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ID

13481

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) Description of Form: Adverse Event Form

Keywords

Versions (3)
  1. 11/10/15 11/10/15 -
  2. 12/23/15 12/23/15 -
  3. 2/11/16 2/11/16 -
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February 11, 2016

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Creative Commons BY-NC 3.0
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    Adverse Event Form HOVON 132 AML/SAKK 30/13 EudraCT 2013-002843-26

    English

    Adverse Event Form

    1 forms  
    1. StudyEvent: ODM
      1. Adverse Event Form
    Adverse Event
    Description

    Adverse Event

    Alias
    UMLS CUI-1
    C0877248
    AE nr
    Description

    AE nr

    Data type

    float

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0750480
    System Organ Class
    Description

    System Organ Class

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C2347091
    UMLS CUI [1,2]
    C0460002
    Adverse Event Term (please use CTCAE Short Name plus Select term if applicable)
    Description

    Adverse Event Term

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826934
    CTCAE grade
    Description

    CTCAE grade

    Data type

    float

    Alias
    UMLS CUI [1,1]
    C1516728
    UMLS CUI [1,2]
    C0441800
    Serious adverse event
    Description

    SAE

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1519255
    Relationship to protocol treatment
    Description

    Relationship to protocol treatment

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0041755
    Related to
    Description

    Related to

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0041755
    UMLS CUI [1,2]
    C0013227
    Treatment changed
    Description

    Treatment changed

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1299575
    AE date start
    Description

    AE date start

    Data type

    date

    Measurement units
    • dd/mm/yyyy
    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0808070
    dd/mm/yyyy
    AE Outcome
    Description

    AE Outcome

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1705586
    Date end
    Description

    AE Date end

    Data type

    date

    Measurement units
    • dd/mm/yyyy
    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0806020
    dd/mm/yyyy
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    Similar models

    Adverse Event Form

    1 forms
    1. StudyEvent: ODM
      1. Adverse Event Form
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Adverse Event
    C0877248 (UMLS CUI-1)
    AE nr
    Item
    AE nr
    float
    C0877248 (UMLS CUI [1,1])
    C0750480 (UMLS CUI [1,2])
    Item
    System Organ Class
    integer
    C2347091 (UMLS CUI [1,1])
    C0460002 (UMLS CUI [1,2])
    System Organ Class
    Code List
    System Organ Class
    CL Item
    Blood and lymphatic system disorders  (1)
    C0851353 (UMLS CUI-1)
    CL Item
    Cardiac disorders  (2)
    C0178273 (UMLS CUI-1)
    CL Item
    Congenital, familial and genetic disorders  (3)
    C0851352 (UMLS CUI-1)
    CL Item
    Ear and labyrinth disorders  (4)
    C0851354 (UMLS CUI-1)
    CL Item
    Endocrine disorders  (5)
    C0014130 (UMLS CUI-1)
    CL Item
    Eye disorders  (6)
    C0015397 (UMLS CUI-1)
    CL Item
    Gastrointestinal disorders  (7)
    C0017178 (UMLS CUI-1)
    CL Item
    General disorders and administration site conditions  (8)
    C0851362 (UMLS CUI-1)
    CL Item
    Hepatobiliary disorders  (9)
    C0267792 (UMLS CUI-1)
    CL Item
    Immune system disorders  (10)
    C1334156 (UMLS CUI-1)
    CL Item
    Infections and infestations  (11)
    C0851565 (UMLS CUI-1)
    CL Item
    Injury, poisoning and procedural complications  (12)
    C0947733 (UMLS CUI-1)
    CL Item
    Investigations  (13)
    C0841577 (UMLS CUI-1)
    CL Item
    Metabolism and nutrition disorders  (14)
    C0851358 (UMLS CUI-1)
    CL Item
    Musculoskeletal and connective tissue disorders  (15)
    C0263660 (UMLS CUI-1)
    CL Item
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)  (16)
    C0027651 (UMLS CUI-1)
    CL Item
    Nervous system disorders  (17)
    C0810273 (UMLS CUI-1)
    CL Item
    Pregnancy, puerperium and perinatal conditions  (18)
    C0851363 (UMLS CUI-1)
    CL Item
    Psychiatric disorders  (19)
    C0004936 (UMLS CUI-1)
    CL Item
    Renal and urinary disorders  (20)
    C0042075 (UMLS CUI-1)
    CL Item
    Reproductive system and breast disorders  (21)
    C0851366 (UMLS CUI-1)
    CL Item
    Respiratory, thoracic and mediastinal disorders  (22)
    C0851355 (UMLS CUI-1)
    CL Item
    Skin and subcutaneous tissue disorders  (23)
    C0178301 (UMLS CUI-1)
    CL Item
    Social circumstances  (24)
    C0851364 (UMLS CUI-1)
    CL Item
    Surgical and medical procedures  (25)
    C1948041 (UMLS CUI-1)
    CL Item
    Vascular disorders (26)
    C0400883 (UMLS CUI-1)
    Adverse Event Term
    Item
    Adverse Event Term (please use CTCAE Short Name plus Select term if applicable)
    text
    C2826934 (UMLS CUI [1])
    CTCAE grade
    Item
    CTCAE grade
    float
    C1516728 (UMLS CUI [1,1])
    C0441800 (UMLS CUI [1,2])
    SAE
    Item
    Serious adverse event
    boolean
    C1519255 (UMLS CUI [1])
    Item
    Relationship to protocol treatment
    integer
    C0041755 (UMLS CUI [1])
    Relationship to protocol treatment
    Code List
    Relationship to protocol treatment
    CL Item
    unrelated  (0)
    C0445356 (UMLS CUI-1)
    CL Item
    unlikely  (1)
    C0750558 (UMLS CUI-1)
    CL Item
    possibly  (2)
    C0332149 (UMLS CUI-1)
    CL Item
    probably  (3)
    C0750492 (UMLS CUI-1)
    CL Item
    definitely  (4)
    C1704787 (UMLS CUI-1)
    CL Item
    unknown (5)
    C0439673 (UMLS CUI-1)
    Item
    Related to
    integer
    C0041755 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Related to
    Code List
    Related to
    CL Item
    Lenalidomide  (1)
    C1144149 (UMLS CUI-1)
    CL Item
    other trial medication/SCT  (2)
    CL Item
    Lenalidomide + other trial medication/SCT  (3)
    CL Item
    unknown (9)
    C0439673 (UMLS CUI-1)
    Treatment changed
    Item
    Treatment changed
    boolean
    C1299575 (UMLS CUI [1])
    AE date start
    Item
    AE date start
    date
    C0877248 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    Item
    AE Outcome
    integer
    C1705586 (UMLS CUI [1])
    AE Outcome
    Code List
    AE Outcome
    CL Item
    resolved completely  (1)
    M (UMLS CUI-1)
    CL Item
    resolved to baseline  (2)
    M (UMLS CUI-1)
    CL Item
    resolved with sequelae  (3)
    M (UMLS CUI-1)
    CL Item
    ongoing (pending)  (4)
    M (UMLS CUI-1)
    CL Item
    ongoing with higher CTCAE grade  (5)
    M (UMLS CUI-1)
    CL Item
    ongoing (closed)  (6)
    M (UMLS CUI-1)
    CL Item
    death (7)
    M (UMLS CUI-1)
    AE Date end
    Item
    Date end
    date
    C0877248 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
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