Table 1.

Patient demographic and baseline clinical characteristics, previous treatment with DMTs and type of first-dose monitoring in the overall population and subgroups (enrolled population)

	Fingolimod 0.5 mg (n = 2,417)
Female, n (%)	1,773 (73.4)
Age groups, years, n (%)
18–30	552 (22.8)
31–40	804 (33.3)
41–55	981 (40.6)
56–65	80 (3.3)
Duration of MS since first symptom, years, mean ± SD	9.3 ± 6.9
Number of relapses in past year, mean ± SD	1.1 ± 1.1
EDSS score, mean ± SD	2.4 ± 1.5
History of macular edema, n (%)	2 (0.1)
History of uveitis, n (%)	25 (1.0)
History of optic neuritis, n (%)	1,022 (42.3)
Patients with diabetes mellitus, n (%)	26 (1.1)
Previously treated with DMTs, n (%)	2,054 (85)
Any interferon β	1,699 (70.3)
Other interferons	636 (26.3)
Glatiramer acetate	747 (30.9)
Natalizumab	254 (10.5)
Azathioprine	86 (3.6)
Methotrexate	6 (0.2)
Other MS medications	123 (5.1)
Patients monitored on-site, n (%)a	1,221 (50.5)
Patients with PCCs, n (%)	296 (12.2)
Patients with PCCs who were monitored on-site, n (%)	271 (11.2)
Patients receiving concomitant treatment with BBs/CCBs, n (%)	120 (5.0)
Patients receiving concomitant treatment with BBs/CCBs who were monitored on-site, n (%)	78 (3.2)

BBs beta blockers, CCBs calcium channel blockers, DMT disease-modifying therapy, EDSS Expanded Disability Status Scale, MS multiple sclerosis, PCCs pre-existing cardiac conditions or baseline cardiac findings, SD standard deviation

^aTwo of these patients did not receive study drug and were, therefore, not included in the safety set