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 1 - Medical History

    12 forms  
    AML First Diagnosis
    Description

    AML First Diagnosis

    Alias
    UMLS CUI-1
    C0023467
    UMLS CUI-2
    C3172269
    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
    Date of first diagnosis
    Description

    Date of first diagnosis

    Data type

    date

    Alias
    UMLS CUI [1]
    C2316983
    Type of Diagnosis
    Description

    Type of Diagnosis

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1550351
    History of malignancy
    Description

    History of malignancy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2735088
    Chemotherapy in anamnesis
    Description

    History of Chemotherapy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0392920
    UMLS CUI [1,2]
    C0262926
    Radiation in anamnesis
    Description

    History of therapeutic radiology procedure

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1522449
    UMLS CUI [1,2]
    C0262926
    FAB Classification: (local) not done or failed
    Description

    FAB Classification (local) not done or failed

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2984084
    FAB Classification (local)
    Description

    FAB Classification (local)

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2984084
    If FAB Classification is M5a or M5b, please mark M5 first.
    Description

    FAB Classification (local)

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2984084
    In case of RAEB-t mark the corresponding WHO subtype group for AML not otherwise specified: (local)
    Description

    WHO subtype group

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1301142
    FAB Classification (central) not done or failed
    Description

    FAB Classification (central) not done or failed

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2984084
    FAB Classification (central)
    Description

    FAB Classification (central)

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2984084
    If FAB Classification is M5a or M5b, please mark M5 first.
    Description

    FAB Classification (central)

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2984084
    In case of RAEB-t mark the corresponding WHO subtype group for AML not otherwise specified: (central)
    Description

    WHO subtype group

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1301142
    Medical History of neoplastic diseases
    Description

    Medical History of neoplastic diseases

    Alias
    UMLS CUI-1
    C2735088
    Which type of malignancy?
    Description

    Type of malignancy

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0006826
    UMLS CUI [1,2]
    C0332307
    year of diagnosis
    Description

    year of diagnosis

    Data type

    partialDate

    Alias
    UMLS CUI [1,1]
    C2316983
    UMLS CUI [1,2]
    C0439234
    Further entry?
    Description

    Further entry?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1705654
    UMLS CUI [1,2]
    C1517331
    Year of chemotherapy
    Description

    Year of chemotherapy

    Data type

    partialDate

    Alias
    UMLS CUI [1,1]
    C0392920
    UMLS CUI [1,2]
    C0439234
    Scheme
    Description

    Chemotherapy regimen

    Data type

    text

    Alias
    UMLS CUI [1]
    C0392920
    Further entry?
    Description

    Further entry?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1705654
    UMLS CUI [1,2]
    C1517331
    Year of radiation
    Description

    Year of therapeutic radiology procedure

    Data type

    partialDate

    Alias
    UMLS CUI [1,1]
    C1522449
    UMLS CUI [1,2]
    C0439234
    Dose
    Description

    Radiation dose

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2919490
    Units used
    Description

    Units used

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1519795
    Molecular Genetics
    Description

    Molecular Genetics

    Alias
    UMLS CUI-1
    C0086345
    Molecular genetics not done or failed
    Description

    Molecular genetics

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0086345
    UMLS CUI [1,2]
    C1272696
    UMLS CUI [2,1]
    C0086345
    UMLS CUI [2,2]
    C0231175
    RUNX1-RUNX1 T1
    Description

    RUNX1-RUNX1 T1

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1851466
    CBF/MYH11
    Description

    CBF/MYH11

    Data type

    integer

    Alias
    UMLS CUI [1]
    C3276534
    Bcr-Abl 1
    Description

    Bcr-Abl 1

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1835417
    NPM1-Mut
    Description

    NPM1-Mut

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2826175
    CEBPA-Mut
    Description

    CEBPA-Mut

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1511473
    FLT3-ITD-Mut
    Description

    FLT3-ITD-Mut

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348499
    FLT3-ITD/wt ratio
    Description

    FLT3-ITD/wt ratio

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C2348499
    UMLS CUI [1,2]
    C0216388
    UMLS CUI [1,3]
    C0456603
    If other, please specify
    Description

    Other

    Data type

    text

    Alias
    UMLS CUI [1]
    C0205394
    Extramedullary Manifestations
    Description

    Extramedullary Manifestations

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1868812
    Extramedullary Manifestations If yes or suspected, location
    Description

    Extramedullary Manifestations

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1868812
    UMLS CUI [1,2]
    C1515974
    Relevant Pre-existing Illnesses and Comorbidities
    Description

    Relevant Pre-existing Illnesses and Comorbidities

    Alias
    UMLS CUI-1
    C0521987
    UMLS CUI-2
    C0009488
    Any relevant pre-existing illnesses and comorbidities?
    Description

    pre-existing illnesses and comorbidities

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0521987
    UMLS CUI [2]
    C0009488
    Pre-existing illnesses and comorbidities
    Description

    Pre-existing illnesses and comorbidities

    Alias
    UMLS CUI-1
    C0521987
    UMLS CUI-2
    C0009488
    Illness
    Description

    Illness

    Data type

    text

    Alias
    UMLS CUI [1]
    C0012634
    Onset (month/year)
    Description

    In case the month of onset is unknown, please fill in 06 (June).

    Data type

    partialDate

    Alias
    UMLS CUI [1]
    C0574845
    Ongoing
    Description

    Ongoing

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0549178
    Severity
    Description

    severity

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1516728
    UMLS CUI [1,2]
    C0457451
    further row
    Description

    further row

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1705654
    UMLS CUI [1,2]
    C1517331
    Examination of Bone Marrow
    Description

    Examination of Bone Marrow

    Alias
    UMLS CUI-1
    C0005957
    Examination of Bone Marrow
    Description

    Examination of Bone Marrow

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0005957
    Date of aspiration or biopsy
    Description

    Bone Marrow biopsy date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0005954
    Percentage of blasts (Local)
    Description

    Percentage of blasts

    Data type

    float

    Measurement units
    • %
    Alias
    UMLS CUI [1]
    C0587348
    %
    Bone Marrow assessment
    Description

    Bone Marrow assessment

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0005957
    Percentage of blasts (central, assessed by cytology)
    Description

    In case the percentage of blasts was assessed by both - cytology and histology,please document only cytology result.

    Data type

    float

    Measurement units
    • %
    Alias
    UMLS CUI [1,1]
    C0587348
    UMLS CUI [1,2]
    C1305671
    %
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    Similar models

    Visit 1 - Medical History

    12 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    AML First Diagnosis
    C0023467 (UMLS CUI-1)
    C3172269 (UMLS CUI-2)
    Randomization number
    Item
    Randomization number
    integer
    C2986235 (UMLS CUI [1])
    Date of first diagnosis
    Item
    Date of first diagnosis
    date
    C2316983 (UMLS CUI [1])
    Item
    Type of Diagnosis
    integer
    C1550351 (UMLS CUI [1])
    Type of Diagnosis
    Code List
    Type of Diagnosis
    CL Item
    De novo (1)
    C1515568 (UMLS CUI-1)
    C0023467 (UMLS CUI-2)
    (Comment:en)
    CL Item
    AML after MDS (2)
    C0280449 (UMLS CUI-1)
    C3463824 (UMLS CUI-2)
    (Comment:en)
    CL Item
    AML after MPN-/OMF (3)
    C0280449 (UMLS CUI-1)
    C0027022 (UMLS CUI-2)
    C0948968 (UMLS CUI-3)
    (Comment:en)
    History of malignancy
    Item
    History of malignancy
    boolean
    C2735088 (UMLS CUI [1])
    History of Chemotherapy
    Item
    Chemotherapy in anamnesis
    boolean
    C0392920 (UMLS CUI [1,1])
    C0262926 (UMLS CUI [1,2])
    History of therapeutic radiology procedure
    Item
    Radiation in anamnesis
    boolean
    C1522449 (UMLS CUI [1,1])
    C0262926 (UMLS CUI [1,2])
    FAB Classification (local) not done or failed
    Item
    FAB Classification: (local) not done or failed
    boolean
    C2984084 (UMLS CUI [1])
    Item
    FAB Classification (local)
    integer
    C2984084 (UMLS CUI [1])
    FAB Classification (local)
    Code List
    FAB Classification (local)
    CL Item
    M0 (1)
    CL Item
    M1 (2)
    CL Item
    M2 (3)
    CL Item
    M4 (4)
    CL Item
    M4Eo (5)
    CL Item
    M5 (6)
    CL Item
    M6 (7)
    CL Item
    M7 (8)
    CL Item
    RAEB-t (9)
    Item
    If FAB Classification is M5a or M5b, please mark M5 first.
    integer
    C2984084 (UMLS CUI [1])
    FAB Classification (local)
    Code List
    If FAB Classification is M5a or M5b, please mark M5 first.
    CL Item
    M5a (1)
    CL Item
    M5b (2)
    Item
    In case of RAEB-t mark the corresponding WHO subtype group for AML not otherwise specified: (local)
    integer
    C1301142 (UMLS CUI [1])
    WHO subtype group
    Code List
    In case of RAEB-t mark the corresponding WHO subtype group for AML not otherwise specified: (local)
    CL Item
    AML with minimal differentiation (1)
    CL Item
    AML without maturation (2)
    CL Item
    AML with maturation (3)
    CL Item
    AML myelomonocytic leukemia (4)
    CL Item
    AML monocytic leukemia (5)
    CL Item
    AML erythroid leukemia (6)
    CL Item
    AML megakaryoblastic leukemia (7)
    CL Item
    AML basophilic leukemia (8)
    CL Item
    AML panmyelosis with fibrosis (9)
    FAB Classification (central) not done or failed
    Item
    FAB Classification (central) not done or failed
    boolean
    C2984084 (UMLS CUI [1])
    Item
    FAB Classification (central)
    integer
    C2984084 (UMLS CUI [1])
    FAB Classification (local)
    Code List
    FAB Classification (central)
    CL Item
    M0 (1)
    CL Item
    M1 (2)
    CL Item
    M2 (3)
    CL Item
    M4 (4)
    CL Item
    M4Eo (5)
    CL Item
    M5 (6)
    CL Item
    M6 (7)
    CL Item
    M7 (8)
    CL Item
    RAEB-t (9)
    Item
    If FAB Classification is M5a or M5b, please mark M5 first.
    integer
    C2984084 (UMLS CUI [1])
    FAB Classification (local)
    Code List
    If FAB Classification is M5a or M5b, please mark M5 first.
    CL Item
    M5a (1)
    CL Item
    M5b (2)
    Item
    In case of RAEB-t mark the corresponding WHO subtype group for AML not otherwise specified: (central)
    integer
    C1301142 (UMLS CUI [1])
    WHO subtype group
    Code List
    In case of RAEB-t mark the corresponding WHO subtype group for AML not otherwise specified: (central)
    CL Item
    AML with minimal differentiation (1)
    CL Item
    AML without maturation (2)
    CL Item
    AML with maturation (3)
    CL Item
    AML myelomonocytic leukemia (4)
    CL Item
    AML monocytic leukemia (5)
    CL Item
    AML erythroid leukemia (6)
    CL Item
    AML megakaryoblastic leukemia (7)
    CL Item
    AML basophilic leukemia (8)
    CL Item
    AML panmyelosis with fibrosis (9)
    Item Group
    Medical History of neoplastic diseases
    C2735088 (UMLS CUI-1)
    Type of malignancy
    Item
    Which type of malignancy?
    text
    C0006826 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    year of diagnosis
    Item
    year of diagnosis
    partialDate
    C2316983 (UMLS CUI [1,1])
    C0439234 (UMLS CUI [1,2])
    Further entry?
    Item
    Further entry?
    boolean
    C1705654 (UMLS CUI [1,1])
    C1517331 (UMLS CUI [1,2])
    Year of chemotherapy
    Item
    Year of chemotherapy
    partialDate
    C0392920 (UMLS CUI [1,1])
    C0439234 (UMLS CUI [1,2])
    Chemotherapy regimen
    Item
    Scheme
    text
    C0392920 (UMLS CUI [1])
    Further entry?
    Item
    Further entry?
    boolean
    C1705654 (UMLS CUI [1,1])
    C1517331 (UMLS CUI [1,2])
    Year of therapeutic radiology procedure
    Item
    Year of radiation
    partialDate
    C1522449 (UMLS CUI [1,1])
    C0439234 (UMLS CUI [1,2])
    Radiation dose
    Item
    Dose
    integer
    C2919490 (UMLS CUI [1])
    Item
    Units used
    integer
    C1519795 (UMLS CUI [1])
    Units used
    Code List
    Units used
    CL Item
    Gy (1)
    CL Item
    GBq (2)
    Item Group
    Molecular Genetics
    C0086345 (UMLS CUI-1)
    Molecular genetics
    Item
    Molecular genetics not done or failed
    boolean
    C0086345 (UMLS CUI [1,1])
    C1272696 (UMLS CUI [1,2])
    C0086345 (UMLS CUI [2,1])
    C0231175 (UMLS CUI [2,2])
    Item
    RUNX1-RUNX1 T1
    integer
    C1851466 (UMLS CUI [1])
    RUNX1-RUNX1 T1
    Code List
    RUNX1-RUNX1 T1
    CL Item
    Yes (1)
    CL Item
    No (2)
    CL Item
    Not done/failed (3)
    Item
    CBF/MYH11
    integer
    C3276534 (UMLS CUI [1])
    RUNX1-RUNX1 T1
    Code List
    CBF/MYH11
    CL Item
    Yes (1)
    CL Item
    No (2)
    CL Item
    Not done/failed (3)
    Item
    Bcr-Abl 1
    integer
    C1835417 (UMLS CUI [1])
    RUNX1-RUNX1 T1
    Code List
    Bcr-Abl 1
    CL Item
    Yes (1)
    CL Item
    No (2)
    CL Item
    Not done/failed (3)
    Item
    NPM1-Mut
    integer
    C2826175 (UMLS CUI [1])
    RUNX1-RUNX1 T1
    Code List
    NPM1-Mut
    CL Item
    Yes (1)
    CL Item
    No (2)
    CL Item
    Not done/failed (3)
    Item
    CEBPA-Mut
    integer
    C1511473 (UMLS CUI [1])
    RUNX1-RUNX1 T1
    Code List
    CEBPA-Mut
    CL Item
    Yes (1)
    CL Item
    No (2)
    CL Item
    Not done/failed (3)
    Item
    FLT3-ITD-Mut
    integer
    C2348499 (UMLS CUI [1])
    RUNX1-RUNX1 T1
    Code List
    FLT3-ITD-Mut
    CL Item
    Yes (1)
    CL Item
    No (2)
    CL Item
    Not done/failed (3)
    Item
    FLT3-ITD/wt ratio
    integer
    C2348499 (UMLS CUI [1,1])
    C0216388 (UMLS CUI [1,2])
    C0456603 (UMLS CUI [1,3])
    RUNX1-RUNX1 T1
    Code List
    FLT3-ITD/wt ratio
    CL Item
    Yes (1)
    CL Item
    No (2)
    CL Item
    Not done/failed (3)
    Other
    Item
    If other, please specify
    text
    C0205394 (UMLS CUI [1])
    Item
    Extramedullary Manifestations
    integer
    C1868812 (UMLS CUI [1])
    Extramedullary Manifestations
    Code List
    Extramedullary Manifestations
    CL Item
    Not done (1)
    CL Item
    No signs (2)
    CL Item
    Yes, histologically proven (3)
    CL Item
    Suspected (4)
    Extramedullary Manifestations
    Item
    Extramedullary Manifestations If yes or suspected, location
    text
    C1868812 (UMLS CUI [1,1])
    C1515974 (UMLS CUI [1,2])
    Item Group
    Relevant Pre-existing Illnesses and Comorbidities
    C0521987 (UMLS CUI-1)
    C0009488 (UMLS CUI-2)
    pre-existing illnesses and comorbidities
    Item
    Any relevant pre-existing illnesses and comorbidities?
    boolean
    C0521987 (UMLS CUI [1])
    C0009488 (UMLS CUI [2])
    Item Group
    Pre-existing illnesses and comorbidities
    C0521987 (UMLS CUI-1)
    C0009488 (UMLS CUI-2)
    Illness
    Item
    Illness
    text
    C0012634 (UMLS CUI [1])
    Date of onset
    Item
    Onset (month/year)
    partialDate
    C0574845 (UMLS CUI [1])
    Ongoing
    Item
    Ongoing
    boolean
    C0549178 (UMLS CUI [1])
    Item
    Severity
    integer
    C1516728 (UMLS CUI [1,1])
    C0457451 (UMLS CUI [1,2])
    severity
    Code List
    Severity
    CL Item
    CTCAE grade 1(mild) (1)
    CL Item
    CTCAE grade 2(moderate) (2)
    CL Item
    CTCAE grade 3(severe) (3)
    CL Item
    CTCAE grade 4(life threatening or disabeling) (4)
    CL Item
    not assessable (0)
    further row
    Item
    further row
    boolean
    C1705654 (UMLS CUI [1,1])
    C1517331 (UMLS CUI [1,2])
    Item Group
    Examination of Bone Marrow
    C0005957 (UMLS CUI-1)
    Item
    Examination of Bone Marrow
    integer
    C0005957 (UMLS CUI [1])
    Examination of Bone Marrow
    Code List
    Examination of Bone Marrow
    CL Item
    Done (1)
    CL Item
    Not done, sufficient amount of blasts in peripheral blood (2)
    Bone Marrow biopsy date
    Item
    Date of aspiration or biopsy
    date
    C0011008 (UMLS CUI [1,1])
    C0005954 (UMLS CUI [1,2])
    Percentage of blasts
    Item
    Percentage of blasts (Local)
    float
    C0587348 (UMLS CUI [1])
    Item
    Bone Marrow assessment
    integer
    C0005957 (UMLS CUI [1])
    Bone Marrow assessment
    Code List
    Bone Marrow assessment
    CL Item
    assessed by cytology (1)
    CL Item
    assessed by histology (2)
    Percentage of blasts
    Item
    Percentage of blasts (central, assessed by cytology)
    float
    C0587348 (UMLS CUI [1,1])
    C1305671 (UMLS CUI [1,2])
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