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ID
13243
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
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Versionen (1)
- 26.01.16 26.01.16 -
Hochgeladen am
26. Januar 2016
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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 Visit 13
Case Report Form Visit 13
- StudyEvent: ODM
Ähnliche Modelle
Case Report Form Visit 13
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Patient Identification
Item
Please give Patient ID composed of Study site Nr and Patient Nr
integer
C1269815 (UMLS CUI [1])
Date
Item
Date of visit 13
date
C0011008 (UMLS CUI [1])
Continued participation
Item
Is the patient still participating in this trial? If no, please fill in study completion form
boolean
C0030699 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
Contraceptive measures
Item
Females of childbearing potential, using safe contraceptive measures? If no please fill in study completion form
boolean
C0700589 (UMLS CUI [1])
Peak flow best value
Item
Peak flow best value during visit 1
integer
C0521299 (UMLS CUI [1,1])
C1299381 (UMLS CUI [1,2])
C1299381 (UMLS CUI [1,2])
Peak flow measurement
Item
Please take 3 consecutive peak flow measurements
integer
C0521299 (UMLS CUI [1])
Peak flow measurement
Item
Second peak flow measurement
integer
C0521299 (UMLS CUI [1])
Peak flow measurement
Item
Third peak flow measurement
integer
C0521299 (UMLS CUI [1])
Peak flow best value
Item
Peak flow best value during visit 13
integer
C0521299 (UMLS CUI [1,1])
C1299381 (UMLS CUI [1,2])
C1299381 (UMLS CUI [1,2])
Continue with allergen exposure
Item
If peak flow measurement is > 80 percent of best value during visit 1, continue with allergen exposure, if no suspend next exposure to allergen and repeat peak flow measurement
boolean
C0238614 (UMLS CUI [1])
Peak flow measurement
Item
First peak flow measurement after suspension
integer
C0521299 (UMLS CUI [1])
Peak flow measurement
Item
Second peak flow measurement after suspension
integer
C0521299 (UMLS CUI [1])
Peak flow measurement
Item
Third peak flow measurement after suspension
integer
C0521299 (UMLS CUI [1])
Blood pressure
Item
Blood pressure measurement
text
C0005823 (UMLS CUI [1])
Heart rate
Item
Heart rate count
integer
C0018810 (UMLS CUI [1])
Body Height
Item
Body Height
integer
C0005890 (UMLS CUI [1])
Body weight
Item
Body weight
float
C0005910 (UMLS CUI [1])
Item
Rhinoscopic evaluation:Edema
text
C0183044 (UMLS CUI [1,1])
C0178628 (UMLS CUI [1,2])
C0178628 (UMLS CUI [1,2])
CL Item
none (0)
CL Item
little (1)
CL Item
severe (2)
Item
Rhinoscopic evaluation: secretion
text
C0183044 (UMLS CUI [1,1])
C0178628 (UMLS CUI [1,2])
C0178628 (UMLS CUI [1,2])
CL Item
none (0)
CL Item
clear fluid (1)
CL Item
thick mucous (2)
Item
Rhinoscopic evaluation:redness
text
C0183044 (UMLS CUI [1,1])
C0178628 (UMLS CUI [1,2])
C0178628 (UMLS CUI [1,2])
CL Item
none (0)
CL Item
little (1)
CL Item
severe (2)
Concomitant agent
Item
Has concomitant medication been subject to change?
boolean
C2347852 (UMLS CUI [1])
Concomitant Agent
Item
Please specify any changes of therapy and review for exclusion criteria
text
C2347852 (UMLS CUI [1])
Comorbidities
Item
Have comorbidities changed?
boolean
C0009488 (UMLS CUI [1])
Comorbidities
Item
If comorbidities have changed,please specify and review for exclusion criteria
text
C0009488 (UMLS CUI [1])
Patient diary
Item
Patient diary part 5 has been retrieved from the patient and reviewed. If no, please collect it during next visit
boolean
C0018700 (UMLS CUI [1])
Item
Dispensation of demand medication
text
C0013227 (UMLS CUI [1,1])
C0679686 (UMLS CUI [1,2])
C0679686 (UMLS CUI [1,2])
CL Item
Pruritus-> eye drops Cromone (0)
CL Item
step 1-> oral antihistamine Loratadine (1)
CL Item
step 2-> nasal steroid Beclomethasone (2)
CL Item
step 3-> Leukotrien-antagonist Montelukast (In case of severe asthmatic symptoms with separate prescription) (3)
Fifteenth desensitization
Item
Has the fifteenth dose of desensitization been administered?
boolean
C0849706 (UMLS CUI [1])
Fifteenth desensitization
Item
Please give the date and time, the fifteenth dose has been administered
datetime
C0849706 (UMLS CUI [1])
Fifteenth desensitization
Item
If the fifteenth dose has not been administered, please specify the reason why
text
C0849706 (UMLS CUI [1])
Item
How much of the trial substance has been injected?
text
C0849706 (UMLS CUI [1])
CL Item
0,5ml (1)
CL Item
adjusted dose (2)
Fifteenth desensitization
Item
If the dose of trial substance has been adjusted, please specify the reason why and how much has actually been administered
text
C0849706 (UMLS CUI [1])
Item
Please specify which arm has been used for injection
text
C0849706 (UMLS CUI [1])
CL Item
right arm (1)
CL Item
left arm (2)
Fifteenth desensitization
Item
30 min after injection, has the patient experienced any local, gastrointestinal, systemic or other symptoms?
boolean
C0849706 (UMLS CUI [1])
Item
Have any of the following symptoms occured?If yes please do not forget to fill in AE report
text
C0849706 (UMLS CUI [1])
Code List
Have any of the following symptoms occured?If yes please do not forget to fill in AE report
CL Item
local reaction of the skin:swelling,itching,rash,or burning sensation (1)
CL Item
gastrointestinal symptoms:nausea,vomiting,dyspepsia,flatulence,diarrhea (2)
CL Item
systemic reactions (3)
CL Item
unspecified symptoms like headache, discomfort (3.1)
CL Item
minor systemic symptoms like rhinitis,or minor asthmatic symptoms (3.2)
CL Item
non-life-threatening systemic symptoms like urticaria, angioedema,severe asthmatic symptoms (3.3)
CL Item
severe systemic symptoms like anaphylactic shock [extended documentation as SAE] (3.4)
CL Item
other (4)
Serious adverse events during fifteenth desensitization
Item
Have severe local, gastrointestinal or systemic symptoms occured during fifteenth desensitization? If yes, the SAE sheet has to be filled in and sent to the sponsor within 24 hours.
boolean
C0849706 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Item
What measures have been taken in response to the SAE?
text
C1519255 (UMLS CUI [1,1])
C1547656 (UMLS CUI [1,2])
C1547656 (UMLS CUI [1,2])
Code List
What measures have been taken in response to the SAE?
CL Item
termination of study -> please fill in study completion form 2=adjustment of dose during next course of desensitization (1)
Adverse Events
Item
Did any Adverse Events occur?
boolean
C0877248 (UMLS CUI [1])
Have these been serious adverse events?
Item
Have these been serious adverse events?
boolean
C1519255 (UMLS CUI [1])
Adverse Event
Item
Please describe the AE
text
C0877248 (UMLS CUI [1])
Adverse Event Start Date
Item
Adverse Event Start Date
date
C2697888 (UMLS CUI [1])
Adverse Event End Date
Item
Adverse Event End Date
date
C2697886 (UMLS CUI [1])
CL Item
once (1)
CL Item
regularly (2)
CL Item
continuing (3)
Item
Please give your opinion to the severity of the AE
text
C1710066 (UMLS CUI [1])
CL Item
minor (1)
CL Item
moderate (2)
CL Item
severe (3)
CL Item
Recovered (1)
CL Item
Subsiding (2)
CL Item
Continuing (3)
CL Item
resolved with sequelae (4)
CL Item
increased symptoms (5)
CL Item
fatal (6)
Item
What actions have been taken regarding the trial substance?
text
C2826626 (UMLS CUI [1])
CL Item
not applicable (1)
CL Item
no adjustment in dose (2)
CL Item
adjustment of dose (3)
CL Item
suspension of treatment (4)
CL Item
discontinuation of treatment (5)
CL Item
other (6)
Item
What other actions have been taken in response to the AE?
text
C2826719 (UMLS CUI [1])
CL Item
none (1)
CL Item
change of concomitant medication (2)
CL Item
hospitalization/prolonged stay in hospital (3)
CL Item
further therapeutic and diagnostic measures (4)
Item
Is the AE related to the trial substance?
text
C2983596 (UMLS CUI [1,1])
C0041755 (UMLS CUI [1,2])
C0041755 (UMLS CUI [1,2])
CL Item
undecided/incomplete (1)
CL Item
inconclusive (2)
CL Item
without context to trial substance (3)
CL Item
unlikely (4)
CL Item
possible (5)
CL Item
probable (6)
CL Item
confirmed (7)
Follow up
Item
Please agree to a date for follow up V14 within next month
date
C1522577 (UMLS CUI [1])
Date
Item
Date of completion of this form
date
C0011008 (UMLS CUI [1])
Signature
Item
Signature
text
C1519316 (UMLS CUI [1])