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ID
1909
Beschreibung
ENR Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=FF19AF22-C849-2763-E034-0003BA3F9857
Link
Stichworte
Versionen (2)
- 19.09.12 19.09.12 -
- 09.01.15 09.01.15 - Martin Dugas
Hochgeladen am
19. September 2012
DOI
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Creative Commons BY-NC 3.0 Legacy
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Leukemia, Myelocytic, Acute null Treatment - ENR - 2395563v3.0
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- StudyEvent: ENR
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- StudyEvent: ENR
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
DateInformedConsentFormsignedbypatient
Item
Record date patient informed consent form was signed
text
PatientBirthDate
Item
Record donor's birthdate
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25367 (NCI Thesaurus ValueDomain)
C25155 (NCI Thesaurus Property)
C0005615 (UMLS 2011AA Property)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25367 (NCI Thesaurus ValueDomain)
C25155 (NCI Thesaurus Property)
C0005615 (UMLS 2011AA Property)
TreatmentStartDate
Item
Record the proposed start date of conditioning
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25431 (NCI Thesaurus Property)
C0439659 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C0011008 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25431 (NCI Thesaurus Property)
C0439659 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
Item
Were Auer rods present
text
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C12431 (NCI Thesaurus Property)
C0005953 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25287 (NCI Thesaurus Property)
C0333828 (UMLS 2011AA Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
C0022885 (UMLS 2011AA ObjectClass)
C12431 (NCI Thesaurus Property)
C0005953 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25287 (NCI Thesaurus Property)
C0333828 (UMLS 2011AA Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
CL Item
Auer Rods Present In Bone Marrow (Yes)
CL Item
Auer Rods Absent From Bone Marrow (No)
BoneMarrowAspirateDate
Item
Date of most recent bone marrow aspirate
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C12431 (NCI Thesaurus ObjectClass)
C0005953 (UMLS 2011AA ObjectClass)
C13347 (NCI Thesaurus Property)
C0370199 (UMLS 2011AA Property)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C12431 (NCI Thesaurus ObjectClass)
C0005953 (UMLS 2011AA ObjectClass)
C13347 (NCI Thesaurus Property)
C0370199 (UMLS 2011AA Property)
LaboratoryProcedureBoneMarrowBlastCellOutcomePercentageValue
Item
If yes, record the percentage of blasts in most recent biopsy
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C12431 (NCI Thesaurus Property)
C0005953 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12918 (NCI Thesaurus Property)
C0368761 (UMLS 2011AA Property)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C0022885 (UMLS 2011AA ObjectClass)
C12431 (NCI Thesaurus Property)
C0005953 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12918 (NCI Thesaurus Property)
C0368761 (UMLS 2011AA Property)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureBoneMarrowBlastCellOutcomePercentageValue
Item
If yes, record the percentage of blasts in most recent biopsy
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C12431 (NCI Thesaurus Property)
C0005953 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12918 (NCI Thesaurus Property)
C0368761 (UMLS 2011AA Property)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C0022885 (UMLS 2011AA ObjectClass)
C12431 (NCI Thesaurus Property)
C0005953 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12918 (NCI Thesaurus Property)
C0368761 (UMLS 2011AA Property)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
BoneMarrowBiopsyDate
Item
Date of bone marrow biopsy
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C15189 (NCI Thesaurus Property)
C0005558 (UMLS 2011AA Property)
C12431 (NCI Thesaurus ObjectClass)
C0005953 (UMLS 2011AA ObjectClass)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C15189 (NCI Thesaurus Property)
C0005558 (UMLS 2011AA Property)
C12431 (NCI Thesaurus ObjectClass)
C0005953 (UMLS 2011AA ObjectClass)
Item
Record the patients Karnofsky performance status
text
C25367 (NCI Thesaurus Property)
C20641 (NCI Thesaurus ObjectClass)
C1518965 (UMLS 2011AA ObjectClass)
C25338 (NCI Thesaurus ValueDomain)
C0449820 (UMLS 2011AA ValueDomain)
C20641 (NCI Thesaurus ObjectClass)
C1518965 (UMLS 2011AA ObjectClass)
C25338 (NCI Thesaurus ValueDomain)
C0449820 (UMLS 2011AA ValueDomain)
CL Item
Normal, No Complaints, No Evidence Of Disease (100 (Normal; no complaints/fully active_)
CL Item
Able To Carry On Normal Activity; Minor Signs Or Symptoms Of Disease (90 (Normal activity/minor restrictions in strenuous play))
CL Item
Normal Activity With Effort; Some Signs Or Symptoms Of Disease (80 (Normal activity with effort/restricted to strenuous play))
CL Item
Cares For Self, Unable To Carry On Normal Activity Or To Do Active Work (70 (Unable to carry on normal activity/less time spent at play))
CL Item
Requires Occasional Assistance, But Is Able To Care For Most Of His/her Needs (60 (Requires occasional assistance/minimal active play))
CL Item
Requires Considerable Assistance And Frequent Medical Care (50 (Requires considerable assistance/no active play))
CL Item
Disabled, Requires Special Care And Assistance (40 (Disabled/needs assistance for quiet play))
CL Item
Severely Disabled, Hospitalization Indicated. Death Not Imminent (30 (severely disabled/needs assistance for quiet play))
CL Item
Very Sick, Hospitalization Indicated. Death Not Imminent (20 (Very sick/limited to very passive activity))
CL Item
Moribund, Fatal Processes Progressing Rapidly (10 (Moribund; completely disabled))
Item
Does the patient meet the World Health Organizations (WHO) criteria for do novo AML
text
CL Item
Yes (Yes)
CL Item
No (No)
Item
Record the patients most recent complete remission stage
text
CL Item
First morphologic CR (First morphologic CR)
CL Item
Second morphologic CR (Second morphologic CR)
Recordthedatethemostrecentcompleteremission
Item
Record the date the most recent complete remission
text
Item
Was an adequate bone marrow aspirate performed within 4 weeks prior to the proposed conditioning date
text
Code List
Was an adequate bone marrow aspirate performed within 4 weeks prior to the proposed conditioning date
CL Item
Yes (Yes)
CL Item
No (No)
Item
If an adequate bone marrow aspirate was not perforned, was a bone marrow biopsy performed within 4 weeks prior to the proposed conditioning date
text
Code List
If an adequate bone marrow aspirate was not perforned, was a bone marrow biopsy performed within 4 weeks prior to the proposed conditioning date
CL Item
Yes (Yes)
CL Item
No (No)
Item
Is there any evidence of a persistently abnormal leaukemia population by flow cytometry
text
Code List
Is there any evidence of a persistently abnormal leaukemia population by flow cytometry
CL Item
Yes (Yes)
CL Item
No (No)
Item
Is there any evidence of extramedullary leukemia
text
CL Item
Yes (Yes)
CL Item
No (No)
Item
Does the patient have a history of CNS involvement
text
CL Item
Yes (Yes)
CL Item
No (No)
Item
If yes, is there any evidence of leukemia blasts in the CSF
text
CL Item
Yes (Yes)
CL Item
No (No)
Item
Indicate the number of cycles of infuction chemotherapy (or in0induction for patients in 2nd CR) the patient received to achieve first or second complete remission
text
Code List
Indicate the number of cycles of infuction chemotherapy (or in0induction for patients in 2nd CR) the patient received to achieve first or second complete remission
CL Item
One prior cycle (One prior cycle)
CL Item
Two prior cycles (Two prior cycles)
Item
Indicate the number of consolidation therapies the patient received prior to transplant (any consolidation regimen that does not require transplantation for hematopoetic recovery can be used)
text
Code List
Indicate the number of consolidation therapies the patient received prior to transplant (any consolidation regimen that does not require transplantation for hematopoetic recovery can be used)
CL Item
One cycle (One cycle)
CL Item
More than one cycle (More than one cycle)
HeartLVEFTestPercentageValue
Item
Most recent value
double
C12727 (NCI Thesaurus ObjectClass)
C0018787 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C37946 (NCI Thesaurus Property)
C2700377 (UMLS 2011AA Property)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C0018787 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C37946 (NCI Thesaurus Property)
C2700377 (UMLS 2011AA Property)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
HeartLVEFTestDate
Item
Date of assessment
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C12727 (NCI Thesaurus ObjectClass)
C0018787 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C37946 (NCI Thesaurus Property)
C2700377 (UMLS 2011AA Property)
C0011008 (UMLS 2011AA ValueDomain)
C12727 (NCI Thesaurus ObjectClass)
C0018787 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C37946 (NCI Thesaurus Property)
C2700377 (UMLS 2011AA Property)
ULNforyourinstitution
Item
ULN for your institution
text
HepaticBilirubinLabValue
Item
Most recent value
double
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C305 (NCI Thesaurus Property)
C0005437 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C1274040 (UMLS 2011AA Property)
C305 (NCI Thesaurus Property)
C0005437 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
HepaticBilirubinLabUpperLimitNormalValue
Item
ULN for your institution
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C305 (NCI Thesaurus Property)
C0005437 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C305 (NCI Thesaurus Property)
C0005437 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
LaboratoryProcedureBilirubinOutcomeDate
Item
Date of assessment
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C305 (NCI Thesaurus Property)
C0005437 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C0011008 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C305 (NCI Thesaurus Property)
C0005437 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
ALTValue
Item
Most recent value
double
SpecimenLaboratoryProcedureCollectionDate
Item
Date of assessment
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25453 (NCI Thesaurus Property)
C1516698 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C0011008 (UMLS 2011AA ValueDomain)
C25453 (NCI Thesaurus Property)
C1516698 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
ULNforyourinstitution
Item
ULN for your institution
text
HepaticSGOT(AST)LabUnspecifiedValue
Item
Most recent value
double
C13308 (NCI Thesaurus ObjectClass)
C0205054 (UMLS 2011AA ObjectClass)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C37984 (NCI Thesaurus Property)
C0022877 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C0205054 (UMLS 2011AA ObjectClass)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C37984 (NCI Thesaurus Property)
C0022877 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedUpperLimitofNormalValue
Item
ULN for your institution
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
C0022885 (UMLS 2011AA ObjectClass)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
SpecimenLaboratoryProcedureCollectionDate
Item
Date of assessment
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25453 (NCI Thesaurus Property)
C1516698 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C0011008 (UMLS 2011AA ValueDomain)
C25453 (NCI Thesaurus Property)
C1516698 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
RenalCreatinineLabSpecifiedValue
Item
Most recent value
double
C25225 (NCI Thesaurus ObjectClass)
C0022646 (UMLS 2011AA ObjectClass)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C0022646 (UMLS 2011AA ObjectClass)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureCreatinineResultUpperLimitofNormalValue
Item
ULN for your institution
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
LaboratoryProcedureEvaluationPerformedDate
Item
Date of assessment
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C0011008 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
LungCarbonMonoxideDiffusingCapabilityTestAssessmentPredictiveValuePercentageValue
Item
Most recent value
double
C12468 (NCI Thesaurus ObjectClass)
C0024109 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C38083 (NCI Thesaurus Property)
C1516251 (UMLS 2011AA Property)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C16238 (NCI Thesaurus ValueDomain)
C1514307 (UMLS 2011AA ValueDomain)
C0024109 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C38083 (NCI Thesaurus Property)
C1516251 (UMLS 2011AA Property)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C16238 (NCI Thesaurus ValueDomain)
C1514307 (UMLS 2011AA ValueDomain)
LaboratoryProcedureEvaluationPerformedDate
Item
Date of assessment
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C0011008 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
ULNforyourinstitution
Item
ULN for your institution
text
CriteriaApprovalDate
Item
Date approved by medical monitor
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item
Is the patient HIV seropositive
text
C14219 (NCI Thesaurus Property)
C0019682 (UMLS 2011AA Property)
C16295 (NCI Thesaurus ObjectClass)
C0003241 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
C0019682 (UMLS 2011AA Property)
C16295 (NCI Thesaurus ObjectClass)
C0003241 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
CL Item
Positive (Yes)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
C1446409 (UMLS 2011AA)
CL Item
Negative (No)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
C0205160 (UMLS 2011AA)
Item
Does the patient have uncontrolled diabetes mellitus
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C1298908 (UMLS 2011AA)
Item
Is the patient diagnosed with an uncontrolled viral, bacterial, or fungal infection
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C26726 (NCI Thesaurus Property)
C0009450 (UMLS 2011AA Property)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C26726 (NCI Thesaurus Property)
C0009450 (UMLS 2011AA Property)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C1705108 (UMLS 2011AA)
Item
Is the donor pregant (positive serum or unie B-HCG) or breastfeeding
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25742 (NCI Thesaurus Property)
C0032961 (UMLS 2011AA Property)
C1522602 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25742 (NCI Thesaurus Property)
C0032961 (UMLS 2011AA Property)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C1705108 (UMLS 2011AA)
CL Item
No, And Not Nursing (No)
CL Item
Not applicable (Not applicable)
Item
Is the patient doagnosed with M3-AML (acute promyelocytic leukemia and in first complete remission)
text
Code List
Is the patient doagnosed with M3-AML (acute promyelocytic leukemia and in first complete remission)
CL Item
Yes (Yes)
CL Item
No (No)
Item
Is the patient diagnosed with acute leukemia following blast transformation of prior chronic myelogenous leukemia (CML) or other myeloproliferative disease
text
Code List
Is the patient diagnosed with acute leukemia following blast transformation of prior chronic myelogenous leukemia (CML) or other myeloproliferative disease
CL Item
Yes (Yes)
CL Item
No (No)
Item
Is the patient diagnosed with M4Eo-AML with inv 16 and in first complete remission
text
CL Item
Yes (Yes)
CL Item
No (No)
Item
Is the patient diagnosed with AML with t(8;21) and in first complete remission
text
CL Item
Yes (Yes)
CL Item
No (No)
Item
Is the patient participating in other clinical trails that involve investigational drugs or devices
text
Code List
Is the patient participating in other clinical trails that involve investigational drugs or devices
CL Item
Yes (Yes)
CL Item
Yes, approved by medical monitor (Yes, approved by medical monitor)
CL Item
No (No)
Item
Does the patient have a history of cytopenia consistent with diagnoses of myelodysplastic syndrome (MDS) for more then 3 months prior to the diagnosis of Aml or does the patient have reatments-related AML
text
Code List
Does the patient have a history of cytopenia consistent with diagnoses of myelodysplastic syndrome (MDS) for more then 3 months prior to the diagnosis of Aml or does the patient have reatments-related AML
CL Item
Yes (Yes)
CL Item
No (No)
Item
Does the patients have evidence of active Hepatitis B or C infection or evidence of cirrhosis
text
Code List
Does the patients have evidence of active Hepatitis B or C infection or evidence of cirrhosis
CL Item
Yes (Yes)
CL Item
No (No)
No
Item
No
text
Item
Does the patient have a documented allergy to iron dextran or murine proteins and rabbit antithymocyte globulin
text
Code List
Does the patient have a documented allergy to iron dextran or murine proteins and rabbit antithymocyte globulin
CL Item
Yes (Yes)
CL Item
No (No)
Item
Has the patient had a prior allogeneic or autologous transplant
text
CL Item
Yes (Yes)
CL Item
No (No)
InformedConsentFormSignedDate
Item
Record date donor centent was signed
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
PatientBirthDate
Item
Record donor's birthdate
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25367 (NCI Thesaurus ValueDomain)
C25155 (NCI Thesaurus Property)
C0005615 (UMLS 2011AA Property)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25367 (NCI Thesaurus ValueDomain)
C25155 (NCI Thesaurus Property)
C0005615 (UMLS 2011AA Property)
PatientWeightMeasurement
Item
Record donor's weight
double
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25208 (NCI Thesaurus Property)
C0043100 (UMLS 2011AA Property)
C0242485 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25208 (NCI Thesaurus Property)
C0043100 (UMLS 2011AA Property)
Item
Is the donor HIV seronegative within 30 days of apheresis collection
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C14219 (NCI Thesaurus ObjectClass)
C0019682 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C1512699 (UMLS 2011AA ValueDomain)
C14219 (NCI Thesaurus ObjectClass)
C0019682 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
CL Item
No (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C1705108 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (No)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C1705108 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Is the donor seronegative for hepatitis B surface antigen within 30 days of apheresis collection
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25168 (NCI Thesaurus ObjectClass)
C0040288 (UMLS 2011AA ObjectClass)
C12981 (NCI Thesaurus ObjectClass)
C0332835 (UMLS 2011AA ObjectClass)
C0019168 (NCI Metathesaurus Property)
C1512699 (UMLS 2011AA ValueDomain)
C25168 (NCI Thesaurus ObjectClass)
C0040288 (UMLS 2011AA ObjectClass)
C12981 (NCI Thesaurus ObjectClass)
C0332835 (UMLS 2011AA ObjectClass)
C0019168 (NCI Metathesaurus Property)
Code List
Is the donor seronegative for hepatitis B surface antigen within 30 days of apheresis collection
CL Item
No (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C1705108 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (No)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C1705108 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Is the donor seronegative for hepatitis C within 30 days of apheresis collection
text
C25168 (NCI Thesaurus ObjectClass)
C0040288 (UMLS 2011AA ObjectClass)
C12981 (NCI Thesaurus ObjectClass)
C0332835 (UMLS 2011AA ObjectClass)
C14312 (NCI Thesaurus Property)
C0220847 (UMLS 2011AA Property)
C16295 (NCI Thesaurus Property)
C0003241 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C0040288 (UMLS 2011AA ObjectClass)
C12981 (NCI Thesaurus ObjectClass)
C0332835 (UMLS 2011AA ObjectClass)
C14312 (NCI Thesaurus Property)
C0220847 (UMLS 2011AA Property)
C16295 (NCI Thesaurus Property)
C0003241 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL Item
No (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C1705108 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (No)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C1705108 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Is the donor pregant (positive serum or unie B-HCG) or breastfeeding
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25742 (NCI Thesaurus Property)
C0032961 (UMLS 2011AA Property)
C1522602 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25742 (NCI Thesaurus Property)
C0032961 (UMLS 2011AA Property)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C1705108 (UMLS 2011AA)
CL Item
No, And Not Nursing (No)
CL Item
Not applicable (Not applicable)
Item
Is the donor seronegative for syphilis within 30 days fo apheresis collection
text
CL Item
Yes (Yes)
CL Item
No (No)
Item
Is the donor agreeable to second donation of PBSC in the event of graft failure of EBV-related lymphopropliferative diesase, if necessary
text
Code List
Is the donor agreeable to second donation of PBSC in the event of graft failure of EBV-related lymphopropliferative diesase, if necessary
CL Item
Yes (Yes)
CL Item
No (No)
Item
Is the donor agreeable to undergo general anesthesia and bone marrow donation, if necessary
text
Code List
Is the donor agreeable to undergo general anesthesia and bone marrow donation, if necessary
CL Item
Yes (Yes)
CL Item
No (No)
Item
Does the donor have adequate veins for leukapheresis or agress to placement fo a central catheter
text
Code List
Does the donor have adequate veins for leukapheresis or agress to placement fo a central catheter
CL Item
Yes (Yes)
CL Item
No (No)
Item
Does the donor have evidence of active infection (including urinary tract infection or respiratory tract infection) or viral hepatitis exposure (on screeninig), unless only HBs, AB+ and HBV DNA negative
text
Code List
Does the donor have evidence of active infection (including urinary tract infection or respiratory tract infection) or viral hepatitis exposure (on screeninig), unless only HBs, AB+ and HBV DNA negative
CL Item
Yes (Yes)
CL Item
No (No)
Item
Does the donoe have any factors which place him-her at increase rick for complications from leukopharesis of G-CSF therapy (e.g., autoimmune disease, sickle cell trait, symptomatic coronary artery disease requiring therapy)
text
Code List
Does the donoe have any factors which place him-her at increase rick for complications from leukopharesis of G-CSF therapy (e.g., autoimmune disease, sickle cell trait, symptomatic coronary artery disease requiring therapy)
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
High level DNA (High level DNA)
CL Item
Low level DNA (Low level DNA)
CL Item
Serologic (Serologic)
CL Item
Loci A, B: serologic, locus DRB1, low level DNA (Loci A, B: serologic, locus DRB1, low level DNA)
CL Item
Loci A, B: low level DNA, locus DRB1: high level DNA (Loci A, B: low level DNA, locus DRB1: high level DNA)
CL Item
Loci A, B: serologic; locus DRB1: high level DNA (Loci A, B: serologic; locus DRB1: high level DNA)
Item
Typing method
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
C12981 (NCI Thesaurus ObjectClass)
C0332835 (UMLS 2011AA ObjectClass)
C0150103 (NCI Metathesaurus Property)
C0332307 (UMLS 2011AA ValueDomain)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
C12981 (NCI Thesaurus ObjectClass)
C0332835 (UMLS 2011AA ObjectClass)
C0150103 (NCI Metathesaurus Property)
CL Item
Dna (DNA technology)
C0012854 (NCI Metathesaurus)
CL Item
Serology (Serology)
CL Item
One (One)
CL Item
Two (Two)
1st
Item
1st
text
2nd
Item
2nd
text
Item
Typing method
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
C12981 (NCI Thesaurus ObjectClass)
C0332835 (UMLS 2011AA ObjectClass)
C0150103 (NCI Metathesaurus Property)
C0332307 (UMLS 2011AA ValueDomain)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
C12981 (NCI Thesaurus ObjectClass)
C0332835 (UMLS 2011AA ObjectClass)
C0150103 (NCI Metathesaurus Property)
CL Item
Dna (DNA technology)
C0012854 (NCI Metathesaurus)
CL Item
Serology (Serology)
CL Item
One (One)
CL Item
Two (Two)
1st
Item
1st
text
2nd
Item
2nd
text
1st
Item
1st
text
2nd
Item
2nd
text
Item
Typing method
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
C12981 (NCI Thesaurus ObjectClass)
C0332835 (UMLS 2011AA ObjectClass)
C0150103 (NCI Metathesaurus Property)
C0332307 (UMLS 2011AA ValueDomain)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
C12981 (NCI Thesaurus ObjectClass)
C0332835 (UMLS 2011AA ObjectClass)
C0150103 (NCI Metathesaurus Property)
CL Item
Dna (DNA technology)
C0012854 (NCI Metathesaurus)
CL Item
Serology (Serology)
CL Item
One (One)
CL Item
Two (Two)
1st
Item
1st
text
2nd
Item
2nd
text
Item
Typing method
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
C12981 (NCI Thesaurus ObjectClass)
C0332835 (UMLS 2011AA ObjectClass)
C0150103 (NCI Metathesaurus Property)
C0332307 (UMLS 2011AA ValueDomain)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
C12981 (NCI Thesaurus ObjectClass)
C0332835 (UMLS 2011AA ObjectClass)
C0150103 (NCI Metathesaurus Property)
CL Item
Dna (DNA technology)
C0012854 (NCI Metathesaurus)
CL Item
Serology (Serology)
CL Item
One (One)
CL Item
Two (Two)
1st
Item
1st
text
2nd
Item
2nd
text
Item
Typing method
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
C12981 (NCI Thesaurus ObjectClass)
C0332835 (UMLS 2011AA ObjectClass)
C0150103 (NCI Metathesaurus Property)
C0332307 (UMLS 2011AA ValueDomain)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
C12981 (NCI Thesaurus ObjectClass)
C0332835 (UMLS 2011AA ObjectClass)
C0150103 (NCI Metathesaurus Property)
CL Item
Dna (DNA technology)
C0012854 (NCI Metathesaurus)
CL Item
Serology (Serology)
CL Item
One (One)
CL Item
Two (Two)
1st
Item
1st
text
2nd
Item
2nd
text
1st
Item
1st
text
2nd
Item
2nd
text
Item
Typing method
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
C12981 (NCI Thesaurus ObjectClass)
C0332835 (UMLS 2011AA ObjectClass)
C0150103 (NCI Metathesaurus Property)
C0332307 (UMLS 2011AA ValueDomain)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
C12981 (NCI Thesaurus ObjectClass)
C0332835 (UMLS 2011AA ObjectClass)
C0150103 (NCI Metathesaurus Property)
CL Item
Dna (DNA technology)
C0012854 (NCI Metathesaurus)
CL Item
Serology (Serology)
ResearchCommentsText
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS 2011AA Property)
C1527021 (UMLS 2011AA ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS 2011AA Property)
CL Item
One (One)
CL Item
Two (Two)
1st
Item
1st
text
2nd
Item
2nd
text
HLAMatchscorerequiredbythisprotocol
Item
HLA Match score required by this protocol
text
Locus-AcalculatedHLAMatchscore
Item
Locus-A calculated HLA Match score
text
Locus-BcalculatedHLAMatchscore
Item
Locus-B calculated HLA Match score
text
Locus-DRB1calculatedHLAMatchscore
Item
Locus-DRB1 calculated HLA Match score
text
TotalcalculatedHLAMatchscore
Item
Total calculated HLA Match score
text
CL Item
Yes (Yes)
CL Item
No (No)
Item
Indicate your institution's HLA Match score for this participant
text
CL Item
0/6 (0/6)
CL Item
1/6 (1/6)
CL Item
2/6 (2/6)
CL Item
3/6 (3/6)
CL Item
4/6 (4/6)
CL Item
5/6 (5/6)
CL Item
6/6 (6/6)