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13252

Beschreibung

Prospective,multicentric,double blind and placebo-controlled Phase III clinical trial to determine efficacy and tolerability of subcutaneous hyposensitization with CLUSTOID in patients with allergic rhinoconjunctivits caused by grass or rye pollen. EudraCT-Nr. 2008-000513-29 Study-code:CLU-2008-001 Sponsor: ROXALL Medizin GmbH Carl-Petersen-Straße 4 20535 Hamburg Phone:040-8972520 Fax:040-89725223 Project coordinator: Dr.Jenny Uhlig ROXALL Medizin GmbH Head of clinical investigation: Prof.Dr.med.Ludger Klimek An den Quellen 10 65183 Wiesbaden Phone:0611-8904381 Fax:0611-3082360 Monitoring,data management and statistical evaluation: IMSIE- Institut for medical statistics,computer sciences and epidemiology University hospital Cologne Lindenburger Allee 42 50931 Cologne Phone:0221-4783456 Fax:0221-4783465

Stichworte

  1. 26.01.16 26.01.16 -
  2. 27.01.16 27.01.16 -
Hochgeladen am

26. Januar 2016

DOI

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Creative Commons BY-NC 3.0

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    Efficacy and tolerability of subcutaneous hyposensitization with CLUSTOID in Patients with allergic rhinoconjunctivitis Study completion

    Case report form Study completion

    Study completion form
    Beschreibung

    Study completion form

    This clinical trail has been completed according to protocol
    Beschreibung

    Completion of clinical trial

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2732579
    If the trial has not been completed according to protocol please specify the reason why
    Beschreibung

    Completion of clinical trial

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2732579
    Please specify any other reason that caused discontinuation
    Beschreibung

    Completion of clinical trial

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2732579
    If the patient was lost to follow up, please specify date the patient was last seen
    Beschreibung

    Completion of clinical trial

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C2732579
    Participation discontinued by
    Beschreibung

    Discontinuation

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0457454
    Patient diary part 1-5 has been retrieved from the patient.
    Beschreibung

    Patient diary

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0018700
    Further comments
    Beschreibung

    Further comments

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C1830770
    Confirmatin of investigator: The treatment of this patient during this investigation was under my supervision and according to study protocol. All data and statements in this CRF are complete and correct
    Beschreibung

    Confirmation

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0750484
    Date of completion of this form
    Beschreibung

    Date

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C0011008
    Signature of investigator
    Beschreibung

    Signature of investigator

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0807938

    Ähnliche Modelle

    Case report form Study completion

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Study completion form
    Completion of clinical trial
    Item
    This clinical trail has been completed according to protocol
    boolean
    C2732579 (UMLS CUI [1])
    Item
    If the trial has not been completed according to protocol please specify the reason why
    text
    C2732579 (UMLS CUI [1])
    Code List
    If the trial has not been completed according to protocol please specify the reason why
    CL Item
    adverse effect during dose titration (1)
    CL Item
    adverse/serious adverse event (2)
    CL Item
    withdrawal of informed consent (3)
    CL Item
    comorbidities (4)
    CL Item
    protocol violation (i.e lack of compliance) (5)
    CL Item
    pregnancy (6)
    CL Item
    private considerations of patient (7)
    CL Item
    other reason (8)
    CL Item
    lost to follow up (9)
    Completion of clinical trial
    Item
    Please specify any other reason that caused discontinuation
    text
    C2732579 (UMLS CUI [1])
    Completion of clinical trial
    Item
    If the patient was lost to follow up, please specify date the patient was last seen
    date
    C2732579 (UMLS CUI [1])
    Item
    Participation discontinued by
    text
    C0457454 (UMLS CUI [1])
    Code List
    Participation discontinued by
    CL Item
    Patient (1)
    CL Item
    Investigator (2)
    Patient diary
    Item
    Patient diary part 1-5 has been retrieved from the patient.
    boolean
    C0018700 (UMLS CUI [1])
    Further comments
    Item
    Further comments
    text
    C1830770 (UMLS CUI [1])
    Confirmation
    Item
    Confirmatin of investigator: The treatment of this patient during this investigation was under my supervision and according to study protocol. All data and statements in this CRF are complete and correct
    boolean
    C0750484 (UMLS CUI [1])
    Date
    Item
    Date of completion of this form
    date
    C0011008 (UMLS CUI [1])
    Signature of investigator
    Item
    Signature of investigator
    text
    C0807938 (UMLS CUI [1])

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