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42912

Description

Description of Form: Follow Up Form

Keywords

  1. 11/9/15 11/9/15 -
  2. 12/28/15 12/28/15 -
  3. 9/17/21 9/17/21 -
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September 17, 2021

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Creative Commons BY-NC 3.0

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    Follow Up Form HOVON 132 AML/SAKK 30/13 EudraCT 2013-002843-26

    Follow Up Form

    1. StudyEvent: ODM
      1. Follow Up Form
    Default Itemgroup
    Description

    Default Itemgroup

    Date last known to be alive or death
    Description

    Date last contact

    Data type

    date

    Measurement units
    • dd/mm/yyyy
    Alias
    UMLS CUI [1]
    C0805839
    dd/mm/yyyy
    Patient status
    Description

    Patient status

    Alias
    UMLS CUI-1
    C0449437
    Survival status
    Description

    Survival status

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1148433
    *Cause of death
    Description

    Cause of death

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0007465
    Specify
    Description

    Specify

    Data type

    text

    Alias
    UMLS CUI [1]
    C1521902
    Remission Status
    Description

    Remission Status

    Alias
    UMLS CUI-1
    C0544452
    Remission status
    Description

    Remission status

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0544452
    Date of relapse
    Description

    Date of Relapse

    Data type

    date

    Measurement units
    • dd/mm/yyyy
    Alias
    UMLS CUI [1,1]
    C0035020
    UMLS CUI [1,2]
    C0011008
    dd/mm/yyyy
    Second malignancy (not previously reported)
    Description

    second malignancy

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0006826
    Specify
    Description

    Specify

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1521902
    UMLS CUI [1,2]
    C0006826
    Date of diagnosis
    Description

    NewCancerDiagnosisDate

    Data type

    date

    Measurement units
    • dd/mm/yyyy
    Alias
    UMLS CUI [1,1]
    C0006826
    UMLS CUI [1,2]
    C0011008
    dd/mm/yyyy
    GvHD
    Description

    GvHD

    Alias
    UMLS CUI-1
    C0018133
    Acute GvHD (not previously reported)
    Description

    Acute GvHD

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0856825
    Chronic GvHD (not previously reported)
    Description

    Chronic GvHD

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0867389
    AML/MDS Treatment Given after End of Protocol
    Description

    AML/MDS Treatment Given after End of Protocol

    Treatment given off protocol
    Description

    Treatment off protocol

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C1518546
    Specify
    Description

    Specify

    Data type

    text

    Alias
    UMLS CUI [1]
    C1521902
    Date of start treatment
    Description

    Date of start treatment

    Data type

    date

    Measurement units
    • dd/mm/yyyy
    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C0808070
    dd/mm/yyyy
    Was CR(i) achieved after off protocol treatment
    Description

    Was CR(i) achieved after off protocol treatment

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1704632
    Date CR(i)
    Description

    Date CR

    Data type

    date

    Measurement units
    • dd/mm/yyyy
    Alias
    UMLS CUI [1,1]
    C0677874
    UMLS CUI [1,2]
    C0011008
    dd/mm/yyyy
    Comments
    Description

    Comments

    Comments
    Description

    Comments

    Data type

    text

    Alias
    UMLS CUI [1]
    C0947611
    Fill in this Page in Case of autoHSCT, alloHSCT or DLI (Given after End of Protocol)
    Description

    Fill in this Page in Case of autoHSCT, alloHSCT or DLI (Given after End of Protocol)

    Conditioning Therapy
    Description

    Conditioning Therapy

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0376450
    Specify
    Description

    Specify

    Data type

    text

    Alias
    UMLS CUI [1]
    C1521902
    Date of Transplant
    Description

    Date of Transplant

    Data type

    date

    Measurement units
    • dd/mm/yyyy
    Alias
    UMLS CUI [1,1]
    C0472699
    UMLS CUI [1,2]
    C0011008
    dd/mm/yyyy
    Source of stem cells (actually infused)
    Description

    Source of stem cells

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0449416
    UMLS CUI [1,2]
    C0038250
    Number of nucleated cells infused
    Description

    Number of nucleated cells infused

    Data type

    float

    Measurement units
    • 10^8/kg
    Alias
    UMLS CUI [1,1]
    C1180059
    UMLS CUI [1,2]
    C0750480
    10^8/kg
    Number of CD34+ cells infused
    Description

    Number of CD34+ cells infused

    Data type

    float

    Measurement units
    • 10^6/kg
    Alias
    UMLS CUI [1,1]
    C0882849
    UMLS CUI [1,2]
    C0750480
    10^6/kg
    T-cell depletion
    Description

    T-Cell Depletion

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0677960
    Number of T-cells infused
    Description

    Number of T-cells infused

    Data type

    float

    Measurement units
    • 10^4/kg
    Alias
    UMLS CUI [1,1]
    C0039194
    UMLS CUI [1,2]
    C0750480
    10^4/kg
    Donor
    Description

    Donor

    Alias
    UMLS CUI-1
    C0013018
    Donor sex
    Description

    Donor sex

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0079399
    Donor date of birth
    Description

    Donor date of birth

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0421451
    UMLS CUI [1,2]
    C0013018
    Relation with patient
    Description

    Donor Relation

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0369128
    Comments 2
    Description

    Comments 2

    Comments
    Description

    Comments

    Data type

    text

    Alias
    UMLS CUI [1]
    C0947611

    Similar models

    Follow Up Form

    1. StudyEvent: ODM
      1. Follow Up Form
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Date last contact
    Item
    Date last known to be alive or death
    date
    C0805839 (UMLS CUI [1])
    Item Group
    Patient status
    C0449437 (UMLS CUI-1)
    Item
    Survival status
    integer
    C1148433 (UMLS CUI [1])
    Code List
    Survival status
    CL Item
    alive  (0)
    CL Item
    dead* (1)
    Item
    *Cause of death
    integer
    C0007465 (UMLS CUI [1])
    Code List
    *Cause of death
    CL Item
    leukemia  (1)
    C0023418 (UMLS CUI-1)
    CL Item
    pneumonia  (2)
    C0032285 (UMLS CUI-1)
    CL Item
    other infection  (3)
    C0009450 (UMLS CUI-1)
    CL Item
    hemorrhage (4)
    C0019080 (UMLS CUI-1)
    CL Item
    veno-occlusive disease*  (5)
    C0948441 (UMLS CUI-1)
    CL Item
    other* (8)
    C0205394 (UMLS CUI-1)
    Specify
    Item
    Specify
    text
    C1521902 (UMLS CUI [1])
    Item Group
    Remission Status
    C0544452 (UMLS CUI-1)
    Item
    Remission status
    integer
    C0544452 (UMLS CUI [1])
    Code List
    Remission status
    CL Item
    no CR(i)  (0)
    C3844738 (UMLS CUI-1)
    CL Item
    CR  (1)
    C0677874 (UMLS CUI-1)
    CL Item
    CRi (2)
    C3538993 (UMLS CUI-1)
    Date of Relapse
    Item
    Date of relapse
    date
    C0035020 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Second malignancy (not previously reported)
    integer
    C0006826 (UMLS CUI [1])
    Code List
    Second malignancy (not previously reported)
    CL Item
    no (0)
    CL Item
    yes* (please complete SPM form (22) and SAE form) (1)
    Specify
    Item
    Specify
    text
    C1521902 (UMLS CUI [1,1])
    C0006826 (UMLS CUI [1,2])
    NewCancerDiagnosisDate
    Item
    Date of diagnosis
    date
    C0006826 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item Group
    GvHD
    C0018133 (UMLS CUI-1)
    Item
    Acute GvHD (not previously reported)
    integer
    C0856825 (UMLS CUI [1])
    Code List
    Acute GvHD (not previously reported)
    CL Item
    none  (0)
    CL Item
    Grade I  (1)
    CL Item
    Grade II (2)
    CL Item
    Grade III  (3)
    CL Item
    Grade IV (4)
    CL Item
    not applicable, no alloHSCT (8 )
    Item
    Chronic GvHD (not previously reported)
    integer
    C0867389 (UMLS CUI [1])
    Code List
    Chronic GvHD (not previously reported)
    CL Item
    none (0)
    CL Item
    too early (3)
    CL Item
    limited (1)
    CL Item
    extensive (2)
    CL Item
    not applicable, no alloHSCT (8)
    Item Group
    AML/MDS Treatment Given after End of Protocol
    Item
    Treatment given off protocol
    integer
    C0087111 (UMLS CUI [1,1])
    C1518546 (UMLS CUI [1,2])
    Code List
    Treatment given off protocol
    CL Item
    no (leave boxes 15 to 20 empty)  (0)
    C0445106 (UMLS CUI-1)
    CL Item
    chemotherapy only (1)
    C3665472 (UMLS CUI-1)
    CL Item
    autoHSCT** (2)
    C0194037 (UMLS CUI-1)
    CL Item
    alloHSCT**  (3)
    C1705576 (UMLS CUI-1)
    CL Item
    DLI** (4)
    C1512034 (UMLS CUI-1)
    CL Item
    other* (8)
    C0205394 (UMLS CUI-1)
    Specify
    Item
    Specify
    text
    C1521902 (UMLS CUI [1])
    Date of start treatment
    Item
    Date of start treatment
    date
    C0087111 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    Item
    Was CR(i) achieved after off protocol treatment
    integer
    C1704632 (UMLS CUI [1])
    Code List
    Was CR(i) achieved after off protocol treatment
    CL Item
    no  (0)
    C3844738 (UMLS CUI-1)
    CL Item
    yes, CR*  (1)
    C0677874 (UMLS CUI-1)
    CL Item
    yes, CRi* (2)
    C3538993 (UMLS CUI-1)
    CL Item
    achieved before  (3)
    CL Item
    unknown (9)
    C0439673 (UMLS CUI-1)
    Date CR
    Item
    Date CR(i)
    date
    C0677874 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item Group
    Comments
    Comments
    Item
    Comments
    text
    C0947611 (UMLS CUI [1])
    Item
    Conditioning Therapy
    integer
    C0376450 (UMLS CUI [1])
    Code List
    Conditioning Therapy
    CL Item
    no conditioning  (0)
    C0445106 (UMLS CUI-1)
    CL Item
    non-myelo ablative (1)
    C1831742 (UMLS CUI-1)
    CL Item
    myelo ablative (2)
    C1513784 (UMLS CUI-1)
    CL Item
    other* (8)
    C0205394 (UMLS CUI-1)
    Specify
    Item
    Specify
    text
    C1521902 (UMLS CUI [1])
    Date of Transplant
    Item
    Date of Transplant
    date
    C0472699 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Source of stem cells (actually infused)
    integer
    C0449416 (UMLS CUI [1,1])
    C0038250 (UMLS CUI [1,2])
    Code List
    Source of stem cells (actually infused)
    CL Item
    bone marrow  (1)
    CL Item
    peripheral blood (2)
    CL Item
    BM + PB (3)
    CL Item
    cord blood (4)
    Number of nucleated cells infused
    Item
    Number of nucleated cells infused
    float
    C1180059 (UMLS CUI [1,1])
    C0750480 (UMLS CUI [1,2])
    Number of CD34+ cells infused
    Item
    Number of CD34+ cells infused
    float
    C0882849 (UMLS CUI [1,1])
    C0750480 (UMLS CUI [1,2])
    T-Cell Depletion
    Item
    T-cell depletion
    boolean
    C0677960 (UMLS CUI [1])
    Number of T-cells infused
    Item
    Number of T-cells infused
    float
    C0039194 (UMLS CUI [1,1])
    C0750480 (UMLS CUI [1,2])
    Item Group
    Donor
    C0013018 (UMLS CUI-1)
    Item
    Donor sex
    integer
    C0079399 (UMLS CUI [1])
    Code List
    Donor sex
    CL Item
    male (1)
    C0086582 (UMLS CUI-1)
    CL Item
    female (2)
    C0086287 (UMLS CUI-1)
    Donor date of birth
    Item
    Donor date of birth
    date
    C0421451 (UMLS CUI [1,1])
    C0013018 (UMLS CUI [1,2])
    Item
    Relation with patient
    integer
    C0369128 (UMLS CUI [1])
    Code List
    Relation with patient
    CL Item
    monozygotic twin (1)
    C0041432 (UMLS CUI-1)
    CL Item
    HLA identical sibling (2)
    C0037047 (UMLS CUI-1)
    CL Item
    HLA identical parent (3)
    C0030551 (UMLS CUI-1)
    CL Item
    1-antigen-mismatched related donor (4)
    M (UMLS CUI-1)
    CL Item
    2-or more-antigen mismatched related donor (haplo-identical) (5)
    M (UMLS CUI-1)
    CL Item
    matched unrelated donor# (6)
    M (UMLS CUI-1)
    CL Item
    mismatched unrelated donor## (7)
    M (UMLS CUI-1)
    CL Item
    cord blood unit identified (8)
    C0162371 (UMLS CUI-1)
    CL Item
    unknown (9)
    C0439673 (UMLS CUI-1)
    Item Group
    Comments 2
    Comments
    Item
    Comments
    text
    C0947611 (UMLS CUI [1])

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