ID

44869

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: Visit 5 (Week 20)

Mots-clés

Versions (2)
  1. 10/06/2016 10/06/2016 -
  2. 18/02/2022 18/02/2022 - Martin Dugas
Détendeur de droits

Biogen

Téléchargé le

18 février 2022

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 4.0
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Visit 5 (Week 20): Vital Signs, Study Drug accountability BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

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Visit 5 (Week 20): Vital Signs, Study Drug accountability BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

1 Formulaires  
Subject Identification
Description

Subject Identification

Number of Facility
Description

Site number

Type de données

integer

Alias
UMLS CUI [1]
C2826711
Subject number
Description

Subject number

Type de données

integer

Alias
UMLS CUI [1]
C2348585
Subject Initials
Description

Subject Initials

Type de données

text

Alias
UMLS CUI [1]
C2986440
Vital Signs
Description

Vital Signs

Date of examination
Description

Date of examination

Type de données

date

Alias
UMLS CUI [1]
C2826643
Blood Pressure
Description

Blood Pressure

Type de données

text

Alias
UMLS CUI [1]
C0005823
Pulse
Description

Pulse

Type de données

integer

Unités de mesure
  • bpm
Alias
UMLS CUI [1]
C0232117
bpm
Temperature
Description

Temperature

Type de données

float

Unités de mesure
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Study Drug Accountability
Description

Study Drug Accountability

date of first dose
Description

first dose date

Type de données

date

Alias
UMLS CUI [1]
C3173309
Number of capsules not taken since previous visit to this visit
Description

number of capsules not taken

Type de données

integer

Alias
UMLS CUI [1,1]
C1705492
UMLS CUI [1,2]
C0178602
Was there a protocol-defined dose reduction/interruption since the previous visit?
Description

If no, please specify on the appropriate adverse events form

Type de données

boolean

Alias
UMLS CUI [1]
C1707814
Retour au début de la page

Similar models

Visit 5 (Week 20): Vital Signs, Study Drug accountability BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Subject Identification
Site number
Item
Number of Facility
integer
C2826711 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Subject Initials
Item
Subject Initials
text
C2986440 (UMLS CUI [1])
Item Group
Vital Signs
Date of examination
Item
Date of examination
date
C2826643 (UMLS CUI [1])
Blood Pressure
Item
Blood Pressure
text
C0005823 (UMLS CUI [1])
Pulse
Item
Pulse
integer
C0232117 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Item Group
Study Drug Accountability
first dose date
Item
date of first dose
date
C3173309 (UMLS CUI [1])
number of capsules not taken
Item
Number of capsules not taken since previous visit to this visit
integer
C1705492 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
protocol-defined dose reduction/interruption
Item
Was there a protocol-defined dose reduction/interruption since the previous visit?
boolean
C1707814 (UMLS CUI [1])
Retour au début de la page 

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