Adverse events.
| Event | All Patients, N = 127 n (%) |
|---|---|
| Any adverse event | 81 (63.8) |
| Mild adverse event | 55 (43.3) |
| Moderate adverse event | 38 (29.9) |
| Severe adverse event | 5 (3.9) |
| Serious adverse event | 3 (2.4) |
| Infection or infestation | 23 (18.1) |
| Adverse event leading to withdrawal | 1 (0.8) |
| Individual adverse event with > 4% incidence | |
| Upper respiratory tract infection | 6 (4.7) |
| Headache | 6 (4.7) |
Mild adverse event: transient and easily tolerated by the patient; moderate adverse event: causes patient discomfort and interrupts the patient’s usual activities; severe adverse event: causes considerable interference with patient’s usual activities and may be incapacitating or life-threatening.