Table 3.
Adverse events
| FIN (n = 184), n (%) | NTZ (n = 130), n (%) | |
|---|---|---|
| AEs reported over the observation period for the first dose of the 2nd-line treatment1 | ||
| Patients with, at least, one AE | 2 (1.1) | 5 (3.8) |
| Total number of AEs2 | 2 | 6 |
| Infusion reaction | 0 (0.0) | 2 (33.3) |
| First-degree atrioventricular block | 1 (50.0) | 0 (0.0) |
| Other | 1 (50.0) | 4 (66.7) |
| AEs reported throughout the study, since 2nd-line treatment initiation3 | ||
| Patients with, at least, one AE | 41 (22.8) | 20 (15.4) |
| Total number of AEs2, 4 | 55 | 49 |
| Infection | 13 (23.6) | 28 (57.1) |
| Increased liver enzymes | 7 (12.7) | 2 (4.1) |
| Lymphopenia (<200 lymphocytes/µL) | 3 (5.4) | 0 (0.0) |
| Infusion reaction | 0 (0.0) | 2 (4.1) |
| 3Symptomatic bradycardia | 0 (0.0) | 1 (2.0) |
| Macular edema | 2 (3.6) | 0 (0.0) |
| Immune reconstitution inflammatory syndrome | 1 (1.8) | 0 (0.0) |
| Other | 30 (54.5) | 16 (32.6) |
More than one AE could be reported by the same patient.
1
AEs reported the same day or the day after the first dose administration (at the beginning of the treatment or once the treatment had been reintroduced after a temporal treatment interruption).
2
Percentages calculated over the total number of AEs in each group.
3
AEs reported over the observation period for the first dose have been excluded.
4
Differences between groups not statistically significant, except for “Infection” (p = 0.0005) and “Other” (p = 0.0248).
AEs, adverse events; FIN, fingolimod; NTZ, natalizumab.