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ID

15177

Description

International Collaborative Treatment Protocol For Children And Adolescents With Acute Lymphoblastic Leukemia. Phase 3 Study. Study Protocol IB. Clinical Trial Number: NCT01117441.

Keywords

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  1. 5/21/16 5/21/16 -
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May 21, 2016

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Creative Commons BY-NC-ND 3.0
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    Protocol IB AIEOP-BFM ALL 2009 DRKS00003772 NCT01117441

    English

    Protocol IB AIEOP-BFM ALL 2009 NCT01117441

    1 forms  
    Patient Information
    Description

    Patient Information

    Alias
    UMLS CUI-1
    C1955348
    Stud.-Nr. (Pat.-ID)
    Description

    Patient ID

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Patient date of birth
    Description

    Patient birthday

    Data type

    date

    Alias
    UMLS CUI [1]
    C0421451
    Body weight
    Description

    Weight

    Data type

    float

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

    Height

    Data type

    float

    Measurement units
    • cm
    Alias
    UMLS CUI [1]
    C0005890
    cm
    Body surface
    Description

    Body surface

    Data type

    float

    Measurement units
    • mˆ2
    Alias
    UMLS CUI [1]
    C0005902
    mˆ2
    Chemotherapy Regimen
    Description

    Chemotherapy Regimen

    Alias
    UMLS CUI-1
    C0392920
    Cyclophosphamide administration form p.i. (1h) (+ MESNA)
    Description

    CPM: administration form

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0010583
    UMLS CUI [1,2]
    C1827465
    Cyclophosphamide 1000 mg/mˆ2/ED
    Description

    CPM: dosage

    Data type

    float

    Measurement units
    • mg
    Alias
    UMLS CUI [1,1]
    C0010583
    UMLS CUI [1,2]
    C0178602
    mg
    Cyclophosphamide Date of administration
    Description

    CPM: date of administration

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0010583
    UMLS CUI [1,2]
    C2584899
    ARA-C administration form i.v.
    Description

    ARA-C: administration form

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0010711
    UMLS CUI [1,2]
    C0013153
    ARA-C dosage 75 mg/mˆ2/ED
    Description

    ARA-C: dosage

    Data type

    float

    Measurement units
    • mg
    Alias
    UMLS CUI [1,1]
    C0010711
    UMLS CUI [1,2]
    C0178602
    mg
    ARA-C Date of administration
    Description

    ARA-C: date of administration

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0010711
    UMLS CUI [1,2]
    C2584899
    6-MP administration form p.o. (28d)
    Description

    6-MP: administration form

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0000618
    UMLS CUI [1,2]
    C0013153
    6-MP dosage 60 mg/mˆ2/d
    Description

    6-MP: dosage

    Data type

    float

    Measurement units
    • mg
    Alias
    UMLS CUI [1,1]
    C0000618
    UMLS CUI [1,2]
    C0178602
    mg
    6-MP Start date of therapy
    Description

    6-MP: start date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0000618
    UMLS CUI [1,2]
    C0808070
    6-MP End date of therapy
    Description

    6-MP: end date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0806020
    MTX administration form i.th
    Description

    MTX: administration form

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0025677
    UMLS CUI [1,2]
    C0677897
    MTX dosage (Age-dependent: 1 - < 2 y/o: 8 mg 2 - < 3y/o: 10 mg >= 3 y/o: 12 mg
    Description

    MTX: dosage

    Data type

    float

    Measurement units
    • mg
    Alias
    UMLS CUI [1,1]
    C0025677
    UMLS CUI [1,2]
    C0178602
    mg
    MTX Date of administration (while MTX infusion)
    Description

    MTX: date of administration

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0025677
    UMLS CUI [1,2]
    C2584899
    Hospitalization
    Description

    Hospitalization

    Alias
    UMLS CUI-1
    C0019993
    If member of randomization group R-HR, specify: Number of Nights in Hospital (Day 36 until start of HR-Block)
    Description

    Hospital nights

    Data type

    float

    Measurement units
    • nights
    Alias
    UMLS CUI [1]
    C0420496
    nights
    Identification and Signature
    Description

    Identification and Signature

    Alias
    UMLS CUI-1
    C0205396
    UMLS CUI-3
    C1519316
    Date and signature of the doctor who calculated and created chemotherapy regimen
    Description

    Chemotherapy creator: signature

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0392920
    UMLS CUI [1,2]
    C1707531
    UMLS CUI [2]
    C1519316
    Date and signature of the person who administered chemotherapy
    Description

    Chemotherapy administration: signature

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0392920
    UMLS CUI [1,2]
    C1533734
    UMLS CUI [2]
    C1519316
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    Similar models

    Protocol IB AIEOP-BFM ALL 2009 NCT01117441

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Patient Information
    C1955348 (UMLS CUI-1)
    Patient ID
    Item
    Stud.-Nr. (Pat.-ID)
    text
    C2348585 (UMLS CUI [1])
    Patient birthday
    Item
    Patient date of birth
    date
    C0421451 (UMLS CUI [1])
    Weight
    Item
    Body weight
    float
    C0005910 (UMLS CUI [1])
    Height
    Item
    Body height
    float
    C0005890 (UMLS CUI [1])
    Body surface
    Item
    Body surface
    float
    C0005902 (UMLS CUI [1])
    Item Group
    Chemotherapy Regimen
    C0392920 (UMLS CUI-1)
    CPM: administration form
    Item
    Cyclophosphamide administration form p.i. (1h) (+ MESNA)
    boolean
    C0010583 (UMLS CUI [1,1])
    C1827465 (UMLS CUI [1,2])
    CPM: dosage
    Item
    Cyclophosphamide 1000 mg/mˆ2/ED
    float
    C0010583 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    CPM: date of administration
    Item
    Cyclophosphamide Date of administration
    date
    C0010583 (UMLS CUI [1,1])
    C2584899 (UMLS CUI [1,2])
    ARA-C: administration form
    Item
    ARA-C administration form i.v.
    boolean
    C0010711 (UMLS CUI [1,1])
    C0013153 (UMLS CUI [1,2])
    ARA-C: dosage
    Item
    ARA-C dosage 75 mg/mˆ2/ED
    float
    C0010711 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    ARA-C: date of administration
    Item
    ARA-C Date of administration
    date
    C0010711 (UMLS CUI [1,1])
    C2584899 (UMLS CUI [1,2])
    6-MP: administration form
    Item
    6-MP administration form p.o. (28d)
    boolean
    C0000618 (UMLS CUI [1,1])
    C0013153 (UMLS CUI [1,2])
    6-MP: dosage
    Item
    6-MP dosage 60 mg/mˆ2/d
    float
    C0000618 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    6-MP: start date
    Item
    6-MP Start date of therapy
    date
    C0000618 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    6-MP: end date
    Item
    6-MP End date of therapy
    date
    C0806020 (UMLS CUI [1])
    MTX: administration form
    Item
    MTX administration form i.th
    boolean
    C0025677 (UMLS CUI [1,1])
    C0677897 (UMLS CUI [1,2])
    MTX: dosage
    Item
    MTX dosage (Age-dependent: 1 - < 2 y/o: 8 mg 2 - < 3y/o: 10 mg >= 3 y/o: 12 mg
    float
    C0025677 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    MTX: date of administration
    Item
    MTX Date of administration (while MTX infusion)
    date
    C0025677 (UMLS CUI [1,1])
    C2584899 (UMLS CUI [1,2])
    Item Group
    Hospitalization
    C0019993 (UMLS CUI-1)
    Hospital nights
    Item
    If member of randomization group R-HR, specify: Number of Nights in Hospital (Day 36 until start of HR-Block)
    float
    C0420496 (UMLS CUI [1])
    Item Group
    Identification and Signature
    C0205396 (UMLS CUI-1)
    C1519316 (UMLS CUI-3)
    Chemotherapy creator: signature
    Item
    Date and signature of the doctor who calculated and created chemotherapy regimen
    text
    C0392920 (UMLS CUI [1,1])
    C1707531 (UMLS CUI [1,2])
    C1519316 (UMLS CUI [2])
    Chemotherapy administration: signature
    Item
    Date and signature of the person who administered chemotherapy
    text
    C0392920 (UMLS CUI [1,1])
    C1533734 (UMLS CUI [1,2])
    C1519316 (UMLS CUI [2])
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