ID

13257

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 (2)
  1. 1/26/16 1/26/16 -
  2. 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 Study completion

English

Case report form Study completion

1 forms  
Study completion form
Description

Study completion form

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

Patient Identification

Data type

integer

Alias
UMLS CUI [1]
C1269815
This clinical trail has been completed according to protocol
Description

Completion of clinical trial

Data type

boolean

Alias
UMLS CUI [1]
C2732579
If the trial has not been completed according to protocol please specify the reason why
Description

Completion of clinical trial

Data type

text

Alias
UMLS CUI [1]
C2732579
Please specify any other reason that caused discontinuation
Description

Completion of clinical trial

Data type

text

Alias
UMLS CUI [1]
C2732579
If the patient was lost to follow up, please specify date the patient was last seen
Description

Completion of clinical trial

Data type

date

Alias
UMLS CUI [1]
C2732579
Participation discontinued by
Description

Discontinuation

Data type

text

Alias
UMLS CUI [1]
C0457454
Patient diary part 1-5 has been retrieved from the patient.
Description

Patient diary

Data type

boolean

Alias
UMLS CUI [1]
C0018700
Further comments
Description

Further comments

Data type

text

Alias
UMLS CUI [1]
C1830770
Confirmatin of investigator: The treatment of this patient during this investigation was under my supervision and according to study protocol. All data and statements in this CRF are complete and correct
Description

Confirmation

Data type

boolean

Alias
UMLS CUI [1]
C0750484
Date of completion of this form
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Signature of investigator
Description

Signature of investigator

Data type

text

Alias
UMLS CUI [1]
C0807938
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Similar models

Case report form Study completion

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Study completion form
Patient Identification
Item
Please give Patient ID composed of Study site Nr and Patient Nr
integer
C1269815 (UMLS CUI [1])
Completion of clinical trial
Item
This clinical trail has been completed according to protocol
boolean
C2732579 (UMLS CUI [1])
Item
If the trial has not been completed according to protocol please specify the reason why
text
C2732579 (UMLS CUI [1])
Completion of clinical trial
Code List
If the trial has not been completed according to protocol please specify the reason why
CL Item
adverse effect during dose titration (1)
CL Item
adverse/serious adverse event (2)
CL Item
withdrawal of informed consent (3)
CL Item
comorbidities (4)
CL Item
protocol violation (i.e lack of compliance) (5)
CL Item
pregnancy (6)
CL Item
private considerations of patient (7)
CL Item
other reason (8)
CL Item
lost to follow up (9)
Completion of clinical trial
Item
Please specify any other reason that caused discontinuation
text
C2732579 (UMLS CUI [1])
Completion of clinical trial
Item
If the patient was lost to follow up, please specify date the patient was last seen
date
C2732579 (UMLS CUI [1])
Item
Participation discontinued by
text
C0457454 (UMLS CUI [1])
Discontinuation
Code List
Participation discontinued by
CL Item
Patient (1)
CL Item
Investigator (2)
Patient diary
Item
Patient diary part 1-5 has been retrieved from the patient.
boolean
C0018700 (UMLS CUI [1])
Further comments
Item
Further comments
text
C1830770 (UMLS CUI [1])
Confirmation
Item
Confirmatin of investigator: The treatment of this patient during this investigation was under my supervision and according to study protocol. All data and statements in this CRF are complete and correct
boolean
C0750484 (UMLS CUI [1])
Date
Item
Date of completion of this form
date
C0011008 (UMLS CUI [1])
Signature of investigator
Item
Signature of investigator
text
C0807938 (UMLS CUI [1])
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