Table 4.
Patients with at least one AE of specific interest, safety population, Study-T (>5 years)
| Patients N (%) |
ASAQ |
AL |
p-value |
|---|---|---|---|
| N = 496 | N = 502 | ||
| AEs “possibly related to study drug” |
382 (77.0) |
348 (69.3) |
0.006 |
| AEs ≥ grade 3 |
17 (3.4) |
8 (1.6) |
0.064 |
| Fatigue (pooled) ** |
200 (39.8) |
81 (16.3) |
<0.001 |
| Abdominal pain |
29 (5.8) |
18 (3.6) |
0.091 |
| Diarrhoea |
20 (4.0) |
14 (2.8) |
0.279 |
| Vomiting |
35 (7.1) |
8 (1.6) |
<0.001 |
| Vomiting after drug intake |
2 (0.4) |
0 |
0.247* |
| Nausea |
16 (3.2) |
5 (1.0) |
0.015* |
| Hepatotoxicity *** |
23 (4.6) |
31 (6.3) |
0.283 |
| Rash |
4 (0.8) |
0 |
0.061* |
| Itching |
0 |
0 |
- |
| Abnormal movements (Dystonia) |
0 |
0 |
- |
| Neutropaenia |
94 (19.0) |
110 (21.9) |
0.246 |
| Anaemia |
74 (14.9) |
49 (9.8) |
0.013 |
| Thrombocytopaenia | 4 (0.8) | 0 | 0.061* |
AE adverse event; * Fisher exact test; ** Frequencies of reported PTs “weakness”, “fatigue” and “asthenia” were pooled; *** defined as any or combination of the following AEs: hepatitis, hepatomegaly, AST and/or ALT increased, jaundice.