ID
13183
Descripción
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
Palabras clave
Versiones (1)
- 22/1/16 22/1/16 -
Subido en
22 de enero de 2016
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
Creative Commons BY-NC 3.0
Comentarios del modelo :
Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.
Comentarios de grupo de elementos para :
Comentarios del elemento para :
Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.
Efficacy and tolerability of subcutaneous hyposensitization with CLUSTOID in Patients with allergic rhinoconjunctivitis Visit 7
Case Report Form Visit 7
- StudyEvent: ODM
Descripción
Subcutaneous desensitization
Descripción
Ninth desensitization
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0849706
Descripción
Ninth desensitization
Tipo de datos
datetime
Alias
- UMLS CUI [1]
- C0849706
Descripción
Ninth desensitization
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0849706
Descripción
Ninth desensitization
Tipo de datos
text
Unidades de medida
- ml
Alias
- UMLS CUI [1]
- C0849706
Descripción
Ninth desensitization
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0849706
Descripción
Ninth desensitization
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0849706
Descripción
if no, continue with injections according to protocol,if yes, please explain further below and eventually adjust dose during next visit.
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0849706
Descripción
Ninth desensitization
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0849706
Descripción
Ninth desensitization
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0849706
Descripción
Serious adverse events during ninth desensitization
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0849706
- UMLS CUI [1,2]
- C1519255
Descripción
Actions taken in response to the SAE
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1547656
Descripción
Adverse Events
Descripción
Adverse Events
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0877248
Descripción
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)
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1519255
Descripción
Adverse Event
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0877248
Descripción
Adverse Event Start Date
Tipo de datos
date
Alias
- UMLS CUI [1]
- C2697888
Descripción
Adverse Event End Date
Tipo de datos
date
Alias
- UMLS CUI [1]
- C2697886
Descripción
Adverse event occurrence
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2697887
Descripción
Adverse event severity
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1710066
Descripción
Adverse Event Outcome
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1705586
Descripción
Adverse Event actions taken
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2826626
Descripción
Adverse event actions taken
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2826719
Descripción
Adverse event context to trial substance
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2983596
- UMLS CUI [1,2]
- C0041755
Descripción
Follow up
Tipo de datos
date
Alias
- UMLS CUI [1]
- C1522577
Descripción
Date
Tipo de datos
date
Alias
- UMLS CUI [1]
- C0011008
Descripción
Signature
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1519316
Similar models
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])