ID

15679

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 Sustained increase in EDSS

English

Nerventra Study Sustained increase in EDSS

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
Sustained increase in EDSS
Description

Sustained increase in EDSS

According to the investigator, did the subject experience a sustained increase in EDSS?
Description

EDSS increase

Data type

boolean

Alias
UMLS CUI [1,1]
C0451246
UMLS CUI [1,2]
C0442805
If there is no increase in EDSS, please specify
Description

EDSS increase

Data type

text

Alias
UMLS CUI [1,1]
C0451246
UMLS CUI [1,2]
C0442805
Neuroexam visit date the EDSS increase is based on
Description

EDSS increase date

Data type

date

Alias
UMLS CUI [1,1]
C0451246
UMLS CUI [1,2]
C0442805
UMLS CUI [1,3]
C0011008
Did the subject sign the re-consent form? If no, please complete the early termination visit
Description

Consent

Data type

boolean

Alias
UMLS CUI [1]
C1511481
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Similar models

Nerventra Study Sustained increase in EDSS

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
Sustained increase in EDSS
EDSS increase
Item
According to the investigator, did the subject experience a sustained increase in EDSS?
boolean
C0451246 (UMLS CUI [1,1])
C0442805 (UMLS CUI [1,2])
EDSS increase
Item
If there is no increase in EDSS, please specify
text
C0451246 (UMLS CUI [1,1])
C0442805 (UMLS CUI [1,2])
EDSS increase date
Item
Neuroexam visit date the EDSS increase is based on
date
C0451246 (UMLS CUI [1,1])
C0442805 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Consent
Item
Did the subject sign the re-consent form? If no, please complete the early termination visit
boolean
C1511481 (UMLS CUI [1])
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