Elevated ALT/AST > 3 x ULN by DoseSafety Database

2000

PAH (%)

CHF

HTN

All

—

4.2

10.0

6.9

—

15.8

11.4

14.5

12.7

13.8

6.9

11.2

All

250/500

1000/1500

12.7

—

4.3

10.9

100

—

—

2.1

2.1

Bosentan Dose (mg/d)

Incidence on placebo was approximately 2%

Database

9090.01

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