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ID

12680

Description

Randomized Phase III Study of Intensive Chemotherapy with or without Dasatinib (Sprycel(TM)) in Adult Patients with Newly Diagnosed Core-Binding Factor Acute Myeloid Leukemia (CBF-AML)

Keywords

Versions (5)
  1. 3/5/15 3/5/15 -
  2. 3/9/15 3/9/15 -
  3. 12/9/15 12/9/15 -
  4. 2/11/16 2/11/16 -
  5. 4/13/21 4/13/21 - Dr. rer. medic Philipp Neuhaus
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December 9, 2015

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Creative Commons BY-NC 3.0
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    Maintenance AMLSG 21-13 NCT02013648 Akute myeloische Leukämie (AML)

    English

    Maintenance AMLSG 21-13 NCT02013648 Akute myeloische Leukämie (AML)

    1 forms  
    Maintenance
    Description

    Maintenance

    Alias
    UMLS CUI-1
    C0481504
    Point in time
    Description

    Point in time

    Data type

    integer

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

    Date of evaluation

    Data type

    date

    Alias
    UMLS CUI [1]
    C2985720
    Weight
    Description

    Weight

    Data type

    integer

    Measurement units
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Body surface area
    Description

    Body surface area

    Data type

    integer

    Measurement units
    • sqm
    Alias
    UMLS CUI-1
    C0005902
    sqm
    Body temperature
    Description

    Body temperature

    Data type

    integer

    Measurement units
    • Degree Celcius
    Alias
    UMLS CUI [1]
    C0005903
    Degree Celcius
    Blood pressure
    Description

    Blood pressure

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0005823
    mmHg
    Pulse
    Description

    Pulse

    Data type

    integer

    Measurement units
    • bpm
    Alias
    UMLS CUI [1]
    C0018810
    bpm
    General Condition (WHO / ECOG)
    Description

    General Condition (WHO / ECOG)

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1520224
    Dasatinib intake during last month (since last visit)
    Description

    Dasatinib intake during last month (since last visit)

    Alias
    UMLS CUI-1
    C0013227
    UMLS CUI-2
    C1455147
    Start Date Desatinib intake
    Description

    Start Date Desatinib intake

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0808070
    UMLS CUI [1,2]
    C1455147
    End Date of Dasatinib intake
    Description

    End Date of Dasatinib intake

    Data type

    date

    Alias
    UMLS CUI-1
    C0806020
    UMLS CUI-2
    C1455147
    Daily dose
    Description

    Daily dose

    Data type

    integer

    Alias
    UMLS CUI-1
    C2348070
    Reason for change of dose
    Description

    Reason for change of dose

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1299575
    UMLS CUI [1,2]
    C1272707
    Date of last administration of Desatinib
    Description

    Date of last administration of Desatinib

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0806020
    UMLS CUI [1,2]
    C1455147
    Urinalysis
    Description

    Urinalysis

    Alias
    UMLS CUI-1
    C0042014
    Urinalysis done
    Description

    Urinalysis done

    Data type

    boolean

    Alias
    UMLS CUI-1
    C0042014
    Urinalysis date
    Description

    Urinalysis date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C0011008
    Urine pH
    Description

    Urine pH

    Data type

    integer

    Measurement units
    • pH
    Alias
    UMLS CUI [1]
    C1826989
    pH
    Urine protein
    Description

    Urine protein

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0262923
    Urinalysis glucose
    Description

    Urinalysis glucose

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0004076
    Pregnancy test done? (Female patients of childbearing age only)
    Description

    Pregnancy test date

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032976
    Pregnancy test result
    Description

    Pregnancy test result

    Data type

    integer

    Alias
    UMLS CUI-1
    C0032976
    Adverse Event
    Description

    Adverse Event

    Alias
    UMLS CUI-1
    C0877248
    Did any Adverse Event occur last month?
    Description

    Adverse Event

    Data type

    boolean

    Alias
    UMLS CUI-1
    C0877248
    Concomitant Medication
    Description

    Concomitant Medication

    Alias
    UMLS CUI-1
    C2347852
    Did the Patient take any Concomitant Medication?
    Description

    Concomitant medication

    Data type

    boolean

    Alias
    UMLS CUI-1
    C2347852
    Signature
    Description

    Signature

    Date
    Description

    Date

    Data type

    date

    Alias
    UMLS CUI-1
    C0011008
    Name of Investigator
    Description

    Name of Investigator

    Data type

    text

    Alias
    UMLS CUI-1
    C2826892
    Signature of investigator
    Description

    Signature of investigator

    Data type

    text

    Alias
    UMLS CUI-1
    C2346576
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    Similar models

    Maintenance AMLSG 21-13 NCT02013648 Akute myeloische Leukämie (AML)

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Maintenance
    C0481504 (UMLS CUI-1)
    Item
    Point in time
    integer
    C1276413 (UMLS CUI [1,1])
    C2348792 (UMLS CUI [1,2])
    Point in time
    Code List
    Point in time
    CL Item
    after 1 Month (1)
    C0439231 (UMLS CUI-1)
    C0205447 (UMLS CUI-2)
    CL Item
    after 2 Month (2)
    C0439231 (UMLS CUI-1)
    C0205448 (UMLS CUI-2)
    CL Item
    after 3 Month (3)
    C0439231 (UMLS CUI-1)
    C0205449 (UMLS CUI-2)
    CL Item
    after 4 Month (4)
    C0439231 (UMLS CUI-1)
    C0205450 (UMLS CUI-2)
    CL Item
    after 5 Month (5)
    C0439231 (UMLS CUI-1)
    C0205451 (UMLS CUI-2)
    CL Item
    after 6 Month (6)
    C0439231 (UMLS CUI-1)
    C0205452 (UMLS CUI-2)
    CL Item
    after 7 Month (7)
    C0439231 (UMLS CUI-1)
    C0205453 (UMLS CUI-2)
    CL Item
    after 8 Month (8)
    C0439231 (UMLS CUI-1)
    C0205454 (UMLS CUI-2)
    CL Item
    after 9 Month (9)
    C0439231 (UMLS CUI-1)
    C0205455 (UMLS CUI-2)
    CL Item
    after 10 Month (10)
    C0439231 (UMLS CUI-1)
    C0205456 (UMLS CUI-2)
    CL Item
    after 11 Month (11)
    C0439231 (UMLS CUI-1)
    C0205457 (UMLS CUI-2)
    CL Item
    after 12 Month (12)
    C0439231 (UMLS CUI-1)
    C0205458 (UMLS CUI-2)
    Date of evaluation
    Item
    Date of evaluation
    date
    C2985720 (UMLS CUI [1])
    Weight
    Item
    Weight
    integer
    C0005910 (UMLS CUI [1])
    Body surface area
    Item
    Body surface area
    integer
    C0005902 (UMLS CUI-1)
    Body temperature
    Item
    Body temperature
    integer
    C0005903 (UMLS CUI [1])
    Blood pressure
    Item
    Blood pressure
    integer
    C0005823 (UMLS CUI [1])
    Pulse
    Item
    Pulse
    integer
    C0018810 (UMLS CUI [1])
    General Condition (WHO / ECOG)
    Item
    General Condition (WHO / ECOG)
    integer
    C1520224 (UMLS CUI [1])
    Item Group
    Dasatinib intake during last month (since last visit)
    C0013227 (UMLS CUI-1)
    C1455147 (UMLS CUI-2)
    Start Date Desatinib intake
    Item
    Start Date Desatinib intake
    date
    C0808070 (UMLS CUI [1,1])
    C1455147 (UMLS CUI [1,2])
    End Date of Dasatinib intake
    Item
    End Date of Dasatinib intake
    date
    C0806020 (UMLS CUI-1)
    C1455147 (UMLS CUI-2)
    Daily dose
    Item
    Daily dose
    integer
    C2348070 (UMLS CUI-1)
    Reason for change of dose
    Item
    Reason for change of dose
    text
    C1299575 (UMLS CUI [1,1])
    C1272707 (UMLS CUI [1,2])
    Date of last administration of Desatinib
    Item
    Date of last administration of Desatinib
    date
    C0806020 (UMLS CUI [1,1])
    C1455147 (UMLS CUI [1,2])
    Item Group
    Urinalysis
    C0042014 (UMLS CUI-1)
    Urinalysis done
    Item
    Urinalysis done
    boolean
    C0042014 (UMLS CUI-1)
    Urinalysis date
    Item
    Urinalysis date
    date
    C0042014 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Urine pH
    Item
    Urine pH
    integer
    C1826989 (UMLS CUI [1])
    Item
    Urine protein
    integer
    C0262923 (UMLS CUI [1])
    Urine protein
    Code List
    Urine protein
    CL Item
    normal (0)
    C0427722 (UMLS CUI-1)
    CL Item
    + (1)
    C0427724 (UMLS CUI-1)
    CL Item
    ++ (2)
    C0427725 (UMLS CUI-1)
    CL Item
    +++ (3)
    C0427726 (UMLS CUI-1)
    CL Item
    ++++ (4)
    C0427727 (UMLS CUI-1)
    Item
    Urinalysis glucose
    integer
    C0004076 (UMLS CUI [1])
    Urinalysis glucose
    Code List
    Urinalysis glucose
    CL Item
    normal (0)
    C0427744 (UMLS CUI-1)
    CL Item
    + (1)
    C0427746 (UMLS CUI-1)
    CL Item
    ++ (2)
    C0427747 (UMLS CUI-1)
    CL Item
    +++ (3)
    C0427748 (UMLS CUI-1)
    CL Item
    ++++ (4)
    C0427749 (UMLS CUI-1)
    Pregnancy test date
    Item
    Pregnancy test done? (Female patients of childbearing age only)
    boolean
    C0032976 (UMLS CUI [1])
    Item
    Pregnancy test result
    integer
    C0032976 (UMLS CUI-1)
    Pregnancy test result
    Code List
    Pregnancy test result
    CL Item
    negative (0)
    C0205160 (UMLS CUI-1)
    CL Item
    positive (End of Study) (1)
    C1446409 (UMLS CUI-1)
    Item Group
    Adverse Event
    C0877248 (UMLS CUI-1)
    Adverse Event
    Item
    Did any Adverse Event occur last month?
    boolean
    C0877248 (UMLS CUI-1)
    Item Group
    Concomitant Medication
    C2347852 (UMLS CUI-1)
    Concomitant medication
    Item
    Did the Patient take any Concomitant Medication?
    boolean
    C2347852 (UMLS CUI-1)
    Item Group
    Signature
    Date
    Item
    Date
    date
    C0011008 (UMLS CUI-1)
    Name of Investigator
    Item
    Name of Investigator
    text
    C2826892 (UMLS CUI-1)
    Signature of investigator
    Item
    Signature of investigator
    text
    C2346576 (UMLS CUI-1)
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