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ID

12351

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: Hematological Evaluation Form

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Versions (3)
  1. 11/10/15 11/10/15 -
  2. 12/23/15 12/23/15 -
  3. 2/11/16 2/11/16 -
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November 10, 2015

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    Hematological Evaluation Form HOVON 132 AML/SAKK 30/13 EudraCT 2013-002843-26

    English

    Hematological Evaluation Form

    1 forms  
    Form Relation
    Description

    Form Relation

    Form related to
    Description

    Form related to

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1302181
    Supportive Care
    Description

    Supportive Care

    Alias
    UMLS CUI-1
    C0344211
    Number of platelet transfusions
    Description

    Number of platelet transfusions

    Data type

    float

    Alias
    UMLS CUI [1,1]
    C0086818
    UMLS CUI [1,2]
    C0750480
    Date last platelet transfusion
    Description

    Date last platelet transfusion

    Data type

    date

    Measurement units
    • dd/mm/yyyy
    Alias
    UMLS CUI [1,1]
    C0086818
    UMLS CUI [1,2]
    C0011008
    dd/mm/yyyy
    Number of RBC transfusions
    Description

    Red Blood Cell Transfusion

    Data type

    float

    Alias
    UMLS CUI [1,1]
    C0086252
    UMLS CUI [1,2]
    C0750480
    Date of last RBC transfusion
    Description

    Date of last RBC transfusion

    Data type

    date

    Measurement units
    • dd/mm/yyyy
    Alias
    UMLS CUI [1,1]
    C0014772
    UMLS CUI [1,2]
    C0011008
    dd/mm/yyyy
    Hematological Evaluations
    Description

    Hematological Evaluations

    Alias
    UMLS CUI-1
    C0018941
    UMLS CUI-2
    C0220825
    Hematological Evaluation at 1=Start of treatment 2=First evaluation ANC < 0.5 x 109/L 3=First evaluation ANC ≥ 0,5 x 109/L 4=First evaluation ANC ≥ 1,0 x 109/L 5=If not ≥ 1,0 x 109/L, last ANC before next treatment 6=If not ≥ 1,0 x 109/L, last ANC before end of protocol 7=First evaluation platelets < 50 x 109/L 8=First evaluation platelets ≥ 50 x 109/L 9=First evaluation platelets ≥ 100 x 109/L 10=If not ≥ 100 x 109/L, last platelets before next treatment 11=If not ≥ 100 x 109/L, last platelets before end of protocol
    Description

    Evaluation to be performed at

    Data type

    float

    Date
    Description

    Date

    Data type

    date

    Measurement units
    • dd/mm/yyyy
    Alias
    UMLS CUI [1]
    C0011008
    dd/mm/yyyy
    Blasts
    Description

    Blasts

    Data type

    float

    Measurement units
    • %
    Alias
    UMLS CUI [1]
    C1982687
    %
    ANC
    Description

    Neutrophil count

    Data type

    float

    Measurement units
    • 10^9/L
    Alias
    UMLS CUI [1]
    C0200633
    10^9/L
    Platelets
    Description

    Platelets

    Data type

    float

    Measurement units
    • x10^9/l
    Alias
    UMLS CUI [1]
    C0005821
    x10^9/l
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    Similar models

    Hematological Evaluation Form

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Item
    integer
    C1302181 (UMLS CUI [1])
    Form related to
    Code List
    Form related to
    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)
    C0687676 (UMLS CUI-1)
    C3179010 (UMLS CUI-2)
    CL Item
    autoHSCT (4)
    C0194037 (UMLS CUI-1)
    CL Item
    alloHSCT (5)
    C1705576 (UMLS CUI-1)
    CL Item
    observation/maintenance (1-6) (11-16)
    C0481504 (UMLS CUI-1)
    C0700325 (UMLS CUI-3)
    Item Group
    C0344211 (UMLS CUI-1)
    Number of platelet transfusions
    Item
    float
    C0086818 (UMLS CUI [1,1])
    C0750480 (UMLS CUI [1,2])
    Date last platelet transfusion
    Item
    date
    C0086818 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Red Blood Cell Transfusion
    Item
    Number of RBC transfusions
    float
    C0086252 (UMLS CUI [1,1])
    C0750480 (UMLS CUI [1,2])
    Date of last RBC transfusion
    Item
    date
    C0014772 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item Group
    C0018941 (UMLS CUI-1)
    C0220825 (UMLS CUI-2)
    Evaluation to be performed at
    Item
    Hematological Evaluation at 1=Start of treatment 2=First evaluation ANC < 0.5 x 109/L 3=First evaluation ANC ≥ 0,5 x 109/L 4=First evaluation ANC ≥ 1,0 x 109/L 5=If not ≥ 1,0 x 109/L, last ANC before next treatment 6=If not ≥ 1,0 x 109/L, last ANC before end of protocol 7=First evaluation platelets < 50 x 109/L 8=First evaluation platelets ≥ 50 x 109/L 9=First evaluation platelets ≥ 100 x 109/L 10=If not ≥ 100 x 109/L, last platelets before next treatment 11=If not ≥ 100 x 109/L, last platelets before end of protocol
    float
    Date
    Item
    date
    C0011008 (UMLS CUI [1])
    Blasts
    Item
    Blasts
    float
    C1982687 (UMLS CUI [1])
    Neutrophil count
    Item
    ANC
    float
    C0200633 (UMLS CUI [1])
    Platelets
    Item
    Platelets
    float
    C0005821 (UMLS CUI [1])
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