Table 6.
Therapy week | 6 | 12 | 24 | 36 | 48 |
n | 55 | 51 | 48 | 38 | 28 |
Adverse events and infections | |||||
Adverse events, n (%) | 29 (52.7) | 18 (35.3) | 13 (27.1) | 20 (52.6) | 18 (64.3) |
Sweat, n (%) | 2 (3.6) | 0 | 2 (4.2) | 1 (2.6) | 1 (3.6) |
Dizziness, n (%) | 0 | 1 (2.0) | 0 | 1 (2.6) | 2 (7.1) |
Arthralgia, n (%) | 6 (10.1) | 6 (11.8) | 4 (8.3) | 5 (13.2) | 2 (7.1) |
Muscle cramps, n (%) | 0 | 0 | 1 (2.1) | 0 | 0 |
Loss of hair, n (%) | 1 (1.8) | 1 (2.0) | 2 (4.2) | 1 (2.6) | 1 (3.6) |
Skin itching, n (%) | 2 (3.6) | 3 (5.9) | 1 (2.1) | 1 (2.6) | 0 |
Headaches, n (%) | 4 (7.3) | 2 (3.9) | 1 (2.1) | 2 (5.3) | 2 (7.1) |
Restlessness, n (%) | 1 (1.8) | 0 | 0 | 0 | 0 |
Fatigue, n (%) | 3 (5.4) | 2 (3.9) | 0 | 2 (5.3) | 1 (3.6) |
Skin lesions, n (%) | 3 (5.4) | 1 (2.0) | 1 (2.1) | 4 (10.5) | 2 (7.1) |
Arterial hypertension, n (%) | 1 (1.8) | 0 | 0 | 2 (5.3) | 1 (3.6) |
Palpitations, n (%) | 1 (1.8) | 0 | 0 | 0 | 0 |
Eye problems, n (%) | 1 (1.8) | 1 (2.0) | 1 (2.1) | 0 | 0 |
Nausea, n (%) | 2 (3.6) | 1 | 0 | 1 (2.6) | 0 |
Diarrhoea, n (%) | 1 (1.8) | 0 | 0 | 0 | 0 |
Vomiting, n (%) | 1 (1.8) | 0 | 0 | 0 | 0 |
Infections, n (%) | 5 (9.1) | 5 (9.8) | 8 (16.7) | 0 | 6 (21.4) |
Tonsillitis, n (%) | 1 (1.8) | 0 | 0 | 0 | 0 |
Upper respiratory infection, n (%) | 2 (3.6) | 3 (5.9) | 6 (12.5) | 0 | 6 (21.4) |
Enteritis (salmonella), n (%) | 1 (1.8) | 0 | 0 | 0 | 0 |
Vaginal infection, n (%) | 1 (1.8) | 0 | 0 | 0 | 0 |
Cytomegalovirus infection, n (%) | 0 | 1 (2.0) | 0 | 0 | 0 |
Otitis externa, n (%) | 0 | 1 (2.0) | 1 (2.1) | 0 | 0 |
Fever of unknown origin, n (%) | 0 | 0 | 1 (2.1) | 0 | 0 |