Table 5.
Summary of adverse drug reactions in three or more patients and serious adverse drug reactions in all patients reported during the 6-month follow-up period: safety set
| ADR type | Total (n = 175) |
|---|---|
| ADRs in three or more patients by preferred term | |
| Palpitations | 23 (13.1) |
| Headache | 19 (10.9) |
| Asthenia | 10 (5.7) |
| Diarrhea | 10 (5.7) |
| Abdominal pain | 5 (2.9) |
| Anemia | 5 (2.9) |
| Nausea | 5 (2.9) |
| Tachycardia | 5 (2.9) |
| Edema peripheral | 4 (2.3) |
| Tinnitus | 4 (2.3) |
| Myalgia | 3 (1.7) |
| Pruritus | 3 (1.7) |
| Rash | 3 (1.7) |
| Vertigo | 3 (1.7) |
| Serious ADRs in all patients by preferred term | |
| Hypertensive crisis | 2 (1.1)2 |
| Anemia | 1 (0.6) |
| Angina pectoris | 1 (0.6) |
| Cardiac failure | 1 (0.6) |
| Cerebrovascular accident | 1 (0.6)3 |
| Headache | 1 (0.6)2 |
| Palpitations | 1 (0.6) |
| Pulmonary arterial hypertension | 1 (0.6) |
ADR, adverse drug reaction.
One patient experienced both serious headache and serious hypertensive crisis.
One patient had two incidences of cerebrovascular accident.