ID
13183
Beskrivning
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
Nyckelord
Versioner (1)
- 2016-01-22 2016-01-22 -
Uppladdad den
22 januari 2016
DOI
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Licens
Creative Commons BY-NC 3.0
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Efficacy and tolerability of subcutaneous hyposensitization with CLUSTOID in Patients with allergic rhinoconjunctivitis Visit 7
Case Report Form Visit 7
- StudyEvent: ODM
Beskrivning
Subcutaneous desensitization
Beskrivning
Ninth desensitization
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0849706
Beskrivning
Ninth desensitization
Datatyp
datetime
Alias
- UMLS CUI [1]
- C0849706
Beskrivning
Ninth desensitization
Datatyp
text
Alias
- UMLS CUI [1]
- C0849706
Beskrivning
Ninth desensitization
Datatyp
text
Måttenheter
- ml
Alias
- UMLS CUI [1]
- C0849706
Beskrivning
Ninth desensitization
Datatyp
text
Alias
- UMLS CUI [1]
- C0849706
Beskrivning
Ninth desensitization
Datatyp
text
Alias
- UMLS CUI [1]
- C0849706
Beskrivning
if no, continue with injections according to protocol,if yes, please explain further below and eventually adjust dose during next visit.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0849706
Beskrivning
Ninth desensitization
Datatyp
text
Alias
- UMLS CUI [1]
- C0849706
Beskrivning
Ninth desensitization
Datatyp
text
Alias
- UMLS CUI [1]
- C0849706
Beskrivning
Serious adverse events during ninth desensitization
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0849706
- UMLS CUI [1,2]
- C1519255
Beskrivning
Actions taken in response to the SAE
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1547656
Beskrivning
Adverse Events
Beskrivning
Adverse Events
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0877248
Beskrivning
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)
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1519255
Beskrivning
Adverse Event
Datatyp
text
Alias
- UMLS CUI [1]
- C0877248
Beskrivning
Adverse Event Start Date
Datatyp
date
Alias
- UMLS CUI [1]
- C2697888
Beskrivning
Adverse Event End Date
Datatyp
date
Alias
- UMLS CUI [1]
- C2697886
Beskrivning
Adverse event occurrence
Datatyp
text
Alias
- UMLS CUI [1]
- C2697887
Beskrivning
Adverse event severity
Datatyp
text
Alias
- UMLS CUI [1]
- C1710066
Beskrivning
Adverse Event Outcome
Datatyp
text
Alias
- UMLS CUI [1]
- C1705586
Beskrivning
Adverse Event actions taken
Datatyp
text
Alias
- UMLS CUI [1]
- C2826626
Beskrivning
Adverse event actions taken
Datatyp
text
Alias
- UMLS CUI [1]
- C2826719
Beskrivning
Adverse event context to trial substance
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2983596
- UMLS CUI [1,2]
- C0041755
Beskrivning
Follow up
Datatyp
date
Alias
- UMLS CUI [1]
- C1522577
Beskrivning
Date
Datatyp
date
Alias
- UMLS CUI [1]
- C0011008
Beskrivning
Signature
Datatyp
text
Alias
- UMLS CUI [1]
- C1519316
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Case Report Form Visit 7
- 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])
C1519255 (UMLS CUI [1,2])
C1547656 (UMLS CUI [1,2])
C0041755 (UMLS CUI [1,2])