ID

15685

Beschrijving

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)

Trefwoorden

Versies (1)
  1. 08-06-16 08-06-16 -
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8 juni 2016

DOI

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Licentie

Creative Commons BY-NC 3.0
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Nerventra Study Adverse event log

Engels

Nerventra Study Adverse event log

1 Formulieren  
Demographic Information
Beschrijving

Demographic Information

Protocol Number
Beschrijving

Protocol Number

Datatype

text

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

i.e "Screening"

Datatype

text

Alias
UMLS CUI [1]
C0545082
Date of visit
Beschrijving

Visit date

Datatype

date

Alias
UMLS CUI [1]
C1320303
Study site number
Beschrijving

Study site

Datatype

integer

Alias
UMLS CUI [1]
C2825164
Subject number:
Beschrijving

Subject number

Datatype

integer

Alias
UMLS CUI [1]
C1709561
Section blank
Beschrijving

Blank

Datatype

boolean

Alias
UMLS CUI [1]
C0750479
Ongoing adverse events
Beschrijving

Ongoing adverse events

Date of automatic update
Beschrijving

Date of automatic update

Datatype

date

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

Date of manual update

Datatype

date

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

Adverse event

Datatype

text

Alias
UMLS CUI [1]
C0877248
Visit Type
Beschrijving

Visit

Datatype

text

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

Adverse events log Baseline

Adverse event
Beschrijving

Adverse event

Datatype

text

Alias
UMLS CUI [1]
C0877248
Adverse event intermittent
Beschrijving

Adverse event intermittent

Datatype

boolean

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

Time since dose

Datatype

time

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

Time since dose

Datatype

boolean

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

Prior to first dose

Datatype

boolean

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

Date of onset

Datatype

date

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

Adverse Event Ongoing

Datatype

boolean

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

Adverse Event less than one day

Datatype

boolean

Alias
UMLS CUI [1]
C3843198
Severity
Beschrijving

Severity

Datatype

text

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

Serious

Datatype

boolean

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

Action Taken with Study Treatment

Datatype

text

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

Primary AE

Datatype

boolean

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

Adverse Event Outcome

Datatype

text

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

Drugs

Datatype

text

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

Adverse events Visit 1

Adverse event
Beschrijving

Adverse event

Datatype

text

Alias
UMLS CUI [1]
C0877248
Adverse event intermittent
Beschrijving

Adverse event intermittent

Datatype

boolean

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

Time since dose

Datatype

time

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

Time since dose

Datatype

boolean

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

Prior to first dose

Datatype

boolean

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

Date of onset

Datatype

date

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

Adverse Event Ongoing

Datatype

boolean

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

Adverse Event less than one day

Datatype

boolean

Alias
UMLS CUI [1]
C3843198
Severity
Beschrijving

Severity

Datatype

text

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

Serious

Datatype

boolean

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

Action Taken with Study Treatment

Datatype

text

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

Primary AE

Datatype

boolean

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

Adverse Event Outcome

Datatype

text

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

Drugs

Datatype

text

Alias
UMLS CUI [1]
C0013227
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Similar models

Nerventra Study Adverse event log

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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