ID

15685

Descripción

Nerventra Study (Eudra CT 2007-003226-19) Study MS-LAQ-301: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS)

Palabras clave

Versiones (1)
  1. 8/6/16 8/6/16 -
Subido en

8 de junio de 2016

DOI

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Licencia

Creative Commons BY-NC 3.0
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Nerventra Study Adverse event log

Inglés

Nerventra Study Adverse event log

1 formularios  
Demographic Information
Descripción

Demographic Information

Protocol Number
Descripción

Protocol Number

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0008971
UMLS CUI [1,2]
C0600091
Visit Type
Descripción

i.e "Screening"

Tipo de datos

text

Alias
UMLS CUI [1]
C0545082
Date of visit
Descripción

Visit date

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303
Study site number
Descripción

Study site

Tipo de datos

integer

Alias
UMLS CUI [1]
C2825164
Subject number:
Descripción

Subject number

Tipo de datos

integer

Alias
UMLS CUI [1]
C1709561
Section blank
Descripción

Blank

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0750479
Ongoing adverse events
Descripción

Ongoing adverse events

Date of automatic update
Descripción

Date of automatic update

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0205554
UMLS CUI [1,3]
C1519814
Date of manual update
Descripción

Date of manual update

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0175674
UMLS CUI [1,3]
C1519814
Adverse event
Descripción

Adverse event

Tipo de datos

text

Alias
UMLS CUI [1]
C0877248
Visit Type
Descripción

Visit

Tipo de datos

text

Alias
UMLS CUI [1]
C0545082
Adverse events log Baseline
Descripción

Adverse events log Baseline

Adverse event
Descripción

Adverse event

Tipo de datos

text

Alias
UMLS CUI [1]
C0877248
Adverse event intermittent
Descripción

Adverse event intermittent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0205267
Time since dose
Descripción

Time since dose

Tipo de datos

time

Alias
UMLS CUI [1]
C0946444
Time since dose unknown
Descripción

Time since dose

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0946444
Prior to first dose
Descripción

Prior to first dose

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0332152
UMLS CUI [1,2]
C3469597
Date of onset
Descripción

Date of onset

Tipo de datos

date

Alias
UMLS CUI [1]
C0574845
Is the Adverse Event Ongoing?
Descripción

Adverse Event Ongoing

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2826663
Adverse Event less than one day
Descripción

Adverse Event less than one day

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3843198
Severity
Descripción

Severity

Tipo de datos

text

Alias
UMLS CUI [1]
C0439793
Serious (If yes, complete SAE report)
Descripción

Serious

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0205404
Action Taken with Study Treatment
Descripción

Action Taken with Study Treatment

Tipo de datos

text

Alias
UMLS CUI [1]
C2826626
If study drug is discontinued, is this the primary AE?
Descripción

Primary AE

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0205225
UMLS CUI [1,2]
C0877248
Outcome to event
Descripción

Adverse Event Outcome

Tipo de datos

text

Alias
UMLS CUI [1]
C1705586
Relation to study drug
Descripción

Drugs

Tipo de datos

text

Alias
UMLS CUI [1]
C0013227
Adverse events Visit 1
Descripción

Adverse events Visit 1

Adverse event
Descripción

Adverse event

Tipo de datos

text

Alias
UMLS CUI [1]
C0877248
Adverse event intermittent
Descripción

Adverse event intermittent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0205267
Time since dose
Descripción

Time since dose

Tipo de datos

time

Alias
UMLS CUI [1]
C0946444
Time since dose unknown
Descripción

Time since dose

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0946444
Prior to first dose
Descripción

Prior to first dose

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0332152
UMLS CUI [1,2]
C3469597
Date of onset
Descripción

Date of onset

Tipo de datos

date

Alias
UMLS CUI [1]
C0574845
Is the Adverse Event Ongoing?
Descripción

Adverse Event Ongoing

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2826663
Adverse Event less than one day
Descripción

Adverse Event less than one day

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3843198
Severity
Descripción

Severity

Tipo de datos

text

Alias
UMLS CUI [1]
C0439793
Serious (If yes, complete SAE report)
Descripción

Serious

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0205404
Action Taken with Study Treatment
Descripción

Action Taken with Study Treatment

Tipo de datos

text

Alias
UMLS CUI [1]
C2826626
If study drug is discontinued, is this the primary AE?
Descripción

Primary AE

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0205225
UMLS CUI [1,2]
C0877248
Outcome to event
Descripción

Adverse Event Outcome

Tipo de datos

text

Alias
UMLS CUI [1]
C1705586
Relation to study drug
Descripción

Drugs

Tipo de datos

text

Alias
UMLS CUI [1]
C0013227
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Similar models

Nerventra Study Adverse event log

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Demographic Information
Protocol Number
Item
Protocol Number
text
C0008971 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Visit
Item
Visit Type
text
C0545082 (UMLS CUI [1])
Visit date
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Study site
Item
Study site number
integer
C2825164 (UMLS CUI [1])
Subject number
Item
Subject number:
integer
C1709561 (UMLS CUI [1])
Blank
Item
Section blank
boolean
C0750479 (UMLS CUI [1])
Item Group
Ongoing adverse events
Date of automatic update
Item
Date of automatic update
date
C0011008 (UMLS CUI [1,1])
C0205554 (UMLS CUI [1,2])
C1519814 (UMLS CUI [1,3])
Date of manual update
Item
Date of manual update
date
C0011008 (UMLS CUI [1,1])
C0175674 (UMLS CUI [1,2])
C1519814 (UMLS CUI [1,3])
Adverse event
Item
Adverse event
text
C0877248 (UMLS CUI [1])
Visit
Item
Visit Type
text
C0545082 (UMLS CUI [1])
Item Group
Adverse events log Baseline
Adverse event
Item
Adverse event
text
C0877248 (UMLS CUI [1])
Adverse event intermittent
Item
Adverse event intermittent
boolean
C0877248 (UMLS CUI [1,1])
C0205267 (UMLS CUI [1,2])
Time since dose
Item
Time since dose
time
C0946444 (UMLS CUI [1])
Time since dose
Item
Time since dose unknown
boolean
C0946444 (UMLS CUI [1])
Prior to first dose
Item
Prior to first dose
boolean
C0332152 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
Date of onset
Item
Date of onset
date
C0574845 (UMLS CUI [1])
Adverse Event Ongoing
Item
Is the Adverse Event Ongoing?
boolean
C2826663 (UMLS CUI [1])
Adverse Event less than one day
Item
Adverse Event less than one day
boolean
C3843198 (UMLS CUI [1])
Severity
Item
Severity
text
C0439793 (UMLS CUI [1])
Serious
Item
Serious (If yes, complete SAE report)
boolean
C0205404 (UMLS CUI [1])
Action Taken with Study Treatment
Item
Action Taken with Study Treatment
text
C2826626 (UMLS CUI [1])
Primary AE
Item
If study drug is discontinued, is this the primary AE?
boolean
C0205225 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Adverse Event Outcome
Item
Outcome to event
text
C1705586 (UMLS CUI [1])
Drugs
Item
Relation to study drug
text
C0013227 (UMLS CUI [1])
Item Group
Adverse events Visit 1
Adverse event
Item
Adverse event
text
C0877248 (UMLS CUI [1])
Adverse event intermittent
Item
Adverse event intermittent
boolean
C0877248 (UMLS CUI [1,1])
C0205267 (UMLS CUI [1,2])
Time since dose
Item
Time since dose
time
C0946444 (UMLS CUI [1])
Time since dose
Item
Time since dose unknown
boolean
C0946444 (UMLS CUI [1])
Prior to first dose
Item
Prior to first dose
boolean
C0332152 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
Date of onset
Item
Date of onset
date
C0574845 (UMLS CUI [1])
Adverse Event Ongoing
Item
Is the Adverse Event Ongoing?
boolean
C2826663 (UMLS CUI [1])
Adverse Event less than one day
Item
Adverse Event less than one day
boolean
C3843198 (UMLS CUI [1])
Severity
Item
Severity
text
C0439793 (UMLS CUI [1])
Serious
Item
Serious (If yes, complete SAE report)
boolean
C0205404 (UMLS CUI [1])
Action Taken with Study Treatment
Item
Action Taken with Study Treatment
text
C2826626 (UMLS CUI [1])
Primary AE
Item
If study drug is discontinued, is this the primary AE?
boolean
C0205225 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Adverse Event Outcome
Item
Outcome to event
text
C1705586 (UMLS CUI [1])
Drugs
Item
Relation to study drug
text
C0013227 (UMLS CUI [1])
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