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15178

Description

International Collaborative Treatment Protocol For Children And Adolescents With Acute Lymphoblastic Leukemia. Phase 3 Study. Study Protocol IIA. 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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    Protocol IIA AIEOP-BFM ALL 2009 DRKS00003772 NCT01117441

    English

    Protocol IIA 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
    Dexamethasone administration form
    Description

    Dexamethasone: administration form

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0011777
    UMLS CUI [1,2]
    C0013153
    Dexamethasone dosage 10 mg/mˆ2/d
    Description

    Dexamethasone: dosage

    Data type

    float

    Measurement units
    • mg
    Alias
    UMLS CUI [1,1]
    C0011777
    UMLS CUI [1,2]
    C0178602
    mg
    Dexamethasone Date of administration
    Description

    Dexamethasone: date of administration

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011777
    UMLS CUI [1,2]
    C2584899
    VCR administration form i.v.
    Description

    VCR: administration form

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0042679
    UMLS CUI [1,2]
    C1522726
    VCR dosage 1,5 mg/mˆ2/ED (max. 2 mg/ED)
    Description

    VCR: dosage

    Data type

    float

    Measurement units
    • mg
    Alias
    UMLS CUI [1,1]
    C0042679
    UMLS CUI [1,2]
    C0178602
    mg
    VCR Date of administration
    Description

    VCR: date of administration

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0042679
    UMLS CUI [1,2]
    C2584899
    Doxorubicin administration form p.i. (1h)
    Description

    DOX: administration form

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0013089
    UMLS CUI [1,2]
    C1827465
    Doxorubicin dosage 30 mg/mˆ2/ED
    Description

    DOX: dosage

    Data type

    float

    Measurement units
    • mg
    Alias
    UMLS CUI [1,1]
    C0013089
    UMLS CUI [1,2]
    C0178602
    mg
    Doxorubicin Date of administration
    Description

    DOX: date of administration

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0013089
    UMLS CUI [1,2]
    C2584899
    PEG-L-ASP administration form p.i. (2h)
    Description

    PEG-L-ASP: administration form

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0071568
    UMLS CUI [1,2]
    C1827465
    PEG-L-ASP dosage 2500 mg/mˆ2/ED (ONCASPAR: 3750 E/ED)
    Description

    PEG-L-ASP: dosage

    Data type

    float

    Measurement units
    • E
    Alias
    UMLS CUI [1,1]
    C0071568
    UMLS CUI [1,2]
    C0178602
    E
    PEG-L-ASP Date of administration
    Description

    PEG-L-ASP: date of administration

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0071568
    UMLS CUI [1,2]
    C2584899
    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
    If initial CNS status CNS3, MTX dose (i.th., on day 1 and 18): Date of administration
    Description

    MTX and CNS status: date of administration

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0025677
    UMLS CUI [1,2]
    C0449389
    UMLS CUI [1,3]
    C2584899
    PEG-L-ASP/ Erwinase
    Description

    PEG-L-ASP/ Erwinase

    Alias
    UMLS CUI-1
    C0071568
    UMLS CUI-3
    C0591457
    Change from PEG-L-ASP to Erwinase in this element
    Description

    Change from PEG-L-ASP to Erwinase

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0580105
    UMLS CUI [1,2]
    C0071568
    UMLS CUI [1,3]
    C0591457
    If "yes", specify: Erwinase: date of first administration
    Description

    Erwinase: date of first administration

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0591457
    UMLS CUI [1,2]
    C2584899
    UMLS CUI [1,3]
    C0205435
    If "yes", specify: Erwinase: date of last administration
    Description

    Erwinase: date of last administration

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0591457
    UMLS CUI [1,2]
    C2584899
    UMLS CUI [1,3]
    C1517741
    If "yes", specify: Numbers of Erwinase doses
    Description

    Numbers of Erwinase doses

    Data type

    float

    Alias
    UMLS CUI [1,1]
    C0591457
    UMLS CUI [1,2]
    C0237753
    If "yes", specify: Reason for change to erwinase: Hypersensitivity
    Description

    Reason for drug change: Hypersensitivity

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0591457
    UMLS CUI [1,2]
    C0392747
    UMLS CUI [2]
    C0020517
    If "yes", specify: Reason for change to erwinase: Date of allergic reaction
    Description

    Reason for drug change: date of hypersensitivity

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0591457
    UMLS CUI [1,2]
    C0392747
    UMLS CUI [2,1]
    C0020517
    UMLS CUI [2,2]
    C0011008
    If "yes", specify: Reason for change to erwinase: Other reason
    Description

    Reason for drug change: Other reason

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0591457
    UMLS CUI [1,2]
    C0392747
    UMLS CUI [2]
    C3840932
    Hospitalization
    Description

    Hospitalization

    Alias
    UMLS CUI-1
    C0019993
    If member of randomization group R2, specify: Number of Nights in Hospital (Day 1 until start of Protocol IIB)
    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
    Back to the top of the page

    Similar models

    Protocol IIA 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)
    Item
    Dexamethasone administration form
    text
    C0011777 (UMLS CUI [1,1])
    C0013153 (UMLS CUI [1,2])
    Dexamethasone: administration form
    Code List
    Dexamethasone administration form
    CL Item
    p.o (p.o)
    CL Item
    i.v. (i.v.)
    Dexamethasone: dosage
    Item
    Dexamethasone dosage 10 mg/mˆ2/d
    float
    C0011777 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    Dexamethasone: date of administration
    Item
    Dexamethasone Date of administration
    date
    C0011777 (UMLS CUI [1,1])
    C2584899 (UMLS CUI [1,2])
    VCR: administration form
    Item
    VCR administration form i.v.
    boolean
    C0042679 (UMLS CUI [1,1])
    C1522726 (UMLS CUI [1,2])
    VCR: dosage
    Item
    VCR dosage 1,5 mg/mˆ2/ED (max. 2 mg/ED)
    float
    C0042679 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    VCR: date of administration
    Item
    VCR Date of administration
    date
    C0042679 (UMLS CUI [1,1])
    C2584899 (UMLS CUI [1,2])
    DOX: administration form
    Item
    Doxorubicin administration form p.i. (1h)
    boolean
    C0013089 (UMLS CUI [1,1])
    C1827465 (UMLS CUI [1,2])
    DOX: dosage
    Item
    Doxorubicin dosage 30 mg/mˆ2/ED
    float
    C0013089 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    DOX: date of administration
    Item
    Doxorubicin Date of administration
    date
    C0013089 (UMLS CUI [1,1])
    C2584899 (UMLS CUI [1,2])
    PEG-L-ASP: administration form
    Item
    PEG-L-ASP administration form p.i. (2h)
    boolean
    C0071568 (UMLS CUI [1,1])
    C1827465 (UMLS CUI [1,2])
    PEG-L-ASP: dosage
    Item
    PEG-L-ASP dosage 2500 mg/mˆ2/ED (ONCASPAR: 3750 E/ED)
    float
    C0071568 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    PEG-L-ASP: date of administration
    Item
    PEG-L-ASP Date of administration
    date
    C0071568 (UMLS CUI [1,1])
    C2584899 (UMLS CUI [1,2])
    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])
    MTX and CNS status: date of administration
    Item
    If initial CNS status CNS3, MTX dose (i.th., on day 1 and 18): Date of administration
    date
    C0025677 (UMLS CUI [1,1])
    C0449389 (UMLS CUI [1,2])
    C2584899 (UMLS CUI [1,3])
    Item Group
    PEG-L-ASP/ Erwinase
    C0071568 (UMLS CUI-1)
    C0591457 (UMLS CUI-3)
    Change from PEG-L-ASP to Erwinase
    Item
    Change from PEG-L-ASP to Erwinase in this element
    boolean
    C0580105 (UMLS CUI [1,1])
    C0071568 (UMLS CUI [1,2])
    C0591457 (UMLS CUI [1,3])
    Erwinase: date of first administration
    Item
    If "yes", specify: Erwinase: date of first administration
    date
    C0591457 (UMLS CUI [1,1])
    C2584899 (UMLS CUI [1,2])
    C0205435 (UMLS CUI [1,3])
    Erwinase: date of last administration
    Item
    If "yes", specify: Erwinase: date of last administration
    date
    C0591457 (UMLS CUI [1,1])
    C2584899 (UMLS CUI [1,2])
    C1517741 (UMLS CUI [1,3])
    Numbers of Erwinase doses
    Item
    If "yes", specify: Numbers of Erwinase doses
    float
    C0591457 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Reason for drug change: Hypersensitivity
    Item
    If "yes", specify: Reason for change to erwinase: Hypersensitivity
    boolean
    C0591457 (UMLS CUI [1,1])
    C0392747 (UMLS CUI [1,2])
    C0020517 (UMLS CUI [2])
    Reason for drug change: date of hypersensitivity
    Item
    If "yes", specify: Reason for change to erwinase: Date of allergic reaction
    date
    C0591457 (UMLS CUI [1,1])
    C0392747 (UMLS CUI [1,2])
    C0020517 (UMLS CUI [2,1])
    C0011008 (UMLS CUI [2,2])
    Reason for drug change: Other reason
    Item
    If "yes", specify: Reason for change to erwinase: Other reason
    text
    C0591457 (UMLS CUI [1,1])
    C0392747 (UMLS CUI [1,2])
    C3840932 (UMLS CUI [2])
    Item Group
    Hospitalization
    C0019993 (UMLS CUI-1)
    Hospital nights
    Item
    If member of randomization group R2, specify: Number of Nights in Hospital (Day 1 until start of Protocol IIB)
    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])
    Back to the top of the page 

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