ID

6263

Description

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

Keywords

Versions (3)
  1. 12/18/14 12/18/14 - Martin Dugas
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 9/17/21 9/17/21 -
Uploaded on

December 18, 2014

DOI

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License

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

English

No Instruction available.

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

Tracking Information

GOG Institution Code
Description

InstitutionGynecologicOncologyGroupIdentifierCode

Data type

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
C25521
UMLS 2011AA Property
C1512288
GOG Affiliate Code
Description

AffiliatedInstitutionGynecologicOncologyGroupIdentifierCode

Data type

text

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

PriorClinicalStudyProtocolGynecologicOncologyGroupIdentifierNumber

Data type

text

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

TreatingPhysicianName

Data type

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
C25705
UMLS 2011AA ObjectClass
C1522326
Other Physician
Description

PhysicianPersonVerificationIdentifierName

Data type

text

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

PatientMedicalRecordNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25261
UMLS 2011AA Property
C0205476
NCI Thesaurus Property
C25198
UMLS 2011AA Property
C0034869
Date of Birth
Description

PersonBirthDate

Data type

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
Description

PatientLastName

Data type

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
C25551
UMLS 2011AA Property
C1517741
Patient First Name
Description

PatientFirstName

Data type

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
C25509
UMLS 2011AA Property
C1279901
Patient Middle Name
Description

PatientMiddleName

Data type

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
C25569
UMLS 2011AA Property
C0444598
Unnamed1
Description

Unnamed1

Did the patient sign an approved informed consent
Description

InformedConsentFormSignedInd-2

Data type

text

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)
Description

LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseUpperLimitofNormalResultInd-2

Data type

text

Has HIPAA authorization been obtained
Description

HealthInsurancePortabilityandAccountabilityActAuthorizationIndicator

Data type

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
Description

PersonPriorityGynecologicOncologyGroupClinicalTrialEligibilityCriteriaInd-2

Data type

text

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

GynecologicMalignantNeoplasmPrimarySite

Data type

text

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

PersonMalignantNeoplasmPathologyClinicalTrialEligibilityCriteriaMalignantNeoplasmPathologyType

Data type

text

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

MalignantNeoplasmInitialHistologicDiagnosisDate

Data type

date

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

GynecologicTumorHistologicGrade

Data type

text

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

PersonMalignantNeoplasmRecurrentDiseaseDiseaseProgressionClinicalTrialEligibilityCriteriaStatus

Data type

text

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

DiseaseTreatmentRefractoryInd-2

Data type

text

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?
Description

PersonMalignantNeoplasmRecurrentDiseaseDiseaseProgressionDiagnosisType

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C38155
UMLS 2011AA Property
C0277556
NCI Thesaurus Property
C9305
UMLS 2011AA Property
C0006826
NCI Thesaurus Property
C17747
UMLS 2011AA Property
C0242656
NCI Thesaurus Property
C15220
UMLS 2011AA Property
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.)
Description

PersonMalignantNeoplasmRecurrentDiseaseDiseaseProgressionDiagnosisDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C38155
UMLS 2011AA Property
C0277556
NCI Thesaurus Property
C9305
UMLS 2011AA Property
C0006826
NCI Thesaurus Property
C17747
UMLS 2011AA Property
C0242656
NCI Thesaurus Property
C15220
UMLS 2011AA Property
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?
Description

PersonMalignantNeoplasmMeasurableDiseasePresentClinicalTrialEligibilityCriteriaIndicator

Data type

text

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

MalignantNeoplasmMeasurableDiseaseEvaluationMethodClinicalTrialEligibilityCriteriaType

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25214
UMLS 2011AA Property
C0220825
NCI Thesaurus Property
C9305
UMLS 2011AA Property
C0006826
NCI Thesaurus Property
C8507
UMLS 2011AA Property
C1513041
NCI Thesaurus Property
C71460
UMLS 2011AA Property
C0025663
NCI Thesaurus Property
C16112
UMLS 2011AA Property
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?
Description

PersonMalignantNeoplasmMeasurableDiseaseSizePresentClinicalTrialEligibilityCriteriaIndicator

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus Property
C9305
UMLS 2011AA Property
C0006826
NCI Thesaurus Property
C8507
UMLS 2011AA Property
C1513041
NCI Thesaurus Property
C16112
UMLS 2011AA Property
C1516637
NCI Thesaurus Property
C25681
UMLS 2011AA Property
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?
Description

PersonMalignantNeoplasmMeasurableDiseaseResponseEvaluationCriteriainSolidTumorsClinicalTrialEligibilityCriteriaIndicator

Data type

text

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

PersonMalignantNeoplasmMeasurableDiseaseRadiationFieldClinicalTrialEligibilityCriteriaIndicator

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C9305
UMLS 2011AA Property
C0006826
NCI Thesaurus Property
C8507
UMLS 2011AA Property
C1513041
NCI Thesaurus Property
C54648
UMLS 2011AA Property
C1882536
NCI Thesaurus Property
C16112
UMLS 2011AA Property
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?
Description

PersonMalignantNeoplasmMeasurableDiseaseRadiationFieldClinicalTrialEligibilityCriteriaInd-3b

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C9305
UMLS 2011AA Property
C0006826
NCI Thesaurus Property
C8507
UMLS 2011AA Property
C1513041
NCI Thesaurus Property
C54648
UMLS 2011AA Property
C1882536
NCI Thesaurus Property
C16112
UMLS 2011AA Property
C1516637
NCI Thesaurus ValueDomain
C49797
UMLS 2011AA ValueDomain
C1708496
Performance Status
Description

PerformanceStatusAssessmentEasternCooperativeOncologyGroupScale

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
NCI Thesaurus Property
C25367
NCI Thesaurus ValueDomain
C25491
UMLS 2011AA ValueDomain
C1512162
NCI Thesaurus ObjectClass
C20641
UMLS 2011AA ObjectClass
C1518965
Does the patient have normal thyroid function?
Description

PersonThyroidGlandFunctionClinicalTrialEligibilityCriteriaInd-2

Data type

text

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

PersonLastTherapeuticProcedureRecoveryClinicalTrialEligibilityCriteriaInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C49236
UMLS 2011AA Property
C0087111
NCI Thesaurus Property
C25746
UMLS 2011AA Property
C2004454
NCI Thesaurus Property
C25551
UMLS 2011AA Property
C1517741
NCI Thesaurus Property
C16112
UMLS 2011AA Property
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)?
Description

PersonNoInfectionRequiredAntibioticClinicalTrialEligibilityCriteriaInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C49487
UMLS 2011AA Property
C1298908
NCI Thesaurus Property
C26726
UMLS 2011AA Property
C0009450
NCI Thesaurus Property
C258
UMLS 2011AA Property
C0003232
NCI Thesaurus Property
C25652
UMLS 2011AA Property
C1514873
NCI Thesaurus Property
C16112
UMLS 2011AA Property
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?
Description

PersonMalignantNeoplasmEndocrineTherapyClinicalTrialEligibilityCriteriaInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C9305
UMLS 2011AA Property
C0006826
NCI Thesaurus Property
C15445
UMLS 2011AA Property
C0279025
NCI Thesaurus Property
C16112
UMLS 2011AA Property
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?
Description

PersonTherapeuticProcedureDiscontinuedPriorRegistrationClinicalTrialEligibilityCriteriaInd-2

Data type

text

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

PriorCytotoxicChemotherapyUterineEndometrialCarcinomaAdministeredInd-2

Data type

text

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

ChemotherapyRegimenOneReceiveName

Data type

text

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

ChemotherapyRegimenOneReceiveBeginDate

Data type

date

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

ChemotherapyRegimenOneReceiveEndDate

Data type

date

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

ChemotherapyRegimenReceiveChemotherapyRegimenReceiveType

Data type

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:
Description

ChemotherapyRegimenTwoReceiveName

Data type

text

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

ChemotherapyRegimenTwoReceiveBeginDate

Data type

date

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

ChemotherapyRegimenTwoReceiveEndDate

Data type

date

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

PersonMalignantNeoplasmRecurrentDiseaseDiseaseProgressionTherapeuticProcedureReceiveInd-2

Data type

text

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

LaboratoryProcedureEvaluationOutcomeDate

Data type

date

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

LaboratoryProcedurePlateletCountEligibilityDeterminationInd-2

Data type

text

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
C25171
UMLS 2011AA Property
C0013893
ANC greater than or equal to 1,500/mcl?
Description

LaboratoryProcedureAbsoluteNeutrophilCountEligibilityDeterminationInd-2

Data type

text

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
C25171
UMLS 2011AA Property
C0013893
Is the creatinine less than or equal to 1.5 X ULN
Description

LaboratoryProcedureCreatinineUpperLimitofNormalOutcomeInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C399
UMLS 2011AA Property
C0010294
NCI Thesaurus Property
C25706
UMLS 2011AA Property
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)
Description

PatientElevatedBilirubinPersonalMedicalHistoryInd-2

Data type

text

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
C18772
UMLS 2011AA Property
C0262926
Is SGPT (ALT) less than or equal to 3.0 X Upper Limits of Normal
Description

SerumGlutamicPyruvateTransaminasesHepaticWithinProtocolUpperLimitofNormalLabInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C13308
UMLS 2011AA ObjectClass
C0205054
NCI Thesaurus ObjectClass
C25293
UMLS 2011AA ObjectClass
C0376147
NCI Thesaurus Property
C25320
UMLS 2011AA Property
C1507394
NCI Thesaurus Property
C37984
UMLS 2011AA Property
C0022877
NCI Thesaurus Property
C25282
UMLS 2011AA Property
C0332285
NCI Thesaurus Property
C25706
UMLS 2011AA Property
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)
Description

LaboratoryProcedureAlkalinePhosphataseEligibilityDeterminationInd-2

Data type

text

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
C16276
UMLS 2011AA Property
C0002059
Is her urine protein creatinine (UPC) ratio less than 1 (or urinary protein less than 1.0g/24 hours)
Description

PersonCreatinineUrineProteinMeasurementClinicalTrialEligibilityCriteriaInd-2

Data type

text

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

LaboratoryProcedureProthrombinTimeResultProthrombinTimeType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C62656
UMLS 2011AA Property
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?
Description

LaboratoryProcedurePartialThromboplastinTimeResultInd-2

Data type

text

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
C38462
UMLS 2011AA Property
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)
Description

ElectrocardiographyDiagnosticProcedureQTcIntervalAssessmentInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C38053
UMLS 2011AA ObjectClass
C1623258
NCI Thesaurus ObjectClass
C18020
UMLS 2011AA ObjectClass
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
Description

PatientEligibilityInd-2

Data type

text

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
Description

PatientNegativePregnancyTestInd-4

Data type

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?
Description

ContraceptionAgreementInd

Data type

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?
Description

PersonPriorAntiangiogenesisTherapyClinicalTrialEligibilityCriteriaInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property
C16112
UMLS 2011AA Property
C1516637
NCI Thesaurus Property
C15568
UMLS 2011AA Property
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?
Description

PatientNeoplasmPersonalMedicalHistoryIndicator

Data type

text

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
C18772
UMLS 2011AA Property
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?
Description

PersonPriorRadiationTherapyAbdominalCavityPelvisClinicalTrialEligibilityCriteriaInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C15313
UMLS 2011AA Property
C1522449
NCI Thesaurus Property
C12664
UMLS 2011AA Property
C0230168
NCI Thesaurus Property
C12767
UMLS 2011AA Property
C0030797
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property
C16112
UMLS 2011AA Property
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?
Description

PersonPriorRadiationTherapyBreastHeadandNeckSkinClinicalTrialEligibilityCriteriaInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C15313
UMLS 2011AA Property
C1522449
NCI Thesaurus Property
C12470
UMLS 2011AA Property
C1123023
NCI Thesaurus Property
C12971
UMLS 2011AA Property
C0006141
NCI Thesaurus Property
C12418
UMLS 2011AA Property
C0460004
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property
C16112
UMLS 2011AA Property
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?
Description

PersonPriorRadiationTherapyBreastHeadandNeckSkinNoCancerProgressionClinicalTrialEligibilityCriteriaInd-4

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C49487
UMLS 2011AA Property
C1298908
NCI Thesaurus Property
C15313
UMLS 2011AA Property
C1522449
NCI Thesaurus Property
C12470
UMLS 2011AA Property
C1123023
NCI Thesaurus Property
C12971
UMLS 2011AA Property
C0006141
NCI Thesaurus Property
C12418
UMLS 2011AA Property
C0460004
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property
C19987
UMLS 2011AA Property
C0242656
NCI Thesaurus Property
C16112
UMLS 2011AA Property
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?
Description

PriorGynecologicChemotherapyAdministeredInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus ObjectClass
C28016
UMLS 2011AA ObjectClass
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?
Description

PersonPriorAdjuvantChemotherapyClinicalTrialEligibilityCriteriaInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C15360
UMLS 2011AA Property
C0085533
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property
C16112
UMLS 2011AA Property
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?
Description

PersonPriorAdjuvantChemotherapyNoCancerProgressionClinicalTrialEligibilityCriteriaInd-4

Data type

text

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

ReceivedTherapyProtocolContraindicatedInd-3

Data type

text

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

PatientWoundComplicationPersonalMedicalHistoryInd-3b

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C3671
UMLS 2011AA Property
C0043250
NCI Thesaurus Property
C2959
UMLS 2011AA Property
C0009566
NCI Thesaurus Property
C18772
UMLS 2011AA Property
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?
Description

PersonAbdominalCavityFistulaPerforationAbscessClinicalTrialEligibilityCriteriaInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C12664
UMLS 2011AA Property
C0230168
NCI Thesaurus Property
C26686
UMLS 2011AA Property
C0549483
NCI Thesaurus Property
C16112
UMLS 2011AA Property
C1516637
NCI Thesaurus Property
C4080
UMLS 2011AA Property
C0549099
NCI Thesaurus Property
C3045
UMLS 2011AA Property
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?
Description

PatientHemorrhagePre-ExistingConditionInd-3b

Data type

text

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
Description

PatientCentralNervousSystemDiseaseorDisorderEligibilityDeterminationInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C12438
UMLS 2011AA Property
C0927232
NCI Thesaurus Property
C2991
UMLS 2011AA Property
C0012634
NCI Thesaurus Property
C25171
UMLS 2011AA Property
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
Description

PatientCentralNervousSystemDiseaseorDisorderEligibilityDeterminationInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C12438
UMLS 2011AA Property
C0927232
NCI Thesaurus Property
C2991
UMLS 2011AA Property
C0012634
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Has the patient had clinically significant cardiovascular disease
Description

CardiovascularDiseasePresentInd-2

Data type

text

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
C2991
UMLS 2011AA ObjectClass
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?
Description

PatientInadequateControlHypertensionExclusionCriteriaInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C3117
UMLS 2011AA Property
C0020538
NCI Thesaurus Property
C61299
UMLS 2011AA Property
C2587213
NCI Thesaurus Property
C25370
UMLS 2011AA Property
C0680251
NCI Thesaurus Property
C69177
UMLS 2011AA Property
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?
Description

MyocardialInfarctionPatientPreviousYearPersonalMedicalHistoryInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C27996
UMLS 2011AA ObjectClass
C0027051
NCI Metathesaurus ObjectClass
C0030705
NCI Thesaurus Property
C25627
UMLS 2011AA Property
C0205156
NCI Thesaurus Property
C29848
UMLS 2011AA Property
C0439234
NCI Thesaurus Property
C18772
UMLS 2011AA Property
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?
Description

PersonNewYorkHeartAssociationClassIIClinicalTrialEligibilityCriteriaInd-2

Data type

text

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
C66905
UMLS 2011AA Property
C1882085
Does the patient have an ejection fraction of less than institutional LLN?
Description

PersonEjectionFractionLowerLimitofNormalClinicalTrialEligibilityCriteriaInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C37946
UMLS 2011AA Property
C2700377
NCI Thesaurus Property
C16112
UMLS 2011AA Property
C1516637
NCI Thesaurus Property
C25555
UMLS 2011AA Property
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)?
Description

PersonVentricularArrhythmiaArrhythmiaMedicationClinicalTrialEligibilityCriteriaInd-2

Data type

text

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

CardiacDiseasePresentInd-2

Data type

text

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?
Description

PersonSurgicalProcedureInjuryEligibilityDeterminationInd-2

Data type

text

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

GynecologicOncologyGroupMajorSurgeryInd-3b

Data type

text

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?
Description

PatientCoreBiopsyMinorSurgicalProcedureExclusionCriteriaInd-2

Data type

text

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

PersonLegalAdolescentClinicalTrialEligibilityCriteriaInd-2

Data type

text

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

PatientPregnancyInd-2

Data type

text

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?
Description

PersonThromboembolismPersonalMedicalHistoryInd-3

Data type

text

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 )
Description

PersonPriorThromboemboliceventInheritedCoagulationDisorderClinicalTrialEligibilityCriteriaInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
CTCAE Property
E13825
NCI Thesaurus Property
C16112
UMLS 2011AA Property
C1516637
NCI Thesaurus Property
C2902
UMLS 2011AA Property
C0005779
NCI Thesaurus Property
C28018
UMLS 2011AA Property
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?
Description

PatientPriorDiseaseorDisorderSystemicAntibioticAntiviralTherapyEligibilityDeterminationInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C13310
UMLS 2011AA Property
C0205373
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property
C2991
UMLS 2011AA Property
C0012634
NCI Thesaurus Property
C258
UMLS 2011AA Property
C0003232
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
NCI Thesaurus Property
C16119
UMLS 2011AA Property
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?
Description

PersonPriorImmunomodulatingAgentClinicalTrialEligibilityCriteriaInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property
C16112
UMLS 2011AA Property
C1516637
NCI Thesaurus Property
C308
UMLS 2011AA Property
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?
Description

PersonPriorPhotosensitivityClinicalTrialEligibilityCriteriaInd-2

Data type

text

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

PatientSwallowingAssessmentInd-2

Data type

text

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
C38028
UMLS 2011AA Property
C0011167
Anticipated date treatment will start
Description

TreatmentPlannedDate

Data type

date

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

Comments

Provide comments about this Fast Fact Sheet
Description

ClinicalTrialEligibilityCriteriaWorksheetCommentText

Data type

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
C73541
UMLS 2011AA Property
C2349155
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  1. StudyEvent: GOG-0229K: Fast Fact Sheet for Protocol 0229-K (Endometrium)
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Name
Type
Description | Question | Decode (Coded Value)
Data type
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)
C1512288 (UMLS 2011AA Property)
AffiliatedInstitutionGynecologicOncologyGroupIdentifierCode
Item
GOG Affiliate Code
text
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25413 (NCI Thesaurus ObjectClass)
C1510826 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25521 (NCI Thesaurus Property)
C1512288 (UMLS 2011AA Property)
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)
C0332152 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25521 (NCI Thesaurus Property)
C1512288 (UMLS 2011AA Property)
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)
C1522326 (UMLS 2011AA ObjectClass)
PhysicianPersonVerificationIdentifierName
Item
Other Physician
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25741 (NCI Thesaurus ObjectClass)
C0031831 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C45513 (NCI Thesaurus Property)
C1711411 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
PatientMedicalRecordNumber
Item
Patient Hospital No.
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25261 (NCI Thesaurus Property)
C0205476 (UMLS 2011AA Property)
C25198 (NCI Thesaurus Property)
C0034869 (UMLS 2011AA Property)
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)
PatientLastName
Item
Patient Last 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)
C25551 (NCI Thesaurus Property)
C1517741 (UMLS 2011AA Property)
PatientFirstName
Item
Patient First 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)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
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)
C0444598 (UMLS 2011AA Property)
Item Group
Unnamed1
Item
Did the patient sign an approved informed consent
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
CL.1
Code List
Did the patient sign an approved informed consent
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Is the SGOT less than or equal to 3 X ULN (regardless of the presence of liver metastases)
text
CL.29
Code List
Is the SGOT less than or equal to 3 X ULN (regardless of the presence of liver metastases)
CL Item
Yes (Yes)
CL Item
No (No)
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)
Item
Is the patient eligible for a higher priority GOG protocol
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25521 (NCI Thesaurus Property)
C1512288 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C48911 (NCI Thesaurus Property)
C0549179 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.3
Code List
Is the patient eligible for a higher priority GOG protocol
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
What is the site of the disease
text
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C28016 (NCI Thesaurus ObjectClass)
C0205480 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25251 (NCI Thesaurus Property)
C0205225 (UMLS 2011AA Property)
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)
C0030664 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
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)
C0205370 (UMLS 2011AA)
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)
C0205462 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
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)
C0205480 (UMLS 2011AA ObjectClass)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
C25526 (NCI Thesaurus ValueDomain)
C0205462 (UMLS 2011AA ValueDomain)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
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)
C0006826 (UMLS 2011AA Property)
C17747 (NCI Thesaurus Property)
C0242656 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
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)
Item
Is the cancer refractory to curative therapy or established treatment?
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)
CL.8
Code List
Is the cancer refractory to curative therapy or established treatment?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
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)
C0006826 (UMLS 2011AA Property)
C17747 (NCI Thesaurus Property)
C0242656 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
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)
C0006826 (UMLS 2011AA Property)
C17747 (NCI Thesaurus Property)
C0242656 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
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?
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property)
C0006826 (UMLS 2011AA Property)
C8507 (NCI Thesaurus Property)
C1513041 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.10
Code List
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?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
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)
C0006826 (UMLS 2011AA Property)
C8507 (NCI Thesaurus Property)
C1513041 (UMLS 2011AA Property)
C71460 (NCI Thesaurus Property)
C0025663 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
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)
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?
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property)
C0006826 (UMLS 2011AA Property)
C8507 (NCI Thesaurus Property)
C1513041 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C25681 (NCI Thesaurus Property)
C0456389 (UMLS 2011AA Property)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.12
Code List
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?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
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?
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus Property)
C0006826 (UMLS 2011AA Property)
C8507 (NCI Thesaurus Property)
C1513041 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C49164 (NCI Thesaurus Property)
C1709926 (UMLS 2011AA Property)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.13
Code List
Does the patient have at least one target lesion to be used to assess response on this protocol as defined by RECIST 1.1?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Is the measurable disease in a previously irradiated field?
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus Property)
C0006826 (UMLS 2011AA Property)
C8507 (NCI Thesaurus Property)
C1513041 (UMLS 2011AA Property)
C54648 (NCI Thesaurus Property)
C1882536 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.14
Code List
Is the measurable disease in a previously irradiated field?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
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)
C1513041 (UMLS 2011AA Property)
C54648 (NCI Thesaurus Property)
C1882536 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
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)
C0349674 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain)
C1512162 (UMLS 2011AA ValueDomain)
C20641 (NCI Thesaurus ObjectClass)
C1518965 (UMLS 2011AA 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)
Item
Does the patient have normal thyroid function?
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C12400 (NCI Thesaurus Property)
C0040132 (UMLS 2011AA Property)
C25518 (NCI Thesaurus Property)
C0542341 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.17
Code List
Does the patient have normal thyroid function?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Has the patient recovered from the effects of recent surgery, radiotherapy or chemotherapy?
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C49236 (NCI Thesaurus Property)
C0087111 (UMLS 2011AA Property)
C25746 (NCI Thesaurus Property)
C2004454 (UMLS 2011AA Property)
C25551 (NCI Thesaurus Property)
C1517741 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.18
Code List
Has the patient recovered from the effects of recent surgery, radiotherapy or chemotherapy?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Is the patient free of active infection requiring antibiotics with the exception of uncomplicated urinary tract infection (UTI)?
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C49487 (NCI Thesaurus Property)
C1298908 (UMLS 2011AA Property)
C26726 (NCI Thesaurus Property)
C0009450 (UMLS 2011AA Property)
C258 (NCI Thesaurus Property)
C0003232 (UMLS 2011AA Property)
C25652 (NCI Thesaurus Property)
C1514873 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.19
Code List
Is the patient free of active infection requiring antibiotics with the exception of uncomplicated urinary tract infection (UTI)?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Has any hormonal therapy directed at the malignant tumor been discontinued at least one week prior to registration?
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus Property)
C0006826 (UMLS 2011AA Property)
C15445 (NCI Thesaurus Property)
C0279025 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.20
Code List
Has any hormonal therapy directed at the malignant tumor been discontinued at least one week prior to registration?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Has all prior therapy directed at the malignant tumor, including immunologic agents, been discontinued for at least three weeks prior to registration?
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C49236 (NCI Thesaurus Property)
C0087111 (UMLS 2011AA Property)
C25484 (NCI Thesaurus Property)
C1444662 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.21
Code List
Has all prior therapy directed at the malignant tumor, including immunologic agents, been discontinued for at least three weeks prior to registration?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Has the patient received one prior chemotherapeutic regimen for management of endometrial carcinoma?
text
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15681 (NCI Thesaurus ObjectClass)
C0677881 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C7558 (NCI Thesaurus Property)
C0476089 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.22
Code List
Has the patient received one prior chemotherapeutic regimen for management of endometrial carcinoma?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
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)
C0205447 (UMLS 2011AA Property)
C1708 (NCI Thesaurus ValueDomain)
C0450442 (UMLS 2011AA ValueDomain)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)
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)
C0205447 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)
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)
C0205447 (UMLS 2011AA Property)
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)
C1514756 (UMLS 2011AA Property)
C1708 (NCI Thesaurus ValueDomain)
C0450442 (UMLS 2011AA ValueDomain)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)
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)
C1514756 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)
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)
C1514756 (UMLS 2011AA Property)
C12218 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
Item
Has the patient received any non-cytotoxic chemotherapy for management of recurrent or persistent disease
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C38155 (NCI Thesaurus Property)
C0277556 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property)
C0006826 (UMLS 2011AA Property)
C17747 (NCI Thesaurus Property)
C0242656 (UMLS 2011AA Property)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C49236 (NCI Thesaurus Property)
C0087111 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.24
Code List
Has the patient received any non-cytotoxic chemotherapy for management of recurrent or persistent disease
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
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)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
Item
Platelets greater than or equal to 100,000/mcl?
text
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)
C0013893 (UMLS 2011AA Property)
CL.25
Code List
Platelets greater than or equal to 100,000/mcl?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
ANC greater than or equal to 1,500/mcl?
text
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)
C0013893 (UMLS 2011AA Property)
CL.26
Code List
ANC greater than or equal to 1,500/mcl?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Is the creatinine less than or equal to 1.5 X ULN
text
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C25706 (NCI Thesaurus Property)
C1519815 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.27
Code List
Is the creatinine less than or equal to 1.5 X ULN
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Is the bilirubin less than or equal to 1.5 x ULN (regardless of the presence of liver metastases)
text
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)
C0262926 (UMLS 2011AA Property)
CL.28
Code List
Is the bilirubin less than or equal to 1.5 x ULN (regardless of the presence of liver metastases)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Is SGPT (ALT) less than or equal to 3.0 X Upper Limits of Normal
text
C13308 (NCI Thesaurus ObjectClass)
C0205054 (UMLS 2011AA ObjectClass)
C25293 (NCI Thesaurus ObjectClass)
C0376147 (UMLS 2011AA ObjectClass)
C25320 (NCI Thesaurus Property)
C1507394 (UMLS 2011AA Property)
C37984 (NCI Thesaurus Property)
C0022877 (UMLS 2011AA Property)
C25282 (NCI Thesaurus Property)
C0332285 (UMLS 2011AA Property)
C25706 (NCI Thesaurus Property)
C1519815 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.30
Code List
Is SGPT (ALT) less than or equal to 3.0 X Upper Limits of Normal
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Is the alkaline phosphatase less than or equal to 2.5 x ULN? (regardless of the presence of liver metastases)
text
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)
C0002059 (UMLS 2011AA Property)
CL.31
Code List
Is the alkaline phosphatase less than or equal to 2.5 x ULN? (regardless of the presence of liver metastases)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Is her urine protein creatinine (UPC) ratio less than 1 (or urinary protein less than 1.0g/24 hours)
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C74760 (NCI Thesaurus Property)
C0262923 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.32
Code List
Is her urine protein creatinine (UPC) ratio less than 1 (or urinary protein less than 1.0g/24 hours)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
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)
C0033707 (UMLS 2011AA Property)
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)
Item
Is the PTT less than or equal to 1.5 times the institutional upper limit of normal?
text
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)
C0030605 (UMLS 2011AA Property)
CL.34
Code List
Is the PTT less than or equal to 1.5 times the institutional upper limit of normal?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
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)
text
C38053 (NCI Thesaurus ObjectClass)
C1623258 (UMLS 2011AA ObjectClass)
C18020 (NCI Thesaurus ObjectClass)
C0430022 (UMLS 2011AA ObjectClass)
C25367 (NCI Thesaurus Property)
C0489625 (NCI Metathesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.35
Code List
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)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Has the patient met the pre-entry requirements as specified in section 7.0
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
CL.36
Code List
Has the patient met the pre-entry requirements as specified in section 7.0
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
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)
Item
Has the patient received prior therapy with BIBF1120?
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C15568 (NCI Thesaurus Property)
C0281318 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.39
Code List
Has the patient received prior therapy with BIBF1120?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
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?
text
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)
C0262926 (UMLS 2011AA Property)
CL.40
Code List
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?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
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?
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C15313 (NCI Thesaurus Property)
C1522449 (UMLS 2011AA Property)
C12664 (NCI Thesaurus Property)
C0230168 (UMLS 2011AA Property)
C12767 (NCI Thesaurus Property)
C0030797 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.41
Code List
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?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Has the patient received prior radiation for localized cancer of the breast, head and neck or skin?
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C15313 (NCI Thesaurus Property)
C1522449 (UMLS 2011AA Property)
C12470 (NCI Thesaurus Property)
C1123023 (UMLS 2011AA Property)
C12971 (NCI Thesaurus Property)
C0006141 (UMLS 2011AA Property)
C12418 (NCI Thesaurus Property)
C0460004 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.42
Code List
Has the patient received prior radiation for localized cancer of the breast, head and neck or skin?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
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)
C1522449 (UMLS 2011AA Property)
C12470 (NCI Thesaurus Property)
C1123023 (UMLS 2011AA Property)
C12971 (NCI Thesaurus Property)
C0006141 (UMLS 2011AA Property)
C12418 (NCI Thesaurus Property)
C0460004 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C19987 (NCI Thesaurus Property)
C0242656 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
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)
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?
text
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C28016 (NCI Thesaurus ObjectClass)
C0205480 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.44
Code List
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?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Has the patient received prior adjuvant chemotherapy for localized breast cancer?
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C15360 (NCI Thesaurus Property)
C0085533 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.45
Code List
Has the patient received prior adjuvant chemotherapy for localized breast cancer?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
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)
C0085533 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C19987 (NCI Thesaurus Property)
C0242656 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
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)
Item
Is the treatment of previous cancer a contraindication to the current protocol therapy?
text
C25639 (NCI Thesaurus ObjectClass)
C1514756 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass)
C25320 (NCI Thesaurus Property)
C1507394 (UMLS 2011AA Property)
C37933 (NCI Thesaurus Property)
C1444657 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.47
Code List
Is the treatment of previous cancer a contraindication to the current protocol therapy?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Does the patient have a serious non-healing wound, ulcer or bone fracture?
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3671 (NCI Thesaurus Property)
C0043250 (UMLS 2011AA Property)
C2959 (NCI Thesaurus Property)
C0009566 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
C49797 (NCI Thesaurus ValueDomain)
C1708496 (UMLS 2011AA ValueDomain)
CL.48
Code List
Does the patient have a serious non-healing wound, ulcer or bone fracture?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
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?
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C12664 (NCI Thesaurus Property)
C0230168 (UMLS 2011AA Property)
C26686 (NCI Thesaurus Property)
C0549483 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C4080 (NCI Thesaurus Property)
C0549099 (UMLS 2011AA Property)
C3045 (NCI Thesaurus Property)
C0016169 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.49
Code List
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?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
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?
text
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)
CL.50
Code List
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?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
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
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C12438 (NCI Thesaurus Property)
C0927232 (UMLS 2011AA Property)
C2991 (NCI Thesaurus Property)
C0012634 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.59
Code List
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
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
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
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C12438 (NCI Thesaurus Property)
C0927232 (UMLS 2011AA Property)
C2991 (NCI Thesaurus Property)
C0012634 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.59
Code List
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
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Has the patient had clinically significant cardiovascular disease
text
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)
C0012634 (UMLS 2011AA ObjectClass)
CL.52
Code List
Has the patient had clinically significant cardiovascular disease
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
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?
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3117 (NCI Thesaurus Property)
C0020538 (UMLS 2011AA Property)
C61299 (NCI Thesaurus Property)
C2587213 (UMLS 2011AA Property)
C25370 (NCI Thesaurus Property)
C0680251 (UMLS 2011AA Property)
C69177 (NCI Thesaurus Property)
C0205412 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.53
Code List
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?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Has the patient had a myocardial infarction or unstable angina within 6 months of the first date of study therapy?
text
C27996 (NCI Thesaurus ObjectClass)
C0027051 (UMLS 2011AA ObjectClass)
C0030705 (NCI Metathesaurus ObjectClass)
C25627 (NCI Thesaurus Property)
C0205156 (UMLS 2011AA Property)
C29848 (NCI Thesaurus Property)
C0439234 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.54
Code List
Has the patient had a myocardial infarction or unstable angina within 6 months of the first date of study therapy?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Using the New York Heart Association (NYHA) guideline, does the patient have Class II or greater congestive heart failure?
text
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)
C1882085 (UMLS 2011AA Property)
CL.55
Code List
Using the New York Heart Association (NYHA) guideline, does the patient have Class II or greater congestive heart failure?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Does the patient have an ejection fraction of less than institutional LLN?
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C37946 (NCI Thesaurus Property)
C2700377 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C25555 (NCI Thesaurus Property)
C1518030 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.56
Code List
Does the patient have an ejection fraction of less than institutional LLN?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
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)?
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C2881 (NCI Thesaurus Property)
C0003811 (UMLS 2011AA Property)
C459 (NCI Thesaurus Property)
C0013227 (UMLS 2011AA Property)
E10230 (CTCAE Property)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.57
Code List
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)?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Does the patient have valvular heart disease greater than or equal to Grade 2?
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
CL.58
Code List
Does the patient have valvular heart disease greater than or equal to Grade 2?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
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?
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C15329 (NCI Thesaurus Property)
C0543467 (UMLS 2011AA Property)
C3671 (NCI Thesaurus Property)
C0043250 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.60
Code List
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?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Is a major surgical procedure anticipated for this patient during the course of this study
text
C25521 (NCI Thesaurus ObjectClass)
C1512288 (UMLS 2011AA ObjectClass)
C0679637 (NCI Metathesaurus Property)
C49797 (NCI Thesaurus ValueDomain)
C1708496 (UMLS 2011AA ValueDomain)
CL.61
Code List
Is a major surgical procedure anticipated for this patient during the course of this study
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
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?
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C15680 (NCI Thesaurus Property)
C1318309 (UMLS 2011AA Property)
C15329 (NCI Thesaurus Property)
C0543467 (UMLS 2011AA Property)
C45367 (NCI Thesaurus Property)
C0205165 (UMLS 2011AA Property)
C25370 (NCI Thesaurus Property)
C0680251 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.62
Code List
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?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Is the patient under age 18?
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C27954 (NCI Thesaurus Property)
C0205653 (UMLS 2011AA Property)
C54074 (NCI Thesaurus Property)
C1301860 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.63
Code List
Is the patient under age 18?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Is the patient pregnant or nursing?
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25742 (NCI Thesaurus Property)
C0032961 (UMLS 2011AA Property)
CL.64
Code List
Is the patient pregnant or nursing?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
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?
text
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)
CL.65
Code List
Does the patient have a history of major thromboembolic event defined as: symptomatic pulmonary embolism (PE), recurrent asymptomatic PE, or recurrent deep vein thrombosis?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
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 )
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
E13825 (CTCAE Property)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C2902 (NCI Thesaurus Property)
C0005779 (UMLS 2011AA Property)
C28018 (NCI Thesaurus Property)
C0439660 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.66
Code List
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 )
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Has the patient had serious infections requiring systemic antibiotics or antiviral therapy including: known active Hepatitis B or C infection; known HIV infection?
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C13310 (NCI Thesaurus Property)
C0205373 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C2991 (NCI Thesaurus Property)
C0012634 (UMLS 2011AA Property)
C258 (NCI Thesaurus Property)
C0003232 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C16119 (NCI Thesaurus Property)
C0280274 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.67
Code List
Has the patient had serious infections requiring systemic antibiotics or antiviral therapy including: known active Hepatitis B or C infection; known HIV infection?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Has the patient been treated with immune modulators such as systemic cyclosporine or tacrolimus within 30 days prior to enrollment?
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C308 (NCI Thesaurus Property)
C0005525 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.68
Code List
Has the patient been treated with immune modulators such as systemic cyclosporine or tacrolimus within 30 days prior to enrollment?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Does the patient have a history of photosensitivity or must she take agents which increase photosensitivity?
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
E13680 (CTCAE Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.69
Code List
Does the patient have a history of photosensitivity or must she take agents which increase photosensitivity?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Does the patient have the ability to swallow oral medication
text
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)
C0011167 (UMLS 2011AA Property)
CL.70
Code List
Does the patient have the ability to swallow oral medication
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
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)
C2349155 (UMLS 2011AA Property)
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