ID

10721

Beskrivning

CALGB: 10603 Follow-Up Form NCT00651261 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

Länk

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

Nyckelord

AML

Clinical Trial

Verlaufsstudien

C95.9

Uppladdad den

8 juni 2015

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0 Legacy

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CALGB: 10603 Follow-Up Form DRKS00003845 NCT00651261

model
Detaljer

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 Formulär

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

Typ

Description | Question | Decode (Coded Value)

Datatyp

Alias

Header

Item Group

Header

Form ID CALGB

Item

CALGB Form (C-1623)

text

C25337 (NCI Thesaurus ValueDomain)
C3262252 (UMLS CUI-1)
C19464 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus ObjectClass-2)

Protocol ID CALGB

Item

CALGB Study No.

text

C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus Property-2)

Trial subject ID CALGB

Item

CALGB Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus Property-2)

Reporting Period Start Date

Item

Reporting Period Start Date

date

C15368 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C2361257 (UMLS CUI-1)
C25651 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)

Reporting Period End Date

Item

Reporting Period End Date

date

C25164 (NCI Thesaurus ValueDomain)
C2361259 (UMLS CUI-1)
C25616 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)
C25651 (NCI Thesaurus Property-2)

Data amended

Item

Are data amended

boolean

C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)

Patient demographics

Item Group

Patient demographics

Patient Initials

Item

Patient Initials (Last, First Middle)

text

C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)

Medical Record Number

Item

Patient Hospital No.

text

C25337 (NCI Thesaurus ValueDomain)
C1301894 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25261 (NCI Thesaurus Property)
C25198 (NCI Thesaurus Property-2)

Institution Name

Item

Institution/Affiliate

text

C25454 (NCI Thesaurus ObjectClass)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)

Participating Group

Item

Participating Group

text

C25191 (NCI Thesaurus ValueDomain)
C2347449 (UMLS CUI-1)
C25608 (NCI Thesaurus ObjectClass)
C17005 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)

Study Number Participating Group

Item

Participating Group Study No.

text

C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)

Trial subject ID Participating Group

Item

Participating Group Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)

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-2)
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

Patient Status

Item

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

text

C16960 (NCI Thesaurus ObjectClass)
C3846084 (UMLS CUI-1)
C18003 (NCI Thesaurus ValueDomain)
C25688 (NCI Thesaurus ValueDomain-2)
C25717 (NCI Thesaurus Property)

CL.3

Code List

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

CL Item

Alive (Alive)

CL Item

Dead (Dead)

Date last contact

Item

Date of Last Contact or Death (mm dd yyyy)

date

C16960 (NCI Thesaurus ObjectClass)
C0805839 (UMLS CUI-1)
C25461 (NCI Thesaurus Property)
C25551 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)

Primary Cause of Death

Item

Primary Cause of Death (Mark one with an X)

text

C25638 (NCI Thesaurus ValueDomain)
C0007465 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C28554 (NCI Thesaurus Property)
C25251 (NCI Thesaurus ValueDomain-2)

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)

Cause of Death, specify

Item

Describe cause of death

text

C25685 (NCI Thesaurus ValueDomain)
C0007465 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1521902 (UMLS CUI-2)
C28554 (NCI Thesaurus Property)

Disease Follow-Up Status

Item Group

Aml/all/apl: Disease Follow-up Status

Documented clinical assessment for this cancer

Item

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

text

C38148 (NCI Thesaurus ValueDomain)
C1522577 (UMLS CUI-1)
C16033 (NCI Thesaurus Property)
C0006826 (UMLS CUI-2)
C9305 (NCI Thesaurus ObjectClass)
C25365 (NCI Thesaurus Property-2)

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)

Follow-Up Date

Item

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

date

C9305 (NCI Thesaurus ObjectClass)
C3694716 (UMLS CUI-1)
C16033 (NCI Thesaurus Property)
C25365 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)

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-3)
C1298908 (UMLS 2011AA-4)

CL Item

Yes (YES)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus-3)
C1705108 (UMLS 2011AA-4)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

Complete Response First Observed Date

Item

Complete Response (CR) First Observed Date

date

C25755 (NCI Thesaurus ObjectClass)
C0677874 (UMLS CUI-1)
C25250 (NCI Thesaurus ObjectClass-2)
C1115465 (UMLS CUI-2)
C25509 (NCI Thesaurus Property)
C25599 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)

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-3)
C1298908 (UMLS 2011AA-4)

CL Item

Yes (YES)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus-3)
C1705108 (UMLS 2011AA-4)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

Partial Response First Observed Date

Item

Partial Response (PR) First Observed Date

date

C25755 (NCI Thesaurus ObjectClass)
C1521726 (UMLS CUI-1)
C25378 (NCI Thesaurus ObjectClass-2)
C1115465 (UMLS CUI-2)
C25509 (NCI Thesaurus Property)
C25599 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)

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-2)
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-2)
C1518422 (UMLS 2011AA Property)
C12431 (NCI Thesaurus Property-3)
C0005953 (UMLS 2011AA Property-2)
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-2)
C1518422 (UMLS 2011AA Property)
C12431 (NCI Thesaurus Property-3)
C0005953 (UMLS 2011AA Property-2)
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-2)
C1518422 (UMLS 2011AA Property)
C12431 (NCI Thesaurus Property-3)
C0005953 (UMLS 2011AA Property-2)
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)

boolean

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

PatientHospitalizationDayCount

Item

Number of extra days hospitalized

float

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25301 (NCI Thesaurus ValueDomain)
C0439228 (UMLS 2011AA ValueDomain)
C25463 (NCI Thesaurus ValueDomain-2)
C0750480 (UMLS 2011AA ValueDomain-2)
C25179 (NCI Thesaurus Property)
C0019993 (UMLS 2011AA Property)

IntravenousTreatmentInfectionInd-3

Item

Did the patient require IV antibiotics or antifungals

boolean

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-2)

IntravenousTreatmentInfectionDayCount

Item

Number of days on IV antibiotics/antifungals

float

C13346 (NCI Thesaurus ObjectClass)
C0348016 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C26726 (NCI Thesaurus Property)
C0009450 (UMLS 2011AA Property)
C25301 (NCI Thesaurus ValueDomain)
C0439228 (UMLS 2011AA ValueDomain)
C25463 (NCI Thesaurus ValueDomain-2)
C0750480 (UMLS 2011AA ValueDomain-2)

PlateletTransfusionRequirementInd-3

Item

Did the patient require platelet transfusion

boolean

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

PlateletTransfusionRequirementDayCount

Item

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

float

C25301 (NCI Thesaurus ValueDomain)
C0439228 (UMLS 2011AA ValueDomain)
C25463 (NCI Thesaurus ValueDomain-2)
C0750480 (UMLS 2011AA ValueDomain-2)
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?

boolean

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

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-2)
C2004454 (UMLS 2011AA Property-2)
C25475 (NCI Thesaurus Property-3)
C1511741 (UMLS 2011AA Property-3)
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-2)
C1517741 (UMLS 2011AA ObjectClass-2)
C25217 (NCI Thesaurus Property)
C1516048 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25294 (NCI Thesaurus ValueDomain-2)
C0022885 (UMLS 2011AA ValueDomain-2)

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-2)
C0332835 (UMLS 2011AA ObjectClass-2)
C12520 (NCI Thesaurus ObjectClass-3)
C0005821 (UMLS 2011AA ObjectClass-3)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25746 (NCI Thesaurus Property-2)
C2004454 (UMLS 2011AA Property-2)
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?

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)

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-2)
C0006826 (UMLS 2011AA ObjectClass-2)
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-2)
C0006826 (UMLS 2011AA ObjectClass-2)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)

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-2)
C0006826 (UMLS 2011AA ObjectClass-2)

Footer Module

Item Group

Comments

Person Completing Form

Item

Completed by (Last name, First name)

text

C25191 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)

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Date Form Completed

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C25164 (NCI Thesaurus ValueDomain)
C1115437 (UMLS CUI-1)
C40988 (NCI Thesaurus ObjectClass)
C25250 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)

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CALGB: 10603 Follow-Up Form DRKS00003845 NCT00651261

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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