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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