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ID
13264
Beschrijving
Study part: Visit V4 (Day 84 + - 7). Effectiveness and tolerance of sublingual desensitization with LAIS grass tablets in Patients with an allergic rhinoconjunctivitis caused by grass pollen. A prospective, multi-center, doubleblind, randomized, placebo-controlled Phase III study. Principal Investigator Prof. Dr. med. Ralph Mösges.
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Versies (1)
- 28-01-16 28-01-16 -
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28 januari 2016
DOI
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Licentie
Creative Commons BY-NC 3.0
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Visit V4_LAIS grass tablets by allergic rhinoconjunctivitis_EudraCT-Nr.2012-004916-79
Visit V4 (Day 84 + - 7)
- StudyEvent: ODM
Similar models
Visit V4 (Day 84 + - 7)
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
date
Item
Date of visit
date
C0011008 (UMLS CUI [1])
Item
Does the patient still take part in the study?
text
C2348568 (UMLS CUI [1])
CL Item
yes (1)
CL Item
no, please then fill up the form "Study completion" (2)
Item
Did the patient take the medication according to the protocol?
text
C1321605 (UMLS CUI [1])
CL Item
always (1)
CL Item
mostly yes (2)
CL Item
mostly no (3)
CL Item
no (4)
details compliance
Item
If the compliance was not always, please mention in detail
text
C0392360 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C1321605 (UMLS CUI [1,2])
Comorbidity
Item
Comorbidity? Please fill up the form "Documentation adverse event"
boolean
Concomitant medication
Item
Concomitant medication? Please use the form "Documentation Concomitant medication"
boolean
C2347852 (UMLS CUI [1])
Date
Item
Date for next visit 5 (Day 140 + - 7 days)
date
C0011008 (UMLS CUI [1])
adverse event
Item
Did an adverse event occur during the treatment? (If yes, please use the form "Documentation adverse event")
boolean
C0877248 (UMLS CUI [1])
serious adverse event
Item
Did a serious adverse event occur during the treatment? (If yes, please use the form "Documentation serious adverse events")
boolean
C1519255 (UMLS CUI [1])
adverse event
Item
Are there any undocumented adverse events, which were not recorded during the previous visit? (If yes, please use the form "Documentation adverse event")
boolean
C0877248 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
systolic blood pressure
Item
Systolic blood pressure
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Diastolic blood pressure
integer
C0428883 (UMLS CUI [1])
heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item Group
Examination (Rhinoscope)
C0582103 (UMLS CUI-1)
C0183044 (UMLS CUI-2)
C0183044 (UMLS CUI-2)
CL Item
no (1)
CL Item
slight (2)
CL Item
medium (3)
CL Item
strong (4)
CL Item
no (1)
CL Item
slight (2)
CL Item
medium (3)
CL Item
strong (4)
CL Item
no (1)
CL Item
slight (2)
CL Item
medium (3)
CL Item
strong (4)
Item Group
Spirometry or Peak expiratory flow measurement (For asthmatics)
C0037981 (UMLS CUI-1)
C0521299 (UMLS CUI-3)
C0521299 (UMLS CUI-3)
FEV1
Item
FEV1 (age-appropriate standard value)
float
C0748133 (UMLS CUI [1])
FEV1
Item
FEV1
float
C0748133 (UMLS CUI [1])
Ratio; FEV1; standard value
Item
FEV1/ Standard value (If FEV1 < 70% of age appropriate standard value, exclusion)
integer
C0456603 (UMLS CUI [1])
C0588029 (UMLS CUI [2])
C1442989 (UMLS CUI [3])
C0588029 (UMLS CUI [2])
C1442989 (UMLS CUI [3])
Peak expiratory flow measurement
Item
PEF 1
integer
C0521299 (UMLS CUI [1])
Peak expiratory flow measurement
Item
PEF 2
integer
C0521299 (UMLS CUI [1])
Peak expiratory flow measurement
Item
PEF 3
integer
C0521299 (UMLS CUI [1])
Peak expiratory flow measurement
Item
Best PEF
integer
C0521299 (UMLS CUI [1])
Peak expiratory flow measurement
Item
Optimum individual value PEF (If FEV1 < 70% of optimum individual value, exclusion)
integer
C0521299 (UMLS CUI [1])
Item Group
Study medication and Concomitant medication (Taking back of the second study medication box with 7 blister pack)
C0013227 (UMLS CUI-1)
medication study
Item
Number of tablets left (study medication)
integer
C0013227 (UMLS CUI [1,1])
C0008972 (UMLS CUI [1,2])
C0008972 (UMLS CUI [1,2])
medication Demand
Item
Number of tablets left (Loratadin)
integer
C0013227 (UMLS CUI [1,1])
C0441516 (UMLS CUI [1,2])
C0441516 (UMLS CUI [1,2])
details
Item
Mention, if incomplete
text
C1522508 (UMLS CUI [1])
medication
Item
Handing out of third study medication box with 8 blister pack and 1 blister pack of concomitant medication (if necessary)
boolean
C0013227 (UMLS CUI [1])
Item
Conjunctival provocation test result 1
text
C0430565 (UMLS CUI [1])
CL Item
positive (1)
CL Item
negative (2)
Item
Conjunctival provocation test result 2 (to be carried out only when test 1 outcome is negative)
text
C0430565 (UMLS CUI [1])
Code List
Conjunctival provocation test result 2 (to be carried out only when test 1 outcome is negative)
CL Item
positive (1)
CL Item
negative (2)
Item
Conjunctival provocation test result 3 (to be carried out only when test 2 outcome is negative)
text
C0430565 (UMLS CUI [1])
Code List
Conjunctival provocation test result 3 (to be carried out only when test 2 outcome is negative)
CL Item
positive (1)
CL Item
negative (2)
Item
Allergen concentration at which the test outcome is positive
text
C1446561 (UMLS CUI [1,1])
C0002092 (UMLS CUI [1,2])
C0002092 (UMLS CUI [1,2])
CL Item
100 SQ- E/ ml (1)
CL Item
1000 SQ-E/ ml (2)
CL Item
10000 SQ-E/ ml (3)
Conjunctival provocation testing
Item
The outcome for all tests is negative
boolean