ID

12749

Description

Randomized study with a run-in dose-selection phase to assess the added value of Lenalidomide in combination with standard remission-induction chemotherapy and post-remission treatment in patients aged 18-65 years with previously untreated acute myeloid leukemia (AML) or high risk myelodysplasia (MDS) (IPSS-R risk score> 4.5) Description of Form: Secondary Primary Malignancy Form With friendly permission of HOVON-Group, Prof. G. Ossenkoppele

Keywords

  1. 11/11/15 11/11/15 -
  2. 12/18/15 12/18/15 -
Uploaded on

December 18, 2015

DOI

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License

Creative Commons BY-NC 3.0

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    Secondary Primary Malignancy Form HOVON 132 AML/SAKK 30/13 EudraCT 2013-002843-26

    Secondary Primary Malignancy Form (Secondary Primary Malignancy Form HOVON 132 AML/SAKK 30/13 EudraCT 2013-002843-26)

    Report Information
    Description

    Report Information

    Alias
    UMLS CUI-1
    C0684224
    Type of report
    Description

    Type of Report Timepoint

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1276413
    UMLS CUI [1,2]
    C2348792
    Date report
    Description

    Date report

    Data type

    date

    Measurement units
    • dd/mm/yyyy
    Alias
    UMLS CUI [1]
    C1302584
    dd/mm/yyyy
    Date of birth
    Description

    Date of birth

    Data type

    date

    Measurement units
    • dd/mm/yyyy
    Alias
    UMLS CUI [1]
    C0421451
    dd/mm/yyyy
    Second Primary Malignancy Information
    Description

    Second Primary Malignancy Information

    Alias
    UMLS CUI-1
    C0751623
    UMLS CUI-2
    C1533716
    Second primary malignancy
    Description

    Second primary malignancy

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0751623
    *Specify
    Description

    Specify

    Data type

    text

    Alias
    UMLS CUI [1]
    C1521902
    Date of diagnosis
    Description

    Date of diagnosis

    Data type

    date

    Measurement units
    • dd/mm/yyyy
    Alias
    UMLS CUI [1,1]
    C2316983
    UMLS CUI [1,2]
    C0751623
    UMLS CUI [2]
    C1302659
    dd/mm/yyyy
    Date clinical diagnosis
    Description

    Date clinical diagnosis

    Data type

    date

    Measurement units
    • dd/mm/yyyy
    Alias
    UMLS CUI [1]
    C2316983
    dd/mm/yyyy
    Diagnosed during study phase
    Description

    Diagnosed during study phase

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1276413
    UMLS CUI [1,2]
    C2348792
    Cycle Number
    Description

    Cycle Number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2045829
    Specify
    Description

    Specify

    Data type

    text

    Alias
    UMLS CUI [1]
    C1521902
    Pathology Result
    Description

    Pathology Result

    Pathology Result (Please send in copy of report if available)
    Description

    Pathology Result

    Data type

    text

    Alias
    UMLS CUI [1]
    C0807321
    Report Information
    Description

    Report Information

    Alias
    UMLS CUI-1
    C0684224
    Type of Report
    Description

    Type of Report Timepoint

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348792
    Date Report
    Description

    Date Report

    Data type

    date

    Measurement units
    • dd/mm/yyyy
    Alias
    UMLS CUI [1]
    C1302584
    dd/mm/yyyy
    Treatment Second Primary Malignancy
    Description

    Treatment Second Primary Malignancy

    Treatment given
    Description

    Treatment given

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0751623
    UMLS CUI [1,2]
    C0949634
    *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]
    C0949634
    UMLS CUI [1,2]
    C0808070
    dd/mm/yyyy
    Response second primary malignancy
    Description

    Response

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1704632
    *Specify
    Description

    Specify

    Data type

    text

    Alias
    UMLS CUI [1]
    C1521902
    Date response achieved
    Description

    Date response

    Data type

    date

    Measurement units
    • dd/mm/yyyy
    Alias
    UMLS CUI [1,1]
    C1704632
    UMLS CUI [1,2]
    C0011008
    dd/mm/yyyy
    Date last contact
    Description

    Date last contact

    Data type

    date

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

    Survival status

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1148433
    External/environmental exposures (Please provide any information about external / environmental exposures that might be risk factors for the reported SPM. If no information is available, fill out as ‘unknown’.)
    Description

    External/environmental exposures (Please provide any information about external / environmental exposures that might be risk factors for the reported SPM. If no information is available, fill out as ‘unknown’.)

    Alias
    UMLS CUI-1
    C0014412
    Tobacco
    Description

    Tobacco

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1519384
    Alcohol
    Description

    Alcohol

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0001948
    Exposure to chemicals
    Description

    Exposure to chemicals

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0220806
    Occupation / hobbies
    Description

    Occupation / hobbies

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0028811
    UMLS CUI [2]
    C0019826
    Sun exposure
    Description

    Sun exposure

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1456711
    Previous chemo or radiation therapy
    Description

    Previous chemo or radiation therapy

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0949634
    Other
    Description

    Other

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0014412
    UMLS CUI [1,2]
    C0205394
    *Specify
    Description

    Specify

    Data type

    text

    Alias
    UMLS CUI [1]
    C1521902
    Report Information
    Description

    Report Information

    Alias
    UMLS CUI-1
    C0684224
    Type of report
    Description

    Type of Report Timepoint

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1276413
    UMLS CUI [1,2]
    C2348792
    Date report
    Description

    Date report

    Data type

    date

    Measurement units
    • dd/mm/yyyy
    Alias
    UMLS CUI [1]
    C1302584
    dd/mm/yyyy
    Relevants Family's History (please provide relevant family’s medical history (such as known genetic mutations for breast cancer, prostate cancer, etc. or family member(s) – such as parents siblings, etc – with the same malignancy). Fill out ‘none’ if there is no relevant family medical history, or fill out ‘unknown’ if information is not available)
    Description

    Relevants Family's History (please provide relevant family’s medical history (such as known genetic mutations for breast cancer, prostate cancer, etc. or family member(s) – such as parents siblings, etc – with the same malignancy). Fill out ‘none’ if there is no relevant family medical history, or fill out ‘unknown’ if information is not available)

    Relevant family's history
    Description

    Relevant familys history

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0241889
    *Specify
    Description

    Specify

    Data type

    text

    Alias
    UMLS CUI [1]
    C1521902
    Comments
    Description

    Comments

    Comments
    Description

    Comments

    Data type

    text

    Alias
    UMLS CUI [1]
    C0947611

    Similar models

    Secondary Primary Malignancy Form (Secondary Primary Malignancy Form HOVON 132 AML/SAKK 30/13 EudraCT 2013-002843-26)

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C0684224 (UMLS CUI-1)
    Item
    Type of report
    integer
    C1276413 (UMLS CUI [1,1])
    C2348792 (UMLS CUI [1,2])
    Code List
    Type of report
    CL Item
    Initial report (1)
    C0684224 (UMLS CUI-1)
    CL Item
    Follow up report (2)
    C1704685 (UMLS CUI-1)
    CL Item
    Final report (3)
    C0460114 (UMLS CUI-1)
    Date report
    Item
    date
    C1302584 (UMLS CUI [1])
    Date of birth
    Item
    date
    C0421451 (UMLS CUI [1])
    Item Group
    C0751623 (UMLS CUI-1)
    C1533716 (UMLS CUI-2)
    Item
    Second primary malignancy
    integer
    C0751623 (UMLS CUI [1])
    Code List
    Second primary malignancy
    CL Item
    acute leukemia* (1)
    C0085669 (UMLS CUI-1)
    CL Item
    MDS* (2)
    C3463824 (UMLS CUI-1)
    CL Item
    lymphoma* (3)
    C0024299 (UMLS CUI-1)
    CL Item
    solid skin tumour* (4)
    C0037286 (UMLS CUI-1)
    CL Item
    solid tumour (excl. skin)* (5)
    C0280100 (UMLS CUI-1)
    CL Item
    other* (8)
    C0205394 (UMLS CUI-1)
    Specify
    Item
    *Specify
    text
    C1521902 (UMLS CUI [1])
    Date of diagnosis
    Item
    Date of diagnosis
    date
    C2316983 (UMLS CUI [1,1])
    C0751623 (UMLS CUI [1,2])
    C1302659 (UMLS CUI [2])
    Date clinical diagnosis
    Item
    date
    C2316983 (UMLS CUI [1])
    Item
    Diagnosed during study phase
    integer
    C1276413 (UMLS CUI [1,1])
    C2348792 (UMLS CUI [1,2])
    Code List
    Diagnosed during study phase
    CL Item
    before start protocol treatment  (0)
    C0040808 (UMLS CUI-1)
    CL Item
    induction cycle I  (1)
    C3179010 (UMLS CUI-1)
    CL Item
    induction cycle II (2)
    C3179010 (UMLS CUI-1)
    CL Item
    post induction cycle III  (3)
    C3179010 (UMLS CUI-1)
    CL Item
    autoHSCT  (4)
    C0194037 (UMLS CUI-1)
    CL Item
    alloHSCT  (5)
    C1705576 (UMLS CUI-1)
    CL Item
    maintenance (1-6)*  (11-16)
    C0481504 (UMLS CUI-1)
    CL Item
    follow up  (17)
    C1522577 (UMLS CUI-1)
    CL Item
    other* (18)
    C0205394 (UMLS CUI-1)
    Cycle Number
    Item
    Cycle Number
    integer
    C2045829 (UMLS CUI [1])
    Specify
    Item
    Specify
    text
    C1521902 (UMLS CUI [1])
    Item Group
    Pathology Result
    Pathology Result
    Item
    Pathology Result (Please send in copy of report if available)
    text
    C0807321 (UMLS CUI [1])
    Item Group
    C0684224 (UMLS CUI-1)
    Item
    Type of Report
    integer
    C2348792 (UMLS CUI [1])
    Code List
    Type of Report
    CL Item
    Initial report (1)
    C0684224 (UMLS CUI-1)
    CL Item
    Follow up report (2)
    C1704685 (UMLS CUI-1)
    CL Item
    Final report (3)
    C0460114 (UMLS CUI-1)
    Date Report
    Item
    Date Report
    date
    C1302584 (UMLS CUI [1])
    Item Group
    Treatment Second Primary Malignancy
    Item
    Treatment given
    integer
    C0751623 (UMLS CUI [1,1])
    C0949634 (UMLS CUI [1,2])
    Code List
    Treatment given
    CL Item
    no  (0)
    C0445106 (UMLS CUI-1)
    CL Item
    chemotherapy only  (1)
    C3665472 (UMLS CUI-1)
    CL Item
    surgery (2)
    C0543467 (UMLS CUI-1)
    CL Item
    radiotherapy  (3)
    C1522449 (UMLS CUI-1)
    CL Item
    monoclonal antibodies  (4)
    C0003250 (UMLS CUI-1)
    CL Item
    combination*  (5)
    C0009429 (UMLS CUI-1)
    CL Item
    other, please specify* (8)
    C0205394 (UMLS CUI-1)
    Specify
    Item
    *Specify
    text
    C1521902 (UMLS CUI [1])
    Date of start treatment
    Item
    Date of start treatment
    date
    C0949634 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    Item
    Response second primary malignancy
    integer
    C1704632 (UMLS CUI [1])
    Code List
    Response second primary malignancy
    CL Item
    CR  (1)
    C0677874 (UMLS CUI-1)
    CL Item
    PR  (2)
    C1521726 (UMLS CUI-1)
    CL Item
    stable disease (3)
    C0677946 (UMLS CUI-1)
    CL Item
    progressive disease (4)
    C1335499 (UMLS CUI-1)
    CL Item
    other, please specify* (8)
    C0205394 (UMLS CUI-1)
    Specify
    Item
    *Specify
    text
    C1521902 (UMLS CUI [1])
    Date response
    Item
    Date response achieved
    date
    C1704632 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Date last contact
    Item
    Date last contact
    date
    C0805839 (UMLS CUI [1])
    Item
    Survival status
    integer
    C1148433 (UMLS CUI [1])
    Code List
    Survival status
    CL Item
    alive  (0)
    C2584946 (UMLS CUI-1)
    CL Item
    dead (1)
    C0011065 (UMLS CUI-1)
    Item Group
    External/environmental exposures (Please provide any information about external / environmental exposures that might be risk factors for the reported SPM. If no information is available, fill out as ‘unknown’.)
    C0014412 (UMLS CUI-1)
    Item
    integer
    C1519384 (UMLS CUI [1])
    Code List
    Tobacco
    CL Item
    no (0)
    C1298908 (UMLS CUI-1)
    CL Item
    yes (1)
    C1705108 (UMLS CUI-1)
    CL Item
    unknown (9)
    C0439673 (UMLS CUI-1)
    Item
    integer
    C0001948 (UMLS CUI [1])
    Code List
    Alcohol
    CL Item
    no (0)
    C1298908 (UMLS CUI-1)
    CL Item
    yes (1)
    C1705108 (UMLS CUI-1)
    CL Item
    unknown (9)
    C0439673 (UMLS CUI-1)
    Item
    integer
    C0220806 (UMLS CUI [1])
    Code List
    Exposure to chemicals
    CL Item
    no (0)
    C1298908 (UMLS CUI-1)
    CL Item
    yes (1)
    C1705108 (UMLS CUI-1)
    CL Item
    unknown (9)
    C0439673 (UMLS CUI-1)
    Item
    integer
    C0028811 (UMLS CUI [1])
    C0019826 (UMLS CUI [2])
    Code List
    Occupation / hobbies
    CL Item
    no (0)
    C1298908 (UMLS CUI-1)
    CL Item
    yes (1)
    C1705108 (UMLS CUI-1)
    CL Item
    unknown (9)
    C0439673 (UMLS CUI-1)
    Item
    integer
    C1456711 (UMLS CUI [1])
    Code List
    Sun exposure
    CL Item
    no (0)
    C1298908 (UMLS CUI-1)
    CL Item
    yes (1)
    C1705108 (UMLS CUI-1)
    CL Item
    unknown (9)
    C0439673 (UMLS CUI-1)
    Item
    Previous chemo or radiation therapy
    integer
    C0949634 (UMLS CUI [1])
    Code List
    Previous chemo or radiation therapy
    CL Item
    no (0)
    C1298908 (UMLS CUI-1)
    CL Item
    yes (1)
    C1705108 (UMLS CUI-1)
    CL Item
    unknown (9)
    C0439673 (UMLS CUI-1)
    Item
    Other
    integer
    C0014412 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    Code List
    Other
    CL Item
    no (0)
    C1298908 (UMLS CUI-1)
    CL Item
    yes (1)
    C1705108 (UMLS CUI-1)
    CL Item
    unknown (9)
    C0439673 (UMLS CUI-1)
    Specify
    Item
    *Specify
    text
    C1521902 (UMLS CUI [1])
    Item Group
    Report Information
    C0684224 (UMLS CUI-1)
    Item
    Type of report
    integer
    C1276413 (UMLS CUI [1,1])
    C2348792 (UMLS CUI [1,2])
    Code List
    Type of report
    CL Item
    Initial report (1)
    C0684224 (UMLS CUI-1)
    CL Item
    Follow up report (2)
    C1704685 (UMLS CUI-1)
    CL Item
    Final report (3)
    C0460114 (UMLS CUI-1)
    Date report
    Item
    date
    C1302584 (UMLS CUI [1])
    Item Group
    Relevants Family's History (please provide relevant family’s medical history (such as known genetic mutations for breast cancer, prostate cancer, etc. or family member(s) – such as parents siblings, etc – with the same malignancy). Fill out ‘none’ if there is no relevant family medical history, or fill out ‘unknown’ if information is not available)
    Item
    Relevant family's history
    integer
    C0241889 (UMLS CUI [1])
    Code List
    Relevant family's history
    CL Item
    no (0)
    C1298908 (UMLS CUI-1)
    CL Item
    yes (1)
    C1705108 (UMLS CUI-1)
    CL Item
    unknown (9)
    C0439673 (UMLS CUI-1)
    Specify
    Item
    *Specify
    text
    C1521902 (UMLS CUI [1])
    Item Group
    Comments
    Item
    text
    C0947611 (UMLS CUI [1])

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