Table 2.
Overall summary of adverse events.
| Placebo (n = 260) | Ubrogepant 100 mg (n = 256) | |
|---|---|---|
| Overall, n (%) | ||
| Any TEAEa | 118 (45.4) | 113 (44.1) |
| Any treatment-related TEAEa | 48 (18.5) | 55 (21.5) |
| SAEb | 1 (0.4) | 2 (0.8) |
| Death | 0 | 0 |
| AE leading to discontinuationc | 3 (1.2) | 0 |
| Common TEAEs ( ≥ 2%), n (%) | ||
| Headache | 25 (9.6) | 29 (11.3) |
| Oropharyngeal pain | 10 (3.8) | 15 (5.9) |
| Nasopharyngitis | 17 (6.5) | 14 (5.5) |
| Cough | 8 (3.1) | 10 (3.9) |
| Nausea | 11 (4.2) | 10 (3.9) |
| Dizziness | 4 (1.5) | 9 (3.5) |
| Diarrhea | 8 (3.1) | 8 (3.1) |
| Fatigue | 6 (2.3) | 6 (2.3) |
| Rhinorrhea | 11 (4.2) | 6 (2.3) |
| Nasal congestion | 6 (2.3) | 4 (1.6) |
| Vomiting | 7 (2.7) | 4 (1.6) |
AE: adverse event; TEAE: treatment-emergent adverse event; SAE: serious adverse event.
TEAEs were defined as events that initially occurred or increased in severity on or after the first dose of treatment. Events that occurred after the safety follow-up visit for participants with safety follow-up visit data or > 30 days after the last dose of treatment for participants without safety follow-up visit data were not considered to be treatment-emergent.
SAEs were defined as events that occurred between the treatment start date and the safety follow-up visit, or within 30 days after the last dose of treatment for participants without safety follow-up visit data.
Discontinuation events that occurred between the treatment start date and the safety follow-up visit, or within 30 days after the last dose of treatment for participants without safety follow-up visit data.