Table 3.
Adverse events during 30 days of intervention.a
| Event | Placebo N (%) | Bosentan N (%) |
|---|---|---|
| Headache | 7 (5) | 16 (12) |
| Dyspnea | 19 (15) | 13 (10) |
| Dizziness | 20 (15) | 11 (9) |
| Abnormal liver enzymes | 1 (0.7) | 7 (5) |
| Pneumonia | 15 (11) | 12 (9) |
| Diarrhea | 8 (6) | 9 (7) |
| Nausea/vomiting | 13 (10) | 15 (12) |
| Jaundice | 0 | 0 |
| Abdominal pain | 8 (6) | 9 (7) |
| Pulmonary Thromboembolism | 1 (0.7) | 0 |
| Cardiovascular event | 1 (0.7) | 0 |
| ARDS | 2 (1.5) | 0 |
| Asymptomatic deep vein thrombosisb | 8 (8) | 1 (1) |
ARDS; Acute Respiratory Distress Syndrome.
a
Some participants had multiple events.
b
It was 97 patients in the placebo group and 104 patients in the bosentan group.