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ID

13184

Description

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

Keywords

Versions (2)
  1. 1/21/16 1/21/16 -
  2. 1/22/16 1/22/16 -
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January 22, 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 Visit 6

    English

    Case Report Form Visit 6

    1 forms  
    Visit 6:Maintenance Visit
    Description

    Visit 6:Maintenance Visit

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

    Patient Identification

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1269815
    Date of visit 6
    Description

    Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0011008
    Is the patient still participating in this trial? If no, please fill in study completion form
    Description

    Continued participation

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0030699
    UMLS CUI [1,2]
    C0549178
    Females of childbearing potential, using safe contraceptive measures? If no please fill in study completion form
    Description

    Contraceptive measures

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0700589
    Peak flow best value during visit 1
    Description

    Peak flow best value

    Data type

    integer

    Measurement units
    • l/min
    Alias
    UMLS CUI [1,1]
    C0521299
    UMLS CUI [1,2]
    C1299381
    l/min
    Please take 3 consecutive peak flow measurements
    Description

    Peak flow measurement

    Data type

    integer

    Measurement units
    • l/min
    Alias
    UMLS CUI [1]
    C0521299
    l/min
    Second peak flow measurement
    Description

    Peak flow measurement

    Data type

    integer

    Measurement units
    • l/min
    Alias
    UMLS CUI [1]
    C0521299
    l/min
    Third peak flow measurement
    Description

    Peak flow measurement

    Data type

    integer

    Measurement units
    • l/min
    Alias
    UMLS CUI [1]
    C0521299
    l/min
    Peak flow best value during visit 6
    Description

    Peak flow best value

    Data type

    integer

    Measurement units
    • l/min
    Alias
    UMLS CUI [1,1]
    C0521299
    UMLS CUI [1,2]
    C1299381
    l/min
    If peak flow measurement is > 80 percent of best value during visit 1, continue with allergen exposure, if no suspend next exposure to allergen and repeat peak flow measurement
    Description

    Continue with allergen exposure

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0238614
    First peak flow measurement after suspension
    Description

    Peak flow measurement

    Data type

    integer

    Measurement units
    • l/min
    Alias
    UMLS CUI [1]
    C0521299
    l/min
    Second peak flow measurement after suspension
    Description

    Peak flow measurement

    Data type

    integer

    Measurement units
    • l/min
    Alias
    UMLS CUI [1]
    C0521299
    l/min
    Third peak flow measurement after suspension
    Description

    Peak flow measurement

    Data type

    integer

    Measurement units
    • l/min
    Alias
    UMLS CUI [1]
    C0521299
    l/min
    Blood pressure measurement
    Description

    Blood pressure

    Data type

    text

    Measurement units
    • mm/Hg
    Alias
    UMLS CUI [1]
    C0005823
    mm/Hg
    Heart rate count
    Description

    Heart rate

    Data type

    integer

    Measurement units
    • bpm
    Alias
    UMLS CUI [1]
    C0018810
    bpm
    Body Height
    Description

    Body Height

    Data type

    integer

    Measurement units
    • cm
    Alias
    UMLS CUI [1]
    C0005890
    cm
    Body Weight
    Description

    Body Weight

    Data type

    float

    Measurement units
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Rhinoscopic evaluation:Edema
    Description

    Rhinoscopic evaluation

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0183044
    UMLS CUI [1,2]
    C0178628
    Rhinoscopic evaluation: secretion
    Description

    Rhinoscopic evaluation

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0183044
    UMLS CUI [1,2]
    C0178628
    Rhinoscopic evaluation:redness
    Description

    Rhinoscopic evaluation

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0183044
    UMLS CUI [1,2]
    C0178628
    Has concomitant medication been subject to change?
    Description

    Concomitant agent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2347852
    Please specify any changes of therapy and review for exclusion criteria
    Description

    Concomitant Agent

    Data type

    text

    Alias
    UMLS CUI [1]
    C2347852
    Have comorbidities changed?
    Description

    Comorbidities

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0009488
    If comorbidities have changed,please specify and review for exclusion criteria
    Description

    Comorbidities

    Data type

    text

    Alias
    UMLS CUI [1]
    C0009488
    Subcutaneous desensitization
    Description

    Subcutaneous desensitization

    Has the eighth dose of desensitization been administered?
    Description

    Eighth desensitization

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0849706
    Please give the date and time, the eighth dose has been administered
    Description

    Eighth desensitization

    Data type

    datetime

    Alias
    UMLS CUI [1]
    C0849706
    If the eighth dose has not been administered, please specify the reason why
    Description

    Eighth desensitization

    Data type

    text

    Alias
    UMLS CUI [1]
    C0849706
    How much of the trial substance has been injected?
    Description

    Eighth desensitization

    Data type

    text

    Measurement units
    • ml
    Alias
    UMLS CUI [1]
    C0849706
    If the dose of trial substance has been adjusted, please specify the reason why and how much has actually been administered
    Description

    Eighth desensitization

    Data type

    text

    Alias
    UMLS CUI [1]
    C0849706
    Please specify which arm has been used for injection
    Description

    Eighth desensitization

    Data type

    text

    Alias
    UMLS CUI [1]
    C0849706
    30 min after injection, has the patient experienced any local, gastrointestinal, systemic or other symptoms?
    Description

    if no, continue with injections according to protocol,if yes, please explain further below and eventually adjust dose during next visit.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0849706
    Have any of the following symptoms occured?If yes please do not forget to fill in AE report
    Description

    Eighth desensitization

    Data type

    text

    Alias
    UMLS CUI [1]
    C0849706
    Please specify any other symptoms that occured within 30 min after injection of eighth desensitization
    Description

    Eighth desensitization

    Data type

    text

    Alias
    UMLS CUI [1]
    C0849706
    Have severe local, gastrointestinal or systemic symptoms occured during eighth desensitization? If yes, the SAE sheet has to be filled in and sent to the sponsor within 24 hours.
    Description

    Serious adverse events during eighth desensitization

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0849706
    UMLS CUI [1,2]
    C1519255
    What measures have been taken in response to the SAE?
    Description

    Actions taken in response to the SAE

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C1547656
    Adverse Events
    Description

    Adverse Events

    Did any Adverse Events occur?
    Description

    Adverse Events

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0877248
    Have these been serious adverse events?
    Description

    In case of SAE please fill in the SAE-form at the end of this CRF asap (24h) and send via FAX to Roxall Medical GmbH (040/89725223)

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1519255
    Please describe the AE
    Description

    Adverse Event

    Data type

    text

    Alias
    UMLS CUI [1]
    C0877248
    Adverse Event Start Date
    Description

    Adverse Event Start Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C2697888
    Adverse Event End Date
    Description

    Adverse Event End Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C2697886
    How often did the event occur?
    Description

    Adverse event occurrence

    Data type

    text

    Alias
    UMLS CUI [1]
    C2697887
    Please give your opinion to the severity of the AE
    Description

    Adverse event severity

    Data type

    text

    Alias
    UMLS CUI [1]
    C1710066
    Adverse Event Outcome
    Description

    Adverse Event Outcome

    Data type

    text

    Alias
    UMLS CUI [1]
    C1705586
    What actions have been taken regarding the trial substance?
    Description

    Adverse Event actions taken

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826626
    What other actions have been taken in response to the AE?
    Description

    Adverse event actions taken

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826719
    Is the AE related to the trial substance?
    Description

    Adverse event context to trial substance

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2983596
    UMLS CUI [1,2]
    C0041755
    Please agree to a date for follow up V7 within next month
    Description

    Follow up

    Data type

    date

    Alias
    UMLS CUI [1]
    C1522577
    Date of completion of this form
    Description

    Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0011008
    Signature
    Description

    Signature

    Data type

    text

    Alias
    UMLS CUI [1]
    C1519316
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    Similar models

    Case Report Form Visit 6

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Visit 6:Maintenance Visit
    Patient Identification
    Item
    Please give Patient ID composed of Study site Nr and Patient Nr
    integer
    C1269815 (UMLS CUI [1])
    Date
    Item
    Date of visit 6
    date
    C0011008 (UMLS CUI [1])
    Continued participation
    Item
    Is the patient still participating in this trial? If no, please fill in study completion form
    boolean
    C0030699 (UMLS CUI [1,1])
    C0549178 (UMLS CUI [1,2])
    Contraceptive measures
    Item
    Females of childbearing potential, using safe contraceptive measures? If no please fill in study completion form
    boolean
    C0700589 (UMLS CUI [1])
    Peak flow best value
    Item
    Peak flow best value during visit 1
    integer
    C0521299 (UMLS CUI [1,1])
    C1299381 (UMLS CUI [1,2])
    Peak flow measurement
    Item
    Please take 3 consecutive peak flow measurements
    integer
    C0521299 (UMLS CUI [1])
    Peak flow measurement
    Item
    Second peak flow measurement
    integer
    C0521299 (UMLS CUI [1])
    Peak flow measurement
    Item
    Third peak flow measurement
    integer
    C0521299 (UMLS CUI [1])
    Peak flow best value
    Item
    Peak flow best value during visit 6
    integer
    C0521299 (UMLS CUI [1,1])
    C1299381 (UMLS CUI [1,2])
    Continue with allergen exposure
    Item
    If peak flow measurement is > 80 percent of best value during visit 1, continue with allergen exposure, if no suspend next exposure to allergen and repeat peak flow measurement
    boolean
    C0238614 (UMLS CUI [1])
    Peak flow measurement
    Item
    First peak flow measurement after suspension
    integer
    C0521299 (UMLS CUI [1])
    Peak flow measurement
    Item
    Second peak flow measurement after suspension
    integer
    C0521299 (UMLS CUI [1])
    Peak flow measurement
    Item
    Third peak flow measurement after suspension
    integer
    C0521299 (UMLS CUI [1])
    Blood pressure
    Item
    Blood pressure measurement
    text
    C0005823 (UMLS CUI [1])
    Heart rate
    Item
    Heart rate count
    integer
    C0018810 (UMLS CUI [1])
    Body Height
    Item
    Body Height
    integer
    C0005890 (UMLS CUI [1])
    Body Weight
    Item
    Body Weight
    float
    C0005910 (UMLS CUI [1])
    Item
    Rhinoscopic evaluation:Edema
    text
    C0183044 (UMLS CUI [1,1])
    C0178628 (UMLS CUI [1,2])
    Rhinoscopic evaluation
    Code List
    Rhinoscopic evaluation:Edema
    CL Item
    none (0)
    CL Item
    little (1)
    CL Item
    severe (2)
    Item
    Rhinoscopic evaluation: secretion
    text
    C0183044 (UMLS CUI [1,1])
    C0178628 (UMLS CUI [1,2])
    Rhinoscopic evaluation
    Code List
    Rhinoscopic evaluation: secretion
    CL Item
    none (0)
    CL Item
    clear fluid (1)
    CL Item
    thick mucous (2)
    Item
    Rhinoscopic evaluation:redness
    text
    C0183044 (UMLS CUI [1,1])
    C0178628 (UMLS CUI [1,2])
    Rhinoscopic evaluation
    Code List
    Rhinoscopic evaluation:redness
    CL Item
    none (0)
    CL Item
    little (1)
    CL Item
    severe (2)
    Concomitant agent
    Item
    Has concomitant medication been subject to change?
    boolean
    C2347852 (UMLS CUI [1])
    Concomitant Agent
    Item
    Please specify any changes of therapy and review for exclusion criteria
    text
    C2347852 (UMLS CUI [1])
    Comorbidities
    Item
    Have comorbidities changed?
    boolean
    C0009488 (UMLS CUI [1])
    Comorbidities
    Item
    If comorbidities have changed,please specify and review for exclusion criteria
    text
    C0009488 (UMLS CUI [1])
    Item Group
    Subcutaneous desensitization
    Eighth desensitization
    Item
    Has the eighth dose of desensitization been administered?
    boolean
    C0849706 (UMLS CUI [1])
    Eighth desensitization
    Item
    Please give the date and time, the eighth dose has been administered
    datetime
    C0849706 (UMLS CUI [1])
    Eighth desensitization
    Item
    If the eighth dose has not been administered, please specify the reason why
    text
    C0849706 (UMLS CUI [1])
    Item
    How much of the trial substance has been injected?
    text
    C0849706 (UMLS CUI [1])
    Eighth desensitization
    Code List
    How much of the trial substance has been injected?
    CL Item
    0,5ml (1)
    CL Item
    adjusted dose (2)
    Eighth desensitization
    Item
    If the dose of trial substance has been adjusted, please specify the reason why and how much has actually been administered
    text
    C0849706 (UMLS CUI [1])
    Item
    Please specify which arm has been used for injection
    text
    C0849706 (UMLS CUI [1])
    Eighth desensitization
    Code List
    Please specify which arm has been used for injection
    CL Item
    right arm (1)
    CL Item
    left arm (2)
    Eighth desensitization
    Item
    30 min after injection, has the patient experienced any local, gastrointestinal, systemic or other symptoms?
    boolean
    C0849706 (UMLS CUI [1])
    Item
    Have any of the following symptoms occured?If yes please do not forget to fill in AE report
    text
    C0849706 (UMLS CUI [1])
    Eighth desensitization
    Code List
    Have any of the following symptoms occured?If yes please do not forget to fill in AE report
    CL Item
    local reaction of the skin:swelling,itching,rash,or burning sensation (1)
    CL Item
    gastrointestinal symptoms:nausea,vomiting,dyspepsia,flatulence,diarrhea (2)
    CL Item
    systemic reactions (3)
    CL Item
    unspecified symptoms like headache, discomfort (3.1)
    CL Item
    minor systemic symptoms like rhinitis,or minor asthmatic symptoms (3.2)
    CL Item
    non-life-threatening systemic symptoms like urticaria, angioedema,severe asthmatic symptoms (3.3)
    CL Item
    severe systemic symptoms like anaphylactic shock [extended documentation as SAE] (3.4)
    CL Item
    other (4)
    Eighth desensitization
    Item
    Please specify any other symptoms that occured within 30 min after injection of eighth desensitization
    text
    C0849706 (UMLS CUI [1])
    Serious adverse events during eighth desensitization
    Item
    Have severe local, gastrointestinal or systemic symptoms occured during eighth desensitization? If yes, the SAE sheet has to be filled in and sent to the sponsor within 24 hours.
    boolean
    C0849706 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Item
    What measures have been taken in response to the SAE?
    text
    C1519255 (UMLS CUI [1,1])
    C1547656 (UMLS CUI [1,2])
    Actions taken in response to the SAE
    Code List
    What measures have been taken in response to the SAE?
    CL Item
    termination of study -> please fill in study completion form 2=adjustment of dose during next course of desensitization (1)
    Item Group
    Adverse Events
    Adverse Events
    Item
    Did any Adverse Events occur?
    boolean
    C0877248 (UMLS CUI [1])
    Have these been serious adverse events?
    Item
    Have these been serious adverse events?
    boolean
    C1519255 (UMLS CUI [1])
    Adverse Event
    Item
    Please describe the AE
    text
    C0877248 (UMLS CUI [1])
    Adverse Event Start Date
    Item
    Adverse Event Start Date
    date
    C2697888 (UMLS CUI [1])
    Adverse Event End Date
    Item
    Adverse Event End Date
    date
    C2697886 (UMLS CUI [1])
    Item
    How often did the event occur?
    text
    C2697887 (UMLS CUI [1])
    Adverse event occurrence
    Code List
    How often did the event occur?
    CL Item
    once (1)
    CL Item
    regularly (2)
    CL Item
    continuing (3)
    Item
    Please give your opinion to the severity of the AE
    text
    C1710066 (UMLS CUI [1])
    Adverse event severity
    Code List
    Please give your opinion to the severity of the AE
    CL Item
    minor (1)
    CL Item
    moderate (2)
    CL Item
    severe (3)
    Item
    Adverse Event Outcome
    text
    C1705586 (UMLS CUI [1])
    Adverse Event Outcome
    Code List
    Adverse Event Outcome
    CL Item
    Recovered (1)
    CL Item
    Subsiding (2)
    CL Item
    Continuing (3)
    CL Item
    resolved with sequelae (4)
    CL Item
    increased symptoms (5)
    CL Item
    fatal (6)
    Item
    What actions have been taken regarding the trial substance?
    text
    C2826626 (UMLS CUI [1])
    Adverse Event actions taken
    Code List
    What actions have been taken regarding the trial substance?
    CL Item
    not applicable (1)
    CL Item
    no adjustment in dose (2)
    CL Item
    adjustment of dose (3)
    CL Item
    suspension of treatment (4)
    CL Item
    discontinuation of treatment (5)
    CL Item
    other (6)
    Item
    What other actions have been taken in response to the AE?
    text
    C2826719 (UMLS CUI [1])
    Adverse event actions taken
    Code List
    What other actions have been taken in response to the AE?
    CL Item
    none (1)
    CL Item
    change of concomitant medication (2)
    CL Item
    hospitalization/prolonged stay in hospital (3)
    CL Item
    further therapeutic and diagnostic measures (4)
    Item
    Is the AE related to the trial substance?
    text
    C2983596 (UMLS CUI [1,1])
    C0041755 (UMLS CUI [1,2])
    Adverse event context to trial substance
    Code List
    Is the AE related to the trial substance?
    CL Item
    undecided/incomplete (1)
    CL Item
    inconclusive (2)
    CL Item
    without context to trial substance (3)
    CL Item
    unlikely (4)
    CL Item
    possible (5)
    CL Item
    probable (6)
    CL Item
    confirmed (7)
    Follow up
    Item
    Please agree to a date for follow up V7 within next month
    date
    C1522577 (UMLS CUI [1])
    Date
    Item
    Date of completion of this form
    date
    C0011008 (UMLS CUI [1])
    Signature
    Item
    Signature
    text
    C1519316 (UMLS CUI [1])
    Back to the top of the page 

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