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ID

42822

Description

Randomized Phase III Study of Intensive Chemotherapy with or without Dasatinib (Sprycel(TM)) in Adult Patients with Newly Diagnosed Core-Binding Factor Acute Myeloid Leukemia (CBF-AML)

Mots-clés

  1. 05/03/2015 05/03/2015 -
  2. 09/03/2015 09/03/2015 -
  3. 23/04/2015 23/04/2015 -
  4. 15/12/2015 15/12/2015 -
  5. 17/09/2021 17/09/2021 -
Téléchargé le

17 septembre 2021

DOI

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Licence

Creative Commons BY-NC 3.0

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    Adverse Event AMLSG 21-13 DRKS00007189 NCT02013648 Akute myeloische Leukämie (AML)

    Adverse Event AMLSG 21-13 NCT02013648 Akute myeloische Leukämie (AML)

    Adverse Event
    Description

    Adverse Event

    Point in time
    Description

    Point in time

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C1276413
    UMLS CUI [1,2]
    C2348792
    If Maintenance: Month
    Description

    Maintenance Month

    Type de données

    integer

    Alias
    UMLS CUI-1
    C0481504
    UMLS CUI-2
    C0439231
    Description of Adverse Event
    Description

    Description of Adverse Event

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0877248
    Adverse Event Term
    Description

    Adverse Event Term

    Type de données

    text

    Alias
    UMLS CUI-1
    C2826934
    Serious Adverse Event
    Description

    Serious Adverse Event

    Type de données

    boolean

    Alias
    UMLS CUI-1
    C1519255
    Grade of Adverse Event
    Description

    Grade of Adverse Event

    Type de données

    integer

    Alias
    UMLS CUI-1
    C2985911
    Outcome
    Description

    Outcome

    Type de données

    integer

    Alias
    UMLS CUI-1
    C1705586
    Treatment/Action taken
    Description

    Treatment/Action taken

    Type de données

    text

    Alias
    UMLS CUI-1
    C0087111
    Adverse Event Start Date
    Description

    Adverse Event Start Date

    Type de données

    date

    Alias
    UMLS CUI-1
    C2697888
    Adverse Event End Date
    Description

    Adverse Event End Date

    Type de données

    date

    Alias
    UMLS CUI-1
    C2697886
    Adverse Event related to
    Description

    Adverse Event related to

    Cytarabine
    Description

    Cytarabine

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0010711
    Daunorubicin
    Description

    Daunorubicin

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0011015
    Dasatinib
    Description

    Dasatinib

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C1455147
    Underlying Disease
    Description

    Underlying Disease

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0277554
    Concomitant medication
    Description

    Concomitant medication

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C2347852
    Other
    Description

    Other

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C0205394
    Signature
    Description

    Signature

    Date
    Description

    Date

    Type de données

    date

    Alias
    UMLS CUI-1
    C0011008
    Name of Investigator
    Description

    Name of Investigator

    Type de données

    text

    Alias
    UMLS CUI-1
    C0008961
    Signature of investigator
    Description

    Signature of investigator

    Type de données

    text

    Alias
    UMLS CUI-1
    C2346576

    Similar models

    Adverse Event AMLSG 21-13 NCT02013648 Akute myeloische Leukämie (AML)

    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    Adverse Event
    Item
    Point in time
    integer
    C1276413 (UMLS CUI [1,1])
    C2348792 (UMLS CUI [1,2])
    Code List
    Point in time
    CL Item
    Diagnostic (0)
    C0086143 (UMLS CUI-1)
    CL Item
    Induction I (1)
    C3179010 (UMLS CUI-1)
    CL Item
    Induction II (optional) (2)
    C3179010 (UMLS CUI-1)
    CL Item
    Consolid. I (3)
    C3179017 (UMLS CUI-1)
    CL Item
    Consolid. II (4)
    C3179017 (UMLS CUI-1)
    CL Item
    Consolid. III (5)
    C3179017 (UMLS CUI-1)
    CL Item
    Consolid. IV (6)
    C3179017 (UMLS CUI-1)
    CL Item
    Maintenance (7)
    C0481504 (UMLS CUI-1)
    Item
    If Maintenance: Month
    integer
    C0481504 (UMLS CUI-1)
    C0439231 (UMLS CUI-2)
    Code List
    If Maintenance: Month
    CL Item
    after 1 Month (1)
    C0439231 (UMLS CUI-1)
    C0205447 (UMLS CUI-2)
    CL Item
    after 2 Months (2)
    C0439231 (UMLS CUI-1)
    C0205448 (UMLS CUI-2)
    CL Item
    after 3 Months (3)
    C0439231 (UMLS CUI-1)
    C0205449 (UMLS CUI-2)
    CL Item
    after 4 Months (4)
    C0439231 (UMLS CUI-1)
    C0205450 (UMLS CUI-2)
    CL Item
    after 5 Months (5)
    C0439231 (UMLS CUI-1)
    C0205451 (UMLS CUI-2)
    CL Item
    after 6 Months (6)
    C0439231 (UMLS CUI-1)
    C0205452 (UMLS CUI-2)
    CL Item
    after 7 Months (7)
    C0439231 (UMLS CUI-1)
    C0205453 (UMLS CUI-2)
    CL Item
    after 8 Months (8)
    C0439231 (UMLS CUI-1)
    C0205454 (UMLS CUI-2)
    CL Item
    after 9Months (9)
    C0439231 (UMLS CUI-1)
    C0205455 (UMLS CUI-2)
    CL Item
    after 10 Months (10)
    C0439231 (UMLS CUI-1)
    C0205456 (UMLS CUI-2)
    CL Item
    after 11 Months (11)
    C0439231 (UMLS CUI-1)
    C0205457 (UMLS CUI-2)
    CL Item
    after 12 Months (12)
    C0439231 (UMLS CUI-1)
    C0205458 (UMLS CUI-2)
    Description of Adverse Event
    Item
    Description of Adverse Event
    text
    C0877248 (UMLS CUI [1])
    Adverse Event Term
    Item
    Adverse Event Term
    text
    C2826934 (UMLS CUI-1)
    Serious Adverse Event
    Item
    Serious Adverse Event
    boolean
    C1519255 (UMLS CUI-1)
    Item
    Grade of Adverse Event
    integer
    C2985911 (UMLS CUI-1)
    Code List
    Grade of Adverse Event
    CL Item
    Mild  (1)
    C2945599 (UMLS CUI-1)
    CL Item
    Moderate (2)
    C0205081 (UMLS CUI-1)
    CL Item
    Severe (3)
    C0205082 (UMLS CUI-1)
    CL Item
    Life-Threatening (4)
    C2826244 (UMLS CUI-1)
    CL Item
    Death related to AE (5)
    C0877248 (UMLS CUI-1)
    C0011065 (UMLS CUI-2)
    Item
    Outcome
    integer
    C1705586 (UMLS CUI-1)
    Code List
    Outcome
    CL Item
    recovered (1)
    C2826210 (UMLS CUI-1)
    CL Item
    not yet recovered (2)
    C1709277 (UMLS CUI-1)
    CL Item
    recovered with sequelae (3)
    C1709862 (UMLS CUI-1)
    CL Item
    Death (4)
    C0011065 (UMLS CUI-1)
    CL Item
    unknown (5)
    C0439673 (UMLS CUI-1)
    Treatment/Action taken
    Item
    Treatment/Action taken
    text
    C0087111 (UMLS CUI-1)
    Adverse Event Start Date
    Item
    Adverse Event Start Date
    date
    C2697888 (UMLS CUI-1)
    Adverse Event End Date
    Item
    Adverse Event End Date
    date
    C2697886 (UMLS CUI-1)
    Item Group
    Adverse Event related to
    Item
    Cytarabine
    integer
    C0877248 (UMLS CUI [1,1])
    C0010711 (UMLS CUI [1,2])
    Code List
    Cytarabine
    CL Item
    definitely (1)
    C1704787 (UMLS CUI-1)
    CL Item
    probably (2)
    C0750492 (UMLS CUI-1)
    CL Item
    possible (3)
    C0332149 (UMLS CUI-1)
    CL Item
    unlikely (4)
    C0750558 (UMLS CUI-1)
    CL Item
    not related (5)
    C1546988 (UMLS CUI-1)
    CL Item
    Medication not administered (6)
    C0445106 (UMLS CUI-1)
    C0806914 (UMLS CUI-2)
    Item
    Daunorubicin
    integer
    C0877248 (UMLS CUI [1,1])
    C0011015 (UMLS CUI [1,2])
    Code List
    Daunorubicin
    CL Item
    definitely (1)
    C1704787 (UMLS CUI-1)
    CL Item
    probably (2)
    C0750492 (UMLS CUI-1)
    CL Item
    possible (3)
    C0332149 (UMLS CUI-1)
    CL Item
    unlikely (4)
    C0750558 (UMLS CUI-1)
    CL Item
    not related (5)
    C1546988 (UMLS CUI-1)
    CL Item
    Medication not administered (6)
    C0445106 (UMLS CUI-1)
    C0806914 (UMLS CUI-2)
    Item
    Dasatinib
    integer
    C0877248 (UMLS CUI [1,1])
    C1455147 (UMLS CUI [1,2])
    Code List
    Dasatinib
    CL Item
    definitely (1)
    C1704787 (UMLS CUI-1)
    CL Item
    probably (2)
    C0750492 (UMLS CUI-1)
    CL Item
    possible (3)
    C0332149 (UMLS CUI-1)
    CL Item
    unlikely (4)
    C0750558 (UMLS CUI-1)
    CL Item
    not related (5)
    C1546988 (UMLS CUI-1)
    CL Item
    Medication not administered (6)
    C0445106 (UMLS CUI-1)
    C0806914 (UMLS CUI-2)
    Item
    Underlying Disease
    integer
    C0877248 (UMLS CUI [1,1])
    C0277554 (UMLS CUI [1,2])
    Code List
    Underlying Disease
    CL Item
    recovered (1)
    C2826210 (UMLS CUI-1)
    CL Item
    not yet recovered (2)
    C1709277 (UMLS CUI-1)
    CL Item
    recovered with sequelae (3)
    C1709862 (UMLS CUI-1)
    CL Item
    Death (4)
    C0011065 (UMLS CUI-1)
    CL Item
    unknown (5)
    C0439673 (UMLS CUI-1)
    Item
    Concomitant medication
    integer
    C2347852 (UMLS CUI [1])
    Code List
    Concomitant medication
    CL Item
    definitely (1)
    C1704787 (UMLS CUI-1)
    CL Item
    probably (2)
    C0750492 (UMLS CUI-1)
    CL Item
    possible (3)
    C0332149 (UMLS CUI-1)
    CL Item
    unlikely (4)
    C0750558 (UMLS CUI-1)
    CL Item
    not related (5)
    C1546988 (UMLS CUI-1)
    CL Item
    Medication not administered (6)
    C0445106 (UMLS CUI-1)
    C0806914 (UMLS CUI-2)
    Item
    Other
    integer
    C0205394 (UMLS CUI [1])
    Code List
    Other
    CL Item
    recovered (1)
    C2826210 (UMLS CUI-1)
    CL Item
    not yet recovered (2)
    C1709277 (UMLS CUI-1)
    CL Item
    recovered with sequelae (3)
    C1709862 (UMLS CUI-1)
    CL Item
    Death (4)
    C0011065 (UMLS CUI-1)
    CL Item
    unknown (5)
    C0439673 (UMLS CUI-1)
    Item Group
    Signature
    Date
    Item
    Date
    date
    C0011008 (UMLS CUI-1)
    Name of Investigator
    Item
    Name of Investigator
    text
    C0008961 (UMLS CUI-1)
    Signature of investigator
    Item
    Signature of investigator
    text
    C2346576 (UMLS CUI-1)

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