0 Évaluations
ID

15179

Description

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

Mots-clés

Versions (1)
  1. 21/05/2016 21/05/2016 -
Téléchargé le

21 mai 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC-ND 3.0
Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Retour au modèle Commentaires
Groupe Item commentaires pour :

Item commentaires pour :

  • Plus récent
  • Plus ancien
  • Favori
  • Plus récent
    • Plus récent
    • Plus ancien
    • Favori

    Aucun commentaire

    Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

    Protocol IB-ASP+ AIEOP-BFM ALL 2009 DRKS00003772 NCT01117441

    Anglais

    Protocol IB-ASP+ AIEOP-BFM ALL 2009 NCT01117441

    1 Formulaires  
    Patient Information
    Description

    Patient Information

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

    Patient ID

    Type de données

    text

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

    Patient birthday

    Type de données

    date

    Alias
    UMLS CUI [1]
    C0421451
    Body weight
    Description

    Weight

    Type de données

    float

    Unités de mesure
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Body height
    Description

    Height

    Type de données

    float

    Unités de mesure
    • cm
    Alias
    UMLS CUI [1]
    C0005890
    cm
    Body surface
    Description

    Body surface

    Type de données

    float

    Unités de mesure
    • mˆ2
    Alias
    UMLS CUI [1]
    C0005902
    mˆ2
    Chemotherapy Regimen
    Description

    Chemotherapy Regimen

    Alias
    UMLS CUI-1
    C0392920
    Dexamethasone administration form
    Description

    Dexamethasone: administration form

    Type de données

    text

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

    Dexamethasone: dosage

    Type de données

    float

    Unités de mesure
    • mg
    Alias
    UMLS CUI [1,1]
    C0011777
    UMLS CUI [1,2]
    C0178602
    mg
    Dexamethasone Date of administration
    Description

    Dexamethasone: date of administration

    Type de données

    date

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

    VCR: administration form

    Type de données

    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

    Type de données

    float

    Unités de mesure
    • mg
    Alias
    UMLS CUI [1,1]
    C0042679
    UMLS CUI [1,2]
    C0178602
    mg
    VCR Date of administration
    Description

    VCR: date of administration

    Type de données

    date

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

    DOX: administration form

    Type de données

    boolean

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

    DOX: dosage

    Type de données

    float

    Unités de mesure
    • mg
    Alias
    UMLS CUI [1,1]
    C0013089
    UMLS CUI [1,2]
    C0178602
    mg
    Doxorubicin Date of administration
    Description

    DOX: date of administration

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C0013089
    UMLS CUI [1,2]
    C2584899
    MTX administration form i.th
    Description

    MTX: administration form

    Type de données

    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

    Type de données

    float

    Unités de mesure
    • 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

    Type de données

    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

    Type de données

    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)
    Description

    PEG-L-ASP: administration form

    Type de données

    boolean

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

    PEG-L-ASP: dosage

    Type de données

    float

    Unités de mesure
    • E
    Alias
    UMLS CUI [1,1]
    C0071568
    UMLS CUI [1,2]
    C0178602
    E
    PEG-L-ASP (Next PEG-L-ASP dose: 14 days after dose of day 22)) Date of administration
    Description

    PEG-L-ASP: date of administration

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C0071568
    UMLS CUI [1,2]
    C2584899
    PEG-L-ASP discontinuation
    Description

    PEG-L-ASP discontinuation

    Alias
    UMLS CUI-1
    C0071568
    UMLS CUI-2
    C0457454
    Discontinuation of PEG-L-ASP therapy in Protocol IIA-ASP+?
    Description

    PEG-L-ASP discontinuation

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0071568
    UMLS CUI [1,2]
    C0457454
    If discontinuation of PEG-L-ASP therapy, specify: Reason for discontinuation:
    Description

    Reason for discontinuation of PEG-L-ASP therapy

    Type de données

    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:
    Description

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

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0071568
    UMLS CUI [1,2]
    C0457454
    UMLS CUI [1,3]
    C0392360
    UMLS CUI [1,4]
    C2348235
    If discontinuation of PEG-L-ASP therapy, specify: PEG-L-ASP: date of last administration
    Description

    PEG-L-ASP: date of last administration

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0071568
    UMLS CUI [1,2]
    C2584899
    UMLS CUI [1,3]
    C1517741
    Change to Erwinase?
    Description

    Change to Erwinase

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0580105
    UMLS CUI [1,2]
    C0591457
    If change to Erwinase, specify: Erwinase: date of first administration
    Description

    Erwinase: date of first administration

    Type de données

    date

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

    Erwinase: date of last administration

    Type de données

    date

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

    Numbers of Erwinase doses

    Type de données

    float

    Alias
    UMLS CUI [1,1]
    C0591457
    UMLS CUI [1,2]
    C0237753
    If change to Erwinase, specify: Erwinase dose
    Description

    Erwinase dose

    Type de données

    float

    Unités de mesure
    • E
    Alias
    UMLS CUI [1,1]
    C0591457
    UMLS CUI [1,2]
    C3174092
    E
    Hospitalization
    Description

    Hospitalization

    Alias
    UMLS CUI-1
    C0019993
    Number of Nights in Hospital (Day 1 until start of Protocol IIB-ASP+)
    Description

    Hospital nights

    Type de données

    float

    Unités de mesure
    • 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

    Type de données

    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

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0392920
    UMLS CUI [1,2]
    C1533734
    UMLS CUI [2]
    C1519316
    Retour au début de la page

    Similar models

    Protocol IB-ASP+ AIEOP-BFM ALL 2009 NCT01117441

    1 Formulaires
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    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)
    Dexamethasone: administration form
    Item
    Dexamethasone administration form
    text
    C0011777 (UMLS CUI [1,1])
    C0013153 (UMLS CUI [1,2])
    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])
    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])
    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 (Next PEG-L-ASP dose: 14 days after dose of day 22)) Date of administration
    date
    C0071568 (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 Protocol IIA-ASP+?
    boolean
    C0071568 (UMLS CUI [1,1])
    C0457454 (UMLS CUI [1,2])
    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
    If discontinuation of PEG-L-ASP therapy, specify: PEG-L-ASP: date of last administration
    text
    C0071568 (UMLS CUI [1,1])
    C2584899 (UMLS CUI [1,2])
    C1517741 (UMLS CUI [1,3])
    PEG-L-ASP: date of last administration
    Code List
    If discontinuation of PEG-L-ASP therapy, specify: PEG-L-ASP: date of last administration
    CL Item
    Protocol Day 8 (Protocol Day 8)
    CL Item
    Protocol Day 22 (Protocol Day 22)
    Change to Erwinase
    Item
    Change to Erwinase?
    boolean
    C0580105 (UMLS CUI [1,1])
    C0591457 (UMLS CUI [1,2])
    Erwinase: date of first administration
    Item
    If change to Erwinase, 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 change to Erwinase, 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 change to Erwinase, specify: Numbers of Erwinase doses
    float
    C0591457 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Erwinase dose
    Item
    If change to Erwinase, specify: Erwinase dose
    float
    C0591457 (UMLS CUI [1,1])
    C3174092 (UMLS CUI [1,2])
    Item Group
    Hospitalization
    C0019993 (UMLS CUI-1)
    Hospital nights
    Item
    Number of Nights in Hospital (Day 1 until start of Protocol IIB-ASP+)
    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])
    Retour au début de la page 

    Aide

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial