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ID
15678
Beschrijving
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)
Trefwoorden
Versies (1)
- 08-06-16 08-06-16 -
Geüploaded op
8 juni 2016
DOI
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Licentie
Creative Commons BY-NC 3.0
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Nerventra Study Termination/Early termination
Nerventra Study Termination/Early termination
- StudyEvent: ODM
Similar models
Nerventra Study Termination/Early termination
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Last dose
Item
Date of last dose of study drug
date
C1762893 (UMLS CUI [1,1])
C3854006 (UMLS CUI [1,2])
C3854006 (UMLS CUI [1,2])
Clinical trial drug code broken
Item
Was the study drug code broken
boolean
C3854006 (UMLS CUI [1,1])
C0349677 (UMLS CUI [1,2])
C0175566 (UMLS CUI [1,3])
C0349677 (UMLS CUI [1,2])
C0175566 (UMLS CUI [1,3])
Study drug code broken
Item
If Study drug code was broken, please specify
text
C3854006 (UMLS CUI [1,1])
C0349677 (UMLS CUI [1,2])
C0175566 (UMLS CUI [1,3])
C0349677 (UMLS CUI [1,2])
C0175566 (UMLS CUI [1,3])
Completion of trial
Item
Did the subject complete the entire duration of the study? If yes, stop here and do not complete the remainder of this module
boolean
C2732579 (UMLS CUI [1])
Item
What was the primary reason for withdrawal?
integer
C2349954 (UMLS CUI [1,1])
C1549995 (UMLS CUI [1,2])
C1549995 (UMLS CUI [1,2])
CL Item
Death (complete AE Log and SAE report) (1)
CL Item
Adverse event (complete AE Log) specify (2)
CL Item
Refusal to sign re-consent form following a confirmed relapse or an increase in EDSS in >2.0 points, sustained for >=3 months (3)
CL Item
Subject withdrew consent, specify (4)
CL Item
Request of primary care physician or investigator, please specify (5)
CL Item
Non-compliance/protocol violation, please specify (6)
CL Item
Pregnancy (7)
CL Item
TEVA requested subject to be withdrawn, please specify (8)
CL Item
Failed to return/Lost to follow-up (9)
CL Item
Other,please specify (10)
Comments
Item
Please specify reason for withdrawal if applicable
text
C0947611 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,2])