Table 3. Most Common TEAEs Occurring in ≥20% of Patients and TEAEs of Special Interest.
| Eventa | Patients, No. (%) | ||
|---|---|---|---|
| IFNβ-1a (n = 72) | DMF (n = 78) | Total (N = 150) | |
| TEAEb | |||
| MS relapse | 33 (45.8) | 27 (34.6) | 60 (40.0) |
| Headache | 26 (36.1) | 22 (28.2) | 48 (32.0) |
| Influenza-like illness | 37 (51.4) | 2 (2.6) | 39 (26.0) |
| Abdominal pain | 5 (6.9) | 32 (41.0) | 37 (24.7) |
| Flushing | 1 (1.4) | 30 (38.5) | 31 (20.7) |
| TEAE of special interestb | |||
| Flushing or other related symptom | 1 (1.4) | 30 (38.5) | 31 (20.7) |
| GI tolerabilityc | 22 (30.6) | 58 (74.4) | 80 (53.3) |
| Hepatic disorder | 1 (1.4) | 1 (1.3) | 2 (1.3) |
| Infection or infestation | 30 (41.7) | 41 (52.6) | 71 (47.3) |
| Vascular disorder | 5 (6.9) | 36 (46.2) | 41 (27.3) |
| Leukopenia | 0 | 0 | 0 |
| Lymphopenia | 0 | 2 (2.6) | 2 (1.3) |
| Malignant neoplasm | 0 | 0 | 0 |
| Kidney disorder | 7 (9.7) | 4 (5.1) | 11 (7.3) |
Abbreviations: DMF, dimethyl fumarate; GI, gastrointestinal; IFNβ-1a, interferon β-1a; MS, multiple sclerosis; TEAE, treatment-emergent adverse event.
a
There were no deaths during the trial.
b
Patients can appear in more than 1 category.
c
GI tolerability included nausea, abdominal pain, diarrhea, and other conditions.