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ID

13480

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: Baseline Concomitant Diseases Form

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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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    Baseline Concomitant Diseases Form HOVON 132 AML/SAKK 30/13 EudraCT 2013-002843-26

    English

    Baseline Concomitant Diseases Form

    1 forms  
    Baseline Concomitant Diseases
    Description

    Baseline Concomitant Diseases

    Alias
    UMLS CUI-1
    C0009488
    Disease nr
    Description

    Disease nr

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0009488
    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 [1,1]
    C2826934
    UMLS CUI [1,2]
    C1516728
    Active at baseline
    Description

    Active at baseline

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0009488
    UMLS CUI [1,2]
    C0205177
    UMLS CUI [1,3]
    C1442488
    CTCAE grade
    Description

    CTCAE grade

    Data type

    float

    Alias
    UMLS CUI [1,1]
    C1516728
    UMLS CUI [1,2]
    C0441800
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    Similar models

    Baseline Concomitant Diseases Form

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Baseline Concomitant Diseases
    C0009488 (UMLS CUI-1)
    Disease nr
    Item
    Disease nr
    integer
    C0009488 (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
    Heart failure (2)
    C0018801 (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)
    C0042373 (UMLS CUI-1)
    Adverse event term
    Item
    Adverse event term (please use CTCAE short name plus select term if applicable)
    text
    C2826934 (UMLS CUI [1,1])
    C1516728 (UMLS CUI [1,2])
    Active at baseline
    Item
    boolean
    C0009488 (UMLS CUI [1,1])
    C0205177 (UMLS CUI [1,2])
    C1442488 (UMLS CUI [1,3])
    CTCAE grade
    Item
    CTCAE grade
    float
    C1516728 (UMLS CUI [1,1])
    C0441800 (UMLS CUI [1,2])
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