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43208

Description

E2906 Allogeneic Transplant Form - Arm G Clofarabine or Daunorubicin Hydrochloride and Cytarabine Followed By Decitabine or Observation in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=758373C9-BE14-F79E-E040-BB89AD433D62

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=758373C9-BE14-F79E-E040-BB89AD433D62

Keywords

Versions (3)
  1. 9/19/12 9/19/12 -
  2. 1/8/15 1/8/15 - Martin Dugas
  3. 9/20/21 9/20/21 -
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September 20, 2021

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Creative Commons BY-NC 3.0 Legacy
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    Leukemia NCT01041703 Treatment - E2906 Allogeneic Transplant Form - Arm G - 2951703v1.0

    English

    INSTRUCTIONS: Complete this form after the allogeneic transplant (30 days post transplant or at the end of hospitalization). Submit original to the ECOG Coordinating Center; keep a copy for your files

    1 forms  
    Header
    Description

    Header

    DCI Name
    Description

    Generic drug form

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C3242750
    NCI Thesaurus Property
    C19464
    NCI Thesaurus ObjectClass
    C25474
    NCI Thesaurus ObjectClass-2
    C25452
    Registration Step (Place ID Label Here)
    Description

    Registration Number

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C1514821
    NCI Thesaurus ObjectClass
    C25646
    UMLS CUI-2
    C0237753
    NCI Thesaurus Property
    C16154
    NCI Thesaurus ValueDomain-2
    C16154
    Patient Initials (Last, First)
    Description

    Patient Initials

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C2986440
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25536
    ECOG Protocol Number
    Description

    Protocol Number ECOG

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C3274381
    NCI Thesaurus ObjectClass
    C25320
    UMLS CUI-2
    C1512162
    NCI Thesaurus Property
    C25364
    NCI Thesaurus Property-2
    C25491
    ECOG Protocol Number
    Description

    Protocol Number ECOG

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C3274381
    NCI Thesaurus ObjectClass
    C25320
    UMLS CUI-2
    C1512162
    NCI Thesaurus Property
    C25364
    NCI Thesaurus Property-2
    C25491
    ECOG Patient ID
    Description

    Patient ID ECOG

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C2348585
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-2
    C1512162
    NCI Thesaurus Property
    C25364
    NCI Thesaurus Property-2
    C25491
    ECOG Patient ID
    Description

    Patient ID ECOG

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C2348585
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-2
    C1512162
    NCI Thesaurus Property
    C25364
    NCI Thesaurus Property-2
    C25491
    Participating Group Protocol Number
    Description

    Study Number Participating Group

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C3274381
    NCI Thesaurus ObjectClass
    C25320
    UMLS CUI-2
    C2347449
    NCI Thesaurus Property
    C25608
    NCI Thesaurus Property-2
    C25364
    Participating Group Patient ID
    Description

    Trial subject ID Participating Group

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25337
    UMLS CUI-1
    C2348585
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-2
    C2347449
    NCI Thesaurus Property
    C25608
    NCI Thesaurus Property-2
    C25364
    Institution/Affiliate
    Description

    Institution Name

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C25454
    UMLS CUI-1
    C1301943
    NCI Thesaurus ObjectClass-2
    C21541
    NCI Thesaurus Property
    C25364
    NCI Thesaurus ValueDomain
    C25191
    NCI Thesaurus ValueDomain-2
    C21541
    On Treatment
    Description

    On Treatment

    On Treatment Reporting Period
    Description

    Cycle number

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS CUI-1
    C2045829
    NCI Thesaurus Property
    C25214
    NCI Thesaurus Property-2
    C25616
    NCI Thesaurus ObjectClass
    C15368
    Unnamed2
    Description

    Unnamed2

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

    Data amended

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS CUI-1
    C0680532
    NCI Thesaurus ObjectClass
    C25474
    NCI Thesaurus Property
    C25416
    Date data amended (s M D Y)
    Description

    Data amended date

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C0680532
    NCI Thesaurus ObjectClass
    C25474
    UMLS CUI-2
    C0011008
    NCI Thesaurus Property
    C25416
    NCI Thesaurus ValueDomain-2
    C25367
    Vital Status
    Description

    Vital Status

    Patient's Vital Status
    Description

    Patient Status

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-1
    C3846084
    NCI Thesaurus ValueDomain
    C18003
    NCI Thesaurus ValueDomain-2
    C25688
    NCI Thesaurus Property
    C25717
    Weight (kg Day 1 of this treatment)
    Description

    Patient Weight

    Data type

    float

    Measurement units
    • Kg
    Alias
    NCI Thesaurus ValueDomain
    C25209
    UMLS CUI-1
    C0005910
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25208
    Kg
    Date of Last Contact or Death (M D Y)
    Description

    Date last contact

    Data type

    date

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-1
    C0805839
    NCI Thesaurus Property
    C25461
    NCI Thesaurus Property-2
    C25551
    NCI Thesaurus ValueDomain
    C25164
    NCI Thesaurus ValueDomain-2
    C25367
    Primary Cause of Death (if applicable)
    Description

    Primary Cause of Death

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25638
    UMLS CUI-1
    C0007465
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C28554
    NCI Thesaurus ValueDomain-2
    C25251
    Describe cause of death
    Description

    Cause of Death, specify

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25685
    UMLS CUI-1
    C0007465
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-2
    C1521902
    NCI Thesaurus Property
    C28554
    Section Ii - Reporting Period
    Description

    Section Ii - Reporting Period

    Treatment Start Date (M D Y)
    Description

    Treatment Begin Date

    Data type

    date

    Alias
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus Property
    C25431
    UMLS CUI-1
    C3173309
    NCI Thesaurus Property-2
    C25275
    NCI Thesaurus ValueDomain
    C25164
    NCI Thesaurus ValueDomain-2
    C25431
    Treatment End Date (M D Y)
    Description

    Treatment End Date

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C1531784
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus Property
    C25275
    NCI Thesaurus Property-2
    C25496
    Therapy Administered
    Description

    Therapy Administered

    Agent Name
    Description

    Agent

    Data type

    text

    Alias
    NCI Thesaurus Property
    C25364
    UMLS CUI-1
    C1521826
    NCI Thesaurus ObjectClass
    C1708
    NCI Thesaurus ValueDomain
    C1708
    NCI Thesaurus ValueDomain-2
    C42614
    Agent Total Dose (mg)
    Description

    Agent Total Dose

    Data type

    float

    Alias
    NCI Thesaurus ValueDomain
    C25304
    UMLS CUI-1
    C2986497
    NCI Thesaurus Property
    C25379
    NCI Thesaurus ValueDomain-2
    C25488
    NCI Thesaurus ObjectClass
    C1708
    Dose modification
    Description

    Dose Modification Status

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C25488
    UMLS CUI-1
    C1707811
    NCI Thesaurus ValueDomain
    C25688
    NCI Thesaurus Property
    C25572
    Dose Modification Reason
    Description

    Dose Modification Reason

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25638
    UMLS CUI-1
    C1707811
    NCI Thesaurus ObjectClass
    C25488
    UMLS CUI-2
    C0392360
    NCI Thesaurus Property
    C25572
    Donor Information
    Description

    Donor Information

    Donor's Relationship to recipient
    Description

    TransplantDonorPatientRelationshipType

    Data type

    text

    Alias
    NCI Thesaurus ObjectClass
    C25168
    UMLS 2011AA ObjectClass
    C0040288
    NCI Thesaurus ObjectClass-2
    C12981
    UMLS 2011AA ObjectClass-2
    C0332835
    NCI Thesaurus Property
    C16960
    UMLS 2011AA Property
    C0030705
    NCI Metathesaurus Property
    CL110661
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    Donor Birth Date (M D Y if known)
    Description

    TransplantDonorBirthDate

    Data type

    date

    Alias
    NCI Thesaurus ObjectClass
    C25168
    UMLS 2011AA ObjectClass
    C0040288
    NCI Thesaurus ObjectClass-2
    C12981
    UMLS 2011AA ObjectClass-2
    C0332835
    NCI Thesaurus Property
    C25155
    UMLS 2011AA Property
    C0005615
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ValueDomain-2
    C25367
    Donor Gender
    Description

    TransplantDonorGenderType

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C25168
    UMLS 2011AA ObjectClass
    C0040288
    NCI Thesaurus ObjectClass-2
    C12981
    UMLS 2011AA ObjectClass-2
    C0332835
    NCI Thesaurus Property
    C17357
    UMLS 2011AA Property
    C0079399
    CMV status (Patient)
    Description

    AntibodyCytomegalovirusTestStatus

    Data type

    text

    Alias
    NCI Thesaurus Property
    C14196
    UMLS 2011AA Property
    C0010825
    NCI Thesaurus ObjectClass
    C16295
    UMLS 2011AA ObjectClass
    C0003241
    NCI Thesaurus Property-2
    C25294
    UMLS 2011AA Property-2
    C0022885
    NCI Thesaurus ValueDomain
    C25688
    UMLS 2011AA ValueDomain
    C0449438
    EBV status
    Description

    AntibodyEBVTestStatus

    Data type

    text

    Alias
    NCI Thesaurus Property
    C14204
    UMLS 2011AA Property
    C0014644
    NCI Thesaurus ObjectClass
    C16295
    UMLS 2011AA ObjectClass
    C0003241
    NCI Thesaurus Property-2
    C25294
    UMLS 2011AA Property-2
    C0022885
    NCI Thesaurus ValueDomain
    C25688
    UMLS 2011AA ValueDomain
    C0449438
    Are patient and donor matched at HLA-A
    Description

    HLA-AAntigenTransplantCompatibleInd-3

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ObjectClass
    C12981
    UMLS 2011AA ObjectClass
    C0332835
    NCI Thesaurus ObjectClass-2
    C28585
    UMLS 2011AA ObjectClass-2
    C1333899
    NCI Thesaurus Property
    C40414
    UMLS 2011AA Property
    C1524057
    Are patient and donor matched at HLA-B
    Description

    HLA-BAntigenTransplantCompatibleInd-3

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ObjectClass
    C12981
    UMLS 2011AA ObjectClass
    C0332835
    NCI Thesaurus ObjectClass-2
    C62778
    UMLS 2011AA ObjectClass-2
    C1415561
    NCI Thesaurus Property
    C40414
    UMLS 2011AA Property
    C1524057
    Are patient and donor matched at HLA-C
    Description

    HLA-CAntigensTransplantCompatibleInd-3

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ObjectClass
    C12981
    UMLS 2011AA ObjectClass
    C0332835
    NCI Thesaurus ObjectClass-2
    C62758
    UMLS 2011AA ObjectClass-2
    C1415562
    NCI Thesaurus Property
    C40414
    UMLS 2011AA Property
    C1524057
    Are patient and donor matched at HLA-DR
    Description

    HLA-DrB1TransplantCompatibleInd-3

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ObjectClass
    C12981
    UMLS 2011AA ObjectClass
    C0332835
    NCI Thesaurus ObjectClass-2
    C19409
    UMLS 2011AA ObjectClass-2
    C1415576
    NCI Thesaurus Property
    C40414
    UMLS 2011AA Property
    C1524057
    Are patient and donor matched at HLA-DQ
    Description

    HLA-DQB1TransplantCompatibleInd-3

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ObjectClass
    C12981
    UMLS 2011AA ObjectClass
    C0332835
    NCI Thesaurus ObjectClass-2
    C62792
    UMLS 2011AA ObjectClass-2
    C0019761
    NCI Thesaurus Property
    C40414
    UMLS 2011AA Property
    C1524057
    Are patient and donor matched at HLA-DP
    Description

    HLA-DPAntigenTransplantCompatibleInd-3

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus ObjectClass
    C12981
    UMLS 2011AA ObjectClass
    C0332835
    NCI Thesaurus ObjectClass-2
    C71274
    UMLS 2011AA ObjectClass-2
    C0019759
    NCI Thesaurus Property
    C40414
    UMLS 2011AA Property
    C1524057
    Allogeneic Transplant
    Description

    Allogeneic Transplant

    Did the patient receive protocol transplant?
    Description

    ProtocolTransplantPerformedInd-3

    Data type

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    NCI Thesaurus Property
    C38000
    UMLS 2011AA Property
    C0884358
    NCI Thesaurus ObjectClass
    C12981
    UMLS 2011AA ObjectClass
    C0332835
    NCI Thesaurus ObjectClass-2
    C42651
    UMLS 2011AA ObjectClass-2
    C0442711
    Source of Stem Cells (If yes)
    Description

    TransplantCellSourceType

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    NCI Thesaurus ObjectClass
    C12981
    UMLS 2011AA ObjectClass
    C0332835
    NCI Thesaurus Property
    C12508
    UMLS 2011AA Property
    C0007634
    NCI Thesaurus Property-2
    C25365
    UMLS 2011AA Property-2
    C0678257
    CMV status (Patient)
    Description

    AntibodyCytomegalovirusTestStatus

    Data type

    text

    Alias
    NCI Thesaurus Property
    C14196
    UMLS 2011AA Property
    C0010825
    NCI Thesaurus ObjectClass
    C16295
    UMLS 2011AA ObjectClass
    C0003241
    NCI Thesaurus Property-2
    C25294
    UMLS 2011AA Property-2
    C0022885
    NCI Thesaurus ValueDomain
    C25688
    UMLS 2011AA ValueDomain
    C0449438
    Date of Peripheral Blood Stem Cell Infusion (M D Y last PBSC If patient completed transplant therapy this date should correspond with the "Last Date Protocol Therapy Was Given" date on the Step 2 Off-Treatment Form)
    Description

    PeripheralBloodStemCellTransplantInfusionDate

    Data type

    date

    Alias
    NCI Thesaurus ObjectClass
    C12981
    UMLS 2011AA ObjectClass
    C0332835
    NCI Thesaurus ObjectClass-2
    C12946
    UMLS 2011AA ObjectClass-2
    C1518999
    NCI Thesaurus Property
    C15388
    UMLS 2011AA Property
    C0574032
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ValueDomain-2
    C25367
    Number of CD34-positive cells infused (Total X 10^6 cells per kg of body weight)
    Description

    TransplantCD34+CellInfusionDose

    Data type

    float

    Alias
    NCI Thesaurus Property
    C15388
    UMLS 2011AA Property
    C0574032
    NCI Thesaurus ObjectClass
    C12981
    UMLS 2011AA ObjectClass
    C0332835
    NCI Thesaurus ValueDomain
    C25488
    UMLS 2011AA ValueDomain
    C0178602
    NCI Metathesaurus Property
    C0882849
    Number of T cells (CD3) infused (X 10^6 cells per kg of body weight)
    Description

    T-LymphocyteTransplantCD3+CellInfusionDose

    Data type

    float

    Alias
    NCI Thesaurus ObjectClass
    C12981
    UMLS 2011AA ObjectClass
    C0332835
    NCI Thesaurus ObjectClass-2
    C12476
    UMLS 2011AA ObjectClass-2
    C0039194
    NCI Thesaurus Property
    C15388
    UMLS 2011AA Property
    C0574032
    NCI Metathesaurus Property
    C0882828
    NCI Thesaurus ValueDomain
    C25488
    UMLS 2011AA ValueDomain
    C0178602
    Comments
    Description

    Comments

    Investigator Signature
    Description

    Investigator Signature

    Data type

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS CUI-1
    C2346576
    NCI Thesaurus Property
    C25678
    NCI Thesaurus ObjectClass
    C17089
    Investigator Signature Date (MM DD YYYY)
    Description

    Investigator Signature Date

    Data type

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS CUI-1
    C2346576
    NCI Thesaurus Property
    C25678
    UMLS CUI-2
    C0011008
    NCI Thesaurus ValueDomain-2
    C25367
    NCI Thesaurus ObjectClass
    C17089
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    INSTRUCTIONS: Complete this form after the allogeneic transplant (30 days post transplant or at the end of hospitalization). Submit original to the ECOG Coordinating Center; keep a copy for your files

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Header
    Generic drug form
    Item
    DCI Name
    text
    C25191 (NCI Thesaurus ValueDomain)
    C3242750 (UMLS CUI-1)
    C19464 (NCI Thesaurus Property)
    C25474 (NCI Thesaurus ObjectClass)
    C25452 (NCI Thesaurus ObjectClass-2)
    Registration Number
    Item
    Registration Step (Place ID Label Here)
    text
    C25337 (NCI Thesaurus ValueDomain)
    C1514821 (UMLS CUI-1)
    C25646 (NCI Thesaurus ObjectClass)
    C0237753 (UMLS CUI-2)
    C16154 (NCI Thesaurus Property)
    C16154 (NCI Thesaurus ValueDomain-2)
    Patient Initials
    Item
    Patient Initials (Last, First)
    text
    C25191 (NCI Thesaurus ValueDomain)
    C2986440 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25536 (NCI Thesaurus Property)
    Protocol Number ECOG
    Item
    ECOG Protocol Number
    text
    C25337 (NCI Thesaurus ValueDomain)
    C3274381 (UMLS CUI-1)
    C25320 (NCI Thesaurus ObjectClass)
    C1512162 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25491 (NCI Thesaurus Property-2)
    Protocol Number ECOG
    Item
    ECOG Protocol Number
    text
    C25337 (NCI Thesaurus ValueDomain)
    C3274381 (UMLS CUI-1)
    C25320 (NCI Thesaurus ObjectClass)
    C1512162 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25491 (NCI Thesaurus Property-2)
    Patient ID ECOG
    Item
    ECOG Patient ID
    text
    C25337 (NCI Thesaurus ValueDomain)
    C2348585 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C1512162 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25491 (NCI Thesaurus Property-2)
    Patient ID ECOG
    Item
    ECOG Patient ID
    text
    C25337 (NCI Thesaurus ValueDomain)
    C2348585 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C1512162 (UMLS CUI-2)
    C25364 (NCI Thesaurus Property)
    C25491 (NCI Thesaurus Property-2)
    Study Number Participating Group
    Item
    Participating Group Protocol Number
    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)
    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)
    Item Group
    On Treatment
    Item
    On Treatment Reporting Period
    text
    C25284 (NCI Thesaurus ValueDomain)
    C2045829 (UMLS CUI-1)
    C25214 (NCI Thesaurus Property)
    C25616 (NCI Thesaurus Property-2)
    C15368 (NCI Thesaurus ObjectClass)
    CL.1
    Code List
    On Treatment Reporting Period
    CL Item
    At Transplant (At Transplant)
    Item Group
    Unnamed2
    Data amended
    Item
    Please mark an 'X' if data have been amended. (Please circle amended items in red)
    text
    C25704 (NCI Thesaurus ValueDomain)
    C0680532 (UMLS CUI-1)
    C25474 (NCI Thesaurus ObjectClass)
    C25416 (NCI Thesaurus Property)
    Data amended date
    Item
    Date data amended (s M D Y)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0680532 (UMLS CUI-1)
    C25474 (NCI Thesaurus ObjectClass)
    C0011008 (UMLS CUI-2)
    C25416 (NCI Thesaurus Property)
    C25367 (NCI Thesaurus ValueDomain-2)
    Item Group
    Vital Status
    Item
    Patient's Vital Status
    text
    C16960 (NCI Thesaurus ObjectClass)
    C3846084 (UMLS CUI-1)
    C18003 (NCI Thesaurus ValueDomain)
    C25688 (NCI Thesaurus ValueDomain-2)
    C25717 (NCI Thesaurus Property)
    CL.2
    Code List
    Patient's Vital Status
    CL Item
    Alive (Alive)
    CL Item
    Dead (Dead)
    Patient Weight
    Item
    Weight (kg Day 1 of this treatment)
    float
    C25209 (NCI Thesaurus ValueDomain)
    C0005910 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C25208 (NCI Thesaurus Property)
    Date last contact
    Item
    Date of Last Contact or Death (M D Y)
    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)
    Item
    Primary Cause of Death (if applicable)
    text
    C25638 (NCI Thesaurus ValueDomain)
    C0007465 (UMLS CUI-1)
    C16960 (NCI Thesaurus ObjectClass)
    C28554 (NCI Thesaurus Property)
    C25251 (NCI Thesaurus ValueDomain-2)
    CL.3
    Code List
    Primary Cause of Death (if applicable)
    CL Item
    Due To Protocol Treatment (Due to protocol treatment)
    CL Item
    Due To This Disease (Due to this disease)
    CL Item
    Due To Other Cause (Due to other cause)
    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)
    Item Group
    Section Ii - Reporting Period
    Treatment Begin Date
    Item
    Treatment Start Date (M D Y)
    date
    C15368 (NCI Thesaurus ObjectClass)
    C25431 (NCI Thesaurus Property)
    C3173309 (UMLS CUI-1)
    C25275 (NCI Thesaurus Property-2)
    C25164 (NCI Thesaurus ValueDomain)
    C25431 (NCI Thesaurus ValueDomain-2)
    Treatment End Date
    Item
    Treatment End Date (M D Y)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C1531784 (UMLS CUI-1)
    C15368 (NCI Thesaurus ObjectClass)
    C25275 (NCI Thesaurus Property)
    C25496 (NCI Thesaurus Property-2)
    Item Group
    Therapy Administered
    Agent
    Item
    Agent Name
    text
    C25364 (NCI Thesaurus Property)
    C1521826 (UMLS CUI-1)
    C1708 (NCI Thesaurus ObjectClass)
    C1708 (NCI Thesaurus ValueDomain)
    C42614 (NCI Thesaurus ValueDomain-2)
    Agent Total Dose
    Item
    Agent Total Dose (mg)
    float
    C25304 (NCI Thesaurus ValueDomain)
    C2986497 (UMLS CUI-1)
    C25379 (NCI Thesaurus Property)
    C25488 (NCI Thesaurus ValueDomain-2)
    C1708 (NCI Thesaurus ObjectClass)
    Item
    Dose modification
    text
    C25488 (NCI Thesaurus ObjectClass)
    C1707811 (UMLS CUI-1)
    C25688 (NCI Thesaurus ValueDomain)
    C25572 (NCI Thesaurus Property)
    CL.4
    Code List
    Dose modification
    CL Item
    No Dose Modification (No dose modification)
    CL Item
    Dose Held (Dose held)
    CL Item
    Dose Delayed (Dose delayed)
    CL Item
    Dose Reduced (Dose reduced)
    C49505 (NCI Thesaurus)
    C1707814 (UMLS 2011AA)
    C49505 (NCI Thesaurus-3)
    C1707814 (UMLS 2011AA-4)
    CL Item
    Dose Delayed And Reduced (Dose delayed and reduced)
    Item
    Dose Modification Reason
    text
    C25638 (NCI Thesaurus ValueDomain)
    C1707811 (UMLS CUI-1)
    C25488 (NCI Thesaurus ObjectClass)
    C0392360 (UMLS CUI-2)
    C25572 (NCI Thesaurus Property)
    CL.5
    Code List
    Dose Modification Reason
    CL Item
    Adverse Event (Adverse event)
    C41331 (NCI Thesaurus)
    C0877248 (UMLS 2011AA)
    CL Item
    Patient Refusal/noncompliance (Patient refusal/noncompliance)
    CL Item
    Scheduling (Scheduling)
    CL Item
    Dosing Error (Dosing error)
    CL Item
    Change In Bsa (Change in BSA)
    Item Group
    Donor Information
    Item
    Donor's Relationship to recipient
    text
    C25168 (NCI Thesaurus ObjectClass)
    C0040288 (UMLS 2011AA ObjectClass)
    C12981 (NCI Thesaurus ObjectClass-2)
    C0332835 (UMLS 2011AA ObjectClass-2)
    C16960 (NCI Thesaurus Property)
    C0030705 (UMLS 2011AA Property)
    CL110661 (NCI Metathesaurus Property)
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    CL.6
    Code List
    Donor's Relationship to recipient
    CL Item
    Sibling (sibling)
    C25204 (NCI Thesaurus)
    C0037047 (UMLS 2011AA)
    CL Item
    Other Family Member (Other family member)
    CL Item
    Not Related (not related)
    C25648 (NCI Thesaurus)
    C0439849 (UMLS 2011AA)
    C25594 (NCI Thesaurus-3)
    C1518422 (UMLS 2011AA-4)
    TransplantDonorBirthDate
    Item
    Donor Birth Date (M D Y if known)
    date
    C25168 (NCI Thesaurus ObjectClass)
    C0040288 (UMLS 2011AA ObjectClass)
    C12981 (NCI Thesaurus ObjectClass-2)
    C0332835 (UMLS 2011AA ObjectClass-2)
    C25155 (NCI Thesaurus Property)
    C0005615 (UMLS 2011AA Property)
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25367 (NCI Thesaurus ValueDomain-2)
    Item
    Donor Gender
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C25168 (NCI Thesaurus ObjectClass)
    C0040288 (UMLS 2011AA ObjectClass)
    C12981 (NCI Thesaurus ObjectClass-2)
    C0332835 (UMLS 2011AA ObjectClass-2)
    C17357 (NCI Thesaurus Property)
    C0079399 (UMLS 2011AA Property)
    CL.7
    Code List
    Donor Gender
    CL Item
    Female (female)
    C16576 (NCI Thesaurus)
    C0086287 (UMLS 2011AA)
    CL Item
    Male (male)
    C20197 (NCI Thesaurus)
    C0086582 (UMLS 2011AA)
    Item
    CMV status (Patient)
    text
    C14196 (NCI Thesaurus Property)
    C0010825 (UMLS 2011AA Property)
    C16295 (NCI Thesaurus ObjectClass)
    C0003241 (UMLS 2011AA ObjectClass)
    C25294 (NCI Thesaurus Property-2)
    C0022885 (UMLS 2011AA Property-2)
    C25688 (NCI Thesaurus ValueDomain)
    C0449438 (UMLS 2011AA ValueDomain)
    CL.16
    Code List
    CMV status (Patient)
    CL Item
    Negative (negative)
    C25247 (NCI Thesaurus)
    C0205160 (UMLS 2011AA)
    CL Item
    Positive (positive)
    C25246 (NCI Thesaurus)
    C1446409 (UMLS 2011AA)
    CL Item
    Unknown (unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    Item
    EBV status
    text
    C14204 (NCI Thesaurus Property)
    C0014644 (UMLS 2011AA Property)
    C16295 (NCI Thesaurus ObjectClass)
    C0003241 (UMLS 2011AA ObjectClass)
    C25294 (NCI Thesaurus Property-2)
    C0022885 (UMLS 2011AA Property-2)
    C25688 (NCI Thesaurus ValueDomain)
    C0449438 (UMLS 2011AA ValueDomain)
    CL.9
    Code List
    EBV status
    CL Item
    Negative (negative)
    C25247 (NCI Thesaurus)
    C0205160 (UMLS 2011AA)
    CL Item
    Positive (positive)
    C25246 (NCI Thesaurus)
    C1446409 (UMLS 2011AA)
    CL Item
    Unknown (unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    Item
    Are patient and donor matched at HLA-A
    text
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C12981 (NCI Thesaurus ObjectClass)
    C0332835 (UMLS 2011AA ObjectClass)
    C28585 (NCI Thesaurus ObjectClass-2)
    C1333899 (UMLS 2011AA ObjectClass-2)
    C40414 (NCI Thesaurus Property)
    C1524057 (UMLS 2011AA Property)
    CL.10
    Code List
    Are patient and donor matched at HLA-A
    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)
    Item
    Are patient and donor matched at HLA-B
    text
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C12981 (NCI Thesaurus ObjectClass)
    C0332835 (UMLS 2011AA ObjectClass)
    C62778 (NCI Thesaurus ObjectClass-2)
    C1415561 (UMLS 2011AA ObjectClass-2)
    C40414 (NCI Thesaurus Property)
    C1524057 (UMLS 2011AA Property)
    CL.11
    Code List
    Are patient and donor matched at HLA-B
    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)
    Item
    Are patient and donor matched at HLA-C
    text
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C12981 (NCI Thesaurus ObjectClass)
    C0332835 (UMLS 2011AA ObjectClass)
    C62758 (NCI Thesaurus ObjectClass-2)
    C1415562 (UMLS 2011AA ObjectClass-2)
    C40414 (NCI Thesaurus Property)
    C1524057 (UMLS 2011AA Property)
    CL.12
    Code List
    Are patient and donor matched at HLA-C
    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)
    Item
    Are patient and donor matched at HLA-DR
    text
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C12981 (NCI Thesaurus ObjectClass)
    C0332835 (UMLS 2011AA ObjectClass)
    C19409 (NCI Thesaurus ObjectClass-2)
    C1415576 (UMLS 2011AA ObjectClass-2)
    C40414 (NCI Thesaurus Property)
    C1524057 (UMLS 2011AA Property)
    CL.13
    Code List
    Are patient and donor matched at HLA-DR
    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)
    Item
    Are patient and donor matched at HLA-DQ
    text
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C12981 (NCI Thesaurus ObjectClass)
    C0332835 (UMLS 2011AA ObjectClass)
    C62792 (NCI Thesaurus ObjectClass-2)
    C0019761 (UMLS 2011AA ObjectClass-2)
    C40414 (NCI Thesaurus Property)
    C1524057 (UMLS 2011AA Property)
    CL.14
    Code List
    Are patient and donor matched at HLA-DQ
    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)
    Item
    Are patient and donor matched at HLA-DP
    text
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C12981 (NCI Thesaurus ObjectClass)
    C0332835 (UMLS 2011AA ObjectClass)
    C71274 (NCI Thesaurus ObjectClass-2)
    C0019759 (UMLS 2011AA ObjectClass-2)
    C40414 (NCI Thesaurus Property)
    C1524057 (UMLS 2011AA Property)
    CL.15
    Code List
    Are patient and donor matched at HLA-DP
    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)
    Item Group
    Allogeneic Transplant
    ProtocolTransplantPerformedInd-3
    Item
    Did the patient receive protocol transplant?
    boolean
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    C38000 (NCI Thesaurus Property)
    C0884358 (UMLS 2011AA Property)
    C12981 (NCI Thesaurus ObjectClass)
    C0332835 (UMLS 2011AA ObjectClass)
    C42651 (NCI Thesaurus ObjectClass-2)
    C0442711 (UMLS 2011AA ObjectClass-2)
    Item
    Source of Stem Cells (If yes)
    text
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    C12981 (NCI Thesaurus ObjectClass)
    C0332835 (UMLS 2011AA ObjectClass)
    C12508 (NCI Thesaurus Property)
    C0007634 (UMLS 2011AA Property)
    C25365 (NCI Thesaurus Property-2)
    C0678257 (UMLS 2011AA Property-2)
    CL.18
    Code List
    Source of Stem Cells (If yes)
    CL Item
    Bone Marrow (bone marrow)
    C12431 (NCI Thesaurus)
    C0005953 (UMLS 2011AA)
    CL Item
    Peripheral Blood (Peripheral Blood)
    C0229664 (NCI Metathesaurus)
    Item
    CMV status (Patient)
    text
    C14196 (NCI Thesaurus Property)
    C0010825 (UMLS 2011AA Property)
    C16295 (NCI Thesaurus ObjectClass)
    C0003241 (UMLS 2011AA ObjectClass)
    C25294 (NCI Thesaurus Property-2)
    C0022885 (UMLS 2011AA Property-2)
    C25688 (NCI Thesaurus ValueDomain)
    C0449438 (UMLS 2011AA ValueDomain)
    CL.16
    Code List
    CMV status (Patient)
    CL Item
    Negative (negative)
    C25247 (NCI Thesaurus)
    C0205160 (UMLS 2011AA)
    CL Item
    Positive (positive)
    C25246 (NCI Thesaurus)
    C1446409 (UMLS 2011AA)
    CL Item
    Unknown (unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    PeripheralBloodStemCellTransplantInfusionDate
    Item
    Date of Peripheral Blood Stem Cell Infusion (M D Y last PBSC If patient completed transplant therapy this date should correspond with the "Last Date Protocol Therapy Was Given" date on the Step 2 Off-Treatment Form)
    date
    C12981 (NCI Thesaurus ObjectClass)
    C0332835 (UMLS 2011AA ObjectClass)
    C12946 (NCI Thesaurus ObjectClass-2)
    C1518999 (UMLS 2011AA ObjectClass-2)
    C15388 (NCI Thesaurus Property)
    C0574032 (UMLS 2011AA Property)
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25367 (NCI Thesaurus ValueDomain-2)
    TransplantCD34+CellInfusionDose
    Item
    Number of CD34-positive cells infused (Total X 10^6 cells per kg of body weight)
    float
    C15388 (NCI Thesaurus Property)
    C0574032 (UMLS 2011AA Property)
    C12981 (NCI Thesaurus ObjectClass)
    C0332835 (UMLS 2011AA ObjectClass)
    C25488 (NCI Thesaurus ValueDomain)
    C0178602 (UMLS 2011AA ValueDomain)
    C0882849 (NCI Metathesaurus Property)
    T-LymphocyteTransplantCD3+CellInfusionDose
    Item
    Number of T cells (CD3) infused (X 10^6 cells per kg of body weight)
    float
    C12981 (NCI Thesaurus ObjectClass)
    C0332835 (UMLS 2011AA ObjectClass)
    C12476 (NCI Thesaurus ObjectClass-2)
    C0039194 (UMLS 2011AA ObjectClass-2)
    C15388 (NCI Thesaurus Property)
    C0574032 (UMLS 2011AA Property)
    C0882828 (NCI Metathesaurus Property)
    C25488 (NCI Thesaurus ValueDomain)
    C0178602 (UMLS 2011AA ValueDomain)
    Item Group
    Comments
    Investigator Signature
    Item
    Investigator Signature
    text
    C25704 (NCI Thesaurus ValueDomain)
    C2346576 (UMLS CUI-1)
    C25678 (NCI Thesaurus Property)
    C17089 (NCI Thesaurus ObjectClass)
    Investigator Signature Date
    Item
    Investigator Signature Date (MM DD YYYY)
    date
    C25164 (NCI Thesaurus ValueDomain)
    C2346576 (UMLS CUI-1)
    C25678 (NCI Thesaurus Property)
    C0011008 (UMLS CUI-2)
    C25367 (NCI Thesaurus ValueDomain-2)
    C17089 (NCI Thesaurus ObjectClass)
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