Table 5 Distribution of absolute numbers of drug-related adverse events between the two treatment groups in the 137 patients of the safety analysis
Intensity | All (n = 137) | ||||||
|---|---|---|---|---|---|---|---|
Frovatriptan (n = 133) | Rizatriptan (n = 130) | ||||||
Mild | Moderate | Severe | Mild | Moderate | Severe | ||
Asthenia | 3 | 5 | 2 | 1 | 4 | 1 | 16 |
Somnolence | 3 | – | – | – | 6 | 5 | 14 |
Dizziness | 1 | – | – | 2 | 4 | 1 | 8 |
Nausea or vomiting | – | – | 3 | – | 1 | – | 4 |
Throat tightness | 1 | – | – | 2 | 2 | 3 | 8 |
Pain increase | – | 1 | 3 | – | – | 2 | 6 |
Burning sensation to nose and forehead | 1 | 1 | 3 | – | 1 | – | 6 |
Palpitation or tachycardia | – | – | – | 2 | 2 | – | 4 |
Sensation of being dazed | 2 | 1 | – | – | 1 | – | 4 |
Instability or imbalance | – | – | – | 1 | 3 | – | 4 |
Abdominal pain | – | – | 1 | – | – | – | 1 |
Muscular or bone pain | – | 2 | – | – | – | – | 2 |
Thoracic constriction | – | – | – | – | 1 | – | 1 |
Tremor or shivers | – | – | – | 1 | 1 | – | 2 |
Other | 1 | 2 | 3 | – | 2 | 1 | 9 |
Total adverse events | 39 | 50 | 89 | ||||
Total patients (%) | 13 (9.8) | 15 (11.5) | 28 (20.4) | ||||