0 Evaluaciones
ID

15181

Descripción

International Collaborative Treatment Protocol For Children And Adolescents With Acute Lymphoblastic Leukemia. Phase 3 Study. Study Protocol IIB (Study Protocol IIB with PEG-L-ASP). Clinical Trial Number: NCT01117441.

Palabras clave

Versiones (1)
  1. 21/5/16 21/5/16 -
Subido en

21 de mayo de 2016

DOI

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Licencia

Creative Commons BY-NC-ND 3.0
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    Protocol IIB-ASP+ AIEOP-BFM ALL 2009 DRKS00003772 NCT01117441

    Inglés

    Protocol IIB-ASP+ 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
    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 E/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 (First dose of PEG-L-ASP in Phase IB: 14 days after last dose in Phase IIA. No delay because of uncomplicated myelosupression or coagulopathy) 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
    Cyclophosphamide administration form p.i. (1h) (+ MESNA)
    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
    ARA-C administration form i.v.
    Descripción

    ARA-C: administration form

    Tipo de datos

    boolean

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

    ARA-C: dosage

    Tipo de datos

    float

    Unidades de medida
    • mg
    Alias
    UMLS CUI [1,1]
    C0010711
    UMLS CUI [1,2]
    C0178602
    mg
    ARA-C Date of administration
    Descripción

    ARA-C: date of administration

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0010711
    UMLS CUI [1,2]
    C2584899
    Thioguanine administration form p.o. (14d)
    Descripción

    TG: administration form

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0039902
    UMLS CUI [1,2]
    C0013153
    Thioguanine dosage 60 mg/mˆ2/d
    Descripción

    TG: dosage

    Tipo de datos

    float

    Unidades de medida
    • mg
    Alias
    UMLS CUI [1,1]
    C0039902
    UMLS CUI [1,2]
    C0178602
    mg
    Thioguanine Start date of therapy
    Descripción

    TG: start date

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0039902
    UMLS CUI [1,2]
    C0808070
    Thioguanine End date of therapy
    Descripción

    TG: end date

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0039902
    UMLS CUI [1,2]
    C0806020
    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
    Descripción

    MTX: date of administration

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0025677
    UMLS CUI [1,2]
    C2584899
    PEG-L-ASP discontinuation
    Descripción

    PEG-L-ASP discontinuation

    Alias
    UMLS CUI-1
    C0071568
    UMLS CUI-2
    C0457454
    Discontinuation of PEG-L-ASP therapy in this element?
    Descripción

    PEG-L-ASP discontinuation

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0071568
    UMLS CUI [1,2]
    C0457454
    If discontinuation of PEG-L-ASP therapy, specify: PEG-L-ASP: date of last administration
    Descripción

    PEG-L-ASP: date of last administration

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0071568
    UMLS CUI [1,2]
    C2584899
    UMLS CUI [1,3]
    C1517741
    If discontinuation of PEG-L-ASP therapy, specify: Reason for discontinuation:
    Descripción

    Reason for discontinuation of PEG-L-ASP therapy

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0071568
    UMLS CUI [1,2]
    C0457454
    UMLS CUI [1,3]
    C0392360
    If discontinuation of PEG-L-ASP therapy, specify: Reason for discontinuation: If other medical or non-medical reason, specify:
    Descripción

    Reason for discontinuation of PEG-L-ASP therapy: specification

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0071568
    UMLS CUI [1,2]
    C0457454
    UMLS CUI [1,3]
    C0392360
    UMLS CUI [1,4]
    C2348235
    Hospitalization
    Descripción

    Hospitalization

    Alias
    UMLS CUI-1
    C0019993
    Number of Nights in Hospital (Day 36 until start of maintenance treatment)
    Descripción

    Hospital nights

    Tipo de datos

    float

    Unidades de medida
    • nights
    Alias
    UMLS CUI [1]
    C0420496
    nights
    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 IIB-ASP+ 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)
    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 E/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 (First dose of PEG-L-ASP in Phase IB: 14 days after last dose in Phase IIA. No delay because of uncomplicated myelosupression or coagulopathy) Date of administration
    date
    C0071568 (UMLS CUI [1,1])
    C2584899 (UMLS CUI [1,2])
    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])
    TG: administration form
    Item
    Thioguanine administration form p.o. (14d)
    boolean
    C0039902 (UMLS CUI [1,1])
    C0013153 (UMLS CUI [1,2])
    TG: dosage
    Item
    Thioguanine dosage 60 mg/mˆ2/d
    float
    C0039902 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    TG: start date
    Item
    Thioguanine Start date of therapy
    date
    C0039902 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    TG: end date
    Item
    Thioguanine End date of therapy
    date
    C0039902 (UMLS CUI [1,1])
    C0806020 (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
    date
    C0025677 (UMLS CUI [1,1])
    C2584899 (UMLS CUI [1,2])
    Item Group
    PEG-L-ASP discontinuation
    C0071568 (UMLS CUI-1)
    C0457454 (UMLS CUI-2)
    PEG-L-ASP discontinuation
    Item
    Discontinuation of PEG-L-ASP therapy in this element?
    boolean
    C0071568 (UMLS CUI [1,1])
    C0457454 (UMLS CUI [1,2])
    PEG-L-ASP: date of last administration
    Item
    If discontinuation of PEG-L-ASP therapy, specify: PEG-L-ASP: date of last administration
    date
    C0071568 (UMLS CUI [1,1])
    C2584899 (UMLS CUI [1,2])
    C1517741 (UMLS CUI [1,3])
    Item
    If discontinuation of PEG-L-ASP therapy, specify: Reason for discontinuation:
    text
    C0071568 (UMLS CUI [1,1])
    C0457454 (UMLS CUI [1,2])
    C0392360 (UMLS CUI [1,3])
    Reason for discontinuation of PEG-L-ASP therapy
    Code List
    If discontinuation of PEG-L-ASP therapy, specify: Reason for discontinuation:
    CL Item
    allergic reaction to PEG-L-ASP (allergic reaction to PEG-L-ASP)
    CL Item
    DVT or SVT (DVT or SVT)
    CL Item
    Pancreatitis (Pancreatitis)
    CL Item
    Insulin-dependent hyperglycaemia (Insulin-dependent hyperglycaemia)
    CL Item
    other medical reason (other medical reason)
    CL Item
    other non-medical reason (other non-medical reason)
    Reason for discontinuation of PEG-L-ASP therapy: specification
    Item
    If discontinuation of PEG-L-ASP therapy, specify: Reason for discontinuation: If other medical or non-medical reason, specify:
    text
    C0071568 (UMLS CUI [1,1])
    C0457454 (UMLS CUI [1,2])
    C0392360 (UMLS CUI [1,3])
    C2348235 (UMLS CUI [1,4])
    Item Group
    Hospitalization
    C0019993 (UMLS CUI-1)
    Hospital nights
    Item
    Number of Nights in Hospital (Day 36 until start of maintenance treatment)
    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])
    Volver a la parte superior de la página 

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