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Table 3 Adverse events

From: Early treatment with ambrisentan of mildly elevated mean pulmonary arterial pressure associated with systemic sclerosis: a randomized, controlled, double-blind, parallel group study (EDITA study)

Event

Placebo

(N = 19)

Ambrisentan

(N = 19)

Number of patients (percent)

Patient with at least 1 adverse event

17 (89.5)

17 (89.5)

Headache

6 (31.58)

6 (31.58)

Edema

4 (21.05)

8 (42.11)

Dizziness

6 (31.58)

0 (0)†

Diarrhea

2 (10.53)

4 (21.05)

Nausea

3 (15.79)

2 (10.53)

Paresthesia

0 (0)

4 (21.05)

Coronary artery disease

3 (15.79)

1 (5.26)

Hypotension

2 (10.53)

2 (10.53)

Epistaxis

1 (5.26)

3 (15.79)

Serious adverse events*

 Lower jaw fracture

0

1

 Angina Pectoris

1

0

 Coronary artery disease

1

0

 Gastrointestinal infection

1

0

 Lymphangitis

1

0

 Raynaud

1

0

  1. The adverse events listed here are those that occurred in at least 10% of patients (total) during the course of the study
  2. †Statistically significant at level 0.05
  3. *All serious adverse events fulfilled the criterion of hospitalization