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

  1. 2/10/16 2/10/16 -
  2. 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

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Female or male patients between 18 and 75 years with at least 2 years known, induced by grass pollen allergic rhinitis and / or allergic rhinoconjunctivitis with or without controlled allergic asthma
Description

age; Allergic rhinoconjunctivitis; Allergic asthma

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0861154
UMLS CUI [3]
C0155877
Clinical sensitization to grass pollen. Patients with sensitization to perennial allergens such as dust mites, cats, dogs may be included where such sensitization during the analysis period are not clinically relevant.
Description

sensitization; Perennial allergy

Data type

boolean

Alias
UMLS CUI [1]
C3662483
UMLS CUI [2]
C2721639
Reliability and ability of the patient to fill out the patient diary for self-assessment of symptoms and taking the anti symptomatic medication selbsständig
Description

compliance behavior; patient diary

Data type

boolean

Alias
UMLS CUI [1]
C1321605
UMLS CUI [2]
C3890583
Signed and dated informed consent of the patient
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Simultaneous participation in other clinical trials
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
Previous immunotherapy with grass pollen allergen or cross-reacting allergen in the last 5 years
Description

immunotherapy; Grass pollen; allergen

Data type

boolean

Alias
UMLS CUI [1]
C0021083
UMLS CUI [2]
C0440307
UMLS CUI [3]
C0002092
Continuing immunotherapy for allergens
Description

immunotherapy; allergen

Data type

boolean

Alias
UMLS CUI [1]
C0021083
UMLS CUI [2]
C0002092
Patients who are in any sort of relationship or dependence on the sponsor and / or investigator
Description

investigator; relationship

Data type

boolean

Alias
UMLS CUI [1]
C0008961
UMLS CUI [2]
C0439849
Other reasons that according to the opinion of the investigator contraindicate an inclusion in the clinical trial (e.g, low reliability, inability of the patient to understand the study documents and instructions)
Description

compliance behavior limited

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
An existing or planned pregnancy, lactation and / or lack of adequate contraception
Description

contraception status

Data type

boolean

Alias
UMLS CUI [1]
C0420837
Mostly perennial allergic rhinitis
Description

perennial allergic rhinitis

Data type

boolean

Alias
UMLS CUI [1]
C0035457
Only partially controlled or non-controlled or predominantly perenniales Asthma
Description

Perennial allergy Asthma

Data type

boolean

Alias
UMLS CUI [1,1]
C2721639
UMLS CUI [1,2]
C0004096
Chronic asthma or emphysema, in particular with an FEV1 <70% of the expected value
Description

comorbidity; asthma; emphysem

Data type

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0004096
UMLS CUI [3]
C0034067
Chronic asthma or emphysema, in particular with an FEV1 <70% of the individual value
Description

comorbidity; asthma; emphysem

Data type

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0004096
UMLS CUI [3]
C0034067
Infections in the oral cavity with severe symptoms
Description

infection oral cavity

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0226896
Patients with hereditary problems of galactose intolerance, lactase deficiency, glucose galactose malabsorption
Description

Intolerance galactose

Data type

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0016945
Patients with deformities of the nose and / or adenoids
Description

adenoid

Data type

boolean

Alias
UMLS CUI [1]
C0001428
Active tuberculosis
Description

Active tuberculosis

Data type

boolean

Alias
UMLS CUI [1]
C0151332
General inflammatory / febrile and severe acute or chronic inflammatory diseases
Description

inflammatory disease

Data type

boolean

Alias
UMLS CUI [1]
C1290884
Immunodeficiencies (for example, also induced by immunosuppressants)
Description

Immunodeficiencies

Data type

boolean

Alias
UMLS CUI [1]
C0596032
Autoimmune diseases
Description

Autoimmune diseases

Data type

boolean

Alias
UMLS CUI [1]
C0004364
By a doctor diagnosed internal diseases (for example, the liver, spleen, nervous system, the thyroid gland and rheumatic disorders), which are due to an autoimmune mechanism.
Description

Autoimmune Diseases; internal disease

Data type

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2]
C0679231
Malignant tumors
Description

Malignant tumors

Data type

boolean

Alias
UMLS CUI [1]
C0006826
Alcohol abuse, drugs or medication abuse
Description

Substance Use Disorder

Data type

boolean

Alias
UMLS CUI [1]
C0038586
Contraindication to epinephrine (e.g. in acute or chronic myocardial ischemia symptomatology, severe hypertension)
Description

Contraindication epinephrine

Data type

boolean

Alias
UMLS CUI [1,1]
C0522473
UMLS CUI [1,2]
C0014563
Completed or ongoing long-term treatment with sedatives, or psychoactive drugs
Description

sedatives

Data type

boolean

Alias
UMLS CUI [1]
C0036557
Patients being treated with contraindicated Drug
Description

Contraindicated drug

Data type

boolean

Alias
UMLS CUI [1]
C3845816
Demographics
Description

Demographics

Alias
UMLS CUI-1
C0011298
Date of screening visit (= Day -28/ -3 of the study)
Description

visit date

Data type

date

Alias
UMLS CUI [1]
C1320303
Date on which informed consent is signed
Description

consent date

Data type

date

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0011008
Birth year
Description

birth year

Data type

partialDate

Alias
UMLS CUI [1]
C2826771
Gender
Description

gender

Data type

text

Alias
UMLS CUI [1]
C0079399
Ethnicity
Description

Ethnicity

Data type

text

Alias
UMLS CUI [1]
C0015031
If other, please mention
Description

other

Data type

text

Alias
UMLS CUI [1]
C0205394
Date of next Visit V1 (3 to 28 days after V0)
Description

visit date

Data type

date

Alias
UMLS CUI [1]
C1320303
Laboratory
Description

Laboratory

Alias
UMLS CUI-1
C0022877
Date of venipuncture for total and specific IgE
Description

venipuncture date

Data type

date

Alias
UMLS CUI [1,1]
C0600406
UMLS CUI [1,2]
C0011008
Date of venipuncture for safety laboratory
Description

venipuncture date

Data type

date

Alias
UMLS CUI [1,1]
C0600406
UMLS CUI [1,2]
C0011008
Does the patient have a safe contraception?
Description

contraception status

Data type

text

Alias
UMLS CUI [1]
C0420837
Pregnancy test date
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
Pregnancy test result
Description

pregnancy test result

Data type

text

Alias
UMLS CUI [1]
C0032976
Physical examination
Description

Physical examination

Alias
UMLS CUI-1
C0031809
Weight
Description

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Systolic blood pressure
Description

systolic blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic blood pressure
Description

Diastolic blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Description

Heart rate

Data type

integer

Measurement units
  • 1/ min
Alias
UMLS CUI [1]
C0018810
1/ min
Examination (Rhinoscope)
Description

Examination (Rhinoscope)

Alias
UMLS CUI-1
C0582103
UMLS CUI-2
C0183044
Edema
Description

Edema

Data type

text

Alias
UMLS CUI [1]
C0013604
Secretion
Description

Secretion

Data type

text

Alias
UMLS CUI [1]
C1546724
Redness
Description

Redness

Data type

text

Alias
UMLS CUI [1]
C0332575
History of allergies
Description

History of allergies

Alias
UMLS CUI-1
C0489531
Grass pollen
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
Tree pollen
Description

tree pollen

Data type

boolean

Alias
UMLS CUI [1]
C3541399
Atopic dermatitis
Description

Atopic dermatitis

Data type

boolean

Alias
UMLS CUI [1]
C0011615
Weed pollen
Description

weed pollen

Data type

boolean

Alias
UMLS CUI [1]
C1328969
Food allergies
Description

Food allergies

Data type

boolean

Alias
UMLS CUI [1]
C0016470
If yes, which?
Description

Food allergies

Data type

text

Alias
UMLS CUI [1]
C0016470
Other allergies
Description

allergy

Data type

text

Alias
UMLS CUI [1]
C0020517
Clinical symptoms
Description

Clinical symptoms

Alias
UMLS CUI-1
C1457887
Allergic rhinitis/ allergic rhinoconjunctivitis
Description

allergic rhinitis; allergic rhinoconjunctivitis

Data type

boolean

Alias
UMLS CUI [1]
C2607914
UMLS CUI [2]
C0861154
Allergic rhinitis/ allergic rhinoconjunctivitis
Description

allergic rhinitis; allergic rhinoconjunctivitis

Data type

text

Alias
UMLS CUI [1]
C2607914
UMLS CUI [2]
C0861154
Allergic rhinoconjunctivitis or allergic rhinitis since
Description

allergic rhinoconjunctivitis date

Data type

date

Alias
UMLS CUI [1,1]
C0861154
UMLS CUI [1,2]
C0011008
Retrospective Rhinoconjunctivitis Total Symptom Score
Description

Retrospective Rhinoconjunctivitis Total Symptom Score

Alias
UMLS CUI-1
C0449820
UMLS CUI-2
C0861155
Sneezing
Description

Sneezing

Data type

text

Alias
UMLS CUI [1]
C0037383
Runny nose
Description

Rhinorrhea

Data type

text

Alias
UMLS CUI [1]
C1260880
Itching in the nose
Description

Nasal pruritus

Data type

text

Alias
UMLS CUI [1]
C0850060
Stuffy nose
Description

Nasal congestion

Data type

text

Alias
UMLS CUI [1]
C0027424
Watery eyes
Description

Watery eyes

Data type

text

Alias
UMLS CUI [1]
C3257803
Itching of eye
Description

Itching of eye

Data type

text

Alias
UMLS CUI [1]
C0022281
Summation (when total RTSS score is < 8, exclusion of patient)
Description

Summation

Data type

integer

Alias
UMLS CUI [1]
C0234108
Concomitant medication
Description

Concomitant medication

Alias
UMLS CUI-1
C2347852
Concomitant medication
Description

Concomitant medication

Data type

boolean

Alias
UMLS CUI [1]
C2347852
Type of concomitant medication
Description

Concomitant medication

Data type

text

Alias
UMLS CUI [1]
C2347852
If other, please mention
Description

other

Data type

text

Medical history
Description

Medical history

Alias
UMLS CUI-1
C0262926
Cardiovascular system
Description

cardiovascular system

Data type

boolean

Alias
UMLS CUI [1]
C0007226
Respiratory
Description

respiratory

Data type

boolean

Alias
UMLS CUI [1]
C0035237
Gastrointestinal Tract
Description

gastrointestinal tract

Data type

boolean

Alias
UMLS CUI [1]
C0017189
Eye
Description

Eye

Data type

boolean

Alias
UMLS CUI [1]
C0015392
Nose
Description

Nose

Data type

boolean

Alias
UMLS CUI [1]
C0028429
Ears
Description

Ears

Data type

boolean

Alias
UMLS CUI [1]
C0013443
Neck
Description

Neck

Data type

boolean

Alias
UMLS CUI [1]
C0027530
Skin
Description

Skin

Data type

boolean

Alias
UMLS CUI [1]
C1123023
Skin
Description

Skin

Data type

boolean

Alias
UMLS CUI [1]
C1123023
Endocrine / lymphatic system
Description

Endocrine system; lymphatic system

Data type

boolean

Alias
UMLS CUI [1]
C0014130
UMLS CUI [2]
C0024235
Muscle/ Skeleton
Description

muscle; skeleton

Data type

boolean

Alias
UMLS CUI [1]
C0026845
UMLS CUI [2]
C0037253
Nervous system
Description

Nervous system

Data type

boolean

Alias
UMLS CUI [1]
C0027763
Genitourinary
Description

genitourinary

Data type

boolean

Alias
UMLS CUI [1]
C0042066
Metabolic System
Description

Metabolic System

Data type

boolean

Alias
UMLS CUI [1]
C0014136
Comorbidity
Description

Comorbidity

Data type

text

Alias
UMLS CUI [1]
C0009488
Specification of comorbidity
Description

comorbidity

Data type

text

Alias
UMLS CUI [1]
C0009488
Retrospective registration of disease or surgical procedures on other organs within the last 10 years
Description

surgical procedures

Data type

text

Alias
UMLS CUI [1]
C0543467
If diagnosis, please describe
Description

Specification

Data type

text

Skin prick test
Description

Skin prick test

Alias
UMLS CUI-1
C0430561
Size of wheal for grass pollen mixture (> = 3 mm)
Description

grass pollen

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1]
C0440307
mm
Size of wheal for histamine dihydrochloride (positive control 10 mg/ml) (>=3 mm)
Description

histamine dihydrochloride

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1]
C0543456
mm
Size of wheal for saline solution (< 2 mm)
Description

Saline Solution

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1]
C0036082
mm
Size of wheal for rye pollen
Description

rye pollen

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1]
C0440328
mm
Size of wheal for hazel pollen
Description

hazel pollen

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1]
C0440377
mm
Size of wheal for ambrosia pollen
Description

ambrosia pollen

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1]
C3495104
mm
Size of wheal for birch pollen
Description

Birch pollen

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1]
C4047367
mm
Size of wheal for mugwort pollen
Description

mugwort pollen

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1]
C3495107
mm
Size of wheal for house dust mite
Description

House dust mite

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1]
C3539110
mm
Size of wheal for cat hair
Description

cat hair

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1]
C0440419
mm
Size of wheal for dog hair
Description

dog hair

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1]
C0440417
mm
Size of wheal for alternaria
Description

Alternaria

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1]
C0002343
mm
Spirometry or Peak expiratory flow measurement (For asthmatics)
Description

Spirometry or Peak expiratory flow measurement (For asthmatics)

Alias
UMLS CUI-1
C0037981
UMLS CUI-2
C0521299
FEV1 (age-appropriate standard value)
Description

FEV1

Data type

float

Alias
UMLS CUI [1]
C0748133
FEV1
Description

FEV1

Data type

float

Alias
UMLS CUI [1]
C0748133
FEV1/ Standard value (If FEV1 < 70% of age appropriate standard value, exclusion)
Description

Ratio; FEV1; standard value

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1]
C0456603
UMLS CUI [2]
C0588029
UMLS CUI [3]
C1442989
%
PEF 1
Description

Peak expiratory flow measurement

Data type

integer

Measurement units
  • l/min
Alias
UMLS CUI [1]
C0521299
l/min
PEF 2
Description

Peak expiratory flow measurement

Data type

integer

Measurement units
  • l/ min
Alias
UMLS CUI [1]
C0521299
l/ min
PEF 3
Description

Peak expiratory flow measurement

Data type

integer

Measurement units
  • l/ min
Alias
UMLS CUI [1]
C0521299
l/ min
Best PEF
Description

Peak expiratory flow measurement

Data type

integer

Measurement units
  • l/ min
Alias
UMLS CUI [1]
C0521299
l/ min
Optimum individual value PEF (If FEV1 < 70% of optimum individual value, exclusion)
Description

Peak expiratory flow measurement

Data type

integer

Measurement units
  • l/ min
Alias
UMLS CUI [1]
C0521299
l/ min
Conjunctival provocation testing
Description

Conjunctival provocation testing

Alias
UMLS CUI-1
C0430565
Conjunctival provocation test result 1
Description

Conjunctival provocation testing

Data type

text

Alias
UMLS CUI [1]
C0430565
Conjunctival provocation test result 2 (to be carried out only when test 1 outcome is negative)
Description

Conjunctival provocation testing

Data type

text

Alias
UMLS CUI [1]
C0430565
Conjunctival provocation test result 3 (to be carried out only when test 2 outcome is negative)
Description

Conjunctival provocation testing

Data type

text

Alias
UMLS CUI [1]
C0430565
Allergen concentration at which the test outcome is positive
Description

concentration allergen

Data type

text

Alias
UMLS CUI [1,1]
C1446561
UMLS CUI [1,2]
C0002092
The outcome for all tests is negative
Description

Conjunctival provocation testing

Data type

boolean

Allergy diagnostics
Description

Allergy diagnostics

Alias
UMLS CUI-1
C0086143
UMLS CUI-2
C0020517
Total Immunoglobulin E
Description

Immunoglobulin E

Data type

float

Measurement units
  • kU/l
Alias
UMLS CUI [1]
C0202086
kU/l
Immunoglobulin IgG4
Description

Immunoglobulin G4

Data type

float

Measurement units
  • kU/l
Alias
UMLS CUI [1]
C0020860
kU/l
Grass (Phleum pratense) Phl p 1
Description

Immunoglobulin; Grass pollen

Data type

float

Measurement units
  • kU/l
Alias
UMLS CUI [1]
C0021027
UMLS CUI [2]
C0440307
kU/l
RAST class for grass Phl p 1
Description

Radioallergosorbent Test

Data type

text

Alias
UMLS CUI [1]
C0034554
Grass (Phleum pratense) Phl p5b
Description

Immunoglobulin; Grass pollen

Data type

float

Measurement units
  • kU/l
Alias
UMLS CUI [1]
C0021027
UMLS CUI [2]
C0440307
kU/l
RAST class for grass Phl p5b
Description

Radioallergosorbent Test

Data type

text

Alias
UMLS CUI [1]
C0034554
Grass (Phleum pratense) Phl p 7
Description

Immunoglobulin; Grass pollen

Data type

float

Measurement units
  • kU/l
Alias
UMLS CUI [1]
C0021027
UMLS CUI [2]
C0440307
kU/l
RAST class for grass Phl p7
Description

Radioallergosorbent Test

Data type

text

Alias
UMLS CUI [1]
C0034554
Grass (Phleum pratense) Phl p 12
Description

Immunoglobulin; Grass pollen

Data type

float

Measurement units
  • kU/l
Alias
UMLS CUI [1]
C0021027
UMLS CUI [2]
C0440307
kU/l
RAST class for grass Phl p 12
Description

Radioallergosorbent Test

Data type

text

Alias
UMLS CUI [1]
C0034554
Birch Bet v 1
Description

Birch antigen

Data type

float

Measurement units
  • kU/l
Alias
UMLS CUI [1]
C1527024
kU/l
RAST class for birch Bet v1
Description

Radioallergosorbent Test

Data type

text

Alias
UMLS CUI [1]
C0034554
Mugwort Art v1
Description

Immunoglobulin Mugwort

Data type

float

Measurement units
  • kU/l
Alias
UMLS CUI [1,1]
C0021027
UMLS CUI [1,2]
C0348066
kU/l
RAST class for mugwort Art v1
Description

Radioallergosorbent Test

Data type

text

Alias
UMLS CUI [1]
C0034554
Ambrosia Amb a1
Description

Immunoglobulin ambrosia

Data type

float

Measurement units
  • kU/l
Alias
UMLS CUI [1,1]
C0021027
UMLS CUI [1,2]
C0331432
kU/l
RAST class for ambrosia Amb a1
Description

Radioallergosorbent Test

Data type

text

Alias
UMLS CUI [1]
C0034554
D. pteronyssinus Der p1
Description

Immunoglobulin Dermatophagoides pteronyssinus

Data type

float

Measurement units
  • kU/l
Alias
UMLS CUI [1,1]
C0021027
UMLS CUI [1,2]
C1122992
kU/l
RAST class for D. pteronyssinus Der p1
Description

Radioallergosorbent Test

Data type

text

Alias
UMLS CUI [1]
C0034554
D. farinae Der p2
Description

Immunoglobulin Dermatophagoides farinae

Data type

float

Measurement units
  • kU/l
Alias
UMLS CUI [1,1]
C0021027
UMLS CUI [1,2]
C0323677
kU/l
RAST class for D. farinae
Description

Radioallergosorbent Test

Data type

text

Alias
UMLS CUI [1]
C0034554
Dog Can f1
Description

Dog antigen

Data type

float

Measurement units
  • kU/l
Alias
UMLS CUI [1]
C1443014
kU/l
RAST class for dog Can f1
Description

Radioallergosorbent Test

Data type

text

Alias
UMLS CUI [1]
C0034554
Cat Fel d1
Description

Cat hair antigen

Data type

float

Measurement units
  • kU/l
Alias
UMLS CUI [1]
C1443200
kU/l
RAST class for cat Fel d1
Description

Radioallergosorbent Test

Data type

text

Alias
UMLS CUI [1]
C0034554
Alternaria Alt a1
Description

Immunoglobulin Alternaria

Data type

float

Measurement units
  • kU/l
Alias
UMLS CUI [1,1]
C0021027
UMLS CUI [1,2]
C0002343
kU/l
RAST class for Alternaria Alt a1
Description

Radioallergosorbent Test

Data type

text

Alias
UMLS CUI [1]
C0034554
Hematology
Description

Hematology

Alias
UMLS CUI-1
C0474523
Hemoglobin
Description

Hemoglobin

Data type

float

Measurement units
  • mmol/l
Alias
UMLS CUI [1]
C0019046
mmol/l
Erythrocyte
Description

Erythrocyte

Data type

float

Measurement units
  • /pl
Alias
UMLS CUI [1]
C0014772
/pl
Thrombocyte
Description

Thrombocyte

Data type

float

Measurement units
  • /nl
Alias
UMLS CUI [1]
C0005821
/nl
Leucocyte (total)
Description

Leucocyte (total)

Data type

float

Measurement units
  • /nl
Alias
UMLS CUI [1]
C0023508
/nl
Hematocrit
Description

Hematocrit

Data type

float

Measurement units
  • l/l
Alias
UMLS CUI [1]
C0518014
l/l
Biochemistry
Description

Biochemistry

Alias
UMLS CUI-1
C0005477
Bilirubin (total)
Description

Bilirubin

Data type

float

Measurement units
  • μmol/l
Alias
UMLS CUI [1]
C1278039
μmol/l
SGPT- Serum Glutamate pyruvate transaminase
Description

Glutamate pyruvate transaminase

Data type

float

Measurement units
  • U/l
U/l
Alkaline phosphatase
Description

alkaline phosphatase

Data type

float

Measurement units
  • U/l
Alias
UMLS CUI [1]
C0201850
U/l
Glucose
Description

Glucose

Data type

float

Measurement units
  • mmol/l
Alias
UMLS CUI [1]
C0202042
mmol/l
Creatinine
Description

Creatinine

Data type

float

Measurement units
  • μmol/l
Alias
UMLS CUI [1]
C0201976
μmol/l
SGOT- Aspartate aminotransferase measurement
Description

Aspartate aminotransferase measurement

Data type

float

Measurement units
  • U/l
Alias
UMLS CUI [1]
C0201899
U/l
CRP C reactive protein
Description

C reactive protein

Data type

float

Measurement units
  • mg/l
Alias
UMLS CUI [1]
C0201657
mg/l
Gamma-glutamyl transpeptidase
Description

Gamma-glutamyl transpeptidase

Data type

float

Measurement units
  • U/l
Alias
UMLS CUI [1]
C1883012
U/l
Inclusion Criteria (Part 2)
Description

Inclusion Criteria (Part 2)

Alias
UMLS CUI-1
C1512693
the occurrence of the majority of the corresponding clinical symptoms during the grass pollen season
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
Patients should not suffer from typical symptoms caused by co-allergens during the grass pollen season (for example, patients with sensitization to animal fur / - dandruff are not be exposed)
Description

The positive clinical case history to grass pollen is evidenced by

Data type

boolean

Alias
UMLS CUI [1]
C3662483
the positive skin prick test (wheal size> = 3 mm, negative control <2 mm)
Description

The positive clinical case history to grass pollen is evidenced by

Data type

boolean

Alias
UMLS CUI [1]
C0430561
The results in the skin prick test for co-seasonal and most of the perennial co-allergenic are smaller than the skin prick test result for Grass pollen
Description

The positive clinical case history to grass pollen is evidenced by

Data type

boolean

Alias
UMLS CUI [1]
C2721639
a positive reaction in the conjunctival Provocation test (CPT) with one of the three dilutions of grass allergy solution
Description

The positive clinical case history to grass pollen is evidenced by

Data type

boolean

Alias
UMLS CUI [1]
C0430565
Retrospective Total symptom score (RRTSS) during the previous grass pollen season is greater than or equal to 8
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
Planned antiallergic or antiasthmatic treatment with the following medicines: local treatment with levocabastine (eye), loratadine (oral), beclomethasone (nasal) or inhaled corticosteroid with a long-acting beta-2 agonists
Description

The positive clinical case history to grass pollen is evidenced by

Data type

boolean

Alias
UMLS CUI [1]
C1535925
Specific IgE reactivity to grass pollen: CAP RAST results for Phl p 1 or Phl p5b> = class 2 (0.70 kU / l) and CAP-RAST results for Phl p 1 or Phl p5b> CAP-RAST results for Phl p 7 or Phl p 12
Description

The positive clinical case history to grass pollen is evidenced by

Data type

boolean

Alias
UMLS CUI [1]
C0202086
The specific IgE values for predominantly perennial co- allergy (animal hair / - dandruff, dust mites) or for the predominantly co-seasonal allergen Alternaria must be less than the sIgE results for grass pollen allergens (Phl p 1 or Phl p5b). The difference must be at least a CAP RAAST class (> = 1).
Description

The positive clinical case history to grass pollen is evidenced by

Data type

boolean

Alias
UMLS CUI [1]
C0202086
UMLS CUI [2]
C1387134

Similar models

Visit V0 Screening visit

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
age; Allergic rhinoconjunctivitis; Allergic asthma
Item
Female or male patients between 18 and 75 years with at least 2 years known, induced by grass pollen allergic rhinitis and / or allergic rhinoconjunctivitis with or without controlled allergic asthma
boolean
C0001779 (UMLS CUI [1])
C0861154 (UMLS CUI [2])
C0155877 (UMLS CUI [3])
sensitization; Perennial allergy
Item
Clinical sensitization to grass pollen. Patients with sensitization to perennial allergens such as dust mites, cats, dogs may be included where such sensitization during the analysis period are not clinically relevant.
boolean
C3662483 (UMLS CUI [1])
C2721639 (UMLS CUI [2])
compliance behavior; patient diary
Item
Reliability and ability of the patient to fill out the patient diary for self-assessment of symptoms and taking the anti symptomatic medication selbsständig
boolean
C1321605 (UMLS CUI [1])
C3890583 (UMLS CUI [2])
informed consent
Item
Signed and dated informed consent of the patient
boolean
C0021430 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Study Subject Participation Status
Item
Simultaneous participation in other clinical trials
boolean
C2348568 (UMLS CUI [1])
immunotherapy; Grass pollen; allergen
Item
Previous immunotherapy with grass pollen allergen or cross-reacting allergen in the last 5 years
boolean
C0021083 (UMLS CUI [1])
C0440307 (UMLS CUI [2])
C0002092 (UMLS CUI [3])
immunotherapy; allergen
Item
Continuing immunotherapy for allergens
boolean
C0021083 (UMLS CUI [1])
C0002092 (UMLS CUI [2])
investigator; relationship
Item
Patients who are in any sort of relationship or dependence on the sponsor and / or investigator
boolean
C0008961 (UMLS CUI [1])
C0439849 (UMLS CUI [2])
compliance behavior limited
Item
Other reasons that according to the opinion of the investigator contraindicate an inclusion in the clinical trial (e.g, low reliability, inability of the patient to understand the study documents and instructions)
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
contraception status
Item
An existing or planned pregnancy, lactation and / or lack of adequate contraception
boolean
C0420837 (UMLS CUI [1])
perennial allergic rhinitis
Item
Mostly perennial allergic rhinitis
boolean
C0035457 (UMLS CUI [1])
Perennial allergy Asthma
Item
Only partially controlled or non-controlled or predominantly perenniales Asthma
boolean
C2721639 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
comorbidity; asthma; emphysem
Item
Chronic asthma or emphysema, in particular with an FEV1 <70% of the expected value
boolean
C0009488 (UMLS CUI [1])
C0004096 (UMLS CUI [2])
C0034067 (UMLS CUI [3])
comorbidity; asthma; emphysem
Item
Chronic asthma or emphysema, in particular with an FEV1 <70% of the individual value
boolean
C0009488 (UMLS CUI [1])
C0004096 (UMLS CUI [2])
C0034067 (UMLS CUI [3])
infection oral cavity
Item
Infections in the oral cavity with severe symptoms
boolean
C0009450 (UMLS CUI [1,1])
C0226896 (UMLS CUI [1,2])
Intolerance galactose
Item
Patients with hereditary problems of galactose intolerance, lactase deficiency, glucose galactose malabsorption
boolean
C1744706 (UMLS CUI [1,1])
C0016945 (UMLS CUI [1,2])
adenoid
Item
Patients with deformities of the nose and / or adenoids
boolean
C0001428 (UMLS CUI [1])
Active tuberculosis
Item
Active tuberculosis
boolean
C0151332 (UMLS CUI [1])
inflammatory disease
Item
General inflammatory / febrile and severe acute or chronic inflammatory diseases
boolean
C1290884 (UMLS CUI [1])
Immunodeficiencies
Item
Immunodeficiencies (for example, also induced by immunosuppressants)
boolean
C0596032 (UMLS CUI [1])
Autoimmune diseases
Item
Autoimmune diseases
boolean
C0004364 (UMLS CUI [1])
Autoimmune Diseases; internal disease
Item
By a doctor diagnosed internal diseases (for example, the liver, spleen, nervous system, the thyroid gland and rheumatic disorders), which are due to an autoimmune mechanism.
boolean
C0004364 (UMLS CUI [1])
C0679231 (UMLS CUI [2])
Malignant tumors
Item
Malignant tumors
boolean
C0006826 (UMLS CUI [1])
Substance Use Disorder
Item
Alcohol abuse, drugs or medication abuse
boolean
C0038586 (UMLS CUI [1])
Contraindication epinephrine
Item
Contraindication to epinephrine (e.g. in acute or chronic myocardial ischemia symptomatology, severe hypertension)
boolean
C0522473 (UMLS CUI [1,1])
C0014563 (UMLS CUI [1,2])
sedatives
Item
Completed or ongoing long-term treatment with sedatives, or psychoactive drugs
boolean
C0036557 (UMLS CUI [1])
Contraindicated drug
Item
Patients being treated with contraindicated Drug
boolean
C3845816 (UMLS CUI [1])
Item Group
Demographics
C0011298 (UMLS CUI-1)
visit date
Item
Date of screening visit (= Day -28/ -3 of the study)
date
C1320303 (UMLS CUI [1])
consent date
Item
Date on which informed consent is signed
date
C0021430 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
birth year
Item
Birth year
partialDate
C2826771 (UMLS CUI [1])
Item
Gender
text
C0079399 (UMLS CUI [1])
Code List
Gender
CL Item
male (1)
CL Item
female (2)
Item
Ethnicity
text
C0015031 (UMLS CUI [1])
Code List
Ethnicity
CL Item
caucasian (1)
CL Item
asian (2)
CL Item
negroid (3)
CL Item
other (4)
other
Item
If other, please mention
text
C0205394 (UMLS CUI [1])
visit date
Item
Date of next Visit V1 (3 to 28 days after V0)
date
C1320303 (UMLS CUI [1])
Item Group
Laboratory
C0022877 (UMLS CUI-1)
venipuncture date
Item
Date of venipuncture for total and specific IgE
date
C0600406 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
venipuncture date
Item
Date of venipuncture for safety laboratory
date
C0600406 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Does the patient have a safe contraception?
text
C0420837 (UMLS CUI [1])
Code List
Does the patient have a safe contraception?
CL Item
no, then exclusion (1)
CL Item
yes, according to Supplement "Recognised methods of reliable contraception" (2)
CL Item
yes, other reasons for a safe contraception (3)
pregnancy test date
Item
Pregnancy test date
date
C0032976 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Pregnancy test result
text
C0032976 (UMLS CUI [1])
Code List
Pregnancy test result
CL Item
positive, exclusion (1)
CL Item
negative (2)
Item Group
Physical examination
C0031809 (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)
Item
Edema
text
C0013604 (UMLS CUI [1])
Code List
Edema
CL Item
no (1)
CL Item
slight (2)
CL Item
medium (3)
CL Item
strong (4)
Item
Secretion
text
C1546724 (UMLS CUI [1])
Code List
Secretion
CL Item
no (1)
CL Item
slight (2)
CL Item
medium (3)
CL Item
strong (4)
Item
Redness
text
C0332575 (UMLS CUI [1])
Code List
Redness
CL Item
no (1)
CL Item
slight (2)
CL Item
medium (3)
CL Item
strong (4)
Item Group
History of allergies
C0489531 (UMLS CUI-1)
grass pollen
Item
Grass pollen
boolean
C0440307 (UMLS CUI [1])
tree pollen
Item
Tree pollen
boolean
C3541399 (UMLS CUI [1])
Atopic dermatitis
Item
Atopic dermatitis
boolean
C0011615 (UMLS CUI [1])
weed pollen
Item
Weed pollen
boolean
C1328969 (UMLS CUI [1])
Food allergies
Item
Food allergies
boolean
C0016470 (UMLS CUI [1])
Food allergies
Item
If yes, which?
text
C0016470 (UMLS CUI [1])
allergy
Item
Other allergies
text
C0020517 (UMLS CUI [1])
Item Group
Clinical symptoms
C1457887 (UMLS CUI-1)
allergic rhinitis; allergic rhinoconjunctivitis
Item
Allergic rhinitis/ allergic rhinoconjunctivitis
boolean
C2607914 (UMLS CUI [1])
C0861154 (UMLS CUI [2])
Item
Allergic rhinitis/ allergic rhinoconjunctivitis
text
C2607914 (UMLS CUI [1])
C0861154 (UMLS CUI [2])
Code List
Allergic rhinitis/ allergic rhinoconjunctivitis
CL Item
seasonal (1)
CL Item
predominantly perennial, then exclusion (2)
allergic rhinoconjunctivitis date
Item
Allergic rhinoconjunctivitis or allergic rhinitis since
date
C0861154 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Retrospective Rhinoconjunctivitis Total Symptom Score
C0449820 (UMLS CUI-1)
C0861155 (UMLS CUI-2)
Item
Sneezing
text
C0037383 (UMLS CUI [1])
Code List
Sneezing
CL Item
no symptoms 0 (1)
CL Item
slight symptoms 1 (2)
CL Item
moderate symptoms 2 (3)
CL Item
strong symptoms 3 (4)
Item
Runny nose
text
C1260880 (UMLS CUI [1])
Code List
Runny nose
CL Item
no symptoms 0 (1)
CL Item
slight symptoms 1 (2)
CL Item
moderate symptoms 2 (3)
CL Item
strong symptoms 3 (4)
Item
Itching in the nose
text
C0850060 (UMLS CUI [1])
Code List
Itching in the nose
CL Item
no symptoms 0 (1)
CL Item
slight symptoms 1 (2)
CL Item
moderate symptoms 2 (3)
CL Item
strong symptoms 3 (4)
Item
Stuffy nose
text
C0027424 (UMLS CUI [1])
Code List
Stuffy nose
CL Item
no symptoms 0 (1)
CL Item
slight symptoms 1 (2)
CL Item
moderate symptoms 2 (3)
CL Item
strong symptoms 3 (4)
Item
Watery eyes
text
C3257803 (UMLS CUI [1])
Code List
Watery eyes
CL Item
no symptoms 0 (1)
CL Item
slight symptoms 1 (2)
CL Item
moderate symptoms 2 (3)
CL Item
strong symptoms 3 (4)
Item
Itching of eye
text
C0022281 (UMLS CUI [1])
Code List
Itching of eye
CL Item
no symptoms 0 (1)
CL Item
slight symptoms 1 (2)
CL Item
moderate symptoms 2 (3)
CL Item
strong symptoms 3 (4)
Summation
Item
Summation (when total RTSS score is < 8, exclusion of patient)
integer
C0234108 (UMLS CUI [1])
Item Group
Concomitant medication
C2347852 (UMLS CUI-1)
Concomitant medication
Item
Concomitant medication
boolean
C2347852 (UMLS CUI [1])
Item
Type of concomitant medication
text
C2347852 (UMLS CUI [1])
Code List
Type of concomitant medication
CL Item
contraindicated drugs (1)
CL Item
other medicines (2)
other
Item
If other, please mention
text
Item Group
Medical history
C0262926 (UMLS CUI-1)
cardiovascular system
Item
Cardiovascular system
boolean
C0007226 (UMLS CUI [1])
respiratory
Item
Respiratory
boolean
C0035237 (UMLS CUI [1])
gastrointestinal tract
Item
Gastrointestinal Tract
boolean
C0017189 (UMLS CUI [1])
Eye
Item
Eye
boolean
C0015392 (UMLS CUI [1])
Nose
Item
Nose
boolean
C0028429 (UMLS CUI [1])
Ears
Item
Ears
boolean
C0013443 (UMLS CUI [1])
Neck
Item
Neck
boolean
C0027530 (UMLS CUI [1])
Skin
Item
Skin
boolean
C1123023 (UMLS CUI [1])
Skin
Item
Skin
boolean
C1123023 (UMLS CUI [1])
Endocrine system; lymphatic system
Item
Endocrine / lymphatic system
boolean
C0014130 (UMLS CUI [1])
C0024235 (UMLS CUI [2])
muscle; skeleton
Item
Muscle/ Skeleton
boolean
C0026845 (UMLS CUI [1])
C0037253 (UMLS CUI [2])
Nervous system
Item
Nervous system
boolean
C0027763 (UMLS CUI [1])
genitourinary
Item
Genitourinary
boolean
C0042066 (UMLS CUI [1])
Metabolic System
Item
Metabolic System
boolean
C0014136 (UMLS CUI [1])
Item
Comorbidity
text
C0009488 (UMLS CUI [1])
Code List
Comorbidity
CL Item
no (1)
CL Item
yes, please match with exclusion criteria and specify (2)
comorbidity
Item
Specification of comorbidity
text
C0009488 (UMLS CUI [1])
surgical procedures
Item
Retrospective registration of disease or surgical procedures on other organs within the last 10 years
text
C0543467 (UMLS CUI [1])
Specification
Item
If diagnosis, please describe
text
Item Group
Skin prick test
C0430561 (UMLS CUI-1)
grass pollen
Item
Size of wheal for grass pollen mixture (> = 3 mm)
float
C0440307 (UMLS CUI [1])
histamine dihydrochloride
Item
Size of wheal for histamine dihydrochloride (positive control 10 mg/ml) (>=3 mm)
float
C0543456 (UMLS CUI [1])
Saline Solution
Item
Size of wheal for saline solution (< 2 mm)
float
C0036082 (UMLS CUI [1])
rye pollen
Item
Size of wheal for rye pollen
float
C0440328 (UMLS CUI [1])
hazel pollen
Item
Size of wheal for hazel pollen
float
C0440377 (UMLS CUI [1])
ambrosia pollen
Item
Size of wheal for ambrosia pollen
float
C3495104 (UMLS CUI [1])
Birch pollen
Item
Size of wheal for birch pollen
float
C4047367 (UMLS CUI [1])
mugwort pollen
Item
Size of wheal for mugwort pollen
float
C3495107 (UMLS CUI [1])
House dust mite
Item
Size of wheal for house dust mite
float
C3539110 (UMLS CUI [1])
cat hair
Item
Size of wheal for cat hair
float
C0440419 (UMLS CUI [1])
dog hair
Item
Size of wheal for dog hair
float
C0440417 (UMLS CUI [1])
Alternaria
Item
Size of wheal for alternaria
float
C0002343 (UMLS CUI [1])
Item Group
Spirometry or Peak expiratory flow measurement (For asthmatics)
C0037981 (UMLS CUI-1)
C0521299 (UMLS CUI-2)
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])
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
Conjunctival provocation testing
C0430565 (UMLS CUI-1)
Item
Conjunctival provocation test result 1
text
C0430565 (UMLS CUI [1])
Code List
Conjunctival provocation test result 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])
Code List
Allergen concentration at which the test outcome is positive
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
Item Group
Allergy diagnostics
C0086143 (UMLS CUI-1)
C0020517 (UMLS CUI-2)
Immunoglobulin E
Item
Total Immunoglobulin E
float
C0202086 (UMLS CUI [1])
Immunoglobulin G4
Item
Immunoglobulin IgG4
float
C0020860 (UMLS CUI [1])
Immunoglobulin; Grass pollen
Item
Grass (Phleum pratense) Phl p 1
float
C0021027 (UMLS CUI [1])
C0440307 (UMLS CUI [2])
Item
RAST class for grass Phl p 1
text
C0034554 (UMLS CUI [1])
Code List
RAST class for grass Phl p 1
CL Item
Class 0 (< 0.35) (1)
CL Item
Class 1 (0.35- 0.69) (2)
CL Item
Class 2 (0.70-3.49) (3)
CL Item
Class 3 (3.50-17.49) (4)
CL Item
Class 4 (17.50-49.99) (5)
CL Item
Class 5 (50-100) (6)
CL Item
Class 6 (> 100) (7)
Immunoglobulin; Grass pollen
Item
Grass (Phleum pratense) Phl p5b
float
C0021027 (UMLS CUI [1])
C0440307 (UMLS CUI [2])
Item
RAST class for grass Phl p5b
text
C0034554 (UMLS CUI [1])
Code List
RAST class for grass Phl p5b
CL Item
Class 0 (< 0.35) (1)
CL Item
Class 1 (0.35- 0.69) (2)
CL Item
Class 2 (0.70-3.49) (3)
CL Item
Class 3 (3.50-17.49) (4)
CL Item
Class 4 (17.50-49.99) (5)
CL Item
Class 5 (50-100) (6)
CL Item
Class 6 (> 100) (7)
Immunoglobulin; Grass pollen
Item
Grass (Phleum pratense) Phl p 7
float
C0021027 (UMLS CUI [1])
C0440307 (UMLS CUI [2])
Item
RAST class for grass Phl p7
text
C0034554 (UMLS CUI [1])
Code List
RAST class for grass Phl p7
CL Item
Class 0 (< 0.35) (1)
CL Item
Class 1 (0.35- 0.69) (2)
CL Item
Class 2 (0.70-3.49) (3)
CL Item
Class 3 (3.50-17.49) (4)
CL Item
Class 4 (17.50-49.99) (5)
CL Item
Class 5 (50-100) (6)
CL Item
Class 6 (> 100) (7)
Immunoglobulin; Grass pollen
Item
Grass (Phleum pratense) Phl p 12
float
C0021027 (UMLS CUI [1])
C0440307 (UMLS CUI [2])
Item
RAST class for grass Phl p 12
text
C0034554 (UMLS CUI [1])
Code List
RAST class for grass Phl p 12
CL Item
Class 0 (< 0.35) (1)
CL Item
Class 1 (0.35- 0.69) (2)
CL Item
Class 2 (0.70-3.49) (3)
CL Item
Class 3 (3.50-17.49) (4)
CL Item
Class 4 (17.50-49.99) (5)
CL Item
Class 5 (50-100) (6)
CL Item
Class 6 (> 100) (7)
Birch antigen
Item
Birch Bet v 1
float
C1527024 (UMLS CUI [1])
Item
RAST class for birch Bet v1
text
C0034554 (UMLS CUI [1])
Code List
RAST class for birch Bet v1
CL Item
Class 0 (< 0.35) (1)
CL Item
Class 1 (0.35- 0.69) (2)
CL Item
Class 2 (0.70-3.49) (3)
CL Item
Class 3 (3.50-17.49) (4)
CL Item
Class 4 (17.50-49.99) (5)
CL Item
Class 5 (50-100) (6)
CL Item
Class 6 (> 100) (7)
Immunoglobulin Mugwort
Item
Mugwort Art v1
float
C0021027 (UMLS CUI [1,1])
C0348066 (UMLS CUI [1,2])
Item
RAST class for mugwort Art v1
text
C0034554 (UMLS CUI [1])
Code List
RAST class for mugwort Art v1
CL Item
Class 0 (< 0.35) (1)
CL Item
Class 1 (0.35- 0.69) (2)
CL Item
Class 2 (0.70-3.49) (3)
CL Item
Class 3 (3.50-17.49) (4)
CL Item
Class 4 (17.50-49.99) (5)
CL Item
Class 5 (50-100) (6)
CL Item
Class 6 (> 100) (7)
Immunoglobulin ambrosia
Item
Ambrosia Amb a1
float
C0021027 (UMLS CUI [1,1])
C0331432 (UMLS CUI [1,2])
Item
RAST class for ambrosia Amb a1
text
C0034554 (UMLS CUI [1])
Code List
RAST class for ambrosia Amb a1
CL Item
Class 0 (< 0.35) (1)
CL Item
Class 1 (0.35- 0.69) (2)
CL Item
Class 2 (0.70-3.49) (3)
CL Item
Class 3 (3.50-17.49) (4)
CL Item
Class 4 (17.50-49.99) (5)
CL Item
Class 5 (50-100) (6)
CL Item
Class 6 (> 100) (7)
Immunoglobulin Dermatophagoides pteronyssinus
Item
D. pteronyssinus Der p1
float
C0021027 (UMLS CUI [1,1])
C1122992 (UMLS CUI [1,2])
Item
RAST class for D. pteronyssinus Der p1
text
C0034554 (UMLS CUI [1])
Code List
RAST class for D. pteronyssinus Der p1
CL Item
Class 0 (< 0.35) (1)
CL Item
Class 1 (0.35- 0.69) (2)
CL Item
Class 2 (0.70-3.49) (3)
CL Item
Class 3 (3.50-17.49) (4)
CL Item
Class 4 (17.50-49.99) (5)
CL Item
Class 5 (50-100) (6)
CL Item
Class 6 (> 100) (7)
Immunoglobulin Dermatophagoides farinae
Item
D. farinae Der p2
float
C0021027 (UMLS CUI [1,1])
C0323677 (UMLS CUI [1,2])
Item
RAST class for D. farinae
text
C0034554 (UMLS CUI [1])
Code List
RAST class for D. farinae
CL Item
Class 0 (< 0.35) (1)
CL Item
Class 1 (0.35- 0.69) (2)
CL Item
Class 2 (0.70-3.49) (3)
CL Item
Class 3 (3.50-17.49) (4)
CL Item
Class 4 (17.50-49.99) (5)
CL Item
Class 5 (50-100) (6)
CL Item
Class 6 (> 100) (7)
Dog antigen
Item
Dog Can f1
float
C1443014 (UMLS CUI [1])
Item
RAST class for dog Can f1
text
C0034554 (UMLS CUI [1])
Code List
RAST class for dog Can f1
CL Item
Class 0 (< 0.35) (1)
CL Item
Class 1 (0.35- 0.69) (2)
CL Item
Class 2 (0.70-3.49) (3)
CL Item
Class 3 (3.50-17.49) (4)
CL Item
Class 4 (17.50-49.99) (5)
CL Item
Class 5 (50-100) (6)
CL Item
Class 6 (> 100) (7)
Cat hair antigen
Item
Cat Fel d1
float
C1443200 (UMLS CUI [1])
Item
RAST class for cat Fel d1
text
C0034554 (UMLS CUI [1])
Code List
RAST class for cat Fel d1
CL Item
Class 0 (< 0.35) (1)
CL Item
Class 1 (0.35- 0.69) (2)
CL Item
Class 2 (0.70-3.49) (3)
CL Item
Class 3 (3.50-17.49) (4)
CL Item
Class 4 (17.50-49.99) (5)
CL Item
Class 5 (50-100) (6)
CL Item
Class 6 (> 100) (7)
Immunoglobulin Alternaria
Item
Alternaria Alt a1
float
C0021027 (UMLS CUI [1,1])
C0002343 (UMLS CUI [1,2])
Item
RAST class for Alternaria Alt a1
text
C0034554 (UMLS CUI [1])
Code List
RAST class for Alternaria Alt a1
CL Item
Class 0 (< 0.35) (1)
CL Item
Class 1 (0.35- 0.69) (2)
CL Item
Class 2 (0.70-3.49) (3)
CL Item
Class 3 (3.50-17.49) (4)
CL Item
Class 4 (17.50-49.99) (5)
CL Item
Class 5 (50-100) (6)
CL Item
Class 6 (> 100) (7)
Item Group
Hematology
C0474523 (UMLS CUI-1)
Hemoglobin
Item
Hemoglobin
float
C0019046 (UMLS CUI [1])
Erythrocyte
Item
Erythrocyte
float
C0014772 (UMLS CUI [1])
Thrombocyte
Item
Thrombocyte
float
C0005821 (UMLS CUI [1])
Leucocyte (total)
Item
Leucocyte (total)
float
C0023508 (UMLS CUI [1])
Hematocrit
Item
Hematocrit
float
C0518014 (UMLS CUI [1])
Item Group
Biochemistry
C0005477 (UMLS CUI-1)
Bilirubin
Item
Bilirubin (total)
float
C1278039 (UMLS CUI [1])
Glutamate pyruvate transaminase
Item
SGPT- Serum Glutamate pyruvate transaminase
float
alkaline phosphatase
Item
Alkaline phosphatase
float
C0201850 (UMLS CUI [1])
Glucose
Item
Glucose
float
C0202042 (UMLS CUI [1])
Creatinine
Item
Creatinine
float
C0201976 (UMLS CUI [1])
Aspartate aminotransferase measurement
Item
SGOT- Aspartate aminotransferase measurement
float
C0201899 (UMLS CUI [1])
C reactive protein
Item
CRP C reactive protein
float
C0201657 (UMLS CUI [1])
Gamma-glutamyl transpeptidase
Item
Gamma-glutamyl transpeptidase
float
C1883012 (UMLS CUI [1])
Item Group
Inclusion Criteria (Part 2)
C1512693 (UMLS CUI-1)
allergy grass pollen
Item
the occurrence of the majority of the corresponding clinical symptoms during the grass pollen season
boolean
C0020517 (UMLS CUI [1,1])
C0440307 (UMLS CUI [1,2])
sensitization
Item
Patients should not suffer from typical symptoms caused by co-allergens during the grass pollen season (for example, patients with sensitization to animal fur / - dandruff are not be exposed)
boolean
C3662483 (UMLS CUI [1])
skin prick test
Item
the positive skin prick test (wheal size> = 3 mm, negative control <2 mm)
boolean
C0430561 (UMLS CUI [1])
perennial allergy
Item
The results in the skin prick test for co-seasonal and most of the perennial co-allergenic are smaller than the skin prick test result for Grass pollen
boolean
C2721639 (UMLS CUI [1])
conjunctival Provocation test
Item
a positive reaction in the conjunctival Provocation test (CPT) with one of the three dilutions of grass allergy solution
boolean
C0430565 (UMLS CUI [1])
Score Rhinoconjunctivitis
Item
Retrospective Total symptom score (RRTSS) during the previous grass pollen season is greater than or equal to 8
boolean
C0449820 (UMLS CUI [1,1])
C0861155 (UMLS CUI [1,2])
Antiallergic therapy
Item
Planned antiallergic or antiasthmatic treatment with the following medicines: local treatment with levocabastine (eye), loratadine (oral), beclomethasone (nasal) or inhaled corticosteroid with a long-acting beta-2 agonists
boolean
C1535925 (UMLS CUI [1])
immunoglobulin E
Item
Specific IgE reactivity to grass pollen: CAP RAST results for Phl p 1 or Phl p5b> = class 2 (0.70 kU / l) and CAP-RAST results for Phl p 1 or Phl p5b> CAP-RAST results for Phl p 7 or Phl p 12
boolean
C0202086 (UMLS CUI [1])
immunoglobulin E; Grass allergy
Item
The specific IgE values for predominantly perennial co- allergy (animal hair / - dandruff, dust mites) or for the predominantly co-seasonal allergen Alternaria must be less than the sIgE results for grass pollen allergens (Phl p 1 or Phl p5b). The difference must be at least a CAP RAAST class (> = 1).
boolean
C0202086 (UMLS CUI [1])
C1387134 (UMLS CUI [2])

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