Table 2.
Adverse events by year after initiating fingolimod treatment
| Adverse event | Year 1 | Year 2 | Year 3 | Total by AE |
|---|---|---|---|---|
| N (%) | N (%) | N (%) | N (%) | |
| Opportunistic infections | 2 (0.7) | 3 (1.1) | 1 (0.4) | 9 (3.3)a |
| Grade 4 lymphopenia (< 200 cells/μl) | 8 (2.9) | 3 (1.1) | 0 (0.0) | 11 (4.0) |
| Hepatic enzymes > 3 × ULN | 5 (1.8) | 2 (0.7) | 0 (0.0) | 8 (2.9)a |
| Hepatic enzymes > 5 × ULN | 1 (0.4) | 0 (0.0) | 0 (0.0) | 1 (0.4) |
| Hypertension | 0 (0.0) | 1 (0.4) | 1 (0.4) | 2 (0.7) |
| Elevation of blood pressure | 0 (0.0) | 2 (0.7) | 0 (0.0) | 2 (0.7) |
| Disease activity (relapses, progression) | 9 (3.3) | 2 (0.7) | 3 (1.1) | 15 (5.5)a |
| Headaches | 3 (1.1) | 0 (0.0) | 0 (0.0) | 3 (1.1) |
| Other | 8 (2.9) | 2 (0.7) | 0 (0.0) | 10 (3.6) |
| Total by year | 36 (13.1) | 15 (5.5) | 5 (1.9) |
N, number of patients; %, percentage of total; ULN, upper limit of normal
aThree opportunistic infections, one hepatic enzymes > 3 × ULN and one disease activity could not be assigned to a specific year given the dates are lacking