ID
43550
Description
Study part: Visit V0 Screening visit. 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 (2)
- 2/10/16 2/10/16 -
- 9/20/21 9/20/21 -
Uploaded on
September 20, 2021
DOI
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License
Creative Commons BY-NC 3.0
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Visit V0 LAIS grass tablets by allergic rhinoconjunctivitis EudraCT-Nr.2012-004916-79
Visit V0 Screening visit
- StudyEvent: ODM
Description
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Description
Study Subject Participation Status
Data type
boolean
Alias
- UMLS CUI [1]
- C2348568
Description
immunotherapy; Grass pollen; allergen
Data type
boolean
Alias
- UMLS CUI [1]
- C0021083
- UMLS CUI [2]
- C0440307
- UMLS CUI [3]
- C0002092
Description
immunotherapy; allergen
Data type
boolean
Alias
- UMLS CUI [1]
- C0021083
- UMLS CUI [2]
- C0002092
Description
investigator; relationship
Data type
boolean
Alias
- UMLS CUI [1]
- C0008961
- UMLS CUI [2]
- C0439849
Description
compliance behavior limited
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1321605
- UMLS CUI [1,2]
- C0439801
Description
contraception status
Data type
boolean
Alias
- UMLS CUI [1]
- C0420837
Description
perennial allergic rhinitis
Data type
boolean
Alias
- UMLS CUI [1]
- C0035457
Description
Perennial allergy Asthma
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2721639
- UMLS CUI [1,2]
- C0004096
Description
comorbidity; asthma; emphysem
Data type
boolean
Alias
- UMLS CUI [1]
- C0009488
- UMLS CUI [2]
- C0004096
- UMLS CUI [3]
- C0034067
Description
comorbidity; asthma; emphysem
Data type
boolean
Alias
- UMLS CUI [1]
- C0009488
- UMLS CUI [2]
- C0004096
- UMLS CUI [3]
- C0034067
Description
infection oral cavity
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0009450
- UMLS CUI [1,2]
- C0226896
Description
Intolerance galactose
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1744706
- UMLS CUI [1,2]
- C0016945
Description
adenoid
Data type
boolean
Alias
- UMLS CUI [1]
- C0001428
Description
Active tuberculosis
Data type
boolean
Alias
- UMLS CUI [1]
- C0151332
Description
inflammatory disease
Data type
boolean
Alias
- UMLS CUI [1]
- C1290884
Description
Immunodeficiencies
Data type
boolean
Alias
- UMLS CUI [1]
- C0596032
Description
Autoimmune diseases
Data type
boolean
Alias
- UMLS CUI [1]
- C0004364
Description
Autoimmune Diseases; internal disease
Data type
boolean
Alias
- UMLS CUI [1]
- C0004364
- UMLS CUI [2]
- C0679231
Description
Malignant tumors
Data type
boolean
Alias
- UMLS CUI [1]
- C0006826
Description
Substance Use Disorder
Data type
boolean
Alias
- UMLS CUI [1]
- C0038586
Description
Contraindication epinephrine
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0522473
- UMLS CUI [1,2]
- C0014563
Description
sedatives
Data type
boolean
Alias
- UMLS CUI [1]
- C0036557
Description
Contraindicated drug
Data type
boolean
Alias
- UMLS CUI [1]
- C3845816
Description
Demographics
Alias
- UMLS CUI-1
- C0011298
Description
visit date
Data type
date
Alias
- UMLS CUI [1]
- C1320303
Description
consent date
Data type
date
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C0011008
Description
birth year
Data type
partialDate
Alias
- UMLS CUI [1]
- C2826771
Description
gender
Data type
text
Alias
- UMLS CUI [1]
- C0079399
Description
Ethnicity
Data type
text
Alias
- UMLS CUI [1]
- C0015031
Description
other
Data type
text
Alias
- UMLS CUI [1]
- C0205394
Description
visit date
Data type
date
Alias
- UMLS CUI [1]
- C1320303
Description
Laboratory
Alias
- UMLS CUI-1
- C0022877
Description
venipuncture date
Data type
date
Alias
- UMLS CUI [1,1]
- C0600406
- UMLS CUI [1,2]
- C0011008
Description
venipuncture date
Data type
date
Alias
- UMLS CUI [1,1]
- C0600406
- UMLS CUI [1,2]
- C0011008
Description
contraception status
Data type
text
Alias
- UMLS CUI [1]
- C0420837
Description
Exception to the pregnancy test: patients with hysterectomy or patients in postmenopause (since at least 1 year.)
Data type
date
Alias
- UMLS CUI [1,1]
- C0032976
- UMLS CUI [1,2]
- C0011008
Description
pregnancy test result
Data type
text
Alias
- UMLS CUI [1]
- C0032976
Description
Physical examination
Alias
- UMLS CUI-1
- C0031809
Description
Weight
Data type
float
Measurement units
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
systolic blood pressure
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Description
Diastolic blood pressure
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Description
Heart rate
Data type
integer
Measurement units
- 1/ min
Alias
- UMLS CUI [1]
- C0018810
Description
Examination (Rhinoscope)
Alias
- UMLS CUI-1
- C0582103
- UMLS CUI-2
- C0183044
Description
History of allergies
Alias
- UMLS CUI-1
- C0489531
Description
If a clinically relevant sensitization to mainly co-seasonal or perennial co- allergens during the grass pollen season--> Exclusion of patients
Data type
boolean
Alias
- UMLS CUI [1]
- C0440307
Description
tree pollen
Data type
boolean
Alias
- UMLS CUI [1]
- C3541399
Description
Atopic dermatitis
Data type
boolean
Alias
- UMLS CUI [1]
- C0011615
Description
weed pollen
Data type
boolean
Alias
- UMLS CUI [1]
- C1328969
Description
Food allergies
Data type
boolean
Alias
- UMLS CUI [1]
- C0016470
Description
Food allergies
Data type
text
Alias
- UMLS CUI [1]
- C0016470
Description
allergy
Data type
text
Alias
- UMLS CUI [1]
- C0020517
Description
Clinical symptoms
Alias
- UMLS CUI-1
- C1457887
Description
allergic rhinitis; allergic rhinoconjunctivitis
Data type
boolean
Alias
- UMLS CUI [1]
- C2607914
- UMLS CUI [2]
- C0861154
Description
allergic rhinitis; allergic rhinoconjunctivitis
Data type
text
Alias
- UMLS CUI [1]
- C2607914
- UMLS CUI [2]
- C0861154
Description
allergic rhinoconjunctivitis date
Data type
date
Alias
- UMLS CUI [1,1]
- C0861154
- UMLS CUI [1,2]
- C0011008
Description
Retrospective Rhinoconjunctivitis Total Symptom Score
Alias
- UMLS CUI-1
- C0449820
- UMLS CUI-2
- C0861155
Description
Sneezing
Data type
text
Alias
- UMLS CUI [1]
- C0037383
Description
Rhinorrhea
Data type
text
Alias
- UMLS CUI [1]
- C1260880
Description
Nasal pruritus
Data type
text
Alias
- UMLS CUI [1]
- C0850060
Description
Nasal congestion
Data type
text
Alias
- UMLS CUI [1]
- C0027424
Description
Watery eyes
Data type
text
Alias
- UMLS CUI [1]
- C3257803
Description
Itching of eye
Data type
text
Alias
- UMLS CUI [1]
- C0022281
Description
Summation
Data type
integer
Alias
- UMLS CUI [1]
- C0234108
Description
Concomitant medication
Alias
- UMLS CUI-1
- C2347852
Description
Medical history
Alias
- UMLS CUI-1
- C0262926
Description
cardiovascular system
Data type
boolean
Alias
- UMLS CUI [1]
- C0007226
Description
respiratory
Data type
boolean
Alias
- UMLS CUI [1]
- C0035237
Description
gastrointestinal tract
Data type
boolean
Alias
- UMLS CUI [1]
- C0017189
Description
Eye
Data type
boolean
Alias
- UMLS CUI [1]
- C0015392
Description
Nose
Data type
boolean
Alias
- UMLS CUI [1]
- C0028429
Description
Ears
Data type
boolean
Alias
- UMLS CUI [1]
- C0013443
Description
Neck
Data type
boolean
Alias
- UMLS CUI [1]
- C0027530
Description
Skin
Data type
boolean
Alias
- UMLS CUI [1]
- C1123023
Description
Skin
Data type
boolean
Alias
- UMLS CUI [1]
- C1123023
Description
Endocrine system; lymphatic system
Data type
boolean
Alias
- UMLS CUI [1]
- C0014130
- UMLS CUI [2]
- C0024235
Description
muscle; skeleton
Data type
boolean
Alias
- UMLS CUI [1]
- C0026845
- UMLS CUI [2]
- C0037253
Description
Nervous system
Data type
boolean
Alias
- UMLS CUI [1]
- C0027763
Description
genitourinary
Data type
boolean
Alias
- UMLS CUI [1]
- C0042066
Description
Metabolic System
Data type
boolean
Alias
- UMLS CUI [1]
- C0014136
Description
Comorbidity
Data type
text
Alias
- UMLS CUI [1]
- C0009488
Description
comorbidity
Data type
text
Alias
- UMLS CUI [1]
- C0009488
Description
surgical procedures
Data type
text
Alias
- UMLS CUI [1]
- C0543467
Description
Specification
Data type
text
Description
Skin prick test
Alias
- UMLS CUI-1
- C0430561
Description
grass pollen
Data type
float
Measurement units
- mm
Alias
- UMLS CUI [1]
- C0440307
Description
histamine dihydrochloride
Data type
float
Measurement units
- mm
Alias
- UMLS CUI [1]
- C0543456
Description
Saline Solution
Data type
float
Measurement units
- mm
Alias
- UMLS CUI [1]
- C0036082
Description
rye pollen
Data type
float
Measurement units
- mm
Alias
- UMLS CUI [1]
- C0440328
Description
hazel pollen
Data type
float
Measurement units
- mm
Alias
- UMLS CUI [1]
- C0440377
Description
ambrosia pollen
Data type
float
Measurement units
- mm
Alias
- UMLS CUI [1]
- C3495104
Description
Birch pollen
Data type
float
Measurement units
- mm
Alias
- UMLS CUI [1]
- C4047367
Description
mugwort pollen
Data type
float
Measurement units
- mm
Alias
- UMLS CUI [1]
- C3495107
Description
House dust mite
Data type
float
Measurement units
- mm
Alias
- UMLS CUI [1]
- C3539110
Description
cat hair
Data type
float
Measurement units
- mm
Alias
- UMLS CUI [1]
- C0440419
Description
dog hair
Data type
float
Measurement units
- mm
Alias
- UMLS CUI [1]
- C0440417
Description
Alternaria
Data type
float
Measurement units
- mm
Alias
- UMLS CUI [1]
- C0002343
Description
Spirometry or Peak expiratory flow measurement (For asthmatics)
Alias
- UMLS CUI-1
- C0037981
- UMLS CUI-2
- C0521299
Description
FEV1
Data type
float
Alias
- UMLS CUI [1]
- C0748133
Description
FEV1
Data type
float
Alias
- UMLS CUI [1]
- C0748133
Description
Ratio; FEV1; standard value
Data type
integer
Measurement units
- %
Alias
- UMLS CUI [1]
- C0456603
- UMLS CUI [2]
- C0588029
- UMLS CUI [3]
- C1442989
Description
Peak expiratory flow measurement
Data type
integer
Measurement units
- l/min
Alias
- UMLS CUI [1]
- C0521299
Description
Peak expiratory flow measurement
Data type
integer
Measurement units
- l/ min
Alias
- UMLS CUI [1]
- C0521299
Description
Peak expiratory flow measurement
Data type
integer
Measurement units
- l/ min
Alias
- UMLS CUI [1]
- C0521299
Description
Peak expiratory flow measurement
Data type
integer
Measurement units
- l/ min
Alias
- UMLS CUI [1]
- C0521299
Description
Peak expiratory flow measurement
Data type
integer
Measurement units
- l/ min
Alias
- UMLS CUI [1]
- C0521299
Description
Conjunctival provocation testing
Alias
- UMLS CUI-1
- C0430565
Description
Conjunctival provocation testing
Data type
text
Alias
- UMLS CUI [1]
- C0430565
Description
Conjunctival provocation testing
Data type
text
Alias
- UMLS CUI [1]
- C0430565
Description
Conjunctival provocation testing
Data type
text
Alias
- UMLS CUI [1]
- C0430565
Description
concentration allergen
Data type
text
Alias
- UMLS CUI [1,1]
- C1446561
- UMLS CUI [1,2]
- C0002092
Description
Conjunctival provocation testing
Data type
boolean
Description
Allergy diagnostics
Alias
- UMLS CUI-1
- C0086143
- UMLS CUI-2
- C0020517
Description
Immunoglobulin E
Data type
float
Measurement units
- kU/l
Alias
- UMLS CUI [1]
- C0202086
Description
Immunoglobulin G4
Data type
float
Measurement units
- kU/l
Alias
- UMLS CUI [1]
- C0020860
Description
Immunoglobulin; Grass pollen
Data type
float
Measurement units
- kU/l
Alias
- UMLS CUI [1]
- C0021027
- UMLS CUI [2]
- C0440307
Description
Radioallergosorbent Test
Data type
text
Alias
- UMLS CUI [1]
- C0034554
Description
Immunoglobulin; Grass pollen
Data type
float
Measurement units
- kU/l
Alias
- UMLS CUI [1]
- C0021027
- UMLS CUI [2]
- C0440307
Description
Radioallergosorbent Test
Data type
text
Alias
- UMLS CUI [1]
- C0034554
Description
Immunoglobulin; Grass pollen
Data type
float
Measurement units
- kU/l
Alias
- UMLS CUI [1]
- C0021027
- UMLS CUI [2]
- C0440307
Description
Radioallergosorbent Test
Data type
text
Alias
- UMLS CUI [1]
- C0034554
Description
Immunoglobulin; Grass pollen
Data type
float
Measurement units
- kU/l
Alias
- UMLS CUI [1]
- C0021027
- UMLS CUI [2]
- C0440307
Description
Radioallergosorbent Test
Data type
text
Alias
- UMLS CUI [1]
- C0034554
Description
Birch antigen
Data type
float
Measurement units
- kU/l
Alias
- UMLS CUI [1]
- C1527024
Description
Radioallergosorbent Test
Data type
text
Alias
- UMLS CUI [1]
- C0034554
Description
Immunoglobulin Mugwort
Data type
float
Measurement units
- kU/l
Alias
- UMLS CUI [1,1]
- C0021027
- UMLS CUI [1,2]
- C0348066
Description
Radioallergosorbent Test
Data type
text
Alias
- UMLS CUI [1]
- C0034554
Description
Immunoglobulin ambrosia
Data type
float
Measurement units
- kU/l
Alias
- UMLS CUI [1,1]
- C0021027
- UMLS CUI [1,2]
- C0331432
Description
Radioallergosorbent Test
Data type
text
Alias
- UMLS CUI [1]
- C0034554
Description
Immunoglobulin Dermatophagoides pteronyssinus
Data type
float
Measurement units
- kU/l
Alias
- UMLS CUI [1,1]
- C0021027
- UMLS CUI [1,2]
- C1122992
Description
Radioallergosorbent Test
Data type
text
Alias
- UMLS CUI [1]
- C0034554
Description
Immunoglobulin Dermatophagoides farinae
Data type
float
Measurement units
- kU/l
Alias
- UMLS CUI [1,1]
- C0021027
- UMLS CUI [1,2]
- C0323677
Description
Radioallergosorbent Test
Data type
text
Alias
- UMLS CUI [1]
- C0034554
Description
Dog antigen
Data type
float
Measurement units
- kU/l
Alias
- UMLS CUI [1]
- C1443014
Description
Radioallergosorbent Test
Data type
text
Alias
- UMLS CUI [1]
- C0034554
Description
Cat hair antigen
Data type
float
Measurement units
- kU/l
Alias
- UMLS CUI [1]
- C1443200
Description
Radioallergosorbent Test
Data type
text
Alias
- UMLS CUI [1]
- C0034554
Description
Immunoglobulin Alternaria
Data type
float
Measurement units
- kU/l
Alias
- UMLS CUI [1,1]
- C0021027
- UMLS CUI [1,2]
- C0002343
Description
Radioallergosorbent Test
Data type
text
Alias
- UMLS CUI [1]
- C0034554
Description
Hematology
Alias
- UMLS CUI-1
- C0474523
Description
Hemoglobin
Data type
float
Measurement units
- mmol/l
Alias
- UMLS CUI [1]
- C0019046
Description
Erythrocyte
Data type
float
Measurement units
- /pl
Alias
- UMLS CUI [1]
- C0014772
Description
Thrombocyte
Data type
float
Measurement units
- /nl
Alias
- UMLS CUI [1]
- C0005821
Description
Leucocyte (total)
Data type
float
Measurement units
- /nl
Alias
- UMLS CUI [1]
- C0023508
Description
Hematocrit
Data type
float
Measurement units
- l/l
Alias
- UMLS CUI [1]
- C0518014
Description
Biochemistry
Alias
- UMLS CUI-1
- C0005477
Description
Bilirubin
Data type
float
Measurement units
- μmol/l
Alias
- UMLS CUI [1]
- C1278039
Description
Glutamate pyruvate transaminase
Data type
float
Measurement units
- U/l
Description
alkaline phosphatase
Data type
float
Measurement units
- U/l
Alias
- UMLS CUI [1]
- C0201850
Description
Glucose
Data type
float
Measurement units
- mmol/l
Alias
- UMLS CUI [1]
- C0202042
Description
Creatinine
Data type
float
Measurement units
- μmol/l
Alias
- UMLS CUI [1]
- C0201976
Description
Aspartate aminotransferase measurement
Data type
float
Measurement units
- U/l
Alias
- UMLS CUI [1]
- C0201899
Description
C reactive protein
Data type
float
Measurement units
- mg/l
Alias
- UMLS CUI [1]
- C0201657
Description
Gamma-glutamyl transpeptidase
Data type
float
Measurement units
- U/l
Alias
- UMLS CUI [1]
- C1883012
Description
Inclusion Criteria (Part 2)
Alias
- UMLS CUI-1
- C1512693
Description
The positive clinical case history to grass pollen is evidenced by
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C0440307
Description
The positive clinical case history to grass pollen is evidenced by
Data type
boolean
Alias
- UMLS CUI [1]
- C3662483
Description
The positive clinical case history to grass pollen is evidenced by
Data type
boolean
Alias
- UMLS CUI [1]
- C0430561
Description
The positive clinical case history to grass pollen is evidenced by
Data type
boolean
Alias
- UMLS CUI [1]
- C2721639
Description
The positive clinical case history to grass pollen is evidenced by
Data type
boolean
Alias
- UMLS CUI [1]
- C0430565
Description
The positive clinical case history to grass pollen is evidenced by
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0449820
- UMLS CUI [1,2]
- C0861155
Description
The positive clinical case history to grass pollen is evidenced by
Data type
boolean
Alias
- UMLS CUI [1]
- C1535925
Description
The positive clinical case history to grass pollen is evidenced by
Data type
boolean
Alias
- UMLS CUI [1]
- C0202086
Description
The positive clinical case history to grass pollen is evidenced by
Data type
boolean
Alias
- UMLS CUI [1]
- C0202086
- UMLS CUI [2]
- C1387134
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C0002092 (UMLS CUI [1,2])
C0440307 (UMLS CUI [2])
C0440307 (UMLS CUI [2])
C0440307 (UMLS CUI [2])
C0440307 (UMLS CUI [2])
C0348066 (UMLS CUI [1,2])
C0331432 (UMLS CUI [1,2])
C1122992 (UMLS CUI [1,2])
C0323677 (UMLS CUI [1,2])
C0002343 (UMLS CUI [1,2])
C0440307 (UMLS CUI [1,2])
C0861155 (UMLS CUI [1,2])
C1387134 (UMLS CUI [2])