ID

43021

Beskrivning

Fast Fact Sheet for Protocol 0186-I (Ovary) Bevacizumab With or Without Fosbretabulin Tromethamine in Patients With Recurrent or Persistent Ovarian Epithelial, Fallopian Tube, or Peritoneal Cavity Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9BF343E9-48AD-0577-E040-BB89AD437EA3

Länk

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9BF343E9-48AD-0577-E040-BB89AD437EA3

Nyckelord

D005185

Clinical Trial

Registration

Uppladdad den

17 de septiembre de 2021

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0 Legacy

Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer

Itemgroup-kommentar för :

Item-kommentar för :

Inga kommentarer

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Fallopian Tube Cancer NCT01305213 Pre-Study - Fast Fact Sheet for Protocol 0186-I (Ovary) - 3190753v1.0

model
Detaljer

No Instruction available.

1 Formulär

StudyEvent: Fast Fact Sheet for Protocol 0186-I (Ovary)
1. No Instruction available.

Name

Typ

Description | Question | Decode (Coded Value)

Datatyp

Alias

Patient Information

Item Group

Tracking Information

InstitutionGynecologicOncologyGroupIdentifierCode

Item

GOG Institution Code

text

C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25521 (NCI Thesaurus Property-2)
C1512288 (UMLS 2011AA Property-2)

AffiliatedInstitutionGynecologicOncologyGroupIdentifierCode

Item

GOG Affiliate Code

text

C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25413 (NCI Thesaurus ObjectClass-2)
C1510826 (UMLS 2011AA ObjectClass-2)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25521 (NCI Thesaurus Property-2)
C1512288 (UMLS 2011AA Property-2)
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)

PriorClinicalStudyProtocolGynecologicOncologyGroupIdentifierNumber

Item

Previous GOG #

text

C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25521 (NCI Thesaurus Property-2)
C1512288 (UMLS 2011AA Property-2)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)

TreatingPhysicianName

Item

Treating physician

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25741 (NCI Thesaurus ObjectClass)
C0031831 (UMLS 2011AA ObjectClass)
C25705 (NCI Thesaurus ObjectClass-2)
C1522326 (UMLS 2011AA ObjectClass-2)

PhysicianPersonVerificationIdentifierName

Item

Other Physician

text

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25741 (NCI Thesaurus ObjectClass-2)
C0031831 (UMLS 2011AA ObjectClass-2)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C45513 (NCI Thesaurus Property-2)
C1711411 (UMLS 2011AA Property-2)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)

Medical Record Number

Item

Patient Hospital No.

text

C25337 (NCI Thesaurus ValueDomain)
C1301894 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25261 (NCI Thesaurus Property)
C25198 (NCI Thesaurus Property-2)

PersonBirthDate

Item

Date of Birth

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25155 (NCI Thesaurus Property)
C0005615 (UMLS 2011AA Property)

Last Name

Item

Patient Last Name

text

C25191 (NCI Thesaurus ValueDomain)
C1301584 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
C25551 (NCI Thesaurus Property-2)

First Name

Item

Patient First Name

text

C25191 (NCI Thesaurus ValueDomain)
C1443235 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
C25509 (NCI Thesaurus Property-2)

PatientMiddleName

Item

Patient Middle Name

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25569 (NCI Thesaurus Property-2)
C0444598 (UMLS 2011AA Property-2)

Eligibility 1

Item Group

Header

InformedConsentFormSignedInd-2

Item

Did the patient sign an approved informed consent

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)

HealthInsurancePortabilityandAccountabilityActAuthorizationIndicator

Item

Has HIPAA authorization been obtained

text

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C62504 (NCI Thesaurus ObjectClass)
C0600593 (UMLS 2011AA ObjectClass)
C41192 (NCI Thesaurus Property)
C1524004 (UMLS 2011AA Property)

CL.2

Code List

Has HIPAA authorization been obtained

CL Item

Yes: C49488 (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Exempt - Non-usa Participant (Exempt - non-USA participant)

PersonPriorityGynecologicOncologyGroupClinicalTrialEligibilityCriteriaInd-2

Item

Is the patient eligible for a higher priority GOG protocol

boolean

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25521 (NCI Thesaurus Property)
C1512288 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property-2)
C1516637 (UMLS 2011AA Property-2)
C48911 (NCI Thesaurus Property-3)
C0549179 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PersonLegalAdolescentClinicalTrialEligibilityCriteriaInd-2

Item

Is the patient under age 18?

boolean

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C27954 (NCI Thesaurus Property-2)
C0205653 (UMLS 2011AA Property-2)
C54074 (NCI Thesaurus Property-3)
C1301860 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

GynecologicMalignantNeoplasmPrimarySite

Item

What is the primary disease site

text

C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C28016 (NCI Thesaurus ObjectClass-2)
C0205480 (UMLS 2011AA ObjectClass-2)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25251 (NCI Thesaurus Property-2)
C0205225 (UMLS 2011AA Property-2)
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)

CL.5

Code List

What is the primary disease site

CL Item

Ovary (Ovary)

C12404 (NCI Thesaurus)
C0029939 (UMLS 2011AA)

CL Item

Fallopian Tube (Fallopian tube)

C12403 (NCI Thesaurus)
C0015560 (UMLS 2011AA)

CL Item

Peritoneum (Peritoneum)

C12770 (NCI Thesaurus)
C0031153 (UMLS 2011AA)

PersonMalignantNeoplasmPathologyClinicalTrialEligibilityCriteriaMalignantNeoplasmPathologyType

Item

What is the cell type?

text

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus Property)
C0006826 (UMLS 2011AA Property)
C18189 (NCI Thesaurus Property-2)
C0030664 (UMLS 2011AA Property-2)
C16112 (NCI Thesaurus Property-3)
C1516637 (UMLS 2011AA Property-3)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.6

Code List

What is the cell type?

CL Item

Unspecified Adenocarcinoma (Adenocarcinoma, Unspecified)

C2852 (NCI Thesaurus)
C0001418 (UMLS 2011AA)
C38046 (NCI Thesaurus-3)
C0205370 (UMLS 2011AA-4)

CL Item

Clear Cell Carcinoma (Clear cell carcinoma)

CL Item

Endometrioid Adenocarcinoma (Endometrioid Adenocarcinoma)

C3769 (NCI Thesaurus)
C0206687 (UMLS 2011AA)

CL Item

Malignant Ovarian Brenner Tumor (Malignant Brenners Tumor)

C4270 (NCI Thesaurus)
C0334495 (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

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 primary confirmed histologically

date

C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
C25526 (NCI Thesaurus Property-2)
C0205462 (UMLS 2011AA Property-2)
C15220 (NCI Thesaurus Property-3)
C0011900 (UMLS 2011AA Property-3)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

GynecologicTumorHistologicGrade

Item

What was the grade of the primary tumor

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C28016 (NCI Thesaurus ObjectClass-2)
C0205480 (UMLS 2011AA ObjectClass-2)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property-2)
C0678257 (UMLS 2011AA Property-2)
C25526 (NCI Thesaurus ValueDomain)
C0205462 (UMLS 2011AA ValueDomain)
C18000 (NCI Thesaurus ValueDomain-2)
C0919553 (UMLS 2011AA ValueDomain-2)

CL.7

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)

PersonMalignantNeoplasmRecurrentDiseaseDiseaseProgressionClinicalTrialEligibilityCriteriaStatus

Item

Is the disease recurrent or persistent with documented progression? Which one?

text

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C38155 (NCI Thesaurus Property)
C0277556 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property-2)
C0006826 (UMLS 2011AA Property-2)
C17747 (NCI Thesaurus Property-3)
C0242656 (UMLS 2011AA Property-3)
C16112 (NCI Thesaurus Property-4)
C1516637 (UMLS 2011AA Property-4)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)

CL.8

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)

PersonMalignantNeoplasmRecurrentDiseaseDiseaseProgressionDiagnosisType

Item

How was it established to be recurrent or persistent?

text

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C38155 (NCI Thesaurus Property)
C0277556 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property-2)
C0006826 (UMLS 2011AA Property-2)
C17747 (NCI Thesaurus Property-3)
C0242656 (UMLS 2011AA Property-3)
C15220 (NCI Thesaurus Property-4)
C0011900 (UMLS 2011AA Property-4)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.9

Code List

How was it established to be recurrent or persistent?

CL Item

Surgical Procedure (Surgery)

C15329 (NCI Thesaurus)
C0543467 (UMLS 2011AA)

CL Item

Biopsy (Biopsy)

C15189 (NCI Thesaurus)
C0005558 (UMLS 2011AA)

CL Item

Non-histologic Evaluation (Non-Histologic)

PersonMalignantNeoplasmRecurrentDiseaseDiseaseProgressionDiagnosisDate

Item

Date recurrence or persistence documented?

date

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C38155 (NCI Thesaurus Property)
C0277556 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property-2)
C0006826 (UMLS 2011AA Property-2)
C17747 (NCI Thesaurus Property-3)
C0242656 (UMLS 2011AA Property-3)
C15220 (NCI Thesaurus Property-4)
C0011900 (UMLS 2011AA Property-4)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

PersonMalignantNeoplasmMeasurable_DiseaseDetectionPresentClinicalTrialEligibilityCriteriaType

Item

Does the patient have measurable disease or detectable disease?

text

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property-2)
C0006826 (UMLS 2011AA Property-2)
C8507 (NCI Thesaurus Property-3)
C1513041 (UMLS 2011AA Property-3)
C16112 (NCI Thesaurus Property-4)
C1516637 (UMLS 2011AA Property-4)
C16210 (NCI Thesaurus Property-5)
C1511790 (UMLS 2011AA Property-5)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.10

Code List

Does the patient have measurable disease or detectable disease?

CL Item

Measurable_disease (Measurable)

C8507 (NCI Thesaurus)
C1513041 (UMLS 2011AA)

CL Item

Detectable (Detectable)

PersonMalignantNeoplasmMeasurableDiseasePresentClinicalTrialEligibilityCriteriaIndicator

Item

Does patient have measurable disease defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded) using RECIST 1.1 criteria?

text

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property-2)
C0006826 (UMLS 2011AA Property-2)
C8507 (NCI Thesaurus Property-3)
C1513041 (UMLS 2011AA Property-3)
C16112 (NCI Thesaurus Property-4)
C1516637 (UMLS 2011AA Property-4)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)

CL.11

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)

CL Item

Not Applicable (Not Applicable)

C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)

MalignantNeoplasmMeasurableDiseaseEvaluationMethodClinicalTrialEligibilityCriteriaType

Item

What method of evaluation is used to obtain tumor measurements?

text

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property-2)
C0006826 (UMLS 2011AA Property-2)
C8507 (NCI Thesaurus Property-3)
C1513041 (UMLS 2011AA Property-3)
C71460 (NCI Thesaurus Property-4)
C0025663 (UMLS 2011AA Property-4)
C16112 (NCI Thesaurus Property-5)
C1516637 (UMLS 2011AA Property-5)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.12

Code List

What method of evaluation is used to obtain tumor measurements?

CL Item

Palpation (Palpatation)

C16950 (NCI Thesaurus)
C0030247 (UMLS 2011AA)

CL Item

X-ray (Plain X-Ray)

C17262 (NCI Thesaurus)
C0017011 (UMLS 2011AA)

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

Spiral Ct (Spiral CT)

C20645 (NCI Thesaurus)
C0860888 (UMLS 2011AA)

CL Item

N/a- Detectable Disease (N/A - Detectable Disease)

PersonMalignantNeoplasmMeasurableDiseaseSizePresentClinicalTrialEligibilityCriteriaIndicator

Item

Is the measurable disease > or = 10 mm when measured by CT, MRI or caliper measurement by clinical exam; or > or = 20 mm when measured by chest x-ray or lymph nodes > or = 15 mm in short axis when measured by CT or MRI?

text

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property-2)
C0006826 (UMLS 2011AA Property-2)
C8507 (NCI Thesaurus Property-3)
C1513041 (UMLS 2011AA Property-3)
C16112 (NCI Thesaurus Property-4)
C1516637 (UMLS 2011AA Property-4)
C25681 (NCI Thesaurus Property-5)
C0456389 (UMLS 2011AA Property-5)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)

CL.13

Code List

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)

PersonMalignantNeoplasmMeasurableDiseaseResponseEvaluationCriteriainSolidTumorsClinicalTrialEligibilityCriteriaIndicator

Item

Does the patient have at least one target lesion to be used to assess response on this protocol as defined by RECIST 1.1?

text

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus Property)
C0006826 (UMLS 2011AA Property)
C8507 (NCI Thesaurus Property-2)
C1513041 (UMLS 2011AA Property-2)
C16112 (NCI Thesaurus Property-3)
C1516637 (UMLS 2011AA Property-3)
C49164 (NCI Thesaurus Property-4)
C1709926 (UMLS 2011AA Property-4)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)

CL.14

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)

CL Item

Not Applicable (Not Applicable)

C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)

PersonMalignantNeoplasmMeasurableDiseaseRadiationFieldClinicalTrialEligibilityCriteriaIndicator

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-2)
C1513041 (UMLS 2011AA Property-2)
C54648 (NCI Thesaurus Property-3)
C1882536 (UMLS 2011AA Property-3)
C16112 (NCI Thesaurus Property-4)
C1516637 (UMLS 2011AA Property-4)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)

CL.15

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)

CL Item

Not Applicable (Not Applicable)

C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)

PersonMalignantNeoplasmMeasurableDiseaseRadiationFieldClinicalTrialEligibilityCriteriaInd-3b

Item

If yes, does the patient have disease in an irradiated field as the only site of measurable disease and has progression been documented or a biopsy obtained to confirm persistent disease at least 90 days following completion of radiation treatment?

text

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

CL.16

Code List

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)

PersonMalignantNeoplasmDetectionEvaluationMethodClinicalTrialEligibilityCriteriaType

Item

How was detectable disease determined?

text

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property-2)
C0006826 (UMLS 2011AA Property-2)
C71460 (NCI Thesaurus Property-3)
C0025663 (UMLS 2011AA Property-3)
C16112 (NCI Thesaurus Property-4)
C1516637 (UMLS 2011AA Property-4)
C16210 (NCI Thesaurus Property-5)
C1511790 (UMLS 2011AA Property-5)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.17

Code List

How was detectable disease determined?

CL Item

Baseline Values Of Ca-125 At Least 2x Uln (Baseline values of CA-125 at least 2x ULN)

CL Item

Ascites And/or Pleural Effusion Attributed To Tumor (Ascites and/or pleural effusion attributed to tumor)

CL Item

Solid/cystic Abnormalities On Radiographic Imaging That Do Not Meet Recist 1.1 (Solid/cystic abnormalities on radiographic imaging that do not meet RECIST 1.1)

CL Item

Not Applicable- Measurable Disease (Not Applicable- Measurable Disease)

PersonLastTherapeuticProcedureRecoveryClinicalTrialEligibilityCriteriaInd-2

Item

Has the patient recovered from the effects of recent surgery, radiotherapy or chemotherapy?

boolean

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C49236 (NCI Thesaurus Property)
C0087111 (UMLS 2011AA Property)
C25746 (NCI Thesaurus Property-2)
C2004454 (UMLS 2011AA Property-2)
C25551 (NCI Thesaurus Property-3)
C1517741 (UMLS 2011AA Property-3)
C16112 (NCI Thesaurus Property-4)
C1516637 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PersonNoInfectionRequiredAntibioticClinicalTrialEligibilityCriteriaInd-2

Item

Is the patient free of acute hepatitis and active infection requiring parenteral antibiotics with the exception of uncomplicated urinary tract infection (UTI)?

boolean

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C49487 (NCI Thesaurus Property)
C1298908 (UMLS 2011AA Property)
C26726 (NCI Thesaurus Property-2)
C0009450 (UMLS 2011AA Property-2)
C258 (NCI Thesaurus Property-3)
C0003232 (UMLS 2011AA Property-3)
C25652 (NCI Thesaurus Property-4)
C1514873 (UMLS 2011AA Property-4)
C16112 (NCI Thesaurus Property-5)
C1516637 (UMLS 2011AA Property-5)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PersonMalignantNeoplasmEndocrineTherapyClinicalTrialEligibilityCriteriaInd-2

Item

Has any hormonal therapy directed at the malignant tumor been discontinued at least one week prior to registration?

boolean

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus Property)
C0006826 (UMLS 2011AA Property)
C15445 (NCI Thesaurus Property-2)
C0279025 (UMLS 2011AA Property-2)
C16112 (NCI Thesaurus Property-3)
C1516637 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PersonTherapeuticProcedureDiscontinuedPriorRegistrationClinicalTrialEligibilityCriteriaInd-2

Item

Has all other prior therapy directed at the malignant tumor, including chemotherapy, biologic/targeted, and immunological agents, been discontinued for at least three weeks prior to today?

boolean

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C49236 (NCI Thesaurus Property-3)
C0087111 (UMLS 2011AA Property-3)
C25484 (NCI Thesaurus Property-4)
C1444662 (UMLS 2011AA Property-4)
C16112 (NCI Thesaurus Property-5)
C1516637 (UMLS 2011AA Property-5)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PersonMonoclonalAntibodyVEGFRTyrosineKinaseInhibitorDiscontinueClinicalTrialEligibilityCriteriaInd-2

Item

Have all chimeric or human or humanized monoclonal antibodies (including Bevacizumab) or VEGF receptor fusion proteins (including VEGF Trap/aflibercept) been discontinued for at least 12 weeks prior to today?

boolean

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25484 (NCI Thesaurus Property)
C1444662 (UMLS 2011AA Property)
C20401 (NCI Thesaurus Property-2)
C0003250 (UMLS 2011AA Property-2)
C16112 (NCI Thesaurus Property-3)
C1516637 (UMLS 2011AA Property-3)
C93259 (NCI Thesaurus Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

TherapyDiscontinuedIndicator

Item

Will all investigational therapy be discontinued within 30 days prior to start of study treatment?

boolean

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25484 (NCI Thesaurus Property)
C1444662 (UMLS 2011AA Property)

PersonRadiationTherapyDiscontinuedPriorRegistrationClinicalTrialEligibilityCriteriaInd-2

Item

Has prior radiation therapy been discontinued for at least four weeks prior to registration?

boolean

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C15313 (NCI Thesaurus Property-2)
C1522449 (UMLS 2011AA Property-2)
C25629 (NCI Thesaurus Property-3)
C0332152 (UMLS 2011AA Property-3)
C25484 (NCI Thesaurus Property-4)
C1444662 (UMLS 2011AA Property-4)
C16112 (NCI Thesaurus Property-5)
C1516637 (UMLS 2011AA Property-5)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PersonPriorPlatinumCompoundChemotherapyPrimaryNeoplasmClinicalTrialEligibilityCriteriaInd-2

Item

Has the patient received one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin or another organoplatinum compound (may include intraperitoneal therapy, consolidation, non-cytotoxic agents, biologic/targeted agents, such as Bevacizumab) or extended therapy administered after surgical or non-surgical assessment?

boolean

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C15632 (NCI Thesaurus Property)
C0392920 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C16112 (NCI Thesaurus Property-3)
C1516637 (UMLS 2011AA Property-3)
C8509 (NCI Thesaurus Property-4)
C0677930 (UMLS 2011AA Property-4)
C1450 (NCI Thesaurus Property-5)
C0206135 (UMLS 2011AA Property-5)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

ChemotherapyRegimenReceiveChemotherapyRegimenReceiveType

Item

How many cytotoxic regimens has the patient received for management of recurrent or persistent disease?

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.26

Code List

How many cytotoxic regimens has the patient received for management of recurrent or persistent disease?

CL Item

No Chemotherapy Regimens (0 Regimens)

CL Item

One Chemotherapy Regimen (1 Regimen)

CL Item

Two Chemotherapy Regimens (2 Regimens)

CL Item

Greater Than Two Regimens (>2 regimens)

PersonNoPlatinumCompoundTaxaneCompoundChemotherapyRegimenRecurrentDiseaseDiseaseProgressionClinicalTrialEligibilityType

Item

How many non-platinum, non-taxane regimens did the patient receive for recurrent or persistent disease?

text

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C49487 (NCI Thesaurus Property)
C1298908 (UMLS 2011AA Property)
C38155 (NCI Thesaurus Property-2)
C0277556 (UMLS 2011AA Property-2)
C17747 (NCI Thesaurus Property-3)
C0242656 (UMLS 2011AA Property-3)
C16112 (NCI Thesaurus Property-4)
C1516637 (UMLS 2011AA Property-4)
C12218 (NCI Thesaurus Property-5)
C0392920 (UMLS 2011AA Property-5)
C1490 (NCI Thesaurus Property-6)
C0796419 (UMLS 2011AA Property-6)
C1450 (NCI Thesaurus Property-7)
C0206135 (UMLS 2011AA Property-7)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.27

Code List

How many non-platinum, non-taxane regimens did the patient receive for recurrent or persistent disease?

CL Item

Zero Or One Regimen (0-1 regimens)

CL Item

More Than One Regimen (>1 regimen)

PersonMalignantNeoplasmRecurrentDiseaseDiseaseProgressionTherapeuticProcedureReceiveInd-2

Item

Has the patient received any non-cytotoxic chemotherapy (biologic/targeted agents) for management of recurrent or persistent disease?

boolean

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C38155 (NCI Thesaurus Property)
C0277556 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property-2)
C0006826 (UMLS 2011AA Property-2)
C17747 (NCI Thesaurus Property-3)
C0242656 (UMLS 2011AA Property-3)
C25639 (NCI Thesaurus Property-4)
C1514756 (UMLS 2011AA Property-4)
C49236 (NCI Thesaurus Property-5)
C0087111 (UMLS 2011AA Property-5)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

ECOG Performance Status

Item

Performance Status (Patients who have received one prior regimen must have GOG performance status of 0, 1 or 2; patients who have received two or three prior regimens must must have GOG performance status of 0 or 1)

text

C25664 (NCI Thesaurus ValueDomain)
C1520224 (UMLS CUI-1)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain-2)
C20641 (NCI Thesaurus ObjectClass)

CL.29

Code List

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)

PersonPriorAntiangiogenesisTherapyClinicalTrialEligibilityCriteriaInd-2

Item

Has the patient received Bevacizumab for management of primary disease?

boolean

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property-2)
C1516637 (UMLS 2011AA Property-2)
C15568 (NCI Thesaurus Property-3)
C0281318 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PersonPriorPlatinumCompoundChemotherapyPrimaryNeoplasmDiscontinueClinicalTrialEligibilityCriteriaInd-2

Item

Is the platinum-free interval from the last platinum containing regimen greater than 6 months?

boolean

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C15632 (NCI Thesaurus Property)
C0392920 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C25484 (NCI Thesaurus Property-3)
C1444662 (UMLS 2011AA Property-3)
C16112 (NCI Thesaurus Property-4)
C1516637 (UMLS 2011AA Property-4)
C8509 (NCI Thesaurus Property-5)
C0677930 (UMLS 2011AA Property-5)
C1450 (NCI Thesaurus Property-6)
C0206135 (UMLS 2011AA Property-6)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PersonPlatinumCompoundChemotherapyRegimenRecurrentDiseaseDiseaseProgressionClinicalTrialEligibilityCriteriaInd-2

Item

Did the patient have a documented recurrence (or disease progression) following (or during) her most recent course of platinum-based chemotherapy?

boolean

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C38155 (NCI Thesaurus Property)
C0277556 (UMLS 2011AA Property)
C17747 (NCI Thesaurus Property-2)
C0242656 (UMLS 2011AA Property-2)
C16112 (NCI Thesaurus Property-3)
C1516637 (UMLS 2011AA Property-3)
C12218 (NCI Thesaurus Property-4)
C0392920 (UMLS 2011AA Property-4)
C1450 (NCI Thesaurus Property-5)
C0206135 (UMLS 2011AA Property-5)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PersonPlatinumCompoundChemotherapyRegimenRecurrentDiseaseDiseaseProgressionClinicalTrialEligibilityCriteriaDuration

Item

What was the PFI in months (period of time between the last dose of platinum-based chemotherapy and the first date of recurrence or progression)

text

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C38155 (NCI Thesaurus Property)
C0277556 (UMLS 2011AA Property)
C17747 (NCI Thesaurus Property-2)
C0242656 (UMLS 2011AA Property-2)
C16112 (NCI Thesaurus Property-3)
C1516637 (UMLS 2011AA Property-3)
C12218 (NCI Thesaurus Property-4)
C0392920 (UMLS 2011AA Property-4)
C1450 (NCI Thesaurus Property-5)
C0206135 (UMLS 2011AA Property-5)
C25330 (NCI Thesaurus ValueDomain)
C0449238 (UMLS 2011AA ValueDomain)

CL.33

Code List

What was the PFI in months (period of time between the last dose of platinum-based chemotherapy and the first date of recurrence or progression)

CL Item

Pfi > 6 And Pfi <= 12 (PFI > 6 and PFI <= 12)

CL Item

Pfi > 12 (PFI > 12)

CL Item

Pfi Unknown (PFI Unknown)

PersonPlatinumCompoundChemotherapyRegimenRecurrentDiseaseDiseaseProgressionEvaluationMethodClinicalTrialEligibilityCriteriaType

Item

What method of evaluation was used to determine that recurrence or progression?

text

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C38155 (NCI Thesaurus Property-2)
C0277556 (UMLS 2011AA Property-2)
C17747 (NCI Thesaurus Property-3)
C0242656 (UMLS 2011AA Property-3)
C71460 (NCI Thesaurus Property-4)
C0025663 (UMLS 2011AA Property-4)
C16112 (NCI Thesaurus Property-5)
C1516637 (UMLS 2011AA Property-5)
C12218 (NCI Thesaurus Property-6)
C0392920 (UMLS 2011AA Property-6)
C1450 (NCI Thesaurus Property-7)
C0206135 (UMLS 2011AA Property-7)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.34

Code List

What method of evaluation was used to determine that recurrence or progression?

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)

CL Item

Ca-125 Antigen (CA-125)

C325 (NCI Thesaurus)
C0006610 (UMLS 2011AA)

CL Item

Not Applicable - No Recurrence/progression During Most Recent Course (Not applicable - no recurrence/progression during most recent course)

LaboratoryProcedureEvaluationOutcomeDate

Item

Date of Results (if more than one, enter earliest:)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)

ANC

Item

ANC (must be 1,500/mcl or greater)

float

C25294 (NCI Thesaurus ObjectClass)
C0948762 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C63321 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)

Platelets

Item

Peripheral Platelet Count (must be 100,000/mcl or greater)

float

C25294 (NCI Thesaurus ObjectClass)
C0005821 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C12520 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)

Hemoglobin

Item

Hemoglobin (Must be greater than or equal to 9 g/dl)

float

C16676 (NCI Thesaurus Property)
C0019046 (UMLS CUI-1)
C20200 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)

LaboratoryProcedureCreatinineResultInd-2

Item

Is the creatinine less than or equal to 1.5 x ULN?

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C399 (NCI Thesaurus Property-2)
C0010294 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)

PersonSerumPotassiumClinicalTrialEligibilityCriteriaInd-2

Item

Is the potassium greater than or equal to 4.0 mEq/L (or mmol/L)?

boolean

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C13325 (NCI Thesaurus Property)
C0229671 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property-2)
C1516637 (UMLS 2011AA Property-2)
C765 (NCI Thesaurus Property-3)
C0032821 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

LaboratoryProcedureMagnesiumEligibilityDeterminationInd-2

Item

Is the magnesium greater than or equal to 1.8 mmol/L?

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)
C29239 (NCI Thesaurus Property-2)
C0024467 (UMLS 2011AA Property-2)

CL.37

Code List

Is the magnesium greater than or equal to 1.8 mmol/L?

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

No (no)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

PersonSerumCalciumClinicalTrialEligibilityCriteriaInd-2

Item

Is the calcium greater than or equal to 8.4 mg/dL (or 2.0 mmol/L)?

boolean

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C331 (NCI Thesaurus Property)
C0006675 (UMLS 2011AA Property)
C13325 (NCI Thesaurus Property-2)
C0229671 (UMLS 2011AA Property-2)
C16112 (NCI Thesaurus Property-3)
C1516637 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PatientElevatedBilirubinPersonalMedicalHistoryInd-2

Item

Is the bilirubin less than or equal to 1.5 x ULN

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C27088 (NCI Thesaurus Property)
C0311468 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property-2)
C0262926 (UMLS 2011AA Property-2)

PatientProteinUrinalysisEligibilityDeterminationInd-2

Item

Does the patient have a urine protein of less than 2+ on dipstick or a 24-hour urine protein of < 1000 mg (<1.0 g/24hrs)

boolean

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C17241 (NCI Thesaurus Property)
C0042014 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
C17021 (NCI Thesaurus Property-3)
C0033684 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseUpperLimitofNormalResultInd-2

Item

Is the SGOT less than or equal to 3 X ULN

boolean

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25706 (NCI Thesaurus Property-3)
C1519815 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

LaboratoryProcedureAlkalinePhosphataseEligibilityDeterminationInd-2

Item

Is the alkaline phosphatase less than or equal to 2.5 x ULN?

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C16276 (NCI Thesaurus Property-2)
C0002059 (UMLS 2011AA Property-2)

LaboratoryProcedureProthrombinTimeResultProthrombinTimeType

Item

Is the Prothrombin Time (PT) such that the International Normalized Ratio (INR) is:

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C62656 (NCI Thesaurus Property-2)
C0033707 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)

CL.43

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

Inr Between 2 And 3 X Uln And On A Stable Dose Of Therapeutic Warfarin (Between 2 and 3 x ULN AND on a stable dose of therapeutic warfarin)

CL Item

Inr Greater Than 3 X Uln (Greater than 3 x ULN)

LaboratoryProcedurePartialThromboplastinTimeResultInd-2

Item

Is the PTT less than or equal to 1.5 times the institutional upper limit of normal?

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C38462 (NCI Thesaurus Property-2)
C0030605 (UMLS 2011AA Property-2)

PatientNegativePregnancyTestInd-4

Item

If the patient is of childbearing potential will she have a serum pregnancy test within 72 hours of starting protocol therapy and has she agreed to practice an effective form of birth control during study treatment and for six months after completion of treatment?

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.45

Code List

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)

PatientEligibilityInd-2

Item

Has the patient met the pre-entry requirements as specified in section 7.0

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)

PersonPriorFosbretabulinTromethamineClinicalTrialEligibilityCriteriaInd-2

Item

Has the patient had prior treatment with fosbretabulin tromethamine or any other VDA?

boolean

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property-2)
C1516637 (UMLS 2011AA Property-2)
C83721 (NCI Thesaurus Property-3)
C2827157 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PatientNeoplasmPersonalMedicalHistoryIndicator

Item

Has the patient had another invasive malignancy other than non-melanoma of the skin, localized cancer of the breast, head and neck or skin diagnosed, present or recur within the past 3 years?

boolean

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3262 (NCI Thesaurus Property)
C0027651 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property-2)
C0262926 (UMLS 2011AA Property-2)

PersonPriorRadiationTherapyAbdominalCavityPelvisClinicalTrialEligibilityCriteriaInd-2

Item

Has the patient received prior radiotherapy to any portion of the abdominal cavity or pelvis other than for the treatment of ovarian, fallopian tube or primary peritoneal cancer within the last three years? (Prior radiation for localized cancer of the breast, head and neck or skin is permitted as long as it was completed more than 3 years prior to registration and the patient remains free of recurrent or metastatic disease)

boolean

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C15313 (NCI Thesaurus Property)
C1522449 (UMLS 2011AA Property)
C12664 (NCI Thesaurus Property-2)
C0230168 (UMLS 2011AA Property-2)
C12767 (NCI Thesaurus Property-3)
C0030797 (UMLS 2011AA Property-3)
C25629 (NCI Thesaurus Property-4)
C0332152 (UMLS 2011AA Property-4)
C16112 (NCI Thesaurus Property-5)
C1516637 (UMLS 2011AA Property-5)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PriorGynecologicChemotherapyAdministeredInd-2

Item

Has the patient received prior chemotherapy for any abdominal or pelvic tumor other than for the treatment of ovarian, fallopian tube or primary peritoneal cancer within the last three years? (Prior adjuvant chemotherapy for localized breast cancer is permitted provided it was completed more than 3 years prior to registration and the patient remains free of recurrent or metastatic disease)

boolean

C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C28016 (NCI Thesaurus ObjectClass-3)
C0205480 (UMLS 2011AA ObjectClass-3)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

ReceivedTherapyProtocolContraindicatedInd-3

Item

Is the treatment of previous cancer a contraindication to the current protocol therapy?

boolean

C25639 (NCI Thesaurus ObjectClass)
C1514756 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C25320 (NCI Thesaurus Property)
C1507394 (UMLS 2011AA Property)
C37933 (NCI Thesaurus Property-2)
C1444657 (UMLS 2011AA Property-2)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

PatientWoundComplicationPersonalMedicalHistoryInd-3b

Item

Does the patient have a serious non-healing wound, ulcer or bone fracture?

boolean

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3671 (NCI Thesaurus Property)
C0043250 (UMLS 2011AA Property)
C2959 (NCI Thesaurus Property-2)
C0009566 (UMLS 2011AA Property-2)
C18772 (NCI Thesaurus Property-3)
C0262926 (UMLS 2011AA Property-3)
C49797 (NCI Thesaurus ValueDomain)
C1708496 (UMLS 2011AA ValueDomain)

PersonAbdominalCavityFistulaPerforationAbscessClinicalTrialEligibilityCriteriaInd-2

Item

Does the patient have a history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess?

boolean

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C12664 (NCI Thesaurus Property)
C0230168 (UMLS 2011AA Property)
C26686 (NCI Thesaurus Property-2)
C0549483 (UMLS 2011AA Property-2)
C16112 (NCI Thesaurus Property-3)
C1516637 (UMLS 2011AA Property-3)
C4080 (NCI Thesaurus Property-4)
C0549099 (UMLS 2011AA Property-4)
C3045 (NCI Thesaurus Property-5)
C0016169 (UMLS 2011AA Property-5)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PersonAbdominalCavityFistulaPerforationAbscessClinicalTrialEligibilityCriteriaIndicator

Item

Did the abdominal fistula, gastrointestinal perforation or intra-abdominal abscess occur within 90 days of the first date of the therapy on this protocol?

text

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C12664 (NCI Thesaurus Property)
C0230168 (UMLS 2011AA Property)
C26686 (NCI Thesaurus Property-2)
C0549483 (UMLS 2011AA Property-2)
C16112 (NCI Thesaurus Property-3)
C1516637 (UMLS 2011AA Property-3)
C4080 (NCI Thesaurus Property-4)
C0549099 (UMLS 2011AA Property-4)
C3045 (NCI Thesaurus Property-5)
C0016169 (UMLS 2011AA Property-5)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)

CL.54

Code List

Did the abdominal fistula, gastrointestinal perforation or intra-abdominal abscess occur within 90 days of the first date of the therapy on this protocol?

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)

PatientHemorrhagePre-ExistingConditionInd-3b

Item

Does the patient have active bleeding or pathologic conditions that carry high risk of bleeding such as known bleeding disorder, coagulopathy or tumor involving major vessels?

boolean

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C26791 (NCI Thesaurus Property)
C0019080 (UMLS 2011AA Property)
CL232826 (NCI Metathesaurus Property)
C49797 (NCI Thesaurus ValueDomain)
C1708496 (UMLS 2011AA ValueDomain)

PatientCentralNervousSystemDiseaseorDisorderEligibilityDeterminationInd-2

Item

Does the patient have a history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy or any brain metastases?

boolean

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C12438 (NCI Thesaurus Property)
C3714787 (UMLS 2011AA Property)
C2991 (NCI Thesaurus Property-2)
C0012634 (UMLS 2011AA Property-2)
C25171 (NCI Thesaurus Property-3)
C0013893 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PersonCerebrovascularAccidentTransientIschemicAttackPostClinicalTialEligibilityCriteriaInd-2

Item

Does the patient have a history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of study therapy?

boolean

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C50781 (NCI Thesaurus Property)
C0007787 (UMLS 2011AA Property)
C38008 (NCI Thesaurus Property-2)
C0687676 (UMLS 2011AA Property-2)
C3390 (NCI Thesaurus Property-3)
C0038454 (UMLS 2011AA Property-3)
C16112 (NCI Thesaurus Property-4)
C1516637 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PatientInadequateControlHypertensionExclusionCriteriaInd-2

Item

Does the patient have uncontrolled hypertension defined as systolic greater than 150 mm Hg or diastolic greater than 90 mm Hg despite anti-hypertensive therapy?

boolean

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3117 (NCI Thesaurus Property)
C0020538 (UMLS 2011AA Property)
C61299 (NCI Thesaurus Property-2)
C2587213 (UMLS 2011AA Property-2)
C25370 (NCI Thesaurus Property-3)
C0680251 (UMLS 2011AA Property-3)
C69177 (NCI Thesaurus Property-4)
C0205412 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PersonTorsadesDePointesPersonalMedicalHistoryClinicalTrialEligibilityCriteriaInd-2

Item

Does the patient have a history of torsade de pointes, ventricular tachycardia or fibrillation, pathologic sinus bradycardia (<60 bpm), heart block (1st degree block, being, PR interval prolongation only), congenital long QT syndrome, new ST segment elevation or depression or new Q waves on ECG?

boolean

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property-2)
C0262926 (UMLS 2011AA Property-2)
C50779 (NCI Thesaurus Property-3)
C0040479 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PersonConcomitantAgentQTcBProlongationGreaterThan500msecTorsadesDePointesIncreaseRiskClinicalTrialEligibilityCriteriaInd-3b

Item

Does the patient require any drug known to prolong QTc interval, including anti-arrhythmic medication?

boolean

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C70902 (NCI Thesaurus Property)
C2347852 (UMLS 2011AA Property)
C25533 (NCI Thesaurus Property-2)
C0442805 (UMLS 2011AA Property-2)
C17102 (NCI Thesaurus Property-3)
C0035647 (UMLS 2011AA Property-3)
C16112 (NCI Thesaurus Property-4)
C1516637 (UMLS 2011AA Property-4)
C71096 (NCI Thesaurus Property-5)
C2347724 (UMLS 2011AA Property-5)
C50779 (NCI Thesaurus Property-6)
C0040479 (UMLS 2011AA Property-6)
C49797 (NCI Thesaurus ValueDomain)
C1708496 (UMLS 2011AA ValueDomain)

PersonQTcBProlongationGreaterThan500msecBaselineClinicalTrialEligibilityCriteriaInd-2

Item

Is the QTc interval greater than or equal to 470 msec?

boolean

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25213 (NCI Thesaurus Property)
C1442488 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property-2)
C1516637 (UMLS 2011AA Property-2)
C71096 (NCI Thesaurus Property-3)
C2347724 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

MyocardialInfarctionPatientPreviousYearPersonalMedicalHistoryInd-2

Item

Has the patient had a myocardial infarction or unstable angina within 6 months of the first date of study therapy?

boolean

C27996 (NCI Thesaurus ObjectClass)
C0027051 (UMLS 2011AA ObjectClass)
C0030705 (NCI Metathesaurus ObjectClass)
C25627 (NCI Thesaurus Property)
C0205156 (UMLS 2011AA Property)
C29848 (NCI Thesaurus Property-2)
C0439234 (UMLS 2011AA Property-2)
C18772 (NCI Thesaurus Property-3)
C0262926 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PersonNewYorkHeartAssociationClassIIClinicalTrialEligibilityCriteriaInd-2

Item

Using the New York Heart Association (NYHA) guideline, does the patient have Class II or greater congestive heart failure?

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C66905 (NCI Thesaurus Property-2)
C1882085 (UMLS 2011AA Property-2)

CardiovascularDiseasePresentInd-2

Item

Has the patient had clinically significant cardiovascular disease

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C25292 (NCI Thesaurus ObjectClass)
C0007226 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus ObjectClass-2)
C0012634 (UMLS 2011AA ObjectClass-2)

PersonVentricularArrhythmiaArrhythmiaMedicationClinicalTrialEligibilityCriteriaInd-2

Item

Does patient have serious cardiac arrhythmia requiring medication (except for asymptomatic atrial fibrillation with controlled ventricular rate)?

boolean

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C2881 (NCI Thesaurus Property)
C0003811 (UMLS 2011AA Property)
C459 (NCI Thesaurus Property-2)
C0013227 (UMLS 2011AA Property-2)
E10230 (CTCAE Property)
C16112 (NCI Thesaurus Property-3)
C1516637 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PriorAnthracyclineTherapyRegimenInd-2

Item

Has the patient received prior treatment with an anthracycline? (including Doxorubicin or Pegylated liposomal Doxorubicin [Doxil, PLD])

boolean

C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C1594 (NCI Thesaurus ObjectClass-3)
C0003234 (UMLS 2011AA ObjectClass-2)
C15697 (NCI Thesaurus Property)
C0040808 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

HeartLeftVentricularEjectionFractionIncreaseFunctionAssessmentIndicator

Item

If yes, has the patient had an echocardiogram assessment and is the LVEF less than 50%?

text

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C12727 (NCI Thesaurus ObjectClass)
C0018787 (UMLS 2011AA ObjectClass)
C25518 (NCI Thesaurus Property)
C0542341 (UMLS 2011AA Property)
C37946 (NCI Thesaurus Property-2)
C2700377 (UMLS 2011AA Property-2)

CL.67

Code List

If yes, has the patient had an echocardiogram assessment and is the LVEF less than 50%?

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)

CardiacDiseasePresentInd-2

Item

Does the patient have CTCAE Grade 2 or greater peripheral vascular disease? (Note: at least brief less than 24 hours episodes of ischemia managed non-surgically and without permanent deficit.)

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)

PatientClinicalStudyAgentHypersensitivityPersonalMedicalHistoryInd-2

Item

Does the patient have known hypersensitivity to any components of fosbretabulin tromethamine or bevacizumab?

boolean

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3114 (NCI Thesaurus Property)
C0020517 (UMLS 2011AA Property)
C1708 (NCI Thesaurus Property-2)
C0450442 (UMLS 2011AA Property-2)
C15206 (NCI Thesaurus Property-3)
C0008972 (UMLS 2011AA Property-3)
C18772 (NCI Thesaurus Property-4)
C0262926 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PersonSurgicalProcedureInjuryEligibilityDeterminationInd-2

Item

Has the patient had a major surgical procedure within 28 days prior to the first date of treatment on this study?

boolean

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C15329 (NCI Thesaurus Property)
C0543467 (UMLS 2011AA Property)
C3671 (NCI Thesaurus Property-2)
C0043250 (UMLS 2011AA Property-2)
C25171 (NCI Thesaurus Property-3)
C0013893 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

GynecologicOncologyGroupMajorSurgeryInd-3b

Item

Is a major surgical procedure anticipated for this patient during the course of this study

boolean

C25521 (NCI Thesaurus ObjectClass)
C1512288 (UMLS 2011AA ObjectClass)
C0679637 (NCI Metathesaurus Property)
C49797 (NCI Thesaurus ValueDomain)
C1708496 (UMLS 2011AA ValueDomain)

PatientCoreBiopsyMinorSurgicalProcedureExclusionCriteriaInd-2

Item

Will a core biopsy be done within 7 days prior to the start of study drug?

boolean

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C15680 (NCI Thesaurus Property)
C1318309 (UMLS 2011AA Property)
C15329 (NCI Thesaurus Property-2)
C0543467 (UMLS 2011AA Property-2)
C45367 (NCI Thesaurus Property-3)
C0205165 (UMLS 2011AA Property-3)
C25370 (NCI Thesaurus Property-4)
C0680251 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

GastrointestinalObstructionSymptomInd-3

Item

Does the patient have clinical symptoms or signs of gastrointestinal obstruction and require parenteral hydration and/or nutrition

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C13359 (NCI Thesaurus ObjectClass)
C0521362 (UMLS 2011AA ObjectClass)
C4876 (NCI Thesaurus Property)
C1457887 (UMLS 2011AA Property)
C3284 (NCI Thesaurus ObjectClass-2)
C0028778 (UMLS 2011AA ObjectClass-2)

OtherPatientMedicalContraindicatedInd-2

Item

Does the patient have any condition which in the investigator's opinion makes the patient unsuitable for study participation?

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C37933 (NCI Thesaurus Property)
C1444657 (UMLS 2011AA Property)

PatientPregnancyInd-2

Item

Is the patient pregnant or nursing?

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25742 (NCI Thesaurus Property)
C0032961 (UMLS 2011AA Property)

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)

Provide comments about this Fast Fact Sheet

Item Group

Comments

ClinicalTrialEligibilityCriteriaWorksheetCommentText

Item

Provide comments about this Fast Fact Sheet

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS 2011AA Property)
C16112 (NCI Thesaurus ObjectClass)
C1516637 (UMLS 2011AA ObjectClass)
C73541 (NCI Thesaurus Property-2)
C2349155 (UMLS 2011AA Property-2)

Tillbaka till toppen

ID

Beskrivning

Länk

Nyckelord

Versioner (3)

Uppladdad den

DOI

Licens

Modellkommentarer :

Itemgroup-kommentar för :

Item-kommentar för :

Fallopian Tube Cancer NCT01305213 Pre-Study - Fast Fact Sheet for Protocol 0186-I (Ovary) - 3190753v1.0

No Instruction available.

Beskrivning

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp