Table 3.
Summary of adverse events and laboratory abnormalities (safety population)
| TDF–TDF (N = 257) | ADV–TDF (N = 252) | |
|---|---|---|
| Any AE | 145 (56.4) | 130 (51.6) |
| Drug-related AEs | 18 (7.0) | 24 (9.5) |
| Discontinuation due to AE | 2 (0.8) | 1 (0.4) |
| Any serious AE | 12 (4.7) | 20 (7.9) |
| Deaths | 1 (0.4) | 0 |
| Frequent AEs (≥ 2% in any group) | ||
| Upper respiratory tract infection | 34 (13.2) | 25 (9.9) |
| Increase in alanine aminotransferase | 16 (6.2) | 8 (3.2) |
| Hepatic steatosis | 10 (3.9) | 11 (4.4) |
| Nasopharyngitis | 8 (3.1) | 8 (3.2) |
| Increase in blood CPK | 7 (2.7) | 8 (3.2) |
| Renal cyst | 6 (2.3) | 3 (1.2) |
| Nephrolithiasis | 5 (1.9) | 13 (5.2) |
| Hepatic pain | 5 (1.9) | 5 (2.0) |
| Asthenia | 4 (1.6) | 5 (2.0) |
| Decrease in blood phosphorus | 3 (1.2) | 5 (2.0) |
| Upper abdominal pain | 2 (0.8) | 6 (2.4) |
| Any grade 3 or 4 abnormality | 56 (21.8) | 51 (20.2) |
| Alanine aminotransferase | 19 (7.4) | 14 (5.6) |
| Aspartate aminotransferase | 10 (3.9) | 6 (2.4) |
| Prothrombin time | 10 (3.9) | 17 (6.7) |
| Creatine kinase | 6 (2.3) | 4 (1.6) |
| Neutrophils | 6 (2.3) | 4 (1.6) |
| Hemoglobin | 4 (1.6) | 5 (2.0) |
| Platelets | 4 (1.6) | 3 (1.2) |
| Sodium | 2 (0.8) | 0 |
| Phosphorus | 2 (0.8) | 3 (1.2) |
| Lymphocytes | 2 (0.8) | 3 (1.2) |
| Potassium | 1 (0.4) | 0 |
| Bilirubin | 1 (0.4) | 1 (0.4) |
| Glucose | 1 (0.4) | 2 (0.8) |
| Amylase | 1 (0.4) | 2 (0.8) |
Data are presented as n (%). ADV adefovir dipivoxil, AE adverse event, CPK creatine phosphokinase, TDF tenofovir disoproxil fumarate