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ID

13269

Description

Study part: Visit V7 (Day 238 + - 14) Final examination. Effectiveness and tolerance of sublingual desensitization with LAIS grass tablets in Patients with an allergic rhinoconjunctivitis caused by grass pollen. A prospective, multi-center, doubleblind, randomized, placebo-controlled Phase III study. Principal Investigator Prof. Dr. med. Ralph Mösges.

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  1. 1/28/16 1/28/16 -
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January 28, 2016

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Creative Commons BY-NC 3.0
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    Visit V7_LAIS grass tablets by allergic rhinoconjunctivitis_EudraCT-Nr.2012-004916-79

    English

    Visit V7 (Day 238 + - 14) Final examination

    1 forms  
    Visit 7
    Description

    Visit 7

    Alias
    UMLS CUI-1
    C0545082
    Date of visit
    Description

    date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0011008
    Does the patient still take part in the study?
    Description

    Study Subject Participation Status

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348568
    Did the patient take the medication according to the protocol?
    Description

    compliance

    Data type

    text

    Alias
    UMLS CUI [1]
    C1321605
    If the compliance was not always, please mention in detail
    Description

    details compliance

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0392360
    UMLS CUI [1,2]
    C1321605
    Comorbidity? Please fill up the form "Documentation adverse event"
    Description

    Comorbidity

    Data type

    boolean

    Concomitant medication? Please use the form "Documentation Concomitant medication"
    Description

    Concomitant medication

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2347852
    Patient diary (part 2) collected and controlled?
    Description

    Patient diary

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3890583
    Did the patient fill up the documentation form on quality of life of rhinoconjunctivitis patients?
    Description

    Quality of life; Rhinoconjunctivitis

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0034380
    UMLS CUI [2]
    C0861155
    Documentation of study completion done? (Please use the form "Study completion")
    Description

    study completion

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2826674
    Physical examination
    Description

    Physical examination

    Alias
    UMLS CUI-1
    C0031809
    Weight
    Description

    Weight

    Data type

    float

    Measurement units
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Systolic blood pressure
    Description

    systolic blood pressure

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Diastolic blood pressure
    Description

    Diastolic blood pressure

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    Heart rate
    Description

    heart rate

    Data type

    integer

    Measurement units
    • 1/ min
    Alias
    UMLS CUI [1]
    C0018810
    1/ min
    Examination (Rhinoscope)
    Description

    Examination (Rhinoscope)

    Alias
    UMLS CUI-1
    C0582103
    UMLS CUI-2
    C0183044
    Edema
    Description

    edema

    Data type

    text

    Alias
    UMLS CUI [1]
    C0013604
    Secretion
    Description

    Secretion, Nasal

    Data type

    text

    Alias
    UMLS CUI [1]
    C1546724
    Redness
    Description

    Redness

    Data type

    text

    Alias
    UMLS CUI [1]
    C0332575
    Spirometry or Peak expiratory flow measurement (For asthmatics)
    Description

    Spirometry or Peak expiratory flow measurement (For asthmatics)

    Alias
    UMLS CUI-1
    C0037981
    UMLS CUI-3
    C0521299
    FEV1 (age-appropriate standard value)
    Description

    FEV1

    Data type

    float

    Alias
    UMLS CUI [1]
    C0748133
    FEV1
    Description

    FEV1

    Data type

    float

    Alias
    UMLS CUI [1]
    C0748133
    FEV1/ Standard value (If FEV1 < 70% of age appropriate standard value, exclusion)
    Description

    Ratio; FEV1; standard value

    Data type

    integer

    Measurement units
    • %
    Alias
    UMLS CUI [1]
    C0456603
    UMLS CUI [2]
    C0588029
    UMLS CUI [3]
    C1442989
    %
    PEF 1
    Description

    Peak expiratory flow measurement

    Data type

    integer

    Measurement units
    • l/min
    Alias
    UMLS CUI [1]
    C0521299
    l/min
    PEF 2
    Description

    Peak expiratory flow measurement

    Data type

    integer

    Measurement units
    • l/ min
    Alias
    UMLS CUI [1]
    C0521299
    l/ min
    PEF 3
    Description

    Peak expiratory flow measurement

    Data type

    integer

    Measurement units
    • l/ min
    Alias
    UMLS CUI [1]
    C0521299
    l/ min
    Best PEF
    Description

    Peak expiratory flow measurement

    Data type

    integer

    Measurement units
    • l/ min
    Alias
    UMLS CUI [1]
    C0521299
    l/ min
    Optimum individual value PEF (If FEV1 < 70% of optimum individual value, exclusion)
    Description

    Peak expiratory flow measurement

    Data type

    integer

    Measurement units
    • l/ min
    Alias
    UMLS CUI [1]
    C0521299
    l/ min
    Pregnancy test
    Description

    Pregnancy test

    Alias
    UMLS CUI-1
    C0032976
    Pregnancy test carried out on
    Description

    date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0011008
    Pregnancy test result
    Description

    Pregnancy test

    Data type

    text

    Alias
    UMLS CUI [1]
    C0032976
    Back to the top of the page

    Similar models

    Visit V7 (Day 238 + - 14) Final examination

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Visit 7
    C0545082 (UMLS CUI-1)
    date
    Item
    Date of visit
    date
    C0011008 (UMLS CUI [1])
    Item
    Does the patient still take part in the study?
    text
    C2348568 (UMLS CUI [1])
    Study Subject Participation Status
    Code List
    Does the patient still take part in the study?
    CL Item
    yes (1)
    CL Item
    no, please then fill up the form "Study completion" (2)
    Item
    Did the patient take the medication according to the protocol?
    text
    C1321605 (UMLS CUI [1])
    compliance
    Code List
    Did the patient take the medication according to the protocol?
    CL Item
    always (1)
    CL Item
    mostly yes (2)
    CL Item
    mostly no (3)
    CL Item
    no (4)
    details compliance
    Item
    If the compliance was not always, please mention in detail
    text
    C0392360 (UMLS CUI [1,1])
    C1321605 (UMLS CUI [1,2])
    Comorbidity
    Item
    Comorbidity? Please fill up the form "Documentation adverse event"
    boolean
    Concomitant medication
    Item
    Concomitant medication? Please use the form "Documentation Concomitant medication"
    boolean
    C2347852 (UMLS CUI [1])
    Patient diary
    Item
    Patient diary (part 2) collected and controlled?
    boolean
    C3890583 (UMLS CUI [1])
    Quality of life; Rhinoconjunctivitis
    Item
    Did the patient fill up the documentation form on quality of life of rhinoconjunctivitis patients?
    boolean
    C0034380 (UMLS CUI [1])
    C0861155 (UMLS CUI [2])
    study completion
    Item
    Documentation of study completion done? (Please use the form "Study completion")
    boolean
    C2826674 (UMLS CUI [1])
    Item Group
    Physical examination
    C0031809 (UMLS CUI-1)
    Weight
    Item
    Weight
    float
    C0005910 (UMLS CUI [1])
    systolic blood pressure
    Item
    Systolic blood pressure
    integer
    C0871470 (UMLS CUI [1])
    Diastolic blood pressure
    Item
    Diastolic blood pressure
    integer
    C0428883 (UMLS CUI [1])
    heart rate
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1])
    Item Group
    Examination (Rhinoscope)
    C0582103 (UMLS CUI-1)
    C0183044 (UMLS CUI-2)
    Item
    Edema
    text
    C0013604 (UMLS CUI [1])
    edema
    Code List
    Edema
    CL Item
    no (1)
    CL Item
    slight (2)
    CL Item
    medium (3)
    CL Item
    strong (4)
    Item
    Secretion
    text
    C1546724 (UMLS CUI [1])
    Secretion, Nasal
    Code List
    Secretion
    CL Item
    no (1)
    CL Item
    slight (2)
    CL Item
    medium (3)
    CL Item
    strong (4)
    Item
    Redness
    text
    C0332575 (UMLS CUI [1])
    Redness
    Code List
    Redness
    CL Item
    no (1)
    CL Item
    slight (2)
    CL Item
    medium (3)
    CL Item
    strong (4)
    Item Group
    Spirometry or Peak expiratory flow measurement (For asthmatics)
    C0037981 (UMLS CUI-1)
    C0521299 (UMLS CUI-3)
    FEV1
    Item
    FEV1 (age-appropriate standard value)
    float
    C0748133 (UMLS CUI [1])
    FEV1
    Item
    FEV1
    float
    C0748133 (UMLS CUI [1])
    Ratio; FEV1; standard value
    Item
    FEV1/ Standard value (If FEV1 < 70% of age appropriate standard value, exclusion)
    integer
    C0456603 (UMLS CUI [1])
    C0588029 (UMLS CUI [2])
    C1442989 (UMLS CUI [3])
    Peak expiratory flow measurement
    Item
    PEF 1
    integer
    C0521299 (UMLS CUI [1])
    Peak expiratory flow measurement
    Item
    PEF 2
    integer
    C0521299 (UMLS CUI [1])
    Peak expiratory flow measurement
    Item
    PEF 3
    integer
    C0521299 (UMLS CUI [1])
    Peak expiratory flow measurement
    Item
    Best PEF
    integer
    C0521299 (UMLS CUI [1])
    Peak expiratory flow measurement
    Item
    Optimum individual value PEF (If FEV1 < 70% of optimum individual value, exclusion)
    integer
    C0521299 (UMLS CUI [1])
    Item Group
    Pregnancy test
    C0032976 (UMLS CUI-1)
    date
    Item
    Pregnancy test carried out on
    date
    C0011008 (UMLS CUI [1])
    Item
    Pregnancy test result
    text
    C0032976 (UMLS CUI [1])
    Pregnancy test
    Code List
    Pregnancy test result
    CL Item
    positive (1)
    CL Item
    negative (2)
    Back to the top of the page 

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