ID
13244
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
Mots-clés
Versions (1)
- 26/01/2016 26/01/2016 -
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26 janvier 2016
DOI
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Licence
Creative Commons BY-NC 3.0
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Efficacy and tolerability of subcutaneous hyposensitization with CLUSTOID in Patients with allergic rhinoconjunctivitis Visit 14
Case Report Form Visit 14
- StudyEvent: ODM
Description
Determination of specific IgE and Safety Laboratory parameter
Description
Identify RAST-categories [kU/L] for each allergen and note corresponding category below
Type de données
text
Alias
- UMLS CUI [1,1]
- C0204726
- UMLS CUI [1,2]
- C0443736
Description
Radioallergosorbent test timothy grass
Type de données
float
Unités de mesure
- kU/L
Alias
- UMLS CUI [1]
- C0799220
Description
Verification of specific IgE
Type de données
text
Alias
- UMLS CUI [1,1]
- C0204726
- UMLS CUI [1,2]
- C0443736
Description
Radioallergosorbent test categories for rye
Type de données
float
Unités de mesure
- kU/L
Alias
- UMLS CUI [1]
- C1271227
Description
Total IgE
Type de données
float
Unités de mesure
- kU/L
Alias
- UMLS CUI [1]
- C0797024
Description
Verification of specific IgG4
Type de données
text
Alias
- UMLS CUI [1,1]
- C0204726
- UMLS CUI [1,2]
- C0443736
Description
Radioallergosorbent test catagories timothy grass
Type de données
float
Unités de mesure
- kU/L
Alias
- UMLS CUI [1]
- C0942402
Description
Verification of specific IgG4
Type de données
text
Alias
- UMLS CUI [1,1]
- C0204726
- UMLS CUI [1,2]
- C0443736
Description
Radioallergosorbent test categories for rye
Type de données
float
Unités de mesure
- kU/L
Alias
- UMLS CUI [1]
- C1271227
Description
Please collect every one of the listed parameters below and add units as applicable
Type de données
text
Alias
- UMLS CUI [1,1]
- C1254595
- UMLS CUI [1,2]
- C1269689
Description
Laboratory results, safety parameter
Type de données
text
Alias
- UMLS CUI [1,1]
- C1254595
- UMLS CUI [1,2]
- C1269689
Description
Laboratory results, safety parameter
Type de données
text
Alias
- UMLS CUI [1,1]
- C1254595
- UMLS CUI [1,2]
- C1269689
Description
Laboratory results, safety parameter
Type de données
text
Alias
- UMLS CUI [1,1]
- C1254595
- UMLS CUI [1,2]
- C1269689
Description
Laboratory results, safety parameter
Type de données
text
Alias
- UMLS CUI [1,1]
- C1254595
- UMLS CUI [1,2]
- C1269689
Description
Laboratory results, safety parameter
Type de données
text
Alias
- UMLS CUI [1,1]
- C1254595
- UMLS CUI [1,2]
- C1269689
Description
Laboratory results, safety parameter
Type de données
text
Alias
- UMLS CUI [1,1]
- C1254595
- UMLS CUI [1,2]
- C1269689
Description
Laboratory results, safety parameter
Type de données
text
Alias
- UMLS CUI [1,1]
- C1254595
- UMLS CUI [1,2]
- C1269689
Description
Laboratory results, safety parameter
Type de données
text
Alias
- UMLS CUI [1,1]
- C1254595
- UMLS CUI [1,2]
- C1269689
Description
Laboratory results, safety parameter
Type de données
text
Alias
- UMLS CUI [1,1]
- C1254595
- UMLS CUI [1,2]
- C1269689
Description
Laboratory results, safety parameter
Type de données
text
Alias
- UMLS CUI [1,1]
- C1254595
- UMLS CUI [1,2]
- C1269689
Description
Laboratory results, safety parameter
Type de données
text
Alias
- UMLS CUI [1,1]
- C1254595
- UMLS CUI [1,2]
- C1269689
Description
Laboratory results, safety parameter
Type de données
text
Alias
- UMLS CUI [1,1]
- C1254595
- UMLS CUI [1,2]
- C1269689
Description
Laboratory results, safety parameter
Type de données
text
Alias
- UMLS CUI [1,1]
- C1254595
- UMLS CUI [1,2]
- C1269689
Description
Laboratory results, safety parameter
Type de données
text
Alias
- UMLS CUI [1,1]
- C1254595
- UMLS CUI [1,2]
- C1269689
Description
Laboratory results, safety parameter
Type de données
text
Alias
- UMLS CUI [1,1]
- C1254595
- UMLS CUI [1,2]
- C1269689
Description
Subcutaneous desensitization
Description
Sixteenth desensitization
Type de données
boolean
Alias
- UMLS CUI [1]
- C0849706
Description
Sixteenth desensitization
Type de données
datetime
Alias
- UMLS CUI [1]
- C0849706
Description
Sixteenth desensitization
Type de données
text
Alias
- UMLS CUI [1]
- C0849706
Description
Sixteenth desensitization
Type de données
text
Unités de mesure
- ml
Alias
- UMLS CUI [1]
- C0849706
Description
Sixteenth desensitization
Type de données
text
Alias
- UMLS CUI [1]
- C0849706
Description
Sixteenth desensitization
Type de données
text
Alias
- UMLS CUI [1]
- C0849706
Description
if no, continue with injections according to protocol,if yes, please explain further below and eventually adjust dose during next visit.
Type de données
boolean
Alias
- UMLS CUI [1]
- C0849706
Description
Sixteenth desensitization
Type de données
text
Alias
- UMLS CUI [1]
- C0849706
Description
Serious adverse events during fifteenth desensitization
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0849706
- UMLS CUI [1,2]
- C1519255
Description
Actions taken in response to the SAE
Type de données
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1547656
Description
Adverse Events
Description
Adverse Events
Type de données
boolean
Alias
- UMLS CUI [1]
- C0877248
Description
Have these been serious adverse events?
Type de données
boolean
Alias
- UMLS CUI [1]
- C1519255
Description
Adverse Event
Type de données
text
Alias
- UMLS CUI [1]
- C0877248
Description
Adverse Event Start Date
Type de données
date
Alias
- UMLS CUI [1]
- C2697888
Description
Adverse Event End Date
Type de données
date
Alias
- UMLS CUI [1]
- C2697886
Description
Adverse event occurrence
Type de données
text
Alias
- UMLS CUI [1]
- C2697887
Description
Adverse event severity
Type de données
text
Alias
- UMLS CUI [1]
- C1710066
Description
Adverse Event Outcome
Type de données
text
Alias
- UMLS CUI [1]
- C1705586
Description
Adverse Event actions taken
Type de données
text
Alias
- UMLS CUI [1]
- C2826626
Description
Adverse event actions taken
Type de données
text
Alias
- UMLS CUI [1]
- C2826719
Description
Adverse event context to trial substance
Type de données
text
Alias
- UMLS CUI [1,1]
- C2983596
- UMLS CUI [1,2]
- C0041755
Description
Date
Type de données
date
Alias
- UMLS CUI [1]
- C0011008
Description
Signature
Type de données
text
Alias
- UMLS CUI [1]
- C1519316
Similar models
Case Report Form Visit 14
- StudyEvent: ODM
C0549178 (UMLS CUI [1,2])
C1299381 (UMLS CUI [1,2])
C1299381 (UMLS CUI [1,2])
C0178628 (UMLS CUI [1,2])
C0178628 (UMLS CUI [1,2])
C0178628 (UMLS CUI [1,2])
C0178628 (UMLS CUI [1,2])
C0178628 (UMLS CUI [1,2])
C0178628 (UMLS CUI [1,2])
C0443736 (UMLS CUI [1,2])
C0443736 (UMLS CUI [1,2])
C0443736 (UMLS CUI [1,2])
C0443736 (UMLS CUI [1,2])
C1269689 (UMLS CUI [1,2])
C1269689 (UMLS CUI [1,2])
C1269689 (UMLS CUI [1,2])
C1269689 (UMLS CUI [1,2])
C1269689 (UMLS CUI [1,2])
C1269689 (UMLS CUI [1,2])
C1269689 (UMLS CUI [1,2])
C1269689 (UMLS CUI [1,2])
C1269689 (UMLS CUI [1,2])
C1269689 (UMLS CUI [1,2])
C1269689 (UMLS CUI [1,2])
C1269689 (UMLS CUI [1,2])
C1269689 (UMLS CUI [1,2])
C1269689 (UMLS CUI [1,2])
C1269689 (UMLS CUI [1,2])
C1269689 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1547656 (UMLS CUI [1,2])
C0041755 (UMLS CUI [1,2])
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