ID

9343

Descrizione

ADVL0212: Eligibility Worksheet FR901228 in Treating Children With Refractory or Recurrent Solid Tumors or Leukemia Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B1EC07E8-6588-30D1-E034-0003BA12F5E7

collegamento

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B1EC07E8-6588-30D1-E034-0003BA12F5E7

Keywords

versioni (3)
  1. 26/08/12 26/08/12 -
  2. 09/01/15 09/01/15 - Martin Dugas
  3. 20/03/15 20/03/15 - Martin Dugas
Caricato su

9 gennaio 2015

DOI

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Licenza

Creative Commons BY-NC 3.0 Legacy
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Brain and Central Nervous System Tumors NCT00053963 Eligibility - ADVL0212: Eligibility Worksheet - 2076012v3.0

Inglese

No Instruction available.

1 moduli  
  1. StudyEvent: ADVL0212: Eligibility Worksheet
    1. No Instruction available.
Header
Descrizione

Header

Institution Name
Descrizione

Institution Name

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass
C21541
NCI Thesaurus ValueDomain-2
C21541
NCI Thesaurus Property
C25364
Study Number
Descrizione

Protocol ID COG

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1516477
NCI Thesaurus Property
C25364
Study Number
Descrizione

Protocol ID COG

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1516477
NCI Thesaurus Property
C25364
COG Number
Descrizione

PatientCOGIdentifierNumber

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property-2
C39353
UMLS 2011AA Property-2
C1516477
Patient's Initials
Descrizione

Patient Initials

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Date worksheet entered into RDE
Descrizione

DataEnteredDate

Tipo di dati

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C37949
UMLS 2011AA Property
C1521975
Unnamed2
Descrizione

Unnamed2

Is the planned start of treatment within seven days of fulfilling all eligibility criteria? (To be eligible, planned start of treatment must be within seven days of fulfilling all eligibility criteria.)
Descrizione

TreatmentRequiredBeginDateInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25383
Is patient less than 22 years of age at the time of study entry? (To be eligible, patient must be less than 22 years of age at the time of study entry.)
Descrizione

PatientRequiredAgeInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25652
UMLS 2011AA Property
C1514873
NCI Thesaurus Property-2
C25150
UMLS 2011AA Property-2
C0001779
Does patient have histologic verification of the malignancy at original diagnosis? (To be eligible, the patient must have histologic verification of the malignancy at original diagnosis.)
Descrizione

DiseaseHistologicDiagnosisInd

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
Is patient's disease considered refractory to conventional therapy, or is there no existing effective conventional therapy? (To be eligible, patient's disease must be considered refractory to conventional therapy, or there is no existing effective conventional therapy.)
Descrizione

DiseaseTreatmentRefractoryInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property
C15368
If patient has a CNS tumor, were neurologic deficits relatively stable for a minimum of two weeks prior to study entry? (To be eligible, if patient has a CNS tumor, neurologic deficits must have been relatively stable for a minimum of two weeks prior to study entry.)
Descrizione

CNSTumorNeurologicalDeficitStableInd

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus Property
C37940
UMLS 2011AA Property
C0011155
Unnamed3
Descrizione

Unnamed3

Karnofsky Performance Score (To be eligible, patients greater than 10 years of age must have a Karnofsky performance status greater than or equal to 60.)
Descrizione

KarnofskyPerformanceStatusScale

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
NCI Thesaurus ObjectClass
C28013
UMLS 2011AA ObjectClass
C0206065
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Lansky Play Score (To be eligible, patients less than or equal to 10 years of age must have a Lansky play status greater than or equal to 60.)
Descrizione

LanskyPerformanceStatusScale

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
NCI Thesaurus ObjectClass
C25361
UMLS 2011AA ObjectClass
C0597198
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Unnamed4
Descrizione

Unnamed4

Does patient have a life expectancy of greater than or equal to 8 weeks? (To be eligible, the patient must have a life expectancy of greater than or equal to 8 weeks.)
Descrizione

PatientLifeExpectancyEligibilityDeterminationInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C37987
UMLS 2011AA Property
C0376558
NCI Thesaurus Property-2
C25171
UMLS 2011AA Property-2
C0013893
NCI Thesaurus Property-3
C25359
UMLS 2011AA Property-3
C0679138
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Has patient fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study? (Myleosuppressive chemotherapy: Must not have received within 3 weeks of entry onto this study 4 weeks if prior nitrosourea.)
Descrizione

PatientRecoveryEligibilityInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25746
UMLS 2011AA Property
C2004454
Unnamed5
Descrizione

Unnamed5

Did patient receive growth factors within 1 week of entry onto this study? (To be eligible, patient must not have received growth factors within 1 week of entry onto this study.)
Descrizione

PriorGrowthFactorReceivedInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus ObjectClass-2
C20424
UMLS 2011AA ObjectClass-2
C0018284
NCI Thesaurus Property
C25639
UMLS 2011AA Property
C1514756
If patient has a CNS tumor and is receiving dexamethasone, is patient on a stable dose for at least two weeks prior to study entry? (To be eligible, if patient has a CNS tumor and is receiving dexamethasone, patient must be on a stable dose for at least two weeks prior to study entry.)
Descrizione

DexamethasoneAgentDoseStableInd

Tipo di dati

text

Alias
NCI Thesaurus Property
C25488
UMLS 2011AA Property
C0178602
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
Unnamed6
Descrizione

Unnamed6

Is patient receiving enzyme-inducing anticonvulsant drugs? (To be eligible, patient must not be receiving enzyme-inducing anticonvulsant drugs.)
Descrizione

AnticonvulsantMedicationReceivedInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C459
UMLS 2011AA ObjectClass
C0013227
Does patient have adequate bone marrow function? (To be eligible, patient must have adequate bone marrow function as defined below:)
Descrizione

PatientBoneMarrowFunctionRequiredInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25518
UMLS 2011AA Property
C0542341
Unnamed8
Descrizione

Unnamed8

Does patient have adequate renal function? (To be eligible, patient must have adequate renal function as defined below:)
Descrizione

PatientRenalFunctionRequiredInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25518
UMLS 2011AA Property
C0542341
Unnamed8
Descrizione

Unnamed8

Does patient have adequate liver function? (To be eligible, patient must have adequate liver function as defined below:)
Descrizione

PatientLiverFunctionRequiredInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25518
UMLS 2011AA Property
C0542341
Does patient have adequate cardiac function? (To be eligible, patient must have adequate cardiac function as defined below:)
Descrizione

PatientCardiacFunctionRequiredInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25518
UMLS 2011AA Property
C0542341
Does patient have adequate pulmonary function? (To be eligible, patient must have adequate pulmonary function as defined below:)
Descrizione

PatientPulmonaryFunctionRequiredInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25518
UMLS 2011AA Property
C0542341
Unnamed9
Descrizione

Unnamed9

Does patient have adequate central nervous system function? (To be eligible, patient must have adequate central nervous system function as defined below:)
Descrizione

PatientCNSFunctionRequiredInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25518
UMLS 2011AA Property
C0542341
Unnamed 10
Descrizione

Unnamed 10

If female and post-menarchal, was a pregnancy test obtained? (To be eligible, if female and post-menarchal, a pregnancy test must be obtained.)
Descrizione

PatientPregnancyTestInd

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25742
UMLS 2011AA Property
C0032961
If patient is of reproductive potential, has he or she agreed to use an effective contraceptive method? (To be eligible, if patient is of reproductive potential, he or she must agree to use an effective contraceptive method.)
Descrizione

ContraceptionAgreementInd-3

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C37932
UMLS 2011AA ObjectClass
C0700589
NCI Thesaurus Property
C25369
UMLS 2011AA Property
C0680240
Does patient have an uncontrolled infection? (To be eligible, patient must not have an uncontrolled infection.)
Descrizione

PatientInfectionInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C26726
UMLS 2011AA Property
C0009450
Unnamed11
Descrizione

Unnamed11

Has patient previously received depsipeptide? (To be eligible, patient must not have previously received depsipeptide.)
Descrizione

AgentReceivedInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
Does patient have the following: Symptoms of congestive heart failure, Uncontrolled cardiac rhythm disturbance, or QTC that is greater than or equal to 480 msec (To be eligible, patient must not have any of the above characteristics.)
Descrizione

PatientRequiredCharacteristicsCOGInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25447
UMLS 2011AA Property
C1521970
Has the patient and/or the parents or legal guardians signed a written informed consent? (To be eligible, the patient and/or the parents or legal guardians must have signed a written informed consent.)
Descrizione

InformedConsentFormSignedDate

Tipo di dati

boolean

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C16468
UMLS 2011AA ObjectClass
C0009797
NCI Thesaurus Property
C25679
Have all institutional, FDA, and NCI requirements for human studies been met? (To be eligible, all institutional, FDA, and NCI requirements for human studies must have been met.)
Descrizione

StudyCompleteRequirementsInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C15206
UMLS 2011AA ObjectClass
C0008972
NCI Thesaurus Property
C38015
Unnamed 12
Descrizione

Unnamed 12

Comments
Descrizione

Research Comments

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
Unnamed13
Descrizione

Unnamed13

Dose level/duration assignment (To be assigned via RDE at the time of study entry.)
Descrizione

TreatmentAssignmentText

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25426
UMLS 2011AA Property
C1516050
Ccrr Module For Advl0212: Eligibility Worksheet
Descrizione

Ccrr Module For Advl0212: Eligibility Worksheet

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1 moduli
  1. StudyEvent: ADVL0212: Eligibility Worksheet
    1. No Instruction available.
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Header
Institution Name
Item
Institution Name
text
C25191 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C21541 (NCI Thesaurus ValueDomain-2)
C25364 (NCI Thesaurus Property)
Protocol ID COG
Item
Study Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1516477 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
Protocol ID COG
Item
Study Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1516477 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
PatientCOGIdentifierNumber
Item
COG Number
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C39353 (NCI Thesaurus Property-2)
C1516477 (UMLS 2011AA Property-2)
Patient Initials
Item
Patient's Initials
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
DataEnteredDate
Item
Date worksheet entered into RDE
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C37949 (NCI Thesaurus Property)
C1521975 (UMLS 2011AA Property)
Item Group
Unnamed2
TreatmentRequiredBeginDateInd-2
Item
Is the planned start of treatment within seven days of fulfilling all eligibility criteria? (To be eligible, planned start of treatment must be within seven days of fulfilling all eligibility criteria.)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25383 (NCI Thesaurus Property)
PatientRequiredAgeInd-2
Item
Is patient less than 22 years of age at the time of study entry? (To be eligible, patient must be less than 22 years of age at the time of study entry.)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25652 (NCI Thesaurus Property)
C1514873 (UMLS 2011AA Property)
C25150 (NCI Thesaurus Property-2)
C0001779 (UMLS 2011AA Property-2)
Item
Does patient have histologic verification of the malignancy at original diagnosis? (To be eligible, the patient must have histologic verification of the malignancy at original diagnosis.)
text
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
CL.3
Code List
Does patient have histologic verification of the malignancy at original diagnosis? (To be eligible, the patient must have histologic verification of the malignancy at original diagnosis.)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Patient Has Either A Brain Stem Or Optic Pathway Tumor (Patient has either a brain stem or optic pathway tumor)
DiseaseTreatmentRefractoryInd-2
Item
Is patient's disease considered refractory to conventional therapy, or is there no existing effective conventional therapy? (To be eligible, patient's disease must be considered refractory to conventional therapy, or there is no existing effective conventional therapy.)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)
Item
If patient has a CNS tumor, were neurologic deficits relatively stable for a minimum of two weeks prior to study entry? (To be eligible, if patient has a CNS tumor, neurologic deficits must have been relatively stable for a minimum of two weeks prior to study entry.)
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C37940 (NCI Thesaurus Property)
C0011155 (UMLS 2011AA Property)
CL.5
Code List
If patient has a CNS tumor, were neurologic deficits relatively stable for a minimum of two weeks prior to study entry? (To be eligible, if patient has a CNS tumor, neurologic deficits must have been relatively stable for a minimum of two weeks prior to study entry.)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
N/a, Patient Does Not Have A Cns Tumor (N/A, patient does not have a CNS tumor)
Item Group
Unnamed3
Item
Karnofsky Performance Score (To be eligible, patients greater than 10 years of age must have a Karnofsky performance status greater than or equal to 60.)
text
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C28013 (NCI Thesaurus ObjectClass)
C0206065 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.6
Code List
Karnofsky Performance Score (To be eligible, patients greater than 10 years of age must have a Karnofsky performance status greater than or equal to 60.)
CL Item
100 (100 - Normal, no complaints, no evidence of disease)
CL Item
90 (90 - Able to carry on normal activity, minor signs or symptoms of disease)
CL Item
80 (80 - Normal activity with effort, some signs or symptoms of disease)
CL Item
70 (70 - Cares for self. Unable to carry on normal activity or to do active work)
CL Item
60 (60 - Requires occasional assistance, but is able to care for most of own needs)
CL Item
50 (50 - Requires considerable assistance and frequent medical care)
CL Item
40 (40 - Disabled, requires special care and assistance)
CL Item
30 (30 - Severely disabled, hospitalization is indicated although death is not imminent)
CL Item
20 (20 - Hospitalization necessary, very sick, active supportive treatment necessary)
CL Item
10 (10 - Moribund, fatal processes progressing rapidly)
CL Item
0 (0 - Dead)
C0919414 (NCI Metathesaurus)
Item
Lansky Play Score (To be eligible, patients less than or equal to 10 years of age must have a Lansky play status greater than or equal to 60.)
text
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C25361 (NCI Thesaurus ObjectClass)
C0597198 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.7
Code List
Lansky Play Score (To be eligible, patients less than or equal to 10 years of age must have a Lansky play status greater than or equal to 60.)
CL Item
100 (100 - Fully active, normal)
CL Item
90 (90 - Minor restrictions in physically strenuous activity)
CL Item
80 (80 - Active, but tires more quickly)
CL Item
70 (70 - Both greater restriction of and less time spent in play activity)
CL Item
60 (60 - Up and around, but minimal active play; keeps busy with quieter activities)
CL Item
50 (50 - Gets dressed but lies around much of the day, no active play, able to participate in all quiet play and activities)
CL Item
40 (40 - Mostly in bed; participates in quiet activities)
CL Item
30 (30 - In bed; needs assistance even for quiet play)
CL Item
20 (20 - Often sleeping; play entirely limited to very passive activities)
CL Item
10 (10 - No play; does not get out of bed)
CL Item
0 (0 - Unresponsive)
C0919414 (NCI Metathesaurus)
Item Group
Unnamed4
PatientLifeExpectancyEligibilityDeterminationInd-2
Item
Does patient have a life expectancy of greater than or equal to 8 weeks? (To be eligible, the patient must have a life expectancy of greater than or equal to 8 weeks.)
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C37987 (NCI Thesaurus Property)
C0376558 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
C25359 (NCI Thesaurus Property-3)
C0679138 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientRecoveryEligibilityInd-2
Item
Has patient fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study? (Myleosuppressive chemotherapy: Must not have received within 3 weeks of entry onto this study 4 weeks if prior nitrosourea.)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25746 (NCI Thesaurus Property)
C2004454 (UMLS 2011AA Property)
Item Group
Unnamed5
PriorGrowthFactorReceivedInd-2
Item
Did patient receive growth factors within 1 week of entry onto this study? (To be eligible, patient must not have received growth factors within 1 week of entry onto this study.)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C20424 (NCI Thesaurus ObjectClass-2)
C0018284 (UMLS 2011AA ObjectClass-2)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
Item
If patient has a CNS tumor and is receiving dexamethasone, is patient on a stable dose for at least two weeks prior to study entry? (To be eligible, if patient has a CNS tumor and is receiving dexamethasone, patient must be on a stable dose for at least two weeks prior to study entry.)
text
C25488 (NCI Thesaurus Property)
C0178602 (UMLS 2011AA Property)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
CL.11
Code List
If patient has a CNS tumor and is receiving dexamethasone, is patient on a stable dose for at least two weeks prior to study entry? (To be eligible, if patient has a CNS tumor and is receiving dexamethasone, patient must be on a stable dose for at least two weeks prior to study entry.)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
N/a, Patient Does Not Have A Cns Tumor (N/A, patient does not have a CNS tumor)
CL Item
N/a, Patient Has Cns Tumor, But Is Not Receiving Dexamethasone (N/A, patient has a CNS tumor, but it not receiving dexamethasone)
Item Group
Unnamed6
AnticonvulsantMedicationReceivedInd-2
Item
Is patient receiving enzyme-inducing anticonvulsant drugs? (To be eligible, patient must not be receiving enzyme-inducing anticonvulsant drugs.)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
PatientBoneMarrowFunctionRequiredInd-2
Item
Does patient have adequate bone marrow function? (To be eligible, patient must have adequate bone marrow function as defined below:)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25518 (NCI Thesaurus Property)
C0542341 (UMLS 2011AA Property)
Item Group
Unnamed8
PatientRenalFunctionRequiredInd-2
Item
Does patient have adequate renal function? (To be eligible, patient must have adequate renal function as defined below:)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25518 (NCI Thesaurus Property)
C0542341 (UMLS 2011AA Property)
Item Group
Unnamed8
PatientLiverFunctionRequiredInd-2
Item
Does patient have adequate liver function? (To be eligible, patient must have adequate liver function as defined below:)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25518 (NCI Thesaurus Property)
C0542341 (UMLS 2011AA Property)
PatientCardiacFunctionRequiredInd-2
Item
Does patient have adequate cardiac function? (To be eligible, patient must have adequate cardiac function as defined below:)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25518 (NCI Thesaurus Property)
C0542341 (UMLS 2011AA Property)
PatientPulmonaryFunctionRequiredInd-2
Item
Does patient have adequate pulmonary function? (To be eligible, patient must have adequate pulmonary function as defined below:)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25518 (NCI Thesaurus Property)
C0542341 (UMLS 2011AA Property)
Item Group
Unnamed9
PatientCNSFunctionRequiredInd-2
Item
Does patient have adequate central nervous system function? (To be eligible, patient must have adequate central nervous system function as defined below:)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25518 (NCI Thesaurus Property)
C0542341 (UMLS 2011AA Property)
Item Group
Unnamed 10
Item
If female and post-menarchal, was a pregnancy test obtained? (To be eligible, if female and post-menarchal, a pregnancy test must be obtained.)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25742 (NCI Thesaurus Property)
C0032961 (UMLS 2011AA Property)
CL.19
Code List
If female and post-menarchal, was a pregnancy test obtained? (To be eligible, if female and post-menarchal, a pregnancy test must be obtained.)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
N/a, Patient Is Female, But Not Post-menarchal (N/A, patient is female, but not post-menarchal)
CL Item
N/a, Patient Is Male (N/A, patient is male)
Item
If patient is of reproductive potential, has he or she agreed to use an effective contraceptive method? (To be eligible, if patient is of reproductive potential, he or she must agree to use an effective contraceptive method.)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C37932 (NCI Thesaurus ObjectClass)
C0700589 (UMLS 2011AA ObjectClass)
C25369 (NCI Thesaurus Property)
C0680240 (UMLS 2011AA Property)
CL.20
Code List
If patient is of reproductive potential, has he or she agreed to use an effective contraceptive method? (To be eligible, if patient is of reproductive potential, he or she must agree to use an effective contraceptive method.)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
N/A, patient is not of reproductive potential (N/A, patient is not of reproductive potential)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
PatientInfectionInd-2
Item
Does patient have an uncontrolled infection? (To be eligible, patient must not have an uncontrolled infection.)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C26726 (NCI Thesaurus Property)
C0009450 (UMLS 2011AA Property)
Item Group
Unnamed11
AgentReceivedInd-2
Item
Has patient previously received depsipeptide? (To be eligible, patient must not have previously received depsipeptide.)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
PatientRequiredCharacteristicsCOGInd-2
Item
Does patient have the following: Symptoms of congestive heart failure, Uncontrolled cardiac rhythm disturbance, or QTC that is greater than or equal to 480 msec (To be eligible, patient must not have any of the above characteristics.)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25447 (NCI Thesaurus Property)
C1521970 (UMLS 2011AA Property)
InformedConsentFormSignedDate
Item
Has the patient and/or the parents or legal guardians signed a written informed consent? (To be eligible, the patient and/or the parents or legal guardians must have signed a written informed consent.)
boolean
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
StudyCompleteRequirementsInd-2
Item
Have all institutional, FDA, and NCI requirements for human studies been met? (To be eligible, all institutional, FDA, and NCI requirements for human studies must have been met.)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15206 (NCI Thesaurus ObjectClass)
C0008972 (UMLS 2011AA ObjectClass)
C38015 (NCI Thesaurus Property)
Item Group
Unnamed 12
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
Item Group
Unnamed13
TreatmentAssignmentText
Item
Dose level/duration assignment (To be assigned via RDE at the time of study entry.)
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25426 (NCI Thesaurus Property)
C1516050 (UMLS 2011AA Property)
Item Group
Ccrr Module For Advl0212: Eligibility Worksheet
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