Multiple Sclerosis, Acute Relapsing
Item
diagnosis of relapsing multiple sclerosis (ms)
boolean
C0393664 (UMLS CUI [1])
Relapse Quantity Period
Item
patients with at least two documented relapses in the previous 2 years or one documented relapse in the last year
boolean
C0035020 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1948053 (UMLS CUI [1,3])
EDSS
Item
patients with an expanded disability status scale (edss) score of 0-6
boolean
C0451246 (UMLS CUI [1])
Extension Clinical Trial
Item
extension study
boolean
C0231448 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Nuclear magnetic resonance imaging gadolinium-enhanced Positive | Magnetic Resonance Imaging
Item
a positive gd-enhanced mri scan at screening (in case the first mri scan obtained at screening was negative, a second scan could have been obtained 1 month later)
boolean
C0855566 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C0024485 (UMLS CUI [2])
Neurologic Stable | Relapse Evidence
Item
neurologically stable with no evidence of relapse within 30 days prior to randomization,or during the screening and baseline periods.
boolean
C0205494 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0035020 (UMLS CUI [2,1])
C3887511 (UMLS CUI [2,2])
Gender | Postmenopausal state | Female Sterilization | Contraceptive methods | Childbearing Potential Pregnancy test negative
Item
female patients either post-menopausal, surgically incapable of bearing children, or practicing an acceptable method of birth control. females of childbearing potential with a negative pregnancy test at baseline prior to entry into the treatment period.
boolean
C0079399 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0015787 (UMLS CUI [3])
C0700589 (UMLS CUI [4])
C3831118 (UMLS CUI [5,1])
C0427780 (UMLS CUI [5,2])
Clinical Trial Main
Item
core study
boolean
C0008976 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Chronic disease of immune system | Malignant Neoplasms | Lung diseases | Heart Diseases
Item
patients with other chronic disease of the immune system, malignancies, pulmonary or heart disease, etc
boolean
C1290894 (UMLS CUI [1])
C0006826 (UMLS CUI [2])
C0024115 (UMLS CUI [3])
C0018799 (UMLS CUI [4])
Pregnancy | Breast Feeding
Item
pregnant or nursing women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Extension Clinical Trial
Item
extension study
boolean
C0231448 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Investigational New Drug Discontinued Permanent
Item
patients who had permanently discontinued study drug prior to the month 6 visit of the core study
boolean
C0013230 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0205355 (UMLS CUI [1,3])
Diabetes Mellitus
Item
patients with diabetes mellitus (to reduce the risk of me), and therefore ongoing patients with diabetes mellitus or who developed diabetes mellitus were discontinued from the study)
boolean
C0011849 (UMLS CUI [1])
Clinical Trial Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])