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 Registration/Randomization I

    12 forms  
    Randomization I
    Description

    Randomization I

    Alias
    UMLS CUI-1
    C0034656
    Patient inclusion number
    Description

    inclusion number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Treatment arm part I
    Description

    treatment arm

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1522541
    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]
    C2986235
    Registration
    Description

    Registration

    Alias
    UMLS CUI-1
    C1514821
    Local trial center number
    Description

    local trial center number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1301943
    UMLS CUI [1,2]
    C0600091
    Registration date
    Description

    Registration date

    Data type

    date

    Alias
    UMLS CUI [1]
    C2985881
    Registration date confirmed
    Description

    confirm registration date

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2985881
    UMLS CUI [1,2]
    C0750484
    Demographics
    Description

    Demographics

    Alias
    UMLS CUI-1
    C0011298
    Age at study inclusion in years
    Description

    Age

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0001779
    Sex
    Description

    Gender

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0079399
    Inclusion/Exclusion Criteria
    Description

    Inclusion/Exclusion Criteria

    Alias
    UMLS CUI-1
    C1516637
    The patient fulfills all criteria for inclusion and no criterion for exclusion
    Description

    Eligibility criteria

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1516637
    The patient has been informed comprehensively about the clinical trial and has consented to participate on date
    Description

    Informed consent date

    Data type

    date

    Alias
    UMLS CUI [1]
    C2985782
    By signing the “patient registration / Rando I” form the local investigator has confirmed, that the patient can participate in the trial.
    Description

    Study subject participation status confirmed

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2348568
    UMLS CUI [1,2]
    C0750484
    Patient inclusion number
    Description

    inclusion number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585
    The patient shall now be randomized
    Description

    Randomization

    Data type

    boolean

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

    Randomization result

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0034656
    UMLS CUI [1,2]
    C1522541
    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]
    C2986235
    SAL Registry
    Description

    SAL Registry

    Alias
    UMLS CUI-1
    C0034975
    The patient has consented to the documentation of his/ her data in the German or the Czech AML registry.
    Description

    Informed consent registries

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C0034975
    Registry Number
    Description

    Registry Numbers

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0034975
    UMLS CUI [1,2]
    C1300638
    Number in GERMAN SAL-AML Registry
    Description

    Register - SAL - Hospital-Nr. (xxx) - Pat.-Nr. (xxx) - ID (xxxx)

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0023467
    UMLS CUI [1,2]
    C0034975
    UMLS CUI [1,3]
    C1549709
    Number in CZECH CELL-AML Registry
    Description

    D T L - (xxx) - (xxx)

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0023467
    UMLS CUI [1,2]
    C0034975
    UMLS CUI [1,3]
    C1549709
    Back to the top of the page

    Similar models

    Visit Registration/Randomization I

    12 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Randomization I
    C0034656 (UMLS CUI-1)
    inclusion number
    Item
    Patient inclusion number
    integer
    C2348585 (UMLS CUI [1])
    treatment arm
    Item
    Treatment arm part I
    integer
    C1522541 (UMLS CUI [1])
    Randomization number
    Item
    Randomization number
    integer
    C2986235 (UMLS CUI [1])
    Item Group
    Registration
    C1514821 (UMLS CUI-1)
    local trial center number
    Item
    Local trial center number
    integer
    C1301943 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Registration date
    Item
    Registration date
    date
    C2985881 (UMLS CUI [1])
    confirm registration date
    Item
    Registration date confirmed
    boolean
    C2985881 (UMLS CUI [1,1])
    C0750484 (UMLS CUI [1,2])
    Item Group
    Demographics
    C0011298 (UMLS CUI-1)
    Age
    Item
    Age at study inclusion in years
    integer
    C0001779 (UMLS CUI [1])
    Item
    Sex
    integer
    C0079399 (UMLS CUI [1])
    Gender
    Code List
    Sex
    CL Item
    Female (1)
    CL Item
    Male (2)
    Item Group
    Inclusion/Exclusion Criteria
    C1516637 (UMLS CUI-1)
    Eligibility criteria
    Item
    The patient fulfills all criteria for inclusion and no criterion for exclusion
    boolean
    C1516637 (UMLS CUI [1])
    Informed consent date
    Item
    The patient has been informed comprehensively about the clinical trial and has consented to participate on date
    date
    C2985782 (UMLS CUI [1])
    Study subject participation status confirmed
    Item
    By signing the “patient registration / Rando I” form the local investigator has confirmed, that the patient can participate in the trial.
    boolean
    C2348568 (UMLS CUI [1,1])
    C0750484 (UMLS CUI [1,2])
    inclusion number
    Item
    Patient inclusion number
    integer
    C2348585 (UMLS CUI [1])
    Randomization
    Item
    The patient shall now be randomized
    boolean
    C0034656 (UMLS CUI [1])
    Randomization result
    Item
    Result NON automatic randomization I
    integer
    C0034656 (UMLS CUI [1,1])
    C1522541 (UMLS CUI [1,2])
    Randomization number
    Item
    Randomization number
    integer
    C2986235 (UMLS CUI [1])
    Item Group
    SAL Registry
    C0034975 (UMLS CUI-1)
    Item
    The patient has consented to the documentation of his/ her data in the German or the Czech AML registry.
    integer
    C0021430 (UMLS CUI [1,1])
    C0034975 (UMLS CUI [1,2])
    Informed consent registries
    Code List
    The patient has consented to the documentation of his/ her data in the German or the Czech AML registry.
    CL Item
    No or unknown (1)
    CL Item
    Yes. Consent to participate. (2)
    Item
    Registry Number
    integer
    C0034975 (UMLS CUI [1,1])
    C1300638 (UMLS CUI [1,2])
    Registry Numbers
    Code List
    Registry Number
    CL Item
    GERMAN SAL-AML Registry (1)
    CL Item
    CZECH CELL-AML Registry (2)
    Registry Number AML Registry
    Item
    Number in GERMAN SAL-AML Registry
    text
    C0023467 (UMLS CUI [1,1])
    C0034975 (UMLS CUI [1,2])
    C1549709 (UMLS CUI [1,3])
    Registry Number AML Registry
    Item
    Number in CZECH CELL-AML Registry
    text
    C0023467 (UMLS CUI [1,1])
    C0034975 (UMLS CUI [1,2])
    C1549709 (UMLS CUI [1,3])
    Back to the top of the page 

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