ID

44614

Description

Study part: Study completion form.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)
  1. 28/01/2016 28/01/2016 -
  2. 27/09/2021 27/09/2021 -
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27 septembre 2021

DOI

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Licence

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

Anglais

Study completion form

1 Formulaires  
  1. StudyEvent: ODM
    1. Study completion form
Study completion
Description

Study completion

Alias
UMLS CUI-1
C2826674
study completion
Description

The study was completed according to plan

Type de données

boolean

Alias
UMLS CUI [1]
C2826674
The study was terminated on
Description

date study termination

Type de données

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0008972
UMLS CUI [1,3]
C0013135
The study was terminated by
Description

Investigator; patient

Type de données

text

Alias
UMLS CUI [1]
C0008961
UMLS CUI [2]
C0030705
The study was terminated due to
Description

reason study termination

Type de données

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0008972
UMLS CUI [1,3]
C0013135
If other, please specify
Description

other

Type de données

text

Alias
UMLS CUI [1]
C0205394
Date of last contact
Description

Date last contact

Type de données

text

Alias
UMLS CUI [1]
C0805839
Hematology
Description

Hematology

Alias
UMLS CUI-1
C0474523
Hemoglobin
Description

Hemoglobin

Type de données

float

Unités de mesure
  • mmol/l
Alias
UMLS CUI [1]
C0019046
mmol/l
Hematocrit
Description

hematocrit

Type de données

float

Unités de mesure
  • l/l
Alias
UMLS CUI [1]
C0518014
l/l
Erythrocyte
Description

erythrocyte

Type de données

float

Unités de mesure
  • /pl
Alias
UMLS CUI [1]
C0014772
/pl
Thrombocyte
Description

Thrombocyte

Type de données

float

Unités de mesure
  • /nl
Alias
UMLS CUI [1]
C0005821
/nl
Leucocyte (total)
Description

Leucocyte

Type de données

float

Unités de mesure
  • /nl
Alias
UMLS CUI [1]
C0023508
/nl
Biochemistry
Description

Biochemistry

Alias
UMLS CUI-1
C0005477
Bilirubin (total)
Description

Bilirubin

Type de données

float

Unités de mesure
  • μmol/l
Alias
UMLS CUI [1]
C1278039
μmol/l
SGPT- Serum Glutamate pyruvate transaminase
Description

Glutamate pyruvate transaminase

Type de données

float

Unités de mesure
  • U/l
Alias
UMLS CUI [1]
C0376147
U/l
Alkaline phosphatase
Description

alkaline phosphatase

Type de données

float

Unités de mesure
  • U/l
Alias
UMLS CUI [1]
C0201850
U/l
Glucose
Description

Glucose

Type de données

float

Unités de mesure
  • mmol/l
Alias
UMLS CUI [1]
C0202042
mmol/l
Creatinine
Description

Creatinine

Type de données

float

Unités de mesure
  • μmol/l
Alias
UMLS CUI [1]
C0201976
μmol/l
SGOT- Aspartate aminotransferase measurement
Description

Aspartate aminotransferase measurement

Type de données

float

Unités de mesure
  • U/l
Alias
UMLS CUI [1]
C0201899
U/l
CRP C reactive protein
Description

CRP C reactive protein

Type de données

float

Unités de mesure
  • mg/l
Alias
UMLS CUI [1]
C0201657
mg/l
Gamma-glutamyl transpeptidase
Description

Gamma-glutamyl transpeptidase

Type de données

float

Unités de mesure
  • U/l
Alias
UMLS CUI [1]
C1883012
U/l
Pregnancy test
Description

Pregnancy test

Type de données

text

Alias
UMLS CUI [1]
C0032976
Date of pregnancy test
Description

date pregnancy test

Type de données

date

Alias
UMLS CUI [1,1]
C0805839
UMLS CUI [1,2]
C0032976
Withdrawal of demand medication
Description

Withdrawal of demand medication

Alias
UMLS CUI-1
C2349954
UMLS CUI-2
C0013227
Patient compliance
Description

compliance

Type de données

text

Alias
UMLS CUI [1]
C1321605
Number of used antihistamines (oral), please specify if incomplete
Description

Antihistamines

Type de données

text

Alias
UMLS CUI [1]
C0019590
Number of opened eyedrops (Levocabastin), please specify if incomplete
Description

Levocabastin

Type de données

text

Alias
UMLS CUI [1]
C0064870
Number of nasal spray bottles opened (Beclometason), please specify if incomplete
Description

Beclometason

Type de données

text

Alias
UMLS CUI [1]
C0004905
Number of opened packets of combination of inhaled cortisone + long acting β2-receptor-agonist, please specify if incomplete
Description

cortisone; beta agonist

Type de données

text

Alias
UMLS CUI [1]
C0010137
UMLS CUI [2]
C0001644
Assessment
Description

Assessment

Alias
UMLS CUI-1
C1516048
Physician's assessment about the efficiency of the treatment
Description

assessment physician

Type de données

text

Alias
UMLS CUI [1,1]
C1516048
UMLS CUI [1,2]
C0031831
Physician's assessment about the tolerance of the treatment
Description

assessment physician

Type de données

text

Alias
UMLS CUI [1,1]
C1516048
UMLS CUI [1,2]
C0031831
Patient's assessment about the satisfaction of the treatment
Description

assessment patient

Type de données

text

Alias
UMLS CUI [1,1]
C1516048
UMLS CUI [1,2]
C0030705
Recommendation
Description

assessment patient

Type de données

text

Alias
UMLS CUI [1,1]
C1516048
UMLS CUI [1,2]
C0030705
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Similar models

Study completion form

1 Formulaires
  1. StudyEvent: ODM
    1. Study completion form
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Study completion
C2826674 (UMLS CUI-1)
study completion
Item
study completion
boolean
C2826674 (UMLS CUI [1])
date study termination
Item
The study was terminated on
date
C0011008 (UMLS CUI [1,1])
C0008972 (UMLS CUI [1,2])
C0013135 (UMLS CUI [1,3])
Item
The study was terminated by
text
C0008961 (UMLS CUI [1])
C0030705 (UMLS CUI [2])
Investigator; patient
Code List
The study was terminated by
CL Item
Investigator  (1)
CL Item
Patient (2)
Item
The study was terminated due to
text
C0392360 (UMLS CUI [1,1])
C0008972 (UMLS CUI [1,2])
C0013135 (UMLS CUI [1,3])
reason study termination
Code List
The study was terminated due to
CL Item
adverse event (1)
CL Item
withdrawal of consent (2)
CL Item
comorbidity (3)
CL Item
protocol violation (e.g. bad compliance) (4)
CL Item
pregnancy (5)
CL Item
other (6)
CL Item
Patient no longer reachable (7)
other
Item
If other, please specify
text
C0205394 (UMLS CUI [1])
Date last contact
Item
Date of last contact
text
C0805839 (UMLS CUI [1])
Item Group
Hematology
C0474523 (UMLS CUI-1)
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
Pregnancy test
text
C0032976 (UMLS CUI [1])
Pregnancy test
Code List
Pregnancy test
CL Item
positive (1)
CL Item
negative (2)
date pregnancy test
Item
Date of pregnancy test
date
C0805839 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
Item Group
Withdrawal of demand medication
C2349954 (UMLS CUI-1)
C0013227 (UMLS CUI-2)
Item
Patient compliance
text
C1321605 (UMLS CUI [1])
compliance
Code List
Patient compliance
CL Item
always (1)
CL Item
mostly yes (2)
CL Item
mostly no (3)
CL Item
no (4)
Antihistamines
Item
Number of used antihistamines (oral), please specify if incomplete
text
C0019590 (UMLS CUI [1])
Levocabastin
Item
Number of opened eyedrops (Levocabastin), please specify if incomplete
text
C0064870 (UMLS CUI [1])
Beclometason
Item
Number of nasal spray bottles opened (Beclometason), please specify if incomplete
text
C0004905 (UMLS CUI [1])
cortisone; beta agonist
Item
Number of opened packets of combination of inhaled cortisone + long acting β2-receptor-agonist, please specify if incomplete
text
C0010137 (UMLS CUI [1])
C0001644 (UMLS CUI [2])
Item Group
Assessment
C1516048 (UMLS CUI-1)
Item
Physician's assessment about the efficiency of the treatment
text
C1516048 (UMLS CUI [1,1])
C0031831 (UMLS CUI [1,2])
assessment physician
Code List
Physician's assessment about the efficiency of the treatment
CL Item
deteriorated condition (1)
CL Item
no change in the state (2)
CL Item
mild to moderate improvement in the state (3)
CL Item
pronounced to very pronounced improvement in the state (4)
Item
Physician's assessment about the tolerance of the treatment
text
C1516048 (UMLS CUI [1,1])
C0031831 (UMLS CUI [1,2])
assessment physician
Code List
Physician's assessment about the tolerance of the treatment
CL Item
bad (1)
CL Item
satisfactory (2)
CL Item
good (3)
CL Item
very good (4)
Item
Patient's assessment about the satisfaction of the treatment
text
C1516048 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
assessment patient
Code List
Patient's assessment about the satisfaction of the treatment
CL Item
unsatisfactory (1)
CL Item
little satisfactory (2)
CL Item
satisfactory (3)
CL Item
absolutely satisfied (4)
Item
Recommendation
text
C1516048 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
assessment patient
Code List
Recommendation
CL Item
I would never recommend this therapy (1)
CL Item
May be I won't recommend this therapy (2)
CL Item
May be I will further recommend this therapy (3)
CL Item
I will absolutely recommend this therapy (4)
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