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ID
13244
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 (1)
- 1/26/16 1/26/16 -
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January 26, 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 14
Case Report Form Visit 14
- StudyEvent: ODM
Similar models
Case Report Form Visit 14
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Data type
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 14
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 14
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])
Quality of life questionnaire
Item
Has the patient filled in the questionnaire regarding the quality of life of patients with rhinoconjunctivitis?
boolean
C0518214 (UMLS CUI [1])
CL Item
0 sneezing 0-2 times (0)
CL Item
1 sneezing 3-5 times (1)
CL Item
2 >5 times (2)
CL Item
0 sneezing 0-2 times (0)
CL Item
1 sneezing 3-5 times (1)
CL Item
2 sneezing >5 times (2)
Item
First provocation value of nasal irritation
text
C0027431 (UMLS CUI [1])
CL Item
0 sneezing 0-2 times (0)
CL Item
1 sneezing 3-5 times (1)
CL Item
2 sneezing >5 times (2)
Item
second provocation value of nasal irritation
text
C0027431 (UMLS CUI [1])
CL Item
0 sneezing 0-2 times (0)
CL Item
1 sneezing 3-5 times (1)
CL Item
2 sneezing >5 times (2)
Item
Baseline value of nasal secretion provocation
text
C0027431 (UMLS CUI [1])
CL Item
0 no secretion (0)
CL Item
1 little secretion (1)
CL Item
2 heavy secretion (2)
CL Item
0 no secretion (0)
CL Item
1 little secretion (1)
CL Item
2 heavy secretion (2)
CL Item
0 no secretion (0)
CL Item
1 little secretion (1)
CL Item
2 heavy secretion (2)
Item
Second provocation value of nasal secretion
text
C0027431 (UMLS CUI [1])
CL Item
0 no secretion (0)
CL Item
1 little secretion (1)
CL Item
2 heavy secretion (2)
Item
Baseline value of remote symptom provocation
text
C0027431 (UMLS CUI [1])
CL Item
0 none (0)
CL Item
1 lacrimation and/or itching of palate/ears (1)
CL Item
2 conjunctivitis and/or urticaria and/or coughing and/or shortness of breath (2)
CL Item
0 none (0)
CL Item
1 lacrimation and/or itching of palate/ears (1)
CL Item
2 conjunctivitis and/or urticaria and/or coughing and/or shortness of breath (2)
CL Item
0 none (0)
CL Item
1 lacrimation and/or itching of palate/ears (1)
CL Item
2 conjunctivitis and/or urticaria and/or coughing and/or shortness of breath (2)
Item
Second provocation value of remote symptoms
text
C0027431 (UMLS CUI [1])
CL Item
0 none (0)
CL Item
1 lacrimation and/or itching of palate/ears (1)
CL Item
2 conjunctivitis and/or urticaria and/or coughing and/or shortness of breath (2)
Nasal provocation test
Item
Sum of nasal provocation test symptom scores: baseline value
integer
C0027431 (UMLS CUI [1])
Nasal provocation test
Item
Sum of nasal provocation test symptom scores: blank value
integer
C0027431 (UMLS CUI [1])
Nasal provocation test
Item
Sum of nasal provocation test symptom scores:first provocation value
integer
C0027431 (UMLS CUI [1])
Nasal provocation test
Item
Sum of nasal provocation test symptom scores:second provocation value
integer
C0027431 (UMLS CUI [1])
Rhinomanometry
Item
Flow volume in cm3/sec baseline value
float
C0430615 (UMLS CUI [1])
Rhinomanometry
Item
Flow volume in cm3/sec blank value
float
C0430615 (UMLS CUI [1])
Rhinomanometry
Item
Flow volume in cm3/sec first provocation value
float
C0430615 (UMLS CUI [1])
Rhinomanometry
Item
Flow volume in cm3/sec second provocation value
float
C0430615 (UMLS CUI [1])
Rhinomanometry
Item
Percentage of flow reduction:blank value
integer
C0430615 (UMLS CUI [1])
Rhinomanometry
Item
Percentage of flow reduction:first provocation value
integer
C0430615 (UMLS CUI [1])
Rhinomanometry
Item
Percentage of flow reduction:second provocation value
integer
C0430615 (UMLS CUI [1])
Item
Rhinoscopic evaluation after provocation tests: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 after provocation test: 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 after provocation tests: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)
Item Group
Determination of specific IgE and Safety Laboratory parameter
Item
Radioallergosorbent test categories for timothy grass
text
C0204726 (UMLS CUI [1,1])
C0443736 (UMLS CUI [1,2])
C0443736 (UMLS CUI [1,2])
CL Item
<0,35 (0)
CL Item
0,35-069 (I)
CL Item
0,70-3,49 (II)
CL Item
3,50-17,49 (III)
CL Item
17,5-49,99 (IV)
CL Item
50-100 (V)
CL Item
>100 (VI)
Radioallergosorbent test timothy grass
Item
Please specify RAST-Category [kU/L] for Timothy grass
float
C0799220 (UMLS CUI [1])
Item
Radioallergosorbent test categories for rye
text
C0204726 (UMLS CUI [1,1])
C0443736 (UMLS CUI [1,2])
C0443736 (UMLS CUI [1,2])
CL Item
<0,35 I= 0,35-069 II= 0,70-3,49 III= 3,50-17,49 IV= 17,5-49,99 V= 50-100 VI= >100 (0)
Radioallergosorbent test categories for rye
Item
Please specify RAST-Category [kU/L] for rye pollen
float
C1271227 (UMLS CUI [1])
Total IgE
Item
Total IgE [kU/L]
float
C0797024 (UMLS CUI [1])
Item
Verification of RAST categories: timothy grass, specific IgG4
text
C0204726 (UMLS CUI [1,1])
C0443736 (UMLS CUI [1,2])
C0443736 (UMLS CUI [1,2])
Code List
Verification of RAST categories: timothy grass, specific IgG4
CL Item
<0,35 I= 0,35-069 II= 0,70-3,49 III= 3,50-17,49 IV= 17,5-49,99 V= 50-100 VI= >100 (0)
Radioallergosorbent test catagories timothy grass
Item
Please specify RAST-Category [kU/L] for Timothy grass, specific IgG4
float
C0942402 (UMLS CUI [1])
Item
Verification of RAST categories for rye ,specific IgG4
text
C0204726 (UMLS CUI [1,1])
C0443736 (UMLS CUI [1,2])
C0443736 (UMLS CUI [1,2])
CL Item
<0,35 I= 0,35-069 II= 0,70-3,49 III= 3,50-17,49 IV= 17,5-49,99 V= 50-100 VI= >100 (0)
Radioallergosorbent test categories for rye
Item
Please specify RAST-Category [kU/L] for rye pollen, specific IgG4
float
C1271227 (UMLS CUI [1])
Laboratory results, safety parameter
Item
Please specify measured hemoglobine and units used
text
C1254595 (UMLS CUI [1,1])
C1269689 (UMLS CUI [1,2])
C1269689 (UMLS CUI [1,2])
Laboratory results, safety parameter
Item
Please specify measured amount of erythrocytes and units used
text
C1254595 (UMLS CUI [1,1])
C1269689 (UMLS CUI [1,2])
C1269689 (UMLS CUI [1,2])
Laboratory results, safety parameter
Item
Please specify measured amount of leucocytes and units used
text
C1254595 (UMLS CUI [1,1])
C1269689 (UMLS CUI [1,2])
C1269689 (UMLS CUI [1,2])
Laboratory results, safety parameter
Item
Please specify measured amount of neutrophils and units used
text
C1254595 (UMLS CUI [1,1])
C1269689 (UMLS CUI [1,2])
C1269689 (UMLS CUI [1,2])
Laboratory results, safety parameter
Item
Please specify measured amount of eosinophils and units used
text
C1254595 (UMLS CUI [1,1])
C1269689 (UMLS CUI [1,2])
C1269689 (UMLS CUI [1,2])
Laboratory results, safety parameter
Item
Please specify measured amount of basophils and units used
text
C1254595 (UMLS CUI [1,1])
C1269689 (UMLS CUI [1,2])
C1269689 (UMLS CUI [1,2])
Laboratory results, safety parameter
Item
Please specify measured amount of monocytes and units used
text
C1254595 (UMLS CUI [1,1])
C1269689 (UMLS CUI [1,2])
C1269689 (UMLS CUI [1,2])
Laboratory results, safety parameter
Item
Please specify measured amount of lymphocytes and units used
text
C1254595 (UMLS CUI [1,1])
C1269689 (UMLS CUI [1,2])
C1269689 (UMLS CUI [1,2])
Laboratory results, safety parameter
Item
Please specify measured hematocrit and units used
text
C1254595 (UMLS CUI [1,1])
C1269689 (UMLS CUI [1,2])
C1269689 (UMLS CUI [1,2])
Laboratory results, safety parameter
Item
Please specify measured amount of thrombocytes and units used
text
C1254595 (UMLS CUI [1,1])
C1269689 (UMLS CUI [1,2])
C1269689 (UMLS CUI [1,2])
Laboratory results, safety parameter
Item
Please specify measured amount of total bilirubin and units used
text
C1254595 (UMLS CUI [1,1])
C1269689 (UMLS CUI [1,2])
C1269689 (UMLS CUI [1,2])
Laboratory results, safety parameter
Item
Please specify the measured SGPT and units used
text
C1254595 (UMLS CUI [1,1])
C1269689 (UMLS CUI [1,2])
C1269689 (UMLS CUI [1,2])
Laboratory results, safety parameter
Item
Please specify the measurement of LDH and units used
text
C1254595 (UMLS CUI [1,1])
C1269689 (UMLS CUI [1,2])
C1269689 (UMLS CUI [1,2])
Laboratory results, safety parameter
Item
Please specify the measurement of creatinine and units used
text
C1254595 (UMLS CUI [1,1])
C1269689 (UMLS CUI [1,2])
C1269689 (UMLS CUI [1,2])
Laboratory results, safety parameter
Item
Please specify the measurement of serum glutamate-oxaloacetate transaminase and units used
text
C1254595 (UMLS CUI [1,1])
C1269689 (UMLS CUI [1,2])
C1269689 (UMLS CUI [1,2])
Laboratory results, safety parameter
Item
Please specify the measurement of CRP and units used
text
C1254595 (UMLS CUI [1,1])
C1269689 (UMLS CUI [1,2])
C1269689 (UMLS CUI [1,2])
Sixteenth desensitization
Item
Has the sixteenth dose of desensitization been administered?
boolean
C0849706 (UMLS CUI [1])
Sixteenth desensitization
Item
Please give the date and time, the sixteenth dose has been administered
datetime
C0849706 (UMLS CUI [1])
Sixteenth desensitization
Item
If the sixteenth 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)
Sixteenth 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)
Sixteenth 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)
Date
Item
Date of completion of this form
date
C0011008 (UMLS CUI [1])
Signature
Item
Signature
text
C1519316 (UMLS CUI [1])