ID
13261
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)
- 1/27/16 1/27/16 -
Uploaded on
January 27, 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 SAE report form
Serious Adverse Event report form
- StudyEvent: ODM
Description
Observed SAE
Description
Date of occurrence
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C2697887
Description
Description of SAE
Data type
text
Alias
- UMLS CUI [1,1]
- C0678257
- UMLS CUI [1,2]
- C1519255
Description
Opinion of investigator
Description
Medication
Data type
text
Alias
- UMLS CUI [1]
- C0013227
Description
Daily dose
Data type
float
Alias
- UMLS CUI [1]
- C2348070
Description
Drug application route
Data type
text
Alias
- UMLS CUI [1]
- C0013153
Description
Medication use start date
Data type
date
Alias
- UMLS CUI [1,1]
- C0240320
- UMLS CUI [1,2]
- C0808070
Description
Medication use end date
Data type
date
Alias
- UMLS CUI [1,1]
- C0240320
- UMLS CUI [1,2]
- C0806020
Description
SAE Context
Data type
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0041755
Description
Outcome and treatment
Description
Lifethreatening
Data type
boolean
Alias
- UMLS CUI [1]
- C1517874
Description
Hospitalization
Data type
boolean
Alias
- UMLS CUI [1]
- C0019993
Description
Date of hospital admission
Data type
date
Alias
- UMLS CUI [1]
- C0806429
Description
Treatment methods
Data type
text
Alias
- UMLS CUI [1]
- C0679624
Description
Attached documents
Data type
text
Alias
- UMLS CUI [1]
- C1999228
Description
Patient outcome
Data type
text
Alias
- UMLS CUI [1,1]
- C1547647
- UMLS CUI [1,2]
- C1519255
Description
Death Related to Adverse Event
Data type
boolean
Alias
- UMLS CUI [1]
- C1705232
Description
Death context to trial substance
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2983596
- UMLS CUI [1,2]
- C0041755
Description
Date
Data type
date
Alias
- UMLS CUI [1]
- C0011008
Description
Signature
Data type
text
Alias
- UMLS CUI [1]
- C1519316
Similar models
Serious Adverse Event report form
- StudyEvent: ODM
C2697887 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0041755 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0041755 (UMLS CUI [1,2])