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ID
13150
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)
- 1/19/16 1/19/16 -
- 1/20/16 1/20/16 -
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January 20, 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 1.1
Case report form Visit1 part 2
- StudyEvent: ODM
Similar models
Case report form Visit1 part 2
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Medical History and documentation of first Dose of trial substance
Patient Identification
Item
Please give Patient ID composed of Study site Nr and Patient Nr
integer
C1269815 (UMLS CUI [1])
CL Item
yes (1)
CL Item
no (2)
CL Item
waiting for washout of Antihistamine or Steroids (3)
Date of Skin prick test
Item
Date Skin prick test was performed
date
C0011008 (UMLS CUI [1])
C0430561 (UMLS CUI [2])
C0430561 (UMLS CUI [2])
skin prick test
Item
Reaction to grass:please give the diameter of the resulting rash
float
C0430561 (UMLS CUI [1])
skin prick test
Item
Reaction to rye: diameter of rash
float
C0430561 (UMLS CUI [1])
skin prick test
Item
Reaction to birch:diameter of rash
float
C0430561 (UMLS CUI [1])
Skin prick test
Item
Reaction to artemisia:diameter of rash
float
C0430561 (UMLS CUI [1])
Skin prick test
Item
Reaction to dust mite:diameter of rash
float
C0430561 (UMLS CUI [1])
Skin prick test
Item
Reaction to cat hair:diameter of rash
float
C0430561 (UMLS CUI [1])
Skin prick test
Item
Reaction to dog hair:diameter of rash
float
C0430561 (UMLS CUI [1])
Skin prick test
Item
Reaction to mold:diameter of rash
float
C0430561 (UMLS CUI [1])
Skin prick test
Item
Reaction to histamin-hydrochloride:diameter of rash
float
C0430561 (UMLS CUI [1])
Skin prick test
Item
Reaction to phenolic glycerine-saline solution
float
C0430561 (UMLS CUI [1])
Spirometry
Item
Please give FVC spirometry result
float
C0037981 (UMLS CUI [1])
Spirometry
Item
Please give FEV1 result of spirometry
float
C0037981 (UMLS CUI [1])
Spirometry
Item
Please give FEV1/FVC spirometry results
integer
C0037981 (UMLS CUI [1])
Peak expiratory flow measurement
Item
Peak expiratory flow measurement 1
float
C0521299 (UMLS CUI [1])
Peak expiratory flow measurement
Item
Peak expiratory flow measurement 2
float
C0521299 (UMLS CUI [1])
Peak expiratory flow measurement
Item
Peak expiratory flow measurement 3
float
C0521299 (UMLS CUI [1])
Peak expiratory flow measurement
Item
Peak expiratory flow measurement: optimum at Visit 1
float
C0521299 (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])
C0178628 (UMLS CUI [2])
C0178628 (UMLS CUI [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])
C0178628 (UMLS CUI [2])
C0178628 (UMLS CUI [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])
C0178628 (UMLS CUI [2])
C0178628 (UMLS CUI [2])
CL Item
none (0)
CL Item
little (1)
CL Item
severe (2)
Item
radioallergosorbent test categories for timothy grass
text
C0204726 (UMLS CUI [1])
C0443736 (UMLS CUI [2])
C0443736 (UMLS CUI [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])
C0443736 (UMLS CUI [2])
C0443736 (UMLS CUI [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 specific IgG4 RAST cetagories: timothy grass
text
C0204726 (UMLS CUI [1])
C0443736 (UMLS CUI [2])
C0443736 (UMLS CUI [2])
Code List
Verification of specific IgG4 RAST cetagories: timothy grass
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 timothy grass
Item
Please specify RAST-Category [kU/L] for Timothy grass
float
C0942402 (UMLS CUI [1])
Item
Radioallergosorbent test categories for rye
text
C0204726 (UMLS CUI [1])
C0443736 (UMLS CUI [2])
C0443736 (UMLS CUI [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])
Laboratory results, safety parameter
Item
Please specify measured hemoglobine and units used
text
C1254595 (UMLS CUI [1])
C1269689 (UMLS CUI [2])
C1269689 (UMLS CUI [2])
Laboratory results, safety parameter
Item
Please specify measured amount of erythrocytes and units used
text
C1254595 (UMLS CUI [1])
C1269689 (UMLS CUI [2])
C1269689 (UMLS CUI [2])
Laboratory results, safety parameter
Item
Please specify measured amount of leucocytes and units used
text
C1254595 (UMLS CUI [1])
C1269689 (UMLS CUI [2])
C1269689 (UMLS CUI [2])
Laboratory results, safety parameter
Item
Please specify measured amount of neutrophils and units used
text
C1254595 (UMLS CUI [1])
C1269689 (UMLS CUI [2])
C1269689 (UMLS CUI [2])
Laboratory results, safety parameter
Item
Please specify measured amount of eosinophils and units used
text
C1254595 (UMLS CUI [1])
C1269689 (UMLS CUI [2])
C1269689 (UMLS CUI [2])
Laboratory results, safety parameter
Item
Please specify measured amount of basophils and units used
text
C1254595 (UMLS CUI [1])
C1269689 (UMLS CUI [2])
C1269689 (UMLS CUI [2])
Laboratory results, safety parameter
Item
Please specify measured amount of monocytes and units used
text
C1254595 (UMLS CUI [1])
C1269689 (UMLS CUI [2])
C1269689 (UMLS CUI [2])
Laboratory results, safety parameter
Item
Please specify measured amount of lymphocytes and units used
text
C1254595 (UMLS CUI [1])
C1269689 (UMLS CUI [2])
C1269689 (UMLS CUI [2])
Laboratory results, safety parameter
Item
Please specify measured hematocrit and units used
text
C1254595 (UMLS CUI [1])
C1269689 (UMLS CUI [2])
C1269689 (UMLS CUI [2])
Laboratory results, safety parameter
Item
Please specify measured amount of thrombocytes and units used
text
C1254595 (UMLS CUI [1])
C1269689 (UMLS CUI [2])
C1269689 (UMLS CUI [2])
Laboratory results, safety parameter
Item
Please specify measured amount of total bilirubin and units used
text
C1254595 (UMLS CUI [1])
C1269689 (UMLS CUI [2])
C1269689 (UMLS CUI [2])
Laboratory results, safety parameter
Item
Please specify the measured SGPT and units used
text
C1254595 (UMLS CUI [1])
C1269689 (UMLS CUI [2])
C1269689 (UMLS CUI [2])
Laboratory results, safety parameter
Item
Please specify the measurement of LDH and units used
text
C1254595 (UMLS CUI [1])
C1269689 (UMLS CUI [2])
C1269689 (UMLS CUI [2])
Laboratory results, safety parameter
Item
Please specify the measurement of creatinine and units used
text
C1254595 (UMLS CUI [1])
C1269689 (UMLS CUI [2])
C1269689 (UMLS CUI [2])
Laboratory results, safety parameter
Item
Please specify the measurement of serum glutamate-oxaloacetate transaminase and units used
text
C1254595 (UMLS CUI [1])
C1269689 (UMLS CUI [2])
C1269689 (UMLS CUI [2])
Laboratory results, safety parameter
Item
Please specify the measurement of CRP and units used
text
C1254595 (UMLS CUI [1])
C1269689 (UMLS CUI [2])
C1269689 (UMLS CUI [2])
Desensitization
Item
Dose one of desensitization substance administered?
boolean
C0849706 (UMLS CUI [1])
Desensitization
Item
Please give the hour the first dose was administered
time
C0849706 (UMLS CUI [1])
Desensitization
Item
If the dose has not been administered, please specify the reason why
text
C0849706 (UMLS CUI [1])
CL Item
0,1 ml according to protocol (1)
CL Item
adjusted dose (2)
Desensitization
Item
If 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 wich arm has been used for injection
text
C0849706 (UMLS CUI [1])
CL Item
right arm (1)
CL Item
left arm (2)
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)
Desensitization
Item
Please specify any other symptoms that occured within 30 min after injection
text
C0849706 (UMLS CUI [1])
Serious adverse events during desensitization
Item
Have severe local, gastrointestinal or systemic symptoms occured? If yes, the SAE sheet has to be filled in and sent to the sponsor within 24 hours.
boolean
C0849706 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
C1519255 (UMLS CUI [2])
Item
What measures have been taken in response to the SAE?
text
C1519255 (UMLS CUI [1])
C1547656 (UMLS CUI [2])
C1547656 (UMLS CUI [2])
CL Item
termination of study -> please fill in study completion form (1)
CL Item
adjustment of dose during next course of desensitization (2)
Quality of life form
Item
Has the quality of life form for patients with rhinoconjunctivits been filled in be the patient?
boolean
C0518214 (UMLS CUI [1])
Second desensitization
Item
Has the second dose of desensitization been administered?
boolean
C0849706 (UMLS CUI [1])
Second desensitization
Item
Please give the time, the second dose has been administered
time
C0849706 (UMLS CUI [1])
Second desensitization
Item
If the second dose has not been administered, please specify the reason why
text
C0849706 (UMLS CUI [1])
Item
How much of the trial substance has been titrated?
text
C0849706 (UMLS CUI [1])
CL Item
0,2ml (1)
CL Item
adjusted dose (2)
Second 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, please don´t use the same arm as during the first round of desensitization
text
C0849706 (UMLS CUI [1])
Code List
Please specify which arm has been used for injection, please don´t use the same arm as during the first round of desensitization
CL Item
right arm (1)
CL Item
left arm (2)
Second 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)
Second desensitization
Item
Please specify any other symptoms that occured within 30 min after injection of second desensitization
text
C0849706 (UMLS CUI [1])
Serious adverse events during second desensitization
Item
Have severe local, gastrointestinal or systemic symptoms occured during second desensitization? If yes, the SAE sheet has to be filled in and sent to the sponsor within 24 hours.
boolean
C0849706 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
C1519255 (UMLS CUI [2])
Item
What measures have been taken in response to the SAE?
text
C1519255 (UMLS CUI [1])
C1547656 (UMLS CUI [2])
C1547656 (UMLS CUI [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])
C0041755 (UMLS CUI [2])
C0041755 (UMLS CUI [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 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])