Table 5.
Most frequent adverse events in patients with background therapy
| Combination therapy: macitentan 10 mg + background therapy (N = 154) | Monotherapy: placebo + background therapy (N = 153a) | |
|---|---|---|
| Patients with at least one AE | 144 (93.5) | 149 (97.4) |
| Number (%) of patients with an AEb | ||
| Worsening of PAH | 35 (22.7) | 57 (37.3) |
| Edema peripheral | 30 (19.5) | 36 (23.5) |
| Anemia | 25 (16.2) | 7 (4.6) |
| URTI | 24 (15.6) | 27 (17.6) |
| RV failure | 22 (14.3) | 38 (24.8) |
| Headache | 21 (13.6) | 16 (10.5) |
| Diarrhea | 20 (13.0) | 15 (9.8) |
| Nasopharyngitis | 17 (11.0) | 16 (10.5) |
| Dizziness | 17 (11.0) | 22 (14.4) |
| Bronchitis | 17 (11.0) | 9 (5.9) |
| Cough | 12 (7.8) | 21 (13.7) |
| Dyspnea | 12 (7.8) | 16 (10.5) |
| Back pain | 6 (3.9) | 16 (10.5) |
Data are presented as n (%) Actelion unpublished data
For each preferred term, a patient is counted once if the patient reported one or more events in that category
AE adverse event, PAH pulmonary arterial hypertension, RV right ventricular, URTI upper respiratory tract infection
aOne patient randomized to placebo did not receive treatment
bAEs listed are those that occurred in more than 10% of the patients in either study group and are presented in descending order based on the frequency count in the “Combination therapy: macitentan + background therapy” group