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ID
13369
Beschreibung
Study part: Visit V1 (Day 0). 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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- 09.02.16 09.02.16 -
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9. Februar 2016
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Visit 1 LAIS grass tablets by allergic rhinoconjunctivitis EudraCT-Nr.2012-004916-79
Ähnliche Modelle
Visit V1 (Day 0)
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
visit date
Item
Date of visit
date
C1320303 (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)
comorbidity
Item
Did new comorbidities occur during the study? (If yes, please fill the form ''Adverse event")
boolean
C0009488 (UMLS CUI [1])
Concomitant medication
Item
Concomitant medication? If yes, please use the form "Documentation Concomitant medication"
boolean
C2347852 (UMLS CUI [1])
inclusion criteria
Item
Inclusion criteria
text
C1512693 (UMLS CUI [1])
visit Date
Item
Date for next visit 2 (Day 7 + - 2 days)
date
C1320303 (UMLS CUI [1])
Questionnaire Allergic rhinoconjunctivitis
Item
Questionnaire on quality of life of rhinoconjunctivitis patients handed out and filled?
boolean
C0034394 (UMLS CUI [1,1])
C0861154 (UMLS CUI [1,2])
C0861154 (UMLS CUI [1,2])
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
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
Medication study
Item
Did the Patient receive study medication and the medications on demand?
boolean
C0013227 (UMLS CUI [1,1])
C0008972 (UMLS CUI [1,2])
C0008972 (UMLS CUI [1,2])
drug administration Date and Time Dose
Item
When was the study drug administered?
datetime
C3469597 (UMLS CUI [1,1])
C1986447 (UMLS CUI [1,2])
C1986447 (UMLS CUI [1,2])
adverse event
Item
Did adverse events occur within 30 minutes of drug intake?
boolean
C0877248 (UMLS CUI [1])
local reaction
Item
Local reaction
text
C0853813 (UMLS CUI [1])
Oral allergy syndrome
Item
Oral allergy syndrome
boolean
C2316159 (UMLS CUI [1])
Gastrointestinal symptom
Item
Gastrointestinal symptom (e.g. nausea, vomiting, bloating, dyspepsia, diarrhea)
boolean
C0426576 (UMLS CUI [1])
CL Item
nonspecific symptoms e.g. headache, discomfort (1)
CL Item
slight systemic symptoms (local urticaria, rhinitis or slight asthma (PEF< 20%)) (2)
CL Item
medium systemic symptoms (slow onset (> 15 min) of urticaria and/ or medium asthma (PEF< 40%)) (3)
CL Item
anaphylactic shock (4)
CL Item
other (5)
other
Item
When other, please mention
text
C0205394 (UMLS CUI [1])
adverse event Serious
Item
Is this a serious adverse event? If yes, please fill the documentation part "serious adverse event"
boolean
C0877248 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0205404 (UMLS CUI [1,2])