Table 10 Percentage of patients in integrated double-blind studies with treatment-emergent high hepatic laboratory measures at any time^a

N = 1202

n (%)

N = 591

n (%)

N = 598

n (%)

ALT ≥3x ULN

4 (0.3)

1 (0.2)

2 (0.3)

ALT ≥5x ULN

0 (0.0)

1 (0.2)

1 (0.2)

ALT ≥10x ULN

0 (0.0)

1 (0.2)

0 (0.0)

N = 1274

n (%)

N = 635

n (%)

N = 636

n (%)

AST ≥3x ULN

1 (0.1)

1 (0.2)

1 (0.2)

AST ≥5x ULN

0 (0.0)

0 (0.0)

0 (0.0)

AST ≥10x ULN

0 (0.0)

0 (0.0)

0 (0.0)

N = 1295

n (%)

N = 648

n (%)

N = 658

n (%)

ALP ≥2x ULN

0 (0.0)

0 (0.0)

0 (0.0)

N = 1306

n (%)

N = 647

n (%)

N = 660

n (%)

TBIL ≥2x ULN

0 (0.0)

0 (0.0)

0 (0.0)