Abstract:BackgroundThis analysis updates on the previously reported serious treatment emergent adverse event (TEAE) profile of cladribine tablets (CT) 10mg (cumulative dose 3.5mg/kg [CT3.5] over 2 years) following integration of final data from the PREMIERE registry and post-approval safety data from worldwide sources.MethodsThe monotherapy oral cohort (CT3.5, N=923, patient-years [PY]=3936.69; placebo, N=641, PY=2421.47) was derived from the CLARITY, CLARITY Extension and ORACLE-MS trials plus the PREMIERE registry. A… Show more
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