Leukemia, Myelocytic, Acute null Treatment - ENR - 2395563v3.0 - Portaal voor medische datamodellen (MDM-portaal)

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)

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)

LaboratoryProcedureAuerRodsOutcomeStatus

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)

CL.4

Code List

Were Auer rods present

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)

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)

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)

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)

KarnofskyPerformanceStatusScore

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)

CL.12

Code List

Record the patients Karnofsky performance status

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))

DoesthepatientmeettheWorldHealthOrganizations(WHO)criteriafordonovoAML

Item

Does the patient meet the World Health Organizations (WHO) criteria for do novo AML

text

CL.1

Code List

Does the patient meet the World Health Organizations (WHO) criteria for do novo AML

CL Item

Yes (Yes)

CL Item

No (No)

Recordthepatientsmostrecentcompleteremissionstage

Item

Record the patients most recent complete remission stage

text

CL.2

Code List

Record the patients most recent complete remission stage

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

Wasanadequatebonemarrowaspirateperformedwithin4weekspriortotheproposedconditioningdate

Item

Was an adequate bone marrow aspirate performed within 4 weeks prior to the proposed conditioning date

text

CL.3

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)

Ifanadequatebonemarrowaspiratewasnotperforned,wasabonemarrowbiopsyperformedwithin4weekspriortotheproposedconditioningdate

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

CL.5

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)

Isthereanyevidenceofapersistentlyabnormalleaukemiapopulationbyflowcytometry

Item

Is there any evidence of a persistently abnormal leaukemia population by flow cytometry

text

CL.6

Code List

Is there any evidence of a persistently abnormal leaukemia population by flow cytometry

CL Item

Yes (Yes)

CL Item

No (No)

Isthereanyevidenceofextramedullaryleukemia

Item

Is there any evidence of extramedullary leukemia

text

CL.7

Code List

Is there any evidence of extramedullary leukemia

CL Item

Yes (Yes)

CL Item

No (No)

DoesthepatienthaveahistoryofCNSinvolvement

Item

Does the patient have a history of CNS involvement

text

CL.8

Code List

Does the patient have a history of CNS involvement

CL Item

Yes (Yes)

CL Item

No (No)

Ifyes,isthereanyevidenceofleukemiablastsintheCSF

Item

If yes, is there any evidence of leukemia blasts in the CSF

text

CL.9

Code List

If yes, is there any evidence of leukemia blasts in the CSF

CL Item

Yes (Yes)

CL Item

No (No)

Indicatethenumberofcyclesofinfuctionchemotherapy(orin0inductionforpatientsin2ndCR)thepatientreceivedtoachievefirstorsecondcompleteremission

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

CL.10

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)

Indicatethenumberofconsolidationtherapiesthepatientreceivedpriortotransplant(anyconsolidationregimenthatdoesnotrequiretransplantationforhematopoeticrecoverycanbeused)

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

CL.11

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

ULNforyourinstitution

Item

ULN for your institution

text

CriteriaApprovalDate

Item

Date approved by medical monitor

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

AntibodyHIVTestStatus

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)

CL.20

Code List

Is the patient HIV seropositive

CL Item

Positive (Yes)

C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)

CL Item

Negative (No)

C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)

Doesthepatienthaveuncontrolleddiabetes?

Item

Does the patient have uncontrolled diabetes mellitus

text

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)

CL.21

Code List

Does the patient have uncontrolled diabetes mellitus

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

PatientInfectionInd-2

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)

CL.22

Code List

Is the patient diagnosed with an uncontrolled viral, bacterial, or fungal infection

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

PatientPregnancyInd

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)

CL.35

Code List

Is the donor pregant (positive serum or unie B-HCG) or breastfeeding

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No, And Not Nursing (No)

CL Item

Not applicable (Not applicable)

IsthepatientdoagnosedwithM3-AML(acutepromyelocyticleukemiaandinfirstcompleteremission)

Item

Is the patient doagnosed with M3-AML (acute promyelocytic leukemia and in first complete remission)

text

CL.13

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)

Isthepatientdiagnosedwithacuteleukemiafollowingblasttransformationofpriorchronicmyelogenousleukemia(CML)orothermyeloproliferativedisease

Item

Is the patient diagnosed with acute leukemia following blast transformation of prior chronic myelogenous leukemia (CML) or other myeloproliferative disease

text

CL.14

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)

IsthepatientdiagnosedwithM4Eo-AMLwithinv16andinfirstcompleteremission

Item

Is the patient diagnosed with M4Eo-AML with inv 16 and in first complete remission

text

CL.15

Code List

Is the patient diagnosed with M4Eo-AML with inv 16 and in first complete remission

CL Item

Yes (Yes)

CL Item

No (No)

IsthepatientdiagnosedwithAMLwitht(8;21)andinfirstcompleteremission

Item

Is the patient diagnosed with AML with t(8;21) and in first complete remission

text

CL.16

Code List

Is the patient diagnosed with AML with t(8;21) and in first complete remission

CL Item

Yes (Yes)

CL Item

No (No)

Isthepatientparticipatinginotherclinicaltrailsthatinvolveinvestigationaldrugsordevices

Item

Is the patient participating in other clinical trails that involve investigational drugs or devices

text

CL.17

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)

Doesthepatienthaveahistoryofcytopeniaconsistentwithdiagnosesofmyelodysplasticsyndrome(MDS)formorethen3monthspriortothediagnosisofAmlordoesthepatienthavereatments-relatedAML

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

CL.18

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)

DoesthepatientshaveevidenceofactiveHepatitisBorCinfectionorevidenceofcirrhosis

Item

Does the patients have evidence of active Hepatitis B or C infection or evidence of cirrhosis

text

CL.19

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

Doesthepatienthaveadocumentedallergytoirondextranormurineproteinsandrabbitantithymocyteglobulin

Item

Does the patient have a documented allergy to iron dextran or murine proteins and rabbit antithymocyte globulin

text

CL.23

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)

Hasthepatienthadapriorallogeneicorautologoustransplant

Item

Has the patient had a prior allogeneic or autologous transplant

text

CL.25

Code List

Has the patient had a prior allogeneic or autologous transplant

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)

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)

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)

HumanImmunodeficiencyVirusDiagnosisInd-3

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)

CL.26

Code List

Is the donor HIV seronegative within 30 days of apheresis collection

CL Item

No (Yes)

C49488 (NCI Thesaurus)
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)

TransplantDonorHepatitisBSurfaceAntigenInd-3

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)

CL.27

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)

CL Item

Yes (No)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

TransplantDonorHepatitisCVirusAntibodyInd-3

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)

CL.28

Code List

Is the donor seronegative for hepatitis C within 30 days of apheresis collection

CL Item

No (Yes)

C49488 (NCI Thesaurus)
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)

PatientPregnancyInd

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)

CL.35

Code List

Is the donor pregant (positive serum or unie B-HCG) or breastfeeding

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No, And Not Nursing (No)

CL Item

Not applicable (Not applicable)

Isthedonorseronegativeforsyphiliswithin30daysfoapheresiscollection

Item

Is the donor seronegative for syphilis within 30 days fo apheresis collection

text

CL.29

Code List

Is the donor seronegative for syphilis within 30 days fo apheresis collection

CL Item

Yes (Yes)

CL Item

No (No)

IsthedonoragreeabletoseconddonationofPBSCintheeventofgraftfailureofEBV-relatedlymphopropliferativediesase,ifnecessary

Item

Is the donor agreeable to second donation of PBSC in the event of graft failure of EBV-related lymphopropliferative diesase, if necessary

text

CL.30

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)

Isthedonoragreeabletoundergogeneralanesthesiaandbonemarrowdonation,ifnecessary

Item

Is the donor agreeable to undergo general anesthesia and bone marrow donation, if necessary

text

CL.31

Code List

Is the donor agreeable to undergo general anesthesia and bone marrow donation, if necessary

CL Item

Yes (Yes)

CL Item

No (No)

Doesthedonorhaveadequateveinsforleukapheresisoragresstoplacementfoacentralcatheter

Item

Does the donor have adequate veins for leukapheresis or agress to placement fo a central catheter

text

CL.32

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)

Doesthedonorhaveevidenceofactiveinfection(includingurinarytractinfectionorrespiratorytractinfection)orviralhepatitisexposure(onscreeninig),unlessonlyHBs,AB+andHBVDNAnegative

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

CL.33

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)

Doesthedonoehaveanyfactorswhichplacehim-heratincreaserickforcomplicationsfromleukopharesisofG-CSFtherapy(e.g.,autoimmunedisease,sicklecelltrait,symptomaticcoronaryarterydiseaserequiringtherapy)

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

CL.34

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)

HLAType

Item

Type of HLA Match required by this protocol

text

CL.36

Code List

Type of HLA Match required by this protocol

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)

TransplantMatchingMethodType

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)

CL.47

Code List

Typing method

CL Item

Dna (DNA technology)

C0012854 (NCI Metathesaurus)

CL Item

Serology (Serology)

Antigens/allelesprovided

Item

Antigens/alleles provided

text

CL.38

Code List

Antigens/alleles provided

CL Item

One (One)

CL Item

Two (Two)

1st

Item

1st

text

2nd

Item

2nd

text

TransplantMatchingMethodType

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)

CL.47

Code List

Typing method

CL Item

Dna (DNA technology)

C0012854 (NCI Metathesaurus)

CL Item

Serology (Serology)

Antigens/allelesprovided

Item

Antigens/alleles provided

text

CL.40

Code List

Antigens/alleles provided

CL Item

One (One)

CL Item

Two (Two)

1st

Item

1st

text

2nd

Item

2nd

text

1st

Item

1st

text

2nd

Item

2nd

text

TransplantMatchingMethodType

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)

CL.47

Code List

Typing method

CL Item

Dna (DNA technology)

C0012854 (NCI Metathesaurus)

CL Item

Serology (Serology)

Antigens/allelesprovided

Item

Antigens/alleles provided

text

CL.42

Code List

Antigens/alleles provided

CL Item

One (One)

CL Item

Two (Two)

1st

Item

1st

text

2nd

Item

2nd

text

TransplantMatchingMethodType

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)

CL.47

Code List

Typing method

CL Item

Dna (DNA technology)

C0012854 (NCI Metathesaurus)

CL Item

Serology (Serology)

Antigens/allelesprovided

Item

Antigens/alleles provided

text

CL.44

Code List

Antigens/alleles provided

CL Item

One (One)

CL Item

Two (Two)

1st

Item

1st

text

2nd

Item

2nd

text

TransplantMatchingMethodType

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)

CL.47

Code List

Typing method

CL Item

Dna (DNA technology)

C0012854 (NCI Metathesaurus)

CL Item

Serology (Serology)

Antigens/allelesprovided

Item

Antigens/alleles provided

text

CL.46

Code List

Antigens/alleles provided

CL Item

One (One)

CL Item

Two (Two)

1st

Item

1st

text

2nd

Item

2nd

text

1st

Item

1st

text

2nd

Item

2nd

text

TransplantMatchingMethodType

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)

CL.47

Code List

Typing method

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)

Antigens/allelesprovided

Item

Antigens/alleles provided

text

CL.48

Code List

Antigens/alleles provided

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

DoyouagreewiththecalculatedHLAMatchscore

Item

Do you agree with the calculated HLA Match score

text

CL.49

Code List

Do you agree with the calculated HLA Match score

CL Item

Yes (Yes)

CL Item

No (No)

Indicateyourinstitution'sHLAMatchscoreforthisparticipant

Item

Indicate your institution's HLA Match score for this participant

text

CL.50

Code List

Indicate your institution's HLA Match score for this participant

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)

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Itemgroep Commentaren voor :

Item Commentaren voor :

Leukemia, Myelocytic, Acute null Treatment - ENR - 2395563v3.0

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