ID

13252

Beschreibung

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

Stichworte

Versionen (2)
  1. 26.01.16 26.01.16 -
  2. 27.01.16 27.01.16 -
Hochgeladen am

26. Januar 2016

DOI

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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

Englisch

Case report form Study completion

1 Formulare  
Study completion form
Beschreibung

Study completion form

This clinical trail has been completed according to protocol
Beschreibung

Completion of clinical trial

Datentyp

boolean

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

Completion of clinical trial

Datentyp

text

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

Completion of clinical trial

Datentyp

text

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

Completion of clinical trial

Datentyp

date

Alias
UMLS CUI [1]
C2732579
Participation discontinued by
Beschreibung

Discontinuation

Datentyp

text

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

Patient diary

Datentyp

boolean

Alias
UMLS CUI [1]
C0018700
Further comments
Beschreibung

Further comments

Datentyp

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
Beschreibung

Confirmation

Datentyp

boolean

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

Date

Datentyp

date

Alias
UMLS CUI [1]
C0011008
Signature of investigator
Beschreibung

Signature of investigator

Datentyp

text

Alias
UMLS CUI [1]
C0807938
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Ähnliche Modelle

Case report form Study completion

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Study completion form
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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