Table 3.
Summary of safety
| Parameter | Value(s) at wk 104 |
||
|---|---|---|---|
| LA-EA (n = 44) | EA-EA (n = 45) | P | |
| No. (%) of patients with: | |||
| Any adverse event | 16 (36.4) | 15 (33.3) | 0.76 |
| Serious adverse event | 4 (9.1) | 5 (11.1) | 1.00 |
| Hepatocellular carcinoma | 0 | 2 (4.4) | 0.49 |
| Dose reduction of study medication | 1 (2.3) | 3 (6.7) | 0.62 |
| Discontinuation of study medication | 0 | 0 | NA |
| ALT flarea | 0 | 0 | NA |
| Increase in serum creatinineb | 1 (2.3) | 2 (4.4) | 1.00 |
| Mean ± SD serum creatinine (mg/dl) | 0.96 ± 0.21 | 0.91 ± 0.23 | 0.26 |
| Mean ± SD serum phosphorus (mg/dl) | 3.32 ± 0.46 | 3.34 ± 0.48 | 0.86 |
| Mean ± SD serum lactic acid (mmol/liter) | 1.50 ± 0.82 | 1.43 ± 0.74 | 0.70 |
a
ALT flare, ALT > 10 × ULN.
b
Increase in serum creatine, ≥0.5 mg/dl above baseline.