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.
Mots-clés
Versions (2)
- 10/02/2016 10/02/2016 -
- 20/09/2021 20/09/2021 -
Téléchargé le
20 septembre 2021
DOI
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Licence
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
Type de données
boolean
Alias
- UMLS CUI [1]
- C2348568
Description
immunotherapy; Grass pollen; allergen
Type de données
boolean
Alias
- UMLS CUI [1]
- C0021083
- UMLS CUI [2]
- C0440307
- UMLS CUI [3]
- C0002092
Description
immunotherapy; allergen
Type de données
boolean
Alias
- UMLS CUI [1]
- C0021083
- UMLS CUI [2]
- C0002092
Description
investigator; relationship
Type de données
boolean
Alias
- UMLS CUI [1]
- C0008961
- UMLS CUI [2]
- C0439849
Description
compliance behavior limited
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1321605
- UMLS CUI [1,2]
- C0439801
Description
contraception status
Type de données
boolean
Alias
- UMLS CUI [1]
- C0420837
Description
perennial allergic rhinitis
Type de données
boolean
Alias
- UMLS CUI [1]
- C0035457
Description
Perennial allergy Asthma
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C2721639
- UMLS CUI [1,2]
- C0004096
Description
comorbidity; asthma; emphysem
Type de données
boolean
Alias
- UMLS CUI [1]
- C0009488
- UMLS CUI [2]
- C0004096
- UMLS CUI [3]
- C0034067
Description
comorbidity; asthma; emphysem
Type de données
boolean
Alias
- UMLS CUI [1]
- C0009488
- UMLS CUI [2]
- C0004096
- UMLS CUI [3]
- C0034067
Description
infection oral cavity
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0009450
- UMLS CUI [1,2]
- C0226896
Description
Intolerance galactose
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1744706
- UMLS CUI [1,2]
- C0016945
Description
adenoid
Type de données
boolean
Alias
- UMLS CUI [1]
- C0001428
Description
Active tuberculosis
Type de données
boolean
Alias
- UMLS CUI [1]
- C0151332
Description
inflammatory disease
Type de données
boolean
Alias
- UMLS CUI [1]
- C1290884
Description
Immunodeficiencies
Type de données
boolean
Alias
- UMLS CUI [1]
- C0596032
Description
Autoimmune diseases
Type de données
boolean
Alias
- UMLS CUI [1]
- C0004364
Description
Autoimmune Diseases; internal disease
Type de données
boolean
Alias
- UMLS CUI [1]
- C0004364
- UMLS CUI [2]
- C0679231
Description
Malignant tumors
Type de données
boolean
Alias
- UMLS CUI [1]
- C0006826
Description
Substance Use Disorder
Type de données
boolean
Alias
- UMLS CUI [1]
- C0038586
Description
Contraindication epinephrine
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0522473
- UMLS CUI [1,2]
- C0014563
Description
sedatives
Type de données
boolean
Alias
- UMLS CUI [1]
- C0036557
Description
Contraindicated drug
Type de données
boolean
Alias
- UMLS CUI [1]
- C3845816
Description
Demographics
Alias
- UMLS CUI-1
- C0011298
Description
visit date
Type de données
date
Alias
- UMLS CUI [1]
- C1320303
Description
consent date
Type de données
date
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C0011008
Description
birth year
Type de données
partialDate
Alias
- UMLS CUI [1]
- C2826771
Description
gender
Type de données
text
Alias
- UMLS CUI [1]
- C0079399
Description
Ethnicity
Type de données
text
Alias
- UMLS CUI [1]
- C0015031
Description
other
Type de données
text
Alias
- UMLS CUI [1]
- C0205394
Description
visit date
Type de données
date
Alias
- UMLS CUI [1]
- C1320303
Description
Laboratory
Alias
- UMLS CUI-1
- C0022877
Description
venipuncture date
Type de données
date
Alias
- UMLS CUI [1,1]
- C0600406
- UMLS CUI [1,2]
- C0011008
Description
venipuncture date
Type de données
date
Alias
- UMLS CUI [1,1]
- C0600406
- UMLS CUI [1,2]
- C0011008
Description
contraception status
Type de données
text
Alias
- UMLS CUI [1]
- C0420837
Description
Exception to the pregnancy test: patients with hysterectomy or patients in postmenopause (since at least 1 year.)
Type de données
date
Alias
- UMLS CUI [1,1]
- C0032976
- UMLS CUI [1,2]
- C0011008
Description
pregnancy test result
Type de données
text
Alias
- UMLS CUI [1]
- C0032976
Description
Physical examination
Alias
- UMLS CUI-1
- C0031809
Description
Weight
Type de données
float
Unités de mesure
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
systolic blood pressure
Type de données
integer
Unités de mesure
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Description
Diastolic blood pressure
Type de données
integer
Unités de mesure
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Description
Heart rate
Type de données
integer
Unités de mesure
- 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
Type de données
boolean
Alias
- UMLS CUI [1]
- C0440307
Description
tree pollen
Type de données
boolean
Alias
- UMLS CUI [1]
- C3541399
Description
Atopic dermatitis
Type de données
boolean
Alias
- UMLS CUI [1]
- C0011615
Description
weed pollen
Type de données
boolean
Alias
- UMLS CUI [1]
- C1328969
Description
Food allergies
Type de données
boolean
Alias
- UMLS CUI [1]
- C0016470
Description
Food allergies
Type de données
text
Alias
- UMLS CUI [1]
- C0016470
Description
allergy
Type de données
text
Alias
- UMLS CUI [1]
- C0020517
Description
Clinical symptoms
Alias
- UMLS CUI-1
- C1457887
Description
allergic rhinitis; allergic rhinoconjunctivitis
Type de données
boolean
Alias
- UMLS CUI [1]
- C2607914
- UMLS CUI [2]
- C0861154
Description
allergic rhinitis; allergic rhinoconjunctivitis
Type de données
text
Alias
- UMLS CUI [1]
- C2607914
- UMLS CUI [2]
- C0861154
Description
allergic rhinoconjunctivitis date
Type de données
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
Type de données
text
Alias
- UMLS CUI [1]
- C0037383
Description
Rhinorrhea
Type de données
text
Alias
- UMLS CUI [1]
- C1260880
Description
Nasal pruritus
Type de données
text
Alias
- UMLS CUI [1]
- C0850060
Description
Nasal congestion
Type de données
text
Alias
- UMLS CUI [1]
- C0027424
Description
Watery eyes
Type de données
text
Alias
- UMLS CUI [1]
- C3257803
Description
Itching of eye
Type de données
text
Alias
- UMLS CUI [1]
- C0022281
Description
Summation
Type de données
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
Type de données
boolean
Alias
- UMLS CUI [1]
- C0007226
Description
respiratory
Type de données
boolean
Alias
- UMLS CUI [1]
- C0035237
Description
gastrointestinal tract
Type de données
boolean
Alias
- UMLS CUI [1]
- C0017189
Description
Eye
Type de données
boolean
Alias
- UMLS CUI [1]
- C0015392
Description
Nose
Type de données
boolean
Alias
- UMLS CUI [1]
- C0028429
Description
Ears
Type de données
boolean
Alias
- UMLS CUI [1]
- C0013443
Description
Neck
Type de données
boolean
Alias
- UMLS CUI [1]
- C0027530
Description
Skin
Type de données
boolean
Alias
- UMLS CUI [1]
- C1123023
Description
Skin
Type de données
boolean
Alias
- UMLS CUI [1]
- C1123023
Description
Endocrine system; lymphatic system
Type de données
boolean
Alias
- UMLS CUI [1]
- C0014130
- UMLS CUI [2]
- C0024235
Description
muscle; skeleton
Type de données
boolean
Alias
- UMLS CUI [1]
- C0026845
- UMLS CUI [2]
- C0037253
Description
Nervous system
Type de données
boolean
Alias
- UMLS CUI [1]
- C0027763
Description
genitourinary
Type de données
boolean
Alias
- UMLS CUI [1]
- C0042066
Description
Metabolic System
Type de données
boolean
Alias
- UMLS CUI [1]
- C0014136
Description
Comorbidity
Type de données
text
Alias
- UMLS CUI [1]
- C0009488
Description
comorbidity
Type de données
text
Alias
- UMLS CUI [1]
- C0009488
Description
surgical procedures
Type de données
text
Alias
- UMLS CUI [1]
- C0543467
Description
Specification
Type de données
text
Description
Skin prick test
Alias
- UMLS CUI-1
- C0430561
Description
grass pollen
Type de données
float
Unités de mesure
- mm
Alias
- UMLS CUI [1]
- C0440307
Description
histamine dihydrochloride
Type de données
float
Unités de mesure
- mm
Alias
- UMLS CUI [1]
- C0543456
Description
Saline Solution
Type de données
float
Unités de mesure
- mm
Alias
- UMLS CUI [1]
- C0036082
Description
rye pollen
Type de données
float
Unités de mesure
- mm
Alias
- UMLS CUI [1]
- C0440328
Description
hazel pollen
Type de données
float
Unités de mesure
- mm
Alias
- UMLS CUI [1]
- C0440377
Description
ambrosia pollen
Type de données
float
Unités de mesure
- mm
Alias
- UMLS CUI [1]
- C3495104
Description
Birch pollen
Type de données
float
Unités de mesure
- mm
Alias
- UMLS CUI [1]
- C4047367
Description
mugwort pollen
Type de données
float
Unités de mesure
- mm
Alias
- UMLS CUI [1]
- C3495107
Description
House dust mite
Type de données
float
Unités de mesure
- mm
Alias
- UMLS CUI [1]
- C3539110
Description
cat hair
Type de données
float
Unités de mesure
- mm
Alias
- UMLS CUI [1]
- C0440419
Description
dog hair
Type de données
float
Unités de mesure
- mm
Alias
- UMLS CUI [1]
- C0440417
Description
Alternaria
Type de données
float
Unités de mesure
- 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
Type de données
float
Alias
- UMLS CUI [1]
- C0748133
Description
FEV1
Type de données
float
Alias
- UMLS CUI [1]
- C0748133
Description
Ratio; FEV1; standard value
Type de données
integer
Unités de mesure
- %
Alias
- UMLS CUI [1]
- C0456603
- UMLS CUI [2]
- C0588029
- UMLS CUI [3]
- C1442989
Description
Peak expiratory flow measurement
Type de données
integer
Unités de mesure
- l/min
Alias
- UMLS CUI [1]
- C0521299
Description
Peak expiratory flow measurement
Type de données
integer
Unités de mesure
- l/ min
Alias
- UMLS CUI [1]
- C0521299
Description
Peak expiratory flow measurement
Type de données
integer
Unités de mesure
- l/ min
Alias
- UMLS CUI [1]
- C0521299
Description
Peak expiratory flow measurement
Type de données
integer
Unités de mesure
- l/ min
Alias
- UMLS CUI [1]
- C0521299
Description
Peak expiratory flow measurement
Type de données
integer
Unités de mesure
- l/ min
Alias
- UMLS CUI [1]
- C0521299
Description
Conjunctival provocation testing
Alias
- UMLS CUI-1
- C0430565
Description
Conjunctival provocation testing
Type de données
text
Alias
- UMLS CUI [1]
- C0430565
Description
Conjunctival provocation testing
Type de données
text
Alias
- UMLS CUI [1]
- C0430565
Description
Conjunctival provocation testing
Type de données
text
Alias
- UMLS CUI [1]
- C0430565
Description
concentration allergen
Type de données
text
Alias
- UMLS CUI [1,1]
- C1446561
- UMLS CUI [1,2]
- C0002092
Description
Conjunctival provocation testing
Type de données
boolean
Description
Allergy diagnostics
Alias
- UMLS CUI-1
- C0086143
- UMLS CUI-2
- C0020517
Description
Immunoglobulin E
Type de données
float
Unités de mesure
- kU/l
Alias
- UMLS CUI [1]
- C0202086
Description
Immunoglobulin G4
Type de données
float
Unités de mesure
- kU/l
Alias
- UMLS CUI [1]
- C0020860
Description
Immunoglobulin; Grass pollen
Type de données
float
Unités de mesure
- kU/l
Alias
- UMLS CUI [1]
- C0021027
- UMLS CUI [2]
- C0440307
Description
Radioallergosorbent Test
Type de données
text
Alias
- UMLS CUI [1]
- C0034554
Description
Immunoglobulin; Grass pollen
Type de données
float
Unités de mesure
- kU/l
Alias
- UMLS CUI [1]
- C0021027
- UMLS CUI [2]
- C0440307
Description
Radioallergosorbent Test
Type de données
text
Alias
- UMLS CUI [1]
- C0034554
Description
Immunoglobulin; Grass pollen
Type de données
float
Unités de mesure
- kU/l
Alias
- UMLS CUI [1]
- C0021027
- UMLS CUI [2]
- C0440307
Description
Radioallergosorbent Test
Type de données
text
Alias
- UMLS CUI [1]
- C0034554
Description
Immunoglobulin; Grass pollen
Type de données
float
Unités de mesure
- kU/l
Alias
- UMLS CUI [1]
- C0021027
- UMLS CUI [2]
- C0440307
Description
Radioallergosorbent Test
Type de données
text
Alias
- UMLS CUI [1]
- C0034554
Description
Birch antigen
Type de données
float
Unités de mesure
- kU/l
Alias
- UMLS CUI [1]
- C1527024
Description
Radioallergosorbent Test
Type de données
text
Alias
- UMLS CUI [1]
- C0034554
Description
Immunoglobulin Mugwort
Type de données
float
Unités de mesure
- kU/l
Alias
- UMLS CUI [1,1]
- C0021027
- UMLS CUI [1,2]
- C0348066
Description
Radioallergosorbent Test
Type de données
text
Alias
- UMLS CUI [1]
- C0034554
Description
Immunoglobulin ambrosia
Type de données
float
Unités de mesure
- kU/l
Alias
- UMLS CUI [1,1]
- C0021027
- UMLS CUI [1,2]
- C0331432
Description
Radioallergosorbent Test
Type de données
text
Alias
- UMLS CUI [1]
- C0034554
Description
Immunoglobulin Dermatophagoides pteronyssinus
Type de données
float
Unités de mesure
- kU/l
Alias
- UMLS CUI [1,1]
- C0021027
- UMLS CUI [1,2]
- C1122992
Description
Radioallergosorbent Test
Type de données
text
Alias
- UMLS CUI [1]
- C0034554
Description
Immunoglobulin Dermatophagoides farinae
Type de données
float
Unités de mesure
- kU/l
Alias
- UMLS CUI [1,1]
- C0021027
- UMLS CUI [1,2]
- C0323677
Description
Radioallergosorbent Test
Type de données
text
Alias
- UMLS CUI [1]
- C0034554
Description
Dog antigen
Type de données
float
Unités de mesure
- kU/l
Alias
- UMLS CUI [1]
- C1443014
Description
Radioallergosorbent Test
Type de données
text
Alias
- UMLS CUI [1]
- C0034554
Description
Cat hair antigen
Type de données
float
Unités de mesure
- kU/l
Alias
- UMLS CUI [1]
- C1443200
Description
Radioallergosorbent Test
Type de données
text
Alias
- UMLS CUI [1]
- C0034554
Description
Immunoglobulin Alternaria
Type de données
float
Unités de mesure
- kU/l
Alias
- UMLS CUI [1,1]
- C0021027
- UMLS CUI [1,2]
- C0002343
Description
Radioallergosorbent Test
Type de données
text
Alias
- UMLS CUI [1]
- C0034554
Description
Hematology
Alias
- UMLS CUI-1
- C0474523
Description
Hemoglobin
Type de données
float
Unités de mesure
- mmol/l
Alias
- UMLS CUI [1]
- C0019046
Description
Erythrocyte
Type de données
float
Unités de mesure
- /pl
Alias
- UMLS CUI [1]
- C0014772
Description
Thrombocyte
Type de données
float
Unités de mesure
- /nl
Alias
- UMLS CUI [1]
- C0005821
Description
Leucocyte (total)
Type de données
float
Unités de mesure
- /nl
Alias
- UMLS CUI [1]
- C0023508
Description
Hematocrit
Type de données
float
Unités de mesure
- l/l
Alias
- UMLS CUI [1]
- C0518014
Description
Biochemistry
Alias
- UMLS CUI-1
- C0005477
Description
Bilirubin
Type de données
float
Unités de mesure
- μmol/l
Alias
- UMLS CUI [1]
- C1278039
Description
Glutamate pyruvate transaminase
Type de données
float
Unités de mesure
- U/l
Description
alkaline phosphatase
Type de données
float
Unités de mesure
- U/l
Alias
- UMLS CUI [1]
- C0201850
Description
Glucose
Type de données
float
Unités de mesure
- mmol/l
Alias
- UMLS CUI [1]
- C0202042
Description
Creatinine
Type de données
float
Unités de mesure
- μmol/l
Alias
- UMLS CUI [1]
- C0201976
Description
Aspartate aminotransferase measurement
Type de données
float
Unités de mesure
- U/l
Alias
- UMLS CUI [1]
- C0201899
Description
C reactive protein
Type de données
float
Unités de mesure
- mg/l
Alias
- UMLS CUI [1]
- C0201657
Description
Gamma-glutamyl transpeptidase
Type de données
float
Unités de mesure
- 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
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C0440307
Description
The positive clinical case history to grass pollen is evidenced by
Type de données
boolean
Alias
- UMLS CUI [1]
- C3662483
Description
The positive clinical case history to grass pollen is evidenced by
Type de données
boolean
Alias
- UMLS CUI [1]
- C0430561
Description
The positive clinical case history to grass pollen is evidenced by
Type de données
boolean
Alias
- UMLS CUI [1]
- C2721639
Description
The positive clinical case history to grass pollen is evidenced by
Type de données
boolean
Alias
- UMLS CUI [1]
- C0430565
Description
The positive clinical case history to grass pollen is evidenced by
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0449820
- UMLS CUI [1,2]
- C0861155
Description
The positive clinical case history to grass pollen is evidenced by
Type de données
boolean
Alias
- UMLS CUI [1]
- C1535925
Description
The positive clinical case history to grass pollen is evidenced by
Type de données
boolean
Alias
- UMLS CUI [1]
- C0202086
Description
The positive clinical case history to grass pollen is evidenced by
Type de données
boolean
Alias
- UMLS CUI [1]
- C0202086
- UMLS CUI [2]
- C1387134
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