ID

13269

Descripción

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.

Palabras clave

Versiones (1)
  1. 28/1/16 28/1/16 -
Subido en

28 de enero de 2016

DOI

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Licencia

Creative Commons BY-NC 3.0
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Visit V7_LAIS grass tablets by allergic rhinoconjunctivitis_EudraCT-Nr.2012-004916-79

Inglés

Visit V7 (Day 238 + - 14) Final examination

1 formularios  
Visit 7
Descripción

Visit 7

Alias
UMLS CUI-1
C0545082
Date of visit
Descripción

date

Tipo de datos

date

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

Study Subject Participation Status

Tipo de datos

text

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

compliance

Tipo de datos

text

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

details compliance

Tipo de datos

text

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

Comorbidity

Tipo de datos

boolean

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

Concomitant medication

Tipo de datos

boolean

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

Patient diary

Tipo de datos

boolean

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

Quality of life; Rhinoconjunctivitis

Tipo de datos

boolean

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

study completion

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2826674
Physical examination
Descripción

Physical examination

Alias
UMLS CUI-1
C0031809
Weight
Descripción

Weight

Tipo de datos

float

Unidades de medida
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Systolic blood pressure
Descripción

systolic blood pressure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic blood pressure
Descripción

Diastolic blood pressure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Descripción

heart rate

Tipo de datos

integer

Unidades de medida
  • 1/ min
Alias
UMLS CUI [1]
C0018810
1/ min
Examination (Rhinoscope)
Descripción

Examination (Rhinoscope)

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

edema

Tipo de datos

text

Alias
UMLS CUI [1]
C0013604
Secretion
Descripción

Secretion, Nasal

Tipo de datos

text

Alias
UMLS CUI [1]
C1546724
Redness
Descripción

Redness

Tipo de datos

text

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

Spirometry or Peak expiratory flow measurement (For asthmatics)

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

FEV1

Tipo de datos

float

Alias
UMLS CUI [1]
C0748133
FEV1
Descripción

FEV1

Tipo de datos

float

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

Ratio; FEV1; standard value

Tipo de datos

integer

Unidades de medida
  • %
Alias
UMLS CUI [1]
C0456603
UMLS CUI [2]
C0588029
UMLS CUI [3]
C1442989
%
PEF 1
Descripción

Peak expiratory flow measurement

Tipo de datos

integer

Unidades de medida
  • l/min
Alias
UMLS CUI [1]
C0521299
l/min
PEF 2
Descripción

Peak expiratory flow measurement

Tipo de datos

integer

Unidades de medida
  • l/ min
Alias
UMLS CUI [1]
C0521299
l/ min
PEF 3
Descripción

Peak expiratory flow measurement

Tipo de datos

integer

Unidades de medida
  • l/ min
Alias
UMLS CUI [1]
C0521299
l/ min
Best PEF
Descripción

Peak expiratory flow measurement

Tipo de datos

integer

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

Peak expiratory flow measurement

Tipo de datos

integer

Unidades de medida
  • l/ min
Alias
UMLS CUI [1]
C0521299
l/ min
Pregnancy test
Descripción

Pregnancy test

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

date

Tipo de datos

date

Alias
UMLS CUI [1]
C0011008
Pregnancy test result
Descripción

Pregnancy test

Tipo de datos

text

Alias
UMLS CUI [1]
C0032976
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Similar models

Visit V7 (Day 238 + - 14) Final examination

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
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])
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])
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
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])
Pregnancy test
Code List
Pregnancy test result
CL Item
positive (1)
CL Item
negative (2)
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