Eligible trials were required to evaluate annualised relapse rate defined as the total number of relapses divided by the total person-time at risk of relapse. The mean age of the included patients ranged from 30 to 39 years and the mean duration of multiple sclerosis ranged from 0.9 to 8.3 years. Where reported, 60% to 74.9% of patients in the trials were female. the placebo group, giving a mean relapse rate, and then extrapolating to an annualized relapse rate by correcting for the time over which relapses were observed. When an adjusted rate was given, i.e. adjusted to age, sex or other parameters, as well as an unadjusted rate, the latter was preferred. Annualized relapse rates in patient subgroups defined by demographic factors and baseline disease characteristics: 1-year truncated analysis of fingolimod 0.5 mg patient group. ARRs and ARR ratios for fingolimod 0.5 mg versus comparators were estimated using a negative binomial regression model adjusted for study.

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