Table 3.
Adverse Events and Laboratory Abnormalities in Study Participants by Treatment Group
| Participants, No. (%) | |||||
|---|---|---|---|---|---|
| Pradefovir | |||||
| AEs and Abnormalities | TDF 300 mg (n = 48) | 30 mg (n = 48) | 45 mg (n = 48) | 60 mg (n = 48) | 75 mg (n = 48) |
| Any AE | 47 (98) | 46 (96) | 43 (90) | 43 (90) | 46 (96) |
| Death | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| SAE | 2 (4) | 3 (6) | 3 (6) | 4 (8) | 2 (4) |
| AE leading to drug discontinuation | 1 (2) | 1 (2) | 0 (0) | 0 (0) | 1 (2) |
| Grade 3 AE | 4 (8) | 4 (8) | 5 (10) | 4 (8) | 7 (15) |
| AEs occurring in ≥5% | |||||
| Upper respiratory tract infection | 7 (15) | 8 (17) | 8 (17) | 2 (4) | 7 (15) |
| Urinary tract infection | 0 (0) | 3 (6) | 5 (10) | 1 (2) | 1 (2) |
| Nausea | 5 (10) | 1 (2) | 0 (0) | 3 (6) | 1 (2) |
| Diarrhea | 1 (2) | 0 (0) | 0 (0) | 0 (0) | 3 (6) |
| Abdominal distention | 0 (0) | 1 (2) | 1 (2) | 2 (4) | 5 (10) |
| Abnormal liver function | 4 (8) | 3 (6) | 4 (8) | 5 (10) | 9 (19) |
| Malaise | 3 (6) | 0 (0) | 1 (2) | 1 (2) | 0 (0) |
| Laboratory abnormalities occurring in >5% | |||||
| Increased CK-MB | 26 (54) | 12 (25) | 14 (29) | 14 (29) | 17 (35) |
| Increased CK | 10 (21) | 8 (17) | 5 (10) | 5 (10) | 2 (4) |
| Hypophosphatemia | 2 (4) | 5 (10) | 2 (4) | 6 (13) | 5 (10) |
| Increased ALT | 3 (6) | 4 (8) | 0 (0) | 5 (10) | 6 (13) |
| Increased bilirubin | 5 (10) | 1 (2) | 0 (0) | 4 (8) | 5 (10) |
| Decreased neutrophil count | 2 (4) | 4 (8) | 1 (2) | 3 (6) | 4 (8) |
| Increased GGT | 1 (2) | 2 (4) | 3 (6) | 2 (4) | 9 (19) |
| Increased transaminase | 3 (6) | 3 (6) | 4 (8) | 3 (6) | 1 (2) |
| Increased AST | 1 (2) | 2 (4) | 0 (0) | 3 (6) | 4 (8) |
| Leukopenia | 1 (2) | 3 (6) | 1 (2) | 2 (4) | 3 (6) |
| Prolonged APTT | 1 (2) | 2 (4) | 0 (0) | 4 (8) | 0 (0) |
| Proteinuria | 4 (8) | 3 (6) | 4 (8) | 2 (4) | 1 (2) |
| Hematuria | 1 (2) | 3 (6) | 4 (8) | 1 (2) | 2 (4) |
| Urine erythrocytes | 4 (8) | 2 (4) | 1 (2) | 1 (2) | 0 (0) |
| Amylase increases | 2 (4) | 3 (6) | 0 (0) | 1 (2) | 2 (4) |
| Elevated blood uric acid | 4 (8) | 2 (4) | 2 (4) | 2 (4) | 1 (2) |
| Total bile acids increase | 0 (0) | 1 (2) | 4 (8) | 1 (2) | 1 (2) |
| Increased creatinine | 1 (2) | 1 (2) | 1 (2) | 1 (2) | 2 (4) |
Abbreviations: AE, adverse event; ALT, alanine aminotransferase; APTT, activated partial thromboplastin time; AST, aspartate aminotransferase; CK-MB, creatine kinase MB; GGT, γ-glutamyl transpeptidase; SAE, serious AE; TDF, tenofovir disoproxil fumarate.