Table 3 Adverse events (AEs) reported during the 12-week study (safety population).
Patients, n (%) (n = 106) | Events, n (%) (n = 193) | |
|---|---|---|
Treatment-emergent AE | ||
Any | 67 (63.2) | 193 (100.0) |
Influenza-like illness* | 22 (20.8) | 54 (28.0) |
Headache* | 12 (11.3) | 25 (13.0) |
Severity of treatment-emergent AEs | ||
Mild | 43 (40.6) | 96 (49.7) |
Moderate | 35 (33.0) | 73 (37.8) |
Severe | 14 (13.2) | 24 (12.4) |
Prespecified AEs | ||
Any | 32 (30.2) | 74 (38.3) |
'Flu-like' symptoms | 22 (20.8) | 54 (28.0) |
Cytopenia | 5 (4.7) | 9 (4.7) |
Injection-site reactions | 4 (3.8) | 8 (4.1) |
Hypersensitivity | 2 (1.9) | 3 (1.6) |
Rash (pruritus) | 1 (0.9) | 2 (1.0) |
Serious AEs | ||
Any | 3 (2.8) | 6 (3.1) |
Myocardial infarction | 1 (0.9) | 1 (0.5) |
Adverse drug reaction | 1 (0.9) | 1 (0.5) |
Biliary colic | 1 (0.9) | 1 (0.5) |
Breast infection | 1 (0.9) | 1 (0.5) |
Seroma | 1 (0.9) | 1 (0.5) |
Hypertensive crisis | 1 (0.9) | 1 (0.5) |