ID
15859
Description
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: Adverse Event
Mots-clés
Versions (2)
- 16/06/2016 16/06/2016 -
- 20/09/2021 20/09/2021 -
Téléchargé le
16 juin 2016
DOI
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Licence
Creative Commons BY-NC 3.0
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Adverse Event BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770
Adverse Event BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770
Description
Adverse Event
Description
diagnosis
Type de données
text
Alias
- UMLS CUI [1]
- C0011900
Description
If yes, List SAE Tracking number
Type de données
boolean
Alias
- UMLS CUI [1]
- C1519255
Description
SAE Tracking number
Type de données
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1300638
Description
Adverse Event Start Date
Type de données
date
Alias
- UMLS CUI [1]
- C2697888
Description
Adverse Event Stop Date
Type de données
date
Alias
- UMLS CUI [1]
- C2697886
Description
Adverse Event not resolved
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1709863
Description
Adverse Event Severity
Type de données
integer
Description
Study treatment
Type de données
integer
Alias
- UMLS CUI [1]
- C0949266
Description
AE Relationship to blinded study treatment
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0439849
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C0681870
Description
if yes, record on the appropriate concomitant therapy form
Type de données
boolean
Alias
- UMLS CUI [1]
- C1707479
Description
withdrawal from study due to Adverse Event
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0877248
Similar models
Adverse Event BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770
C0600091 (UMLS CUI [1,2])
C1300638 (UMLS CUI [1,2])
C1709863 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
C0681870 (UMLS CUI [1,3])
C0877248 (UMLS CUI [1,2])