Safety of cladribine tablets in the treatment of patients with multiple sclerosis: An integrated analysis

•Integrated safety of cladribine tablets from Phase 3 trials & PREMIERE is reported.•A Monotherapy Oral cohort and an All Exposed cohort were evaluated.•Most TEAEs (mainly lymphopenia) were expected with cladribine due to mode of action.•No increased risk for infections with cladribine tablets except for herpes zoster.•There was no increase in malignancy rates for cladribine in patients with MS.