ID

13271

Beschrijving

Study part: Documentation adverse events. 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.

Trefwoorden

Versies (1)
  1. 28-01-16 28-01-16 -
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28 januari 2016

DOI

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

Engels

Documentation adverse events

1 Formulieren  
Register form adverse event
Beschrijving

Register form adverse event

Alias
UMLS CUI-1
C0877248
Adverse event
Beschrijving

Adverse event

Datatype

text

Alias
UMLS CUI [1]
C0877248
Date on which adverse event began
Beschrijving

date

Datatype

date

Alias
UMLS CUI [1]
C0011008
Is it a systemic reaction? (based on SLIT)
Beschrijving

Systemic Reaction

Datatype

text

Alias
UMLS CUI [1]
C1710276
Relation to medication
Beschrijving

medication

Datatype

text

Alias
UMLS CUI [1]
C0013227
Frequency of adverse event
Beschrijving

Frequency Adverse event

Datatype

text

Alias
UMLS CUI [1,1]
C0439603
UMLS CUI [1,2]
C0877248
Seriousness of adverse event
Beschrijving

Seriousness Adverse event

Datatype

text

Alias
UMLS CUI [1,1]
C0871902
UMLS CUI [1,2]
C0877248
Course of adverse event
Beschrijving

course adverse event

Datatype

text

Alias
UMLS CUI [1,1]
C0750729
UMLS CUI [1,2]
C0877248
Measures related to study medication
Beschrijving

drug study

Datatype

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0008972
Other taken measures
Beschrijving

concomitant medication; hospital

Datatype

text

Alias
UMLS CUI [1]
C2347852
UMLS CUI [2]
C0019994
Date on which adverse event ended
Beschrijving

date

Datatype

date

Alias
UMLS CUI [1]
C0011008
Ongoing of adverse event (beyond V7)?
Beschrijving

ongoing adverse event

Datatype

boolean

Alias
UMLS CUI [1,1]
C0549178
UMLS CUI [1,2]
C0877248
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Similar models

Documentation adverse events

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Register form adverse event
C0877248 (UMLS CUI-1)
Adverse event
Item
Adverse event
text
C0877248 (UMLS CUI [1])
date
Item
Date on which adverse event began
date
C0011008 (UMLS CUI [1])
Item
Is it a systemic reaction? (based on SLIT)
text
C1710276 (UMLS CUI [1])
Systemic Reaction
Code List
Is it a systemic reaction? (based on SLIT)
CL Item
nonspecific symptoms (e.g. headache, apprehension) (1)
CL Item
slight specific symptoms (local urticaria, rhinitis or slight asthma (PEF<20%)) (2)
CL Item
medium specific symptoms (slow onset of (> 15 min) of urticaria and/ or medium asthma (PEF < 40%)) (3)
CL Item
serious (not life threatening) systemic symptoms (rapid onset (< 15min) of urticaria, Angioedema or serious asthma (PEF > 40%)) (4)
CL Item
anaphylactic shock (please document additionally as SAE) (5)
CL Item
not applicable (6)
Item
Relation to medication
text
C0013227 (UMLS CUI [1])
medication
Code List
Relation to medication
CL Item
not related (1)
CL Item
may be related (2)
CL Item
related (3)
Item
Frequency of adverse event
text
C0439603 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Frequency
Code List
Frequency of adverse event
CL Item
once only (1)
CL Item
regular (2)
CL Item
continuous (3)
Item
Seriousness of adverse event
text
C0871902 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Seriousness
Code List
Seriousness of adverse event
CL Item
slight (1)
CL Item
medium (2)
CL Item
serious (3)
Item
Course of adverse event
text
C0750729 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
course
Code List
Course of adverse event
CL Item
finished (1)
CL Item
subsided (2)
CL Item
continuous (3)
CL Item
finished/ resulting in additional symptoms (4)
CL Item
increased (5)
CL Item
deadly (6)
CL Item
unknown (7)
Item
Measures related to study medication
text
C0013227 (UMLS CUI [1,1])
C0008972 (UMLS CUI [1,2])
drug study
Code List
Measures related to study medication
CL Item
no (1)
CL Item
dose adjustment (2)
CL Item
second interruption of therapy (3)
CL Item
discontinuation of therapy (4)
CL Item
other (5)
Item
Other taken measures
text
C2347852 (UMLS CUI [1])
C0019994 (UMLS CUI [2])
concomitant medication; hospital
Code List
Other taken measures
CL Item
no (1)
CL Item
change of concomitant medication (2)
CL Item
hospitalization/ extension of a hospital stay (3)
CL Item
additional therapeutic or diagnostic measure (4)
date
Item
Date on which adverse event ended
date
C0011008 (UMLS CUI [1])
ongoing adverse event
Item
Ongoing of adverse event (beyond V7)?
boolean
C0549178 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
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