Table 3. Adverse events by preferred term regardless of relationship to study drug and by year of emergence (>15% of patients).
| Adverse events, n (%) | ≤12 months N = 112 |
13–24 months n = 101 |
25–36 months n = 100 |
37–48 months n = 91 |
49–60 months n = 52 |
|---|---|---|---|---|---|
| Stomatitis | 46 (41.1) | 9 (8.9) | 5 (5.0) | 5 (5.5) | 2 (3.8) |
| Nasopharyngitis | 36 (32.1) | 21 (20.8) | 20 (20.0) | 20 (22.0) | 6 (11.5) |
| Acne | 28 (25.0) | 8 (7.9) | 6 (6.0) | 2 (2.2) | 0 |
| Headache | 26 (23.2) | 11 (10.9) | 6 (6.0) | 4 (4.4) | 1 (1.9) |
| Hypercholesterolemia | 25 (22.3) | 13 (12.9) | 11 (11.0) | 7 (7.7) | 1 (1.9) |
| Aphthous stomatitis | 21 (18.8) | 15 (14.9) | 9 (9.0) | 5 (5.5) | 2 (3.8) |
| Fatigue | 19 (17.0) | 2 (2.0) | 4 (4.0) | 4 (4.4) | 2 (3.8) |
| Cough | 18 (16.1) | 4 (4.0) | 4 (4.0) | 3 (3.3) | 0 |
| Diarrhoea | 17 (15.2) | 7 (6.9) | 7 (7.0) | 4 (4.4) | 1 (1.9) |
| Mouth ulceration | 17 (15.2) | 6 (5.9) | 5 (5.0) | 2 (2.2) | 0 |
| Nausea | 17 (15.2) | 5 (5.0) | 2 (2.0) | 3 (3.3) | 0 |