Number of adverse drug reactions and number of patients with adverse drug reactions (including serum L-carnitine abnormality) till week 48
| Besifovir 90 mg (AE=127, n=36) | Besifovir 150 mg (AE=115, n=39) | Entecavir 0.5 mg (AE=53, n=39) | ||||
|---|---|---|---|---|---|---|
| Number of AE (%) | Number of patients (%) | Number of AE (%) | Number of patients (%) | Number of AE (%) | Number of patients (%) | |
| Blood and lymphatic system disorders | ||||||
| Anaemia | 1 (0.79) | 1 (2.78) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Cardiac disorders | ||||||
| Atrioventricular block first degree | 1 (0.79) | 1 (2.78) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Sick sinus syndrome | 1 (0.79) | 1 (2.78) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Ventricular extrasystoles | 2 (1.57) | 1 (2.78) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Gastrointestinal disorders | ||||||
| Abdominal pain upper | 0 (0) | 0 (0) | 2 (1.74) | 2 (5.13) | 0 (0) | 0 (0) |
| Dyspepsia | 1 (0.79) | 1 (2.78) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| General disorders | ||||||
| Chest discomfort | 0 (0) | 0 (0) | 1 (0.87) | 1 (2.56) | 0 (0) | 0 (0) |
| Face oedema | 1 (0.79) | 1 (2.78) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Investigations | ||||||
| ALT and AST increased | 0 (0) | 0 (0) | 1 (0.87) | 1 (2.56) | 1 (1.89) | 1 (2.56) |
| Blood CPK increased | 1 (0.79) | 1 (2.78) | 2 (1.74) | 2 (5.13) | 0 (0) | 0 (0) |
| ECG QT prolonged | 1 (0.79) | 1 (2.78) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Carnitine decreased | 40 (31.5) | 27 (75) | 53 (46.09) | 38 (97.44) | NA | NA |
| Carnitine increased | 1 (0.79) | 1 (2.78) | 3 (2.61) | 2 (5.13) | NA | NA |
| Nervous system disorders | ||||||
| Dizziness | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 1 (1.89) | 1 (2.56) |
| Paraesthesia | 1 (0.79) | 1 (2.78) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
AE, adverse events; ALT, alanine aminotransferase; AST, aspartate aminotransferase; CPK, creatine phosphokinase; NA, not applicable (carnitine level not checked in entecavir-treated patients); p, not significant for all groups and all parameters.