ID
15859
Beschreibung
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
Stichworte
Versionen (2)
- 16.06.16 16.06.16 -
- 20.09.21 20.09.21 -
Hochgeladen am
16. Juni 2016
DOI
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Lizenz
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
Beschreibung
Adverse Event
Beschreibung
diagnosis
Datentyp
text
Alias
- UMLS CUI [1]
- C0011900
Beschreibung
If yes, List SAE Tracking number
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1519255
Beschreibung
SAE Tracking number
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1300638
Beschreibung
Adverse Event Start Date
Datentyp
date
Alias
- UMLS CUI [1]
- C2697888
Beschreibung
Adverse Event Stop Date
Datentyp
date
Alias
- UMLS CUI [1]
- C2697886
Beschreibung
Adverse Event not resolved
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1709863
Beschreibung
Adverse Event Severity
Datentyp
integer
Beschreibung
Study treatment
Datentyp
integer
Alias
- UMLS CUI [1]
- C0949266
Beschreibung
AE Relationship to blinded study treatment
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0439849
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C0681870
Beschreibung
if yes, record on the appropriate concomitant therapy form
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1707479
Beschreibung
withdrawal from study due to Adverse Event
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0877248
Ähnliche Modelle
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])