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ID

13271

Description

Study part: Documentation adverse events. 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.

Mots-clés

  1. 28/01/2016 28/01/2016 -
Téléchargé le

28 janvier 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0

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    Adverse events_LAIS grass tablets by allergic rhinoconjunctivitis_EudraCT-Nr.2012-004916-79Test Study

    Documentation adverse events

    Register form adverse event
    Description

    Register form adverse event

    Alias
    UMLS CUI-1
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    Adverse event
    Description

    Adverse event

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    Date on which adverse event began
    Description

    date

    Type de données

    date

    Alias
    UMLS CUI [1]
    C0011008 (Date in time)
    SNOMED
    410671006
    Is it a systemic reaction? (based on SLIT)
    Description

    Systemic Reaction

    Type de données

    text

    Alias
    UMLS CUI [1]
    C1710276 (Systemic Reaction)
    Relation to medication
    Description

    medication

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    Frequency of adverse event
    Description

    Frequency Adverse event

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0439603 (Frequencies (time pattern))
    SNOMED
    272123002
    LOINC
    LP130485-8
    UMLS CUI [1,2]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    Seriousness of adverse event
    Description

    Seriousness Adverse event

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0871902 (Seriousness)
    UMLS CUI [1,2]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    Course of adverse event
    Description

    course adverse event

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0750729 (Course)
    SNOMED
    288524001
    UMLS CUI [1,2]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    Measures related to study medication
    Description

    drug study

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    UMLS CUI [1,2]
    C0008972 (Clinical Research)
    Other taken measures
    Description

    concomitant medication; hospital

    Type de données

    text

    Alias
    UMLS CUI [1]
    C2347852 (Concomitant Agent)
    UMLS CUI [2]
    C0019994 (Hospitals)
    Date on which adverse event ended
    Description

    date

    Type de données

    date

    Alias
    UMLS CUI [1]
    C0011008 (Date in time)
    SNOMED
    410671006
    Ongoing of adverse event (beyond V7)?
    Description

    ongoing adverse event

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0549178 (Continuous)
    SNOMED
    255238004
    LOINC
    LA16902-1
    UMLS CUI [1,2]
    C0877248 (Adverse event)
    LOINC
    MTHU014542

    Similar models

    Documentation adverse events

    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    Register form adverse event
    C0877248 (UMLS CUI-1)
    Adverse event
    Item
    Adverse event
    text
    C0877248 (UMLS CUI [1])
    date
    Item
    Date on which adverse event began
    date
    C0011008 (UMLS CUI [1])
    Item
    Is it a systemic reaction? (based on SLIT)
    text
    C1710276 (UMLS CUI [1])
    Code List
    Is it a systemic reaction? (based on SLIT)
    CL Item
    nonspecific symptoms (e.g. headache, apprehension) (1)
    CL Item
    slight specific symptoms (local urticaria, rhinitis or slight asthma (PEF<20%)) (2)
    CL Item
    medium specific symptoms (slow onset of (> 15 min) of urticaria and/ or medium asthma (PEF < 40%)) (3)
    CL Item
    serious (not life threatening) systemic symptoms (rapid onset (< 15min) of urticaria, Angioedema or serious asthma (PEF > 40%)) (4)
    CL Item
    anaphylactic shock (please document additionally as SAE) (5)
    CL Item
    not applicable (6)
    Item
    Relation to medication
    text
    C0013227 (UMLS CUI [1])
    Code List
    Relation to medication
    CL Item
    not related (1)
    CL Item
    may be related (2)
    CL Item
    related (3)
    Item
    Frequency of adverse event
    text
    C0439603 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    Code List
    Frequency of adverse event
    CL Item
    once only (1)
    CL Item
    regular (2)
    CL Item
    continuous (3)
    Item
    Seriousness of adverse event
    text
    C0871902 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    Code List
    Seriousness of adverse event
    CL Item
    slight (1)
    CL Item
    medium (2)
    CL Item
    serious (3)
    Item
    Course of adverse event
    text
    C0750729 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    Code List
    Course of adverse event
    CL Item
    finished (1)
    CL Item
    subsided (2)
    CL Item
    continuous (3)
    CL Item
    finished/ resulting in additional symptoms (4)
    CL Item
    increased (5)
    CL Item
    deadly (6)
    CL Item
    unknown (7)
    Item
    Measures related to study medication
    text
    C0013227 (UMLS CUI [1,1])
    C0008972 (UMLS CUI [1,2])
    Code List
    Measures related to study medication
    CL Item
    no (1)
    CL Item
    dose adjustment (2)
    CL Item
    second interruption of therapy (3)
    CL Item
    discontinuation of therapy (4)
    CL Item
    other (5)
    Item
    Other taken measures
    text
    C2347852 (UMLS CUI [1])
    C0019994 (UMLS CUI [2])
    Code List
    Other taken measures
    CL Item
    no (1)
    CL Item
    change of concomitant medication (2)
    CL Item
    hospitalization/ extension of a hospital stay (3)
    CL Item
    additional therapeutic or diagnostic measure (4)
    date
    Item
    Date on which adverse event ended
    date
    C0011008 (UMLS CUI [1])
    ongoing adverse event
    Item
    Ongoing of adverse event (beyond V7)?
    boolean
    C0549178 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])

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