ID

6289

Beschreibung

E2905 Follow Up Disease Evaluation Form Lenalidomide With or Without Epoetin Alfa in Treating Patients With Myelodysplastic Syndrome and Anemia Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=0F12A9EE-8D74-6165-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=0F12A9EE-8D74-6165-E044-0003BA3F9857

Stichworte

Hochgeladen am

18. Dezember 2014

DOI

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Lizenz

Creative Commons BY-NC 3.0 Legacy

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Leukemia NCT00843882 On-Study - E2905 Follow Up Disease Evaluation Form - 2459288v1.0

Modell
Details

INSTRUCTIONS: Complete this form and submit original to the ECOG Coordinating Center within one week of registration. Keep a copy for your files

1 Formulare

StudyEvent: E2905 Follow Up Disease Evaluation Form
1. INSTRUCTIONS: Complete this form and submit original to the ECOG Coordinating Center within one week of registration. Keep a copy for your files

Name

Typ

Description | Question | Decode (Coded Value)

Datentyp

Alias

Unnamed1

Item Group

Unnamed1

ProtocolECOGIdentifierNumber

Item

ECOG Protocol Number

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25491 (NCI Thesaurus Property)
C1512162 (UMLS 2011AA Property)

PatientECOGIdentifierNumber

Item

ECOG Patient ID

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)
C25491 (NCI Thesaurus Property)
C1512162 (UMLS 2011AA Property)

CollectedDataFormName

Item

DCI Name

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C19464 (NCI Thesaurus Property)
C0376315 (UMLS 2011AA Property)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25452 (NCI Thesaurus ObjectClass)

RegistrationStepNumber

Item

Registration Step

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25646 (NCI Thesaurus ObjectClass)
C1514821 (UMLS 2011AA ObjectClass)
C16154 (NCI Thesaurus Property)
C1704379 (UMLS 2011AA Property)
C16154 (NCI Thesaurus ValueDomain)
C1704379 (UMLS 2011AA ValueDomain)

Unnamed2

Item Group

Unnamed2

PatientInitialsName

Item

Patient Initials (Last, First)

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)

ProtocolECOGIdentifierNumber

Item

ECOG Protocol Number

text

PatientECOGIdentifierNumber

Item

ECOG Patient ID

text

ProtocolParticipatingIdentifierNumber

Item

Participating Group Protocol Number

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

PatientParticipatingIdentifierNumber

Item

Participating Group Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

CombinedInstitutionName

Item

Institution/Affiliate

text

C25454 (NCI Thesaurus ObjectClass)
C0205195 (UMLS 2011AA ObjectClass)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ValueDomain)
C0018704 (UMLS 2011AA ValueDomain)

Unnamed3

Item Group

Unnamed3

DataAmendedText

Item

Please mark an 'X' if data have been amended. (Please circle amended items in red)

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)

DataAmendedDate

Item

Date data amended (MM/DD/YYYY)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain)

ON TREATMENT

Item Group

On Treatment

TreatmentEvaluationPeriodType

Item

On Treatment Report Period (Step 2 - Choose one x)

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C15368 (NCI Thesaurus ObjectClass)

CL.2

Code List

On Treatment Report Period (Step 2 - Choose one x)

CL Item

Cycle 1 Step 2 (Cycle 1 Step 2)

CL Item

Cycle 2 Step 2 (Cycle 2 Step 2)

CL Item

Cycle 3 Step 2 (Cycle 3 Step 2)

CL Item

Cycle 4 Step 2 (Cycle 4 Step 2)

CL Item

Cycle 5 Step 2 (Cycle 5 Step 2)

CL Item

Cycle 6 Step 2 (Cycle 6 Step 2)

CL Item

Cycle 7 Step 2 (Cycle 7 Step 2)

CL Item

Cycle 8 Step 2 (Cycle 8 Step 2)

CL Item

Cycle 9 Step 2 (Cycle 9 Step 2)

CL Item

Cycle 10 Step 2 (Cycle 10 Step 2)

CL Item

Cycle 11 Step 2 (Cycle 11 Step 2)

CL Item

Cycle 12 Step 2 (Cycle 12 Step 2)

CL Item

Cycle 13-step 2 (Cycle 13-Step 2)

CL Item

>cycle 13-step 2 (>Cycle 13-Step 2)

TreatmentEvaluationPeriodType

Item

On Treatment Report Period (Step 2 - Choose one x)

text

CL.2

Code List

On Treatment Report Period (Step 2 - Choose one x)

CL Item

Cycle 1 Step 2 (Cycle 1 Step 2)

CL Item

Cycle 2 Step 2 (Cycle 2 Step 2)

CL Item

Cycle 3 Step 2 (Cycle 3 Step 2)

CL Item

Cycle 4 Step 2 (Cycle 4 Step 2)

CL Item

Cycle 5 Step 2 (Cycle 5 Step 2)

CL Item

Cycle 6 Step 2 (Cycle 6 Step 2)

CL Item

Cycle 7 Step 2 (Cycle 7 Step 2)

CL Item

Cycle 8 Step 2 (Cycle 8 Step 2)

CL Item

Cycle 9 Step 2 (Cycle 9 Step 2)

CL Item

Cycle 10 Step 2 (Cycle 10 Step 2)

CL Item

Cycle 11 Step 2 (Cycle 11 Step 2)

CL Item

Cycle 12 Step 2 (Cycle 12 Step 2)

CL Item

Cycle 13-step 2 (Cycle 13-Step 2)

CL Item

>cycle 13-step 2 (>Cycle 13-Step 2)

TreatmentEvaluationPeriodCycleSpecify

Item

Specify Cycle

text

C15368 (NCI Thesaurus ObjectClass)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25472 (NCI Thesaurus ValueDomain)
C1511572 (UMLS 2011AA ValueDomain)
C25275 (NCI Thesaurus ValueDomain)
C2745955 (UMLS 2011AA ValueDomain)

TreatmentEvaluationPeriodCycleSpecify

Item

Specify Cycle

text

OFF TREATMENT

Item Group

Off Treatment

PersonOff-TreatmentTimePeriodType

Item

Off Treatment Report Period (since registration - Choose one x)

text

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25601 (NCI Thesaurus Property)
C1518544 (UMLS 2011AA Property)
C25207 (NCI Thesaurus Property)
C0040223 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.3

Code List

Off Treatment Report Period (since registration - Choose one x)

CL Item

3 Months Post End Of Treatment (3 months post end of treatment)

CL Item

6 Months Post End Of Treatment (6 months post end of treatment)

Section I

Item Group

Unnamed5

MyelodysplasticSyndromeWorldHealthOrganizationClassificationCategory

Item

MDS classification

text

C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C3247 (NCI Thesaurus ObjectClass)
C0026986 (UMLS 2011AA ObjectClass)
C25161 (NCI Thesaurus Property)
C0008902 (UMLS 2011AA Property)
C75419 (NCI Thesaurus Property)
C0043237 (UMLS 2011AA Property)

CL.4

Code List

MDS classification

CL Item

Chronic Myelomonocytic Leukemia (Chronic Myelomonocytic Leukemia)

C3178 (NCI Thesaurus)
C0023480 (UMLS 2011AA)

CL Item

Myelodysplastic Syndrome Associated With Isolated Del (5q) Chromosome Abnormality (MDS associated with isolated del(5q))

C6867 (NCI Thesaurus)
C1292779 (UMLS 2011AA)

CL Item

Myelodysplastic Syndrome, Unclassifiable (Myelodysplastic Syndrome, unclassified)

C8648 (NCI Thesaurus)
C0854809 (UMLS 2011AA)

CL Item

No Evidence Of Disease (No evidence of disease)

CL Item

Refractory Anemia (Refractory Anemia)

C2872 (NCI Thesaurus)
C0002893 (UMLS 2011AA)

CL Item

Raeb-1 (Refractory anemia with excess blasts-1)

C7167 (NCI Thesaurus)
C1318550 (UMLS 2011AA)

CL Item

Raeb-2 (Refractory anemia with excess blasts-2)

C7168 (NCI Thesaurus)
C1318551 (UMLS 2011AA)

CL Item

Refractory Anemia With Ringed Sideroblasts (Refractory Anemia with Ringed Sideroblasts)

C4036 (NCI Thesaurus)
C1264195 (UMLS 2011AA)

CL Item

Refractory Cytopenia With Multilineage Dysplasia (Refractory Cytopenia with Multilineage Dysplasia)

C8574 (NCI Thesaurus)
C0796466 (UMLS 2011AA)

CL Item

Refractory Cytopenia With Multilineage Dysplasia And Ringed Sideroblasts (Refractory Cytopenia with Multilineage Dysplasia and Ringed Sideroblasts)

C27726 (NCI Thesaurus)
C1301356 (UMLS 2011AA)

BoneMarrowBiopsyInd

Item

Was bone marrow biopsy done

text

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C15189 (NCI Thesaurus Property)
C0005558 (UMLS 2011AA Property)
C12431 (NCI Thesaurus ObjectClass)
C0005953 (UMLS 2011AA ObjectClass)

CL.5

Code List

Was bone marrow biopsy done

CL Item

No (no)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

BoneMarrowBiopsyDate

Item

Date of Bone Marrow Biopsy (Aspirate)

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)

LaboratoryProcedureBoneMarrowBlastCellOutcomePercentageValue

Item

Marrow Blasts (%)

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)

LaboratoryProcedureBoneMarrowCellularityOutcomePercentageValue

Item

Marrow Cellularity (%)

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)
C37923 (NCI Thesaurus Property)
C1516377 (UMLS 2011AA Property)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LaboratoryProcedureBoneMarrowCellularityNegationReportOutcomeReason

Item

Reason bone marrow cellularity was not recorded

text

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C12431 (NCI Thesaurus Property)
C0005953 (UMLS 2011AA Property)
C25375 (NCI Thesaurus Property)
C0684224 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C37923 (NCI Thesaurus Property)
C1516377 (UMLS 2011AA Property)
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)

CL.6

Code List

Reason bone marrow cellularity was not recorded

CL Item

Cellularity Status Of Bone Marrow Unknown, Procedure Resulted In No Material To Analyze (Dry Tap or inaspirable)

CL Item

Local Pathologist Did Not Quantify Cellularity (Local pathologist did not quantify cellularity)

DysplasiaPresentInd-3

Item

Dysplasia

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C4086 (NCI Thesaurus ObjectClass)
C0334044 (UMLS 2011AA ObjectClass)

CL.7

Code List

Dysplasia

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

DysplasiaHistologyType

Item

Specify type

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16681 (NCI Thesaurus Property)
C0019638 (UMLS 2011AA Property)
C4086 (NCI Thesaurus ObjectClass)
C0334044 (UMLS 2011AA ObjectClass)

CL.8

Code List

Specify type

CL Item

Erythroid (Erythroid)

C13805 (NCI Thesaurus)
C1516960 (UMLS 2011AA)

CL Item

Megakaryocyte (Megakaryocyte)

C12553 (NCI Thesaurus)
C0025166 (UMLS 2011AA)

CL Item

Myeloid (Myeloid)

C13349 (NCI Thesaurus)
C0439677 (UMLS 2011AA)

CytogeneticAbnormalityPresentIndicator

Item

Is cytogenetic abnormality present now

text

C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C2950 (NCI Thesaurus ObjectClass)
C0008625 (UMLS 2011AA ObjectClass)
C0021212 (NCI Metathesaurus ValueDomain)

CL.9

Code List

Is cytogenetic abnormality present now

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Inevaluable (Inevaluable)

Section II

Item Group

Section Ii

PackedRedBloodCellTransfusionRequirementInd-3

Item

Did the patient require packed red blood cell (PRBC) transfusions (in the last 8 weeks)

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15409 (NCI Thesaurus ObjectClass)
C0199962 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

CL.10

Code List

Did the patient require packed red blood cell (PRBC) transfusions (in the last 8 weeks)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

PackedRedBloodCellTransfusionReceivedUnitCount

Item

Total number of units PRBC (transfused in the last 8 weeks)

double

C44278 (NCI Thesaurus ValueDomain)
C0439148 (UMLS 2011AA ValueDomain)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C15409 (NCI Thesaurus ObjectClass)
C0199962 (UMLS 2011AA ObjectClass)

PackedRedBloodCellTransfusionReceivedFirstDate

Item

Date of First Transfusion (in the last 8 weeks)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C25509 (NCI Thesaurus ValueDomain)
C1279901 (UMLS 2011AA ValueDomain)
C15409 (NCI Thesaurus ObjectClass)
C0199962 (UMLS 2011AA ObjectClass)

PackedRedBloodCellTransfusionReceivedMostRecentDate

Item

Date of most recent PRBC transfusion

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C15409 (NCI Thesaurus ObjectClass)
C0199962 (UMLS 2011AA ObjectClass)
C25577 (NCI Thesaurus ValueDomain)
C1513491 (UMLS 2011AA ValueDomain)

Response

Item Group

Mds Response

MyelodysplasticSyndromeResponseType

Item

Best response to date

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25755 (NCI Thesaurus Property)
C0871261 (UMLS 2011AA Property)
C3247 (NCI Thesaurus ObjectClass)
C0026986 (UMLS 2011AA ObjectClass)

CL.11

Code List

Best response to date

CL Item

Complete Remission (CR)

C4870 (NCI Thesaurus)
C0677874 (UMLS 2011AA)

CL Item

Partial Remission (PR)

C18058 (NCI Thesaurus)
C1521726 (UMLS 2011AA)

CL Item

Stable Disease (SD)

C18213 (NCI Thesaurus)
C0677946 (UMLS 2011AA)

CL Item

Better Hematologic (HI)

C62780 (NCI Thesaurus)
C0205488 (UMLS 2011AA)
C71685 (NCI Thesaurus)
C0332272 (UMLS 2011AA)

CL Item

Progressive Disease (PD)

C35571 (NCI Thesaurus)
C1335499 (UMLS 2011AA)

CL Item

Transformation To Aml (Transformation to AML)

MyelodysplasticSyndromeResponseFirstDate

Item

First observed date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25755 (NCI Thesaurus Property)
C0871261 (UMLS 2011AA Property)
C3247 (NCI Thesaurus ObjectClass)
C0026986 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus ValueDomain)
C1279901 (UMLS 2011AA ValueDomain)

MyelodysplasticSyndromeResponseDiagnosisDate

Item

First Confirmed Date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25755 (NCI Thesaurus Property)
C0871261 (UMLS 2011AA Property)
C3247 (NCI Thesaurus ObjectClass)
C0026986 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus ValueDomain)
C0011900 (UMLS 2011AA ValueDomain)

DiseaseRelapseInd-3

Item

Relapse

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C18265 (NCI Thesaurus Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)

CL.12

Code List

Relapse

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

DiseaseRelapseDate

Item

Date of relapse

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C18265 (NCI Thesaurus Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)

DiseaseMyelodysplasticSyndromeHematologyResponseType

Item

If Hematologic improvement

text

C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C3247 (NCI Thesaurus Property)
C0026986 (UMLS 2011AA Property)
C16673 (NCI Thesaurus Property)
C0018943 (UMLS 2011AA Property)
C50995 (NCI Thesaurus Property)
C1704632 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.13

Code List

If Hematologic improvement

CL Item

Major Erythroid Response (Major erythroid response)

CL Item

Minor Erythroid Response (Minor erythroid response)

CL Item

Relapse Major Erythroid Response (Relaspe MER)

DiseaseMyelodysplasticSyndromeHematologyResponseFirstDate

Item

First observed date (HI)

date

C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C3247 (NCI Thesaurus Property)
C0026986 (UMLS 2011AA Property)
C16673 (NCI Thesaurus Property)
C0018943 (UMLS 2011AA Property)
C50995 (NCI Thesaurus Property)
C1704632 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25509 (NCI Thesaurus ValueDomain)
C1279901 (UMLS 2011AA ValueDomain)

DiseaseMyelodysplasticSyndromeHematologyResponseDiagnosisDate

Item

First confirmed date (HI)

date

C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C3247 (NCI Thesaurus Property)
C0026986 (UMLS 2011AA Property)
C16673 (NCI Thesaurus Property)
C0018943 (UMLS 2011AA Property)
C50995 (NCI Thesaurus Property)
C1704632 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15220 (NCI Thesaurus ValueDomain)
C0011900 (UMLS 2011AA ValueDomain)

Cytogenetic Response

Item Group

Cytogenetic Response

CytogeneticResponseType

Item

Cytogenetic Response

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C50995 (NCI Thesaurus Property)
C1704632 (UMLS 2011AA Property)
C17938 (NCI Thesaurus ObjectClass)
C0314603 (UMLS 2011AA ObjectClass)

CL.14

Code List

Cytogenetic Response

CL Item

Complete Cytogenetic Response (Complete Cytogenetic Response)

CL Item

Partial Cytogenetic Response (Partial Cytogenetic Response)

Footer Module

Item Group

Comments

InvestigatorSignatureText

Item

Investigator Signature

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)

InvestigatorSignatureDate

Item

Investigator Signature Date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)

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Leukemia NCT00843882 On-Study - E2905 Follow Up Disease Evaluation Form - 2459288v1.0

INSTRUCTIONS: Complete this form and submit original to the ECOG Coordinating Center within one week of registration. Keep a copy for your files

Beschreibung

Beschreibung

Datentyp

Alias

Beschreibung

Datentyp

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