ID

13269

Description

Study part: Visit V7 (Day 238 + - 14) Final examination. 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. 1/28/16 1/28/16 -
Uploaded on

January 28, 2016

DOI

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License

Creative Commons BY-NC 3.0

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Visit V7_LAIS grass tablets by allergic rhinoconjunctivitis_EudraCT-Nr.2012-004916-79

Visit V7 (Day 238 + - 14) Final examination

Visit 7
Description

Visit 7

Alias
UMLS CUI-1
C0545082
Date of visit
Description

date

Data type

date

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

Study Subject Participation Status

Data type

text

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

compliance

Data type

text

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

details compliance

Data type

text

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

Comorbidity

Data type

boolean

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

Concomitant medication

Data type

boolean

Alias
UMLS CUI [1]
C2347852
Patient diary (part 2) collected and controlled?
Description

Patient diary

Data type

boolean

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

Quality of life; Rhinoconjunctivitis

Data type

boolean

Alias
UMLS CUI [1]
C0034380
UMLS CUI [2]
C0861155
Documentation of study completion done? (Please use the form "Study completion")
Description

study completion

Data type

boolean

Alias
UMLS CUI [1]
C2826674
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, Nasal

Data type

text

Alias
UMLS CUI [1]
C1546724
Redness
Description

Redness

Data type

text

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

Spirometry or Peak expiratory flow measurement (For asthmatics)

Alias
UMLS CUI-1
C0037981
UMLS CUI-3
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
Pregnancy test
Description

Pregnancy test

Alias
UMLS CUI-1
C0032976
Pregnancy test carried out on
Description

date

Data type

date

Alias
UMLS CUI [1]
C0011008
Pregnancy test result
Description

Pregnancy test

Data type

text

Alias
UMLS CUI [1]
C0032976

Similar models

Visit V7 (Day 238 + - 14) Final examination

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Visit 7
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])
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])
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])
Patient diary
Item
Patient diary (part 2) collected and controlled?
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?
boolean
C0034380 (UMLS CUI [1])
C0861155 (UMLS CUI [2])
study completion
Item
Documentation of study completion done? (Please use the form "Study completion")
boolean
C2826674 (UMLS CUI [1])
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
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
Pregnancy test
C0032976 (UMLS CUI-1)
date
Item
Pregnancy test carried out on
date
C0011008 (UMLS CUI [1])
Item
Pregnancy test result
text
C0032976 (UMLS CUI [1])
Code List
Pregnancy test result
CL Item
positive (1)
CL Item
negative (2)

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