ID

44878

Beskrivning

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 15 (Week 132)

Nyckelord

Versioner (2)
  1. 2016-06-17 2016-06-17 -
  2. 2022-02-19 2022-02-19 - Martin Dugas
Rättsinnehavare

Biogen

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19 februari 2022

DOI

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Creative Commons BY-NC 4.0
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Visit 15 (Week 132): Vital Signs BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

Engelsk

Visit 15 (Week 132): Vital Signs BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

1 Formulär  
Subject Identification
Beskrivning

Subject Identification

Number of Facility
Beskrivning

Site number

Datatyp

integer

Alias
UMLS CUI [1]
C2826711
Subject number
Beskrivning

Subject number

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Subject Initials
Beskrivning

Subject Initials

Datatyp

text

Alias
UMLS CUI [1]
C2986440
Vital Signs
Beskrivning

Vital Signs

Date of examination
Beskrivning

Date of examination

Datatyp

date

Alias
UMLS CUI [1]
C2826643
Blood Pressure
Beskrivning

Blood Pressure

Datatyp

text

Alias
UMLS CUI [1]
C0005823
Pulse
Beskrivning

Pulse

Datatyp

integer

Måttenheter
  • bpm
Alias
UMLS CUI [1]
C0232117
bpm
Temperature
Beskrivning

Temperature

Datatyp

float

Måttenheter
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Study Drug Accountability
Beskrivning

Study Drug Accountability

date of first dose
Beskrivning

first dose date

Datatyp

date

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

number of capsules not taken

Datatyp

integer

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

If no, please specify on the appropriate adverse events form

Datatyp

boolean

Alias
UMLS CUI [1]
C1707814
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Similar models

Visit 15 (Week 132): Vital Signs BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
dose reduction or interruption
Item
Was there a protocol-defined dose reduction/interruption since the previous visit?
boolean
C1707814 (UMLS CUI [1])
Tillbaka till toppen 

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