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ID

13499

Description

Randomized study with a run-in dose-selection phase to assess the added value of Lenalidomide in combination with standard remission-induction chemotherapy and post-remission treatment in patients aged 18-65 years with previously untreated acute myeloid leukemia (AML) or high risk myelodysplasia (MDS) (IPSS-R risk score> 4.5) Form Description: Dose Limiting Toxicity (DLT) Form

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Versions (3)
  1. 06/11/2015 06/11/2015 -
  2. 01/01/2016 01/01/2016 -
  3. 11/02/2016 11/02/2016 -
Téléchargé le

11 février 2016

DOI

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Creative Commons BY-NC 3.0
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    Dose Limiting Toxicity (DLT) Form HOVON 132 AML/SAKK 30/13 EudraCT 2013-002843-26

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    Dose Limiting Toxicity (DLT) Form

    1 Formulaires  
    Form Relation
    Description

    Form Relation

    Alias
    UMLS CUI-1
    C1276413
    UMLS CUI-2
    C2348792
    DLT form related to induction cycle
    Description

    Form related to

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C1302181
    Date DLT evaluation was done
    Description

    DLT Date

    Type de données

    date

    Unités de mesure
    • dd/mm/yyyy
    Alias
    UMLS CUI [1,1]
    C0013221
    UMLS CUI [1,2]
    C1512043
    UMLS CUI [1,3]
    C0011008
    dd/mm/yyyy
    Treatment
    Description

    Treatment

    Alias
    UMLS CUI-1
    C0087111
    Has Induction cycle been given (either partially or completely)
    Description

    Has Induction cycle been given

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C3179010
    Dose level Lenalidomide (fill out 20 mg, 15 mg, 10 mg)
    Description

    Dose level

    Type de données

    float

    Unités de mesure
    • mg
    Alias
    UMLS CUI [1,1]
    C0178602
    UMLS CUI [1,2]
    C1144149
    mg
    Date start of this induction cycle
    Description

    Induction start date

    Type de données

    date

    Unités de mesure
    • dd/mm/yyyy
    Alias
    UMLS CUI [1,1]
    C3179010
    UMLS CUI [1,2]
    C0808070
    dd/mm/yyyy
    Planned start date next treatment
    Description

    Next start date

    Type de données

    date

    Unités de mesure
    • dd/mm/yyyy
    Alias
    UMLS CUI [1]
    C1115731
    dd/mm/yyyy
    Planned next treatment
    Description

    Planned next treatment

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C3641097
    Date off protocoll
    Description

    Date off protocoll

    Type de données

    date

    Unités de mesure
    • dd/mm/yyyy
    Alias
    UMLS CUI [1,1]
    C2348563
    UMLS CUI [1,2]
    C0011008
    dd/mm/yyyy
    Survival Status
    Description

    Survival Status

    Alias
    UMLS CUI-1
    C1148433
    Date last known to be alive or death
    Description

    Date last contact

    Type de données

    date

    Unités de mesure
    • dd/mm/yyyy
    Alias
    UMLS CUI [1]
    C0805839
    dd/mm/yyyy
    Survival Status
    Description

    Survival Status

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C1148433
    Cause of death
    Description

    Cause of death

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C0007465
    *Specify
    Description

    *Specify

    Type de données

    text

    Alias
    UMLS CUI [1]
    C1521902
    Toxicity
    Description

    Toxicity

    Alias
    UMLS CUI-1
    C0013221
    CTCAE grade ≥ 4 non hematological toxicity
    Description

    CTCAE grade ≥ 4 non hematological toxicity

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0013221
    UMLS CUI [1,2]
    C1516728
    CTCAE grade ≥ 4 non hematological toxicity Date onset
    Description

    CTCAE grade ≥ 4 non hematological toxicity Date onset

    Type de données

    date

    Unités de mesure
    • dd/mm/yyyy
    Alias
    UMLS CUI [1,1]
    C0013221
    UMLS CUI [1,2]
    C1516728
    UMLS CUI [1,3]
    C0011008
    dd/mm/yyyy
    CTCAE grade ≥ 4 non hematological toxicity Specification
    Description

    CTCAE grade ≥ 4 non hematological toxicity Specification

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0013221
    UMLS CUI [1,2]
    C1516728
    UMLS CUI [1,3]
    C1521902
    Recovery
    Description

    Recovery

    Was ANC recovered to > 0.5x109/L
    Description

    ANC Recovery

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C1882078
    Last date ANC was measured
    Description

    Last date ANC

    Type de données

    date

    Unités de mesure
    • dd/mm/yyyy
    Alias
    UMLS CUI [1,1]
    C0948762
    UMLS CUI [1,2]
    C0011008
    dd/mm/yyyy
    First date ANC >0.5 x 109/L
    Description

    First date ANC

    Type de données

    date

    Unités de mesure
    • dd/mm/yyyy
    Alias
    UMLS CUI [1]
    C1882078
    dd/mm/yyyy
    First date ANC >1.0 x 109/L
    Description

    First date ANC greater

    Type de données

    date

    Unités de mesure
    • dd/mm/yyyy
    Alias
    UMLS CUI [1,1]
    C1882078
    UMLS CUI [1,2]
    C0011008
    dd/mm/yyyy
    Platelets recovered to > 50x109/L
    Description

    Platelets recovered

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C1882407
    First date platelets >50 x 109/L
    Description

    First date blood platelets

    Type de données

    date

    Unités de mesure
    • dd/mm/yyyy
    Alias
    UMLS CUI [1,1]
    C1882407
    UMLS CUI [1,2]
    C0011008
    dd/mm/yyyy
    Retour au début de la page

    Similar models

    Dose Limiting Toxicity (DLT) Form

    1 Formulaires
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    Form Relation
    C1276413 (UMLS CUI-1)
    C2348792 (UMLS CUI-2)
    Item
    DLT form related to induction cycle
    integer
    C1302181 (UMLS CUI [1])
    Form related to
    Code List
    DLT form related to induction cycle
    CL Item
    induction cycle I  (1)
    C3179010 (UMLS CUI-1)
    CL Item
    induction cycle II (2)
    C3179010 (UMLS CUI-1)
    DLT Date
    Item
    Date DLT evaluation was done
    date
    C0013221 (UMLS CUI [1,1])
    C1512043 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Item Group
    Treatment
    C0087111 (UMLS CUI-1)
    Has Induction cycle been given
    Item
    Has Induction cycle been given (either partially or completely)
    boolean
    C3179010 (UMLS CUI [1])
    Dose level
    Item
    Dose level Lenalidomide (fill out 20 mg, 15 mg, 10 mg)
    float
    C0178602 (UMLS CUI [1,1])
    C1144149 (UMLS CUI [1,2])
    Induction start date
    Item
    Date start of this induction cycle
    date
    C3179010 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    Next start date
    Item
    Planned start date next treatment
    date
    C1115731 (UMLS CUI [1])
    Item
    Planned next treatment
    integer
    C3641097 (UMLS CUI [1])
    Planned next treatment
    Code List
    Planned next treatment
    CL Item
    cycle II (2)
    C1302181 (UMLS CUI-1)
    CL Item
    cycle III  (3)
    C1302181 (UMLS CUI-1)
    CL Item
    autoHSCT  (4)
    C0194037 (UMLS CUI-1)
    CL Item
    alloHSCT  (5)
    C1705576 (UMLS CUI-1)
    CL Item
    treatment off protocol (6)
    C0087111 (UMLS CUI-1)
    C1518546 (UMLS CUI-2)
    Date off protocoll
    Item
    Date off protocoll
    date
    C2348563 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item Group
    Survival Status
    C1148433 (UMLS CUI-1)
    Date last contact
    Item
    Date last known to be alive or death
    date
    C0805839 (UMLS CUI [1])
    Item
    Survival Status
    integer
    C1148433 (UMLS CUI [1])
    Survival Status
    Code List
    Survival Status
    CL Item
    alive (0)
    C2584946 (UMLS CUI-1)
    CL Item
    dead (1)
    C0011065 (UMLS CUI-1)
    Item
    Cause of death
    integer
    C0007465 (UMLS CUI [1])
    Cause of death
    Code List
    Cause of death
    CL Item
    leukemia  (1)
    C0023418 (UMLS CUI-1)
    CL Item
    pneumonia  (2)
    C0032285 (UMLS CUI-1)
    CL Item
    other infection  (3)
    C0009450 (UMLS CUI-1)
    CL Item
    hemorrhage (4)
    C0019080 (UMLS CUI-1)
    CL Item
    veno-occlusive disease*  (5)
    C0948441 (UMLS CUI-1)
    CL Item
    other* (8)
    *Specify
    Item
    *Specify
    text
    C1521902 (UMLS CUI [1])
    Item Group
    Toxicity
    C0013221 (UMLS CUI-1)
    Item
    CTCAE grade ≥ 4 non hematological toxicity
    integer
    C0013221 (UMLS CUI [1,1])
    C1516728 (UMLS CUI [1,2])
    CTCAE grade ≥ 4 non hematological toxicity Date onset
    Code List
    CTCAE grade ≥ 4 non hematological toxicity
    CL Item
    no (0)
    CL Item
    yes, fill out items 15 and 16 (1)
    CTCAE grade ≥ 4 non hematological toxicity Date onset
    Item
    CTCAE grade ≥ 4 non hematological toxicity Date onset
    date
    C0013221 (UMLS CUI [1,1])
    C1516728 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    CTCAE grade ≥ 4 non hematological toxicity Specification
    Item
    CTCAE grade ≥ 4 non hematological toxicity Specification
    text
    C0013221 (UMLS CUI [1,1])
    C1516728 (UMLS CUI [1,2])
    C1521902 (UMLS CUI [1,3])
    Item Group
    Recovery
    Item
    Was ANC recovered to > 0.5x109/L
    integer
    C1882078 (UMLS CUI [1])
    ANC Recovery
    Code List
    Was ANC recovered to > 0.5x109/L
    CL Item
    no, give last date ANC was measured box 18 (0)
    CL Item
    yes, fill out date of recovery box 19 and/or 20 (1)
    CL Item
    never below (2)
    Last date ANC
    Item
    Last date ANC was measured
    date
    C0948762 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    First date ANC
    Item
    First date ANC >0.5 x 109/L
    date
    C1882078 (UMLS CUI [1])
    First date ANC greater
    Item
    First date ANC >1.0 x 109/L
    date
    C1882078 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Platelets recovered to > 50x109/L
    integer
    C1882407 (UMLS CUI [1])
    Platelets recovered
    Code List
    Platelets recovered to > 50x109/L
    CL Item
    no  (0)
    CL Item
    yes, fill out date of recovery  (1)
    CL Item
    never below (2)
    First date blood platelets
    Item
    First date platelets >50 x 109/L
    date
    C1882407 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Retour au début de la page 

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