Table 3 TEAEs reported by ≥5% of patients in either group during the comparative phase (safety population)
Adverse event | Number of patients (%) | |
|---|---|---|
IFNβ-1a (N= 65) | IFNβ-1b (N= 64) | |
Influenza-like illness | 20 (30.8) | 18 (28.1) |
Headache | 17 (26.2) | 16 (25.0) |
Injection-site reaction | 18 (27.7) | 9 (14.1) |
Injection-site erythema | 8 (12.3) | 8 (12.5) |
Depression | 4 (6.2) | 8 (12.5) |
Fatigue | 3 (4.6) | 9 (14.1) |
Urinary tract infection | 7 (10.8) | 5 (7.8) |
Extremity pain | 6 (9.2) | 6 (9.4) |
Nausea | 7 (10.8) | 3 (4.7) |
Insomnia | 5 (7.7) | 5 (7.8) |
Injection-site pain | 4 (6.2) | 5 (7.8) |
Alanine aminotransferase increased | 8 (12.3) | 1 (1.6) |
Back pain | 4 (6.2) | 4 (6.3) |
Dizziness | 2 (3.1) | 6 (9.4) |
Muscle spasms | 5 (7.7) | 3 (4.7) |
Pain | 4 (6.2) | 3 (4.7) |
Diarrhea | 2 (3.1) | 5 (7.8) |
Chills | 5 (7.7) | 2 (3.1) |
Influenza | 5 (7.7) | 2 (3.1) |
Injection-site bruising | 5 (7.7) | 2 (3.1) |
Serum ferritin increased | 6 (9.2) | 0 |
Liver-function test abnormal | 5 (7.7) | 0 |