0 Evaluaciones
ID

15175

Descripción

International Collaborative Treatment Protocol For Children And Adolescents With Acute Lymphoblastic Leukemia. Phase 3 Study. Study Protocol IA-CPM (Study Protocol IA with additional Cyclophosphamid). Clinical Trial Number: NCT01117441.

Palabras clave

Versiones (1)
  1. 21.05.16 21.05.16 -
Subido en

21. Mai 2016

DOI

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Licencia

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

    Inglés

    Protocol IA-CPM AIEOP-BFM ALL 2009 NCT01117441

    1 formularios  
    Patient Information
    Descripción

    Patient Information

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

    Patient ID

    Tipo de datos

    text

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

    Patient birthday

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C0421451
    Body weight
    Descripción

    Weight

    Tipo de datos

    float

    Unidades de medida
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Body height
    Descripción

    Height

    Tipo de datos

    float

    Unidades de medida
    • cm
    Alias
    UMLS CUI [1]
    C0005890
    cm
    Body surface
    Descripción

    Body surface

    Tipo de datos

    float

    Unidades de medida
    • mˆ2
    Alias
    UMLS CUI [1]
    C0005902
    mˆ2
    Chemotherapy Regimen
    Descripción

    Chemotherapy Regimen

    Alias
    UMLS CUI-1
    C0392920
    Prednisone administration form
    Descripción

    Prednisone: administration form

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0032952
    UMLS CUI [1,2]
    C0013153
    Prednisone dosage 60 mg/mˆ2/d
    Descripción

    Prednisone: dosage

    Tipo de datos

    float

    Unidades de medida
    • mg
    Alias
    UMLS CUI [1,1]
    C0032952
    UMLS CUI [1,2]
    C0178602
    mg
    Prednisone Date of administration
    Descripción

    Prednisone: date of administration

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0032952
    UMLS CUI [1,2]
    C2584899
    VCR administration form i.v.
    Descripción

    VCR: administration form

    Tipo de datos

    boolean

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

    VCR: dosage

    Tipo de datos

    float

    Unidades de medida
    • mg
    Alias
    UMLS CUI [1,1]
    C0042679
    UMLS CUI [1,2]
    C0178602
    mg
    VCR Date of administration
    Descripción

    VCR: date of administration

    Tipo de datos

    date

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

    DNR: administration form

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0011015
    UMLS CUI [1,2]
    C1827465
    DNR dosage 30 mg/mˆ2/d
    Descripción

    DNR: dosage

    Tipo de datos

    float

    Unidades de medida
    • mg
    Alias
    UMLS CUI [1,1]
    C0011015
    UMLS CUI [1,2]
    C0178602
    mg
    DNR Date of administration
    Descripción

    DNR: date of administration

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0011015
    UMLS CUI [1,2]
    C2584899
    Cyclophosphamide administration form p.i.
    Descripción

    CPM: administration form

    Tipo de datos

    boolean

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

    CPM: dosage

    Tipo de datos

    float

    Unidades de medida
    • mg
    Alias
    UMLS CUI [1,1]
    C0010583
    UMLS CUI [1,2]
    C0178602
    mg
    Cyclophosphamide Date of administration
    Descripción

    CPM: date of administration

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0010583
    UMLS CUI [1,2]
    C2584899
    MTX administration form i.th
    Descripción

    MTX: administration form

    Tipo de datos

    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
    Descripción

    MTX: dosage

    Tipo de datos

    float

    Unidades de medida
    • mg
    Alias
    UMLS CUI [1,1]
    C0025677
    UMLS CUI [1,2]
    C0178602
    mg
    MTX Date of administration (while MTX infusion)
    Descripción

    MTX: date of administration

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0025677
    UMLS CUI [1,2]
    C2584899
    If CNS status CNS2 or CNS3, extra MTX dose (i.th., on day 19 and 26): Date of administration
    Descripción

    MTX and CNS status: date of administration

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0025677
    UMLS CUI [1,2]
    C0449389
    UMLS CUI [1,3]
    C2584899
    PEG-L-ASP administration form p.i. (2h)
    Descripción

    PEG-L-ASP: administration form

    Tipo de datos

    boolean

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

    PEG-L-ASP: dosage

    Tipo de datos

    float

    Unidades de medida
    • E
    Alias
    UMLS CUI [1,1]
    C0071568
    UMLS CUI [1,2]
    C0178602
    E
    PEG-L-ASP (If Randomisation in Group HR-ASP+, continue PEG-L-ASP therapy 14 days after dose on day 26) Date of administration
    Descripción

    PEG-L-ASP: date of administration

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0071568
    UMLS CUI [1,2]
    C2584899
    PEG-L-ASP/ Erwinase
    Descripción

    PEG-L-ASP/ Erwinase

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

    Change from PEG-L-ASP to Erwinase

    Tipo de datos

    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
    Descripción

    Erwinase: date of first administration

    Tipo de datos

    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
    Descripción

    Erwinase: date of last administration

    Tipo de datos

    date

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

    Numbers of Erwinase doses

    Tipo de datos

    float

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

    Reason for drug change: Hypersensitivity

    Tipo de datos

    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
    Descripción

    Reason for drug change: date of hypersensitivity

    Tipo de datos

    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
    Descripción

    Reason for drug change: Other reason

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0591457
    UMLS CUI [1,2]
    C0392747
    UMLS CUI [2]
    C3840932
    Identification and Signature
    Descripción

    Identification and Signature

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

    Chemotherapy creator: signature

    Tipo de datos

    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
    Descripción

    Chemotherapy administration: signature

    Tipo de datos

    text

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

    Protocol IA-CPM AIEOP-BFM ALL 2009 NCT01117441

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    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
    Prednisone administration form
    text
    C0032952 (UMLS CUI [1,1])
    C0013153 (UMLS CUI [1,2])
    Dexamethasone: administration form
    Code List
    Prednisone administration form
    CL Item
    p.o (p.o)
    CL Item
    i.v. (i.v.)
    Prednisone: dosage
    Item
    Prednisone dosage 60 mg/mˆ2/d
    float
    C0032952 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    Prednisone: date of administration
    Item
    Prednisone Date of administration
    date
    C0032952 (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])
    DNR: administration form
    Item
    DNR administration form p.i. (1h)
    boolean
    C0011015 (UMLS CUI [1,1])
    C1827465 (UMLS CUI [1,2])
    DNR: dosage
    Item
    DNR dosage 30 mg/mˆ2/d
    float
    C0011015 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    DNR: date of administration
    Item
    DNR Date of administration
    date
    C0011015 (UMLS CUI [1,1])
    C2584899 (UMLS CUI [1,2])
    CPM: administration form
    Item
    Cyclophosphamide administration form p.i.
    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])
    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 CNS status CNS2 or CNS3, extra MTX dose (i.th., on day 19 and 26): Date of administration
    date
    C0025677 (UMLS CUI [1,1])
    C0449389 (UMLS CUI [1,2])
    C2584899 (UMLS CUI [1,3])
    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 (If Randomisation in Group HR-ASP+, continue PEG-L-ASP therapy 14 days after dose on day 26) Date of administration
    date
    C0071568 (UMLS CUI [1,1])
    C2584899 (UMLS CUI [1,2])
    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
    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])
    Volver a la parte superior de la página 

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