ID

44607

Beschreibung

Study part: Visit V5 (Day 140 + - 14). 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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Versionen (2)
  1. 28.01.16 28.01.16 -
  2. 27.09.21 27.09.21 -
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27. September 2021

DOI

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Visit V5_LAIS grass tablets by allergic rhinoconjunctivitis_EudraCT-Nr.2012-004916-79

Englisch

Visit V5 (Day 140 + - 14)

1 Formulare  
Visit 5
Beschreibung

Visit 5

Alias
UMLS CUI-1
C0545082
Date of visit
Beschreibung

date

Datentyp

date

Alias
UMLS CUI [1]
C0011008
Does the patient still take part in the study?
Beschreibung

Study Subject Participation Status

Datentyp

text

Alias
UMLS CUI [1]
C2348568
Did the patient take the medication according to the protocol?
Beschreibung

compliance

Datentyp

text

Alias
UMLS CUI [1]
C1321605
If the compliance was not always, please mention in detail
Beschreibung

details compliance

Datentyp

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C1321605
Comorbidity? Please fill up the form "Documentation adverse event"
Beschreibung

Comorbidity

Datentyp

boolean

Concomitant medication? Please use the form "Documentation Concomitant medication"
Beschreibung

Concomitant medication

Datentyp

boolean

Alias
UMLS CUI [1]
C2347852
Date for next visit 6 (Day 196 + - 14 days)
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1]
C0011008
Did an adverse event occur during the treatment? (If yes, please use the form "Documentation adverse event")
Beschreibung

adverse event

Datentyp

boolean

Alias
UMLS CUI [1]
C0877248
Did a serious adverse event occur during the treatment? (If yes, please use the form "Documentation serious adverse events")
Beschreibung

serious adverse event

Datentyp

boolean

Alias
UMLS CUI [1]
C1519255
Are there any undocumented adverse events, which were not recorded during the previous visit? (If yes, please use the form "Documentation adverse event")
Beschreibung

adverse event

Datentyp

boolean

Alias
UMLS CUI [1]
C0877248
Patient diary (part 1) handed out?
Beschreibung

To document daily symptoms and the use of concomitant medication

Datentyp

boolean

Alias
UMLS CUI [1]
C3890583
Did the patient fill up the documentation form on quality of life of rhinoconjunctivitis patients?
Beschreibung

Quality of life; Rhinoconjunctivitis

Datentyp

text

Alias
UMLS CUI [1]
C0034380
UMLS CUI [2]
C0861155
Physical examination
Beschreibung

Physical examination

Alias
UMLS CUI-1
C0031809
Weight
Beschreibung

Weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Systolic blood pressure
Beschreibung

systolic blood pressure

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic blood pressure
Beschreibung

Diastolic blood pressure

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Beschreibung

heart rate

Datentyp

integer

Maßeinheiten
  • 1/ min
Alias
UMLS CUI [1]
C0018810
1/ min
Examination (Rhinoscope)
Beschreibung

Examination (Rhinoscope)

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

edema

Datentyp

text

Alias
UMLS CUI [1]
C0013604
Secretion
Beschreibung

Secretion, Nasal

Datentyp

text

Alias
UMLS CUI [1]
C1546724
Redness
Beschreibung

Redness

Datentyp

text

Alias
UMLS CUI [1]
C0332575
Spirometry or Peak expiratory flow measurement (For asthmatics)
Beschreibung

Spirometry or Peak expiratory flow measurement (For asthmatics)

Alias
UMLS CUI-1
C0037981
UMLS CUI-3
C0521299
FEV1 (age-appropriate standard value)
Beschreibung

FEV1

Datentyp

float

Alias
UMLS CUI [1]
C0748133
FEV1
Beschreibung

FEV1

Datentyp

float

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

Ratio; FEV1; standard value

Datentyp

integer

Maßeinheiten
  • %
Alias
UMLS CUI [1]
C0456603
UMLS CUI [2]
C0588029
UMLS CUI [3]
C1442989
%
PEF 1
Beschreibung

Peak expiratory flow measurement

Datentyp

integer

Maßeinheiten
  • l/min
Alias
UMLS CUI [1]
C0521299
l/min
PEF 2
Beschreibung

Peak expiratory flow measurement

Datentyp

integer

Maßeinheiten
  • l/ min
Alias
UMLS CUI [1]
C0521299
l/ min
PEF 3
Beschreibung

Peak expiratory flow measurement

Datentyp

integer

Maßeinheiten
  • l/ min
Alias
UMLS CUI [1]
C0521299
l/ min
Best PEF
Beschreibung

Peak expiratory flow measurement

Datentyp

integer

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

Peak expiratory flow measurement

Datentyp

integer

Maßeinheiten
  • l/ min
Alias
UMLS CUI [1]
C0521299
l/ min
Study medication and Concomitant medication (Taking back of the third study medication box with 8 blister pack)
Beschreibung

Study medication and Concomitant medication (Taking back of the third study medication box with 8 blister pack)

Alias
UMLS CUI-1
C0013227
Number of tablets left (study medication)
Beschreibung

medication study

Datentyp

integer

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0008972
Number of tablets left (Loratadin)
Beschreibung

medication Demand

Datentyp

integer

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0441516
Mention, if incomplete
Beschreibung

details

Datentyp

text

Alias
UMLS CUI [1]
C1522508
Hematology
Beschreibung

Hematology

Alias
UMLS CUI-1
C0474523
Blood collection on
Beschreibung

date blood collection

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0005834
Ig G4 Gräser
Beschreibung

diagnostic allergy

Datentyp

float

Maßeinheiten
  • mg/l
Alias
UMLS CUI [1,1]
C0086143
UMLS CUI [1,2]
C0020517
mg/l
Hemoglobin
Beschreibung

Hemoglobin

Datentyp

float

Maßeinheiten
  • mmol/l
Alias
UMLS CUI [1]
C0019046
mmol/l
Hematocrit
Beschreibung

hematocrit

Datentyp

float

Maßeinheiten
  • l/l
Alias
UMLS CUI [1]
C0518014
l/l
Erythrocyte
Beschreibung

Erythrocyte

Datentyp

float

Maßeinheiten
  • /pl
Alias
UMLS CUI [1]
C0014772
/pl
Thrombocyte
Beschreibung

Thrombocyte

Datentyp

float

Maßeinheiten
  • /nl
Alias
UMLS CUI [1]
C0005821
/nl
Leucocyte (total)
Beschreibung

Leucocyte

Datentyp

float

Maßeinheiten
  • /nl
Alias
UMLS CUI [1]
C0023508
/nl
Biochemistry
Beschreibung

Biochemistry

Alias
UMLS CUI-1
C0005477
Bilirubin (total)
Beschreibung

Bilirubin

Datentyp

float

Maßeinheiten
  • μmol/l
Alias
UMLS CUI [1]
C1278039
μmol/l
SGPT- Serum Glutamate pyruvate transaminase
Beschreibung

Glutamate pyruvate transaminase

Datentyp

float

Maßeinheiten
  • U/l
Alias
UMLS CUI [1]
C0376147
U/l
Alkaline phosphatase
Beschreibung

Alkaline phosphatase

Datentyp

float

Maßeinheiten
  • U/l
Alias
UMLS CUI [1]
C0201850
U/l
Glucose
Beschreibung

Glucose

Datentyp

float

Maßeinheiten
  • mmol/l
Alias
UMLS CUI [1]
C0202042
mmol/l
Creatinine
Beschreibung

Creatinine

Datentyp

float

Maßeinheiten
  • μmol/l
Alias
UMLS CUI [1]
C0201976
μmol/l
SGOT- Aspartate aminotransferase measurement
Beschreibung

Aspartate aminotransferase measurement

Datentyp

float

Maßeinheiten
  • U/l
Alias
UMLS CUI [1]
C0201899
U/l
CRP C reactive protein
Beschreibung

C reactive protein

Datentyp

float

Maßeinheiten
  • mg/l
Alias
UMLS CUI [1]
C0201657
mg/l
Gamma-glutamyl transpeptidase
Beschreibung

Gamma-glutamyl transpeptidase

Datentyp

float

Maßeinheiten
  • U/l
Alias
UMLS CUI [1]
C1883012
U/l
Demand medication
Beschreibung

Demand medication

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0441516
Number of antihistamines (oral) handed out
Beschreibung

Antihistamines

Datentyp

integer

Alias
UMLS CUI [1]
C0019590
Number of Levocabastin eye drops given out
Beschreibung

Levocabastin

Datentyp

integer

Alias
UMLS CUI [1]
C0064870
Number of Beclometason nasal sprays given out
Beschreibung

Beclometason

Datentyp

integer

Alias
UMLS CUI [1]
C0004905
Number of combination of inhaled cortisone + long acting β2-receptor-agonist handed out
Beschreibung

cortisone; beta agonist

Datentyp

integer

Alias
UMLS CUI [1]
C0010137
UMLS CUI [2]
C0001644
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Ähnliche Modelle

Visit V5 (Day 140 + - 14)

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Visit 5
C0545082 (UMLS CUI-1)
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])
Study Subject Participation Status
Code List
Does the patient still take part in the study?
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])
compliance
Code List
Did the patient take the medication according to the protocol?
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])
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])
Date
Item
Date for next visit 6 (Day 196 + - 14 days)
date
C0011008 (UMLS CUI [1])
adverse event
Item
Did an adverse event occur during the treatment? (If yes, please use the form "Documentation adverse event")
boolean
C0877248 (UMLS CUI [1])
serious adverse event
Item
Did a serious adverse event occur during the treatment? (If yes, please use the form "Documentation serious adverse events")
boolean
C1519255 (UMLS CUI [1])
adverse event
Item
Are there any undocumented adverse events, which were not recorded during the previous visit? (If yes, please use the form "Documentation adverse event")
boolean
C0877248 (UMLS CUI [1])
Patient diary
Item
Patient diary (part 1) handed out?
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?
text
C0034380 (UMLS CUI [1])
C0861155 (UMLS CUI [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])
edema
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])
Secretion, Nasal
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])
Redness
Code List
Redness
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)
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
Study medication and Concomitant medication (Taking back of the third study medication box with 8 blister pack)
C0013227 (UMLS CUI-1)
medication study
Item
Number of tablets left (study medication)
integer
C0013227 (UMLS CUI [1,1])
C0008972 (UMLS CUI [1,2])
medication Demand
Item
Number of tablets left (Loratadin)
integer
C0013227 (UMLS CUI [1,1])
C0441516 (UMLS CUI [1,2])
details
Item
Mention, if incomplete
text
C1522508 (UMLS CUI [1])
Item Group
Hematology
C0474523 (UMLS CUI-1)
date blood collection
Item
Blood collection on
date
C0011008 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
diagnostic allergy
Item
Ig G4 Gräser
float
C0086143 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
Hemoglobin
Item
Hemoglobin
float
C0019046 (UMLS CUI [1])
hematocrit
Item
Hematocrit
float
C0518014 (UMLS CUI [1])
Erythrocyte
Item
Erythrocyte
float
C0014772 (UMLS CUI [1])
Thrombocyte
Item
Thrombocyte
float
C0005821 (UMLS CUI [1])
Leucocyte
Item
Leucocyte (total)
float
C0023508 (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
C0376147 (UMLS CUI [1])
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
Demand medication
C0013227 (UMLS CUI-1)
C0441516 (UMLS CUI-2)
Antihistamines
Item
Number of antihistamines (oral) handed out
integer
C0019590 (UMLS CUI [1])
Levocabastin
Item
Number of Levocabastin eye drops given out
integer
C0064870 (UMLS CUI [1])
Beclometason
Item
Number of Beclometason nasal sprays given out
integer
C0004905 (UMLS CUI [1])
cortisone; beta agonist
Item
Number of combination of inhaled cortisone + long acting β2-receptor-agonist handed out
integer
C0010137 (UMLS CUI [1])
C0001644 (UMLS CUI [2])
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