Table 2.
Overview of adverse events (AEs)
| All patients (N = 59) | 3 days 1000 mg/day (N = 30) | 5 days 1000 mg/day (N = 12) | No previous IVMP course (N = 22) | At least one IVMP course (N = 34) | EDSS < 3 (N = 15) | EDSS ≥ 3 (N = 11) | MSIP-FSS ≤ 15 (N = 28) | MSIP-FSS > 15 (N = 30) | |
|---|---|---|---|---|---|---|---|---|---|
| Patients with | |||||||||
| No AE | 2 (3.4 %) | 0 | 0 | 1 (4.5 %) | 1 (2.9 %) | 0 | 1 (9.1 %) | 2 (7.1 %) | 0 |
| One AE | 4 (6.8 %) | 2 (6.7 %) | 0 | 1 (4.5 %) | 3 (8.8 %) | 2 (13.3 %) | 0 | 4 (14.3 %) | 0 |
| 2 or more AEs | 53 (89.8 %) | 28 (93.3 %) | 12 (100 %) | 20 (91.0 %) | 30 (88.3 %) | 13 (86.7 %) | 10 (90.9 %) | 22 (78.6 %) | 30 (100 %) |
| AEs per patient | |||||||||
| Median | 4 | 4 | 7 | 5 | 4 | 5 | 4 | 4 | 5 |
| Range | 0–12 | 1–11 | 2–12 | 0–12 | 0–12 | 1–12 | 0–9 | 0–12 | 2–11 |
| Total number of AEs | 306 | 153 | 85 | 118 | 176 | 83 | 47 | 135 | 169 |
| Severe AEs | 105 (34.3 %) | 49 (32.0 %) | 23 (27.1 %) | 47 (39.8 %) | 56 (31.8 %) | 13 (15.7 %) | 21 (44.7 %) | 44 (32.6 %) | 61 (36.1 %) |
| Bothering AEs | 79 (25.8 %) | 37 (24.2 %) | 20 (23.5 %) | 33 (28.0 %) | 45 (25.6 %) | 12 (14.4 %) | 15 (31.9 %) | 34 (25.2 %) | 45 (26.6 %) |
| AEs with impact on ADL | 116 (37.9 %) | 52 (34.0 %) | 36 (42.4 %) | 50 (42.4 %) | 66 (37.5 %) | 27 (32.5 %) | 18 (38.3 %) | 51 (37.8 %) | 65 (38.5 %) |
IVMP intravenous methylprednisolone, EDSS expanded disability status scale score, MSIP-FSS multiple sclerosis impact profile-functions and specific symptoms score