ID

13258

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

  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 Telephone Visit 1

Case report form: Telephone Visit 1

Telephone Visit
Description

Telephone Visit

Please give Patient ID composed of Study site Nr and Patient Nr
Description

Patient Identification

Data type

integer

Alias
UMLS CUI [1]
C1269815
Date of phone contact
Description

Date of phone contact

Data type

date

Alias
UMLS CUI [1]
C0011008
Safety laboratory results of visit 14 have been completed. If yes, please inform your patient of the results.
Description

Safety laboratory results

Data type

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C1269689
Laboratory results are without findings, no additional visit required
Description

Safety laboratory results

Data type

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C1269689
One or more laboratory results are abnormal: this is an AE, please arrange for an additional visit, note the date of appointment below and complete the AE report form.
Description

Safety laboratory result

Data type

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C1269689
Please fill in the date of the additional appointment
Description

Appointment date

Data type

date

Alias
UMLS CUI [1]
C0585085
Date of completion of this form
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Signature
Description

Signature

Data type

text

Alias
UMLS CUI [1]
C1519316

Similar models

Case report form: Telephone Visit 1

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Telephone Visit
Patient Identification
Item
Please give Patient ID composed of Study site Nr and Patient Nr
integer
C1269815 (UMLS CUI [1])
Date of phone contact
Item
Date of phone contact
date
C0011008 (UMLS CUI [1])
Safety laboratory results
Item
Safety laboratory results of visit 14 have been completed. If yes, please inform your patient of the results.
boolean
C1254595 (UMLS CUI [1,1])
C1269689 (UMLS CUI [1,2])
Safety laboratory results
Item
Laboratory results are without findings, no additional visit required
boolean
C1254595 (UMLS CUI [1,1])
C1269689 (UMLS CUI [1,2])
Safety laboratory result
Item
One or more laboratory results are abnormal: this is an AE, please arrange for an additional visit, note the date of appointment below and complete the AE report form.
boolean
C1254595 (UMLS CUI [1,1])
C1269689 (UMLS CUI [1,2])
Appointment date
Item
Please fill in the date of the additional appointment
date
C0585085 (UMLS CUI [1])
Date
Item
Date of completion of this form
date
C0011008 (UMLS CUI [1])
Signature
Item
Signature
text
C1519316 (UMLS CUI [1])

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