Information:
Fel:
ID
15679
Beskrivning
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)
Nyckelord
Versioner (1)
- 2016-06-08 2016-06-08 -
Uppladdad den
8 juni 2016
DOI
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Licens
Creative Commons BY-NC 3.0
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Nerventra Study Sustained increase in EDSS
Nerventra Study Sustained increase in EDSS
- StudyEvent: ODM
Similar models
Nerventra Study Sustained increase in EDSS
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Protocol Number
Item
Protocol Number
text
C0008971 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
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])
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])
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])
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])
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])