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ID

13261

Beschrijving

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

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Versies (1)
  1. 27-01-16 27-01-16 -
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27 januari 2016

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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 SAE report form

    Engels

    Serious Adverse Event report form

    1 Formulieren  
    SAE report form
    Beschrijving

    SAE report form

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

    Patient Identification

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C1269815
    Patient date of birth
    Beschrijving

    Birthdate

    Datatype

    date

    Alias
    UMLS CUI [1]
    C0421451
    At which visit has the SAE occurred?
    Beschrijving

    Visit number

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C1549755
    Patient Gender
    Beschrijving

    Gender

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0079399
    Body Height
    Beschrijving

    Body Height

    Datatype

    integer

    Maateenheden
    • cm
    Alias
    UMLS CUI [1]
    C0005890
    cm
    Body Weight
    Beschrijving

    Body Weight

    Datatype

    float

    Maateenheden
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Observed SAE
    Beschrijving

    Observed SAE

    When did the SAE occur? Please note day/month/year
    Beschrijving

    Date of occurrence

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C2697887
    Please describe anything relevant to this specific event: clinically relevant findings,laboratory results, medical history and comorbidities
    Beschrijving

    Description of SAE

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0678257
    UMLS CUI [1,2]
    C1519255
    Opinion of investigator
    Beschrijving

    Opinion of investigator

    Applied medication with lot number, please include also the investigational product.
    Beschrijving

    Medication

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0013227
    Daily dose of medication
    Beschrijving

    Daily dose

    Datatype

    float

    Alias
    UMLS CUI [1]
    C2348070
    Drug application route (i.e: i.v, s.c, i.m,oral,...)
    Beschrijving

    Drug application route

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0013153
    Medication use start date
    Beschrijving

    Medication use start date

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0240320
    UMLS CUI [1,2]
    C0808070
    Medication use end date
    Beschrijving

    Medication use end date

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0240320
    UMLS CUI [1,2]
    C0806020
    Is the SAE related to the pharmaceutical product?
    Beschrijving

    SAE Context

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0041755
    Outcome and treatment
    Beschrijving

    Outcome and treatment

    Lifethreatening adverse event
    Beschrijving

    Lifethreatening

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1517874
    Event resulted in a hospitalization
    Beschrijving

    Hospitalization

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0019993
    Date of hospital admission
    Beschrijving

    Date of hospital admission

    Datatype

    date

    Alias
    UMLS CUI [1]
    C0806429
    Please describe treatment (i.e chronological sequence, determining factors, discontinuation of medication, clinical condition of the patient at this point)
    Beschrijving

    Treatment methods

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0679624
    Please describe any attached documents (hospital report, lab results or other tests contributing to the diagnosis)
    Beschrijving

    Attached documents

    Datatype

    text

    Alias
    UMLS CUI [1]
    C1999228
    What ist the result of the reported SAE?
    Beschrijving

    Patient outcome

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C1547647
    UMLS CUI [1,2]
    C1519255
    Death related to Serious Adverse Event
    Beschrijving

    Death Related to Adverse Event

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1705232
    Death of the patient is not related to the trial substance
    Beschrijving

    Death context to trial substance

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C2983596
    UMLS CUI [1,2]
    C0041755
    Date of completion of this form
    Beschrijving

    Date

    Datatype

    date

    Alias
    UMLS CUI [1]
    C0011008
    Signature
    Beschrijving

    Signature

    Datatype

    text

    Alias
    UMLS CUI [1]
    C1519316
    Terug naar het begin van de pagina

    Similar models

    Serious Adverse Event report form

    1 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    SAE report form
    Patient Identification
    Item
    Please give Patient ID composed of Study site Nr and Patient Nr
    integer
    C1269815 (UMLS CUI [1])
    Birthdate
    Item
    Patient date of birth
    date
    C0421451 (UMLS CUI [1])
    Visit number
    Item
    At which visit has the SAE occurred?
    integer
    C1549755 (UMLS CUI [1])
    Item
    Patient Gender
    text
    C0079399 (UMLS CUI [1])
    Gender
    Code List
    Patient Gender
    CL Item
    Female (1)
    CL Item
    Male (2)
    Body Height
    Item
    Body Height
    integer
    C0005890 (UMLS CUI [1])
    Body Weight
    Item
    Body Weight
    float
    C0005910 (UMLS CUI [1])
    Item Group
    Observed SAE
    Date of occurrence
    Item
    When did the SAE occur? Please note day/month/year
    date
    C0011008 (UMLS CUI [1,1])
    C2697887 (UMLS CUI [1,2])
    Description of SAE
    Item
    Please describe anything relevant to this specific event: clinically relevant findings,laboratory results, medical history and comorbidities
    text
    C0678257 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Item Group
    Opinion of investigator
    Medication
    Item
    Applied medication with lot number, please include also the investigational product.
    text
    C0013227 (UMLS CUI [1])
    Daily dose
    Item
    Daily dose of medication
    float
    C2348070 (UMLS CUI [1])
    Drug application route
    Item
    Drug application route (i.e: i.v, s.c, i.m,oral,...)
    text
    C0013153 (UMLS CUI [1])
    Medication use start date
    Item
    Medication use start date
    date
    C0240320 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    Medication use end date
    Item
    Medication use end date
    date
    C0240320 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Item
    Is the SAE related to the pharmaceutical product?
    text
    C0013227 (UMLS CUI [1,1])
    C0041755 (UMLS CUI [1,2])
    SAE Context
    Code List
    Is the SAE related to the pharmaceutical product?
    CL Item
    no correlation (1)
    CL Item
    unlikely  (2)
    CL Item
    possible (3)
    CL Item
    confirmed (4)
    CL Item
    inconclusive/insufficent data (5)
    Item Group
    Outcome and treatment
    Lifethreatening
    Item
    Lifethreatening adverse event
    boolean
    C1517874 (UMLS CUI [1])
    Hospitalization
    Item
    Event resulted in a hospitalization
    boolean
    C0019993 (UMLS CUI [1])
    Date of hospital admission
    Item
    Date of hospital admission
    date
    C0806429 (UMLS CUI [1])
    Treatment methods
    Item
    Please describe treatment (i.e chronological sequence, determining factors, discontinuation of medication, clinical condition of the patient at this point)
    text
    C0679624 (UMLS CUI [1])
    Attached documents
    Item
    Please describe any attached documents (hospital report, lab results or other tests contributing to the diagnosis)
    text
    C1999228 (UMLS CUI [1])
    Item
    What ist the result of the reported SAE?
    text
    C1547647 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Patient outcome
    Code List
    What ist the result of the reported SAE?
    CL Item
    Recovered (1)
    CL Item
    Recovered with persisting sequelae (2)
    CL Item
    Continuing  (3)
    CL Item
    Unknown (4)
    CL Item
    Lethal (5)
    Death Related to Adverse Event
    Item
    Death related to Serious Adverse Event
    boolean
    C1705232 (UMLS CUI [1])
    Death context to trial substance
    Item
    Death of the patient is not related to the trial substance
    boolean
    C2983596 (UMLS CUI [1,1])
    C0041755 (UMLS CUI [1,2])
    Date
    Item
    Date of completion of this form
    date
    C0011008 (UMLS CUI [1])
    Signature
    Item
    Signature
    text
    C1519316 (UMLS CUI [1])
    Terug naar het begin van de pagina 

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