Table 2.
Number (%) of patients reporting common AEs (≥ 2% in any group) and biochemistry abnormalities (safety population)
| Preferred term | Vilda 100 mg qd/metformin 500 mg bid N = 456 n (%) | Metformin up to 1000 mg bid N = 458 n (%) |
| Any preferred term | 220 (48.2) | 237 (51.7) |
| Diarrhea | 21 (4.6) | 39 (8.5) |
| Headache | 18 (3.9) | 28 (6.1) |
| Nasopharyngitis | 15 (3.3) | 13 (2.8) |
| Back pain | 14 (3.1) | 18 (3.9) |
| Dizziness | 14 (3.1) | 16 (3.5) |
| Flatulence | 13 (2.9) | 8 (1.7) |
| Upper respiratory tract infection | 13 (2.9) | 10 (2.2) |
| Arthralgia | 11 (2.4) | 6 (1.3) |
| Hypertension | 11 (2.4) | 12 (2.6) |
| Nausea | 11 (2.4) | 22 (4.8) |
| Pharyngitis | 10 (2.2) | 12 (2.6) |
| Pain in extremity | 8 (1.8) | 10 (2.2) |
| Urinary tract infection | 8 (1.8) | 24 (5.2) |
| Dyspepsia | 7 (1.5) | 11 (2.4) |
| Influenza | 7 (1.5) | 11 (2.4) |
| Abdominal pain | 5 (1.1) | 12 (2.6) |
| Laboratory evaluation | ||
| Any notable abnormalitya | 14 (3.2) | 14 (3.2) |
| Alkaline phosphatase ≥ 3 × ULN | 0 (0.0) | 0 (0.0) |
| ALT (Alanine aminotransferase) ≥ 3 × ULN | 1 (0.2) | 1 (0.2) |
| AST (aspartate aminotransferase) ≥ 3 × ULN | 1 (0.2) | 2 (0.5) |
| Bilirubin (direct/conjugated) ≥ 3 × ULN | 0 (0.0) | 0 (0.0) |
| Blood Urea Nitrogen (BUN) ≥ 9.99 mmol/L | 9 (2.0) | 6 (1.4)b |
| Creatine phosphokinase (CPK) ≥ 5 × ULN | 1 (0.2) | 0 (0.0)b |
| Creatinine ≥ 176.8 μmol/L | 0 (0.0) | 0 (0.0)b |
| Potassium ≤ 3.0 or ≥ 6.0 mmol/Ll | 3 (0.7)c | 5 (1.1)b |
| Sodium ≤ 125 or ≥ 160 mmol/L | 1 (0.2) | 0 (0.0)b |
a
No. of patients with evaluable criterion in both categories is 441.
b
No. of patients with evaluable criterion is 437.
c
No. of patients with evaluable criterion is 440. AEs: Adverse events; ULN: Upper limits of normal.