 (NCI Thesaurus Property-3)
C1519815 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientElevatedBilirubinPersonalMedicalHistoryInd-2
Item
Is the bilirubin less than or equal to 1.5 x ULN (regardless of the presence of liver metastases)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C27088 (NCI Thesaurus Property)
C0311468 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property-2)
C0262926 (UMLS 2011AA Property-2)
SerumGlutamicPyruvateTransaminasesHepaticWithinProtocolUpperLimitofNormalLabInd-2
Item
Is SGPT (ALT) less than or equal to 3.0 X Upper Limits of Normal
boolean
C13308 (NCI Thesaurus ObjectClass)
C0205054 (UMLS 2011AA ObjectClass)
C25293 (NCI Thesaurus ObjectClass-2)
C0376147 (UMLS 2011AA ObjectClass-2)
C25320 (NCI Thesaurus Property)
C1507394 (UMLS 2011AA Property)
C37984 (NCI Thesaurus Property-2)
C0022877 (UMLS 2011AA Property-2)
C25282 (NCI Thesaurus Property-3)
C0332285 (UMLS 2011AA Property-3)
C25706 (NCI Thesaurus Property-4)
C1519815 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
LaboratoryProcedureAlkalinePhosphataseEligibilityDeterminationInd-2
Item
Is the alkaline phosphatase less than or equal to 2.5 x ULN? (regardless of the presence of liver metastases)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C16276 (NCI Thesaurus Property-2)
C0002059 (UMLS 2011AA Property-2)
PersonCreatinineUrineProteinMeasurementClinicalTrialEligibilityCriteriaInd-2
Item
Is her urine protein creatinine (UPC) ratio less than 1 (or urinary protein less than 1.0g/24 hours)
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property-2)
C1516637 (UMLS 2011AA Property-2)
C74760 (NCI Thesaurus Property-3)
C0262923 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item
Is the Prothrombin Time (PT) such that the International Normalized Ratio (INR) is:
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C62656 (NCI Thesaurus Property-2)
C0033707 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
CL.33
Code List
Is the Prothrombin Time (PT) such that the International Normalized Ratio (INR) is:
CL Item
Less Than Or Equal To 1.5 X Uln (Less than or equal to 1.5 x ULN)
CL Item
Between 2 And 3 And On A Stable Dose Of Therapeutic Warfarin (Between 2 and 3 AND on a stable dose of therapeutic warfarin)
CL Item
Greater Than 3 (Greater than 3)
LaboratoryProcedurePartialThromboplastinTimeResultInd-2
Item
Is the PTT less than or equal to 1.5 times the institutional upper limit of normal?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C38462 (NCI Thesaurus Property-2)
C0030605 (UMLS 2011AA Property-2)
ElectrocardiographyDiagnosticProcedureQTcIntervalAssessmentInd-2
Item
Has the patient had a baseline electrocardiogram completed within 28 days prior to study entry and was the QTc found to be less than or equal to 450 msec? (ventricular tachycardia must be less than 3 beats in a row or ventricular fibrillation)
boolean
C38053 (NCI Thesaurus ObjectClass)
C1623258 (UMLS 2011AA ObjectClass)
C18020 (NCI Thesaurus ObjectClass-2)
C0430022 (UMLS 2011AA ObjectClass-2)
C25367 (NCI Thesaurus Property)
C0489625 (NCI Metathesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientEligibilityInd-2
Item
Has the patient met the pre-entry requirements as specified in section 7.0
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
Item
If the patient has childbearing potential, has she had a negative serum pregnancy test within 14 days prior to initiation protocol therapy
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25247 (NCI Thesaurus Property)
C0205160 (UMLS 2011AA Property)
C0032976 (NCI Metathesaurus Property)
C49486 (NCI Thesaurus ValueDomain)
C1704854 (UMLS 2011AA ValueDomain)
CL.37
Code List
If the patient has childbearing potential, has she had a negative serum pregnancy test within 14 days prior to initiation protocol therapy
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Not Applicable (Not Applicable)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
Item
If patient has the capacity to become pregnant, has she agreed to use adequate contraception (two barrier methods of birth control) prior to study entry and for the duration of the study and up to three months after the final dose of BIBF1120?
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C37932 (NCI Thesaurus ObjectClass)
C0700589 (UMLS 2011AA ObjectClass)
C25369 (NCI Thesaurus Property)
C0680240 (UMLS 2011AA Property)
CL.38
Code List
If patient has the capacity to become pregnant, has she agreed to use adequate contraception (two barrier methods of birth control) prior to study entry and for the duration of the study and up to three months after the final dose of BIBF1120?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Not Applicable (Not Applicable)
PersonPriorAntiangiogenesisTherapyClinicalTrialEligibilityCriteriaInd-2
Item
Has the patient received prior therapy with BIBF1120?
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property-2)
C1516637 (UMLS 2011AA Property-2)
C15568 (NCI Thesaurus Property-3)
C0281318 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientNeoplasmPersonalMedicalHistoryIndicator
Item
Has the patient had another invasive malignancy other than non-melanoma of the skin, localized cancer of the breast, head and neck or skin diagnosed, present or recur within the past 3 years?
boolean
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3262 (NCI Thesaurus Property)
C0027651 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property-2)
C0262926 (UMLS 2011AA Property-2)
PersonPriorRadiationTherapyAbdominalCavityPelvisClinicalTrialEligibilityCriteriaInd-2
Item
Has the patient received prior radiotherapy to any portion of the abdominal cavity or pelvis other than for the treatment of endometrial cancer within the last three years?
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C15313 (NCI Thesaurus Property)
C1522449 (UMLS 2011AA Property)
C12664 (NCI Thesaurus Property-2)
C0230168 (UMLS 2011AA Property-2)
C12767 (NCI Thesaurus Property-3)
C0030797 (UMLS 2011AA Property-3)
C25629 (NCI Thesaurus Property-4)
C0332152 (UMLS 2011AA Property-4)
C16112 (NCI Thesaurus Property-5)
C1516637 (UMLS 2011AA Property-5)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PersonPriorRadiationTherapyBreastHeadandNeckSkinClinicalTrialEligibilityCriteriaInd-2
Item
Has the patient received prior radiation for localized cancer of the breast, head and neck or skin?
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C15313 (NCI Thesaurus Property)
C1522449 (UMLS 2011AA Property)
C12470 (NCI Thesaurus Property-2)
C1123023 (UMLS 2011AA Property-2)
C12971 (NCI Thesaurus Property-3)
C0006141 (UMLS 2011AA Property-3)
C12418 (NCI Thesaurus Property-4)
C0460004 (UMLS 2011AA Property-4)
C25629 (NCI Thesaurus Property-5)
C0332152 (UMLS 2011AA Property-5)
C16112 (NCI Thesaurus Property-6)
C1516637 (UMLS 2011AA Property-6)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item
Was the prior radiation for localized cancer of the breast, head and neck or skin completed more than 3 years prior to registration and does the patient remain free of recurrent or metastatic disease?
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C49487 (NCI Thesaurus Property)
C1298908 (UMLS 2011AA Property)
C15313 (NCI Thesaurus Property-2)
C1522449 (UMLS 2011AA Property-2)
C12470 (NCI Thesaurus Property-3)
C1123023 (UMLS 2011AA Property-3)
C12971 (NCI Thesaurus Property-4)
C0006141 (UMLS 2011AA Property-4)
C12418 (NCI Thesaurus Property-5)
C0460004 (UMLS 2011AA Property-5)
C25629 (NCI Thesaurus Property-6)
C0332152 (UMLS 2011AA Property-6)
C19987 (NCI Thesaurus Property-7)
C0242656 (UMLS 2011AA Property-7)
C16112 (NCI Thesaurus Property-8)
C1516637 (UMLS 2011AA Property-8)
C49486 (NCI Thesaurus ValueDomain)
C1704854 (UMLS 2011AA ValueDomain)
CL.43
Code List
Was the prior radiation for localized cancer of the breast, head and neck or skin completed more than 3 years prior to registration and does the patient remain free of recurrent or metastatic disease?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Not Applicable (Not Applicable)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
PriorGynecologicChemotherapyAdministeredInd-2
Item
Has the patient received prior chemotherapy for any abdominal or pelvic tumor other than for the treatment of endometrial cancer within the last three years?
boolean
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C28016 (NCI Thesaurus ObjectClass-3)
C0205480 (UMLS 2011AA ObjectClass-3)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PersonPriorAdjuvantChemotherapyClinicalTrialEligibilityCriteriaInd-2
Item
Has the patient received prior adjuvant chemotherapy for localized breast cancer?
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C15360 (NCI Thesaurus Property)
C0085533 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C16112 (NCI Thesaurus Property-3)
C1516637 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item
Was the prior adjuvant chemotherapy for localized cancer of the breast completed more than 3 years prior to registration and does the patient remain free of recurrent or metastatic disease?
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C49487 (NCI Thesaurus Property)
C1298908 (UMLS 2011AA Property)
C15360 (NCI Thesaurus Property-2)
C0085533 (UMLS 2011AA Property-2)
C25629 (NCI Thesaurus Property-3)
C0332152 (UMLS 2011AA Property-3)
C19987 (NCI Thesaurus Property-4)
C0242656 (UMLS 2011AA Property-4)
C16112 (NCI Thesaurus Property-5)
C1516637 (UMLS 2011AA Property-5)
C49486 (NCI Thesaurus ValueDomain)
C1704854 (UMLS 2011AA ValueDomain)
CL.46
Code List
Was the prior adjuvant chemotherapy for localized cancer of the breast completed more than 3 years prior to registration and does the patient remain free of recurrent or metastatic disease?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Not Applicable (Not Applicable)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
ReceivedTherapyProtocolContraindicatedInd-3
Item
Is the treatment of previous cancer a contraindication to the current protocol therapy?
boolean
C25639 (NCI Thesaurus ObjectClass)
C1514756 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C25320 (NCI Thesaurus Property)
C1507394 (UMLS 2011AA Property)
C37933 (NCI Thesaurus Property-2)
C1444657 (UMLS 2011AA Property-2)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
PatientWoundComplicationPersonalMedicalHistoryInd-3b
Item
Does the patient have a serious non-healing wound, ulcer or bone fracture?
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3671 (NCI Thesaurus Property)
C0043250 (UMLS 2011AA Property)
C2959 (NCI Thesaurus Property-2)
C0009566 (UMLS 2011AA Property-2)
C18772 (NCI Thesaurus Property-3)
C0262926 (UMLS 2011AA Property-3)
C49797 (NCI Thesaurus ValueDomain)
C1708496 (UMLS 2011AA ValueDomain)
PersonAbdominalCavityFistulaPerforationAbscessClinicalTrialEligibilityCriteriaInd-2
Item
Does the patient have a history of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess within 28 days prior to first day of study therapy or an underlying lesion(s) that caused the fistula or perforation in the past that have not been corrected?
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C12664 (NCI Thesaurus Property)
C0230168 (UMLS 2011AA Property)
C26686 (NCI Thesaurus Property-2)
C0549483 (UMLS 2011AA Property-2)
C16112 (NCI Thesaurus Property-3)
C1516637 (UMLS 2011AA Property-3)
C4080 (NCI Thesaurus Property-4)
C0549099 (UMLS 2011AA Property-4)
C3045 (NCI Thesaurus Property-5)
C0016169 (UMLS 2011AA Property-5)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientHemorrhagePre-ExistingConditionInd-3b
Item
Does the patient have active bleeding or pathologic conditions that carry high risk of bleeding such as known bleeding disorder, coagulopathy or tumor involving major vessels?
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C26791 (NCI Thesaurus Property)
C0019080 (UMLS 2011AA Property)
CL232826 (NCI Metathesaurus Property)
C49797 (NCI Thesaurus ValueDomain)
C1708496 (UMLS 2011AA ValueDomain)
PatientCentralNervousSystemDiseaseorDisorderEligibilityDeterminationInd-2
Item
Does the patient have a history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C12438 (NCI Thesaurus Property)
C3714787 (UMLS 2011AA Property)
C2991 (NCI Thesaurus Property-2)
C0012634 (UMLS 2011AA Property-2)
C25171 (NCI Thesaurus Property-3)
C0013893 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientCentralNervousSystemDiseaseorDisorderEligibilityDeterminationInd-2
Item
Does the patient have a history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C12438 (NCI Thesaurus Property)
C3714787 (UMLS 2011AA Property)
C2991 (NCI Thesaurus Property-2)
C0012634 (UMLS 2011AA Property-2)
C25171 (NCI Thesaurus Property-3)
C0013893 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CardiovascularDiseasePresentInd-2
Item
Has the patient had clinically significant cardiovascular disease
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C25292 (NCI Thesaurus ObjectClass)
C0007226 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus ObjectClass-2)
C0012634 (UMLS 2011AA ObjectClass-2)
PatientInadequateControlHypertensionExclusionCriteriaInd-2
Item
Does the patient have uncontrolled hypertension defined as systolic greater than 140 mm Hg or diastolic greater than 90 mm Hg despite anti-hypertensive therapy?
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3117 (NCI Thesaurus Property)
C0020538 (UMLS 2011AA Property)
C61299 (NCI Thesaurus Property-2)
C2587213 (UMLS 2011AA Property-2)
C25370 (NCI Thesaurus Property-3)
C0680251 (UMLS 2011AA Property-3)
C69177 (NCI Thesaurus Property-4)
C0205412 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
MyocardialInfarctionPatientPreviousYearPersonalMedicalHistoryInd-2
Item
Has the patient had a myocardial infarction or unstable angina within 6 months of the first date of study therapy?
boolean
C27996 (NCI Thesaurus ObjectClass)
C0027051 (UMLS 2011AA ObjectClass)
C0030705 (NCI Metathesaurus ObjectClass)
C25627 (NCI Thesaurus Property)
C0205156 (UMLS 2011AA Property)
C29848 (NCI Thesaurus Property-2)
C0439234 (UMLS 2011AA Property-2)
C18772 (NCI Thesaurus Property-3)
C0262926 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PersonNewYorkHeartAssociationClassIIClinicalTrialEligibilityCriteriaInd-2
Item
Using the New York Heart Association (NYHA) guideline, does the patient have Class II or greater congestive heart failure?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C66905 (NCI Thesaurus Property-2)
C1882085 (UMLS 2011AA Property-2)
PersonEjectionFractionLowerLimitofNormalClinicalTrialEligibilityCriteriaInd-2
Item
Does the patient have an ejection fraction of less than institutional LLN?
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C37946 (NCI Thesaurus Property)
C2700377 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property-2)
C1516637 (UMLS 2011AA Property-2)
C25555 (NCI Thesaurus Property-3)
C1518030 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PersonVentricularArrhythmiaArrhythmiaMedicationClinicalTrialEligibilityCriteriaInd-2
Item
Does the patient have a history of serious ventricular arrhythmia (ventricular tachycardia or ventricular fibrillation) or arrhythmias requiring anti-arrhythmic medications (except for atrial fibrillation that is well controlled with anti-arrhythmic medication)?
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C2881 (NCI Thesaurus Property)
C0003811 (UMLS 2011AA Property)
C459 (NCI Thesaurus Property-2)
C0013227 (UMLS 2011AA Property-2)
E10230 (CTCAE Property)
C16112 (NCI Thesaurus Property-3)
C1516637 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CardiacDiseasePresentInd-2
Item
Does the patient have valvular heart disease greater than or equal to Grade 2?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
PersonSurgicalProcedureInjuryEligibilityDeterminationInd-2
Item
Has the patient undergone a major surgical procedure, open biopsy or incurred a significant traumatic injury within 28 days prior to the first date of study therapy?
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C15329 (NCI Thesaurus Property)
C0543467 (UMLS 2011AA Property)
C3671 (NCI Thesaurus Property-2)
C0043250 (UMLS 2011AA Property-2)
C25171 (NCI Thesaurus Property-3)
C0013893 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
GynecologicOncologyGroupMajorSurgeryInd-3b
Item
Is a major surgical procedure anticipated for this patient during the course of this study
boolean
C25521 (NCI Thesaurus ObjectClass)
C1512288 (UMLS 2011AA ObjectClass)
C0679637 (NCI Metathesaurus Property)
C49797 (NCI Thesaurus ValueDomain)
C1708496 (UMLS 2011AA ValueDomain)
PatientCoreBiopsyMinorSurgicalProcedureExclusionCriteriaInd-2
Item
Has the patient had any minor surgical procedures, fine needle aspirates or core biopsies within 7 days prior to the first date of study therapy?
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C15680 (NCI Thesaurus Property)
C1318309 (UMLS 2011AA Property)
C15329 (NCI Thesaurus Property-2)
C0543467 (UMLS 2011AA Property-2)
C45367 (NCI Thesaurus Property-3)
C0205165 (UMLS 2011AA Property-3)
C25370 (NCI Thesaurus Property-4)
C0680251 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PersonLegalAdolescentClinicalTrialEligibilityCriteriaInd-2
Item
Is the patient under age 18?
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C27954 (NCI Thesaurus Property-2)
C0205653 (UMLS 2011AA Property-2)
C54074 (NCI Thesaurus Property-3)
C1301860 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientPregnancyInd-2
Item
Is the patient pregnant or nursing?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25742 (NCI Thesaurus Property)
C0032961 (UMLS 2011AA Property)
PersonThromboembolismPersonalMedicalHistoryInd-3
Item
Does the patient have a history of major thromboembolic event defined as: symptomatic pulmonary embolism (PE), recurrent asymptomatic PE, or recurrent deep vein thrombosis?
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
C0040038 (NCI Metathesaurus Property)
PersonPriorThromboemboliceventInheritedCoagulationDisorderClinicalTrialEligibilityCriteriaInd-2
Item
Has the patient had prior thrombosis or thromboembolic event due to a known inherited coagulopathy? (ie, antithrombin-III deficiency, Protein C or Protein S deficiency, Factor V Leiden mutation presence, prothrombin G20210A mutation )
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
E13825 (CTCAE Property)
C16112 (NCI Thesaurus Property-2)
C1516637 (UMLS 2011AA Property-2)
C2902 (NCI Thesaurus Property-3)
C0005779 (UMLS 2011AA Property-3)
C28018 (NCI Thesaurus Property-4)
C0439660 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientPriorDiseaseorDisorderSystemicAntibioticAntiviralTherapyEligibilityDeterminationInd-2
Item
Has the patient had serious infections requiring systemic antibiotics or antiviral therapy including: known active Hepatitis B or C infection; known HIV infection?
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C13310 (NCI Thesaurus Property)
C0205373 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C2991 (NCI Thesaurus Property-3)
C0012634 (UMLS 2011AA Property-3)
C258 (NCI Thesaurus Property-4)
C0003232 (UMLS 2011AA Property-4)
C25171 (NCI Thesaurus Property-5)
C0013893 (UMLS 2011AA Property-5)
C16119 (NCI Thesaurus Property-6)
C0280274 (UMLS 2011AA Property-6)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PersonPriorImmunomodulatingAgentClinicalTrialEligibilityCriteriaInd-2
Item
Has the patient been treated with immune modulators such as systemic cyclosporine or tacrolimus within 30 days prior to enrollment?
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property-2)
C1516637 (UMLS 2011AA Property-2)
C308 (NCI Thesaurus Property-3)
C0005525 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PersonPriorPhotosensitivityClinicalTrialEligibilityCriteriaInd-2
Item
Does the patient have a history of photosensitivity or must she take agents which increase photosensitivity?
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property-2)
C1516637 (UMLS 2011AA Property-2)
E13680 (CTCAE Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientSwallowingAssessmentInd-2
Item
Does the patient have the ability to swallow oral medication
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C38028 (NCI Thesaurus Property-2)
C0011167 (UMLS 2011AA Property-2)
TreatmentPlannedDate
Item
Anticipated date treatment will start
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25619 (NCI Thesaurus Property)
C1301732 (UMLS 2011AA Property)
ClinicalTrialEligibilityCriteriaWorksheetCommentText
Item
Provide comments about this Fast Fact Sheet
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS 2011AA Property)
C16112 (NCI Thesaurus ObjectClass)
C1516637 (UMLS 2011AA ObjectClass)
C73541 (NCI Thesaurus Property-2)
C2349155 (UMLS 2011AA Property-2)
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