ID

15698

Descripción

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)

Palabras clave

  1. 8/6/16 8/6/16 -
  2. 8/6/16 8/6/16 -
Subido en

8 de junio de 2016

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0

Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

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
Descripción

Subject Identification

Number of Facility
Descripción

Site number

Tipo de datos

integer

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

Subject number

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
Subject Initials
Descripción

Subject Initials

Tipo de datos

text

Alias
UMLS CUI [1]
C2986440
Medical history Update
Descripción

Medical history Update

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

If yes, record below

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0262926
Medical history List
Descripción

Medical history List

Medical History, Category
Descripción

Category of Event

Tipo de datos

integer

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

ongoing

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0549178
Medical Condition
Descripción

Medical Condition

Tipo de datos

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
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial