Table 5

- Fingolimod complications reported during study of monitored patients.

ComplicationNumber of patients affected
Bradycardia with first dose18 out of 113 monitored patients
Macular edema4 out of 22 monitored patients
InfectionUrinary tract infection4 out of 12 monitored patients
Liver enzyme elevation
AST (Mean ± SD) (U/L) 87±99.1
ALT (Mean ± SD) (U/L) 158±163.4
Total bilirubin (Mean ± SD) (ummol/l) 11.5±11.3
6 out of 77 monitored patients