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ID

13257

Descrição

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

Palavras-chave

  1. 26/01/2016 26/01/2016 -
  2. 27/01/2016 27/01/2016 -
Transferido a

27 de janeiro de 2016

DOI

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Licença

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
    Descrição

    Study completion form

    Please give Patient ID composed of Study site Nr and Patient Nr
    Descrição

    Patient Identification

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C1269815 (Patient identification)
    SNOMED
    372039005
    This clinical trail has been completed according to protocol
    Descrição

    Completion of clinical trial

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C2732579 (Completion of clinical trial)
    SNOMED
    443729008
    If the trial has not been completed according to protocol please specify the reason why
    Descrição

    Completion of clinical trial

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2732579 (Completion of clinical trial)
    SNOMED
    443729008
    Please specify any other reason that caused discontinuation
    Descrição

    Completion of clinical trial

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2732579 (Completion of clinical trial)
    SNOMED
    443729008
    If the patient was lost to follow up, please specify date the patient was last seen
    Descrição

    Completion of clinical trial

    Tipo de dados

    date

    Alias
    UMLS CUI [1]
    C2732579 (Completion of clinical trial)
    SNOMED
    443729008
    Participation discontinued by
    Descrição

    Discontinuation

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0457454 (Discontinuation (procedure))
    Patient diary part 1-5 has been retrieved from the patient.
    Descrição

    Patient diary

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0018700 (Health Diaries)
    Further comments
    Descrição

    Further comments

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C1830770 (Additional comments)
    LOINC
    MTHU021545
    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
    Descrição

    Confirmation

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0750484 (Confirmation)
    LOINC
    LA15290-2
    Date of completion of this form
    Descrição

    Date

    Tipo de dados

    date

    Alias
    UMLS CUI [1]
    C0011008 (Date in time)
    SNOMED
    410671006
    Signature of investigator
    Descrição

    Signature of investigator

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0807938 (Signature of responsible attending physician on file)
    LOINC
    MTHU008308

    Similar models

    Case report form Study completion

    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Study completion form
    Patient Identification
    Item
    Please give Patient ID composed of Study site Nr and Patient Nr
    integer
    C1269815 (UMLS CUI [1])
    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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