ID

13224

Beskrivning

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

Nyckelord

  1. 2016-01-25 2016-01-25 -
Uppladdad den

25 januari 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 Visit 9

Case Report Form Visit 9

Visit 9:Maintenance Visit
Beskrivning

Visit 9:Maintenance Visit

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

Patient Identification

Datatyp

integer

Alias
UMLS CUI [1]
C1269815
Date of visit 9
Beskrivning

Date

Datatyp

date

Alias
UMLS CUI [1]
C0011008
Is the patient still participating in this trial? If no, please fill in study completion form
Beskrivning

Continued participation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030699
UMLS CUI [1,2]
C0549178
Females of childbearing potential, using safe contraceptive measures? If no please fill in study completion form
Beskrivning

Contraceptive measures

Datatyp

boolean

Alias
UMLS CUI [1]
C0700589
Peak flow best value during visit 1
Beskrivning

Peak flow best value

Datatyp

integer

Måttenheter
  • l/min
Alias
UMLS CUI [1,1]
C0521299
UMLS CUI [1,2]
C1299381
l/min
Please take 3 consecutive peak flow measurements
Beskrivning

Peak flow measurement

Datatyp

integer

Måttenheter
  • l/min
Alias
UMLS CUI [1]
C0521299
l/min
Second peak flow measurement
Beskrivning

Peak flow measurement

Datatyp

integer

Måttenheter
  • l/min
Alias
UMLS CUI [1]
C0521299
l/min
Third peak flow measurement
Beskrivning

Peak flow measurement

Datatyp

integer

Måttenheter
  • l/min
Alias
UMLS CUI [1]
C0521299
l/min
Peak flow best value during visit 9
Beskrivning

Peak flow best value

Datatyp

integer

Måttenheter
  • l/min
Alias
UMLS CUI [1,1]
C0521299
UMLS CUI [1,2]
C1299381
l/min
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
Beskrivning

Continue with allergen exposure

Datatyp

boolean

Alias
UMLS CUI [1]
C0238614
First peak flow measurement after suspension
Beskrivning

Peak flow measurement

Datatyp

integer

Måttenheter
  • l/min
Alias
UMLS CUI [1]
C0521299
l/min
Second peak flow measurement after suspension
Beskrivning

Peak flow measurement

Datatyp

integer

Måttenheter
  • l/min
Alias
UMLS CUI [1]
C0521299
l/min
Third peak flow measurement after suspension
Beskrivning

Peak flow measurement

Datatyp

integer

Måttenheter
  • l/min
Alias
UMLS CUI [1]
C0521299
l/min
Blood pressure measurement
Beskrivning

Blood pressure

Datatyp

text

Måttenheter
  • mm/Hg
Alias
UMLS CUI [1]
C0005823
mm/Hg
Heart rate count
Beskrivning

Heart rate

Datatyp

integer

Måttenheter
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Body height
Beskrivning

Body height

Datatyp

integer

Måttenheter
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Body weight
Beskrivning

Body weight

Datatyp

float

Måttenheter
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Rhinoscopic evaluation:Edema
Beskrivning

Rhinoscopic evaluation

Datatyp

text

Alias
UMLS CUI [1,1]
C0183044
UMLS CUI [1,2]
C0178628
Rhinoscopic evaluation: secretion
Beskrivning

Rhinoscopic evaluation

Datatyp

text

Alias
UMLS CUI [1,1]
C0183044
UMLS CUI [1,2]
C0178628
Rhinoscopic evaluation:redness
Beskrivning

Rhinoscopic evaluation

Datatyp

text

Alias
UMLS CUI [1,1]
C0183044
UMLS CUI [1,2]
C0178628
Has concomitant medication been subject to change?
Beskrivning

Concomitant agent

Datatyp

boolean

Alias
UMLS CUI [1]
C2347852
Please specify any changes of therapy and review for exclusion criteria
Beskrivning

Concomitant Agent

Datatyp

text

Alias
UMLS CUI [1]
C2347852
Have comorbidities changed?
Beskrivning

Comorbidities

Datatyp

boolean

Alias
UMLS CUI [1]
C0009488
If comorbidities have changed,please specify and review for exclusion criteria
Beskrivning

Comorbidities

Datatyp

text

Alias
UMLS CUI [1]
C0009488
Patient diary part 1 has been retrieved from the patient. If no, please collect it during next visit
Beskrivning

Patient diary

Datatyp

boolean

Alias
UMLS CUI [1]
C0018700
Patient diary part 2 has been handed out to the patient for documentation purposes of daily symptoms and required demand medication.
Beskrivning

Please instruct the patient to fill in this diary daily and to bring it back for the next appointment

Datatyp

boolean

Alias
UMLS CUI [1]
C0018700
Dispensation of demand medication
Beskrivning

Please dispense the rescue medication to the patient which he/she should be using in case of any allergic symptoms and keep record of dispensation. Instruct the patient how and when to use his demand medication and to list each use of demand medication in his patient diary. Please advise the patient as well under which circumstances he/she should contact the investigator.

Datatyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0679686
Subcutaneous desensitization
Beskrivning

Subcutaneous desensitization

Has the eleventh dose of desensitization been administered?
Beskrivning

Eleventh desensitization

Datatyp

boolean

Alias
UMLS CUI [1]
C0849706
Please give the date and time, the eleventh dose has been administered
Beskrivning

Eleventh desensitization

Datatyp

datetime

Alias
UMLS CUI [1]
C0849706
If the eleventh dose has not been administered, please specify the reason why
Beskrivning

Eleventh desensitization

Datatyp

text

Alias
UMLS CUI [1]
C0849706
How much of the trial substance has been injected?
Beskrivning

Eleventh desensitization

Datatyp

text

Måttenheter
  • ml
Alias
UMLS CUI [1]
C0849706
If the dose of trial substance has been adjusted, please specify the reason why and how much has actually been administered
Beskrivning

Eleventh desensitization

Datatyp

text

Alias
UMLS CUI [1]
C0849706
Please specify which arm has been used for injection
Beskrivning

Eleventh desensitization

Datatyp

text

Alias
UMLS CUI [1]
C0849706
30 min after injection, has the patient experienced any local, gastrointestinal, systemic or other symptoms?
Beskrivning

if no, continue with injections according to protocol,if yes, please explain further below and eventually adjust dose during next visit.

Datatyp

boolean

Alias
UMLS CUI [1]
C0849706
Have any of the following symptoms occured?If yes please do not forget to fill in AE report
Beskrivning

Eleventh desensitization

Datatyp

text

Alias
UMLS CUI [1]
C0849706
Please specify any other symptoms that occured within 30 min after injection of eleventh desensitization
Beskrivning

Eleventh desensitization

Datatyp

text

Alias
UMLS CUI [1]
C0849706
Have severe local, gastrointestinal or systemic symptoms occured during eleventh desensitization? If yes, the SAE sheet has to be filled in and sent to the sponsor within 24 hours.
Beskrivning

Serious adverse events during eleventh desensitization

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0849706
UMLS CUI [1,2]
C1519255
What measures have been taken in response to the SAE?
Beskrivning

Actions taken in response to the SAE

Datatyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1547656
Adverse Events
Beskrivning

Adverse Events

Did any Adverse Events occur?
Beskrivning

Adverse Events

Datatyp

boolean

Alias
UMLS CUI [1]
C0877248
Have these been serious adverse events?
Beskrivning

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)

Datatyp

boolean

Alias
UMLS CUI [1]
C1519255
Please describe the AE
Beskrivning

Adverse Event

Datatyp

text

Alias
UMLS CUI [1]
C0877248
Adverse Event Start Date
Beskrivning

Adverse Event Start Date

Datatyp

date

Alias
UMLS CUI [1]
C2697888
Adverse Event End Date
Beskrivning

Adverse Event End Date

Datatyp

date

Alias
UMLS CUI [1]
C2697886
How often did the event occur?
Beskrivning

Adverse event occurrence

Datatyp

text

Alias
UMLS CUI [1]
C2697887
Please give your opinion to the severity of the AE
Beskrivning

Adverse event severity

Datatyp

text

Alias
UMLS CUI [1]
C1710066
Adverse Event Outcome
Beskrivning

Adverse Event Outcome

Datatyp

text

Alias
UMLS CUI [1]
C1705586
What actions have been taken regarding the trial substance?
Beskrivning

Adverse Event actions taken

Datatyp

text

Alias
UMLS CUI [1]
C2826626
What other actions have been taken in response to the AE?
Beskrivning

Adverse event actions taken

Datatyp

text

Alias
UMLS CUI [1]
C2826719
Is the AE related to the trial substance?
Beskrivning

Adverse event context to trial substance

Datatyp

text

Alias
UMLS CUI [1,1]
C2983596
UMLS CUI [1,2]
C0041755
Please agree to a date for follow up V10 within next month
Beskrivning

Follow up

Datatyp

date

Alias
UMLS CUI [1]
C1522577
Date of completion of this form
Beskrivning

Date

Datatyp

date

Alias
UMLS CUI [1]
C0011008
Signature
Beskrivning

Signature

Datatyp

text

Alias
UMLS CUI [1]
C1519316

Similar models

Case Report Form Visit 9

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Visit 9:Maintenance Visit
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 9
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])
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])
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 9
integer
C0521299 (UMLS CUI [1,1])
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])
Code List
Rhinoscopic evaluation:Edema
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])
Code List
Rhinoscopic evaluation: secretion
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])
Code List
Rhinoscopic evaluation:redness
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 1 has been retrieved from the patient. If no, please collect it during next visit
boolean
C0018700 (UMLS CUI [1])
Patient diary
Item
Patient diary part 2 has been handed out to the patient for documentation purposes of daily symptoms and required demand medication.
boolean
C0018700 (UMLS CUI [1])
Item
Dispensation of demand medication
text
C0013227 (UMLS CUI [1,1])
C0679686 (UMLS CUI [1,2])
Code List
Dispensation of demand medication
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)
Item Group
Subcutaneous desensitization
Eleventh desensitization
Item
Has the eleventh dose of desensitization been administered?
boolean
C0849706 (UMLS CUI [1])
Eleventh desensitization
Item
Please give the date and time, the eleventh dose has been administered
datetime
C0849706 (UMLS CUI [1])
Eleventh desensitization
Item
If the eleventh 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])
Code List
How much of the trial substance has been injected?
CL Item
0,5ml (1)
CL Item
adjusted dose (2)
Eleventh 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])
Code List
Please specify which arm has been used for injection
CL Item
right arm (1)
CL Item
left arm (2)
Eleventh 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)
Eleventh desensitization
Item
Please specify any other symptoms that occured within 30 min after injection of eleventh desensitization
text
C0849706 (UMLS CUI [1])
Serious adverse events during eleventh desensitization
Item
Have severe local, gastrointestinal or systemic symptoms occured during eleventh 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])
Item
What measures have been taken in response to the SAE?
text
C1519255 (UMLS CUI [1,1])
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)
Item Group
Adverse Events
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])
Item
How often did the event occur?
text
C2697887 (UMLS CUI [1])
Code List
How often did the event occur?
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])
Code List
Please give your opinion to the severity of the AE
CL Item
minor (1)
CL Item
moderate (2)
CL Item
severe (3)
Item
Adverse Event Outcome
text
C1705586 (UMLS CUI [1])
Code List
Adverse Event Outcome
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])
Code List
What actions have been taken regarding the trial substance?
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])
Code List
What other actions have been taken in response to the AE?
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])
Code List
Is the AE related to the trial substance?
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 V10 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])

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