Table 6.
Adverse reactions | Prostanoid-naïve n = 6 (21.4%) | Transition n = 22 (78.6%) | Overall n = 28 |
---|---|---|---|
Total adverse events | 22 | 59 | 81 |
Gastrointestinal | 13 | 32 | 45 |
Abdominal pain | 2 | 2 | 4 |
Decreased appetite | 0 | 4 | 4 |
Diarrhea | 4 | 8 | 12 |
Nausea | 3 | 9 | 12 |
Vomiting | 2 | 9 | 11 |
Reflux | 2 | 0 | 2 |
Neurologic | 3 | 12 | 15 |
Headache | 3 | 9 | 12 |
Facial numbness | 0 | 1 | 1 |
Altered mood | 0 | 2 | 2 |
Cardiovascular | 3 | 7 | 10 |
Chest pain | 1 | 1 | 2 |
Flushing | 1 | 2 | 3 |
Hypotension | 0 | 1 | 1 |
Tachycardia with exercise | 0 | 1 | 1 |
Dizziness | 1 | 1 | 2 |
Pre-syncope | 0 | 1 | 1 |
Respiratory | 2 | 5 | 7 |
Shortness of breath | 1 | 1 | 2 |
Decreased exercise tolerance | 0 | 2 | 2 |
Decreased oxygen saturation | 1 | 2 | 3 |
Musculoskeletal | 1 | 3 | 4 |
Jaw pain | 0 | 1 | 1 |
Leg pain | 0 | 1 | 1 |
Back pain | 1 | 1 | 2 |
Adverse reaction per patient (n (%)) | |||
0 | 1 (16.6) | 6 (27.2) | 7 (25) |
1 | 0 (0) | 3 (13.6) | 3 (10.7) |
2 | 0 (0) | 4 (18.2) | 4 (14.3) |
3–5 | 4 (66.8) | 6 (27.2) | 10 (35.7) |
6–9 | 1 (16.6) | 3 (13.6) | 4 (14.3) |
Number of adverse reactions by organ system that occurred during initial study period through 1 June 2017; includes initiation, transition, and maintenance.