Information:
Error:
ID
34508
Description
An Efficacy and Safety Study of BG00012 (Dimethyl Fumarate) in Asian Subjects With Relapsing Remitting Multiple Sclerosis (RRMS); ODM derived from: https://clinicaltrials.gov/show/NCT01838668
Link
https://clinicaltrials.gov/show/NCT01838668
Keywords
Versions (1)
- 1/18/19 1/18/19 -
Copyright Holder
See clinicaltrials.gov
Uploaded on
January 18, 2019
DOI
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License
Creative Commons BY 4.0
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Eligibility Relapsing-Remitting Multiple Sclerosis NCT01838668
Eligibility Relapsing-Remitting Multiple Sclerosis NCT01838668
- StudyEvent: Eligibility
Similar models
Eligibility Relapsing-Remitting Multiple Sclerosis NCT01838668
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Inclusion criteria Part Number
Item
inclusion criteria for part i:
boolean
C1512693 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C0449719 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Multiple Sclerosis, Relapsing-Remitting
Item
must have a diagnosis of relapsing-remitting multiple sclerosis (rrms).
boolean
C0751967 (UMLS CUI [1])
EDSS
Item
must have a baseline expanded disability status scale (edss) score between 0.0 and 5.0, inclusive.
boolean
C0451246 (UMLS CUI [1])
Inclusion criteria Main Part Number
Item
key inclusion criteria for part ii:
boolean
C1512693 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
C0449719 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,4])
C1542147 (UMLS CUI [1,2])
C0449719 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,4])
Participation Clinical Trial Part Number | Clinical Trial Part Number Completed
Item
• subjects who participated in and completed part i per protocol.
boolean
C0679823 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0449719 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,4])
C0008976 (UMLS CUI [2,1])
C0449719 (UMLS CUI [2,2])
C0237753 (UMLS CUI [2,3])
C0205197 (UMLS CUI [2,4])
C0008976 (UMLS CUI [1,2])
C0449719 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,4])
C0008976 (UMLS CUI [2,1])
C0449719 (UMLS CUI [2,2])
C0237753 (UMLS CUI [2,3])
C0205197 (UMLS CUI [2,4])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
C1542147 (UMLS CUI [1,2])
Chronic disease of immune system | Malignant Neoplasms | Urologic Disease | Lung disease | Gastrointestinal Disease
Item
other chronic disease of the immune system, malignancies, acute urologic, pulmonary, gastrointestinal disease.
boolean
C1290894 (UMLS CUI [1])
C0006826 (UMLS CUI [2])
C0042075 (UMLS CUI [3])
C0024115 (UMLS CUI [4])
C0017178 (UMLS CUI [5])
C0006826 (UMLS CUI [2])
C0042075 (UMLS CUI [3])
C0024115 (UMLS CUI [4])
C0017178 (UMLS CUI [5])
Pregnancy | Breast Feeding
Item
pregnant or nursing women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0006147 (UMLS CUI [2])
Eligibility Criteria Study Protocol
Item
note: other protocol-defined inclusion/exclusion criteria may apply.
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,2])