ID

13273

Descripción

Study part: Documentation serious 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.

Palabras clave

  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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Serious adverse events_LAIS grass tablets by allergic rhinoconjunctivitis EudraCT-Nr. 2012-004916-79

Documentation serious adverse events

Patient information
Descripción

Patient information

Alias
UMLS CUI-1
C1955348
Patient ID
Descripción

Patient id

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
Date of birth
Descripción

date of birth

Tipo de datos

date

Alias
UMLS CUI [1]
C0421451
Visit number
Descripción

Visit number

Tipo de datos

integer

Alias
UMLS CUI [1]
C1549755
Gender
Descripción

Gender

Tipo de datos

text

Alias
UMLS CUI [1]
C0079399
Height
Descripción

Height

Tipo de datos

integer

Unidades de medida
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Descripción

Weight

Tipo de datos

float

Unidades de medida
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Serious adverse events
Descripción

Serious adverse events

Alias
UMLS CUI-1
C1519255
Date of serious adverse event appearance
Descripción

date

Tipo de datos

date

Alias
UMLS CUI [1]
C0011008
Symptoms of serious adverse event
Descripción

symptom serious adverse event

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C1519255
Laboratory test
Descripción

laboratory test

Tipo de datos

text

Alias
UMLS CUI [1]
C0022885
Medical history
Descripción

Medical history

Tipo de datos

text

Alias
UMLS CUI [1]
C0262926
Comorbidity
Descripción

Comorbidity

Tipo de datos

text

Alias
UMLS CUI [1]
C0009488
Medication
Descripción

Medication

Alias
UMLS CUI-1
C0013227
Medication name
Descripción

drug

Tipo de datos

text

Alias
UMLS CUI [1]
C0013227
Medication dose
Descripción

dose

Tipo de datos

text

Alias
UMLS CUI [1]
C3174092
Drug administration route
Descripción

Drug administration route

Tipo de datos

text

Alias
UMLS CUI [1]
C0013153
Drug intake begin
Descripción

date

Tipo de datos

date

Alias
UMLS CUI [1]
C0011008
Drug intake ended
Descripción

date

Tipo de datos

date

Alias
UMLS CUI [1]
C0011008
Relation between study drug and serious adverse event
Descripción

drug; Serious Adverse Event

Tipo de datos

text

Alias
UMLS CUI [1]
C0013227
UMLS CUI [2]
C1519255

Similar models

Documentation serious adverse events

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Patient information
C1955348 (UMLS CUI-1)
Patient id
Item
Patient ID
integer
C2348585 (UMLS CUI [1])
date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Visit number
Item
Visit number
integer
C1549755 (UMLS CUI [1])
Item
Gender
text
C0079399 (UMLS CUI [1])
Code List
Gender
CL Item
male (1)
CL Item
female (2)
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item Group
Serious adverse events
C1519255 (UMLS CUI-1)
date
Item
Date of serious adverse event appearance
date
C0011008 (UMLS CUI [1])
symptom serious adverse event
Item
Symptoms of serious adverse event
text
C1457887 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
laboratory test
Item
Laboratory test
text
C0022885 (UMLS CUI [1])
Medical history
Item
Medical history
text
C0262926 (UMLS CUI [1])
Comorbidity
Item
Comorbidity
text
C0009488 (UMLS CUI [1])
Item Group
Medication
C0013227 (UMLS CUI-1)
drug
Item
Medication name
text
C0013227 (UMLS CUI [1])
dose
Item
Medication dose
text
C3174092 (UMLS CUI [1])
Drug administration route
Item
Drug administration route
text
C0013153 (UMLS CUI [1])
date
Item
Drug intake begin
date
C0011008 (UMLS CUI [1])
date
Item
Drug intake ended
date
C0011008 (UMLS CUI [1])
Item
Relation between study drug and serious adverse event
text
C0013227 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
Code List
Relation between study drug and serious adverse event
CL Item
no relation (1)
CL Item
implausible (2)
CL Item
possible (3)
CL Item
plausible (4)
CL Item
certain (5)
CL Item
undecidable, insufficient data (6)

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