Table 1 Safety, effectiveness and exploratory endpoints of CONFIDENCE

Primary safety endpoint (ocrelizumab cohort)

Incidence and type of uncommon AEs (including AEs with an incidence of 0.1 to 1% [1 to 10 out of 1000 patients] or less) and death (including primary and underlying causes) in patients with MS newly exposed to ocrelizumab

Key secondary safety endpoint (other DMT cohort)

Incidence and type of uncommon AEs (including AEs with an incidence of 0.1 to 1% [1 to 10 out of 1000 patients] or less) and death (including primary and underlying causes) in patients with MS newly exposed to selected DMTs other than ocrelizumab

Secondary effectiveness endpoints (both cohorts)

Treatment success: proportion of patients with no clinical disease activity measured by relapse and disease progression and no discontinuation of current treatment due to AEs (excluding pregnancies) and lack of effectiveness

Annualized relapse rate since start of treatment

Proportion of patients with relapses since start of treatment

Mean number of relapses per patients within the last 3 years before start of treatment

Change in expanded disability status scale (EDSS) from baseline

Proportion of patients with confirmed disability progression (CDP)

Time to onset of CDP

Time to onset of confirmed disability improvement (CDI)

Patient reported outcomes: treatment satisfaction, cognitive function, and health related quality of life

Other safety endpoints (both cohorts)

Incidence of all AEs

Incidence of serious infections

Incidence of malignancies

Incidence of mortality due to malignancies

Exploratory endpoints (both cohorts)

Mean number of gadolinium (Gd) enhancing T1 lesions as detected by brain magnetic resonance imaging (MRI)

Change from baseline in MRI lesions (T2 and Gd + lesions)

Global impression on the disease course as reported by physician and patient using an adapted ‘Clinical Global Impression (CGI)’ scale: Severity Score (change from baseline) and Improvement Score (by descriptive statistics [mean, standard deviation])

Change from baseline in pharmacoeconomic outcomes as measured by ‘Work Productivity and Activity Impairment Questionnaire: Multiple Sclerosis (WPAI:MS)’