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ID

13244

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 -
Hochgeladen am

26. Januar 2016

DOI

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    Efficacy and tolerability of subcutaneous hyposensitization with CLUSTOID in Patients with allergic rhinoconjunctivitis Visit 14

    Case Report Form Visit 14

    Visit 14:Study Completion Visit
    Beschreibung

    Visit 14:Study Completion Visit

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

    Patient Identification

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C1269815
    Date of visit 14
    Beschreibung

    Date

    Datentyp

    date

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

    Continued participation

    Datentyp

    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
    Beschreibung

    Contraceptive measures

    Datentyp

    boolean

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

    Peak flow best value

    Datentyp

    integer

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

    Peak flow measurement

    Datentyp

    integer

    Maßeinheiten
    • l/min
    Alias
    UMLS CUI [1]
    C0521299
    l/min
    Second peak flow measurement
    Beschreibung

    Peak flow measurement

    Datentyp

    integer

    Maßeinheiten
    • l/min
    Alias
    UMLS CUI [1]
    C0521299
    l/min
    Third peak flow measurement
    Beschreibung

    Peak flow measurement

    Datentyp

    integer

    Maßeinheiten
    • l/min
    Alias
    UMLS CUI [1]
    C0521299
    l/min
    Peak flow best value during visit 14
    Beschreibung

    Peak flow best value

    Datentyp

    integer

    Maßeinheiten
    • 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
    Beschreibung

    Continue with allergen exposure

    Datentyp

    boolean

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

    Peak flow measurement

    Datentyp

    integer

    Maßeinheiten
    • l/min
    Alias
    UMLS CUI [1]
    C0521299
    l/min
    Second peak flow measurement after suspension
    Beschreibung

    Peak flow measurement

    Datentyp

    integer

    Maßeinheiten
    • l/min
    Alias
    UMLS CUI [1]
    C0521299
    l/min
    Third peak flow measurement after suspension
    Beschreibung

    Peak flow measurement

    Datentyp

    integer

    Maßeinheiten
    • l/min
    Alias
    UMLS CUI [1]
    C0521299
    l/min
    Blood pressure measurement
    Beschreibung

    Blood pressure

    Datentyp

    text

    Maßeinheiten
    • mm/Hg
    Alias
    UMLS CUI [1]
    C0005823
    mm/Hg
    Heart rate count
    Beschreibung

    Heart rate

    Datentyp

    integer

    Maßeinheiten
    • bpm
    Alias
    UMLS CUI [1]
    C0018810
    bpm
    Body Height
    Beschreibung

    Body Height

    Datentyp

    integer

    Maßeinheiten
    • cm
    Alias
    UMLS CUI [1]
    C0005890
    cm
    Body weight
    Beschreibung

    Body weight

    Datentyp

    float

    Maßeinheiten
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Rhinoscopic evaluation:Edema
    Beschreibung

    Rhinoscopic evaluation

    Datentyp

    text

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

    Rhinoscopic evaluation

    Datentyp

    text

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

    Rhinoscopic evaluation

    Datentyp

    text

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

    Concomitant agent

    Datentyp

    boolean

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

    Concomitant Agent

    Datentyp

    text

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

    Comorbidities

    Datentyp

    boolean

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

    Comorbidities

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0009488
    Has the patient filled in the questionnaire regarding the quality of life of patients with rhinoconjunctivitis?
    Beschreibung

    Quality of life questionnaire

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0518214
    Baseline value of nasal irritation
    Beschreibung

    Nasal provocation test

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0027431
    blank value of nasal irritation
    Beschreibung

    Nasal provocation test

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0027431
    First provocation value of nasal irritation
    Beschreibung

    Nasal provocation test

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0027431
    second provocation value of nasal irritation
    Beschreibung

    Nasal provocation test

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0027431
    Baseline value of nasal secretion provocation
    Beschreibung

    Nasal provocation test

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0027431
    Blank value of nasal secretion provocation
    Beschreibung

    Nasal provocation test

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0027431
    First provocation value of nasal secretion
    Beschreibung

    Nasal provocation test

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0027431
    Second provocation value of nasal secretion
    Beschreibung

    Nasal provocation test

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0027431
    Baseline value of remote symptom provocation
    Beschreibung

    Nasal provocation test

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0027431
    Blank value of remote symptom provocation
    Beschreibung

    Nasal provocation test

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0027431
    First provocation value of remote symptoms
    Beschreibung

    Nasal provocation test

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0027431
    Second provocation value of remote symptoms
    Beschreibung

    Nasal provocation test

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0027431
    Sum of nasal provocation test symptom scores: baseline value
    Beschreibung

    Nasal provocation test

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0027431
    Sum of nasal provocation test symptom scores: blank value
    Beschreibung

    Nasal provocation test

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0027431
    Sum of nasal provocation test symptom scores:first provocation value
    Beschreibung

    Nasal provocation test

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0027431
    Sum of nasal provocation test symptom scores:second provocation value
    Beschreibung

    Nasal provocation test

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0027431
    Flow volume in cm3/sec baseline value
    Beschreibung

    Rhinomanometry

    Datentyp

    float

    Maßeinheiten
    • cm3
    Alias
    UMLS CUI [1]
    C0430615
    cm3
    Flow volume in cm3/sec blank value
    Beschreibung

    Rhinomanometry

    Datentyp

    float

    Maßeinheiten
    • cm3
    Alias
    UMLS CUI [1]
    C0430615
    cm3
    Flow volume in cm3/sec first provocation value
    Beschreibung

    Rhinomanometry

    Datentyp

    float

    Maßeinheiten
    • cm3
    Alias
    UMLS CUI [1]
    C0430615
    cm3
    Flow volume in cm3/sec second provocation value
    Beschreibung

    Rhinomanometry

    Datentyp

    float

    Maßeinheiten
    • cm3
    Alias
    UMLS CUI [1]
    C0430615
    cm3
    Percentage of flow reduction:blank value
    Beschreibung

    Flow volume reduction >20%=termination of provocation test due to unspecified reaction.

    Datentyp

    integer

    Maßeinheiten
    • %
    Alias
    UMLS CUI [1]
    C0430615
    %
    Percentage of flow reduction:first provocation value
    Beschreibung

    Flow volume reduction >40% or symptom score>3 or flow volume reduction >20% plus additional symptom score >2=termination of provocation test Otherwise record second provocation value

    Datentyp

    integer

    Maßeinheiten
    • %
    Alias
    UMLS CUI [1]
    C0430615
    %
    Percentage of flow reduction:second provocation value
    Beschreibung

    Flow volume reduction >40% or symptom score >3 or flow volume reduction >20% and aditional symptom score >2 = termination of provocation tests anyway

    Datentyp

    integer

    Maßeinheiten
    • %
    Alias
    UMLS CUI [1]
    C0430615
    %
    Rhinoscopic evaluation after provocation tests:Edema
    Beschreibung

    Rhinoscopic evaluation

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0183044
    UMLS CUI [1,2]
    C0178628
    Rhinoscopic evaluation after provocation test: secretion
    Beschreibung

    Rhinoscopic evaluation

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0183044
    UMLS CUI [1,2]
    C0178628
    Rhinoscopic evaluation after provocation tests:redness
    Beschreibung

    Rhinoscopic evaluation

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0183044
    UMLS CUI [1,2]
    C0178628
    Determination of specific IgE and Safety Laboratory parameter
    Beschreibung

    Determination of specific IgE and Safety Laboratory parameter

    Radioallergosorbent test categories for timothy grass
    Beschreibung

    Identify RAST-categories [kU/L] for each allergen and note corresponding category below

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0204726
    UMLS CUI [1,2]
    C0443736
    Please specify RAST-Category [kU/L] for Timothy grass
    Beschreibung

    Radioallergosorbent test timothy grass

    Datentyp

    float

    Maßeinheiten
    • kU/L
    Alias
    UMLS CUI [1]
    C0799220
    kU/L
    Radioallergosorbent test categories for rye
    Beschreibung

    Verification of specific IgE

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0204726
    UMLS CUI [1,2]
    C0443736
    Please specify RAST-Category [kU/L] for rye pollen
    Beschreibung

    Radioallergosorbent test categories for rye

    Datentyp

    float

    Maßeinheiten
    • kU/L
    Alias
    UMLS CUI [1]
    C1271227
    kU/L
    Total IgE [kU/L]
    Beschreibung

    Total IgE

    Datentyp

    float

    Maßeinheiten
    • kU/L
    Alias
    UMLS CUI [1]
    C0797024
    kU/L
    Verification of RAST categories: timothy grass, specific IgG4
    Beschreibung

    Verification of specific IgG4

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0204726
    UMLS CUI [1,2]
    C0443736
    Please specify RAST-Category [kU/L] for Timothy grass, specific IgG4
    Beschreibung

    Radioallergosorbent test catagories timothy grass

    Datentyp

    float

    Maßeinheiten
    • kU/L
    Alias
    UMLS CUI [1]
    C0942402
    kU/L
    Verification of RAST categories for rye ,specific IgG4
    Beschreibung

    Verification of specific IgG4

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0204726
    UMLS CUI [1,2]
    C0443736
    Please specify RAST-Category [kU/L] for rye pollen, specific IgG4
    Beschreibung

    Radioallergosorbent test categories for rye

    Datentyp

    float

    Maßeinheiten
    • kU/L
    Alias
    UMLS CUI [1]
    C1271227
    kU/L
    Please specify measured hemoglobine and units used
    Beschreibung

    Please collect every one of the listed parameters below and add units as applicable

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1254595
    UMLS CUI [1,2]
    C1269689
    Please specify measured amount of erythrocytes and units used
    Beschreibung

    Laboratory results, safety parameter

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1254595
    UMLS CUI [1,2]
    C1269689
    Please specify measured amount of leucocytes and units used
    Beschreibung

    Laboratory results, safety parameter

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1254595
    UMLS CUI [1,2]
    C1269689
    Please specify measured amount of neutrophils and units used
    Beschreibung

    Laboratory results, safety parameter

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1254595
    UMLS CUI [1,2]
    C1269689
    Please specify measured amount of eosinophils and units used
    Beschreibung

    Laboratory results, safety parameter

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1254595
    UMLS CUI [1,2]
    C1269689
    Please specify measured amount of basophils and units used
    Beschreibung

    Laboratory results, safety parameter

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1254595
    UMLS CUI [1,2]
    C1269689
    Please specify measured amount of monocytes and units used
    Beschreibung

    Laboratory results, safety parameter

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1254595
    UMLS CUI [1,2]
    C1269689
    Please specify measured amount of lymphocytes and units used
    Beschreibung

    Laboratory results, safety parameter

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1254595
    UMLS CUI [1,2]
    C1269689
    Please specify measured hematocrit and units used
    Beschreibung

    Laboratory results, safety parameter

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1254595
    UMLS CUI [1,2]
    C1269689
    Please specify measured amount of thrombocytes and units used
    Beschreibung

    Laboratory results, safety parameter

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1254595
    UMLS CUI [1,2]
    C1269689
    Please specify measured amount of total bilirubin and units used
    Beschreibung

    Laboratory results, safety parameter

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1254595
    UMLS CUI [1,2]
    C1269689
    Please specify the measured SGPT and units used
    Beschreibung

    Laboratory results, safety parameter

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1254595
    UMLS CUI [1,2]
    C1269689
    Please specify the measurement of LDH and units used
    Beschreibung

    Laboratory results, safety parameter

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1254595
    UMLS CUI [1,2]
    C1269689
    Please specify the measurement of creatinine and units used
    Beschreibung

    Laboratory results, safety parameter

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1254595
    UMLS CUI [1,2]
    C1269689
    Please specify the measurement of serum glutamate-oxaloacetate transaminase and units used
    Beschreibung

    Laboratory results, safety parameter

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1254595
    UMLS CUI [1,2]
    C1269689
    Please specify the measurement of CRP and units used
    Beschreibung

    Laboratory results, safety parameter

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1254595
    UMLS CUI [1,2]
    C1269689
    Subcutaneous desensitization
    Beschreibung

    Subcutaneous desensitization

    Has the sixteenth dose of desensitization been administered?
    Beschreibung

    Sixteenth desensitization

    Datentyp

    boolean

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

    Sixteenth desensitization

    Datentyp

    datetime

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

    Sixteenth desensitization

    Datentyp

    text

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

    Sixteenth desensitization

    Datentyp

    text

    Maßeinheiten
    • 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
    Beschreibung

    Sixteenth desensitization

    Datentyp

    text

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

    Sixteenth desensitization

    Datentyp

    text

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

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

    Datentyp

    boolean

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

    Sixteenth desensitization

    Datentyp

    text

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

    Serious adverse events during fifteenth desensitization

    Datentyp

    boolean

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

    Actions taken in response to the SAE

    Datentyp

    text

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

    Adverse Events

    Did any Adverse Events occur?
    Beschreibung

    Adverse Events

    Datentyp

    boolean

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

    Have these been serious adverse events?

    Datentyp

    boolean

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

    Adverse Event

    Datentyp

    text

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

    Adverse Event Start Date

    Datentyp

    date

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

    Adverse Event End Date

    Datentyp

    date

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

    Adverse event occurrence

    Datentyp

    text

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

    Adverse event severity

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C1710066
    Adverse Event Outcome
    Beschreibung

    Adverse Event Outcome

    Datentyp

    text

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

    Adverse Event actions taken

    Datentyp

    text

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

    Adverse event actions taken

    Datentyp

    text

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

    Adverse event context to trial substance

    Datentyp

    text

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

    Date

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C0011008
    Signature
    Beschreibung

    Signature

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C1519316

    Ähnliche Modelle

    Case Report Form Visit 14

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Visit 14:Study Completion 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 14
    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 14
    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])
    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])
    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])
    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])
    Quality of life questionnaire
    Item
    Has the patient filled in the questionnaire regarding the quality of life of patients with rhinoconjunctivitis?
    boolean
    C0518214 (UMLS CUI [1])
    Item
    Baseline value of nasal irritation
    text
    C0027431 (UMLS CUI [1])
    Code List
    Baseline value of nasal irritation
    CL Item
    0 sneezing 0-2 times (0)
    CL Item
    1 sneezing 3-5 times (1)
    CL Item
    2 >5 times (2)
    Item
    blank value of nasal irritation
    text
    C0027431 (UMLS CUI [1])
    Code List
    blank value of nasal irritation
    CL Item
    0 sneezing 0-2 times (0)
    CL Item
    1 sneezing 3-5 times (1)
    CL Item
    2 sneezing >5 times (2)
    Item
    First provocation value of nasal irritation
    text
    C0027431 (UMLS CUI [1])
    Code List
    First provocation value of nasal irritation
    CL Item
    0 sneezing 0-2 times (0)
    CL Item
    1 sneezing 3-5 times (1)
    CL Item
    2 sneezing >5 times (2)
    Item
    second provocation value of nasal irritation
    text
    C0027431 (UMLS CUI [1])
    Code List
    second provocation value of nasal irritation
    CL Item
    0 sneezing 0-2 times (0)
    CL Item
    1 sneezing 3-5 times (1)
    CL Item
    2 sneezing >5 times (2)
    Item
    Baseline value of nasal secretion provocation
    text
    C0027431 (UMLS CUI [1])
    Code List
    Baseline value of nasal secretion provocation
    CL Item
    0 no secretion (0)
    CL Item
    1 little secretion (1)
    CL Item
    2 heavy secretion (2)
    Item
    Blank value of nasal secretion provocation
    text
    C0027431 (UMLS CUI [1])
    Code List
    Blank value of nasal secretion provocation
    CL Item
    0 no secretion (0)
    CL Item
    1 little secretion (1)
    CL Item
    2 heavy secretion (2)
    Item
    First provocation value of nasal secretion
    text
    C0027431 (UMLS CUI [1])
    Code List
    First provocation value of nasal secretion
    CL Item
    0 no secretion (0)
    CL Item
    1 little secretion (1)
    CL Item
    2 heavy secretion (2)
    Item
    Second provocation value of nasal secretion
    text
    C0027431 (UMLS CUI [1])
    Code List
    Second provocation value of nasal secretion
    CL Item
    0 no secretion (0)
    CL Item
    1 little secretion (1)
    CL Item
    2 heavy secretion (2)
    Item
    Baseline value of remote symptom provocation
    text
    C0027431 (UMLS CUI [1])
    Code List
    Baseline value of remote symptom provocation
    CL Item
    0 none (0)
    CL Item
    1 lacrimation and/or itching of palate/ears (1)
    CL Item
    2 conjunctivitis and/or urticaria and/or coughing and/or shortness of breath (2)
    Item
    Blank value of remote symptom provocation
    text
    C0027431 (UMLS CUI [1])
    Code List
    Blank value of remote symptom provocation
    CL Item
    0 none (0)
    CL Item
    1 lacrimation and/or itching of palate/ears (1)
    CL Item
    2 conjunctivitis and/or urticaria and/or coughing and/or shortness of breath (2)
    Item
    First provocation value of remote symptoms
    text
    C0027431 (UMLS CUI [1])
    Code List
    First provocation value of remote symptoms
    CL Item
    0 none  (0)
    CL Item
    1 lacrimation and/or itching of palate/ears  (1)
    CL Item
    2 conjunctivitis and/or urticaria and/or coughing and/or shortness of breath (2)
    Item
    Second provocation value of remote symptoms
    text
    C0027431 (UMLS CUI [1])
    Code List
    Second provocation value of remote symptoms
    CL Item
    0 none  (0)
    CL Item
    1 lacrimation and/or itching of palate/ears  (1)
    CL Item
    2 conjunctivitis and/or urticaria and/or coughing and/or shortness of breath (2)
    Nasal provocation test
    Item
    Sum of nasal provocation test symptom scores: baseline value
    integer
    C0027431 (UMLS CUI [1])
    Nasal provocation test
    Item
    Sum of nasal provocation test symptom scores: blank value
    integer
    C0027431 (UMLS CUI [1])
    Nasal provocation test
    Item
    Sum of nasal provocation test symptom scores:first provocation value
    integer
    C0027431 (UMLS CUI [1])
    Nasal provocation test
    Item
    Sum of nasal provocation test symptom scores:second provocation value
    integer
    C0027431 (UMLS CUI [1])
    Rhinomanometry
    Item
    Flow volume in cm3/sec baseline value
    float
    C0430615 (UMLS CUI [1])
    Rhinomanometry
    Item
    Flow volume in cm3/sec blank value
    float
    C0430615 (UMLS CUI [1])
    Rhinomanometry
    Item
    Flow volume in cm3/sec first provocation value
    float
    C0430615 (UMLS CUI [1])
    Rhinomanometry
    Item
    Flow volume in cm3/sec second provocation value
    float
    C0430615 (UMLS CUI [1])
    Rhinomanometry
    Item
    Percentage of flow reduction:blank value
    integer
    C0430615 (UMLS CUI [1])
    Rhinomanometry
    Item
    Percentage of flow reduction:first provocation value
    integer
    C0430615 (UMLS CUI [1])
    Rhinomanometry
    Item
    Percentage of flow reduction:second provocation value
    integer
    C0430615 (UMLS CUI [1])
    Item
    Rhinoscopic evaluation after provocation tests:Edema
    text
    C0183044 (UMLS CUI [1,1])
    C0178628 (UMLS CUI [1,2])
    Code List
    Rhinoscopic evaluation after provocation tests:Edema
    CL Item
    none (0)
    CL Item
    little (1)
    CL Item
    severe (2)
    Item
    Rhinoscopic evaluation after provocation test: secretion
    text
    C0183044 (UMLS CUI [1,1])
    C0178628 (UMLS CUI [1,2])
    Code List
    Rhinoscopic evaluation after provocation test: secretion
    CL Item
    none (0)
    CL Item
    clear fluid (1)
    CL Item
    thick mucous (2)
    Item
    Rhinoscopic evaluation after provocation tests:redness
    text
    C0183044 (UMLS CUI [1,1])
    C0178628 (UMLS CUI [1,2])
    Code List
    Rhinoscopic evaluation after provocation tests:redness
    CL Item
    none (0)
    CL Item
    little (1)
    CL Item
    severe (2)
    Item Group
    Determination of specific IgE and Safety Laboratory parameter
    Item
    Radioallergosorbent test categories for timothy grass
    text
    C0204726 (UMLS CUI [1,1])
    C0443736 (UMLS CUI [1,2])
    Code List
    Radioallergosorbent test categories for timothy grass
    CL Item
    <0,35 (0)
    CL Item
    0,35-069 (I)
    CL Item
    0,70-3,49 (II)
    CL Item
    3,50-17,49 (III)
    CL Item
    17,5-49,99 (IV)
    CL Item
    50-100 (V)
    CL Item
    >100 (VI)
    Radioallergosorbent test timothy grass
    Item
    Please specify RAST-Category [kU/L] for Timothy grass
    float
    C0799220 (UMLS CUI [1])
    Item
    Radioallergosorbent test categories for rye
    text
    C0204726 (UMLS CUI [1,1])
    C0443736 (UMLS CUI [1,2])
    Code List
    Radioallergosorbent test categories for rye
    CL Item
    <0,35 I= 0,35-069 II= 0,70-3,49 III= 3,50-17,49 IV= 17,5-49,99 V= 50-100 VI= >100 (0)
    Radioallergosorbent test categories for rye
    Item
    Please specify RAST-Category [kU/L] for rye pollen
    float
    C1271227 (UMLS CUI [1])
    Total IgE
    Item
    Total IgE [kU/L]
    float
    C0797024 (UMLS CUI [1])
    Item
    Verification of RAST categories: timothy grass, specific IgG4
    text
    C0204726 (UMLS CUI [1,1])
    C0443736 (UMLS CUI [1,2])
    Code List
    Verification of RAST categories: timothy grass, specific IgG4
    CL Item
    <0,35 I= 0,35-069 II= 0,70-3,49 III= 3,50-17,49 IV= 17,5-49,99 V= 50-100 VI= >100 (0)
    Radioallergosorbent test catagories timothy grass
    Item
    Please specify RAST-Category [kU/L] for Timothy grass, specific IgG4
    float
    C0942402 (UMLS CUI [1])
    Item
    Verification of RAST categories for rye ,specific IgG4
    text
    C0204726 (UMLS CUI [1,1])
    C0443736 (UMLS CUI [1,2])
    Code List
    Verification of RAST categories for rye ,specific IgG4
    CL Item
    <0,35 I= 0,35-069 II= 0,70-3,49 III= 3,50-17,49 IV= 17,5-49,99 V= 50-100 VI= >100 (0)
    Radioallergosorbent test categories for rye
    Item
    Please specify RAST-Category [kU/L] for rye pollen, specific IgG4
    float
    C1271227 (UMLS CUI [1])
    Laboratory results, safety parameter
    Item
    Please specify measured hemoglobine and units used
    text
    C1254595 (UMLS CUI [1,1])
    C1269689 (UMLS CUI [1,2])
    Laboratory results, safety parameter
    Item
    Please specify measured amount of erythrocytes and units used
    text
    C1254595 (UMLS CUI [1,1])
    C1269689 (UMLS CUI [1,2])
    Laboratory results, safety parameter
    Item
    Please specify measured amount of leucocytes and units used
    text
    C1254595 (UMLS CUI [1,1])
    C1269689 (UMLS CUI [1,2])
    Laboratory results, safety parameter
    Item
    Please specify measured amount of neutrophils and units used
    text
    C1254595 (UMLS CUI [1,1])
    C1269689 (UMLS CUI [1,2])
    Laboratory results, safety parameter
    Item
    Please specify measured amount of eosinophils and units used
    text
    C1254595 (UMLS CUI [1,1])
    C1269689 (UMLS CUI [1,2])
    Laboratory results, safety parameter
    Item
    Please specify measured amount of basophils and units used
    text
    C1254595 (UMLS CUI [1,1])
    C1269689 (UMLS CUI [1,2])
    Laboratory results, safety parameter
    Item
    Please specify measured amount of monocytes and units used
    text
    C1254595 (UMLS CUI [1,1])
    C1269689 (UMLS CUI [1,2])
    Laboratory results, safety parameter
    Item
    Please specify measured amount of lymphocytes and units used
    text
    C1254595 (UMLS CUI [1,1])
    C1269689 (UMLS CUI [1,2])
    Laboratory results, safety parameter
    Item
    Please specify measured hematocrit and units used
    text
    C1254595 (UMLS CUI [1,1])
    C1269689 (UMLS CUI [1,2])
    Laboratory results, safety parameter
    Item
    Please specify measured amount of thrombocytes and units used
    text
    C1254595 (UMLS CUI [1,1])
    C1269689 (UMLS CUI [1,2])
    Laboratory results, safety parameter
    Item
    Please specify measured amount of total bilirubin and units used
    text
    C1254595 (UMLS CUI [1,1])
    C1269689 (UMLS CUI [1,2])
    Laboratory results, safety parameter
    Item
    Please specify the measured SGPT and units used
    text
    C1254595 (UMLS CUI [1,1])
    C1269689 (UMLS CUI [1,2])
    Laboratory results, safety parameter
    Item
    Please specify the measurement of LDH and units used
    text
    C1254595 (UMLS CUI [1,1])
    C1269689 (UMLS CUI [1,2])
    Laboratory results, safety parameter
    Item
    Please specify the measurement of creatinine and units used
    text
    C1254595 (UMLS CUI [1,1])
    C1269689 (UMLS CUI [1,2])
    Laboratory results, safety parameter
    Item
    Please specify the measurement of serum glutamate-oxaloacetate transaminase and units used
    text
    C1254595 (UMLS CUI [1,1])
    C1269689 (UMLS CUI [1,2])
    Laboratory results, safety parameter
    Item
    Please specify the measurement of CRP and units used
    text
    C1254595 (UMLS CUI [1,1])
    C1269689 (UMLS CUI [1,2])
    Item Group
    Subcutaneous desensitization
    Sixteenth desensitization
    Item
    Has the sixteenth dose of desensitization been administered?
    boolean
    C0849706 (UMLS CUI [1])
    Sixteenth desensitization
    Item
    Please give the date and time, the sixteenth dose has been administered
    datetime
    C0849706 (UMLS CUI [1])
    Sixteenth desensitization
    Item
    If the sixteenth 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])
    Code List
    How much of the trial substance has been injected?
    CL Item
    0,5ml (1)
    CL Item
    adjusted dose (2)
    Sixteenth 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])
    Code List
    Please specify which arm has been used for injection
    CL Item
    right arm (1)
    CL Item
    left arm (2)
    Sixteenth 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])
    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)
    Serious adverse events during fifteenth desensitization
    Item
    Have severe local, gastrointestinal or systemic symptoms occured during fifteenth 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])
    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])
    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])
    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])
    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])
    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])
    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])
    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)
    Date
    Item
    Date of completion of this form
    date
    C0011008 (UMLS CUI [1])
    Signature
    Item
    Signature
    text
    C1519316 (UMLS CUI [1])

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