Table 2.

The prognostic value of relapses for subsequent disability worsening

	Full dataset (n = 27 328)			Phase 3 trials (n = 8346)			Phase 3 placebo-controlled trials (n = 4970)
6-month CDW	HR	95% CI	P-value	HR	95% CI	P-value	HR	95% CI	P-value
ARR1	1.47	1.41, 1.55	<0.001	1.48	1.40, 1.57	<0.001	1.31	1.21, 1.41	<0.001
ARR2	1.38	1.29, 1.47	<0.001	1.37	1.25, 1.49	<0.001	1.17	1.03, 1.33	<0.019

n refers to the analysis set totals. The prognostic value of relapses was analysed using Andersen-Gill models. The annualized relapse rate (ARR) 1 (ARR₁) or 2 (ARR₂) years prior to time ‘t’ were used in separate models as time-varying covariates. The prognostic value of relapses was summarized with hazard ratios (hazard ratio >1 corresponds to an increased risk) for a 6-month CDW event. The ARR₁ is calculated as the cumulative number of relapses as reported by investigators in the year prior to time t and divided by 365.25 days if the patient has been observed for the full year. The ARR₂ is calculated analogously but for 2 years, i.e. 2 × 365.25 days. Andersen-Gill models, adjusting for additional covariates, are further described in the Supplementary material.