ID

15698

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: Baseline Visit (Day 1)

Keywords

  1. 6/8/16 6/8/16 -
  2. 6/8/16 6/8/16 -
Uploaded on

June 8, 2016

DOI

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License

Creative Commons BY-NC 3.0

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Baseline Visit (Day 1): Medical History BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

Baseline Visit (Day 1): Medical History BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

Subject Identification
Description

Subject Identification

Number of Facility
Description

Site number

Data type

integer

Alias
UMLS CUI [1,1]
C0018704
UMLS CUI [1,2]
C0600091
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Subject Initials
Description

Subject Initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Medical history Update
Description

Medical history Update

Has the subject had any new medical or surgical history since enrolling in 109-MS-301 or 109-MS-302
Description

If yes, record below

Data type

boolean

Alias
UMLS CUI [1]
C0262926
Medical history List
Description

Medical history List

Medical History, Category
Description

Category of Event

Data type

integer

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0683312
ongoing
Description

ongoing

Data type

boolean

Alias
UMLS CUI [1]
C0549178
Medical Condition
Description

Medical Condition

Data type

text

Alias
UMLS CUI [1]
C0012634

Similar models

Baseline Visit (Day 1): Medical History BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Subject Identification
Site number
Item
Number of Facility
integer
C0018704 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Subject Initials
Item
Subject Initials
text
C2986440 (UMLS CUI [1])
Item Group
Medical history Update
Medical history
Item
Has the subject had any new medical or surgical history since enrolling in 109-MS-301 or 109-MS-302
boolean
C0262926 (UMLS CUI [1])
Item Group
Medical history List
Item
Medical History, Category
integer
C0262926 (UMLS CUI [1,1])
C0683312 (UMLS CUI [1,2])
Code List
Medical History, Category
CL Item
Allergy  (1)
CL Item
Hepatic (2)
CL Item
Respiratory  (3)
CL Item
Cardiovascular (4)
CL Item
Gastrointestinal  (5)
CL Item
Hepatic (6)
CL Item
Genitourinary  (7)
CL Item
Hematopoetic/Lymphatic (8)
CL Item
Neurological (9)
CL Item
Endocrine/Metabolic (10)
CL Item
Musculoskeletal (11)
CL Item
Dermatilogical  (12)
CL Item
Psychosocial/ Psychiatric  (13)
CL Item
Infectious disease (14)
CL Item
Other (15)
ongoing
Item
ongoing
boolean
C0549178 (UMLS CUI [1])
Medical Condition
Item
Medical Condition
text
C0012634 (UMLS CUI [1])

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