0 Ratings
ID

42900

Description

Randomized Comparison Between Two Dose Levels of Daunorubicin and Between One Versus Two Cycles of Induction Therapy for Adult Patients With Acute Myeloid Leukemia <=60 Years. See: https://www.clinicaltrials.gov/ct2/show/NCT02140242 Copyright Holder: PD Dr. med. Christoph Röllig, MSc Source:PD Dr. med. Christoph Röllig, MSc Universitätsklinikum Dresden

Link

https://www.clinicaltrials.gov/ct2/show/NCT02140242

Keywords

Versions (2)
  1. 3/7/18 3/7/18 -
  2. 9/17/21 9/17/21 -
Copyright Holder

Technische Universität Dresden,Dr. Röllig

Uploaded on

September 17, 2021

DOI

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License

Creative Commons BY-NC 3.0
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    26496_Daunorubicin Acute Myeloid Leukemia NCT02140242

    English

    Visit Randomization II

    12 forms  
    Cytogenetics
    Description

    Cytogenetics

    Alias
    UMLS CUI-1
    C0010802
    Randomization number
    Description

    2DAUNO - xxx(local trial center number) - xxx(patient inclusion number) - xx(treatment arm part I)

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C2348585
    UMLS CUI [1,2]
    C0034656
    Cytogenetics analysis
    Description

    Cytogenetics analysis

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0752095
    Total Number of analyzed metaphases
    Description

    Number of analyzed metaphases

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1621812
    UMLS CUI [1,2]
    C0260877
    UMLS CUI [1,3]
    C0449788
    Karyotype
    Description

    Karyotype

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1261273
    UMLS CUI [1,2]
    C0678257
    If karyotype is not normal, which characteristics apply?
    Description

    Karyotype characteristics

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1261273
    UMLS CUI [1,2]
    C0008625
    Have you marked all karyotype characteristics?
    Description

    Complete

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0205197
    UMLS CUI [1,2]
    C1511726
    Chromosome aberrations
    Description

    Chromosome aberrations

    Alias
    UMLS CUI-1
    C0008625
    High risk aberrations
    Description

    High risk aberrations

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0008625
    UMLS CUI [1,2]
    C0684030
    Low risk aberrations
    Description

    Low risk aberrations

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0008625
    UMLS CUI [1,2]
    C3538919
    Other aberrations, please specify
    Description

    Other aberrations

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0008625
    UMLS CUI [1,2]
    C0205394
    Further entry
    Description

    Further entry

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1705654
    UMLS CUI [1,2]
    C1517331
    Randomization II
    Description

    Randomization II

    Alias
    UMLS CUI-1
    C0034656
    Date of Randomization II
    Description

    Randomization Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0034656
    Percentage of blasts:
    Description

    (locally assessed in bone marrow at visit 7) xxx . x

    Data type

    float

    Measurement units
    • %
    Alias
    UMLS CUI [1]
    C1982687
    %
    The patient is allocated to stratum
    Description

    Patient allocation, automatic entry

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1522541
    UMLS CUI [1,2]
    C1706778
    UMLS CUI [1,3]
    C0004374
    The patient is allocated to stratum
    Description

    Patient allocation

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1522541
    UMLS CUI [1,2]
    C1706778
    UMLS CUI [1,3]
    C0175674
    By signing the “Rando II” form the local investigator has confirmed, that the patient can proceed to Randomization II.
    Description

    Study subject participation status confirmed

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2348568
    UMLS CUI [1,2]
    C0750484
    The patient shall now be randomized
    Description

    Randomization

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0034656
    Result NON automatic randomization II
    Description

    Randomization result

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0034656
    UMLS CUI [1,2]
    C1522541
    Randomization II Result
    Description

    Randomization II Result

    Alias
    UMLS CUI-1
    C0034656
    UMLS CUI-2
    C1274040
    Randomization number
    Description

    2DAUNO - xxx(local trial center number) - xxx(patient inclusion number) - xx(treatment arm part I) - x(treatment arm part II)

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C2348585
    UMLS CUI [1,2]
    C0034656
    Assigned Treatment Arm
    Description

    Treatment Arm

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1522541
    Back to the top of the page

    Similar models

    Visit Randomization II

    12 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Cytogenetics
    C0010802 (UMLS CUI-1)
    Randomization number
    Item
    Randomization number
    integer
    C2348585 (UMLS CUI [1,1])
    C0034656 (UMLS CUI [1,2])
    Item
    Cytogenetics analysis
    integer
    C0752095 (UMLS CUI [1])
    Cytogenetics analysis
    Code List
    Cytogenetics analysis
    CL Item
    Not done (1)
    CL Item
    Failed (e.g. technical problems, EDTA conditioned) (2)
    CL Item
    Failure (bad morphology, no proliferation) (3)
    CL Item
    Done (4)
    Number of analyzed metaphases
    Item
    Total Number of analyzed metaphases
    integer
    C1621812 (UMLS CUI [1,1])
    C0260877 (UMLS CUI [1,2])
    C0449788 (UMLS CUI [1,3])
    Item
    Karyotype
    integer
    C1261273 (UMLS CUI [1,1])
    C0678257 (UMLS CUI [1,2])
    Karyotype
    Code List
    Karyotype
    CL Item
    Normal karyotype (1)
    CL Item
    Abnormal karyotype (2)
    Item
    If karyotype is not normal, which characteristics apply?
    integer
    C1261273 (UMLS CUI [1,1])
    C0008625 (UMLS CUI [1,2])
    Karyotype characteristics
    Code List
    If karyotype is not normal, which characteristics apply?
    CL Item
    high risk aberrations (1)
    CL Item
    low risk aberrations (2)
    Complete
    Item
    Have you marked all karyotype characteristics?
    boolean
    C0205197 (UMLS CUI [1,1])
    C1511726 (UMLS CUI [1,2])
    Item Group
    Chromosome aberrations
    C0008625 (UMLS CUI-1)
    Item
    High risk aberrations
    integer
    C0008625 (UMLS CUI [1,1])
    C0684030 (UMLS CUI [1,2])
    High risk aberrations
    Code List
    High risk aberrations
    CL Item
    -5 (1)
    C0439075 (UMLS CUI-1)
    (Comment:en)
    CL Item
    -7 (2)
    C3846158 (UMLS CUI-1)
    (Comment:en)
    CL Item
    abnl(17p) (3)
    C0796349 (UMLS CUI-1)
    (Comment:en)
    CL Item
    del(5q) (4)
    C1521461 (UMLS CUI-1)
    (Comment:en)
    CL Item
    inv(3)(q21q26.2) (5)
    C1515666 (UMLS CUI-1)
    (Comment:en)
    CL Item
    t(3;3)(q21;q26.2) (6)
    C1515764 (UMLS CUI-1)
    (Comment:en)
    CL Item
    t(6;9) (q23;q34) (7)
    C1515781 (UMLS CUI-1)
    (Comment:en)
    CL Item
    t(v;11)(v;q23) (8)
    C1515714 (UMLS CUI-1)
    (Comment:en)
    CL Item
    complex karyotype (≥ 3 aberrations) (9)
    C3273253 (UMLS CUI-1)
    (Comment:en)
    Item
    Low risk aberrations
    integer
    C0008625 (UMLS CUI [1,1])
    C3538919 (UMLS CUI [1,2])
    Low risk aberrations
    Code List
    Low risk aberrations
    CL Item
    inv(16) (1)
    C3897144 (UMLS CUI-1)
    (Comment:en)
    CL Item
    t(8;21) (2)
    C3897139 (UMLS CUI-1)
    (Comment:en)
    CL Item
    t(16;16) (3)
    C4287945 (UMLS CUI-1)
    (Comment:en)
    CL Item
    other aberrations (4)
    C0008625 (UMLS CUI-1)
    C0205394 (UMLS CUI-2)
    (Comment:en)
    Other aberrations
    Item
    Other aberrations, please specify
    text
    C0008625 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    Further entry
    Item
    Further entry
    boolean
    C1705654 (UMLS CUI [1,1])
    C1517331 (UMLS CUI [1,2])
    Item Group
    Randomization II
    C0034656 (UMLS CUI-1)
    Randomization Date
    Item
    Date of Randomization II
    date
    C0011008 (UMLS CUI [1,1])
    C0034656 (UMLS CUI [1,2])
    Bone marrow Blasts
    Item
    Percentage of blasts:
    float
    C1982687 (UMLS CUI [1])
    Item
    The patient is allocated to stratum
    integer
    C1522541 (UMLS CUI [1,1])
    C1706778 (UMLS CUI [1,2])
    C0004374 (UMLS CUI [1,3])
    Patient allocation, automatic entry
    Code List
    The patient is allocated to stratum
    CL Item
    non high risk (1)
    CL Item
    high risk (2)
    Item
    The patient is allocated to stratum
    integer
    C1522541 (UMLS CUI [1,1])
    C1706778 (UMLS CUI [1,2])
    C0175674 (UMLS CUI [1,3])
    Patient allocation, automatic entry
    Code List
    The patient is allocated to stratum
    CL Item
    non high risk (1)
    CL Item
    high risk (2)
    Study subject participation status confirmed
    Item
    By signing the “Rando II” form the local investigator has confirmed, that the patient can proceed to Randomization II.
    boolean
    C2348568 (UMLS CUI [1,1])
    C0750484 (UMLS CUI [1,2])
    Randomization
    Item
    The patient shall now be randomized
    boolean
    C0034656 (UMLS CUI [1])
    Randomization result
    Item
    Result NON automatic randomization II
    integer
    C0034656 (UMLS CUI [1,1])
    C1522541 (UMLS CUI [1,2])
    Item Group
    Randomization II Result
    C0034656 (UMLS CUI-1)
    C1274040 (UMLS CUI-2)
    Randomization number
    Item
    Randomization number
    integer
    C2348585 (UMLS CUI [1,1])
    C0034656 (UMLS CUI [1,2])
    Item
    Assigned Treatment Arm
    integer
    C1522541 (UMLS CUI [1])
    Treatment Arm
    Code List
    Assigned Treatment Arm
    CL Item
    45 mg/m2 Daunorubicin day 3-5 during second induction (1)
    CL Item
    no second induction (2)
    CL Item
    60 mg/m2 Daunorubicin day 3-5 during second induction (3)
    Back to the top of the page 

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