ID
13157
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 (1)
- 1/20/16 1/20/16 -
Uploaded on
January 20, 2016
DOI
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License
Creative Commons BY-NC 3.0
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Efficacy and tolerability of subcutaneous hyposensitization with CLUSTOID in Patients with allergic rhinoconjunctivitis Visit 4
Case report form Visit 4
- StudyEvent: ODM
Description
Subcutaneous desensitization
Description
Sixth desensitization
Data type
boolean
Alias
- UMLS CUI [1]
- C0849706
Description
Sixth desensitization
Data type
datetime
Alias
- UMLS CUI [1]
- C0849706
Description
Sixth desensitization
Data type
text
Alias
- UMLS CUI [1]
- C0849706
Description
Sixth desensitization
Data type
text
Measurement units
- ml
Alias
- UMLS CUI [1]
- C0849706
Description
Sixth desensitization
Data type
text
Alias
- UMLS CUI [1]
- C0849706
Description
Sixth desensitization
Data type
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.
Data type
boolean
Alias
- UMLS CUI [1]
- C0849706
Description
Sixth desensitization
Data type
text
Alias
- UMLS CUI [1]
- C0849706
Description
Sixth desensitization
Data type
text
Alias
- UMLS CUI [1]
- C0849706
Description
Serious adverse events during sixth desensitization
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0849706
- UMLS CUI [1,2]
- C1519255
Description
Actions taken in response to the SAE
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1547656
Description
Adverse Events
Description
Adverse Events
Data type
boolean
Alias
- UMLS CUI [1]
- C0877248
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
Description
Adverse Event
Data type
text
Alias
- UMLS CUI [1]
- C0877248
Description
Adverse Event Start Date
Data type
date
Alias
- UMLS CUI [1]
- C2697888
Description
Adverse Event End Date
Data type
date
Alias
- UMLS CUI [1]
- C2697886
Description
Adverse event occurrence
Data type
text
Alias
- UMLS CUI [1]
- C2697887
Description
Adverse event severity
Data type
text
Alias
- UMLS CUI [1]
- C1710066
Description
Adverse Event Outcome
Data type
text
Alias
- UMLS CUI [1]
- C1705586
Description
Adverse Event actions taken
Data type
text
Alias
- UMLS CUI [1]
- C2826626
Description
Adverse event actions taken
Data type
text
Alias
- UMLS CUI [1]
- C2826719
Description
Adverse event context to trial substance
Data type
text
Alias
- UMLS CUI [1,1]
- C2983596
- UMLS CUI [1,2]
- C0041755
Description
Follow up
Data type
date
Alias
- UMLS CUI [1]
- C1522577
Description
Date
Data type
date
Alias
- UMLS CUI [1]
- C0011008
Description
Signature
Data type
text
Alias
- UMLS CUI [1]
- C1519316
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Case report form Visit 4
- StudyEvent: ODM
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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])