ID
15872
Beschrijving
The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test. NCT00835770 Part: Protocol deviation and Investigator Sign off
Trefwoorden
Versies (1)
- 17-06-16 17-06-16 -
Geüploaded op
17 juni 2016
DOI
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Licentie
Creative Commons BY-NC 3.0
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Protocol deviation and Investigator Sign off BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770
Protocol deviation and Investigator Sign off BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770
Beschrijving
Protocol deviations
Beschrijving
Deviation number
Datatype
integer
Beschrijving
Protocol deviation Category Code
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1705236
- UMLS CUI [1,2]
- C2985755
Beschrijving
Timed point or visit name
Datatype
text
Alias
- UMLS CUI [1]
- C2826704
- UMLS CUI [2]
- C0011008
Beschrijving
Protocol deviation
Datatype
text
Alias
- UMLS CUI [1]
- C1705236
Beschrijving
Action taken
Datatype
text
Alias
- UMLS CUI [1]
- C0441472
Beschrijving
Investigator sign off
Beschrijving
I confirm that the entries on the case report from pages corresonding to this case book accurately and completely represent the results of these examinations, tests and evaluations performed on the dates specified.
Datatype
text
Alias
- UMLS CUI [1]
- C0807938
Beschrijving
Date of signature
Datatype
date
Alias
- UMLS CUI [1]
- C0807937
Beschrijving
Investigator
Datatype
text
Alias
- UMLS CUI [1]
- C2826892
Similar models
Protocol deviation and Investigator Sign off BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770
C0600091 (UMLS CUI [1,2])
C2985755 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])