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ID
13269
Description
Study part: Visit V7 (Day 238 + - 14) Final examination. 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.
Keywords
Versions (1)
- 1/28/16 1/28/16 -
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January 28, 2016
DOI
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License
Creative Commons BY-NC 3.0
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Visit V7_LAIS grass tablets by allergic rhinoconjunctivitis_EudraCT-Nr.2012-004916-79
Visit V7 (Day 238 + - 14) Final examination
- StudyEvent: ODM
Similar models
Visit V7 (Day 238 + - 14) Final examination
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Patient diary
Item
Patient diary (part 2) collected and controlled?
boolean
C3890583 (UMLS CUI [1])
Quality of life; Rhinoconjunctivitis
Item
Did the patient fill up the documentation form on quality of life of rhinoconjunctivitis patients?
boolean
C0034380 (UMLS CUI [1])
C0861155 (UMLS CUI [2])
C0861155 (UMLS CUI [2])
study completion
Item
Documentation of study completion done? (Please use the form "Study completion")
boolean
C2826674 (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])
date
Item
Pregnancy test carried out on
date
C0011008 (UMLS CUI [1])
CL Item
positive (1)
CL Item
negative (2)