ID

2129

Beschrijving

CALGB: 10603 Follow-Up Form Daunorubicin, Cytarabine, and Midostaurin in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=43C5D677-EB7A-6D45-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=43C5D677-EB7A-6D45-E044-0003BA3F9857

Trefwoorden

Geüploaded op

19 september 2012

DOI

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Licentie

Creative Commons BY-NC 3.0 Legacy

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Leukemia NCT00651261 Follow-Up - CALGB: 10603 Follow-Up Form - 2720473v1.0

model
Details

INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink. Mark an X in the appropriate box for fields with a choice

1 Formulieren

StudyEvent: CALGB: 10603 Follow-Up Form
1. INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink. Mark an X in the appropriate box for fields with a choice

Name

Type

Description | Question | Decode (Coded Value)

Datatype

Alias

Unnamed1

Item Group

Unnamed1

CALGBFormIdentifierNumber

Item

CALGB Form (C-1623)

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C19464 (NCI Thesaurus ObjectClass)
C0376315 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25442 (NCI Thesaurus ObjectClass)
C1516238 (UMLS 2011AA ObjectClass)

ProtocolCALGBIdentifierNumber

Item

CALGB Study No.

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)
C25442 (NCI Thesaurus Property)
C1516238 (UMLS 2011AA Property)

PatientCALGBIdentifierNumber

Item

CALGB 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)
C25442 (NCI Thesaurus Property)
C1516238 (UMLS 2011AA Property)

TreatmentReportingPeriodBeginDate

Item

Reporting Period Start Date

date

C15368 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25651 (NCI Thesaurus Property)
C0700287 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)

TreatmentReportingPeriodEndDate

Item

Reporting Period End Date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C15368 (NCI Thesaurus ObjectClass)
C25651 (NCI Thesaurus Property)
C0700287 (UMLS 2011AA Property)

DataAmendedInd-3

Item

Are data amended

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)

CL.1

Code List

Are data amended

CL Item

Yes (Yes)

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

Unnamed2

Item Group

Unnamed2

PatientInitialsName

Item

Patient Initials (Last, First Middle)

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)

PatientMedicalRecordNumber

Item

Patient Hospital No.

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25261 (NCI Thesaurus Property)
C0205476 (UMLS 2011AA Property)
C25198 (NCI Thesaurus Property)
C0034869 (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)

ParticipatingGroupName

Item

Participating Group

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25608 (NCI Thesaurus ObjectClass)
C0679823 (UMLS 2011AA ObjectClass)
C17005 (NCI Thesaurus ObjectClass)
C1257890 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

ProtocolParticipatingIdentifierNumber

Item

Participating Group Study No.

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)

Treatment Phase Information

Item Group

Treatment Phase Information

ProtocolTherapyPhaseType

Item

Treatment Phase

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C42651 (NCI Thesaurus ObjectClass)
C0442711 (UMLS 2011AA ObjectClass)
C25257 (NCI Thesaurus Property)
C0205390 (UMLS 2011AA Property)

CL.2

Code List

Treatment Phase

CL Item

Induction #1 (Induction #1)

CL Item

Induction #2 (Induction #2)

CL Item

Consolidation #1 (Consolidation #1)

CL Item

Consolidation #2 (Consolidation #2)

CL Item

Consolidation #3 (Consolidation #3)

CL Item

Consolidation #4 (Consolidation #4)

CL Item

Continuation (Continuation)

CL Item

Post-therapy (Post-therapy follow-up)

C54735 (NCI Thesaurus)
C1882428 (UMLS 2011AA)

Vital Status

Item Group

Aml/all/apl: Vital Status

PatientVitalStatus

Item

Patient's Vital Status (Mark one with an X)

text

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C18003 (NCI Thesaurus ValueDomain)
C0442732 (UMLS 2011AA ValueDomain)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
C25717 (NCI Thesaurus Property)
C1148433 (UMLS 2011AA Property)

CL.3

Code List

Patient's Vital Status (Mark one with an X)

CL Item

Alive (Alive)

CL Item

Dead (Dead)

PatientLastContactDate

Item

Date of Last Contact or Death (mm dd yyyy)

date

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25461 (NCI Thesaurus Property)
C0337611 (UMLS 2011AA Property)
C25551 (NCI Thesaurus Property)
C1517741 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)

PatientDeathPatientDeathPrimaryReason

Item

Primary Cause of Death (Mark one with an X)

text

C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C28554 (NCI Thesaurus Property)
C0011065 (UMLS 2011AA Property)
C25251 (NCI Thesaurus ValueDomain)
C0205225 (UMLS 2011AA ValueDomain)

CL.4

Code List

Primary Cause of Death (Mark one with an X)

CL Item

Due To Other Cause (Due to other cause)

CL Item

Due To Protocol Treatment (Due to protocol treatment)

CL Item

Due To This Disease (Due to this disease)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

PatientDeathSpecify

Item

Describe cause of death

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C28554 (NCI Thesaurus Property)
C0011065 (UMLS 2011AA Property)

Disease Follow-Up Status

Item Group

Aml/all/apl: Disease Follow-up Status

CancerFollow-upStatusInd-3

Item

Has the patient had a documented clinical assessment for this cancer? (during this reporting period)

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C16033 (NCI Thesaurus Property)
C1522577 (UMLS 2011AA Property)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)

CL.5

Code List

Has the patient had a documented clinical assessment for this cancer? (during this reporting period)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

CancerFollow-UpStatusDate

Item

Date of Last Clinical Assessment (mm dd yyyy only provide date if assessment during this reporting period)

date

C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C16033 (NCI Thesaurus Property)
C1522577 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)

HematologyCompleteResponseInd-3

Item

Did the patient achieve a complete response according to clinical/ hematologic criteria (during this reporting period)

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C16673 (NCI Thesaurus ObjectClass)
C0018943 (UMLS 2011AA ObjectClass)
C0677874 (NCI Metathesaurus Property)

CL.6

Code List

Did the patient achieve a complete response according to clinical/ hematologic criteria (during this reporting period)

CL Item

No (NO)

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

CL Item

Yes (YES)

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

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

CompleteResponseFirstObservedDate

Item

Complete Response (CR) First Observed Date

date

C25755 (NCI Thesaurus ObjectClass)
C0871261 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus ObjectClass)
C0205197 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25599 (NCI Thesaurus Property)
C1441672 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)

HematologyPartialRemissionInd-3

Item

Did the patient achieve a partial response according to clinical/ hematologic criteria

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C16673 (NCI Thesaurus ObjectClass)
C0018943 (UMLS 2011AA ObjectClass)
C18058 (NCI Thesaurus Property)
C1521726 (UMLS 2011AA Property)

CL.7

Code List

Did the patient achieve a partial response according to clinical/ hematologic criteria

CL Item

No (NO)

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

CL Item

Yes (YES)

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

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

PartialResponseFirstObservedDate

Item

Partial Response (PR) First Observed Date

date

C25755 (NCI Thesaurus ObjectClass)
C0871261 (UMLS 2011AA ObjectClass)
C25378 (NCI Thesaurus ObjectClass)
C0728938 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25599 (NCI Thesaurus Property)
C1441672 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)

Notice of Progression

Item Group

Cll: Notice Of Progression

DiseaseProgressionInd-3

Item

Has the patient developed a first progression (or relapse) that has not been previously reported? (Mark one with an X.)

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25331 (NCI Thesaurus Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)

CL.8

Code List

Has the patient developed a first progression (or relapse) that has not been previously reported? (Mark one with an X.)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

DiseaseBoneMarrowRelapseDate

Item

Date of bone marrow relapse

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C18265 (NCI Thesaurus Property)
C12431 (NCI Thesaurus Property)
C0005953 (UMLS 2011AA Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)

DiseaseNonBoneMarrowRelapseDate

Item

Date of non-marrow relapse

date

C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C18265 (NCI Thesaurus Property)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C12431 (NCI Thesaurus Property)
C0005953 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

DiseaseNonBoneMarrowRelapseType

Item

Type of non-marrow relapse

text

C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C18265 (NCI Thesaurus Property)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C12431 (NCI Thesaurus Property)
C0005953 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.9

Code List

Type of non-marrow relapse

CL Item

Cns (CNS)

CL Item

Gonadal (Gonadal)

CL Item

Other, Specify (Other, specify)

CL Item

Peripheral Blood (Peripheral blood)

C0229664 (NCI Metathesaurus)

CL Item

Skin (Skin)

C12470 (NCI Thesaurus)
C1123023 (UMLS 2011AA)

DiseaseNonBoneMarrowRelapseSpecify

Item

Other, specify (Type of non-marrow relapse)

text

C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C18265 (NCI Thesaurus Property)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C12431 (NCI Thesaurus Property)
C0005953 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)

RECOVERY

Item Group

Recovery

PatientHospitalizationInd-2

Item

Did the patient require hospitalization (other than for chemotherapy administration)

text

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25179 (NCI Thesaurus Property)
C0019993 (UMLS 2011AA Property)

CL.10

Code List

Did the patient require hospitalization (other than for chemotherapy administration)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

PatientHospitalizationDayCount

Item

Number of extra days hospitalized

double

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25301 (NCI Thesaurus ValueDomain)
C0439228 (UMLS 2011AA ValueDomain)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25179 (NCI Thesaurus Property)
C0019993 (UMLS 2011AA Property)

IntravenousTreatmentInfectionInd-3

Item

Did the patient require IV antibiotics or antifungals

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C13346 (NCI Thesaurus ObjectClass)
C0348016 (UMLS 2011AA ObjectClass)
C26726 (NCI Thesaurus Property)
C0009450 (UMLS 2011AA Property)
C15368 (NCI Thesaurus ObjectClass)

CL.11

Code List

Did the patient require IV antibiotics or antifungals

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

IntravenousTreatmentInfectionDayCount

Item

Number of days on IV antibiotics/antifungals

double

C13346 (NCI Thesaurus ObjectClass)
C0348016 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass)
C26726 (NCI Thesaurus Property)
C0009450 (UMLS 2011AA Property)
C25301 (NCI Thesaurus ValueDomain)
C0439228 (UMLS 2011AA ValueDomain)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)

PlateletTransfusionRequirementInd-3

Item

Did the patient require platelet transfusion

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15366 (NCI Thesaurus ObjectClass)
C0086818 (UMLS 2011AA ObjectClass)
C38015 (NCI Thesaurus Property)

CL.12

Code List

Did the patient require platelet transfusion

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

PlateletTransfusionRequirementDayCount

Item

Number of days platelet transfusion(s) given (If yes,)

double

C25301 (NCI Thesaurus ValueDomain)
C0439228 (UMLS 2011AA ValueDomain)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C15366 (NCI Thesaurus ObjectClass)
C0086818 (UMLS 2011AA ObjectClass)
C38015 (NCI Thesaurus Property)

PlateletTransfusionAdministeredType

Item

Type of platelet transfusion

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15366 (NCI Thesaurus ObjectClass)
C0086818 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

CL.13

Code List

Type of platelet transfusion

CL Item

Random Donor (Random donor)

CL Item

Single Donor (Single donor)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

PlateletTransfusionAdministeredSpecify

Item

Other specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C15366 (NCI Thesaurus ObjectClass)
C0086818 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

PackedRedBloodCellTransfusionRequirementInd-3

Item

Did the patient require red blood cell (RBC) transfusions?

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.14

Code List

Did the patient require red blood cell (RBC) transfusions?

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

RedCellTransfusionUnitsSpecify

Item

Number of units of RBC transfusions (If yes, )

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C15408 (NCI Thesaurus ObjectClass)
CL110548 (NCI Metathesaurus Property)
CL285914 (NCI Metathesaurus ObjectClass)

AbsoluteNeutrophilCountDecliningDate

Item

First date ANC (Absolute Neutrophil Count) dropped below 500/ul

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C63321 (NCI Thesaurus ObjectClass)
C0948762 (UMLS 2011AA ObjectClass)
C25475 (NCI Thesaurus Property)
C1511741 (UMLS 2011AA Property)

AbsoluteNeutrophilCountRecoveryPostDecliningDate

Item

First date of ANC (Absolute Neutrophil Count) recovery over 500/ul

date

C63321 (NCI Thesaurus ObjectClass)
C0948762 (UMLS 2011AA ObjectClass)
C38008 (NCI Thesaurus Property)
C0687676 (UMLS 2011AA Property)
C25746 (NCI Thesaurus Property)
C2004454 (UMLS 2011AA Property)
C25475 (NCI Thesaurus Property)
C1511741 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

LastPlateletCountAssessmentLaboratoryProcedureDate

Item

First date platelets dropped below 20,000/ul

date

C51951 (NCI Thesaurus ObjectClass)
C0032181 (UMLS 2011AA ObjectClass)
C25551 (NCI Thesaurus ObjectClass)
C1517741 (UMLS 2011AA ObjectClass)
C25217 (NCI Thesaurus Property)
C1516048 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25294 (NCI Thesaurus ValueDomain)
C0022885 (UMLS 2011AA ValueDomain)

PostTransplantPlateletRecoveryAssessmentDate

Item

First date platelets recovered over 20,000/ul (non-transfused)

date

C38008 (NCI Thesaurus ObjectClass)
C0687676 (UMLS 2011AA ObjectClass)
C12981 (NCI Thesaurus ObjectClass)
C0332835 (UMLS 2011AA ObjectClass)
C12520 (NCI Thesaurus ObjectClass)
C0005821 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25746 (NCI Thesaurus Property)
C2004454 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

Transplant Treatment Plan

Item Group

Notice Of Progression2

BMSCTAdministeredDate

Item

Date of First Bone Marrow or Peripheral Blood Stem Cell (PBSC) Infusion

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25437 (NCI Thesaurus ObjectClass)
C0842093 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

BMSCTType

Item

Type of Bone Marrow or Peripheral Blood Stem Cell (PBSC) Transplant

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25437 (NCI Thesaurus ObjectClass)
C0842093 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)

CL.15

Code List

Type of Bone Marrow or Peripheral Blood Stem Cell (PBSC) Transplant

CL Item

Bone Marrow Stem Cells Used For Transplant Obtained From Antigen-matched Sibling Or Family Member Of Recipient (Bone marrow from matched sibling or family member)

CL Item

Peripheral Blood Stem Cells Used For Transplant Obtained From Antigen-matched Sibling Or Family Member Of Recipient (PBSC from matched sibling or family member)

CL Item

Bone Marrow Stem Cells Used For Transplant Obtained From Antigen-matched Individual Unrelated To Recipient (Bone marrow from matched unrelated donor)

CL Item

Peripheral Blood Stem Cells Used For Transplant Obtained From Antigen-matched Individual Unrelated To Recipient (PBSC from matched unrelated donor)

CL Item

Bone Marrow Stem Cells Used For Transplant Obtained From Recipient Him/herself (Autologous bone marrow)

CL Item

Peripheral Blood Stem Cells Used For Transplant Obtained From Recipient Him/herself (Autologous PBSC)

CL Item

Cord Blood (Cord blood)

CL Item

Other Specify (Other)

TransplantProcedureSpecify

Item

Other specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C12981 (NCI Thesaurus ObjectClass)
C0332835 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)

Notice of New Primary Cancer

Item Group

Notice Of New Primary

NewCancerDiagnosisInd-3

Item

Has a new primary cancer or MDS been diagnosed that has not been previously reported?

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)

CL.16

Code List

Has a new primary cancer or MDS been diagnosed that has not been previously reported?

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

NewCancerDiagnosisText

Item

New Primary Diagnosis

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)

NewCancerDiagnosisDate

Item

Date of diagnosis

date

C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)

NewCancerSiteText

Item

Site of New Primary (s)

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)

Footer Module

Item Group

Comments

ResponsiblePersonName

Item

Completed by (Last name, First name)

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

FormCompleteDate

Item

Date Form Completed

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C40988 (NCI Thesaurus ObjectClass)
C1516308 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain)

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Leukemia NCT00651261 Follow-Up - CALGB: 10603 Follow-Up Form - 2720473v1.0

INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink. Mark an X in the appropriate box for fields with a choice

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