ID

15676

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

  1. 6/8/16 6/8/16 -
Uploaded on

June 8, 2016

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Nerventra Study Visit 10

Nerventra Study Visit 10

Demographic Information Visit 10
Description

Demographic Information Visit 10

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
Safety measurements
Description

Safety measurements

Weight
Description

Weight

Data type

float

Alias
UMLS CUI [1]
C0005910
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
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

Similar models

Nerventra Study Visit 10

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Demographic Information Visit 10
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
Safety measurements
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item
Units used for measurement
integer
C1519795 (UMLS CUI [1])
Code List
Units used for measurement
CL Item
lbs (1)
CL Item
kg (2)
not done
Item
Measurement not done
boolean
C1272696 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Item
Temperature type of measurement
integer
C0005903 (UMLS CUI [1])
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])
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])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial