Treatment-emergent AEs8 Placebo-controlled Studies

Flushing (%)

Leg edema / edema

Abnormal hepatic func

Headache

Anemia

% with ? 1 AE

Placebo

(N = 288)

1.7

2.7

2.1

12.8

1.0

76.4

With a placebo-subtracted difference of ? 2%

6.6

7.4

5.9

15.8

3.4

78.1

Bosentan

(N = 677)

4.9

4.6

3.8

3.0

2.4

1.7

Placebo-subtracted

9058.01

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