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13268
Beschreibung
Study part: Visit V6 (Day 196 + - 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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- 28.01.16 28.01.16 -
- 27.09.21 27.09.21 -
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28. Januar 2016
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Visit V6_LAIS grass tablets by allergic rhinoconjunctivitis_EudraCT-Nr.2012-004916-79
Visit V6 (Day 196 + - 14)
- StudyEvent: ODM
Ähnliche Modelle
Visit V6 (Day 196 + - 14)
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
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])
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])
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])
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 7 (Day 238 + - 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 collected and part 2 handed out?
boolean
C3890583 (UMLS CUI [1])
Quality of life; Rhinoconjunctivitis
Item
Did the patient fill up the documentation forms on quality of life of rhinoconjunctivitis patients and Rhinitis control assessment test?
text
C0034380 (UMLS CUI [1])
C0861155 (UMLS CUI [2])
C0861155 (UMLS CUI [2])
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)
C0183044 (UMLS CUI-2)
CL Item
no (1)
CL Item
slight (2)
CL Item
medium (3)
CL Item
strong (4)
CL Item
no (1)
CL Item
slight (2)
CL Item
medium (3)
CL Item
strong (4)
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)
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])
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])
Antihistamines
Item
Number of used antihistamines (oral), please specify if incomplete
text
C0003360 (UMLS CUI [1])
medication Demand
Item
Return of unused medications
boolean
C0013227 (UMLS CUI [1,1])
C0441516 (UMLS CUI [1,2])
C0441516 (UMLS CUI [1,2])
Levocabastin
Item
Number of opened eyedrops (Levocabastin), please specify if incomplete
text
C0064870 (UMLS CUI [1])
medication Demand
Item
Return of unused medications
boolean
C0013227 (UMLS CUI [1,1])
C0441516 (UMLS CUI [1,2])
C0441516 (UMLS CUI [1,2])
Beclometason
Item
Number of nasal spray bottles opened (Beclometason), please specify if incomplete
text
C0004905 (UMLS CUI [1])
medication Demand
Item
Return of unused medications
boolean
C0013227 (UMLS CUI [1,1])
C0441516 (UMLS CUI [1,2])
C0441516 (UMLS CUI [1,2])
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])
C0001644 (UMLS CUI [2])
medication Demand
Item
Return of unused medications
boolean
C0013227 (UMLS CUI [1,1])
C0441516 (UMLS CUI [1,2])
C0441516 (UMLS CUI [1,2])
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