ID

15693

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 Unscheduled Visit

English

Nerventra Study Unscheduled Visit

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
Reason for unscheduled visit
Description

Reason for unscheduled visit

Reason for unscheduled visit
Description

Reason

Data type

integer

Alias
UMLS CUI [1]
C0392360
Other reason
Description

Other reason

Data type

text

Alias
UMLS CUI [1]
C3840932
Safety measurements
Description

Safety measurements

Temperature
Description

Temperature

Data type

float

Alias
UMLS CUI [1]
C0005903
Temperature type of measurement
Description

Temperature

Data type

integer

Alias
UMLS CUI [1]
C0005903
Units used for measurement
Description

Units used for measurement

Data type

integer

Alias
UMLS CUI [1]
C1519795
Measurement not done
Description

not done

Data type

boolean

Alias
UMLS CUI [1]
C1272696
Blood pressure measurement
Description

Blood pressure

Data type

text

Measurement units
  • mm/Hg
Alias
UMLS CUI [1]
C0005823
mm/Hg
Measurement not done
Description

not done

Data type

boolean

Alias
UMLS CUI [1]
C1272696
Pulse
Description

Pulse Rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0232117
beats/min
Measurement not done
Description

not done

Data type

boolean

Alias
UMLS CUI [1]
C1272696
Investigators ECG interpretation
Description

ECG

Data type

text

Alias
UMLS CUI [1]
C1623258
ECG interpretation not done
Description

ECG

Data type

boolean

Alias
UMLS CUI [1]
C1623258
Date of chest x-ray
Description

Chest x-ray

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0039985
Chest x-ray not done
Description

Chest x-ray

Data type

boolean

Alias
UMLS CUI [1]
C0039985
Chest x-ray interpretation
Description

Chest x-ray interpretation

Data type

text

Alias
UMLS CUI [1,1]
C0039985
UMLS CUI [1,2]
C0420833
Chest x-ray, if abnormal, please specify
Description

Chest x-ray

Data type

text

Alias
UMLS CUI [1]
C0039985
Where all required laboratory samples obtained?
Description

Laboratory specimen

Data type

boolean

Alias
UMLS CUI [1]
C0200345
Menstruation
Description

Menstruation

Data type

boolean

Alias
UMLS CUI [1]
C0025344
Exacerbation
Description

Exacerbation

Date of onset of symptoms of suspected exacerbation
Description

Date of onset

Data type

date

Alias
UMLS CUI [1]
C0574845
Relatively stable or improving neurological state for 30 days prior to onset
Description

Any answer "No" in this section indicates that exacerbation is not confirmed

Data type

boolean

Alias
UMLS CUI [1,1]
C0581392
UMLS CUI [1,2]
C0521091
One or more neurological abnormalities appeared or re-appeared if seen previously
Description

Any answer "No" in this section indicates that exacerbation is not confirmed

Data type

boolean

Alias
UMLS CUI [1,1]
C0581392
UMLS CUI [1,2]
C0521091
Neurological abnormalities lasted 48 hours or more
Description

Any answer "No" in this section indicates that exacerbation is not confirmed

Data type

boolean

Alias
UMLS CUI [1,1]
C0581392
UMLS CUI [1,2]
C0521091
In the opinion of the investigator, the change in EDSS score is not solely attributed to normal fluctuations of the subjects MS symptoms and is consistent with acute exacerbation
Description

Any answer "No" in this section indicates that exacerbation is not confirmed

Data type

boolean

Alias
UMLS CUI [1,1]
C0581392
UMLS CUI [1,2]
C0521091
There was an increase of at least one of the below: 0.5 or more on EDSS or 2 grades in score for one function of the FS or one grade in score for 2 or more functions of the FS
Description

Any answer "No" in this section indicates that exacerbation is not confirmed

Data type

boolean

Alias
UMLS CUI [1,1]
C0581392
UMLS CUI [1,2]
C0521091
Change in EDSS or FS scores cannot be attributed solely to change in bowel/bladder function or to change in cognitive function
Description

Any answer "No" in this section indicates that exacerbation is not confirmed

Data type

boolean

Alias
UMLS CUI [1,1]
C0581392
UMLS CUI [1,2]
C0521091
Based on neuroexam visit date
Description

Exacerbation confirmation neuroexam visit date

Data type

date

Alias
UMLS CUI [1,1]
C0581392
UMLS CUI [1,2]
C0521091
Did subject experience a confirmed exacerbation?
Description

Exacerbation of multiple sclerosis

Data type

boolean

Alias
UMLS CUI [1]
C0581392
Re- consent signed
Description

If nor, complete ET visit

Data type

boolean

Alias
UMLS CUI [1]
C0514044
Was i.v Methylprednisolone treatment instituted? If yes, complete concomitant medication log
Description

Treatment of exacerbation

Data type

boolean

Alias
UMLS CUI [1]
C0087111
Event resulted in a hospitalization
Description

Hospitalization

Data type

integer

Alias
UMLS CUI [1]
C0019993
Approximate date of stabilization
Description

Stabilization date

Data type

date

Alias
UMLS CUI [1,1]
C1293130
UMLS CUI [1,2]
C0011008
Based on neuroexam visit date
Description

Visit date

Data type

date

Alias
UMLS CUI [1]
C1320303
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Similar models

Nerventra Study Unscheduled Visit

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
Reason for unscheduled visit
Item
Reason for unscheduled visit
integer
C0392360 (UMLS CUI [1])
Reason
Code List
Reason for unscheduled visit
CL Item
Adverse event (complete AE-Log) (1)
CL Item
Change in concomitant medication (complete concomitant medication log) (2)
CL Item
A possible exacerbation (Complete neuro-exam and exacerbation confirmation form) (3)
CL Item
Follow-up of exacerbation (Complete neuro-exam and exacerbation confirmation form if applicable) (4)
CL Item
Unscheduled study drug dispensing (complete dispensing and compliance log) (5)
CL Item
Laboratory follow-up (6)
CL Item
ET follow-up visit (7)
CL Item
Other, specify (8)
Other reason
Item
Other reason
text
C3840932 (UMLS CUI [1])
Item Group
Safety measurements
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Item
Temperature type of measurement
integer
C0005903 (UMLS CUI [1])
Temperature
Code List
Temperature type of measurement
CL Item
oral (1)
CL Item
axillary (2)
CL Item
aural (3)
CL Item
temporal (4)
Item
Units used for measurement
integer
C1519795 (UMLS CUI [1])
Units used for measurement
Code List
Units used for measurement
CL Item
F (1)
CL Item
C (2)
not done
Item
Measurement not done
boolean
C1272696 (UMLS CUI [1])
Blood pressure
Item
Blood pressure measurement
text
C0005823 (UMLS CUI [1])
not done
Item
Measurement not done
boolean
C1272696 (UMLS CUI [1])
Pulse Rate
Item
Pulse
integer
C0232117 (UMLS CUI [1])
not done
Item
Measurement not done
boolean
C1272696 (UMLS CUI [1])
ECG
Item
Investigators ECG interpretation
text
C1623258 (UMLS CUI [1])
ECG
Item
ECG interpretation not done
boolean
C1623258 (UMLS CUI [1])
Chest x-ray
Item
Date of chest x-ray
date
C0011008 (UMLS CUI [1,1])
C0039985 (UMLS CUI [1,2])
Chest x-ray
Item
Chest x-ray not done
boolean
C0039985 (UMLS CUI [1])
Chest x-ray interpretation
Item
Chest x-ray interpretation
text
C0039985 (UMLS CUI [1,1])
C0420833 (UMLS CUI [1,2])
Chest x-ray
Item
Chest x-ray, if abnormal, please specify
text
C0039985 (UMLS CUI [1])
Laboratory specimen
Item
Where all required laboratory samples obtained?
boolean
C0200345 (UMLS CUI [1])
Menstruation
Item
Menstruation
boolean
C0025344 (UMLS CUI [1])
Item Group
Exacerbation
Date of onset
Item
Date of onset of symptoms of suspected exacerbation
date
C0574845 (UMLS CUI [1])
Exacerbation confirmation
Item
Relatively stable or improving neurological state for 30 days prior to onset
boolean
C0581392 (UMLS CUI [1,1])
C0521091 (UMLS CUI [1,2])
Exacerbation confirmation
Item
One or more neurological abnormalities appeared or re-appeared if seen previously
boolean
C0581392 (UMLS CUI [1,1])
C0521091 (UMLS CUI [1,2])
Exacerbation confirmation
Item
Neurological abnormalities lasted 48 hours or more
boolean
C0581392 (UMLS CUI [1,1])
C0521091 (UMLS CUI [1,2])
Exacerbation confirmation
Item
In the opinion of the investigator, the change in EDSS score is not solely attributed to normal fluctuations of the subjects MS symptoms and is consistent with acute exacerbation
boolean
C0581392 (UMLS CUI [1,1])
C0521091 (UMLS CUI [1,2])
Exacerbation confirmation
Item
There was an increase of at least one of the below: 0.5 or more on EDSS or 2 grades in score for one function of the FS or one grade in score for 2 or more functions of the FS
boolean
C0581392 (UMLS CUI [1,1])
C0521091 (UMLS CUI [1,2])
Exacerbation confirmation
Item
Change in EDSS or FS scores cannot be attributed solely to change in bowel/bladder function or to change in cognitive function
boolean
C0581392 (UMLS CUI [1,1])
C0521091 (UMLS CUI [1,2])
Exacerbation confirmation neuroexam visit date
Item
Based on neuroexam visit date
date
C0581392 (UMLS CUI [1,1])
C0521091 (UMLS CUI [1,2])
Exacerbation of multiple sclerosis
Item
Did subject experience a confirmed exacerbation?
boolean
C0581392 (UMLS CUI [1])
Consent
Item
Re- consent signed
boolean
C0514044 (UMLS CUI [1])
Treatment of exacerbation
Item
Was i.v Methylprednisolone treatment instituted? If yes, complete concomitant medication log
boolean
C0087111 (UMLS CUI [1])
Item
Event resulted in a hospitalization
integer
C0019993 (UMLS CUI [1])
Hospitalization
Code List
Event resulted in a hospitalization
CL Item
No (1)
CL Item
Yes-due to neurological deterioration (2)
CL Item
Yes-due to i.v methylprednisolone treatment (3)
Stabilization date
Item
Approximate date of stabilization
date
C1293130 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Visit date
Item
Based on neuroexam visit date
date
C1320303 (UMLS CUI [1])
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