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44607

Description

Study part: Visit V5 (Day 140 + - 14). 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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Versions (2)
  1. 1/28/16 1/28/16 -
  2. 9/27/21 9/27/21 -
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September 27, 2021

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Creative Commons BY-NC 3.0
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    Visit V5_LAIS grass tablets by allergic rhinoconjunctivitis_EudraCT-Nr.2012-004916-79

    English

    Visit V5 (Day 140 + - 14)

    1 forms  
    Visit 5
    Description

    Visit 5

    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
    Date for next visit 6 (Day 196 + - 14 days)
    Description

    Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0011008
    Did an adverse event occur during the treatment? (If yes, please use the form "Documentation adverse event")
    Description

    adverse event

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0877248
    Did a serious adverse event occur during the treatment? (If yes, please use the form "Documentation serious adverse events")
    Description

    serious adverse event

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1519255
    Are there any undocumented adverse events, which were not recorded during the previous visit? (If yes, please use the form "Documentation adverse event")
    Description

    adverse event

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0877248
    Patient diary (part 1) handed out?
    Description

    To document daily symptoms and the use of concomitant medication

    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

    text

    Alias
    UMLS CUI [1]
    C0034380
    UMLS CUI [2]
    C0861155
    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
    Study medication and Concomitant medication (Taking back of the third study medication box with 8 blister pack)
    Description

    Study medication and Concomitant medication (Taking back of the third study medication box with 8 blister pack)

    Alias
    UMLS CUI-1
    C0013227
    Number of tablets left (study medication)
    Description

    medication study

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0008972
    Number of tablets left (Loratadin)
    Description

    medication Demand

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0441516
    Mention, if incomplete
    Description

    details

    Data type

    text

    Alias
    UMLS CUI [1]
    C1522508
    Hematology
    Description

    Hematology

    Alias
    UMLS CUI-1
    C0474523
    Blood collection on
    Description

    date blood collection

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0005834
    Ig G4 Gräser
    Description

    diagnostic allergy

    Data type

    float

    Measurement units
    • mg/l
    Alias
    UMLS CUI [1,1]
    C0086143
    UMLS CUI [1,2]
    C0020517
    mg/l
    Hemoglobin
    Description

    Hemoglobin

    Data type

    float

    Measurement units
    • mmol/l
    Alias
    UMLS CUI [1]
    C0019046
    mmol/l
    Hematocrit
    Description

    hematocrit

    Data type

    float

    Measurement units
    • l/l
    Alias
    UMLS CUI [1]
    C0518014
    l/l
    Erythrocyte
    Description

    Erythrocyte

    Data type

    float

    Measurement units
    • /pl
    Alias
    UMLS CUI [1]
    C0014772
    /pl
    Thrombocyte
    Description

    Thrombocyte

    Data type

    float

    Measurement units
    • /nl
    Alias
    UMLS CUI [1]
    C0005821
    /nl
    Leucocyte (total)
    Description

    Leucocyte

    Data type

    float

    Measurement units
    • /nl
    Alias
    UMLS CUI [1]
    C0023508
    /nl
    Biochemistry
    Description

    Biochemistry

    Alias
    UMLS CUI-1
    C0005477
    Bilirubin (total)
    Description

    Bilirubin

    Data type

    float

    Measurement units
    • μmol/l
    Alias
    UMLS CUI [1]
    C1278039
    μmol/l
    SGPT- Serum Glutamate pyruvate transaminase
    Description

    Glutamate pyruvate transaminase

    Data type

    float

    Measurement units
    • U/l
    Alias
    UMLS CUI [1]
    C0376147
    U/l
    Alkaline phosphatase
    Description

    Alkaline phosphatase

    Data type

    float

    Measurement units
    • U/l
    Alias
    UMLS CUI [1]
    C0201850
    U/l
    Glucose
    Description

    Glucose

    Data type

    float

    Measurement units
    • mmol/l
    Alias
    UMLS CUI [1]
    C0202042
    mmol/l
    Creatinine
    Description

    Creatinine

    Data type

    float

    Measurement units
    • μmol/l
    Alias
    UMLS CUI [1]
    C0201976
    μmol/l
    SGOT- Aspartate aminotransferase measurement
    Description

    Aspartate aminotransferase measurement

    Data type

    float

    Measurement units
    • U/l
    Alias
    UMLS CUI [1]
    C0201899
    U/l
    CRP C reactive protein
    Description

    C reactive protein

    Data type

    float

    Measurement units
    • mg/l
    Alias
    UMLS CUI [1]
    C0201657
    mg/l
    Gamma-glutamyl transpeptidase
    Description

    Gamma-glutamyl transpeptidase

    Data type

    float

    Measurement units
    • U/l
    Alias
    UMLS CUI [1]
    C1883012
    U/l
    Demand medication
    Description

    Demand medication

    Alias
    UMLS CUI-1
    C0013227
    UMLS CUI-2
    C0441516
    Number of antihistamines (oral) handed out
    Description

    Antihistamines

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0019590
    Number of Levocabastin eye drops given out
    Description

    Levocabastin

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0064870
    Number of Beclometason nasal sprays given out
    Description

    Beclometason

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0004905
    Number of combination of inhaled cortisone + long acting β2-receptor-agonist handed out
    Description

    cortisone; beta agonist

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0010137
    UMLS CUI [2]
    C0001644
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    Similar models

    Visit V5 (Day 140 + - 14)

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Visit 5
    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])
    Date
    Item
    Date for next visit 6 (Day 196 + - 14 days)
    date
    C0011008 (UMLS CUI [1])
    adverse event
    Item
    Did an adverse event occur during the treatment? (If yes, please use the form "Documentation adverse event")
    boolean
    C0877248 (UMLS CUI [1])
    serious adverse event
    Item
    Did a serious adverse event occur during the treatment? (If yes, please use the form "Documentation serious adverse events")
    boolean
    C1519255 (UMLS CUI [1])
    adverse event
    Item
    Are there any undocumented adverse events, which were not recorded during the previous visit? (If yes, please use the form "Documentation adverse event")
    boolean
    C0877248 (UMLS CUI [1])
    Patient diary
    Item
    Patient diary (part 1) handed out?
    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?
    text
    C0034380 (UMLS CUI [1])
    C0861155 (UMLS CUI [2])
    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
    Study medication and Concomitant medication (Taking back of the third study medication box with 8 blister pack)
    C0013227 (UMLS CUI-1)
    medication study
    Item
    Number of tablets left (study medication)
    integer
    C0013227 (UMLS CUI [1,1])
    C0008972 (UMLS CUI [1,2])
    medication Demand
    Item
    Number of tablets left (Loratadin)
    integer
    C0013227 (UMLS CUI [1,1])
    C0441516 (UMLS CUI [1,2])
    details
    Item
    Mention, if incomplete
    text
    C1522508 (UMLS CUI [1])
    Item Group
    Hematology
    C0474523 (UMLS CUI-1)
    date blood collection
    Item
    Blood collection on
    date
    C0011008 (UMLS CUI [1,1])
    C0005834 (UMLS CUI [1,2])
    diagnostic allergy
    Item
    Ig G4 Gräser
    float
    C0086143 (UMLS CUI [1,1])
    C0020517 (UMLS CUI [1,2])
    Hemoglobin
    Item
    Hemoglobin
    float
    C0019046 (UMLS CUI [1])
    hematocrit
    Item
    Hematocrit
    float
    C0518014 (UMLS CUI [1])
    Erythrocyte
    Item
    Erythrocyte
    float
    C0014772 (UMLS CUI [1])
    Thrombocyte
    Item
    Thrombocyte
    float
    C0005821 (UMLS CUI [1])
    Leucocyte
    Item
    Leucocyte (total)
    float
    C0023508 (UMLS CUI [1])
    Item Group
    Biochemistry
    C0005477 (UMLS CUI-1)
    Bilirubin
    Item
    Bilirubin (total)
    float
    C1278039 (UMLS CUI [1])
    Glutamate pyruvate transaminase
    Item
    SGPT- Serum Glutamate pyruvate transaminase
    float
    C0376147 (UMLS CUI [1])
    Alkaline phosphatase
    Item
    Alkaline phosphatase
    float
    C0201850 (UMLS CUI [1])
    Glucose
    Item
    Glucose
    float
    C0202042 (UMLS CUI [1])
    Creatinine
    Item
    Creatinine
    float
    C0201976 (UMLS CUI [1])
    Aspartate aminotransferase measurement
    Item
    SGOT- Aspartate aminotransferase measurement
    float
    C0201899 (UMLS CUI [1])
    C reactive protein
    Item
    CRP C reactive protein
    float
    C0201657 (UMLS CUI [1])
    Gamma-glutamyl transpeptidase
    Item
    Gamma-glutamyl transpeptidase
    float
    C1883012 (UMLS CUI [1])
    Item Group
    Demand medication
    C0013227 (UMLS CUI-1)
    C0441516 (UMLS CUI-2)
    Antihistamines
    Item
    Number of antihistamines (oral) handed out
    integer
    C0019590 (UMLS CUI [1])
    Levocabastin
    Item
    Number of Levocabastin eye drops given out
    integer
    C0064870 (UMLS CUI [1])
    Beclometason
    Item
    Number of Beclometason nasal sprays given out
    integer
    C0004905 (UMLS CUI [1])
    cortisone; beta agonist
    Item
    Number of combination of inhaled cortisone + long acting β2-receptor-agonist handed out
    integer
    C0010137 (UMLS CUI [1])
    C0001644 (UMLS CUI [2])
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