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  1. StudyEvent: ADVL0212: Eligibility Worksheet
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Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
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)
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)
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)
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
Item Group
Eligibility criteria
C1516637 (UMLS CUI-1)
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)
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)
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
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)
C28013 (NCI Thesaurus ObjectClass)
C25365 (NCI Thesaurus Property)
C0206065 (UMLS CUI-1)
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
Normal, no complaints, no evidence of disease (100)
CL Item
Able to carry on normal activity, minor signs or symptoms of disease (90)
CL Item
Normal activity with effort, some signs or symptoms of disease (80)
CL Item
Cares for self. Unable to carry on normal activity or to do active work (70)
CL Item
Requires occasional assistance, but is able to care for most of own needs (60)
CL Item
Requires considerable assistance and frequent medical care (50)
CL Item
Disabled, requires special care and assistance (40)
CL Item
Severely disabled, hospitalization is indicated although death is not imminent (30)
CL Item
Hospitalization necessary, very sick, active supportive treatment necessary (20)
CL Item
Moribund, fatal processes progressing rapidly (10)
CL Item
Dead (0)
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)
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)
life expectancy 8 weeks
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)
C37987 (NCI Thesaurus Property)
C25171 (NCI Thesaurus Property-2)
C25359 (NCI Thesaurus Property-3)
C38147 (NCI Thesaurus ValueDomain)
C0023671 (UMLS CUI-1)
C1442456 (UMLS CUI-2)
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)
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)
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)
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)
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)
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)
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
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)
C25742 (NCI Thesaurus Property)
C0032976 (UMLS CUI-1)
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)
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)
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)
Informed Consent
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)
C25367 (NCI Thesaurus ValueDomain-2)
C16468 (NCI Thesaurus ObjectClass)
C25679 (NCI Thesaurus Property)
C0021430 (UMLS CUI-1)
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)
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)

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