0 Ratings
ID

43301

Description

AML2003 - Standard-Therapy vs Intensified Therapy for Adult Acute Myeloid Leukemia Patients <= 60 Years http://clinicaltrials.gov/show/NCT00180102 Prospektive, randomisierte, multizentrische Therapieoptimierungsstudie - Studienprotokoll AML2003

Link

http://clinicaltrials.gov/show/NCT00180102

Keywords

Versions (3)
  1. 7/30/13 7/30/13 - Martin Dugas
  2. 8/26/15 8/26/15 - Martin Dugas
  3. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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Creative Commons BY 4.0
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    1. Induction Acute Myeloid Leukemia <=60 years (AML2003) NCT00180102

    German English

    1. Induction Acute Myeloid Leukemia <=60 years (AML2003) NCT00180102

    1 forms  
    General information
    Description

    General information

    Alias
    SNOMEDCT_2012_01_31
    106227002
    UMLS CUI-1
    C1508263
    Clinic no.:
    Description

    Klinik-Nr.

    Data type

    integer

    Alias
    UMLS CUI 2011AB
    C0442592
    SNOMEDCT_2012_01_31
    257585005
    UMLS CUI 2011AB
    C0237753
    SNOMEDCT_2012_01_31
    410680006
    LOINC Version 232
    MTHU024869
    Patient No.: 2-
    Description

    Patienten-Nr.

    Data type

    integer

    Alias
    UMLS CUI 2011AB
    C1830427
    LOINC Version 232
    MTHU021361
    Patient initials: (Last name/Forename)
    Description

    Patienten-Initialen

    Data type

    string

    Alias
    UMLS CUI 2011AB
    C0030705
    SNOMEDCT_2012_01_31
    116154003
    UMLS CUI 2011AB
    C1555582
    HL7 V3 2006_05
    IN
    UMLS CUI 2011AB
    C1301584
    SNOMEDCT_2012_01_31
    397678008
    LOINC Version 232
    MTHU020554
    UMLS CUI 2011AB
    C1443235
    SNOMEDCT_2012_01_31
    408677003
    LOINC Version 232
    MTHU020551
    Start date:
    Description

    Beginn

    Data type

    date

    Alias
    UMLS CUI 2011AB
    C0808070
    LOINC Version 232
    MTHU008298
    End date:
    Description

    Ende

    Data type

    date

    Alias
    UMLS CUI 2011AB
    C0806020
    LOINC Version 232
    MTHU008302
    Size
    Description

    Height

    Data type

    float

    Measurement units
    • cm
    Alias
    SNOMEDCT_2012_01_31
    246115007
    LOINC Version 232
    MTHU010347
    SNOMEDCT_2012_01_31
    258672001
    UMLS CUI [1]
    C0005890
    cm
    Weight
    Description

    Weight

    Data type

    float

    Measurement units
    • kg
    Alias
    SNOMEDCT_2012_01_31
    272102008
    LOINC Version 232
    MTHU021563
    SNOMEDCT_2012_01_31
    258683005
    UMLS CUI [1]
    C0005910
    kg
    Body Surface Area
    Description

    BSA

    Data type

    float

    Measurement units
    • m²
    Alias
    SNOMEDCT_2012_01_31
    301898006
    MedDRA 14.1
    10050311
    SNOMEDCT_2012_01_31
    278077005
    UMLS CUI [1]
    C0005902
    m²
    Daunorubicin
    Description

    Daunorubicin

    Alias
    UMLS CUI 2011AB
    C0011015
    SNOMEDCT_2012_01_31
    372715008
    Day - actual (scheduled 3-5)
    Description

    Day - actual

    Data type

    string

    Alias
    UMLS CUI 2011AB
    C0439228
    SNOMEDCT_2012_01_31
    258703001
    HL7 V3 2006_05
    D
    UMLS CUI 2011AB
    C0237400
    Daunorubicin daily dose - actual (scheduled 60 mg/sqm intravenous for 2 h)
    Description

    Daily dose - actual

    Data type

    string

    Alias
    UMLS CUI 2011AB
    C2348070
    UMLS CUI 2011AB
    C0237400
    Absolute total dose (mg)
    Description

    Total dose absolute

    Data type

    float

    Measurement units
    • mg
    Alias
    SNOMEDCT_2012_01_31
    56136002
    SNOMEDCT_2012_01_31
    258684004
    UMLS CUI [1]
    C2986497
    mg
    Dose Reduced
    Description

    Dosisreduktion

    Data type

    boolean

    Alias
    UMLS CUI 2011AB
    C1707814
    Ara-C
    Description

    Ara-C

    Alias
    UMLS CUI 2011AB
    C0010711
    SNOMEDCT_2012_01_31
    89265009
    Day - actual (scheduled 1-7)
    Description

    Day - actual

    Data type

    string

    Alias
    UMLS CUI 2011AB
    C0439228
    SNOMEDCT_2012_01_31
    258703001
    HL7 V3 2006_05
    D
    UMLS CUI 2011AB
    C0237400
    Ara-C Daily dose - actual (scheduled 100 mg/sqm intravenous for 24 h)
    Description

    Daily dose - actual

    Data type

    string

    Alias
    UMLS CUI 2011AB
    C2348070
    UMLS CUI 2011AB
    C0237400
    Absolute total dose
    Description

    Total dose absolute

    Data type

    float

    Measurement units
    • mg
    Alias
    SNOMEDCT_2012_01_31
    56136002
    SNOMEDCT_2012_01_31
    258684004
    UMLS CUI [1]
    C2986497
    mg
    Dose Reduced
    Description

    Dosis reduction

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1707814
    G-CSF dose:
    Description

    G-CSF dose:

    Alias
    UMLS CUI 2011AB
    C0079459
    SNOMEDCT_2012_01_31
    80572003
    LOINC Version 232
    MTHU031847
    UMLS CUI 2011AB
    C0178602
    SNOMEDCT_2012_01_31
    260911001
    Start date:
    Description

    begin

    Data type

    date

    Alias
    UMLS CUI 2011AB
    C0808070
    LOINC Version 232
    MTHU008298
    End date:
    Description

    end

    Data type

    date

    Alias
    UMLS CUI 2011AB
    C0806020
    LOINC Version 232
    MTHU008302
    Proprietary Name:
    Description

    Proprietary Name

    Data type

    string

    Alias
    UMLS CUI 2011AB
    C0592503
    Total Dose
    Description

    Total dose

    Data type

    float

    Measurement units
    • µg
    Alias
    SNOMEDCT_2012_01_31
    258685003
    UMLS CUI [1]
    C2986497
    µg
    Cytopenia duration:
    Description

    Cytopenia duration:

    Alias
    SNOMEDCT_2012_01_31
    50820005
    MedDRA 14.1
    10066274
    SNOMEDCT_2012_01_31
    103335007
    LOINC Version 232
    MTHU001938
    UMLS CUI-1
    C0010828
    UMLS CUI-2
    C0449238
    Start date leucocytes <1,0 GPt/l or <1000 /ul:
    Description

    start leukopenia

    Data type

    date

    Alias
    UMLS CUI 2011AB
    C0808070
    LOINC Version 232
    MTHU008298
    UMLS CUI 2011AB
    C0023516
    SNOMEDCT_2012_01_31
    52501007
    MedDRA 14.1
    10047955
    LOINC Version 232
    MTHU001946
    UMLS CUI 2011AB
    C0439243
    SNOMEDCT_2012_01_31
    258774008
    End date (3x leucocytes >1,0 GPt/l or >=1000 /ul):
    Description

    end leukpenia

    Data type

    date

    Alias
    UMLS CUI 2011AB
    C0806020
    LOINC Version 232
    MTHU008302
    UMLS CUI 2011AB
    C0439243
    SNOMEDCT_2012_01_31
    258774008
    Ongoing cytopenia
    Description

    Ongoing cytopenia

    Data type

    boolean

    Alias
    UMLS CUI 2011AB
    C0010828
    SNOMEDCT_2012_01_31
    50820005
    MedDRA 14.1
    10066274
    UMLS CUI 2011AB
    C0549178
    Start date neutrophils <0,5 GPt/l or <500 /ul:
    Description

    start neutropenia

    Data type

    date

    Alias
    UMLS CUI 2011AB
    C0808070
    LOINC Version 232
    MTHU008298
    UMLS CUI 2011AB
    C0439243
    SNOMEDCT_2012_01_31
    258774008
    End date (3x neutrophils >0,5 GPt/l or >=500 /ul):
    Description

    end neutropenia

    Data type

    date

    Alias
    UMLS CUI 2011AB
    C0806020
    LOINC Version 232
    MTHU008302
    UMLS CUI 2011AB
    C0439243
    SNOMEDCT_2012_01_31
    258774008
    Ongoing cytopenia
    Description

    Zytopenie andauernd

    Data type

    boolean

    Alias
    UMLS CUI 2011AB
    C0010828
    SNOMEDCT_2012_01_31
    50820005
    MedDRA 14.1
    10066274
    UMLS CUI 2011AB
    C0549178
    Start date platelets <20 GPt/l or <20000 /ul:
    Description

    start thrombopenia

    Data type

    date

    Alias
    UMLS CUI 2011AB
    C0808070
    LOINC Version 232
    MTHU008298
    UMLS CUI 2011AB
    C0439243
    SNOMEDCT_2012_01_31
    258774008
    End date (3x platelets>20 GPt/l or >=20000 /ul):
    Description

    end thrombopenia

    Data type

    date

    Alias
    UMLS CUI 2011AB
    C0806020
    LOINC Version 232
    MTHU008302
    UMLS CUI 2011AB
    C0439243
    SNOMEDCT_2012_01_31
    258774008
    Ongoing cytopenia
    Description

    Zytopenie andauernd

    Data type

    boolean

    Alias
    UMLS CUI 2011AB
    C0010828
    SNOMEDCT_2012_01_31
    50820005
    MedDRA 14.1
    10066274
    UMLS CUI 2011AB
    C0549178
    Transfusions:
    Description

    Transfusions:

    Alias
    UMLS CUI-1
    C1879316
    Number of erythrocyte transfusions
    Description

    Number of erythrocyte transfusions

    Data type

    integer

    Alias
    UMLS CUI 2011AB
    C0237753
    SNOMEDCT_2012_01_31
    260299005
    LOINC Version 232
    MTHU024869
    ongoing erythrocyte transfusions
    Description

    ongoing erythrocyte transfusions

    Data type

    boolean

    Alias
    UMLS CUI 2011AB
    C0549178
    Number of platelet transfusions (single donors)
    Description

    platelets single donors

    Data type

    integer

    Alias
    UMLS CUI 2011AB
    C0237753
    SNOMEDCT_2012_01_31
    260299005
    LOINC Version 232
    MTHU024869
    ongoing thrombocyte transfusions
    Description

    ongoing thrombocyte transfusions

    Data type

    boolean

    Alias
    UMLS CUI 2011AB
    C0549178
    Number of platelet transfusions (pooled donors)
    Description

    platelets pooled

    Data type

    integer

    Alias
    UMLS CUI 2011AB
    C0237753
    SNOMEDCT_2012_01_31
    260299005
    LOINC Version 232
    MTHU024869
    ongoing thrombocyte transfusions
    Description

    ongoing thrombocyte transfusions

    Data type

    boolean

    Alias
    UMLS CUI 2011AB
    C0549178
    Signature
    Description

    Signature

    Alias
    UMLS CUI-1
    C1519316
    Date
    Description

    Datum

    Data type

    date

    Alias
    UMLS CUI 2011AB
    C0011008
    SNOMEDCT_2012_01_31
    410671006
    LOINC Version 232
    MTHU021546
    Name of study physician/Signature
    Description

    Name des Studienarztes/Unterschrift

    Data type

    string

    Alias
    UMLS CUI 2011AB
    C0027365
    LOINC Version 232
    MTHU008539
    UMLS CUI 2011AB
    C0008976
    SNOMEDCT_2012_01_31
    110465008
    UMLS CUI 2011AB
    C0031831
    SNOMEDCT_2012_01_31
    309343006
    LOINC Version 232
    MTHU010489
    HL7 V3 2006_05
    PHYS
    UMLS CUI 2011AB
    C1519316
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    Similar models

    1. Induction Acute Myeloid Leukemia <=60 years (AML2003) NCT00180102

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    General information
    106227002 (SNOMEDCT_2012_01_31)
    C1508263 (UMLS CUI-1)
    Klinik-Nr.
    Item
    Clinic no.:
    integer
    C0442592 (UMLS CUI 2011AB)
    257585005 (SNOMEDCT_2012_01_31)
    C0237753 (UMLS CUI 2011AB)
    410680006 (SNOMEDCT_2012_01_31)
    MTHU024869 (LOINC Version 232)
    Patienten-Nr.
    Item
    Patient No.: 2-
    integer
    C1830427 (UMLS CUI 2011AB)
    MTHU021361 (LOINC Version 232)
    Patienten-Initialen
    Item
    Patient initials: (Last name/Forename)
    string
    C0030705 (UMLS CUI 2011AB)
    116154003 (SNOMEDCT_2012_01_31)
    C1555582 (UMLS CUI 2011AB)
    IN (HL7 V3 2006_05)
    C1301584 (UMLS CUI 2011AB)
    397678008 (SNOMEDCT_2012_01_31)
    MTHU020554 (LOINC Version 232)
    C1443235 (UMLS CUI 2011AB)
    408677003 (SNOMEDCT_2012_01_31)
    MTHU020551 (LOINC Version 232)
    Beginn
    Item
    Start date:
    date
    C0808070 (UMLS CUI 2011AB)
    MTHU008298 (LOINC Version 232)
    Ende
    Item
    End date:
    date
    C0806020 (UMLS CUI 2011AB)
    MTHU008302 (LOINC Version 232)
    Height
    Item
    Size
    float
    246115007 (SNOMEDCT_2012_01_31)
    MTHU010347 (LOINC Version 232)
    258672001 (SNOMEDCT_2012_01_31)
    C0005890 (UMLS CUI [1])
    Weight
    Item
    Weight
    float
    272102008 (SNOMEDCT_2012_01_31)
    MTHU021563 (LOINC Version 232)
    258683005 (SNOMEDCT_2012_01_31)
    C0005910 (UMLS CUI [1])
    BSA
    Item
    Body Surface Area
    float
    301898006 (SNOMEDCT_2012_01_31)
    10050311 (MedDRA 14.1)
    278077005 (SNOMEDCT_2012_01_31)
    C0005902 (UMLS CUI [1])
    Item Group
    Daunorubicin
    C0011015 (UMLS CUI 2011AB)
    372715008 (SNOMEDCT_2012_01_31)
    Day - actual
    Item
    Day - actual (scheduled 3-5)
    string
    C0439228 (UMLS CUI 2011AB)
    258703001 (SNOMEDCT_2012_01_31)
    D (HL7 V3 2006_05)
    C0237400 (UMLS CUI 2011AB)
    Daily dose - actual
    Item
    Daunorubicin daily dose - actual (scheduled 60 mg/sqm intravenous for 2 h)
    string
    C2348070 (UMLS CUI 2011AB)
    C0237400 (UMLS CUI 2011AB)
    Total dose absolute
    Item
    Absolute total dose (mg)
    float
    56136002 (SNOMEDCT_2012_01_31)
    258684004 (SNOMEDCT_2012_01_31)
    C2986497 (UMLS CUI [1])
    Dosisreduktion
    Item
    Dose Reduced
    boolean
    C1707814 (UMLS CUI 2011AB)
    Item Group
    Ara-C
    C0010711 (UMLS CUI 2011AB)
    89265009 (SNOMEDCT_2012_01_31)
    Day - actual
    Item
    Day - actual (scheduled 1-7)
    string
    C0439228 (UMLS CUI 2011AB)
    258703001 (SNOMEDCT_2012_01_31)
    D (HL7 V3 2006_05)
    C0237400 (UMLS CUI 2011AB)
    Daily dose - actual
    Item
    Ara-C Daily dose - actual (scheduled 100 mg/sqm intravenous for 24 h)
    string
    C2348070 (UMLS CUI 2011AB)
    C0237400 (UMLS CUI 2011AB)
    Total dose absolute
    Item
    Absolute total dose
    float
    56136002 (SNOMEDCT_2012_01_31)
    258684004 (SNOMEDCT_2012_01_31)
    C2986497 (UMLS CUI [1])
    Dosis reduction
    Item
    Dose Reduced
    boolean
    C1707814 (UMLS CUI [1])
    Item Group
    G-CSF dose:
    C0079459 (UMLS CUI 2011AB)
    80572003 (SNOMEDCT_2012_01_31)
    MTHU031847 (LOINC Version 232)
    C0178602 (UMLS CUI 2011AB)
    260911001 (SNOMEDCT_2012_01_31)
    begin
    Item
    Start date:
    date
    C0808070 (UMLS CUI 2011AB)
    MTHU008298 (LOINC Version 232)
    end
    Item
    End date:
    date
    C0806020 (UMLS CUI 2011AB)
    MTHU008302 (LOINC Version 232)
    Proprietary Name
    Item
    Proprietary Name:
    string
    C0592503 (UMLS CUI 2011AB)
    Total dose
    Item
    Total Dose
    float
    258685003 (SNOMEDCT_2012_01_31)
    C2986497 (UMLS CUI [1])
    Item Group
    Cytopenia duration:
    50820005 (SNOMEDCT_2012_01_31)
    10066274 (MedDRA 14.1)
    103335007 (SNOMEDCT_2012_01_31)
    MTHU001938 (LOINC Version 232)
    C0010828 (UMLS CUI-1)
    C0449238 (UMLS CUI-2)
    start leukopenia
    Item
    Start date leucocytes <1,0 GPt/l or <1000 /ul:
    date
    C0808070 (UMLS CUI 2011AB)
    MTHU008298 (LOINC Version 232)
    C0023516 (UMLS CUI 2011AB)
    52501007 (SNOMEDCT_2012_01_31)
    10047955 (MedDRA 14.1)
    MTHU001946 (LOINC Version 232)
    C0439243 (UMLS CUI 2011AB)
    258774008 (SNOMEDCT_2012_01_31)
    end leukpenia
    Item
    End date (3x leucocytes >1,0 GPt/l or >=1000 /ul):
    date
    C0806020 (UMLS CUI 2011AB)
    MTHU008302 (LOINC Version 232)
    C0439243 (UMLS CUI 2011AB)
    258774008 (SNOMEDCT_2012_01_31)
    Ongoing cytopenia
    Item
    Ongoing cytopenia
    boolean
    C0010828 (UMLS CUI 2011AB)
    50820005 (SNOMEDCT_2012_01_31)
    10066274 (MedDRA 14.1)
    C0549178 (UMLS CUI 2011AB)
    start neutropenia
    Item
    Start date neutrophils <0,5 GPt/l or <500 /ul:
    date
    C0808070 (UMLS CUI 2011AB)
    MTHU008298 (LOINC Version 232)
    C0439243 (UMLS CUI 2011AB)
    258774008 (SNOMEDCT_2012_01_31)
    end neutropenia
    Item
    End date (3x neutrophils >0,5 GPt/l or >=500 /ul):
    date
    C0806020 (UMLS CUI 2011AB)
    MTHU008302 (LOINC Version 232)
    C0439243 (UMLS CUI 2011AB)
    258774008 (SNOMEDCT_2012_01_31)
    Zytopenie andauernd
    Item
    Ongoing cytopenia
    boolean
    C0010828 (UMLS CUI 2011AB)
    50820005 (SNOMEDCT_2012_01_31)
    10066274 (MedDRA 14.1)
    C0549178 (UMLS CUI 2011AB)
    start thrombopenia
    Item
    Start date platelets <20 GPt/l or <20000 /ul:
    date
    C0808070 (UMLS CUI 2011AB)
    MTHU008298 (LOINC Version 232)
    C0439243 (UMLS CUI 2011AB)
    258774008 (SNOMEDCT_2012_01_31)
    end thrombopenia
    Item
    End date (3x platelets>20 GPt/l or >=20000 /ul):
    date
    C0806020 (UMLS CUI 2011AB)
    MTHU008302 (LOINC Version 232)
    C0439243 (UMLS CUI 2011AB)
    258774008 (SNOMEDCT_2012_01_31)
    Zytopenie andauernd
    Item
    Ongoing cytopenia
    boolean
    C0010828 (UMLS CUI 2011AB)
    50820005 (SNOMEDCT_2012_01_31)
    10066274 (MedDRA 14.1)
    C0549178 (UMLS CUI 2011AB)
    Item Group
    Transfusions:
    C1879316 (UMLS CUI-1)
    Number of erythrocyte transfusions
    Item
    Number of erythrocyte transfusions
    integer
    C0237753 (UMLS CUI 2011AB)
    260299005 (SNOMEDCT_2012_01_31)
    MTHU024869 (LOINC Version 232)
    ongoing erythrocyte transfusions
    Item
    ongoing erythrocyte transfusions
    boolean
    C0549178 (UMLS CUI 2011AB)
    platelets single donors
    Item
    Number of platelet transfusions (single donors)
    integer
    C0237753 (UMLS CUI 2011AB)
    260299005 (SNOMEDCT_2012_01_31)
    MTHU024869 (LOINC Version 232)
    ongoing thrombocyte transfusions
    Item
    ongoing thrombocyte transfusions
    boolean
    C0549178 (UMLS CUI 2011AB)
    platelets pooled
    Item
    Number of platelet transfusions (pooled donors)
    integer
    C0237753 (UMLS CUI 2011AB)
    260299005 (SNOMEDCT_2012_01_31)
    MTHU024869 (LOINC Version 232)
    ongoing thrombocyte transfusions
    Item
    ongoing thrombocyte transfusions
    boolean
    C0549178 (UMLS CUI 2011AB)
    Item Group
    Signature
    C1519316 (UMLS CUI-1)
    Datum
    Item
    Date
    date
    C0011008 (UMLS CUI 2011AB)
    410671006 (SNOMEDCT_2012_01_31)
    MTHU021546 (LOINC Version 232)
    Name des Studienarztes/Unterschrift
    Item
    Name of study physician/Signature
    string
    C0027365 (UMLS CUI 2011AB)
    MTHU008539 (LOINC Version 232)
    C0008976 (UMLS CUI 2011AB)
    110465008 (SNOMEDCT_2012_01_31)
    C0031831 (UMLS CUI 2011AB)
    309343006 (SNOMEDCT_2012_01_31)
    MTHU010489 (LOINC Version 232)
    PHYS (HL7 V3 2006_05)
    C1519316 (UMLS CUI 2011AB)
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