ID
13261
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)
- 2016-01-27 2016-01-27 -
Uppladdad den
27 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 SAE report form
Serious Adverse Event report form
- StudyEvent: ODM
Beskrivning
Observed SAE
Beskrivning
Date of occurrence
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C2697887
Beskrivning
Description of SAE
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0678257
- UMLS CUI [1,2]
- C1519255
Beskrivning
Opinion of investigator
Beskrivning
Medication
Datatyp
text
Alias
- UMLS CUI [1]
- C0013227
Beskrivning
Daily dose
Datatyp
float
Alias
- UMLS CUI [1]
- C2348070
Beskrivning
Drug application route
Datatyp
text
Alias
- UMLS CUI [1]
- C0013153
Beskrivning
Medication use start date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0240320
- UMLS CUI [1,2]
- C0808070
Beskrivning
Medication use end date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0240320
- UMLS CUI [1,2]
- C0806020
Beskrivning
SAE Context
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0041755
Beskrivning
Outcome and treatment
Beskrivning
Lifethreatening
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1517874
Beskrivning
Hospitalization
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0019993
Beskrivning
Date of hospital admission
Datatyp
date
Alias
- UMLS CUI [1]
- C0806429
Beskrivning
Treatment methods
Datatyp
text
Alias
- UMLS CUI [1]
- C0679624
Beskrivning
Attached documents
Datatyp
text
Alias
- UMLS CUI [1]
- C1999228
Beskrivning
Patient outcome
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1547647
- UMLS CUI [1,2]
- C1519255
Beskrivning
Death Related to Adverse Event
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1705232
Beskrivning
Death context to trial substance
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2983596
- UMLS CUI [1,2]
- C0041755
Beskrivning
Date
Datatyp
date
Alias
- UMLS CUI [1]
- C0011008
Beskrivning
Signature
Datatyp
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])