Table 2 Adverse events
No. (%) | Entire cohort (n = 39) | GT1b without cirrhosis (no RBV) (n = 27) | GT1b with cirrhosis/ GT1a (with RBV) (n = 12) | P value |
|---|---|---|---|---|
Patients with at least one AE | 15 (38.5%) | 7 (25.9%) | 8 (66.7%) | 0.031 |
Total number of AEs | 25 | 13 | 12 | – |
Patients with any serious AE | 7 (17.9%) | 4 (14.8%) | 3 (25.0%) | 0.654 |
Patients with any common AE | 12 (30.8) | 6 (22.2) | 6 (50.0) | 0.133 |
Early termination due to AE | 2 (5.1%) | 1 (3.7%) | 1 (8.3%) | 0.526 |
Serious AE | ||||
Psychiatric admission | 3 (7.7%) | 1 (3.7%) | 2 (16.7%) | 0.219 |
Pneumonia (admission) | 1 (2.6%) | 0 (0.0%) | 1 (8.3%) | 0.308 |
Ankle fracture | 1 (2.6%) | 1 (3.7%) | 0 (0.0%) | 1.000 |
Palpitations | 2 (5.1%) | 2 (7.4%) | 0 (0.0%) | 1.000 |
Common AE | ||||
Weakness | 8 (20.5%) | 4 (14.8%) | 4 (33.3%) | 0.221 |
Leg oedema | 2 (5.1%) | 1 (3.7%) | 1 (8.3%) | 0.526 |
Rash | 2 (5.1%) | 1 (3.7%) | 1 (8.3%) | 0.526 |
Diarrhoea | 1 (2.6%) | 1 (3.7%) | 0 (0.0%) | 1.000 |
Anaemia | 2 (5.1%) | 2 (16.7%) | 0 (0.0%) | 0.089 |