ID

15685

Description

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)

Keywords

Versions (1)
  1. 6/8/16 6/8/16 -
Uploaded on

June 8, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Nerventra Study Adverse event log

English

Nerventra Study Adverse event log

1 forms  
Demographic Information
Description

Demographic Information

Protocol Number
Description

Protocol Number

Data type

text

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

i.e "Screening"

Data type

text

Alias
UMLS CUI [1]
C0545082
Date of visit
Description

Visit date

Data type

date

Alias
UMLS CUI [1]
C1320303
Study site number
Description

Study site

Data type

integer

Alias
UMLS CUI [1]
C2825164
Subject number:
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C1709561
Section blank
Description

Blank

Data type

boolean

Alias
UMLS CUI [1]
C0750479
Ongoing adverse events
Description

Ongoing adverse events

Date of automatic update
Description

Date of automatic update

Data type

date

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

Date of manual update

Data type

date

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

Adverse event

Data type

text

Alias
UMLS CUI [1]
C0877248
Visit Type
Description

Visit

Data type

text

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

Adverse events log Baseline

Adverse event
Description

Adverse event

Data type

text

Alias
UMLS CUI [1]
C0877248
Adverse event intermittent
Description

Adverse event intermittent

Data type

boolean

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

Time since dose

Data type

time

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

Time since dose

Data type

boolean

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

Prior to first dose

Data type

boolean

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

Date of onset

Data type

date

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

Adverse Event Ongoing

Data type

boolean

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

Adverse Event less than one day

Data type

boolean

Alias
UMLS CUI [1]
C3843198
Severity
Description

Severity

Data type

text

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

Serious

Data type

boolean

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

Action Taken with Study Treatment

Data type

text

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

Primary AE

Data type

boolean

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

Adverse Event Outcome

Data type

text

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

Drugs

Data type

text

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

Adverse events Visit 1

Adverse event
Description

Adverse event

Data type

text

Alias
UMLS CUI [1]
C0877248
Adverse event intermittent
Description

Adverse event intermittent

Data type

boolean

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

Time since dose

Data type

time

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

Time since dose

Data type

boolean

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

Prior to first dose

Data type

boolean

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

Date of onset

Data type

date

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

Adverse Event Ongoing

Data type

boolean

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

Adverse Event less than one day

Data type

boolean

Alias
UMLS CUI [1]
C3843198
Severity
Description

Severity

Data type

text

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

Serious

Data type

boolean

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

Action Taken with Study Treatment

Data type

text

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

Primary AE

Data type

boolean

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

Adverse Event Outcome

Data type

text

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

Drugs

Data type

text

Alias
UMLS CUI [1]
C0013227
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Similar models

Nerventra Study Adverse event log

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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